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Active substance(s): BACLOFEN

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09 June 2015


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Read all of this leaflet carefully before you start taking this
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
• This 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.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this listed. See section 4.


What Baclofen is and what it is used for
Before you take Baclofen
How to take Baclofen
Possible side effects
How to store Baclofen
Further information



Please read this product information carefully before you
or your child is given Baclofen since it contains important
Your doctor has decided that you or your child needs this
medicine to help treat your condition.


231-30-83914-X LEA BACLOFEN 10mg TAB TUK
Baclofen is a muscle relaxant that acts on the central
nervous system.

Taking other medicines
Talk to your doctor if you are taking any of the following:
• drugs to lower your blood pressure, including ACE
inhibitors e.g. captopril
• tricyclic antidepressants e.g. amitriptyline,
clomipramine, dothiepin or dosulepin
• drugs which also affect the kidney such as ibuprofen
• lithium
• levodopa plus carbidopa, for Parkinson’s Disease
• synthetic opiates e.g. dihydrocodeine or tramadol.
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Taking Baclofen with food and drink
You should be aware that taking alcohol with Baclofen
may cause drowsiness.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
You should not use Baclofen during pregnancy unless your
doctor advises you to do so. Tell your doctor if you are
pregnant, or planning to become pregnant.
Only a very small amount of Baclofen passes into breast
milk. Your doctor will discuss with you whether you should
breast-feed whilst taking Baclofen.
Driving and using machines
Baclofen may cause drowsiness, decreased alertness,
dizziness, incoordination, and shaking. If you are affected,
do not drive or operate machinery.
Important information about some of the ingredients of
Patients who are intolerant to lactose should note that
Baclofen tablets contain a small amount of lactose. If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.

Baclofen Tablets are used:
• to treat muscle rigidity caused by brain injury
• to reduce and relieve cramping, muscle rigidity, the
excessive tension in your muscles (spasms) occurring in
various illnesses such as cerebral palsy, multiple
Always take Baclofen exactly as your doctor has told you.
scelrosis, cerebrovascular accidents, spinal cord
Your doctor will tell you exactly how long you should take
diseases, injuries to the spinal cord and other nervous
this medicine. You should check with your doctor or
system disorders.
pharmacist if you are not sure
Your doctor may sometimes prescribe these tablets for


other reasons. If you have any questions ask your doctor
or pharmacist for information.



Do NOT take Baclofen if you:
• are allergic (hypersensitive) to baclofen or any of the
other ingredients of this medicine. These are listed at
the end of the leaflet.)
• suffer from stomach ulcers.
Children and adolescents:
Baclofen tablets are not suitable for use in children under
33 kg body weight.
Take special care with Baclofen
Talk to your doctor before you start to take this medicine if
• suffer from schizophrenia, psychotic, depressive or
manic disorders (any mental illness)
• suffer from Parkinson’s disease
• suffer from confusion
• suffer from epilepsy
• have had a stroke
• suffer from liver or kidney problems
• have Diabetes Mellitus
• suffer from heart problems or have breathing difficulties
due to weak muscles. Your doctor will want to carefully
monitor your treatment
• suffer from porphyria
• have problems with your bladder muscles (difficulty
• are pregnant or breast-feeding (see section 2: Pregnancy
and breast-feeding).

The tablets should be swallowed preferably with a drink of
water. The timing and usual range of doses is:
• Use in children (0 to <18 years)
Children's treatment is adjusted to their body weight.
Children's treatment usually starts with very low dose
(approximately 0.3 mg/kg/day), in 2-4 divided doses
(preferably in 4 doses). The dosage is then gradually
increased until it becomes sufficient for the child's
individual requirements, this may be between 0.75 and
2 mg/kg body weight. The total daily dose should not
exceed a maximum of 40 mg/day in children below 8 years
of age. In children over 8 years of age a maximum daily
dose of 60 mg/day may be given. Baclofen tablets are not
suitable for use in children below 33 kg body weight.
• Adults
The dosage you receive will gradually be increased until
your condition is under adequate control. The dosage
schedule given below is only a guide and may vary from
person to person.
• Start with 5 mg three times a day for three days
• Then 10 mg three times a day for the next three days
• Then 15 mg three times a day for the next three days
• Finally 20 mg three times a day for three days.
The usual maintenance dose is 20 mg three times a day
(60 mg a day). The maximum dose is 100 mg a day.
• Elderly
You may be more likely to suffer from side effects,
especially at the start of treatment. Therefore, your
doctor may start you on a lower dose than the usual
adult dosage.

