País: Malta
Idioma: anglès
Font: Medicines Authority
CLOBAZAM
Atnahs Pharma Netherlands B.V. Copenhagen Towers Ørestads Boulevard 108, 5.tv DK-2300 København S , Denmark
N05BA09
CLOBAZAM 10 mg/5ml
ORAL SUSPENSION
CLOBAZAM 10 mg/5ml
POM
PSYCHOLEPTICS
Authorised
2016-11-18
PAGE 1 OF 11 PACKAGE LEAFLET: INFORMATION FOR THE USER CLOBAZAM ATNAHS 5MG/5ML AND 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. 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Clobazam Oral Suspension is and what it is used for 2. What you need to know before you take Clobazam Oral Suspension 3. How to take Clobazam Oral Suspension 4. Possible side effects 5. How to store Clobazam Oral Suspension 6. Contents of the pack and other information 1. WHAT CLOBAZAM ORAL SUSPENSION IS AND WHAT IT IS USED FOR Clobazam Oral Suspension contains a medicine called clobazam. This belongs to a group of medicines called benzodiazepines. Clobazam Oral Suspension works by having a calming effect on the brain. Clobazam Oral Suspension can be used to treat: • 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 ORAL SUSPENSION DO NOT TAKE CLOBAZAM ORAL SUSPENSION • If you are allergic (hypersensitive) to clobazam, other benzodiazepine medicines or any of the other ingredients of this medicine (see section 6: contents of the pack and other information). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue • If 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). • If you are breast-feeding. • If you have ever had p Llegiu el document complet
PAGE 1 OF 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Clobazam Atnahs 10mg/5ml Oral Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of suspension contains 10mg of clobazam Excipients with known effect Each 5 ml of suspension contains 875mg of sorbitol, 15.25mg of sodium, 10.25mg of sodium methyl parahydroxybenzoate (E219) and 1.12mg of sodium propyl parahydroxybenzoate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral Suspension An off white viscous suspension with an odour of raspberry 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 in adults or children over 2 years of age, if standard treatment with one or more anticonvulsants has failed. Clobazam oral suspension should only be used in children from 6 month to 2 years old, under exceptional situations, where there is a clear epilepsy indication. PAGE 2 OF 16 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology If low doses are required, the 5 mg/5ml strength product is a more suitable prese Llegiu el document complet