Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
TRANYLCYPROMINE SULPHATE
Lime Pharma Ltd
N06AF04
TRANYLCYPROMINE SULPHATE
10 Milligram
Coated Tablets
Product subject to prescription which may not be renewed (A)
Monoamine oxidase inhibitors, non-selective
Authorised
2015-08-13
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 Lugege kogu dokumenti