BACLOFEN 10MG TABLETS

Active substance: BACLOFEN

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BACLOFEN 10 mg TABLETS
baclofen

Taking other medicines
Talk to your doctor if you are taking any of the
following:
PACKAGE LEAFLET: INFORMATION FOR THE USER
• drugs to lower your blood pressure, including ACE
inhibitors e.g. captopril
Read all of this leaflet carefully before you start taking • tricyclic antidepressants e.g. amitriptyline,
this medicine.
clomipramine, dothiepin or dosulepin
• Keep this leaflet. You may need to read it again.
• drugs which also affect the kidney such as ibuprofen
• If you have any further questions, ask your doctor or • lithium
pharmacist.
• levodopa plus carbidopa, for Parkinson’s Disease
• This medicine has been prescribed for you. Do not
• synthetic opiates e.g. dihydrocodeine or tramadol.
pass it on to others. It may harm them, even if their
Please tell your doctor or pharmacist if you are taking
symptoms are the same as yours.
• If any of the side effects get serious, or if you notice or have recently taken any other medicines, including
medicines obtained without a prescription.
any side effects not listed in this leaflet, please tell
Taking Baclofen with food and drink
your doctor or pharmacist.
You should be aware that taking alcohol with Baclofen
may cause drowsiness.
1. What Baclofen is and what it is used for
Pregnancy and breast-feeding
2. Before you take Baclofen
Ask your doctor or pharmacist for advice before taking
3. How to take Baclofen
any medicine.
4. Possible side effects
You should not use Baclofen during pregnancy unless
5. How to store Baclofen
your doctor advises you to do so. Tell your doctor if
6. Further information
you are pregnant, or planning to become pregnant.
Only a very small amount of Baclofen passes into
WHAT BACLOFEN IS AND WHAT IT IS USED
breast milk. Your doctor will discuss with you whether
FOR
you should breast-feed whilst taking Baclofen.
Please read this product information carefully before
Driving and using machines
you or your child is given Baclofen since it contains
Baclofen may cause drowsiness, decreased alertness,
important information
dizziness, incoordination, and shaking. If you are
Your doctor has decided that you or your child needs
affected, do not drive or operate machinery.
this medicine to help treat your condition.
Important information about some of the ingredients
Baclofen is a muscle relaxant that acts on the central
of Baclofen
nervous system.
Patients who are intolerant to lactose should note that
Baclofen Tablets are used:
Baclofen tablets contain a small amount of lactose. If
• to treat muscle rigidity caused by brain injury
you have been told by your doctor that you have an
• to reduce and relieve cramping, muscle rigidity, the intolerance to some sugars, contact your doctor before
excessive tension in your muscles (spasms)
taking this medicinal product.
occurring in various illnesses such as cerebral palsy,
HOW TO TAKE BACLOFEN
multiple scelrosis, cerebrovascular accidents, spinal
cord diseases, injuries to the spinal cord and other
Always take Baclofen exactly as your doctor has told
nervous system disorders.
you. Your doctor will tell you exactly how long you
Your doctor may sometimes prescribe these tablets for should take this medicine. You should check with your
other reasons. If you have any questions ask your
doctor or pharmacist if you are not sure
doctor or pharmacist for information.
The tablets should be swallowed preferably with a
drink of water. The timing and usual range of doses is:
BEFORE YOU TAKE BACLOFEN
• Use in children (0 to <18 years)
Do NOT take Baclofen if you:
Children’s treatment is adjusted to their body
• are allergic (hypersensitive) to baclofen or any of the
weight. Children’s treatment usually starts with very
other ingredients of this medicine. These are listed
low dose (approximately 0.3 mg/kg/day), in 2-4
at the end of the leaflet.)
divided doses (preferably in 4 doses). The dosage is
• suffer from stomach ulcers.
then gradually increased until it becomes sufficient
for the child's individual requirements, this may be
Children and adolescents:
between 0.75 and 2 mg/kg body weight. The total
Baclofen tablets are not suitable for use in children
daily dose should not exceed a maximum of
under 33 kg body weight.
40 mg/day in children below 8 years of age. In
Take special care with Baclofen
children over 8 years of age a maximum daily dose
Talk to your doctor before you start to take this
of 60 mg/day may be given. Baclofen tablets are not
medicine if you:
suitable for use in children below 33 kg body weight.
• suffer from schizophrenia, psychotic, depressive or
• Adults
manic disorders (any mental illness)
The dosage you receive will gradually be increased
• suffer from Parkinson’s disease
until your condition is under adequate control. The
• suffer from confusion
dosage schedule given below is only a guide and
• suffer from epilepsy
may vary from person to person.
• have had a stroke
• Start with 5 mg three times a day for three days
• suffer from liver or kidney problems
• Then 10 mg three times a day for the next three days
• have Diabetes Mellitus
• Then 15 mg three times a day for the next three days
• suffer from heart problems or have breathing
• Finally 20 mg three times a day for three days.
difficulties due to weak muscles. Your doctor will
want to carefully monitor your treatment
The usual maintenance dose is 20 mg three times a day
• suffer from porphyria
(60 mg a day). The maximum dose is 100 mg a day.
• have problems with your bladder muscles (difficulty
urinating)
• are pregnant or breast-feeding (see section 2:
Pregnancy and breast-feeding).

