Country: Malta
Language: English
Source: Medicines Authority
ALENDRONIC ACID
Arrow Generics Limited Whiddon Valley Barnstaple, North Devon, EX32 8NS, United Kingdom
M05BA04
ALENDRONIC ACID 10 mg
TABLET
ALENDRONIC ACID 10 mg
POM
DRUGS FOR TREATMENT OF BONE DISEASES
Withdrawn
2010-03-18
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ALENDRONIC ACID 10MG 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 10mg Tablets are and what they are used for 2. Before you take Alendronic Acid 10mg Tablets 3. How to take Alendronic Acid 10mg Tablets 4. Possible side effects 5. How to store Alendronic Acid 10mg Tablets 6. Further information 1. WHAT ALENDRONIC ACID 10MG 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. Treatment with glucocorticoids (such as prednisolone) can also cause bone loss and osteoporosis in post-menopausal women. Osteoporosis can occur in men due to a number of causes including ageing and/or a low level of the male hormone testosterone. 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 Read the complete document
Page 1 of 10 S UMMARY OF P RODUCT C HARACTERISTICS 1 N AME OF THE M EDICINAL P RODUCT _ _ Alendronic Acid 10mg tablets_ _ 2 Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Each tablet contains 10mg alendronic acid (as sodium alendronate trihydrate). Excipient: Each tablet contains 103.95 mg lactose monohydrate For a full list of excipients see section 6.1. 3 P HARMACEUTICAL F ORM Tablet White to off-white, capsule-shaped tablet, embossed "AN 10" on one side and "Arrow logo" on the other. 4 C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of post-menopausal osteoporosis. Alendronate reduces the risk of vertebral and hip fractures. Treatment of osteoporosis in men. Alendronate reduces the risk of vertebral fractures. Treatment and prophylaxis of glucocorticoid-induced osteoporosis in post-menopausal women who are not receiving hormone replacement therapy (HRT) with an oestrogen. See 5.1 Pharmacodynamic properties. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Post-menopausal osteoporosis:_ The recommended dosage is 10 mg once daily. _ _ _Osteoporosis in men:_ The recommended dosage is 10 mg once daily. _ _ _Glucocorticoid-induced osteoporosis:_ For post-menopausal women who are not receiving oestrogen treatment the recommended dose is one 10 mg tablet daily. For other patients, preparations containing 5 mg alendronate should be used. _To permit adequate absorption of alendronate: _ Alendronic Acid 10 mg 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 Page 2 of 10 and some medicinal products are likely to reduce the absorption of Read the complete document