Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler)

1. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) © The Swiss Pharmacy

2. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler is indicated in the maintenance treatment of mild, moderate or severe asthma as prophylactic therapy in patients 5 years of age and older. This medicine is not indicated for the relief of acute bronchospasm. © The Swiss Pharmacy

3. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Beclate Inhaler (Beclomethasone Dipropionate Inhaler) is manufactured by Cipla Limited, India in the strength of 100mcg and 200mcg. © The Swiss Pharmacy

4. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Chemical Structure © The Swiss Pharmacy

5. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) The active ingredient contained in Beclate Inhaler is Beclomethasone Dipropionate. Each actuation of Beclate Inhaler delivers 100 mcg or 200 mcg of Beclomethasone Dipropionate IP. © The Swiss Pharmacy

6. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Uses of Beclate 100 mcg and 200 mcg Inhaler: Beclate Inhaler contains Beclomethasone Dipropionate, which is one of a group of medicines known as corticosteroids and is used to prevent the symptoms of mild, moderate, or severe asthma, in patients who require regular treatment. It works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms. Beclate Inhaler works deep in your lungs to make breathing easier by reducing the inflammation, swelling and irritation in the airways. This type of medicine is known as a ‘preventer’. It needs to be taken regularly every day, even if you have no symptoms. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html © The Swiss Pharmacy

7. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Uses of Beclate 100 mcg and 200 mcg Inhaler: It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines, or when a patient's condition is so severe that more than one medicine is needed every day. This inhaler will not give immediate relief of wheezing or breathlessness during a sudden asthma attack. You will need to use a ‘reliever’ inhaler, which contains a different medicine. You should still continue to use this inhaler. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html © The Swiss Pharmacy

8. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Recommended Dosage For Adults And Children Over 12 Years Of Age Patients should be given a starting dose of inhaled Beclomethasone Dipropionate (Beclate Inhaler Beclate Inhaler) which is appropriate for the severity of their disease based on the following guidance: For Mild Asthma: For Mild Asthma: 200 to 600 micrograms per day in divided doses. For Moderate Asthma: For Moderate Asthma: 600 to 1000 micrograms per day in divided doses. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html © The Swiss Pharmacy

9. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Recommended Dosage For Severe Asthma (Adults And Children Over 12 Years Of Age): For Severe Asthma (Adults And Children Over 12 Years Of Age): 1000 to 2000 micrograms per day in divided doses. Children over 4 years of age: Up to 400 micrograms per day in divided doses. Children should be given a starting dose of inhaled Beclomethasone Dipropionate , which is appropriate for the severity of their disease. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html © The Swiss Pharmacy

10. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Contraindications ➔Beclate Inhaler is contraindicated in patients with a known hypersensitivity to Beclomethasone Dipropionate or any component of the medicine. ➔Beclate Inhaler is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html © The Swiss Pharmacy

11. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Storage Instructions Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) 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=p9642_Beclomethasone-Dipropionate-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html © The Swiss Pharmacy

12. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Warnings Local Effects: Localized infections with Candida albicans have occurred in the mouth and pharynx in some patients receiving Beclate Inhaler. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with Beclate Inhaler therapy, but at times therapy with Beclate Inhaler may need to be temporarily interrupted under close medical supervision. Rinsing the mouth with water without swallowing after inhalation is advised. Deterioration of Asthma and Acute Episodes: Beclate Inhaler is not indicated for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short-acting beta-2 agonist, not Beclate Inhaler, should be used to relieve acute symptoms such as shortness of breath. Instruct patients to contact their physician immediately if episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with Beclate Inhaler. During such episodes, patients may require therapy with oral corticosteroids. © The Swiss Pharmacy

13. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Warnings Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed in patients who are transferred from systemically active corticosteroids to Beclate Inhaler because deaths due to adrenal insufficiency have occurred in asthmatic patients 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-adrenal (HPA) function. Immunosuppression: Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. Immediate Hypersensitivity Reactions: Hypersensitivity reactions, such as urticaria, angioedema, rash, and bronchospasm, may occur after administration of Beclate Inhaler. Discontinue Beclate Inhaler if such reactions occur. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html © The Swiss Pharmacy

14. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Warnings Paradoxical Bronchospasm: Inhaled corticosteroids may produce inhalation induced bronchospasm with an immediate increase in wheezing after dosing that may be life-threatening. If inhalation induced bronchospasm occurs following dosing with Beclate Inhaler, it should be treated immediately with an inhaled, short-acting bronchodilator. Treatment with Beclate Inhaler should be discontinued and alternate therapy instituted. Hypercorticism and Adrenal Suppression: Beclate Inhaler will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of Prednisone. Since Beclomethasone Dipropionate is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of Beclate Inhaler in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html © The Swiss Pharmacy

15. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Warnings Reduction in Bone Mineral Density: Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids. The clinical significance of small changes in BMD with regard to long-term outcomes, such as fracture, is unknown. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants and corticosteroids) should be monitored and treated with established standards of care. Eye Disorders: Glaucoma, increased intraocular pressure, blurred vision and cataracts have been reported following the use of long-term administration of inhaled corticosteroids. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, blurred vision, glaucoma and/or cataracts while using Beclate Inhaler. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html © The Swiss Pharmacy

16. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Possible Side Effects Most common side effects reported by at least 3% of the patients for Beclomethasone Dipropionate Inhaler (Beclate Inhaler) during the clinical trials include Headache, Pharyngitis, Upper Respiratory Tract Infection, Rhinitis, Increased Asthma Symptoms, Oral Symptoms Inhalation Route, Sinusitis, Pain, Back Pain and Dysphonia. Other side effects that occurred in these clinical trials using Beclomethasone Dipropionate Inhaler with an incidence of 1% to 3% and which occurred at a greater incidence than placebo were nausea, dysmenorrhea, and coughing. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html © The Swiss Pharmacy

17. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Possible Side Effects The following Beclomethasone Dipropionate Inhaler (Beclate Inhaler) side effects have been reported during post-approval use of this medicine: Local Effects: Localized infections with Candida albicans have occurred in patients treated with Beclomethasone Dipropionate Inhaler or other orally inhaled corticosteroids. Psychiatric and Behavioral Changes: Aggression, depression, sleep disorders, psychomotor hyperactivity, and suicidal ideation have been reported (primarily in children). Eye Disorders: Blurred vision, central serous chorioretinopathy (CSC). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html © The Swiss Pharmacy

18. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Beclate Inhaler Overdosage Acute overdosage of Beclomethasone Dipropionate Inhaler (Beclate Inhaler) is unlikely to cause problems. The only harmful effect that follows inhalation of large amounts of the drug over a short time period is suppression of HPA axis function. Specific emergency action need not be taken. Treatment with Beclate Inhaler should be continued at the recommended dose to control the asthma; HPA axis function recovers in a day or two. If excessive doses of Beclomethasone Dipropionate Inhaler were taken over a prolonged period a degree of atrophy of the adrenal cortex could occur in addition to HPA axis suppression. In this event the patient should be treated as steroid dependent and transferred to a suitable maintenance dose of a systemic steroid such as Prednisolone. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html © The Swiss Pharmacy

19. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Beclate Inhaler During Pregnancy Beclomethasone Dipropionate (Beclate Inhaler) has been classified by the US FDA as Pregnancy Category C. There are no adequate and well-controlled studies with Beclomethasone Dipropionate Inhaler (Beclate Inhaler) in pregnant women. Animal studies were conducted with Beclomethasone Dipropionate in rats, mice, and rabbits. In rats exposed to beclomethasone dipropionate by inhalation at doses greater than 180 times the maximum recommended adult human daily inhalation dose (MRHDID), dose-related gross injury to the fetal adrenal glands was observed. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html © The Swiss Pharmacy

20. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Beclate Inhaler During Pregnancy Beclomethasone dipropionate was teratogenic (mice and rabbits) and embryolethal (rabbits) at subcutaneous doses equal to or greater than approximately 0.75 times the MRHDID. Beclomethasone Dipropionate Inhaler (Beclate Inhaler) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html © The Swiss Pharmacy

21. Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) Beclate Inhaler Beclate Inhaler (Generic Beclomethasone Dipropionate Inhaler) is manufactured by Cipla Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9642_Beclomethasone-Dipropionate-Inhaler.html © The Swiss Pharmacy