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• 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
You may be started on a lower dose of Baclofen e.g.
5 mg a day. The doctor will decide what the dose
should be.
If you take more Baclofen than you should
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 or your doctor immediately.
An overdose is likely to cause coma, drowsiness, loss
of consciousness and breathing problems.
Please take this leaflet, any remaining tablets, and the
container with you to the hospital or doctor so that
they know which tablets were consumed.
If you forget to take Baclofen
If you forget to take a tablet, take one as soon as you
remember, unless it is nearly time to take the next one.
Do NOT take a double dose to make up for a forgotten
dose. Take the remaining doses at the correct time.
If you stop taking Baclofen
Do NOT stop taking Baclofen without talking to your
doctor first even if you feel better.
Do NOT stop taking your tablets suddenly because
unwanted effects such as muscle spasms and
increased muscle rigidity, difficulty in controlling
movement, fast heart rate, fever, confusion,
hallucinations, changes in mood and emotion, mental
disorders, anxiety, manic or paranoid state, or fits may
occur. Your doctor will reduce your dose gradually.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

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POSSIBLE SIDE EFFECTS

Like all medicines, Baclofen can cause side effects,
although not everybody gets them. Side effects may
be more serious in patients with a history of
psychiatric 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
hives).
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
shaking
difficulty focusing and controlling eye movements
skin rash
excessive sweating
retching, being sick, constipation, diarrhoea or
stomach problems.
• needing to pass water often
• pain or difficulty passing water
• incontinence.
Uncommon (affecting less than one person in 100 but
more than one person in 1,000):
• speech disorder
• pins-and-needles
• fits (particularly in epileptics)
• unusual taste sensations
• abdominal pain
• impotence (inability to get or maintain an erection)
• inability to pass water
• abnormal liver function leading to changes in blood
sugar or blood levels of certain liver enzymes.
Very rare (less than 1 person in 10,000; includes
isolated reports)
• hypothermia (low body temperature).
Not known (cannot be estimated from available data)
• nettle rash.
Some patients have experienced an unexpected
(paradoxical) increase in involuntary muscle stiffness
(spasticity).
If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

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HOW TO STORE BACLOFEN

Keep out of the reach and sight of children. Store in a
dry place at or below 25°C 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.

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FURTHER INFORMATION

What Baclofen tablets contain:
• The active ingredient is baclofen
• The other ingredients are lactose, microcrystalline
cellulose, sodium starch glycolate and magnesium
stearate.
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: February 2012
PL 00289/0243
83914-W

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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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