Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
ALENDRONATE SODIUM
Merck Sharp and Dohme Limited
ALENDRONATE SODIUM
70 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
BG620x220_155x55 1 160211 620x220_155x55 Black Technical I nf o XXXXXXX XXXXXX -X XXX 428658A01 Profile PACKAGE LEAFLET: INFORMATION FOR THE USER FOSAMAX® ONCE WEEKLY 70 MG TABLETS ALENDRONIC ACID AS ALENDRONATE SODIUM TRIHYDRATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE, EVEN IF THIS IS A REPEAT PRESCRIPTION. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. - It is particularly important to understand the information in section 3. HOW TO TAKE FOSAMAX, before taking this medicine. IN THIS LEAFLET: 1. What FOSAMAX is and what it is used for 2. Before you take FOSAMAX 3. How to take FOSAMAX 4. Possible side effects 5 How to store FOSAMAX 6. Further information 1. WHAT FOSAMAX IS AND WHAT IT IS USED FOR WHAT IS FOSAMAX? FOSAMAX belongs to a group of non-hormonal medicines called bisphosphonates. FOSAMAX prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. It reduces the risk of spine and hip fractures. WHAT IS FOSAMAX USED FOR? Your doctor has prescribed FOSAMAX to treat your osteoporosis. FOSAMAX reduces the risk of spine and hip fractures. FOSAMAX IS A ONCE WEEKLY TREATMENT. WHAT IS OSTEOPOROSIS? Osteoporosis is a thinning and weakening of the bones. It is common in women after the menopause. At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman’s skeleton healthy. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis. Early on, osteoporosis usually has no symptoms. If left untreated, ho Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fosamax Once Weekly 70 mg tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains the equivalent of 70 mg alendronic acid as 91.37 mg of alendronate sodium trihydrate. Excipients: Each tablet contains 113.4 mg lactose anhydrous. For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet. Oval white tablets, marked with an outline of a bone image on one side, and ‘31’ on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of postmenopausal osteoporosis. ‘Fosamax’ reduces the risk of vertebral and hip fractures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dosage is one 70 mg tablet once weekly. The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of ‘Fosamax’ on an individual patient basis, particularly after 5 or more years of use. _To permit adequate absorption of alendronate:_ ‘Fosamax’ must be taken at least 30 minutes before the first food, beverage, or medicinal product of the day with plain water only. Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronate (see section 4.5). _To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation/adverse_ _experiences (see section 4.4):_ o ‘Fosamax’ should only be swallowed upon arising for the day with a full glass of water (not less than 200 ml or 7 fl.oz.). o Patients should only swallow ‘Fosamax’ whole. Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a pote Soma hati kamili