Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Betahistine dihydrochloride
Primecrown 2010 Limited
N07CA; N07CA01
Betahistine dihydrochloride
8 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Antivertigo preparations; betahistine
Authorised
2013-02-08
Health Products Regulatory Authority 31 January 2019 CRN008LTD Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Serc 8mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8 mg betahistine dihydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from UK_ A white to almost white, round, flat tablet, imprinted '256' on one face. 4 CLINICAL PARTICULARS As per PA2010/016/001 5 PHARMACOLOGICAL PROPERTIES As per PA2010/016/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Microcrystalline cellulose Mannitol (E421) Citric acid monohydrate Colloidal anhydrous silica Talc 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE Health Products Regulatory Authority 31 January 2019 CRN008LTD Page 2 of 2 The shelf –life expiry date of this product shall be 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 Do not store above 25°C. Store in the original package. 6.5 NATURE AND CONTENTS OF CONTAINER 120 tablets in blister strips. The blister strips are made of PVC/PVDC film with a covering aluminium foil. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements 7 PARALLEL PRODUCT AUTHORISATION HOLDER Primecrown 2010 Limited 4/5 Northolt Trading Estate Belvue Road Northolt Middlesex UB5 5QS United Kingdom 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1633/026/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 8 th February 2013 10 DATE OF REVISION OF THE TEXT January 2019 Διαβάστε το πλήρες έγγραφο