FORACORT Inhaler (Formoterol fumarate dihydrate + Budesonide)

Table of Content

For the use of Registered Medical Practitioner or a Hospital or a Laboratory only

Quantitative and Qualitative Composition

FORACORT FORTE Inhaler

Each actuation contains:

Formoterol fumarate dihydrate IP …....12 mcg

Budesonide IP ..............400 mcg

Suspended in propellant HFA 134a…q.s.

Dosage Form and Strength

Inhalation Aerosol that contains Formoterol fumarate dihydrate 12 mcg and Budesonide 400 mcg

Clinical Particulars

Therapeutic Indications

Asthma

FORACORT FORTE Inhaler is indicated in the regular treatment of asthma where use of combination of inhaled regular corticosteroid & long acting beta2-agonist is appropriate

Important Limitations of Use

FORACORT FORTE Inhaler is NOT indicated for the relief of acute bronchospasm.

Chronic Obstructive Pulmonary Disease (COPD)

FORACORT FORTE Inhaler is indicated in patients with moderate to severe COPD with frequent symptoms and a history of exacerbations

Posology and Method of Administration

Route of administration: For inhalation use

Asthma

FORACORT FORTE Inhaler is not intended for the initial management of asthma. The dosage of the components of FORACORT FORTE Inhaler is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the maintenance dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhalers, appropriate doses of beta2-agonists and/or corticosteroids by individual inhalers should be prescribed.

Recommended doses:

Adults (18 years and older):

1 inhalation twice daily. Some patients may require up to a maximum of 2 inhalations twice daily.

Adolescents (12-17 years):

1 inhalation twice daily.

Pediatric Population

Efficacy and safety have not been fully studied in children 12 years and younger and adolescents, 13 to 17 years of age. FORACORT FORTE Inhaler is not recommended for children under 12 years of age.

Patients should be regularly reassessed by their health care provider, so that the dosage of FORACORT FORTE Inhaler remains optimal. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. When control of symptoms is maintained with the lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone.

In usual practice when control of symptoms is achieved with the twice daily regimen, titration to the lowest effective dose could include FORACORT FORTE Inhaler given once daily, when in the opinion of the prescriber, a long-acting bronchodilator would be required to maintain control.

Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.

Children under 12 years

Efficacy and safety have not been fully studied in children. FORACORT FORTE Inhaler is not recommended for children under 12 years of age.

FORACORT FORTE Inhaler should be used as formoterol/budesonide maintenance therapy only. Lower strengths are available for the formoterol/budesonide maintenance and reliever therapy regimen.

COPD

Recommended doses:

Adults:

1 inhalation twice daily.

FORACORT FORTE Inhaler may be used with a Zerostat/Zerostat VT Spacer devicein patients who find it difficult to synchronize aerosol actuation with inspiration of breath.

Special Populations:

Elderly patients (≥65 years old)

There are no special dosing requirements for elderly patients.

Patients with Renal or Hepatic Impairment

There are no data available for use of a fixed-dose combination of budesonide and formoterol fumarate dihydrate in patients with hepatic or renal impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver cirrhosis.

Method of administration

Instructions for correct use of FORACORT FORTE Inhaler:

Administration Information

  • FORACORT FORTE Inhaler should be administered as 1 inhalation twice daily (morning and evening, approximately 12 hours apart), every day by the orally inhaled route only. Some patients may require up to a maximum of 2inhalations twice daily.
  • After inhalation, the patient should rinse the mouth with water without swallowing.
  • More frequent administration or a higher number of inhalations (more than 2 inhalations twice daily) of the prescribed strength of FORACORT FORTE Inhaler is not recommended as some patients are more likely to experience adverse effects with higher doses of formoterol.
  • Patients using FORACORT FORTE Inhaler should not use additional LABA for any reason.

Note: It is important to instruct the patient

  • To carefully read the instructions for use in the patient information leaflet which is packed together with each FORACORT FORTE Inhaler.
  • To rinse their mouth out with water after inhaling the maintenance dose to minimise the risk of oropharyngeal thrush.

Inhaler.

Contraindications

  • Hypersensitivity (allergy) to budesonide or formoterol
  • Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.

Special Warnings and Precautions for Use

It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly.

Asthma-Related Death

LABA, such as formoterol, one of the active ingredients in FORACORT FORTE Inhaler, increase the risk of asthma-related death. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, FORACORT FORTE Inhaler should only be used for patients not adequately controlled on a long-term asthma-control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue FORACORT FORTE Inhaler if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use FORACORT FORTE Inhaler for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

Deterioration of Disease and Acute Episodes

FORACORT FORTE Inhaler should not be initiated in patients during rapidly deteriorating or potentially life threatening episodes of asthma or COPD. The fixed dose combination of budesonide and formoterol fumarate dihydrate has not been studied in patients with acutely deteriorating asthma or COPD. The initiation of FORACORT FORTE Inhaler in this setting is not appropriate.

Increasing use of inhaled, short-acting beta -agonists is a marker of deteriorating asthma. In this situation, the patient requires immediate re-evaluation with reassessment of the treatment regimen, giving special consideration to the possible need for replacing the current strength of FORACORT FORTE Inhaler with a higher strength, adding additional inhaled corticosteroid, or initiating systemic corticosteroids.

Patients should not use more than 2 inhalations twice daily (morning and evening) of FORACORT FORTE Inhaler. FORACORT FORTE Inhaler should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short-acting beta -agonist, not FORACORT FORTE Inhaler, should be used to relieve acute symptoms such as shortness of breath.

When beginning treatment with FORACORT FORTE Inhaler, patients who have been taking oral or inhaled, short acting beta -agonists on a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs.

