Risofos Tablets (Generic Risedronate Sodium Tablets)

1. Risofos Tablets (Generic Risedronate Sodium Tablets) © The Swiss Pharmacy

2. Risofos Tablets (Generic Risedronate Sodium Tablets) Risofos (Generic Risedronate Sodium Tablets) is a bisphosphonate and is used to prevent and treat osteoporosis (thinning of the bone) in women after menopause. Risedronate tablets may also be used to increase bone mass in men who have osteoporosis, and in men and women to prevent and treat osteoporosis caused by long-term use of corticosteroids (cortisone-like medicine). Risedronate tablets are also used to treat Paget's disease of the bone. © The Swiss Pharmacy

3. Risofos Tablets (Generic Risedronate Sodium Tablets) Risofos Tablets are manufactured by Cipla Limited, India in the strengths of 35 mg and 150 mg. © The Swiss Pharmacy

4. Risofos Tablets (Generic Risedronate Sodium Tablets) Chemical Structure © The Swiss Pharmacy

5. Risofos Tablets (Generic Risedronate Sodium Tablets) The active ingredient contained in Risofos tablets is Risedronate Sodium. Each Risofos tablet contains 35 mg or 150 mg of Risedronate Sodium. © The Swiss Pharmacy

6. Risofos Tablets (Generic Risedronate Sodium Tablets) Uses of Risofos 35 mg and 150 mg Tablets: Risofos (Generic Risedronate Sodium Tablets) is a bisphosphonate indicated for treatment and prevention of postmenopausal osteoporosis, treatment to increase bone mass in men with osteoporosis, treatment and prevention of glucocorticoid-induced osteoporosis and treatment of Paget’s disease. This medication helps to reduce bone pain and may prevent long-term complications from this disease. Risedronate works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Postmenopausal Osteoporosis: Postmenopausal Osteoporosis: Risofos (Generic Risedronate Sodium Tablets) is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, Risedronate reduces the incidence of vertebral fractures and a composite endpoint of non-vertebral osteoporosis-related fractures. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html © The Swiss Pharmacy

7. Risofos Tablets (Generic Risedronate Sodium Tablets) Uses of Risofos 35 mg and 150 mg Tablets: Osteoporosis in Men: Osteoporosis in Men: Risofos is indicated for treatment to increase bone mass in men with osteoporosis. Glucocorticoid-Induced Osteoporosis: Glucocorticoid-Induced Osteoporosis: Risofos is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of 7.5 mg or greater Prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D. Paget’s Disease: Paget’s Disease: Risofos is indicated for treatment of Paget’s disease of the bone in men and women. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html © The Swiss Pharmacy

8. Risofos Tablets (Generic Risedronate Sodium Tablets) Recommended Adult Dosage Risofos Tablets Risofos Tablets (Generic Risedronate Sodium Tablets) should be taken at least 30 minutes before the first food or drink of the day other than water and before taking any oral medication or supplementation, including calcium, antacids, or vitamins to maximize absorption and clinical benefit. The use of water with supplements, including mineral water, should be avoided because they may have a higher concentration of calcium. To facilitate delivery to the stomach, Risofos Tablets should be swallowed while the patient is in an upright position and with a full glass of plain water (177 to 236 ml). Patients should not lie down for 30 minutes after taking the medication. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html © The Swiss Pharmacy

9. Risofos Tablets (Generic Risedronate Sodium Tablets) Recommended Adult Dosage The tablet should not be chewed or sucked because of a potential for oropharyngeal ulceration. Patients should not eat or drink anything except plain water or take other medications for at least 30 minutes after taking Risofos Tablets. Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. Calcium supplements and calcium-, aluminium-, iron- and magnesium-containing medications may interfere with the absorption of Risofos Tablets and should be taken at a different time of the day. Treatment of Postmenopausal Osteoporosis: The recommended dosage is one 35 mg tablet orally, taken once-a-week OR one 150 mg tablet orally, taken once-a-month. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html © The Swiss Pharmacy

