Baclofen 10mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Baclofen

متاح من:

Accord-UK Ltd

ATC رمز:

M03BX01

INN (الاسم الدولي):

Baclofen

جرعة:

10mg

الشكل الصيدلاني:

Oral tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 10020200; GTIN: 5012617005526

نشرة المعلومات

148x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Baclofen Tablets
10mg x 84 (UK)
148x210 (Reel Fed)
51003594
Leaflet for Blisters
1072
T. Hull
13/08/21
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DATE SENT:
DATE RECEIVED:
Item number:
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ORIGINATION DATE:
REVISION DATE:
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SUPPLIER:
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[e-mail]
BACLOFEN 10 MG TABLETS PIL - UK
Black
Profile
BBBB2481
M.Doak
16/09/2021
21/10/2021
M.Doak
148 x 210mm
7pt
Accord Barnstaple
N/A
N/A
3
Version 7
12.02.2020
German GTIN 14
(incorporating PZN):
N/A
Cartons and label leaflets only
(labels only when specified)
BACLOFEN 10MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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, pharmacist or nurse.
•
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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1 WHAT BACLOFEN TABLETS ARE AND WHAT THEY
ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
BACLOFEN TABLETS
3 HOW TO TAKE BACLOFEN TABLETS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE BACLOFEN TABLETS
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT BACLOFEN TABLETS ARE AND WHAT THEY ARE USED
FOR
Baclofen is a muscle-relaxant drug. Baclofen Tablets are used to
reduce and relieve the excessive tension in your muscles

خصائص المنتج

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