Baclofen 10mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Baclofen

Sẵn có từ:

Viatris UK Healthcare Ltd

Mã ATC:

M03BX01

INN (Tên quốc tế):

Baclofen

Liều dùng:

10mg

Dạng dược phẩm:

Oral tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 10020200; GTIN: 5016695280158 5016695008912

Tờ rơi thông tin

PACKAGE LEAFLET: INFORMATION FOR THE USER
BACLOFEN TABLETS 10MG
(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 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 Tablets contain the active substance baclofen, which is a
muscle-relaxant drug.
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BACLOFEN
DO NOT TAKE BACLOFEN:

if you are allergic to baclofen or any of the other ingredients of
this medicine (listed in
section 6). Signs of an allergic reaction include rash, itching and
swelling of the face, lips,
throat or tongue

if you have ever had a stomach ulcer.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Baclofen:

if you suffer from a mental disorder

if you suffer from liver or kidney disease

if you have breathing difficulties or lung disease

if you have diabetes as your doctor may want to monitor your condition

if you have suffered from a stroke

if you suffer from epilepsy

if you have difficulty urinating (urinary retention)

if you suffer from Parkinson’s disease

if y

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Baclofen Tablets 10 mg
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each tablet contains baclofen 10 mg.
Excipient with known effect: Each tablet contains 40 mg lactose
monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
A 7 mm flat bevelled edge tablet marked “BN” breakline “10” on
one side and “G” on the
reverse.
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
stabilized.
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
DOSAGE
Baclofen
is given orally in either tablet or liquid form. These two
formulations are
bioequivalent. Th