The prophylactic use of FORACORT FORTE Inhaler e.g. before exercise, has not been studied. The reliever inhalations of FORACORT FORTE Inhaler should be taken in response to symptoms but are not intended for regular prophylactic use, e.g. before exercise. For such, a separate rapid-acting bronchodilator should be considered

Asthma Control

Regular review of patients as treatment is stepped down is important.

Patients should not be initiated on FORACORT FORTE Inhaler during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.

Serious asthma-related adverse events and exacerbations may occur during treatment with formoterol/budesonide combination. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with formoterol/budesonide combination therapy.

As with other inhalation therapy, paradoxical bronchospasm may occur, with an immediate increase in wheezing and shortness of breath after dosing. If the patient experiences paradoxical bronchospasm FORACORT FORTE Inhaler should then be discontinued; treatment should be assessed and alternative therapy instituted if necessary. Paradoxical bronchospasm responds to a rapid-acting inhaled bronchodilator and should be treated straightaway.

Excessive Use of FORACORT FORTE and Use with Other Long-Acting Beta2-Agonists

As with other inhaled drugs containing beta -adrenergic agents, FORACORT FORTE should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medications containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using FORACORT FORTE should not use an additional LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate) for any reason, including prevention of exercise-induced bronchospasm (EIB) or the treatment of asthma or COPD.

Serious Asthma-Related Events – Hospitalizations, Intubations and Death

Use of long-acting beta -adrenergic agonist (LABA) as monotherapy (without inhaled corticosteroids ) for asthma is associated with an increased risk of asthma related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA. When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to ICS alone.

Local Effects

In clinical studies, the development of localized infections of the mouth and pharynx with Candida albicans has occurred in patients treated with budesonide/formoterol combination. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral antifungal) therapy while treatment with budesonide/formoterol combination continues, but at times therapy with budesonide/formoterol combination may need to be interrupted. Advise the patient to rinse his/her mouth with water without swallowing following inhalation to help reduce the risk of oropharyngeal candidiasis.

Systemic Effects

Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur with inhalation treatment than with oral corticosteroids. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma, and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be re-evaluated with the aim of reducing the dose of inhaled corticosteroid. The benefits of the corticosteroid therapy and the possible risks of growth suppression must be carefully weighed. In addition consideration should be given to referring the patient to a paediatric respiratory specialist.

Limited data from long-term studies suggest that most children and adolescents treated with inhaled budesonide will ultimately achieve their adult target height. However, an initial small but transient reduction in growth (approximately 1cm) has been observed. This generally occurs within the first year of treatment.

Visual Disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Glaucoma and Cataracts

Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with asthma and COPD following the long-term administration of inhaled corticosteroids, including budesonide, a component of FORACORT FORTE Inhaler. Therefore, close monitoring is warranted in patients with a change in vision or with history of increased intraocular pressure, glaucoma, and/or cataracts.

Eosinophilic Conditions and Churg-Strauss Syndrome

In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic conditions. Some of these patients have clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction and/or withdrawal of oral corticosteroid therapy following the introduction of inhaled corticosteroids. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal relationship between budesonide and these underlying conditions has not been established.

Effects on Bone Density

Potential effects on bone should be considered, particularly in patients on high doses for prolonged periods that have co-existing risk factors for osteoporosis. Long-term studies with inhaled budesonide in children at mean daily doses of 400 mcg (metered dose) or in adults at daily doses of 800 mcg (metered dose) have not shown any significant effects on bone mineral density. No information regarding the effect of formoterol/budesonide at higher doses is available.

Adrenal Function

If there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy, care should be taken when transferring patients to formoterol/budesonide fixed-dose combination therapy.

The benefits of inhaled budesonide therapy would normally minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time. Recovery may take a considerable amount of time after cessation of oral steroid therapy and hence oral steroid-dependent patients transferred to inhaled budesonide may remain at risk from impaired adrenal function for some considerable time. In such circumstances hypothalamic pituitary adrenocortical (HPA) axis function should be monitored regularly.

Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with FORACORT FORTE Inhaler should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients, particularly when budesonide is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of FORACORT FORTE Inhaler should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms.

High Dose Corticosteroids

Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than recommended doses, may also result in clinically significant adrenal suppression. Therefore additional systemic corticosteroid cover should be considered during periods of stress such as severe infections or elective surgery. Rapid reduction in the dose of steroids can induce acute adrenal crisis. Symptoms and signs which might be seen in acute adrenal crisis may be somewhat vague but may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, decreased level of consciousness, seizures, hypotension and hypoglycaemia.

Treatment with supplementary systemic steroids or inhaled budesonide should not be stopped abruptly.

Transfer from Oral Therapy

During transfer from oral therapy to formoterol/budesonide combination therapy, a generally lower systemic steroid action will be experienced which may result in the appearance of allergic or arthritic symptoms such as rhinitis, eczema and muscle and joint pain. Specific treatment should be initiated for these conditions. A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting should occur. In these cases a temporary increase in the dose of oral glucocorticosteroids is sometimes necessary.

Immunosuppression

Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. If chicken pox develops, treatment with antiviral agents may be considered. The immune responsiveness to varicella vaccine was evaluated in pediatric patients with asthma ages 12 months to 8 years with budesonide inhalation suspension. Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

Transferring Patients from Systemic Corticosteroid Therapy

Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of HPA function.

Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Although formoterol/ budesonide combination may provide control of asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of glucocorticoid systemically and does NOT provide the mineralocorticoid activity that is necessary for coping with these emergencies.

During periods of stress, a severe asthma attack or a severe COPD exacerbation, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction. These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic corticosteroids during periods of stress, a severe asthma attack, or a severe COPD exacerbation.

Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to formoterol/ budesonide combination. Prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis during therapy with formoterol/ budesonide combination. Lung function (mean forced expiratory volume in 1 second or morning peak expiratory flow ), beta-agonist use, and asthma or COPD symptoms should be carefully monitored during withdrawal of oral corticosteroids. In addition, patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.

Transfer of patients from systemic corticosteroid therapy to inhaled corticosteroids or formoterol/ budesonide combination may unmask conditions previously suppressed by the systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions). Some patients may experience symptoms of systemically active corticosteroid withdrawal (e.g., joint and/or muscular pain, lassitude, depression) despite maintenance or even improvement of respiratory function.

Oral Infections

To minimize the risk of oropharyngeal candida infection, the patient should be instructed to rinse their mouth out with water after inhaling the maintenance dose. If oropharyngeal thrush occurs, patients should also rinse their mouth with water after the as-needed inhalations. In clinical studies, the development of localized infections of the mouth and pharynx with Candida albicans has occurred in patients treated with budesonide/formoterol combination. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral antifungal) therapy while treatment with budesonide/formoterol combination continues, but at times therapy with budesonide/formoterol combination may need to be interrupted. Advise the patient to rinse his/her mouth with water without swallowing following inhalation to help reduce the risk of oropharyngeal candidiasis.

Pneumonia in Patients with COPD

An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.

There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.

Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.

Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD.

Drug Interactions

Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors

Caution should be exercised when considering the coadministration of FORACORT FORTE Inhaler with ketoconazole, and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) because adverse effects related to increased systemic exposure to budesonide may occur In patients using potent CYP3A4 inhibitors, a budesonide/formoterol fumarate fixed-dose combination is not recommended.

Paradoxical Bronchospasm and Upper Airway Symptoms

As with other inhaled medications, FORACORT FORTE Inhaler can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with FORACORT FORTE Inhaler, it should be treated immediately with an inhaled, short-acting bronchodilator, FORACORT FORTE Inhaler should be discontinued immediately, and alternative therapy should be instituted.

Immediate Hypersensitivity Reactions

Immediate hypersensitivity reactions may occur after administration of FORACORT FORTE Inhaler, as demonstrated by cases of urticaria, angioedema, rash, and bronchospasm.

Cardiovascular and Central Nervous System Effects

Excessive beta-adrenergic stimulation has been associated with seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Therefore, FORACORT FORTE Inhaler, like all products containing sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Formoterol, a component of FORACORT FORTE Inhaler, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of formoterol at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.

Effect on Growth

Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving FORACORT FORTE Inhaler routinely (e.g., via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including FORACORT FORTE Inhaler, titrate each patient's dose to the lowest dosage that effectively controls his/her symptoms.

Caution with Special Diseases

FORACORT FORTE Inhaler should be administered with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.

Caution should be observed when treating patients with prolongation of the QTc-interval. Formoterol itself may induce prolongation of the QTc-interval.

The need for, and dose of inhaled corticosteroids should be re-evaluated in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways.

Monoamine Oxidase Inhibitors and Tricyclic Antidepressants

FORACORT FORTE Inhaler should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of formoterol, a component of FORACORT FORTE Inhaler, on the vascular system may be potentiated by these agents. In clinical trials with FORACORT FORTE Inhaler, a limited number of COPD and asthma patients received tricyclic antidepressants, and, therefore, no clinically meaningful conclusions on adverse events can be made.

Beta2 Adrenoceptor Agonists

Potentially serious hypokalaemia may result from high doses of beta2-agonists. Concomitant treatment of beta2-agonists with drugs which can induce hypokalaemia or potentiate a hypokalaemic effect, e.g. xanthine-derivatives, steroids and diuretics, may add to a possible hypokalaemic effect of the beta2-agonist.

Treatment with beta2 adrenoceptor agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.

Particular caution is recommended in unstable asthma with variable use of rescue bronchodilators, in acute severe asthma as the associated risk may be augmented by hypoxia and in other conditions when the likelihood for hypokalaemia adverse effects is increased. It is recommended that serum potassium levels are monitored during these circumstances.

As for all beta2-agonists, additional blood glucose controls should be considered in diabetic patients.

Coexisting Conditions

FORACORT FORTE Inhaler, like all medications containing sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis and in those who are unusually responsive to sympathomimetic amines. Doses of the related beta2-adrenoceptor agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

Hypokalemia and Hyperglycemia

Beta-adrenergic agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation. Clinically significant changes in blood glucose and/or serum potassium were seen infrequently during clinical studies with FORACORT FORTE Inhaler at recommended doses.

Pharmacokinetic Interactions

Potent inhibitors of CYP3A4 (eg, ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone and HIV protease inhibitors) are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided. If this is not possible the time interval between administration of the inhibitor and budesonide should be as long as possible.

The potent CYP3A4 inhibitor ketoconazole, 200 mg once daily, increased plasma levels of concomitantly orally administered budesonide (single dose of 3 mg) on average six-fold. When ketoconazole was administered 12 hours after budesonide the concentration was on average increased only three-fold showing that separation of the administration times can reduce the increase in plasma levels. Limited data about this interaction for high-dose inhaled budesonide indicates that marked increases in plasma levels (on average four fold) may occur if itraconazole, 200 mg once daily, is administered concomitantly with inhaled budesonide (single dose of 1000 µg).

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

Pharmacodynamic Interactions

Beta-adrenergic blockers can weaken or inhibit the effect of formoterol. Formoterol/budesonide combination should therefore not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons.

Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), monoamine oxidase inhibitors and tricyclic antidepressants can prolong the QTc-interval and increase the risk of ventricular arrhythmias.

In addition L-Dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics.

