Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
TRANYLCYPROMINE SULPHATE
NRIM Limited
TRANYLCYPROMINE SULPHATE
10 Milligram
Coated Tablets
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER TRANYLCYPROMINE 10MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Tranylcypromine 10mg Tablets are and what are they used for 2. What you need to know before you take Tranylcypromine 10mg Tablets 3. How to take Tranylcypromine 10mg Tablets 4. Possible side effects 5. How to store Tranylcypromine 10mg Tablets 6. Contents of the pack and other information 1. WHAT TRANYLCYPROMINE 10MG TABLETS ARE AND WHAT THEY ARE USED FOR Tranylcypromine 10mg Tablets contain the active substance tranylcypromine which belongs to a group of antidepressant medicines known as monoamine oxidase inhibitors (MAOIs). It works by stopping the breakdown of two substances in the brain called serotonin and noradrenaline. Your medicine should help bring these substances back to normal levels. Tranylcypromine 10mg Tablets are used to treat moderate to severe depression in adults. They can also help feelings of fear (phobia), which sometimes occur in depression. This medicine is often used when other types of antidepressant medicines have not worked. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRANYLCYPROMINE 10MG TABLETS DO NOT TAKE T Прочитајте комплетан документ
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 Прочитајте комплетан документ