• Patients with kidney problems
• shaking
You may be started on a lower dose of Baclofen e.g. 5 mg • difficulty focusing and controlling eye movements
a day. The doctor will decide what the dose should be.
• skin rash
• excessive sweating
If you take more Baclofen than you should
• retching, being sick, constipation, diarrhoea or stomach
If you (or someone else) swallow a lot of the tablets all
together, or if you think a child has swallowed any of the
tablets, contact your nearest hospital casualty department • needing to pass water often
• pain or difficulty passing water
or your doctor immediately.
• incontinence.
An overdose is likely to cause coma, drowsiness, loss of
consciousness and breathing problems.
Uncommon (affecting less than one person in 100 but
more than one person in 1,000):
Please take this leaflet, any remaining tablets, and the
• speech disorder
container with you to the hospital or doctor so that they
• pins-and-needles
know which tablets were consumed.
• fits (particularly in epileptics)
If you forget to take Baclofen
• unusual taste sensations
If you forget to take a tablet, take one as soon as you
• abdominal pain
remember, unless it is nearly time to take the next one. Do • impotence (inability to get or maintain an erection)
NOT take a double dose to make up for a forgotten dose.
• inability to pass water
Take the remaining doses at the correct time.
• abnormal liver function leading to changes in blood
sugar or blood levels of certain liver enzymes.
If you stop taking Baclofen
Do NOT stop taking Baclofen without talking to your doctor Very rare (less than 1 person in 10,000; includes isolated
first even if you feel better.
Do NOT stop taking your tablets suddenly because
• hypothermia (low body temperature).
unwanted effects such as muscle spasms and increased
Not known (cannot be estimated from available data)
muscle rigidity, difficulty in controlling movement, fast
• nettle rash.
heart rate, fever, confusion, hallucinations, changes in
mood and emotion, mental disorders, anxiety, manic or
Some patients have experienced an unexpected
paranoid state, or fits may occur. Your doctor will reduce
(paradoxical) increase in involuntary muscle stiffness
your dose gradually.
If you have any further questions on the use of this
Reporting of side effects
product, ask your doctor or pharmacist.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at:
Like all medicines, Baclofen can cause side effects,
although not everybody gets them. Side effects may be
By reporting side effects you can help provide more
more serious in patients with a history of psychiatric
information on the safety of this medicine.
illness, stroke and in the elderly.


If the following happens, stop taking the tablets and tell
your doctor immediately or go to the casualty department
at your nearest hospital:
• an allergic reaction (swelling of the lips, face or neck
leading to severe difficulty in breathing; skin rash or
This is a very serious but rare side effect. You may need
urgent medical attention or hospitalisation.
You may notice the following side effects when you first
start taking Baclofen, but they may lessen as you get used
to your medicine or if the dose is reduced:
• daytime drowsiness
• feeling sick.
If the feeling of sickness continues after your dosage has
been decreased, it may be lessened by taking Baclofen
with food or milk. Discuss this with your doctor.
The following side effects have been reported at the
approximate frequencies shown:
Very common (affecting more than one person in 10):
• drowsiness and sleepiness
• feeling sick (nausea).
Common (affecting less than one person in 10 but more
than one person in 100):
• nightmares
• light-headedness
• shallow breathing
• exhaustion or lack of energy
• dizziness
• headache
• reduced heart function
• low blood pressure
• confusion
• difficulty in sleeping
• changes in mood
• muscle weakness and pain
• hallucinations
• dry mouth
• loss of co-ordination



Keep out of the reach and sight of children. Store in a dry
place at or below 25ºC in the package or container
supplied. Do not transfer them to another container.
Do not use Baclofen after the expiry date that is stated on
the outer packaging. 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 environment.



What Baclofen tablets contain:
• The active ingredient is baclofen
• The other ingredients are lactose, microcrystalline
cellulose, sodium starch glycolate and magnesium
What Baclofen tablets look like and contents of the pack:
• Baclofen 10 mg Tablets are white, plain, flat bevel-edged
tablets. They are marked breakline and ‘3K2’
• Baclofen 10 mg Tablets are available in pack sizes of 10,
28, 30, 50, 56, 60, 84, 100, 250, 500, or 1000.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible
for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: June 2015
PL 00289/0243


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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.