Concomitant treatment with monoamine oxidase inhibitors, including medicinal products with similar properties such as furazolidone and procarbazine, may precipitate hypertensive reactions. There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.

Concomitant use of other beta-adrenergic drugs and anticholinergic medicinal products can have a potentially additive bronchodilating effect.

Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.

Budesonide and formoterol have not been observed to interact with any other drugs used in the treatment of asthma.

Diuretics

The ECG changes and/or hypokalemia that may result from the administration of non-potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of FORACORT FORTE Inhaler with non-potassium sparing diuretics.

Use in Special Population

Patients with Renal impairment

There are no data available for use of formoterol/budesonide combination in patients with renal impairment.

Patients with Hepatic Impairment

There are no data available for use of formoterol/budesonide combination in patients with hepatic impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism, impairment of liver function may lead to accumulation of budesonide and formoterol fumarate in plasma. Therefore, patients with hepatic disease should be closely monitored.

Pregnant Women

For formoterol/budesonide combination or the concomitant treatment with formoterol and budesonide, no clinical data on exposed pregnancies are available. Data from an embryo-fetal development study in the rat, showed no evidence of any additional effect from the combination.

There are no adequate data from use of formoterol in pregnant women. In animal studies formoterol has caused adverse effects in reproduction studies at very high systemic exposure levels.

Data on approximately 2000 exposed pregnancies indicate no increased teratogenic risk associated with the use of inhaled budesonide. In animal studies glucocorticosteroids have been shown to induce malformations. This is not likely to be relevant for humans given recommended doses.

Animal studies have also identified an involvement of excess prenatal glucocorticoids in increased risks for intrauterine growth retardation, adult cardiovascular disease and permanent changes in glucocorticoid receptor density, neurotransmitter turnover and behaviour at exposures below the teratogenic dose range.

During pregnancy, FORACORT FORTE Inhaler should only be used when the benefits outweigh the potential risks. The lowest effective dose of budesonide needed to maintain adequate asthma control should be used.

Lactating Women

Budesonide is excreted in breast milk. However, at therapeutic doses no effects on the suckling child are anticipated. It is not known whether formoterol passes into human breast milk. In rats, small amounts of formoterol have been detected in maternal milk. Administration of FORACORT FORTE Inhaler to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.

Fertility

There is no data available on the potential effect of budesonide on fertility. Animal reproduction studies with formoterol have shown a somewhat reduced fertility in male rats at high systemic exposure.

Geriatric Patients

There are no special dosing requirements for elderly patients. No overall differences in safety were observed between these patients and younger patients. As with other products containing beta2-agonists, special caution should be observed when using FORACORT FORTE Inhaler in geriatric patients who have concomitant cardiovascular disease that could be adversely affected by beta2-agonists

Effects on Ability to Drive and Use Machines

FORACORT FORTE Inhaler have no or negligible influence on the ability to drive and use machines.

Undesirable Effects

Since FORACORT FORTE Inhaler contains both Budesonide and Formoterol, the same pattern of undesirable effects as reported for these substances may occur. No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds. The most common drug related adverse reactions are pharmacologically predictable side-effects of beta2-agonist therapy, such as tremor and palpitations. These tend to be mild and usually disappear within a few days of treatment.

Budesonide

Adverse reactions, which have been associated with budesonide or formoterol, are as follows (frequencies are defined as: very common , common , uncommon (≥1/1,000, < 1/100), rare (≥1/10,000, < 1/1,000), very rare and not known :

Infections and infestations; (common): Candida infections in the oropharynx, pneumonia (in COPD patients).

Immune system disorders; (Rare):  Immediate and delayed hypersensitivity reactions, e.g. exanthema, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction.

Endocrine disorders: (very rare) Cushing's syndrome, adrenal suppression, growth retardation, decrease in bone mineral density.

Metabolism and nutrition disorders:  Hypokalaemia (rare) and hyperglycaemia (very rare).

Nervous system disorders:  (common) Headache, tremor, (uncommon) dizziness, (very rare) taste disturbances.

Eye disorders: Cataract and glaucoma (very rare), Vision, blurred (uncommon).

Cardiac disorders: (common) Palpitations, (uncommon), tachycardia, (rare), cardiac arrhythmias, eg. atrial fibrillation, supraventricular tachycardia, extrasystoles, (very rare) angina pectoris, prolongation of QTc- interval.

Vascular disorders; (very rare): Variations in blood pressure.

Respiratory, thoracic and mediastinal disorders; (common):  Mild irritation in the throat, coughing, hoarseness, (rare) bronchospasm, (very rare) paradoxical bronchospasm.

Gastrointestinal disorders; (Uncommon):  Nausea.

Skin and subcutaneous tissue disorders; (Uncommon):  Bruises.

Musculoskeletal and connective tissue disorders; (Uncommon): Muscle cramps

Candida infection in the oropharynx is due to drug deposition. Advice the patient to rinse the mouth out with water after each maintenance dose will minimise the risk. Oropharyngeal Candida infection usually responds to topical anti-fungal treatment without the need to discontinue the inhaled corticosteroid. If oropharyngeal thrush occurs, patients should also rinse their mouth with water after the as-needed inhalations.

As with other inhalation therapy, paradoxical bronchospasm may occur very rarely, affecting less than 1 in 10,000    people, with an immediate increase in wheezing and shortness of breath after dosing. Paradoxical bronchospasm responds to a rapid-acting inhaled bronchodilator and should be treated straightaway. FORACORT FORTE Inhaler should be discontinued immediately, the patient should be assessed and an alternative therapy instituted if necessary

Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. Increased susceptibility to infections and impairment of the ability to adapt to stress may also occur. Effects are probably dependent on dose, exposure time, concomitant and previous steroid exposure and individual sensitivity.

