Clonazepam 2mg/5ml oral solution sugar free

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Clonazepam

Dostupno od:

Thame Laboratories Ltd

ATC koda:

N03AE01

INN (International ime):

Clonazepam

Doziranje:

400microgram/1ml

Farmaceutski oblik:

Oral solution

Administracija rute:

Oral

Razred:

Schedule 4 (CD Benz)

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 04080100; GTIN: 5055935100986

Uputa o lijeku

PIL/UK/MFG103/05-06/v6
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLONAZEPAM THAME 0.5MG/5ML ORAL SOLUTION
CLONAZEPAM THAME 2MG/5ML ORAL SOLUTION
(clonazepam)
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 of the side effects,
talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. See
section 4.
The name of your medicine is
Clonazepam
Thame 0.5mg/5ml or
2mg/5ml Oral Solution but will be
referred to as Clonazepam throughout
this leaflet.
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
Clonazepam belongs to a group of
medicines called benzodiazepine.
It is used to treat epilepsy in adults and
elderly.

It lowers the number of fits
(seizures) that you have.

Any fits that you do have will be less
serious.
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE CLONAZEPAM
DO NOT TAKE THIS MEDICINE IF:

You are allergic (hypersensitive) to
Clonazepam or any of the other
ingredients of this medicine (listed in
Section 6) or to other
‘benzodiazepine’ medicines. These
include diazepam, flurazepam and
temazepam.

You have breathing problems or lung
disease.

You have severe liver problems.

You have a condition called
‘myasthenia gravis’ (where your
muscles become weak and get tired
easily).

You have a condition called ‘sleep
apnoea syndrome’ (where your
breathing stops when you are
asleep).

You have problems with alcohol or
drug (prescription or

Svojstava lijeka

OBJECT 1
CLONAZEPAM THAME 2MG/5ML ORAL SOLUTION
Summary of Product Characteristics Updated 20-Jun-2018 | Thame
Laboratories
1. Name of the medicinal product
Clonazepam Thame 2mg/5ml Oral Solution
2. Qualitative and quantitative composition
Each 5ml solution contains 2mg Clonazepam.
_Excipients with known effect _
Each 5ml solution contains 64.68mg of ethanol (96%).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Solution
Clear, colourless to pale yellow colour solution
4. Clinical particulars
4.1 Therapeutic indications
All clinical forms of epileptic disease and seizures in adults,
especially absence seizures (petit mal)
including atypical absence; primary or secondarily generalised
tonic-clonic (grand mal), tonic or clonic
seizures; 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
The 0.5mg/5ml oral solution facilitates the administration of lower
daily doses in the initial stages of
treatment.
The 2mg/5ml solution should be used for maintenance and maximum dosage
regimens.
_Adults_
Initial dosage should not exceed 1mg/day. The maintenance dosage for
adults normally falls within the
range 4 to 8 mg.
_Elderly_
The elderly are particularly sensitive to the effects of centrally
depressant drugs and may experience
confusion. It is recommended that the initial dosage of clonazepam
should not exceed 0.5mg/day.
These are total daily dosages which should be divided into 4 doses
taken at intervals throughout the day.
If necessary, larger doses may be given at the discretion of the
physician, up to a maximum of 20mg
daily. The maintenance dose should be attained after 2 to 4 weeks of
treatment.
_Children_
Due to the presence of ethanol in the formulation, this product is not
indicated for paediatric use.
Method of administration
Treatment should be started with low doses. The dose may be increased
progressively until the
maintenance dose suit