Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Alendronic acid
WPR Healthcare Limited
M05BA; M05BA04
Alendronic acid
70 milligram(s)
Tablet
Oral use
pack of 4 tablets
Product subject to prescription which may be renewed (B)
TEVA UK Limited
Bisphosphonates, for the treatment of bone diseases
Bisphosphonates; alendronic acid
Treatment of postmenopausal osteoporosis. Alendronic acid reduces the risk of vertebral and hip fractures.
Authorised
2015-05-29
_ _ PACKAGE LEAFLET: INFORMATION FOR THE USER ALENDRONIC ACID 70 MG TABLETS ONCE WEEKLY READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. What is in this leaflet: 1. What Alendronic Acid 70 mg Tablets is and what it is used for 2. What you need to know before you take Alendronic Acid 70 mg Tablets 3. How to take Alendronic Acid 70 mg Tablets 4. Possible side effects 5. How to store Alendronic Acid 70 mg Tablets 6. Contents of the pack and other information 1. WHAT ALENDRONIC ACID 70 MG TABLETS IS AND WHAT IT IS USED FOR Alendronic acid belongs to a group of drugs called bisphosphonates, which prevent bone loss from the body. Your medicine is used to treat osteoporosis (thinning of the bones) in post-menopausal women. It will reduce your risk of back and hip fractures. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALENDRONIC ACID 70 MG TABLES DO NOT TAKE ALENDRONIC ACID 70 MG TABLETS If you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6) If you suffer from certain disorders of the oesophagus (also called the gullet, the tube that connects your mouth with your stomach) If you are unable to stand or sit upright for at least 30 minutes If you have been told by your doctor that you have low blood calcium levels. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Alendronic Acid 70 mg Tablets: If you have difficulty swallowing If your doctor has told you that you have Barrett’s oesophagus (a condition associated with change Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alendronic Acid 70 mg Tablets Once Weekly 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 70 mg alendronic acid (as alendronate sodium monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from the UK_ White to off-white, flat-faced bevel-edged round tablet, debossed with T on one side, plain on the other side. 4 CLINICAL PARTICULARS As per PA0749/016/001 5 PHARMACOLOGICAL PROPERTIES As per PA0749/016/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Microcrystalline cellulose (E460) Croscarmellose sodium Magnesium Stearate 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. 6.5 NATURE AND CONTENTS OF CONTAINER Blister pack of 4 tablets contained in a carton. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _2_ _/_ _0_ _2_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _2_ _3_ _3_ _0_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER WPR Healthcare Limited Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0565/058/ Læs hele dokumentet