Treatment with β2 agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.

Reporting of suspected adverse reactions

If you experience any side-effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com. You can also report side effects directly via the national pharmacovigilance program of India by calling on 1800 180 3024 or you can report to Cipla Ltd on 18002677779.

By reporting side-effects, you can help provide more information on the safety of this product.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of FORACORT FORTE Inhaler. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Some of these adverse reactions may also have been observed in clinical studies with FORACORT FORTE Inhaler.

Cardiac disorders: angina pectoris, tachycardia, atrial and ventricular tachyarrhythmias, atrial fibrillation, extrasystoles, palpitations

Endocrine disorders: hypercorticism, growth velocity reduction in pediatric patients

Eye disorders: cataract, glaucoma, increased intraocular pressure

Gastrointestinal disorders: oropharyngeal candidiasis, nausea

Immune system disorders: immediate and delayed hypersensitivity reactions, such as anaphylactic reaction, angioedema, bronchospasm, urticaria, exanthema, dermatitis, pruritus

Metabolic and nutrition disorders: hyperglycemia, hypokalemia

Musculoskeletal, connective tissue, and bone disorders: muscle cramps

Nervous system disorders: tremor, dizziness

Psychiatric disorders: behavior disturbances, sleep disturbances, nervousness, agitation, depression, restlessness

Respiratory, thoracic, and mediastinal disorders: dysphonia, cough, throat irritation

Skin and subcutaneous tissue disorders: skin bruising

Vascular disorders: hypotension, hypertension

Overdose

Acute overdosage with budesonide, even in excessive doses, is not expected to be a clinical problem. When used chronically in excessive doses, systemic glucocorticosteroid effects, such as hypercorticism and adrenal suppression, may appear.

An overdose of formoterol would likely lead to effects that are typical for beta2-adrenergic agonists: tremor, headache, palpitations. Symptoms reported from isolated cases are tachycardia, hyperglycaemia, hypokalaemia, prolonged QTc- interval, arrhythmia, nausea and vomiting. Supportive and symptomatic treatment may be indicated. A dose of 90 micrograms administered during three hours in patients with acute bronchial obstruction raised no safety concerns.

If therapy with FORACORT FORTE Inhaler has to be withdrawn due to overdose of the Formoterol component of the drug, provision of appropriate inhaled corticosteroid therapy must be considered.

Pharmacological Properties

Mechanism of Action

FORACORT FORTE Inhaler contain formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma and chronic obstructive pulmonary disease (COPD) exacerbations.

Budesonide

Budesonide is a glucocorticosteroid which when inhaled has a dose-dependent anti-inflammatory action in the airways, resulting in reduced symptoms and fewer asthma exacerbations. Inhaled budesonide has less severe adverse effects than systemic corticosteroids. The exact mechanism responsible for the anti-inflammatory effect of glucocorticosteroids  is unknown.

Formoterol

Formoterol is a selective β2 adrenoceptor agonist that when inhaled results in rapid and long-acting relaxation of bronchial smooth muscle in patients with reversible airways obstruction. The bronchodilating effect is dose-dependent, with an onset of effect within 1-3 minutes. The duration of effect is at least 12 hours after a single dose.

Pharmacodynamic Properties

Asthma

Clinical studies in adults have shown that the addition of formoterol to budesonide improved asthma symptoms and lung function, and reduced exacerbations. In two 12-week studies, the effect on lung function of budesonide/formoterol was equal to that of the free combination of budesonide and formoterol, and exceeded that of budesonide alone. All    treatment arms used a short-acting β2 adrenoceptor agonist as needed. There was no sign of attenuation of the anti- asthmatic effect over time.

Two 12-week paediatric studies have been performed in which 265 children aged 6-11 years were treated with a maintenance dose of budesonide/formoterol (2 inhalations of 80 micrograms /4.5 micrograms/inhalation twice daily), and   a short-acting β2-adrenoceptor agonist as needed. In both studies, lung function was improved and the treatment was well tolerated compared to the corresponding dose of budesonide alone.

COPD

In two 12-month studies, the effect on lung function and the rate of exacerbation (defined as courses of oral steroids and/or course of antibiotics and/or hospitalisations) in patients with moderate to severe COPD was evaluated. The inclusion criteria for both studies was pre-bronchodilator FEV1 <50% predicted normal. Median post-bronchodilator FEV1 at inclusion in the trials was 42% predicted normal.

The mean number of exacerbations per year (as defined above) was significantly reduced with budesonide/formoterol as compared with treatment with formoterol alone or placebo (mean rate 1.4 compared with 1.8-1.9 in the    placebo/formoterol group). The mean number of days on oral corticosteroids/patient during the 12 months was slightly reduced in the budesonide/formoterol group (7-8 days/patient/year compared with 11-12 and 9-12 days in the placebo    and formoterol groups, respectively). For changes in lung-function parameters, such as FEV1, budesonide/formoterol was not superior to treatment with formoterol alone.

Pharmacokinetic Properties

Absorption

Formoterol/budesonide combination and the corresponding monoproducts have been shown to be bioequivalent with regard to systemic exposure of budesonide and formoterol, respectively. In spite of this, a small increase in cortisol suppression was seen after administration of formoterol/budesonide combination compared with the monoproducts. The difference is considered not to have an impact on clinical safety.

There was no evidence of pharmacokinetic interactions between budesonide and formoterol.

