Clonazepam Rosemont 0.5 mg/5 ml oral solution

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Clonazepam

থেকে পাওয়া:

Taw Pharma (Ireland) Limited

এটিসি কোড:

N03AE; N03AE01

INN (আন্তর্জাতিক নাম):

Clonazepam

ডোজ:

0.5 mg/5ml

ফার্মাসিউটিকাল ফর্ম:

Oral solution

থেরাপিউটিক এলাকা:

Benzodiazepine derivatives; clonazepam

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

2012-02-24

তথ্য লিফলেট

CLONAZEPAM 0.5MG/5ML ORAL SOLUTION
MODULE 1.3.1
LEAFLET - IE
VERSION: DECEMBER 2023
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 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)
▪
if you are allergic to other benzodiazepine medicines. These include
diazepam,
flurazepam and temazepam.
An allergic reaction can include a rash, itching or shortness of
breath.
▪
if you have breathing problems or lung disease
▪
if your breathing stops when you are asleep (sleep apnoea)
▪
if you have severe liver problems
▪
if your muscles become weak and get tired easily (myasthenia gravis)
▪
if you have problems with alcohol or drug (prescription or
recreational) use.
1. WHAT CLONAZEPAM
ROSEMONT ORAL SOLUTION IS AND WHAT I

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
15 March 2024
CRN00F192
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clonazepam Rosemont 0.5 mg/5 ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains 0.5mg Clonazepam
Excipient with known effect
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.
METHOD OF ADMINISTRATION
A 2.5ml/ 5ml double ended spoon with a further 1.25ml graduation is
supplied