Clobazam Atnahs 10mg/5ml Oral Suspension

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

CLOBAZAM

可用日期:

Atnahs Pharma Netherlands B.V. Copenhagen Towers Ørestads Boulevard 108, 5.tv DK-2300 København S , Denmark

ATC代码:

N05BA09

INN（国际名称）:

CLOBAZAM 10 mg/5ml

药物剂型:

ORAL SUSPENSION

组成:

CLOBAZAM 10 mg/5ml

处方类型:

POM

治疗领域:

PSYCHOLEPTICS

授权状态:

Authorised

授权日期:

2016-11-18

资料单张

PAGE 1 OF 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOBAZAM ATNAHS 5MG/5ML AND 10MG/5ML 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.
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 Clobazam Oral Suspension is and what it is used for
2.
What you need to know before you take Clobazam Oral Suspension
3.
How to take Clobazam Oral Suspension
4.
Possible side effects
5.
How to store Clobazam Oral Suspension
6.
Contents of the pack and other information
1.
WHAT CLOBAZAM ORAL SUSPENSION IS AND WHAT IT IS USED FOR
Clobazam Oral Suspension contains a medicine called clobazam. This
belongs to a group of medicines
called benzodiazepines. Clobazam Oral Suspension works by having a
calming effect on the brain.
Clobazam Oral Suspension can be used to treat:
•
Severe anxiety over a short time
•
Epilepsy (fits) over a longer time
•
Mental illness such as schizophrenia (in combination with other
treatments)
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLOBAZAM ORAL SUSPENSION
DO NOT TAKE CLOBAZAM ORAL SUSPENSION
•
If you are allergic (hypersensitive) to clobazam, other benzodiazepine
medicines or any of the
other ingredients of this medicine (see section 6: contents of the
pack and other information).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips,
face, throat or tongue
•
If you are in the first three months of pregnancy or think you might
be pregnant (see
below under 'Pregnancy and breast-feeding' for more information).
•
If you are breast-feeding.
•
If you have ever had p

产品特点

PAGE 1 OF 16
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Clobazam Atnahs 10mg/5ml Oral Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of suspension contains 10mg of clobazam
Excipients with known effect
Each 5 ml of suspension contains 875mg of sorbitol, 15.25mg of sodium,
10.25mg of sodium
methyl parahydroxybenzoate (E219) and 1.12mg of sodium propyl
parahydroxybenzoate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral Suspension
An off white viscous suspension with an odour of raspberry
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clobazam is a 1,5-benzodiazepine indicated for the short-term relief
(2-4 weeks) only of
anxiety that is severe, disabling or subjecting the individual to
unacceptable distress,
occurring alone or in association with insomnia or short term
psychosomatic, organic or
psychotic illness. The use of clobazam to treat short-term “mild”
anxiety is inappropriate and
unsuitable.
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. Indeed, in patients with anxiety associated with
depression, clobazam
must be used only in conjunction with adequate concomitant treatment.
Use of
benzodiazepine (such as clobazam) alone, can precipitate suicide in
such patients.
In patients with schizophrenic or other psychotic illnesses, use of
benzodiazepines is
recommended only for adjunctive, i.e. not for primary treatment.
Clobazam may be used as adjunctive therapy in epilepsy in adults or
children over 2 years of
age, if standard treatment with one or more anticonvulsants has
failed.
Clobazam oral suspension should only be used in children from 6 month
to 2 years old, under
exceptional situations, where there is a clear epilepsy indication.
PAGE 2 OF 16
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
If low doses are required, the 5 mg/5ml strength product is a more
suitable prese