Baclofen 10mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Baclofen

Tilgjengelig fra:

Waymade Healthcare Plc

ATC-kode:

M03BX01

INN (International Name):

Baclofen

Dosering :

10mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 10020200

Informasjon til brukeren

Dimensions:
148 X 210 MM
Created By:
DTAWDE
Artwork Code:
A0030/O/PIL/A2
Bar Code:
-
Font Type:
ARIAL NARROW
Font Size:
7.5 PT
Printing Colours:
Non-Printing Colours:
Black
Profile
Final Preparation Date For Submission: 06/03/2020
Packing Site Technical Approval:
00/00/0000
Authority Approval Date:
00/00/0000
Latest Implementation Deadline:
00/00/0000
Print Proof Approval:
00/00/0000
Product:
MA Holder:
ACTIVASE
PL No.:
28444/0030
Pack Size:
ALL
Livery:
ACTIVASE
Manufacturer:
-
Market:
UK
Component:
LEAFLET
BACLOFEN
10 MG TABLETS
OTHER SPECIAL WARNINGS

Be careful when drinking alcohol - it may affect you more than
usual

Some people being treated with baclofen have had thoughts
of harming or killing themselves or have tried to kill
themselves. Most of these people also had depression, had
been using alcohol excessively or were prone to having
thoughts of killing themselves. If you have thoughts of
harming or killing yourself at any time, speak to your doctor
straightaway or go to a hospital. Also, ask a relative or close
friend to tell you if they are worried about any changes in your
behaviour and ask them to read this leaflet.

Your doctor may want to give you a check up from time to
time while you are taking Baclofen Tablets.

If you are going to have an operation of any kind, make sure
that the doctor knows that you are taking Baclofen Tablets.
CHILDREN AND ADOLESCENTS:
Baclofen tablets are not suitable for use in children under 33 kg
body weight.
OTHER MEDICINES AND BACLOFEN:
Tell your doctor or pharmacist if you are taking, or have recently
taken or might take any other medicines including medicines
obtained without prescription:
Check with your doctor before taking these tablets if you are
taking any of the following;

Medicines for depression, e.g. tricyclic antidepressants, such
as imipramine or amitriptyline

Medicines for muscle relaxation e.g. tizanidine

Morphine

Lithium

Medicines for high blood pressure e.g. diltiazem

Medicines for arthritis or pain, e.g. ibuprofen

Preparatomtale

1
NAME OF THE MEDICINAL PRODUCT
BACLOFEN TABLETS BP 10mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg Baclofen PhEur.
Excipient with known effect:_ _Lactose PhEur 89.50mg
_ _
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White to off-white uncoated tablets.
White to off-white, circular, biconvex uncoated tablets impressed
“C” on one face,
and the identifying letters “B” “L” on either side of a
central division line on the
reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Baclofen is indicated for:
1) The relief of spasticity of voluntary muscle resulting from
disorders such as multiple
sclerosis and other spinal lesions, including tumours of the spinal
cord, motor neurone
disease, syringomyelia, transverse myelitis and traumatic partial
section of the spinal cord.
2) Adults and children in the relief of spasticity of voluntary muscle
arising from conditions
such as cerebral palsy, cerebrovascular accidents, traumatic head
injury and meningitis.
Treatment with Baclofen should not be initiated until the spastic
state has become stabilised
and it should be administered selectively; it is most likely to be of
benefit to patients whose
spasticity constitutes a handicap to activities 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,
transverse myelitis, traumatic paraplegia or paraparesis, and
compression of the spinal cord.
4.2
POSOLOGY