Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
ALENDRONATE SODIUM TRIHYDRATE
Imbat Limited
M05BA04
ALENDRONATE SODIUM TRIHYDRATE
70 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Bisphosphonates
Authorised
2006-09-22
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FOSAMAX ® ONCE WEEKLY 70MG TABLETS Alendronic acid (as alendronate sodium trihydrate) Your medicine is available using the above name, but will be referred to as ‘Fosamax’ throughout this leaflet. 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 Fosamax, before taking this medicine. WHAT IS IN THIS LEAFLET: 1. What Fosamax is and what it is used for 2. What you need to know before you take Fosamax 3. How to take Fosamax 4. Possible side effects 5. How to store Fosamax 6. Contents of the pack and other information 1. WHAT FOSAMAX IS AND WHAT IT IS USED FOR WHAT IS FOSAMAX? FOSAMAX is a tablet containing the active substance alendronic acid (commonly called alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. Fosamax 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 FOSAMAX USED FOR? Your doctor has prescribed Fosamax to treat your osteoporosis. Fosamax reduces the risk of spine and hip Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fosamax Once Weekly 70 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains the equivalent of 70 mg of alendronic acid as 91.37 mg alendronate sodium trihydrate. Excipients: Lactose anhydrous _For full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Tablet. _Product imported from the UK, France, Italy and the Netherlands:_ Oval white tablets, marked with an outline of a bone image on one side, and '31' on the other. 4 CLINICAL PARTICULARS As per PA1286/008/001 5 PHARMACOLOGICAL PROPERTIES As per PA1286/008/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Microcrystalline cellulose (E460) Lactose anhydrous Croscarmellose sodium Magnesium stearate (E572) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the blister strips and outer carton of the product as marketed in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 30/11/2015_ _CRN 2168701_ _page number: 1_ 6.5 NATURE AND CONTENTS OF CONTAINER Aluminium blisters in a cardboard carton containing 4 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Imbat Limited Unit L2 North Ring Business Park Santry Dublin 9 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1151/015/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 September 2006 Date of last renewal: 22 September 2011 10 DATE OF REVISION OF THE TEXT November 2015 HEALTH PRODUCTS REGULATORY AUTHORITY Pročitajte cijeli dokument