Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Betahistine dihydrochloride
Primecrown 2010 Limited
N07CA; N07CA01
Betahistine dihydrochloride
16 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 16mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 16 mg betahistine dihydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from UK_ Round, biconvex, scored, white to almost white tablets imprinted '267' on one face. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS As per PA2010/016/002 5 PHARMACOLOGICAL PROPERTIES As per PA2010/016/002 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 Blister strips of 21 tablets. The blister strips are made of PVC/PVDC film with a covering aluminium foil. Pack size 84 tablets 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 PPA1633/026/002 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 Прочитајте комплетан документ