Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
natriumalendronattrihydrat
1A Farma A/S
M05BA04
sodium
70 mg
Filmdragerad tablett
natriumalendronattrihydrat 91,35 mg Aktiv substans
Apotek
Receptbelagt
Alendronsyra
Förpacknings: Blister, 2 tabletter; Blister, 4 tabletter; Blister, 6 tabletter; Blister, 8 tabletter; Blister, 12 tabletter; Blister, 40 tabletter; Blister, 16 tabletter; Blister, 20 tabletter; Blister, 24 tabletter
Avregistrerad
2008-09-05
PACKAGE LEAFLET: INFORMATION FOR THE USER ALENDRONAT 1A FARMA VECKOTABLETT 70 MG FILM-COATED 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 signs of illness 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 Alendronat 1A Farma Veckotablett before taking this medicine. WHAT IS IN THIS LEAFLET 1. What Alendronat 1A Farma Veckotablett is and what it is used for 2. What you need to know before you take Alendronat 1A Farma Veckotablett 3. How to take Alendronat 1A Farma Veckotablett 4. Possible side effects 5. How to store Alendronat 1A Farma Veckotablett 6. Contents of the pack and other information 1. WHAT ALENDRONAT 1A FARMA VECKOTABLETT IS AND WHAT IT IS USED FOR WHAT IS ALENDRONAT 1A FARMA VECKOTABLETT? Alendronat 1A Farma Veckotablett is a film-coated tablet containing the active substance alendronate sodium. WHAT IS ALENDRONATE? Alendronate belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate 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 ALENDRONAT 1A FARMA VECKOTABLETT USED FOR? Your doctor has prescribed Alendronat 1A Farma Veckotablett to treat your osteoporosis. Alendronat 1A Farma Veckotablett reduces the risk of spine and hip fractures. Alendronat 1A Farma Veckotablett 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 me Läs hela dokumentet
Produktinformationen för Alendronat 1A Farma Veckotablett 70 mg filmdragerad tablett, MTnr 25385, gäller vid det tillfälle då läkemedlet godkändes. Informationen kommer inte att uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma anledning finns inte någon svensk produktinformation. Om läkemedelsnamnet i följande produktinformation inte stämmer med namnet på dokumentet, beror det på att läkemedlet i Sverige är godkänt under ett annat namn. S UMMARY OF P RODUCT C HARACTERISTICS 1 N AME OF THE M EDICINAL P RODUCT Alendronat 1A Farma Veckotablett 70 mg Film-coated tablets 2 Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Each film-coated tablet contains 70 mg alendronic acid (as sodium alendronate). For a full list of excipients see section 6.1. 3 P HARMACEUTICAL F ORM Film-coated tablet. White, round, biconvex film coated tablet, debossed with "ALN 70" on one side. 4 C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of post-menopausal osteoporosis. Alendronate 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. _To obtain satisfactory absorption of alendronate_ Alendronat 1A Farma Veckotablett must be taken on an empty stomach immediately on rising in the morning, with plain water only, at least 30 minutes before the first food, drink or other medication of the day. Other drinks (including mineral water), food and some medicines are likely to reduce the absorption of alendronate (see section 4.5). _To assist delivery to the stomach and thus reduce the risk of irritation/side effects locally and _ _in the oesophagus (see section 4.4)._ • Alendronat 1A Farma Veckotablett should only be swallowed on arising for the day with a whole glass of water (not less than 200 ml or 7 fl.oz). • Alendronat 1A Farma Veckotablett should be swallowed whole. The tablets should not be chewed, sucked or allowed to dissolve in the mouth on account of the risk of oropharyngeal ulceration. Pat Läs hela dokumentet