Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Imipramine hydrochloride 10mg
AFT Pharmaceuticals Ltd
Imipramine hydrochloride 10 mg
10 mg
Coated tablet
Active: Imipramine hydrochloride 10mg Excipient: Colloidal silicon dioxide Copovidone Glycerol Hypromellose 15028 Dispersed Red Lactose monohydrate Macrogol 8000 Magnesium stearate Maize starch Microcrystalline cellulose Povidone Purified talc Purified water Stearic acid Sucrose Titanium dioxide
Blister pack, PVC/PE/PVDC-Al, 50 tablets
Prescription
Prescription
Plantex Ltd
All forms of depression, including endogenous, organic and psychogenic forms, and depression associated with personality disorders or chronic alcoholism.
Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC-Al - 50 tablets - 60 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PE/PVDC-Al - 60 tablets - 60 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PE/PVDC-Al - 100 tablets - 60 months from date of manufacture stored at or below 30°C
2001-02-09
NEW ZEALAND CONSUMER MEDICINE INFORMATION TOFRANIL IMIPRAMINE HYDROCHLORIDE 10 MG AND 25 MG COATED TABLETS WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Tofranil. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you or your child taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT TOFRANIL IS USED FOR Tofranil is used to treat depression that is longer lasting and/or more severe than the "low moods" that everyone has from time to time due to the stress of everyday life. It is thought to be caused by a chemical imbalance in parts of the brain. This imbalance affects your whole body and can cause emotional and physical symptoms such as feeling low in spirit, loss of interest in activities, being unable to enjoy life, poor appetite or overeating, disturbed sleep, loss of sex drive, lack of energy and feelings of guilt. Tofranil belongs to a group of medicines called tricyclic antidepressants. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. TOFRANIL IS NOT RECOMMENDED FOR USE IN CHILDREN 12 YEARS OF AGE AND UNDER. TOFRANIL IS NOT RECOMMENDED FOR USE IN ADOLESCENTS (13-18 YEARS OF AGE) FOR THE TREATMENT OF DEPRESSION, UNLESS UNDER THE SUPERVISION OF A SPECIALIST. This medicine is only available with a doctor's prescription. BEFORE YOU TAKE TOFRANIL _WHEN YOU MUST NOT TAKE IT_ _ _ DO NOT TAKE TOFRANIL IF YOU HAVE EVER HAD AN ALLERGIC REACTION AFTER TAKING: • imipramine (the active ingredient in Tofranil) • any of the other ingredients listed at the end of this leaflet • any other tricyclic antidepressant Some of the symptoms of an allergic reaction may include shor Read the complete document
TOFRANIL IMIPRAMINE HYDROCHLORIDE 10 MG AND 25 MG COATED TABLETS Page 1 of 18 DATA SHEET 1 TOFRANIL (10 MG AND 25 MG COATED TABLET) TOFRANIL 10 mg and 25mg coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of imipramine hydrochloride Each tablet contains 25 mg of imipramine hydrochloride For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tofranil 10 mg tablets are convex, reddish brown, sugar coated, triangular tablets. Tofranil 25 mg tablets are biconvex, reddish brown, sugar coated, round tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS All forms of depression, including endogenous, organic and psychogenic forms, and depression associated with personality disorders or chronic alcoholism. 4.2 DOSE AND METHOD OF ADMINISTRATION The dosage and method of administration should be adapted to the individual patient's condition. The aim is to achieve an optimum effect while keeping doses as low as possible and increasing them cautiously, particularly in elderly patients or adolescents, who generally show a stronger response to Tofranil than patients of the intermediate age group. TOFRANIL IMIPRAMINE HYDROCHLORIDE 10 MG AND 25 MG COATED TABLETS Page 2 of 18 _ADULTS_ _ _ _DEPRESSION AND DEPRESSIVE SYNDROMES_ Outpatients: Start treatment with 25 mg 1-3 times daily. Raise the daily dosage gradually to 150-200 mg. This dosage should be reached by the end of the first week and maintained to this dose until a clear improvement is seen. The maintenance dose, which must be individually determined by cautiously reducing the dosage, is usually 50-100 mg daily. Hospitalised patients: Start treatment with 25 mg 3 times daily. Raise the dosage by 25 mg daily until a dose of 200 mg has been reached, and keep to this dose until the patient's condition has improved. In severe cases the dose may be increased to 100 mg 3 times daily. Once a clear improvement has set in, the maintenance dose should be determined according to the patient's individual requirements (generally Read the complete document