Baclopar 10 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Baclofen

Available from:

Viatris Limited

ATC code:

M03BX; M03BX01

INN (International Name):

Baclofen

Pharmaceutical form:

Tablet

Therapeutic area:

Other centrally acting agents; baclofen

Authorization status:

Marketed

Authorization date:

1989-11-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BACLOPAR 10 MG TABLETS
(baclofen)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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 Baclopar is and what it is used for
2.
What you need to know before you take Baclopar
3.
How to take Baclopar
4.
Possible side effects
5.
How to store Baclopar
6.
Contents of the pack and other information
1.
WHAT BACLOPAR IS AND WHAT IT IS USED FOR
Baclopar contains the active ingredient, baclofen. Baclofen is a
muscle-relaxant drug belonging to a group of
medicines called antispasticity agents. Baclopar is used to reduce and
relieve 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BACLOPAR
DO NOT TAKE BACLOPAR:
-
if you are allergic to baclofen or any of the other ingredients of
this medicine (listed in section 6)
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING BACLOPAR IF YOU
-
have porphyria (an inherited condition causing skin blisters,
abdominal pain and brain or nervous
system disorders).
-
have Parkinson’s disease
-
suffer from any mental health condition such as schizophrenia,
psychosis, depressive or manic
disorders or confusional states
-
recently had a stroke or have reduced blood flow to the brain.
-
have breathing difficulties or lung disease
-
have a history of stomach or gut ulcers
-
have a history of fits or suffer from ep

Summary of Product characteristics

Health Products Regulatory Authority
15 March 2024
CRN00F29Q
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Baclopar 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of baclofen.
Excipient with known effect: Each tablet contains 40 mg of lactose
monohydrate and 20 mg of Sodium starch glycolate (Type
A).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
White flat bevel-edge tablet, marked “BN” breakline “10” on
one side with “G” logo on the reverse.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Baclopar is indicated for the relief of voluntary muscle spasticity as
occurs in conditions such as multiple sclerosis and spinal
cord lesions including syringomyelia, transverse myelitis and motor
neurone disease.
Baclopar is also indicated in adults for the management of spasticity
of cerebral origin including meningitis, cerebral palsy,
traumatic head injury, cerebrovascular accident.
Patient selection is important when initiating Baclopar therapy. It is
of most benefit in relief of spasticity which is seriously
interfering with activity. Treatment should not be commenced until the
spastic state has been stabilised.
_Paediatric Population_
Baclofen is indicated in patients below 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, transverse myelitis, traumatic paraplegia or
paraparesis, and compression of the spinal cord.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Titration of the dose is necessary to meet