GAMANIL Film Coated Tablet 70 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
LOFEPRAMINE HYDROCHLORIDE
Available from:
Merck Serono Limited
Dosage:
70 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
1999-05-14
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gamanil 70mg Film-Coated Tablet.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains lofepramine hydrochloride 76.10mg equivalent to lofepramine 70mg.
Excipents: Each tablet contains lactose 126.05mg and Ponceau 4R Aluminium Lake (E124) 1.15 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round, lacquered, brown-violet tablet, with occasional white dots, with a spindle shaped scoring on one side.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of symptoms of depressive illness. This includes depression/anxiety states associated with panic
disorder features.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral
Recommended dosage:
The usual dose is 70mg twice daily (140mg) or three times daily (210mg) depending upon patient response. The daily
dose should always be given in divided doses not exceeding 70 mg per dose.
In the treatment of depression/anxiety states associated with panic disorder features, the initial dosage should be 70 mg
daily for the first week.
Paediatric patients
Use in children and adolescents under the age of 18 is not recommended (see section 4.4).
Elderly
Elderly patients may respond to lower doses in some cases.
4.3 CONTRAINDICATIONS
Lofepramine must not be used in patients hypersensitive to lofepramine, dibenzazepines, or any of the excipients.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/10/2010_
_CRN 2079881_
_page number: 1_
Lofepramine must not be used in patients
• with mania,
• with
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