Pharmacokinetic parameters for the respective substances were comparable after the administration of budesonide and formoterol as monoproducts or as formoterol/budesonide combination. For budesonide, AUC was slightly higher; rate of absorption more rapid and maximal plasma concentration higher after administration of the fixed combination. For formoterol, maximal plasma concentration was similar after administration of the fixed combination. Inhaled budesonide is rapidly absorbed and the maximum plasma concentration is reached within 30 minutes after inhalation. In studies,  mean lung deposition of budesonide after inhalation via the powder inhaler ranged from 32% to 44% of the delivered dose. The systemic bioavailability is approximately 49% of the delivered dose. In children 6-16 years of age the lung deposition falls in the same range as in adults for the same given dose. The resulting plasma concentrations were not determined.

Inhaled formoterol is rapidly absorbed and the maximum plasma concentration is reached within 10 minutes after inhalation. In studies the mean lung deposition of formoterol after inhalation via the powder inhaler ranged from 28% to 49% of the delivered dose. The systemic bioavailability is about 61% of the delivered dose.

Distribution and Metabolism

Plasma protein binding is approximately 50% for formoterol and 90% for budesonide. Volume of distribution is about 4 L/kg for Formoterol and 3 L/kg for budesonide. Formoterol is inactivated via conjugation reactions (active O-demethylated and deformylated metabolites are formed, but they are seen mainly as inactivated conjugates). Budesonide undergoes an extensive degree (approximately 90%) of biotransformation on first passage through the liver to metabolites of low glucocorticosteroid activity. The glucocorticosteroid activity of the major metabolites, 6-beta-hydroxy-budesonide and 16-alfa-hydroxy-prednisolone, is less than 1% of that of budesonide. There are no indications of any metabolic interactions or any displacement reactions between formoterol and budesonide.

Elimination

The major part of a dose of formoterol is transformed by liver metabolism followed by renal elimination. After inhalation, 8% to 13% of the delivered dose of Formoterol is excreted unmetabolised in the urine. Formoterol has a high systemic clearance (approximately 1.4 L/min) and the terminal elimination half-life averages 17 hours.

Budesonide is eliminated via metabolism mainly catalysed by the enzyme CYP3A4. The metabolites of budesonide are eliminated in urine as such or in conjugated form. Only negligible amounts of unchanged budesonide have been detected in the urine. Budesonide has a high systemic clearance (approximately 1.2 L/min) and the plasma elimination half-life after i.v. dosing averages 4 hours.

The pharmacokinetics of budesonide or formoterol in children and patients with renal failure are unknown. The exposure of budesonide and formoterol may be increased in patients with liver disease.

Linearity/Non-linearity

Systemic exposure for both budesonide and formoterol correlates in a linear fashion to administered dose.

Nonclinical Properties

The toxicity observed in animal studies with budesonide and formoterol, given in combination or separately, were effects associated with exaggerated pharmacological activity.

In animal reproduction studies, corticosteroids such as budesonide have been shown to induce malformations (cleft palate, skeletal malformations). However, these animal experimental results do not seem to be relevant in humans at the recommended doses. Animal reproduction studies with formoterol have shown a somewhat reduced fertility in male rats   at high systemic exposure and implantation losses as well as decreased early postnatal survival and birth weight at considerably higher systemic exposures than those reached during clinical use. However, these animal experimental results do not seem to be relevant in humans.

Description

FORACORT FORTE Inhaler are a combination of Budesonide, a potent glucocorticoid, and Formoterol fumarate, a selective, long-acting beta2-agonist which have different modes of action and show additive effects in terms of reduction of asthma exacerbations

Budesonide is a potent glucocorticoid that binds with high affinity to the glucocorticoid receptor. It has a high ratio of topical to systemic activity.

Budesonide, a corticosteroid designated chemically as (RS)­ 11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is:

Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103.

Formoterol is a very potent, long-acting, beta2 adrenoceptor-agonist with a high intrinsic activity and a rapid onset of action.

Formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is:

 

Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group.

Pharmaceutical Particulars

Incompatibilities

Not applicable

Shelf-Life

As on the pack

Packaging Information

FORACORT FORTE Inhaler……… Each canister contains 120 metered doses

Storage and Handling Information

Store below 30ºC.

Do not freeze.

Keep the inhaler in an upright position, with the mouth piece down.

Patient Counselling Information

  1. What FORACORT FORTE Inhaler is and what it is used for?

FORACORT FORTE Inhaler is an inhaled medication. It is indicated to treat asthma in adults and adolescents aged 12-17 years. It is also used to treat the symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults aged 18 years and older. It contains two different medicines: budesonide and formoterol fumarate dihydrate.

  • Budesonide belongs to a group of medicines called ‘corticosteroids’. It works by reducing and preventing swelling and inflammation in your lungs.

Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting beta2 adrenoceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This helps you to breathe more easily.

Asthma

For asthma, your doctor will prescribe two asthma inhalers: FORACORT FORTE Inhaler and a separate ‘reliever inhaler’.

  • Use FORACORT FORTE Inhaler every day. This helps to prevent asthma symptoms from happening.
  • Use your ‘reliever inhaler’ when you get asthma symptoms, to make it easier to breathe again.

Do not use FORACORT FORTE Inhaler 400/12 as a ‘reliever inhaler’.

Chronic obstructive pulmonary disease (COPD)

FORACORT FORTE Inhaler can also be used to treat the symptoms of COPD in adults. COPD is a long-term disease of the airways in the lungs, which is often caused by cigarette smoking.

  1. What you need to know before you use FORACORT FORTE Inhaler?

Do not use FORACORT FORTE Inhaler: if you are allergic to budesonide, formoterol or the other ingredient of this medicine, which is lactose (which contains small amounts of milk protein).

