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BACLOFEN TABLETS BP 10MG

Active substance(s): BACLOFEN

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Package leaflet: Information for the patient

Baclofen 10mg tablets
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 belongs to a group of medicines called muscle relaxants.
These medicines work by acting on the central nervous system and
may be used for the relief of muscle spasms, cramping or tightness
caused by diseases such as:
• cerebral palsy
• diseases of the spinal cord
• meningitis
• motor neurone disease
• multiple sclerosis
• cerebrovascular accidents
• other injuries or diseases which affect the brain and nervous
system.

2 What you need to know before you take Baclofen

Tablets

Do not take Baclofen tablets if you

• are allergic to baclofen or to any of the other ingredients of this
medicine (listed in section 6)
• c urrently have a stomach ulcer
• have porphyria (an inherited condition causing skin blisters,
abdominal pain and brain or nervous system disorders).

Children and adolescents

Baclofen tablets are not suitable for use in children under 33kg body
weight.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Baclofen
tablets if you have
• problems with your lungs, heart, liver, kidney or bladder
• a mental illness as Baclofen tablets may make some of the
symptoms worse or cause new ones
• ever had stomach ulcers
• e pilepsy, may make the fits worse
• ever suffered any bleeding in the brain (a “stroke”)
•d
 iabetes mellitus
• been taking any medicines for high blood pressure
• muscle tension in the bladder.

Other medicines and Baclofen Tablets

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
• a nxiolytics or hypnotics (to help you sleep), taking these
medicines with Baclofen could make you very sleepy
•m
 edicines to lower high blood pressure or diuretics (water
tablets) as these could lower your blood pressure too much
• l evodopa (to treat Parkinson’s Disease), may cause worsening of
side effects
• l ithium (for depression), may aggravate symptoms of over activity
•N
 SAIDs (Non-Steroidal Anti-inflammatory Drugs) such as
ibuprofen, may cause baclofen to be removed from the body more
slowly
• t ricyclic antidepressants (eg amitriptyline or imipramine), may
cause an increase in the muscle relaxant effect
•m
 emantine (used in alzheimers disease), effects of Baclofen may
be changed
• a naesthetics, if you need an operation, tell your doctor or dentist
you are taking Baclofen tablets.

Baclofen and alcohol

Do not drink alcohol while you are taking Baclofen tablets. Alcohol
may increase the sedative effects of Baclofen tablets and make you
very sleepy.

Pregnancy and breast-feeding

You should not take Baclofen tablets if you are pregnant, planning
to become pregnant or are breast feeding. If you are pregnant or
breast-feeding, think you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for advice before taking this
medicine.

Driving and using machines

Baclofen tablets may make you feel drowsy, dizzy or light-headed
or less alert. Do not drive or use any tools or machines if you are
affected in this way.

Baclofen tablets contains lactose

If you have been told that you have intolerance to some sugars
contact your doctor before taking this medicine.

Tests

If you are diabetic or have liver disease your doctor may take regular
blood tests. As Baclofen tablets may cause certain blood levels to
rise.

Continued top of next column

Continued over page

148x210 Leaflet Reel Fed Profile (BST)

Baclofen Tablets 10mg x 84’s (UK)
colours/plates:

Baclofen 10mg 84 Tablets PIL- UK

1. Black

item no: AAAI7012

dimensions: 148 x 210

print proof no: 3

pharmacode:

origination date: 26.01.16

min pt size: 7

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 01.03.16

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1.
2.
3.

JDE No.:

50886006

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 6681
Date Sent:
22/01/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

3 How to take Baclofen Tablets

Always take this medicine exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Swallow the tablets whole, with a glass of water. If you feel sick you may
find taking baclofen with a milky drink or with food makes you feel better.

