Pays: Malte
Langue: anglais
Source: Medicines Authority
alendronic acid 70 mg
Arrow Generics Limited
M05BA04
alendronic acid
tablet
Authorised
2010-03-18
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER ALENDRONIC ACID 70MG TABLETS (alendronic acid) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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 get serious, or if_ _you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Alendronic Acid 70mg Tablets are and what they are used for 2. Before you take Alendronic Acid 70mg Tablets 3. How to take Alendronic Acid 70mg Tablets 4. Possible side effects 5. How to store Alendronic Acid 70mg Tablets 6. Further information 1. WHAT ALENDRONIC ACID 70MG TABLETS ARE AND WHAT THEY ARE USED FOR Alendronic acid belongs to a group of non-hormonal medicines known as bisphosphonates, which prevent bone loss from the body. Alendronic acid is used to treat a condition called osteoporosis (brittle bones). This condition is common in women after the menopause. The earlier a woman reaches the menopause, the greater the risk of her developing osteoporosis. Without treatment, osteoporosis can cause thinning and weakening of the bones in the skeleton which can then lead to fractures, usually of the hip, backbone and wrists. Fractures can occur easily in people suffering from osteoporosis including during normal everyday activities such as heavy lifting or from a minor injury or fall. Alendronic acid helps to prevent bone loss and to build up bone which may have been lost due to osteoporosis. Lire le document complet
Page 1 of 10 S UMMARY OF P RODUCT C HARACTERISTICS 1 N AME OF THE M EDICINAL P RODUCT Alendronic Acid 70mg Tablets 2 Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Each tablet contains 70mg alendronic acid (as sodium alendronate trihydrate) Excipient: Each tablet contains 142.64 mg lactose monohydrate For a full list of excipients see section 6.1. 3 P HARMACEUTICAL F ORM Tablet. White to off-white, oval tablet, embossed "AN 70" on one side and the Arrow logo on the other. 4 C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of post-menopausal osteoporosis. Alendronic Acid 70mg Tablets reduces the risk of vertebral and hip fractures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. The recommended dose is one 70 mg tablet per week. 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 70mg Tablets on an individual patient basis, particularly after 5 or more years of use. _To permit adequate absorption of alendronate: _ Alendronic Acid 70mg Tablets 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)_: Alendronic Acid 70mg Tablets should only be swallowed upon arising for the day with a full glass of water (not less than 200 ml or 7 fl.oz.). Patients should only swallow Alendronic Acid 70mg Tablets whole. Patients should not crush or Lire le document complet