Baclofen 5mg/5ml oral solution

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Baclofen

Tilgjengelig fra:

Syri Pharma Limited t/a Thame Laboratories

ATC-kode:

M03BX; M03BX01

INN (International Name):

Baclofen

Dosering :

5 mg/5ml

Legemiddelform:

Oral solution

Terapeutisk område:

Other centrally acting agents; baclofen

Autorisasjon status:

Not marketed

Autorisasjon dato:

2016-02-12

Informasjon til brukeren

VAR/IA-020
1.3.1. Package Leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
BACLOFEN 5MG/5ML ORAL SOLUTION
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.
The name of the medicine is Baclofen 5mg/5ml Oral Solution but will be
referred to as
‘Baclofen’ throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. WHAT BACLOFEN IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BACLOFEN
3. HOW TO TAKE BACLOFEN
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE BACLOFEN
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT BACLOFEN IS AND WHAT IT IS USED FOR
Baclofen belongs to a group of medicines called muscle-relaxant drugs.
Baclofen is used to
reduce and relieve the excessive tension in your muscles (spasms)
occurring in various
illnesses such as cerebral palsy, multiple sclerosis, cerebrovascular
accidents, spinal cord
diseases and other nervous system disorders.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BACLOFEN
DO NOT TAKE BACLOFEN:
Talk to your doctor if

You are allergic to baclofen or any of the other ingredients of this
medicine (listed in
section 6)

You have ever had a stomach ulcer.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Baclofen:

If you have had a stroke

If you suffer from epilepsy

If you suffer from any mental illness

If you are being treated for high blood pressure

If you have Parkinson’s disease

If you suffer from any liver, kidney or lung disease

If you have di

Preparatomtale

Health Products Regulatory Authority
13 October 2021
CRN00CM1J
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Baclofen 5mg/5ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is baclofen, a racemic mixture of the R, (-) and
S, (+) isomers.
Each 5ml of oral solution contains 5mg baclofen.
_Excipients with known effect_:
Each 5ml of oral solution contains 7mg methyl parahydroxybenzoate
(E218), 1925mg sorbitol (E420), 6.675mg propylene glycol
and 8.1mg of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
Clear, pale yellow to yellow coloured oral solution with raspberry
flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Baclofen is indicated for the relief of spasticity of voluntary muscle
resulting from such disorders as: multiple sclerosis, other
spinal lesions, e.g. tumours of the spinal cord, syringomyelia, motor
neurone disease, transverse myelitis, traumatic partial
section of the cord.
Baclofen is also indicated in adults and children for the relief of
spasticity of voluntary muscle arising from e.g. cerebrovascular
accidents, cerebral palsy, meningitis, traumatic head injury.
Patient selection is important when initiating Baclofen therapy; it is
likely to be of most benefit in patients whose spasticity
constitutes a handicap to activities and/or physiotherapy. Treatment
should not be commenced until the spastic state has
become stabilised.
_Paediatric population _
Baclofen is indicated in patients 0 to <18 years for the symptomatic
treatment of spasticity of cerebral origin, especially where
due to infantile cerebral palsy, as well as following cerebrovascular
accidents or in the presence of neoplastic or degenerative
brain disease.
Baclofen is also indicated for the symptomatic treatment of muscle
spasms occurring in spinal cord diseases of infectious,
degenerative, traumatic, neoplastic, or unknown origin such as
multiple sclerosis, spastic spinal paralysis, amyotrophic lateral
sclerosis, syri