Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Clobazam
Rosemont Pharmaceuticals Ltd
N05BA; N05BA09
Clobazam
1 milligram(s)/millilitre
Oral suspension
Oral use
Pack size: 150ml
Product subject to prescription which may not be renewed (A)
Rosemont Pharmaceuticals Ltd
Anxiolytics
Benzodiazepine derivatives; clobazam
It is indicated in adults for the short-term symptomatic treatment (2-4 weeks) only of anxiety that is severe, disabling or subjecting the individual to unacceptable distress. In treatment of anxiety states associated with affected disorders, Perizam must only be used in conjunction with adequate treatments for the underlying disorder. In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for short term symptomatic management of hyperarousal and agitation. Benzodiazepines do not possess antipsychotic properties. Perizam may be used as adjunctive therapy in epilepsy in adults or children over 6, if standard treatment with one or more anticonvulsants has failed.
Marketed
2015-03-13
0 10 20 30 40 50 60 70 80 90 100 JOB INFORMATION Product Name: Strength: Keyline Ref: Font Type: Font Size: Pharmacode: Dimensions: EAN Code: Folded Size: No. of Colours: Tabbed: Pack Size: Bottle Size: Design Icon: Print Colours: Non-print Colours: New Item Code: Previous Item Code: Supplier Code: Page Number: COLOURS ARTWORK VERSION: Date: Date: Operator: Operator: PREFLIGHT VERSION: JOB SPECIFICATION MAIN BODY TEXT Univers Roman UNIVERS BOLD 1mg/ml BLACK 7474 PANTONE PANTONE 265 KEYLINE UKL445 367 330 x 300mm N/A 37 x 150mm 1 8.5pt Yes 150ml 180ml N/A G4ND1RBJ1 P0802 N/A 1 of 2 Perizam 1mg/ml Oral Suspension (Clobazam) 16/08/17 - DH - 1 - APPROVALS THIRD PARTY APPROVAL REQUIRED Name: Name: Signature: Signature: Date: Date: AUTHORITY APPROVAL SUPPLIED REGULATORY SIGN-OFF YES YES NO N/A TICK APPLICABLE BOX TICK APPLICABLE BOX FREQUENCY UNKNOWN n memory problems n problems with walking or other movement problems n being aggressive n eye problems such as double vision and rapid uncontrollable movement of the eyes n becoming dependent on Perizam, (‘psychological dependence’, see section 2 ‘Dependence, withdrawal and tolerance’) n weight gain n loss of sexual drive n dry mouth, constipation, loss of appetite, feeling sick, shaking fingers (these are more likely to happen at the start of treatment and may only last a short time). If you take this medicine for a long time, you are more likely to get the following side effects: anxiety, confusion, depression, loss of appetite and difficulty sleeping. REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. UNITED KINGDOM Yellow Card Scheme: www.mhra.gov.uk/yellowcard IRELAND HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafet Izlasiet visu dokumentu
Health Products Regulatory Authority 09 January 2019 CRN008HLH Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perizam 1mg/ml Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral solution contains 1mg Clobazam Excipient(s) with known effect: Sodium Methyl parahydroxybenzoate (E219) (1.32mg) Sodium Propyl parahydroxybenzoate (E217) (0.33mg) Liquid Maltitol (0.3g) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Suspension. An off-white suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Perizam is a 1,5-benzodiazepine indicated in adults for the short-term symptomatic treatment (2-4 weeks) only of anxiety that is severe, disabling or subjecting the individual to unacceptable distress. In treatment of anxiety states associated with affective disorders, Perizam must only be used in conjunction with adequate treatments for the underlying disorder. In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for short term symptomatic management of hyperarousal and agitation. Benzodiazepines do not possess antipsychotic properties. Perizam may be used as adjunctive therapy in epilepsy in adults or children over 2 years, if standard treatment with one or more anticonvulsants has failed: Treatment of simple or complex partial epilepsy with or without secondary generalisation and treatment of all types of generalised epilepsy (tonic/clonic, myoclonic, absence seizures). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Health Products Regulatory Authority 09 January 2019 CRN008HLH Page 2 of 15 If low doses are required, the 1mg/ml strength product the most suitable presentation. If high doses are required, the 2mg/ml strength product is the most suitable presentation. Treatment of anxiety Adults The usual anxiolytic dose for adults is 20-30 mg 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 sever Izlasiet visu dokumentu