Perizam 2 mg/ml oral suspension

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Clobazam

থেকে পাওয়া:

Perrigo Pharma International Designated Activity Company

এটিসি কোড:

N05BA; N05BA09

INN (আন্তর্জাতিক নাম):

Clobazam

ডোজ:

2 milligram(s)/millilitre

ফার্মাসিউটিকাল ফর্ম:

Oral suspension

থেরাপিউটিক এলাকা:

Benzodiazepine derivatives; clobazam

অনুমোদন অবস্থা:

Not marketed

অনুমোদন তারিখ:

2015-03-13

তথ্য লিফলেট

CLOBAZAM 2MG/ML ORAL SUSPENSION M131 - LEAFLET - IE
VERSION: OCTOBER 2020
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 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
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:

symptomatic treatment of severe anxiety (short term use only)

epilepsy (fits) in adults and children over 2 (together with other
treatments)

mental illness such as schizophrenia (together with other treatments).
DO NOT TAKE PERIZAM IF:

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

you have ever been addicted to drugs or alcohol

you have an illness that causes muscle weakness (‘myasthenia
gravis’)

you have breathing problems

you stop breathing for short periods while you sleep (‘sleep apnoea
syndrome�

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
15 December 2020
CRN00C0G4
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perizam 2 mg/ml oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral suspension contains 2mg Clobazam
Excipient(s) with known effect:
Sodium Methyl parahydroxybenzoate (E219) (1.32mg)
Sodium Propyl parahydroxybenzoate (E217) (0.33mg)
Liquid Maltitol (E965) (0.3g)
Propylene Glycol (E1520) (6.21mg)
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
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
anxiety.
The lowest dose that