BACLOPAR 10 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BACLOFEN

Available from:

Generics (UK) Limited

ATC code:

M03BX01

INN (International Name):

BACLOFEN

Dosage:

10 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other centrally acting agents

Authorization status:

Authorised

Authorization date:

1989-11-21

Patient Information leaflet

PAGE 1 OF 6
PACKAGE LEAFLET
PAGE 2 OF 6
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)
-
if you suffer from pulmonary insufficiency, where blood backflows into
the right side of the heart
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

Summary of Product characteristics

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 40mg of lactose
monohydrate.
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 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, 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 the individual patients
requirements while avoiding adverse effects or
interference with function depending on the acti