Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Imipramine hydrochloride
Alliance Healthcare (Distribution) Ltd
N06AA02
Imipramine hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100
148x210 Leaflet Reel Fed Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Imipramine Tablets 25mg x 28’s (UK) 148x210 (Reel Fed) 50955500 Leaflet for Blisters 9251 T. Hull 07/08/18 * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@accord-healthcare.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. FMD info NA (not a carton) £ No £ Yes £ Details IMIPRAMINE 10MG & 25MG 28 TABLETS PIL - UK Black Profile BBBA2676 T. Hull 13.08.2018 148x210 7pt Actavis UK n/a n/a 1 Version 2 01.11.2017 IMIPRAMINE 10MG AND 25MG TABLETS _Continued over page_ _Continued top of next column_ 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. INDEX 1 WHAT IMIPRAMINE TABLETS ARE AND WHAT THEY ARE USED FOR 2 BEFORE YOU TAKE 3 HOW TO TAKE 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE 6 FURTHER INFORMATION 1 WHAT IMIPRAMINE TABLETS ARE AND WHAT THEY ARE USED FOR Imipramine belongs to a group of medicines called tricyclic antidepressant drugs. These medicines alter the levels of chemicals in the brain to relieve the symptoms of depression. Imipramine is used: • to treat the symptoms of depression. • for the relief of bed-wetting at night by children. 2 BEFORE YOU TAKE DO NOT TAKE Imipramine tablets and TELL your doctor if you or your child (if they are the patient): • are ALLERGIC (hypersensitive) to imipramine, other tricyclic antidepressants or Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT IMIPRAMINE TABLETS BP 10mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg Imipramine Hydrochloride PhEur. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Sugar-coated tablet. Red, circular, biconvex, sugar-coated tablets, nominal diameter 5.9mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1) Treatment of symptoms of depressive illness. 2) Relief of nocturnal enuresis in children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ _Posology _ _Adults: _1 x 25mg up to three times daily, increasing stepwise to 150-200mg. This should be reached by the end of the first week and maintained until definite improvement has occurred. The subsequent maintenance dose should be individually determined by gradually reducing the dosage, usually to about 50-100mg daily. In patients in hospital, i.e. severe cases, the dose may be increased to 100mg three times daily until a distinct improvement is seen. Again the subsequent maintenance dose should be determined individually by reducing the dosage, usually to about 100mg daily. _Elderly: _Patients over 60 years may respond to lower doses of imipramine than those recommended above. Treatment should be initiated with 10mg daily, gradually increasing to 30-50mg daily. The optimum dose should be reached after about 10 days and then continued until the end of treatment. _Children (for nocturnal enuresis only): _The tablets should be administered just before bedtime. _Over 11 years (weight 35-54kg or 77-119lbs): _50-75mg daily. _8-11 years (weight 25-35kg or 55-77lbs): _25-50mg daily. _6-7 years (weight 20-25kg or 44-55lbs): _25mg daily. _Under 6 years: _Not to be given to children under 6 years of age. The dose should not exceed 75mg daily. The maximum period of treatment should not exceed three months, and withdrawal should be gradual. If relapse should occur, treatment should not be re-instituted until a full physical examination has been carried out. _ _ _Method of Administration _ For oral adm Soma hati kamili