Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
ALENDRONIC ACID
Accord Healthcare Limited
M05BA04
ALENDRONIC ACID
70 Milligram
Tablets
Product subject to prescription which may be renewed (B)
alendronic acid
Marketed
2011-02-18
PACKAGE LEAFLET: INFORMATION FOR THE USER ALENDRONIC ACID ONCE WEEKLY 70 MG TABLETS (ALENDRONIC ACID) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. It is particularly important to understand the information in section 3. How to take Alendronic acid, before taking this medicine. WHAT IS IN THIS LEAFLET 1. What Alendronic Acid Tablets are and what they are used for 2. What you need to know before you take Alendronic Acid Tablets 3. How to take Alendronic Acid Tablets 4. Possible side effects 5. How to store Alendronic Acid Tablets 6. Contents of the pack and other information 1. WHAT ALENDRONIC ACID TABLETS ARE AND WHAT THEY ARE USED FOR WHAT IS Alendronic acid? Alendronic acid tablet is a tablet containing the active substance alendronic acid (commonly called alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. Alendronic acid 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 ARE ALENDRONIC ACID TABLETS USED FOR? Your doctor has prescribed alendronic acid tablets to treat your osteoporosis. Alendronic acid reduces the risk of spine and hip fractures. ALENDRONIC ACID 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 bo Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alendronic Acid Once Weekly 70 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 70mg alendronic acid (as alendronate sodium) Excipients: Each tablet contains 272.070 mg of Lactose Anhydrous For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Tablet White to off- white, oval, biconvex, tablet, debossed with ‘AHI’ on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of post-menopausal osteoporosis. Alendronic acid reduces the risk of vertebral and hip fractures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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 Alendronic acid Once Weekly 70 mg on an individual patient basis, particularly after 5 or more years of use. _Elderly_ In clinical studies there was no age-related difference in the efficacy or safety profiles of alendronic acid. Therefore no dosage adjustment is necessary for the elderly. _Renal impairment_ No dosage adjustment is necessary for patients with GFR greater than 35 ml/min. Alendronic acid Tablet is not recommended for patients with renal impairment where GFR is less than 35 ml/min, due to lack of experience. _Paediatric population_ Alendronate Sodium is not recommended for use in children under the age of 18 years due to insufficient data on safety and efficacy in conditions associated with paediatric osteoporosis (See also section 5.1). Alendronic acid Once Weekly 70 mg has not been investigated in the treatment of glucocorticoid-induced osteoporosis. Method of administration Oral use. _To permit adequate absorption of alendrnic acid:_ Alendronic acid Tablet must be taken at least 30 minutes before the first food, beverage, or medicinal product of the day with plain water only. Ot Прочетете целия документ