Clobazam Essential Pharmaceuticals 1 mg/ml oral suspension

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Clobazam

Disponível em:

Essential Pharmaceuticals Limited

Código ATC:

N05BA09

DCI (Denominação Comum Internacional):

Clobazam

Dosagem:

1 milligram(s)/millilitre

Forma farmacêutica:

Oral suspension

Área terapêutica:

clobazam

Status de autorização:

Not marketed

Data de autorização:

2021-11-26

Folheto informativo - Bula

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOBAZAM ESSENTIAL PHARMACEUTICALS 1 MG/ML 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.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Clobazam Essential Pharmaceuticals is and what it is used for
2.
What you need to know before you take Clobazam Essential
Pharmaceuticals
3.
How to take Clobazam Essential Pharmaceuticals
4.
Possible side effects
5.
How to store Clobazam Essential Pharmaceuticals
6.
Contents of the pack and other information
1.
WHAT CLOBAZAM ESSENTIAL PHARMACEUTICALS IS AND WHAT IT IS USED FOR
Clobazam Essential Pharmaceuticals contains clobazam which belongs to
a group of medicines called
benzodiazepines.
Clobazam works by having a calming effect on the brain.
Clobazam is used to treat epilepsy (fits) (in combination with other
treatments) in adults and children
from 6 months of age, if standard treatment with one or more
anticonvulsants has failed.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLOBAZAM ESSENTIAL
PHARMACEUTICALS
DO NOT TAKE CLOBAZAM ESSENTIAL PHARMACEUTICALS
-
if you are allergic to clobazam or any of the other ingredients of
this medicine (listed in section
6)
-
if you have ever had problems with drugs or alcohol dependence in the
past
-
if you suffer from an illness that causes muscle weakness (called
‘myasthenia gravis’)
-
if you have breathing problems
-
if you stop breathing for short periods during sleep (called ‘sleep
apnoea syndrome’)
-
if you have severe liver problems
-
if you are breast-

Características técnicas

Health Products Regulatory Authority
24 February 2022
CRN00CT8Q
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clobazam Essential Pharmaceuticals 1 mg/ml oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of suspension contains 1 mg of clobazam.
Excipients with known effect
Each 1 ml suspension contains 2 mg sodium benzoate (E 211).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
Colourless, slightly hazy liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clobazam Essential Pharmaceuticals may be used as adjunctive therapy
in epilepsy in adults and children from 6 months of age,
if standard treatment with one or more anticonvulsants has failed.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment of epilepsy in association with one or more other
anticonvulsants
ADULTS
A starting dose of 5–15 mg/day is recommended. If needed, the dose
may be gradually increased as necessary up to a
maximum of 60 mg daily until the required clinical effect is achieved
or side effects occur (see sections 4.4 and 4.8). The dose
may be divided in 1–3 doses with the largest dose to be taken in the
evening. A single dose up to 30 mg can be taken in the
evening.
PAEDIATRIC POPULATION
When prescribed for children, treatment requires low initial doses and
gradual dose increments under careful observation since
there may be an increased or paradoxical response to the treatment.
Plasma drug concentrations may be measured where
there is worsening seizures, status epilepticus, suspected
noncompliance or suspected toxicity.
_Paediatric population aged 6 months–2 years _
Data are limited about the use of Clobazam Essential Pharmaceuticals
under 2 years of age and it should only be used under
the supervision of a paediatrician with experience in the treatment of
severe childhood epileptic syndromes.
Use 0.1 mg/kg/day and titrate upwards very slowly (increasing not more
often than every 5 days) to achieve required clinical
effect, in divided