Perizam 2mg/ml Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clobazam

Available from:

Rosemont Pharmaceuticals Ltd

ATC code:

N05BA; N05BA09

INN (International Name):

Clobazam

Dosage:

2 milligram(s)/millilitre

Pharmaceutical form:

Oral suspension

Administration route:

oral use

Units in package:

Pack size: 150ml

Prescription type:

Product subject to prescription which may not be renewed (A)

Manufactured by:

Rosemont Pharmaceuticals Ltd

Therapeutic group:

Anxiolytics

Therapeutic area:

Benzodiazepine derivatives; clobazam

Therapeutic indications:

It 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 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.

Authorization status:

Marketed

Authorization date:

2015-03-13

Patient Information leaflet

PERIZAM 2MG/ML ORAL SUSPENSION (CLOBAZAM)
16.10.15
THREE
274
1 of 2
2MG/ML
P0772
-
YES
-
330 x 300mm (folded 150 x 37mm) tabbed
1
Black
Keyline
150ML/180ML
P0803
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE - BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
n
Keep this leaflet. You may need to read it again.
n
If you have any further questions, ask your doctor or pharmacist.
n
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.
n
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 Perizam Oral Suspension is and what it is used for
2. What you need to know before you take Perizam Oral
Suspension
3. How to take Perizam Oral Suspension
4. Possible side effects
5. How to store Perizam Oral Suspension
6. Contents of the pack and other information
1. WHAT PERIZAM ORAL SUSPENSION IS AND WHAT IT IS USED FOR
The full name of your medicine is Perizam 2mg/ml Oral Suspension. In
this leaflet the shorter name Perizam
is used. It contains the active ingredient Clobazam.
Perizam belongs to a group of medicines called ‘benzodiazepines’.
It works by having a calming effect on the
brain.
Perizam can be used for:
n
symptomatic treatment of severe anxiety (short term use only)
n
epilepsy (fits) in adults and children over 2 (together with other
treatments)
n
mental illness such as schizophrenia (together with other treatments).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERIZAM ORAL SUSPENSION
DO NOT TAKE PERIZAM IF:
n
you are allergic to clobazam or any of the other ingredients of this
medicine (listed in section 6).
The signs of an allergic reaction may include swelling of your face,
lips, tongue or throat, difficulty
breathing or swallowing, severe itching of your skin with raised lumps
n
you have ever been addicted to drugs or alcohol
n
you have an illness that causes muscle w

Summary of Product characteristics

Health Products Regulatory Authority
09 January 2019
CRN008HLH
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perizam 2mg/ml Oral Suspension
2 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 (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 severe