ZOPICALM Tablets 7.5mg Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-05-2024
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Active ingredient:
ZOPICLONE
Available from:
Stada Arzneimittel AG
Dosage:
7.5mg Milligram
Pharmaceutical form:
Tablets
Authorization date:
1999-10-01
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0593/018/001
Case No: 2043112
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
STADA ARZNEIMITTEL AG
STADASTRASSE 2-18, D-61118 BAD VILBEL, GERMANY
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ZOPICALM TABLETS 7.5 MG
The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
may be specified in the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 13/02/2008 until 21/09/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 14/02/2008_
_CRN 2043112_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zopicalm Tablets 7.5 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 7.5 mg zopiclone.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Film coated tablets.
White, round biconvex film-coated tablets. The film-coated tablets are embossed with “ZOC 7,5” on one side and
scored on both sides. The film-coated tablets are breakable.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term treatment of insomnia.
Benzodiazepines and benzodiazepine-like substances are only indicated when the disorder is severe, disabling or
subjecting the individual to extreme distress.
4.2 POSOLOGY AND METHOD O
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