Serc 16mg Tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Betahistine dihydrochloride

Dostopno od:

Primecrown 2010 Limited

Koda artikla:

N07CA; N07CA01

INN (mednarodno ime):

Betahistine dihydrochloride

Odmerek:

16 milligram(s)

Farmacevtska oblika:

Tablet

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

Antivertigo preparations; betahistine

Status dovoljenje:

Authorised

Datum dovoljenje:

2013-02-08

Lastnosti izdelka

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