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Active substance: BACLOFEN

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Baclofen 10mg tablets
Read all of this leaflet carefully before
you start taking this medicine.
• Keep this leaflet. You may need to read it

•  f you have any further questions, ask your
doctor or pharmacist.
•  his medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
•  f any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or

In this leaflet:
1 What Baclofen tablets are and
what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further 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
•  ther injuries or diseases which affect the brain and
nervous system.

2 Before you take

Do not take Baclofen tablets and tell your
doctor if you

•  re allergic (hypersensitive) to baclofen or to any of
the other ingredients in your tablets (see section 6)
• currently have a stomach ulcer
• have porphyria (an inherited condition causing skin

blisters, abdominal pain and brain or nervous system

Continued top of next column

Children and adolescents

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

Check with your doctor or pharmacist before
taking Baclofen tablets if you have

• problems with your heart, liver, kidney or bladder
•  mental illness as Baclofen tablets may make some of
the symptoms worse or cause new ones
• ever had stomach ulcers
• epilepsy, may make the fits worse
• ever suffered any bleeding in the brain (a “stroke”)
• diabetes mellitus
• been taking any medicines for high blood pressure
• muscle tension in the bladder.

Taking other medicines

Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription. Especially:
• anxiolytics or hypnotics (to help you sleep), taking

these medicines with Baclofen could make you very
• medicines to lower high blood pressure or diuretics

(water tablets) as these could lower your blood
pressure too much
• levodopa (to treat Parkinson’s Disease), may cause

worsening of side effects
• lithium (for depression), may aggravate symptoms of

over activity
• NSAIDs (Non-Steroidal Anti-inflammatory Drugs) such

as ibuprofen, may cause baclofen to be removed from
the body more slowly
•  ricyclic antidepressants (eg amitriptyline or
imipramine), may cause an increase in the muscle
relaxant effect
•  emantine (used in alzheimers disease), effects of
Baclofen may be changed
•  naesthetics, if you need an operation, tell your
doctor or dentist you are taking Baclofen tablets.


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. Ask your doctor or pharmacist for advice before
taking any 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.
Continued over page

Important information about one of the
ingredients of Baclofen tablets

Baclofen tablets contain lactose (a type of sugar). If you have
been told that you have intolerance to some sugars contact
your doctor before taking this medicine.


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.

3 How to take

Always take Baclofen tablets 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.
• Adults: 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.
• Elderly: Your doctor may give you a smaller dose
• Children: 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.
- Children below 8 years of age: the maximum daily dose

should not exceed 40mg per day
- Children above 8 years of age: the maximum daily dose

should not exceed 60mg per day
-  aclofen tablets are not suitable for use in children below
33kg body weight.
• Patients 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.
Continued top of next column
AAAH3763 50828720

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

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:
• allergic reaction: skin rashes
• nervous 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
• stomach: feeling or being sick, retching, constipation,

diarrhoea, dry mouth, changes in taste
• muscles: muscle pain or weakness, lack of muscle control

or muscle tension, tremor, irregular and jerky movements,
increase in spastic symptoms
• other: changes in the liver function (shown by a blood test),

excessive sweating, shallow heart beat, visual disturbances,
low blood pressure, frequent or painful passing of urine,
bed wetting, difficulty breathing, low body temperature
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:
By reporting side effects you can help provide more
information on the safety of this medicine.

5 How to store

Keep out of the reach and sight of children.
Store below 25°C and protected from light.
Do not use Baclofen tablets after the expiry date stated on
the label/carton/bottle. The expiry date refers to the last day
of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the

6 Further Information

What Baclofen tablets contain:

• The active substance (the ingredient that makes

the tablet work) is baclofen. Each tablet contains
10mg of the active ingredient.
•  he other ingredients are lactose, pregelatinised
maize starch, maize starch, magnesium stearate,

What Baclofen tablets looks like and
contents of the pack

Baclofen tablets are white to off-white, uncoated
Pack sizes are 84 tablets.
Marketing Authorisation Holder and
Actavis, Barnstaple, EX32 8NS, UK.
Date of Revision: October 2014

Actavis, Barnstaple, EX32 8NS, UK

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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.