Clonazepam Rosemont 0.5mg/5ml Oral Solution

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Clonazepam

Commercializzato da:

Rosemont Pharmaceuticals Ltd

Codice ATC:

N03AE; N03AE01

INN (Nome Internazionale):

Clonazepam

Dosaggio:

0.5 mg/5ml

Forma farmaceutica:

Oral solution

Tipo di ricetta:

Product subject to prescription which may not be renewed (A)

Area terapeutica:

Benzodiazepine derivatives; clonazepam

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

2012-02-24

Foglio illustrativo

CLONAZEPAM 0.5MG/5ML ORAL SOLUTION
MODULE 1.3.1
LEAFLET - IE
VERSION: AUGUST 2017
PAGE 1
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 Rosemont 0.5mg/5ml Oral Solution is and what it is
used for
2. What you need to know before you take Clonazepam Rosemont Oral
Solution
3. How to take Clonazepam Rosemont Oral Solution
4. Possible side effects
5. How to store Clonazepam Rosemont Oral Solution
6. Contents of the pack and other information
The name of your medicine is Clonazepam Rosemont 0.5mg/5ml Oral
Solution
(called Clonazepam in this leaflet). Clonazepam belongs to a group of
medicines
called benzodiazepines.
It is used to treat epilepsy in adults.

It lowers the number of fits (seizures) that you have.

Any fits that you do have will be less serious.
DO NOT TAKE CLONAZEPAM ROSEMONT ORAL SOLUTION, IF YOU ARE ALLERGIC TO:

clonazepam or any of the other ingredients of this medicine listed in
Section 6

other benzodiazepine medicines. These include diazepam, flurazepam and
temazepam.
An allergic reaction can include a rash, itching or shortness of
breath.
Do not take this medicine if any of the above apply to you. If you are
not sure, talk to
your doctor or pharmacist before taking Clonazepam.
DO NOT TAKE THIS MEDICINE IF:

you have breathing problems or lung disease

your breathing stops when you are asleep (sleep apnoea)

you have severe liver problems
1. WHAT CLONAZEPAM ROSEMONT ORAL SOLUTION IS AND WHAT IT IS USED

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clonazepam Rosemont 0.5mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains 0.5mg Clonazepam
Excipients with known effects: Ethanol – 100mg/5ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
A clear, pale straw coloured oily solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clonazepam Rosemont
Oral
Solution is indicated in 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 may facilitate the administration of lower
daily doses in the initial stages of treatment or
treatment for the elderly.
The 2mg/5ml oral 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 8mg.
_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.
_Paediatric Population_
Due to the presence of ethanol in the formulation, this product is not
indicated for paediatric use.
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