Clonazepam 2mg tablets

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Kauptu það núna

Vara einkenni Vara einkenni (SPC)
13-09-2018
Opinber matsskýrsla Opinber matsskýrsla (PAR)
20-04-2020

Virkt innihaldsefni:

Clonazepam

Fáanlegur frá:

Star Pharmaceuticals Ltd

ATC númer:

N03AE01

INN (Alþjóðlegt nafn):

Clonazepam

Skammtar:

2mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

Schedule 4 (CD Benz)

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04080100; GTIN: 5050114176714

Upplýsingar fylgiseðill

                                CLONAZEPAM AUDEN 500 MICROGRAM AND 2 MG TABLETS
EAS3565a
EAS3565a
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 Clonazepam is and what it is used for
2. What you need to know before you take Clonazepam
3. How to take Clonazepam
4. Possible side effects
5. How to store Clonazepam
6. Contents of the pack and other information 1.
WHAT CLONAZEPAM IS AND WHAT IT IS USED FOR
The name of your medicine is Clonazepam Auden 500 microgram and 2 mg
Tablets (called Clonazepam in this leaflet).
Clonazepam belongs to a group of medicines called
‘benzodiazepines’. It is used to treat epilepsy. Clonazepam works
by
preventing seizures or fits. 2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLONAZEPAM
DO NOT TAKE CLONAZEPAM:
•
if you are allergic to clonazepam or any of the other ingredients of
this medicine (listed in section 6).
•
if you are allergic to other benzodiazepine medicines. These include
diazepam, chlordiazepoxide, bromazepam and
flurazepam.
•
if you have lung disease.
•
if you have myasthenia gravis (severe muscle weakness)
•
if you suffer from sleeping disorders, such as difficulty breathing
while asleep (sleep apnoea)
•
if you have a severe liver condition
•
if you have problems with alcohol or drug (prescription or
recreational) use
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Clonazepam if:
-
you have a lung, liver or kidney condition
-
you have a history of depression or have attempted suicide
-
you have 
                                
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Vara einkenni

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clonazepam Auden 2mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg clonazepam.
Excipients with known effect:
Each tablet contains 142mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Round white tablets with cross-score break line, marked ‘CLN 2’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
All clinical forms of epileptic disease and seizures in infants,
children and adults,
especially absence seizures (petit mal), including atypical absence;
primary or
secondarily generalised tonic-clonic seizures (grand mal); partial
(focal) seizures with
elementary or complex symptomatology; various forms of myoclonic
seizures,
myoclonus and associated abnormal movements.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Mode of administration: _
Treatment should be started with low doses. The dose may be increased
progressively
until the maintenance dose suited to the individual patient has been
found. The cross-
scored tablets facilitate the administration of lower daily doses in
the initial stages of
treatment.
The dosage of clonazepam must be adjusted to the needs of each
individual and
depends on the individual response to therapy. The maintenance dosage
must be
determined according to clinical response and tolerance.
The daily dose should be divided into 3 or 4 doses throughout the day.
If doses are
not equally divided, the largest dose should be given before retiring.
Once the
maintenance dose level has been reached, the daily amount may be given
in a single
dose in the evening.
Simultaneous administration of more than one antiepileptic drug is a
common
practice in the treatment of epilepsy and may be undertaken with
clonazepam. The
dosage of each drug may be required to be adjusted to obtain the
optimum effect. If
status epilepticus occurs in a patient receiving oral clonazepam,
intravenous
clonazepam may still control the status. Before adding clonazepam to

                                
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