PERIZAM Oral suspension (2020)
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Περιεχόμενα
Name of the medicinal product
Perizam 2mg/ml Oral Suspension.
Qualitative and quantitative composition
Each ml of oral solution contains 2mg Clobazam. Excipient(s) with known effect: Sodium Methyl parahydroxybenzoate (E219) (1.32mg) Sodium Propyl parahydroxybenzoate (E217) (0.33mg) Liquid Maltitol (E965) ...
Pharmaceutical form
Oral Suspension. An off-white suspension.
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. ...
Posology and method of administration
Posology 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 ...
Contraindications
Perizam must not be used: In patients with hypersensitivity to benzodiazepines or any of the excipients of Perizam. In patients with any history of drug or alcohol dependence (increased risk of development ...
Special warnings and precautions for use
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. ...
Interaction with other medicinal products and other forms of interaction
Alcohol Concomitant consumption of alcohol can increase the bioavailability of clobazam by 50% (please refer to Section 5.2) and therefore increase the effects of clobazam e.g. sedation (please refer to ...
Fertility, pregnancy and lactation
Pregnancy Clobazam must not be used in the first trimester of pregnancy or in breast-feeding women. If the product is prescribed to a woman of childbearing potential, she should be warned to contact her ...
Effects on ability to drive and use machines
Clobazam has major influence on the ability to drive and use machines. Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive or to use machines. ...
Undesirable effects
The following CIOMS frequency rating is used, when applicable: Very common (≥1/10); common (≥1/100 to ≤1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000); not known ...
Overdose
Overdose of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy, ...
Pharmacodynamic properties
<b>Pharmaco-therapeutic group:</b> Anxiolytics <b>ATC code:</b> N05BA09 Clobazam is a 1,5-benzodiazepine and the pharmacodynamic activity is qualitatively similar to that of other compounds of this class: ...
Pharmacokinetic properties
Absorption After oral administration, clobazam is rapidly and extensively absorbed. Time to peak plasma concentrations (T<sub>max</sub>) is achieved from 0.5–4.0 hrs. The peak plasma level of clobazam ...
Preclinical safety data
Chronic toxicity In chronic toxicity studies in rats with daily oral clobazam administration of 12-1000 mg/kg, spontaneous activity was dose-dependently reduced, whereas respiratory depression and hypothermia ...
List of excipients
Aluminium magnesium silicate Citric acid monohydrate (E330) Disodium hydrogen phosphate dihydrate Simethicone emulsion Sucralose (E955) Polysorbate 80 (E433) Masking flavour (contains propylene glycol ...
Incompatibilities
In the absence of compatibility studies, this product must not be mixed with other medicinal products or beverages.
Shelf life
<u>Unopened:</u> 3 years. <u>After opening:</u> 28 days.
Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze.
Nature and contents of container
Bottle: Amber (Type III glass) Closure: HDPE, EPE wadded, child resistant closure. Pack size: 150ml Syringe: Polypropylene body and HDPE plunger with a capacity of 5ml. Bottle adaptor: Low Density Polyethylene. ...
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK
Marketing authorization number(s)
PL00427/0228
Date of first authorization / renewal of the authorization
Date of last renewal: 26th of January 2020
Date of revision of the text
15/12/2020
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