LORAMET Tablets 1.0 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-05-2024
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Active ingredient:
LORMETAZEPAM
Available from:
Meda Health Sales Ireland Limited
Dosage:
1.0 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2008-05-02
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)
PA1332/026/001
Case No: 2050567
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Transferred from PA0022/037/002.
MEDA HEALTH SALES IRELAND LIMITED
OFFICE 10, DUNBOYNE BUSINESS PARK, DUNBOYNE, CO. MEATH, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
LORAMET 1.0MG TABLETS
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 02/05/2008 until 09/01/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 07/05/2008_
_CRN 2050567_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Loramet 1.0mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.0 mg lormetazepam.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Circular, white uncoated tablets embossed ‘WYETH’ on one face ‘WY037’ on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the short term treatment of insomnia when it is disabling or subjecting the individual to extreme distress.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage and duration of therapy should be individualised. The lowest effective dose should be prescribed
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