Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Trimipramine maleate
Alliance Healthcare (Distribution) Ltd
N06AA06
Trimipramine maleate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100
TRIMIPRAMINE 10MG TABLETS PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE * 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. * If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Your medicine is called Trimipramine 10mg Tablets but will be referred to as Trimipramine Tablets throughout this leaflet. Please note that the leaflet also contains information about other strength of the medicine Trimipramine 25mg Tablets. IN THIS LEAFLET: What Trimipramine Tablets are and what they are used for Before you take Trimipramine Tablets How to take Trimipramine Tablets Possible side effects How to store Trimipramine Tablets Further information WHAT TRIMIPRAMINE TABLETS ARE AND WHAT THEY ARE USED FOR Your tablets contain a medicine called trimipramine. This belongs to a group of medicines called antidepressants. Trimipramine can be used to treat depression. They are especially useful for treating depression in people who also have problems sleeping, stress (anxiety) or feel irritable and restless (agitation). BEFORE YOU TAKE TRIMIPRAMINE TABLETS DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF: X You are allergic (hypersensitive) to trimipramine or any of the other ingredients of Trimipramine Tablets (listed in Section 6 Further information). Signs of an allergic reaction include: a rash, swelling or breathing problems, swelling of your lips, face, throat or tongue X You have had a heart attack X You have had any other heart problems including slow or uneven heart beat X You have severe liver problems X You have mania (signs include very high mood, energy and unusual behaviour) X You are breast-feeding Do not take this medicine if this applies to you. If you are not sure, talk to Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trimipramine 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 14mg of trimipramine maleate equivalent to 10mg of trimipramine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White to pale yellow, circular, biconvex, film coated tablet, embossed ‘TM’ above ‘10’ on one side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide the dose. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Trimipramine has a potent antidepressant action similar to that of other tricyclic antidepressants. It also possesses pronounced sedative action. It is, therefore, indicated in the treatment of depressive illness, especially where sleep disturbance, anxiety or agitation are presenting symptoms. Sleep disturbance is controlled within 24 hours and true antidepressant action follows within 7 to 10 days. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults For depression 50-75 mg/day initially increasing to 150-300 mg/day in divided doses or one dose at night. The maintenance dose is 75-150 mg/day. Elderly 10-25 mg three times a day initially. The initial dose should be increased with caution under close supervision. Half the normal maintenance dose may be sufficient to produce a satisfactory clinical response. Children Not recommended. Route of administration is oral. 4.3 CONTRAINDICATIONS • Recent myocardial infarction • Any degree of heart block or other cardiac arrhythmias • Mania. Severe liver disease • During breast feeding • Hypersensitivity to trimipramine maleate or to any of the excipients 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE SUICIDE/SUICIDAL THOUGHTS OR CLINICAL WORSENING Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be Läs hela dokumentet