Warnings and precautions

Talk to your doctor or pharmacist before using FORACORT FORTE Inhaler if:

  • You are diabetic.
  • You have a lung infection.
  • You have high blood pressure or you have ever had a heart problem (including an uneven heart beat, a very fast pulse, narrowing of the arteries or heart failure).
  • You have problems with your thyroid or adrenal glands.
  • You have low levels of potassium in your blood.
  • You have severe liver problems.

Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and FORACORT FORTE Inhaler

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

In particular, tell your doctor or pharmacist if you are using any of the following medicines:

  • Beta-blocker medicines (such as atenolol or propranolol for high blood pressure), including eyedrops (such as timolol for glaucoma).
  • Medicines for a fast or uneven heart beat (such as quinidine).
  • Medicines like digoxin, often used to treat heart failure.
  • Diuretics, also known as ‘water tablets’ (such as furosemide). These are used to treat high blood pressure.
  • Steroid medicines that you take by mouth (such as prednisolone).
  • Xanthine medicines (such as theophylline or aminophylline). These are often used to treat asthma.
  • Other bronchodilators (such as salbutamol).
  • Tricyclic anti-depressants (such as amitriptyline) and the anti-depressant nefazodone.
  • Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
  • Medicines called ‘HIV-protease inhibitors’ (such as ritonavir) to treat HIV infection.
  • Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin and telithromycin).
  • Medicines for Parkinson’s disease (such as leva-dopa).
  • Medicines for thyroid problems (such as levo-thyroxine).

If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using FORACORT FORTE Inhaler.

Also tell your doctor or pharmacist if you are going to have a general anaesthetic for an operation or for dental work.

Pregnancy breast-feeding and fertility

  • If you are pregnant, or planning to get pregnant, talk to your doctor before using FORACORT FORTE Inhaler - do not use FORACORT FORTE Inhaler unless your doctor tells you to.
  • If you get pregnant while using FORACORT FORTE Inhaler, do not stop using FORACORT FORTE Inhaler but talk to your doctor immediately.
  • If you are breast-feeding, talk to your doctor before using FORACORT FORTE Inhaler.

Driving and using machines

FORACORT FORTE Inhaler has no or negligible effect on your ability to drive or to use tools or machines.

  1. How to use FORACORT FORTE Inhaler?

  • Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
  • It is important to use FORACORT FORTE Inhaler every day, even if you have no asthma or COPD symptoms at the time.
  • If you are using FORACORT FORTE Inhaler for asthma, your doctor will want to regularly check your symptoms.

If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of tablets that you take, once you start to use FORACORT FORTE Inhaler. If you have been taking oral steroid tablets for a long time, your doctor may want you to have blood tests from time to time. When reducing oral steroid tablets, you may feel generally unwell even though your chest symptoms may be improving. You might experience symptoms such as a stuffy or runny nose, weakness or joint or muscle pain and rash (eczema). If any of these symptoms bother you, or if symptoms such as headache, tiredness, nausea (feeling sick) or vomiting (being sick) occur, please contact your doctor immediately. You may need to take other medication if you develop allergic or arthritic symptoms. You should speak to your doctor if you are concerned as to whether you should continue to use FORACORT FORTE Inhaler.

Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (for example, when you have a chest infection or before an operation).

Important information about your asthma or COPD symptoms

If you feel you are getting breathless or wheezy while using FORACORT FORTE Inhaler, you should continue to use FORACORT FORTE Inhaler but go to see your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediately if:

  • Your breathing is getting worse or you often wake up at night with asthma.
  • Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.

These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately.

Asthma

Use your FORACORT FORTE Inhaler 400/12 every day. This helps to prevent asthma symptoms from happening.

Adults (18 years and above)

  • The usual dose is 1 inhalation, twice a day.
  • Your doctor may increase this to 2 inhalations, twice a day.

Adolescents (12 to 17 years)

  • The usual dose is 1 inhalation, twice a day.

Your doctor (or asthma nurse) will help you to manage your asthma. They will adjust the dose of this medicine to the lowest dose that controls your asthma. However, do not adjust the dose without talking to your doctor (or asthma nurse) first.

Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen. Always keep your ‘reliever inhaler’ with you to use when you need it.

Do not use FORACORT FORTE Inhaler 400/12 to treat asthma symptoms - use your separate ‘reliever inhaler’.

Chronic Obstructive Pulmonary Disease (COPD)

  • Only to be used by adults (aged 18 years and above).
  • The usual dose is 1 inhalation twice a day.

Your doctor may also prescribe other bronchodilator drugs, for example anticholinergics (such as tiotropium or ipratropium bromide) for your COPD disease.

Read the step-by-step instructions for using FORACORT FORTE Inhaler

  • Do not use FORACORT FORTE INHALER unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
  • Use FORACORT FORTE INHALER exactly as your healthcare provider tells you to use it.
  • Do not use FORACORT FORTE INHALER more often than prescribed.
  • Use 1 inhalation of FORACORT FORTE INHALER 2 times each day. Use FORACORT FORTE INHALER at the same time each day, about 12 hours apart.
  • The metal canister holds the medicine and has a counter to show how many sprays of medicine you have left. Do not try to change the numbers or take the counter off the metal canister. The counter cannot be reset.
  • Before you use FORACORT FORTE INHALER for the first time, you must prime the inhaler two times so that you will get the right amount of medicine when you use it. To prime the inhaler, take the cap off the mouthpiece and shake the inhaler well for five seconds and spray the inhaler into the air away from your face. Repeat this procedure one more time.
  • You must prime your inhaler again if you have not used it in more than 4 weeks or if you drop it.
  1. Shake the inhaler well for 5 seconds before every use. Take the cap off the mouthpiece, hold the inhaler with the mouthpiece down. Breathe out through your mouth and push as much air out of your lungs as possible. Put the mouthpiece in your mouth and close your lips around it.
  2. Push the top of the metal canister all the way down while you breathe in deeply and slowly through your mouth.
  3. Hold your breath for about 10 seconds, or for as long as comfortable. Breathe out slowly as long as you can.

