Baclofen 5mg/5ml oral solution sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Baclofen

Available from:

Crescent Pharma Ltd

ATC code:

M03BX01

INN (International Name):

Baclofen

Dosage:

1mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10020200; GTIN: 5017123013966

Patient Information leaflet

Package leaflet: Information for the patient
Baclofen 5mg/5ml Oral Solution
baclofen
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 Baclofen Solution is and what it is used for
2.
What you need to know before you take Baclofen Solution
3.
How to take Baclofen Solution
4.
Possible side effects
5.
How to store Baclofen Solution
6.
Contents of the pack and other information
1.
What Baclofen Solution is and what it is used for
The full name of this medicine is Baclofen 5mg/5ml Oral Solution but
within the leaflet it will be
referred to as Baclofen Solution. This oral solution contains the
active substance baclofen which is a
muscle relaxant. It works by relaxing the muscles and preventing
spasms, cramping or tightening so
reducing any pain and discomfort.
Your doctor has decided that you or your child needs this medicine to
help treat your condition.
Baclofen is used to reduce and relieve excessive tension in your
muscles (spasms) occurring in
various illnesses such as multiple sclerosis, cerebral palsy,
cerebrovascular accidents, spinal cord
diseases and other nervous system disorders. It is also used to
relieve muscle spasms following
injuries to the head or spine.
2.
What you need to know before you take Baclofen Solution
Do not take Baclofen Solution if:
• You are allergic to baclofen or any of the other ingredients of
this medicine (listed in section 6).
• You have a peptic (stomach) ulcer.
Warnings and precautions
Talk to your doctor before taking Baclofen Solution if:
• You suf

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Baclofen 5 mg/5 ml Oral Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of Baclofen Oral Solution contains 5mg baclofen.
Excipients with known effect:
Each 5 ml of oral solution contains 10 mg of Sodium methyl
parahydroxybenzoate,
0.70mg of (E219); Sodium propyl parahydroxybenzoate and 1.250g of
(E217); Liquid
maltitol. (E965); 4.48 mg of Sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral solution.
A clear, almost colourless solution with a raspberry odour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
Also 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 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, syringomyelia, tranverse myelitis, traumatic paraplegia or
paraparesis, and
compression of the spinal cord.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Before starting treatment with