TRANYLCYPROMINE 10 Milligram Coated Tablets
Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Résumé des caractéristiques du produit
(SPC)
05-07-2016
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Ingrédients actifs:
TRANYLCYPROMINE SULPHATE
Disponible depuis:
Lime Pharma Ltd
Code ATC:
N06AF04
DCI (Dénomination commune internationale):
TRANYLCYPROMINE SULPHATE
Dosage:
10 Milligram
forme pharmaceutique:
Coated Tablets
Type d'ordonnance:
Product subject to prescription which may not be renewed (A)
Domaine thérapeutique:
Monoamine oxidase inhibitors, non-selective
Statut de autorisation:
Authorised
Date de l'autorisation:
2015-08-13
Résumé des caractéristiques du produit
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tranylcypromine 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains tranylcypromine sulfate equivalent to 10mg of tranylcypromine base.
Excipients with known effect
Each tablet contains:
Aspartame (E951) 0.73 mg
Sucrose 0.09 mg
Ponceau 4R lake (E124) 0.14 mg
Carmoisine lake (E122) 0.16 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated Tablets
Red, round, biconvex coated tablets imprinted in black with TRN on one side and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tranylcypromine is a non-hydrazine monoamine oxidase inhibitor for the treatment of symptoms of depressive illness
especially where phobic symptoms are present or where treatment with other types of anti-depressants has failed. It is
not recommended for mild depressive states resulting from temporary situational difficulties.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Tranylcypromine 10mg tablets are for oral administration only.
_Adults_
Initially, 1 tablet morning and afternoon. If the response is not adequate after the first week add a further tablet at
midday, and continue for at least a week. A dosage of 3 tablets a day should only be exceeded with caution. When a
satisfactory response has been obtained, dosage may be reduced to maintenance level often of 1 tablet a day.
When given with a tranquillizer, the dosage of‘tranylcypromine’ is not affected when given concurrently with
electroconvulsive therapy; the usual dosage is 1 tablet twice a day during the series and 1 tablet a day afterwards as
maintenance therapy.
Elderly (over 65 years):
Use with great caution and at a lower dosage
Children:
Tranylcypromine is not indicated for children under 18 y
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