10. Risofos Tablets (Generic Risedronate Sodium Tablets) Recommended Adult Dosage Treatment to Increase Bone Mass in Men with Osteoporosis: Treatment to Increase Bone Mass in Men with Osteoporosis: The recommended dosage is one 35 mg tablet orally, taken once-a- week. Treatment and Prevention of Glucocorticoid-Induced Osteoporosis: Treatment and Prevention of Glucocorticoid-Induced Osteoporosis: The recommended dosage is one 35 mg tablet orally, taken weekly. Paget’s Disease: Paget’s Disease: The recommended treatment regimen is 30 mg orally once daily for 2 months. Re-treatment may be considered (following post-treatment observation of at least 2 months) if relapse occurs, or if treatment fails to normalize serum alkaline phosphatase. For re-treatment, the dose and duration of therapy are the same as for initial treatment. No data are available on more than one course of re-treatment. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html © The Swiss Pharmacy

11. Risofos Tablets (Generic Risedronate Sodium Tablets) Contraindications ➔Risofos is contraindicated in patients with a known hypersensitivity to Risedronate Sodium or any component of the tablet. ➔Hypocalcaemia. ➔Inability to stand or sit upright for at least 30 minutes. ➔Abnormalities of the oesophagus, which delay oesophageal emptying, such as stricture or achalasia. ➔Severe renal impairment (creatinine clearance less than 30 mL/min). ➔Pregnancy and lactation. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html © The Swiss Pharmacy

12. Risofos Tablets (Generic Risedronate Sodium Tablets) Storage Instructions Risofos Tablets (Generic Risedronate Sodium Tablets 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=p9477_Risedronate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html © The Swiss Pharmacy

13. Risofos Tablets (Generic Risedronate Sodium Tablets) Warnings Upper gastrointestinal irritation may occur. Dosing instructions should be followed. Discontinue use if new or worsening symptoms occur. Hypocalcemia may worsen and must be corrected prior to use. Osteonecrosis of the jaw has been reported rarely. Severe bone, joint, or muscle pain may occur. Consider discontinuing use if severe symptoms develop. Before initiating treatment in patients with glucocorticoid-induced osteoporosis, sex steroid hormonal status of both men and women should be ascertained and appropriate replacement considered. Bisphosphonates may interfere with bone-imaging agents. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html © The Swiss Pharmacy

14. Risofos Tablets (Generic Risedronate Sodium Tablets) Possible Side Effects Most common Risedronate Sodium (Risofos tablets) side effects with an incidence rate of greater than or equal to 10% and with a higher frequency than placebo include back pain, arthralgia, abdominal pain, and dyspepsia . Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions), and eye inflammation (iritis, uveitis) have been reported rarely. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html © The Swiss Pharmacy

15. Risofos Tablets (Generic Risedronate Sodium Tablets) Possible Side Effects The side effects from the Phase 3 postmenopausal osteoporosis trials reported in greater than or equal to 5% of patients include Infection, Back Pain, Accidental Injury, Pain, Abdominal Pain, Flu Syndrome, Headache, Asthenia, Neck Pain, Chest Pain, Allergic Reaction, Hypertension, Digestive System, Constipation, Diarrhea, Dyspepsia, Nausea, Peripheral Edema, Arthralgia, Arthritis, Traumatic Bone Fracture, Joint Disorder, Myalgia, Bone Pain, Dizziness, Depression, Insomnia, Bronchitis, Sinusitis, Rhinitis, Pharyngitis, Increased Cough, Rash, Cataract and Urinary Tract Infection. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html © The Swiss Pharmacy

16. Risofos Tablets (Generic Risedronate Sodium Tablets) Risofos Tablets Overdosage Decreases in serum calcium and phosphorus following substantial overdose may be expected in some patients. Signs and symptoms of hypocalcemia may also occur in some of these patients. Milk or antacids containing calcium should be given to bind Risedronate and reduce absorption of the medicine. In cases of substantial overdose, gastric lavage may be considered to remove unabsorbed drug. Standard procedures that are effective for treating hypocalcemia, including the administration of calcium intravenously, would be expected to restore physiologic amounts of ionized calcium and to relieve signs and symptoms of hypocalcemia. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html © The Swiss Pharmacy

17. Risofos Tablets (Generic Risedronate Sodium Tablets) Risofos Tablets During Pregnancy Risedronate Sodium (Risofos tablets) has been classified by the US FDA as Pregnancy Category C. There are no adequate and well-controlled studies of Risedronate Sodium in pregnant women. Risedronate should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and foetus. There are no data on fetal risk in humans. However, there is a theoretical risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on this risk has not been studied. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html © The Swiss Pharmacy

18. Risofos Tablets (Generic Risedronate Sodium Tablets) Risofos Tablets Risofos Tablets (Generic Risedronate Sodium Tablets) are manufactured by Cipla Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html © The Swiss Pharmacy