Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Trimipramine maleate
Sigma Pharmaceuticals Plc
N06AA06
Trimipramine maleate
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100
PACKAGE LEAFLET: INFORMATION FOR THE USER TRIMIPRAMINE 25MG TABLETS (trimipramine maleate) 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. IN THIS LEAFLET: 1. What Trimipramine 25mg Tablets are and what they are used for 2. Before you take Trimipramine 25mg Tablets 3. How to take Trimipramine 25mg Tablets 4. Possible side effects 5. How to store Trimipramine 25mg Tablets 6. Further information 1. WHAT TRIMIPRAMINE 25MG 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 25mg Tablets 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). 2. BEFORE YOU TAKE TRIMIPRAMINE 25MG TABLETS DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF: Ï You are allergic (hypersensitive) to trimipramine or any of the other ingredients of Trimipramine 25mg 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 Ï You have had a heart attack Ï You have had any other heart problems including slow or uneven heart beat Ï You have severe liver problems Ï You have mania (signs include very high mood, energy and unusual behaviour) Ï You are breast-feeding Do not take this medicine if this applies to you. If you are not sure, talk to your doctor or pharmacist before taking Trimipramine 25mg Tablets. TAKE SPECIAL CARE WITH TRIMIPRAMINE 25MG TABLETS THO Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trimipramine 25mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Trimpramine 25mg tablets contain Trimipramine Maleate 34.87mg equivalent to 25mg trimipramine per tablet. Excipient(s) with known effect: Lactose Monohydrate For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet 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 Posology _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. Paediatric population: Not recommended. Method of administration Oral 4.3 CONTRAINDICATIONS Hypersensitivity to trimipramine maleate or to any of the excipients listed in Section 6.1 Recent myocardial infarction. Any degree of heart block or other cardiac arrhythmias. Mania. Severe liver disease. During breast feeding. 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 closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide Przeczytaj cały dokument