Repeat steps 1-3 once again to take your second inhalation.

  • Rinse your mouth with water after breathing in the medicine. Spit out the water. Do not swallow it.
  • Put the cap back on the mouthpiece after every use. Make sure it snaps firmly into place.
  • Clean your inhaler at least once every week after your evening dose using a clean dry cloth. Do not soak any part of the inhaler in water.
  • When the dose counter reads “20”, ask your healthcare professional for another prescription of FORACORT FORTE INHALER.
  • When the counter reads 00, throw the inhaler away.
  • Do not use the inhaler after the expiration date, which is mentioned on the packaging it comes with.
  • If you miss a dose of FORACORT FORTE INHALER, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
  • If you take too much FORACORT FORTE INHALER, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
  • Do not use other medicines that contain a LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
  • Do not stop using FORACORT FORTE Inhaler, even if you are feeling better, unless your healthcare provider tells you to.
  • FORACORT FORTE Inhaler are for maintenance therapy and not to be used as rescue medicine. Your healthcare provider will prescribe you a separate inhaler for rescue medication for relieving sudden breathing problems.
  • Rinse your mouth with water without swallowing after each dose of FORACORT FORTE Inhaler. This will help lessen the chance of getting a yeast infection (thrush) in your mouth and throat.
  • Call your healthcare provider or get medical care right away if:
  • Your breathing problems get worse.
  • You need to use your rescue medicine more often than usual.
  • Your rescue medicine does not work as well to relieve your symptoms.
  • You need to use 4 or more inhalations of your rescue medicine in 24 hours for 2 or more days in a row.
  • You use 1 whole canister of your rescue inhaler in 8 weeks.
  • Your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
  • You have asthma and your symptoms do not improve after using FORACORT FORTE Inhaler regularly for 1 week.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If either of the following happens to you, stop using FORACORT FORTE Inhaler and talk to your doctor immediately:

  • Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to swallow) or hives together with difficulties to breathe (angioedema) and/or sudden feeling of faintness. This may mean that you are having an allergic reaction. This happens rarely, affecting less than 1 in 1,000 people.
  • Sudden acute wheezing or shortness of breath immediately after using your inhaler. If either of these symptoms occur, stop using your FORACORT FORTE Inhaler straightaway and use your ‘reliever’ inhaler. Contact your doctor immediately as you may need to have your treatment changed. This happens very rarely, affecting less than 1 in 10,000 people.

Other possible side effects:

Common (may affect up to 1 in 10 people)

  • Palpitations (awareness of your heart beating), trembling or shaking. If these effects occur, they are usually mild and usually disappear as you continue to use FORACORT FORTE Inhaler.
  • Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth out with water after using your FORACORT FORTE Inhaler.
  • Mild sore throat, coughing and a hoarse voice.
  • Headache.
  • Pneumonia (infection of the lung) in COPD patients.

Tell your doctor if you have any of the following while taking FORACORT FORTE Inhaler, they could be symptoms of a lung infection:

  • Fever or chills.
  • Increased mucus production, change in mucus colour.
  • Increased cough or increased breathing difficulties.

Uncommon (may affect up to 1 in 100 people)

  • Feeling restless, nervous or agitated.
  • Disturbed sleep.
  • Feeling dizzy.
  • Nausea (feeling sick).
  • Fast heart beat.
  • Bruising of the skin.
  • Muscle cramps.
  • Blurred vision.

Rare (may affect up to 1 in 1,000 people)

  • Rash, itching.
  • Bronchospasm (tightening of the muscles in the airways which causes wheezing). If the wheezing comes on suddenly after using FORACORT FORTE Inhaler stop using FORACORT FORTE Inhaler and talk to your doctor immediately.
  • Low levels of potassium in your blood.
  • Uneven heart beat.

Very rare (may affect up to 1 in 10,000 people)

  • Depression.
  • Changes in behaviour, especially in children.
  • Chest pain or tightness in the chest (angina pectoris).
  • An increase in the amount of sugar (glucose) in your blood.
  • Taste changes, such as an unpleasant taste in the mouth.
  • Changes in your blood pressure.

Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. The effects include:

  • changes in bone mineral density (thinning of the bones)
  • cataract (clouding of the lens in the eye)
  • glaucoma (increased pressure in the eye)
  • a slowing of the rate of growth of children and adolescents
  • An effect on the adrenal gland (a small gland next to the kidney).

These effects are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.

If you experience any side effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com. You can also report side effects directly to the National Pharmacovigilance Programme of India by calling on 1800 180 3024 or you can report to Cipla Ltd on 1800 267 7779.

By reporting side effects, you can help provide more information on the safety of this product

  1. How to store FORACORT FORTE Inhaler?
  • Keep the container tightly closed.
  • Store below 30ºC.
  • Protect from heat & moisture.
  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton or on the label of your inhaler. The expiry date refers to the last day of that month.
  • This medicine does not require any special storage conditions.
  • Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
  • Do not throw into fire or an incinerator.
  • Safely throw away FORACORT FORTE Inhaler in the trash when the counter reads 00.
  1. Contents of the pack and other information

The active substances are budesonide and formoterol fumarate dihydrate.

Details of Manufacturer

M/S. Cipla Ltd., Unit II, Taza Block, Amba Tareythang Illaka, Rorathang, East Sikkim – 737133

Details of Permission or License Number with Date

Cipla Sikkim Unit II - M/719/2016 - 12.11.2016

Date of Revision

01/02/2021