국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Clomipramine hydrochloride
Novartis Pharmaceuticals UK Ltd
N06AA; N06AA04
Clomipramine hydrochloride
25 milligram(s)
Capsule
Product subject to prescription which may not be renewed (A)
Non-selective monoamine reuptake inhibitors; clomipramine
Marketed
1978-04-01
Package leaflet: Information for the user ANAFRANIL ® 10MG CAPSULES ANAFRANIL ® 25MG CAPSULES ANAFRANIL ® 50MG CAPSULES CLOMIPRAMINE HYDROCHLORIDE This medicine will be referred to as Anafranil in this leaflet. READ ALL OF THIS INFORMATION CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have 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 symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1. What Anafranil is and what it is used for………………………………………………....... 2 2. What you need to know before you take Anafranil………………………………………………………………….. 3 3. How to take Anafranil…………………………………………………………………........ 5 4. Possible side effects……………………………………………………………………….... 6 5. How to store Anafranil……………………………………………………………………... 8 6. Further information………………………………………………………………………..... 8 1 WHAT ANAFRANIL IS AND WHAT IT IS USED FOR Anafranil contains a medicine called clomipramine hydrochloride. This belongs to a group of medicines called “tricyclic antidepressants”. Anafranil is thought to work either by increasing the amount of chemical “messengers” in the brain or by making their effects last longer. Anafranil is used to treat depression, obsessions and phobias (irrational fears). It is also used to treat muscular weakness (cataplexy) associated with repeat attacks of extreme sleepiness (narcolepsy) in adults. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANAFRANIL DO NOT 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anafranil 25mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 25mg clomipramine hydrochloride. Also contains lactose monohydrate, 123.0mg per capsule For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Hard capsules Size No. 4, opaque hard gelatin capsules with a caramel cap and a brownish-orange body, imprinted with the ‘GEIGY’ logo and containing a white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of endogenous depression including manic depression, periodic and involutional depression, reactive and neurotic depression, obsessional and phobic states and as an adjunctive treatment of cataplexy associated with narcolepsy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Before initiating treatment with Anafranil, hypokalemia should be treated (see 4.4 Special warnings and precautions for use). As a precaution against possible QTc prolongation and serotonergic toxicity, adherence to the recommended doses of Anafranil is advised and any increase in dose should be made with caution if other serotonergic agents are co- administered (see sections 4.4 Special Warnings and Precautions for use and 4.5 Interaction with other Medicinal Products and other forms of Interaction). The dosage should be adapted to the individual patient’s condition. The aim is to achieve an optimum effect while keeping the doses as low as possible and increasing them cautiously. After a response has been obtained, maintenance therapy should be continued at the optimum dose to avoid relapse. Patients with a history of recurrent depression require maintenance treatment for a longer duration. Duration of maintenance treatment and need for further treatment should be reviewed periodically. Abrupt discontinuation of Anafranil therapy should be avoided because of possible withdrawal symptoms. Therefore, dosage should be stopped gradually after regular use for long duration and the patient should be monitored ca 전체 문서 읽기