Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
NIFEDIPINE
Clear Pharmacy
C08CA05
NIFEDIPINE
20 Milligram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
Dihydropyridine derivatives
Authorised
2011-01-21
PACKAGE LEAFLET - INFORMATION FOR THE USER ADALAT® LA 20MG PROLONGED RELEASE TABLET nifedipine 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 more 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1. What Adalat LA is 2. Before you take Adalat LA 3. How you take Adalat LA 4. Possible side effects 5. How to store Adalat LA 6. Further information 1. WHAT ADALAT LA IS Adalat LA contains nifedipine, which belongs to a group of medicines called _calcium antagonists._ ADALAT LA IS USED TO TREAT HIGH BLOOD PRESSURE OR ANGINA _(chest pain). _ _For high blood pressure_: Adalat LA works by relaxing and expanding the blood vessels. This makes the blood flow more easily and lowers blood pressure. Lower blood pressure reduces the strain on your heart. _For angina_: Adalat LA works by relaxing and expanding the arteries supplying the heart. This allows more blood and oxygen to reach the heart and decreases the strain on it. Your angina attacks will be less severe and less frequent if there is less strain on the heart. 2. BEFORE YOU TAKE ADALAT LA DO NOT TAKE ADALAT LA: IF YOU HAVE HAD A HEART ATTACK within the last month. IF YOU GET A SUDDEN ANGINA ATTACK. Adalat LA will not help relieve symptoms of angina quickly. IF YOU HAVE UNSTABLE ANGINA. IF YOU ARE Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adalat LA 20mg Prolonged-Release Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 20 mg nifedipine. Excipients: sodium For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release film-coated tablet. _Product imported from UK:_ Pink, circular convex tablets with Adalat 20 marked on one side 4 CLINICAL PARTICULARS As per PA1410/025/005 5 PHARMACOLOGICAL PROPERTIES As per PA1410/025/005 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablet Core Polyethylene oxide Hypromellose (5 cp) Magnesium stearate Sodium chloride Ferric oxide, red (E172) Coating Cellulose acetate Macrogol (3350) Hydroxypropylcellulose Hypromellose (3 cp) Propylene glycol Hypromellose (5 cp) Titanium dioxide (E171) Ferric oxide, red (E172) Polish and Print Black ink for printing Opacode S-1-81 06 (Contains: iron oxide black (E172) and Shellac) HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 11/02/2015_ _CRN 2155855_ _page number: 1_ 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 Store in the original container. The tablets should be protected from strong light. Do not remove the tablet from the blister until immediately before use. 6.5 NATURE AND CONTENTS OF CONTAINER Blisters packed into a cardboard carton of 28 tablets 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Clear Pharmacy 157-173 Roden Street Belfast BT12 5QA United Kingdom 8 PARALLEL PRODUCT AUTHORISA Olvassa el a teljes dokumentumot