Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLOMIPRAMINE HYDROCHLORIDE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
CLOMIPRAMINE HYDROCHLORIDE
30 Tablets
NOVARTIS FARMA S.P.A.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ANAFRANIL ® TABLETS Clomipramine (25 mg) 1 WHAT IS IN THIS LEAFLET 1. What Anafranil is used for 2. How Anafranil works 3. Before you use Anafranil 4. How to use Anafranil 5. While you are using Anafranil 6. Side effects 7. Storage and Disposal of Anafranil 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ANAFRANIL IS USED FOR Anafranil is used to treat depression obsessive-compulsive disorder panic states phobias (irrational fears) long-term painful conditions muscular weakness (cataplexy) associated with repeat attacks of extreme sleepiness (narcolepsy) In children aged above 5 years, Anafranil is used to treat obsessive-compulsive disorder and bed-wetting. HOW ANAFRANIL WORKS Anafranil belongs to group of medicines called tricyclic antidepressants. Anafranil is believed to work either by increasing the amount of naturally occurring chemical messengers (noradrenaline and serotonin) in the brain or by making their effects last longer. If you have any questions about how Anafranil works or why this medicine has been prescribed for you, ask your doctor. BEFORE YOU USE ANAFRANIL It is important to tell your doctor if you have other medical problems. - _When you must not use it _ Make sure your doctor knows: If you are allergic (hypersensitive) to clomipramine, to any other tricyclic antidepressant, or to any of the other ingredients of Anafranil listed at the end of this leaflet. If you are taking certain medicines used to treat depression such as monoamine oxidase inhibitors (MAO inhibitors), selective serotonin reuptake inhibitors (SSRI), or serotonin and noradrenergic reuptake inhibitors (SNaRI). If you have recently had a heart attack or if you suffer from a serious heart disease. If the answer to any of these is YES, Anafranil is probably not suitable for you. _ _ _PREGNANCY _ Tell your doctor if you are pregnant or breast-feeding. Anafranil should not be used during pregnancy Läs hela dokumentet
Novartis Page 2 Malaysian Package Leaflet 23 Jan 2015 Anafranil Tablets ANAFRANIL Tricyclic antidepressant. Noradrenaline and preferential serotonin-reuptake inhibitor (non selective monoamine reuptake inhibitors). DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS Coated tablets (Anafranil ® 25). ACTIVE SUBSTANCE The active ingredient is 3-Chloro-5-[3-(dimethylamino)-propyl] 10, 11-dihydro-5H-dibenz- [b,f]azepine hydrochloride (clomipramine hydrochloride). One coated tablet contains 25 mg clomipramine hydrochloride. ACTIVE MOIETY Clomipramine. EXCIPIENTS 25 mg Coated tablets: Lactose monohydrate, Maize starch, Hypromellose (hydroxypropyl methylcellulose), Magnesium stearate, Silica colloidal anhydrous, Talc, Copovidone (vinylpyrrolidone/vinylacetate copolymer), Titanium dioxide (E171), Sucrose, Povidone (polyvinylpyrrolidone), Iron oxide, yellow (E172), Macrogol 8000 (polyethylene glycol 8000), Cellulose microcrystalline, Stearic acid and Glycerol (85%). DESCRIPTION Light-yellow, round, biconvex sugar-coated tablets.. INDICATIONS ADULTS Treatment of depressive states of varying aetiology and symptomatology, e.g. endogenous, reactive, neurotic, organic, masked, and involutional forms of depression, depression associated with schizophrenia and personality disorders, depressive syndromes due to presenility or senility, to chronic painful conditions, and to chronic somatic diseases, depressive mood disorders of a reactive, neurotic, or psychopathic nature. Obsessive-compulsive syndromes. Phobias and panic attacks. Cataplexy accompanying narcolepsy. Novartis Page 3 Malaysian Package Leaflet 23 Jan 2015 Anafranil Tablets Chronic painful conditions. CHILDREN AND ADOLESCENTS Obsessive-compulsive syndromes. Nocturnal enuresis (only in patients over the age of 5 years and if organic causes have been excluded). When initiating clomipramine for nocturnal enuresis to children and adolescents, careful consideration should be given to the benefits versus the risks for the individual. Potential alternative therap Läs hela dokumentet