Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
Clomipramine hydrochloride
Alphapharm Pty Ltd
Medicine Registered
PLACIL _contains the active ingredient clomipramine hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Placil. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Placil against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. PLEASE READ THIS LEAFLET CAREFULLY AND KEEP IT WITH YOUR MEDICINE. You may need to read it again. WHAT PLACIL IS USED FOR Placil is used to treat: • depression • obsessive-compulsive disorders and phobias in adults • muscle weakness in people with a sleep disorder called narcolepsy. Depression 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, 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. Placil belongs to a group of medicines called tricyclic antidepressants. These medicines are thought to work by their action on brain chemicals called amines. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PLACIL HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Placil for another reason. PLACIL IS NOT APPROVED FOR USE IN CHILDREN AND ADOLESCENTS BELOW 18 YEARS OF AGE FOR THE TREATMENT OF DEPRESSION AND OTHER PSYCHIATRIC DISORDERS. The safe use and effectiveness of Placil in treating the above conditions, for this age group, has not been established. Placil is available only with a doctor's prescription. BEFORE YOU TAKE PLACIL _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE PLACIL IF YOU ARE ALLERGIC TO: • medicines containing clomipramine or any other tricyclic antidepressant • any of the ingredients listed at the end of this leaflet. Symptoms of a Citiți documentul complet
,HCl PLACIL _Clomipramine hydrochloride_ PRODUCT INFORMATION NAME OF THE MEDICINE The active ingredient is clomipramine hydrochloride. The chemical name is 3-chloro-5-[3- (dimethylamino)-propyl]-10,11-dihydro-5H-dibenz[b,f]azepine hydrochloride. Molecular formula: C 19 H 23 ClN 2 ,HCl Molecular weight: 351.3 CAS Registry No.: 17321-77-6 DESCRIPTION Clomipramine is the 3-chloro derivative of imipramine. It is a white crystalline powder, soluble in water, slightly soluble in ethyl alcohol and insoluble in diethyl ether. Each tablet contains 25 mg of clomipramine hydrochloride. The tablets also contain the following excipients: lactose, starch – maize, povidone, sodium starch glycollate, magnesium stearate, talc and Opadry Complete film coating system White Y-1-7000, Proprietary Ingredient No. 1475. PHARMACOLOGY PHARMACODYNAMICS Placil is a tricyclic antidepressant. It inhibits the neuronal reuptake of noradrenaline (NA) and serotonin (5HT) released in the synaptic cleft. The dominant component of this activity is inhibition of 5HT uptake. Placil also has a wide spectrum of pharmacological action, including 1 -adrenolytic, anticholinergic, antihistaminic and antiserotoninergic (5HT-receptor blocking) properties. PHARMACOKINETICS _Absorption._ Following oral administration, the active substance is completely absorbed but due to extensive hepatic first-pass metabolism to the active metabolite, _N_-desmethylclomipramine, less than 50% of a dose reaches the systemic circulation unchanged. During oral administration of constant daily doses of clomipramine, the steady state plasma concentrations of clomipramine Citiți documentul complet