The recommended dose is

•A
 dults: 5mg three times a day gradually increasing up to 20mg three
times a day. In some cases your doctor may decide on a dose of up to
100mg a day.
If you suffer from painful muscle spasms your doctor may recommend
that you take baclofen as a single dose at night. Alternatively it may be
recommended you take baclofen one hour before performing specific
tasks, such as shaving or dressing, to improve your mobility.
• E lderly: Your doctor may give you a smaller dose
•C
 hildren: treatment should be calculated according to body weight and
given in 2-4 divided doses. Your doctor may increase the dosage slowly
to reach the appropriate dose. A more appropriate dosage form may
also be used.
•C
 hildren below 8 years of age: the maximum daily dose should not
exceed 40mg per day
•C
 hildren above 8 years of age: the maximum daily dose should not
exceed 60mg per day
• Baclofen tablets are not suitable for use in children below 33kg body
weight.
•P
 atients with kidney problems: Your doctor may give you a smaller
dose such as 5mg a day.

If you take more Baclofen tablets than you should

If you (or someone else) swallow a lot of tablets at the same time, or you
think a child may have swallowed any, contact your nearest hospital
casualty department or tell your doctor immediately. Signs of an overdose
include drowsiness, breathing difficulties, changes in consciousness or
coma (unrousable unconsciousness). Also muscle weakness or spasm,
confusion, hallucinations, agitation, fits, low blood pressure, slow heart
beat, feeling or being sick, diarrhoea, excessive saliva production, reflex
problems.

If you forget to take Baclofen tablets

Do not take a double dose to make up for a forgotten dose. If you forget
to take a dose take it as soon as you remember it and then take the next
dose at the right time.

If you stop taking Baclofen tablets

Do not stop taking your medicine without telling your doctor as he
may wish to gradually reduce the number of tablets you take before
stopping them completely. If you stop taking Baclofen tablets suddenly,
you may experience unpleasant side effects including anxiety, confusion,
hallucinations, convulsions, unusual behaviour, fast heart beat and
temporary worsening of the condition being treated.

• s tomach: feeling or being sick, retching, constipation, diarrhoea, dry
mouth, changes in taste
•m
 uscles: muscle pain or weakness, lack of muscle control or muscle
tension, tremor, irregular and jerky movements, increase in spastic
symptoms
•o
 ther: changes in the liver function (shown by a blood test), excessive
sweating, shallow heartbeat, visual disturbances, low blood pressure,
frequent or painful passing of urine, bed wetting, difficulty breathing, low
body temperature (hypothermia).
Withdrawal symptoms: see Section 3, ‘If you stop taking Baclofen
tablets.’

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

5 How to store Baclofen Tablets

Keep this medicine out of the sight and reach of children.
Store below 25°C and protected from light.
Do not use Baclofen tablets after the expiry date stated on the carton
after Exp. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6 Contents of the pack and other Information
What Baclofen tablets contain

• T he active substance (the ingredient that makes the tablet work) is
baclofen. Each tablet contains 10mg of the active ingredient
• T he other ingredients are lactose, pregelatinised maize starch, maize
starch, magnesium stearate, water.
What Baclofen tablets looks like and contents of the pack
Baclofen tablets are white to off-white, uncoated tablets.
Pack sizes are 84 tablets.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised March 2016

If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.

4 Possible Side Effects

Like all medicines, Baclofen tablets can cause side-effects, although not
everybody gets them.

Tell your doctor if you notice any of the following side effects or notice
any other effects not listed:
• a llergic reaction: skin rashes
•n
 ervous system: sedation during the day, drowsiness, confusion,
depression, insomnia, light-headedness, euphoria (extreme sense of
well being), hallucinations, nightmares, headache, dizziness, exhaustion,
unusual tiredness or weakness, ‘pins and needles’, fits, involuntary eye
movements, difficulty focusing
Continued top of next column
50886006 AAAI7012

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)

Baclofen Tablets 10mg x 84’s (UK)
colours/plates:

Baclofen 10mg 84 Tablets PIL- UK

1. Black

item no: AAAI7012

dimensions: 148 x 210

print proof no: 3

pharmacode:

origination date: 26.01.16

min pt size: 7

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 01.03.16

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1.
2.
3.

JDE No.:

50886006

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 6681
Date Sent:
22/01/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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