Foracort Rotacaps (Generic Budesonide and Formoterol powder for Inhalation)

1. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) © The Swiss Pharmacy

2. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for inhalation) are used in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting beta2 adrenoceptor agonist) is appropriate. Foracort Rotacaps are also indicated as maintenance treatment of airflow obstruction in patients with COPD including chronic bronchitis and emphysema. © The Swiss Pharmacy

3. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Foracort Rotacaps are manufactured by Cipla Limited, India in the strengths of Foracort- 100 Rotacaps (Formoterol 6 mcg and Budesonide 100 mcg), Foracort-200 Rotacaps (Formoterol 6 mcg and Budesonide 200 mcg) and Foracort-400 Rotacaps (Formoterol 6 mcg and Budesonide 400 mcg). © The Swiss Pharmacy

4. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Chemical Structure - Formoterol Fumarate Dihydrate © The Swiss Pharmacy

5. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Chemical Structure - Budesonide © The Swiss Pharmacy

6. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) The active ingredients contained in Foracort Rotacaps are Formoterol Fumarate Dihydrate and Budesonide. Each Foracort rotacap (capsule) contains 6 mcg of Formoterol Fumarate Dihydrate whereas the amount of Budesonide is 100 mcg, 200 mcg or 400 mcg. © The Swiss Pharmacy

7. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Uses of Foracort Rotacaps (Generic Formoterol Fumarate Dihydrate and Budesonide Capsules): Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for inhalation) is used to treat asthma in adults and adolescents aged 12 to 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html © The Swiss Pharmacy

8. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Recommended Adult Dosage The dosage ofForacort Rotacaps Foracort Rotacaps(Budesonide and Formoterol powder for inhalation) for various indications is given below: Asthma (Maintenance Therapy): The recommended dosage for adults (18 Years and Older) is Foracort-100 Rotacaps 1 to 2 rotacaps, twice daily. Maximum dose is 4 rotacaps, twice daily Foracort-200 Rotacaps 1 to 2 rotacaps, twice daily. Maximum dose is 4 rotacaps, twice daily Foracort-400 Rotacaps 1 rotacap, twice daily. Maximum dose is 2 rotacaps, twice daily Patients should be advised to have their separate rapid acting bronchodilator available for rescue use at all times. © The Swiss Pharmacy

9. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Recommended Adult Dosage Asthma: Adults (18 years and older - Single Maintenance and Reliever Therapy for Foracort 100 and Foracort 200 Rotacaps only): Patients take a daily maintenance dose of Foracort Rotacaps and in combination take Foracort Rotacaps as needed in response to symptoms. Patients should be advised to always have Foracort Rotacaps available for rescue use. Close monitoring for dose-related adverse effects is needed in patients who frequently take high numbers of Foracort Rotacaps as-needed inhalations. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html © The Swiss Pharmacy

10. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Recommended Adult Dosage The recommended maintenance dosage is 2 rotacaps per day as maintenance therapy (either one rotacap twice daily, or two rotacaps in either the morning or the evening). Patients should take 1 additional rotacap as needed in response to symptoms. If symptoms persist after a few minutes, an additional rotacap should be taken. Not more than 6 rotacaps should be taken on any single occasion. A total daily dose of more than 8 rotacaps is not normally needed. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html © The Swiss Pharmacy

11. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Recommended Adult Dosage The dosage is individual and should be adjusted according to disease severity. When control has been achieved, the dose should be titrated to the lowest effective dose, which could include Foracort Rotacaps used once daily. Foracort Rotacaps should only be used for inhalation through Cipla Rotahaler/ Revolizer. COPD (Chronic Obstructive Pulmonary Disease) in Adults: COPD (Chronic Obstructive Pulmonary Disease) in Adults: Foracort-200 Rotacaps 2 rotacaps, twice daily Foracort Rotacaps should only be used for inhalation through Cipla Rotahaler/ Revolizer. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html © The Swiss Pharmacy

12. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Contraindications ➔Foracort Rotacaps are contraindicated in patients with a known hypersensitivity to Formoterol Fumarate Dihydrate, Budesonide or any component of the medication. ➔Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required. ➔Relief from acute bronchospasm URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html © The Swiss Pharmacy

13. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Storage Instructions Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html © The Swiss Pharmacy

14. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Warnings 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. Deterioration of Disease and Acute Episodes: Formoterol/Budesonide combination should not be initiated in patients during rapidly deteriorating or potentially life threatening episodes of asthma or COPD. Excessive Use of Formoterol/Budesonide Combination and Use with Other Long-Acting Beta-Agonists: As with other inhaled drugs containing beta -adrenergic agents, formoterol/budesonide combination 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. © The Swiss Pharmacy

15. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Warnings Local Effects: During clinical studies, the development of localized infections of the mouth and pharynx with Candida albicans has occurred in patients treated with Formoterol/Budesonide combination. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral antifungal) therapy while treatment with Formoterol/Budesonide combination continues, but at times therapy with Formoterol/Budesonide combination may need to be interrupted. Pneumonia and Other Lower Respiratory Tract Infections: Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap. Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids. © The Swiss Pharmacy

16. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Warnings 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. 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 hypothalamic pituitary adrenocortical (HPA) function. Paradoxical Bronchospasm and Upper Airway Symptoms: As with other inhaled medications, Formoterol/ Budesonide combination can produce paradoxical bronchospasm, which may be life threatening. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html © The Swiss Pharmacy

17. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Warnings Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of Formoterol/Budesonide combination, 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, Formoterol/Budesonide combination, like all products containing sympathomimetic amines, should be used with caution in patients with cardiovascular disorders. 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html © The Swiss Pharmacy

18. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Warnings Effect on Growth: Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. 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. 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 Formoterol / Budesonide combination. Coexisting Conditions: Formoterol/Budesonide combination, like all medications containing sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis, pheochromocytoma, diabetes mellitus, and in those who are unusually responsive to sympathomimetic amines. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html © The Swiss Pharmacy

19. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Warnings 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 Formoterol/Budesonide combination at recommended doses. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html © The Swiss Pharmacy

20. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Possible Side Effects The common side effects seen in 3% or more of the patients in clinical trials with asthmatic patients 12 years and older are: nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting and oral candidiasis. The common side effects with an incidence of 3% or more in clinical trials with duration of 12 weeks in adult COPD patients are: nasopharyngitis, oral candidiasis, bronchitis, sinusitis, viral upper respiratory tract infections. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html © The Swiss Pharmacy

21. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Foracort Rotacaps Overdosage Foracort contains both Budesonide and Formoterol; therefore, the risks associated with overdosage for the individual components described below apply to Foracort Rotacaps. 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, hyperglycemia, hypokalemia, prolonged QTc-interval, arrhythmia, nausea and vomiting. Supportive and symptomatic treatment may be indicated. A dose of 90 mcg administered during three hours in patients with acute bronchial obstruction raised no safety concerns. 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. © The Swiss Pharmacy

22. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Treatment of Foracort Rotacaps Overdosage Treatment of Formoterol overdosage consists of discontinuation of the medication together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Formoterol. Cardiac monitoring is recommended in cases of overdosage. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html © The Swiss Pharmacy

23. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Foracort Rotacaps During Pregnancy Budesonide and Formoterol Fumarate Dihydrate powder for inhalation (Foracort Rotacaps) has been classified by the US FDA as Pregnancy Category C. 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html © The Swiss Pharmacy

24. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Foracort Rotacaps During Pregnancy During pregnancy, Foracort Rotacaps 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html © The Swiss Pharmacy

25. Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) Foracort Rotacaps Foracort Rotacaps (Generic Budesonide and Formoterol Fumarate Dihydrate powder for Inhalation) are manufactured by Cipla Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html https://www.theswisspharmacy.com/product_info.php?info=p9824_Foracort-Rotacaps.html © The Swiss Pharmacy