País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Clobazam
SYRI Limited, t/a Thame Laboratories
N05BA; N05BA09
Clobazam
5 mg/5ml
Oral suspension
Product subject to prescription which may not be renewed (A)
Benzodiazepine derivatives; clobazam
Not marketed
2016-02-19
VAR/IB-010 1.3.1 Package leaflet PACKAGE LEAFLET: INFORMATION FOR THE USER CLOBAZAM THAME 5MG/5ML ORAL SUSPENSION CLOBAZAM THAME 10MG/5ML ORAL SUSPENSION (clobazam) READ ALL OF THIS LEAFLET 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 any 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 signs of illness are the same as yours. If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is Clobazam Thame 5mg/5ml or 10mg/5ml Oral Suspension but will be referred to as Clobazam throughout this leaflet. WHAT IS IN THIS LEAFLET: 1. WHAT CLOBAZAM IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLOBAZAM 3. HOW TO TAKE CLOBAZAM 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CLOBAZAM 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT CLOBAZAM IS AND WHAT IT IS USED FOR This medicine contains the active substance clobazam which belongs to a group of medicines called benzodiazepines. It works by having a calming effect on the brain. CLOBAZAM CAN BE USED FOR: ► Severe anxiety over a short time. ► Epilepsy (fits) over a longer time. ► Mental illness such as schizophrenia (in combination with other treatments). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLOBAZAM DO NOT TAKE CLOBAZAM IF: You are allergic (hypersensitive) to clobazam, other benzodiazepine medicines or any of the other ingredients of Clobazam (see section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. You are in the first three months of pregnancy or think you might be pregnant (see below under ‘Pregnancy and breast-feeding’ for more information). You are breast-feeding. You have ever Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clobazam Thame 5mg/5ml Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is clobazam. Each 5ml of oral suspension contains 5mg clobazam. Excipients with known effect: Each 5ml of oral suspension contains 7.5mg of methyl parahydroxybenzoate (E218), 10mg sucralose (E955) and 2.24mg of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Suspension White to off-white viscous suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clobazam is a 1,5-benzodiazepine indicated for the short-term relief (2-4 weeks) only of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short term psychosomatic, organic or psychotic illness. The use of clobazam to treat short-term “mild” anxiety is inappropriate and unsuitable. Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive or different treatment. Indeed, in patients with anxiety associated with depression, clobazam must be used only in conjunction with adequate concomitant treatment. Use of benzodiazepine (such as clobazam) alone, can precipitate suicide in such patients. In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for adjunctive, i.e. not for primary treatment. Clobazam may be used as adjunctive therapy in epilepsy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Treatment of anxiety The usual anxiolytic dose for adults is 20-30mg daily in divided doses or as a single dose given at night. Doses up to 60mg daily have been used in the treatment of adult in-patients with severe anxiety. The lowest dose that can control symptoms should be used. After improvement of the symptoms, the dose may be reduced. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ Leer el documento completo