REDUCTIL Capsule 15 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
05-05-2024
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Active ingredient:
SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE
Available from:
Abbott Laboratories Ireland Ltd
Dosage:
15 Milligram
Pharmaceutical form:
Capsule
Authorization date:
2001-05-17
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)
PA0038/075/002
Case No: 2053840
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ABBOTT LABORATORIES IRELAND LTD
4051 KINGSWOOD DRIVE, CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
REDUCTIL 15MG CAPSULES, HARD
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 14/01/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/11/2009_
_CRN 2053840_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Reductil 15 mg capsules, hard.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule of Reductil 15 mg contains 15 mg of sibutramine hydrochloride monohydrate (equivalent to 12.55 mg of
sibutramine).
Contains 196.7 mg of lactose.
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
With a blue cap and white body
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reductil 15 mg is indicated as adjunctive therapy within a weight management programme for:
o
Patients with nutritional obesity and a body mass index (BMI) of 30 kg/m
2
or higher
o
Patients with nutritional excess we
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