Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Isocarboxazid
Alliance Pharmaceuticals Ltd
N06AF01
Isocarboxazid
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030200; GTIN: 5036631009155
PACKAGE LEAFLET: INFORMATION FOR THE USER ISOCARBOXAZID TABLETS 10MG 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. See section 4. WHAT IS IN THIS LEAFLET: 1. What Isocarboxazid tablets are and what they are used for 2. What you need to know before you take Isocarboxazid tablets 3. How to take Isocarboxazid tablets 4. Possible side effects 5. How to store Isocarboxazid tablets 6. Contents of the pack and other information 1. WHAT ISOCARBOXAZID TABLETS ARE AND WHAT THEY ARE USED FOR Isocarboxazid is one of the group of medicines known as Monoamine Oxidase Inhibitors (MAOIs). These are drugs that block the action of a substance called monoamine oxidase which is present in the brain and which plays an important part in controlling mood. Isocarboxazid tablets are used in the treatment of depression. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOCARBOXAZID TABLETS DO NOT TAKE THESE TABLETS IF: • You are allergic to Isocarboxazid or any of the other ingredients of this medicine (listed in section 6). • You have severe heart disease or any disease of the blood vessels of the brain • You have phaeochromocytoma which is a tumour of the adrenal glands causing high blood pressure • You have known liver damage • You are taking any medications for the treatment of depression and/or anxiety. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking these tablets if you: • are elderly or in a weak state of health • have any sort of heart problem • Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Isocarboxazid Tablets 10mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg Isocarboxazid . Excipient(s) with known effect Each tablet contains 100mg Lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of the symptoms of depressive illness. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Isocarboxazid Tablets are for oral administration. Adults A daily dose of 30mg, in single or divided doses, should be given until improvement is obtained. The maximal effect is only observed after a period varying from 1 - 4 weeks. If no improvement has been seen by 4 weeks, doses up to 60mg may be tried, according to the patient’s tolerance, for no longer than 4 - 6 weeks, provided the patient is closely monitored because of the increased risk of adverse reactions occurring. Once the optimal effect is achieved, the dose should be reduced to the lowest possible amount sufficient to maintain the improvement. Clinical experience has shown this to be usually 10 - 20mg daily but up to 40mg daily may be required in some cases. The elderly The elderly are more likely to experience adverse reactions such as agitation, confusion and postural hypotension. Half the normal maintenance dose may be sufficient to produce a satisfactory clinical response. Children Isocarboxazid Tablets are not indicated for paediatric use. 4.3 CONTRAINDICATIONS Isocarboxazid is contra-indicated in patients with any impairment of hepatic function, cerebrovascular disorders or severe cardiovascular disease, and in those with actual or suspected phaeochromocytoma. Selective serotonin reuptake inhibitors (SSRIs): Cases of serious and sometimes fatal reactions (serotonin syndrome) have been reported in patients receiving monoamine oxidase inhibitors (MAOIs) in combination with SSRIs, and in patients who have recently discontinued an SSRI and have been started on a MAOI. Treatment w Read the complete document