BACLOFEN 10MG TABLETS
Active substance(s): BACLOFEN
EAS1585b LEA BACLOFEN 10mg TAB TUK
PANTONE® GREEN C
• drugs which also affect the kidney such as
PACKAGE LEAFLET: INFORMATION FOR THE USER • levodopa plus carbidopa, for Parkinson’s Disease
• synthetic opiates e.g. dihydrocodeine or tramadol.
Read all of this leaflet carefully before you start
taking this medicine because it contains important Please tell your doctor or pharmacist if you are
information for you.
taking or have recently taken any other medicines,
• Keep this leaflet. You may need to read it again.
including medicines obtained without a prescription.
• If you have any further questions, ask your
Baclofen with food and alcohol
doctor or pharmacist.
You should be aware that taking alcohol with
• This medicine has been prescribed for you only.
Baclofen may cause drowsiness.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours. Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
• If you get any side effects, talk to your doctor or
may be pregnant or are planning to have a baby,
pharmacist. This includes any possible side
ask your doctor or pharmacist for advice before
effects not listed in this leaflet. See section 4.
taking this medicine.
What is in this leaflet
Only a very small amount of Baclofen passes into
1. What Baclofen is and what it is used for
breast milk. Your doctor will discuss with you
2. What you need to know before you take Baclofen whether you should breast-feed whilst taking
3. How to take Baclofen
4. Possible side effects
Driving and using machines
5. How to store Baclofen
Baclofen may cause drowsiness, decreased
6. Contents of the pack and other information
alertness, dizziness, incoordination, and shaking. If
What Baclofen is and what it is used for you are affected, do not drive or operate machinery.
Baclofen contains lactose
Your doctor has decided that you or your child
Patients who are intolerant to lactose should note
needs this medicine to help treat your condition.
that Baclofen tablets contain a small amount of
Baclofen is a muscle relaxant that acts on the
lactose. If you have been told by your doctor that
central nervous system.
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
How to take Baclofen
• to reduce and relieve cramping, muscle rigidity,
the excessive tension in your muscles (spasms)
Always take this medicine exactly as your doctor
occurring in various illnesses such as cerebral
has told you. Check with your doctor or pharmacist
palsy, multiple sclerosis, cerebrovascular
if you are not sure.
accidents, spinal cord diseases, injuries to the
spinal cord and other nervous system disorders. The tablets should be swallowed preferably with a
drink of water. The timing and usual range of doses is:
Your doctor may sometimes prescribe these tablets
• Use in children and adolescents
for other reasons. If you have any questions ask
(0 to <18 years)
your doctor or pharmacist for information.
Children's treatment is adjusted to their body
What you need to know before you take 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
Do not take Baclofen if you:
then gradually increased until it becomes sufficient
• are allergic to baclofen or any of the other
ingredients of this medicine (listed in section 6). for the child's individual requirements, this may be
between 0.75 and 2 mg/kg body weight. The total
• suffer from stomach ulcers.
daily dose should not exceed a maximum of
Children and adolescents:
40 mg/day in children below 8 years of age. In
Baclofen tablets are not suitable for use in children children over 8 years of age a maximum daily dose
of 60 mg/day may be given. Baclofen tablets are not
under 33 kg body weight.
suitable for use in children below 33 kg body weight.
Warnings and precautions
Talk to your doctor before taking Baclofen if you:
The dosage you receive will gradually be
• suffer from schizophrenia, psychotic, depressive
increased until your condition is under adequate
or manic disorders (any mental illness)
control. The dosage schedule given below is only
• suffer from Parkinson’s disease
a guide and may vary from person to person.
• suffer from confusion
• Start with 5 mg three times a day for three
• suffer from epilepsy
• have had a stroke
• Then 10 mg three times a day for the next
• suffer from liver or kidney problems
• have Diabetes Mellitus
• Then 15 mg three times a day for the next
• suffer from heart problems or have breathing
difficulties due to weak muscles. Your doctor will
• Finally 20 mg three times a day for three
want to carefully monitor your treatment
• suffer from porphyria
• have problems with your bladder muscles
The usual maintenance dose is 20 mg three
times a day (60 mg a day). The maximum dose
• are pregnant or breast-feeding (see section 2:
is 100 mg a day.
Pregnancy and breast-feeding).
Other medicines and Baclofen
You may be more likely to suffer from side
Tell your doctor or pharmacist if you are taking, have
effects, especially at the start of treatment.
recently taken or might take any other medicines.
Therefore, your doctor may start you on a lower
dose than the usual adult dosage.
Talk to your doctor or pharmacist if you are taking
any of the following:
• Patients with kidney problems
• drugs to lower your blood pressure, including
You may be started on a lower dose of Baclofen
ACE inhibitors e.g. captopril
e.g. 5 mg a day. The doctor will decide what the
• tricyclic antidepressants e.g. amitriptyline,
dose should be.
clomipramine, dothiepin or dosulepin
BACLOFEN 10 mg TABLETS
19 January 2018
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EAS1585b LEA BACLOFEN 10mg TAB TUK
Possible side effects
Like all medicines, this medicine 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.
• retching, being sick, constipation, diarrhoea or
• needing to pass water often
• pain or difficulty passing water
Rare (may affect up to 1 in 1,000 people):
• speech disorder
• 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 (may affect up to 1 in 10,000 people)
• hypothermia (low body temperature).
Not known (cannot be estimated from available data)
• nettle rash
• trouble breathing during sleep (sleep apnoea
• fits (particularly in epileptics)
Some patients have experienced an unexpected
(paradoxical) increase in involuntary muscle
Reporting of side effects
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:
www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more
information on the safety of this medicine.
How to store Baclofen
Keep this medicine out of the sight and reach of
Do not use this medicine after the expiry date that
is stated on the carton after “EXP”.The expiry date
refers to the last day of that month.
Store in a dry place at or below 25oC. Store in the
You may notice the following side effects when you Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
first start taking Baclofen, but they may lessen as
throw away medicines you no longer use. These
you get used to your medicine or if the dose is
measures will help protect the environment.
• 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
The following side effects have been reported at
the approximate frequencies shown:
Very common (may affect more than 1 in
• drowsiness and sleepiness
• feeling sick (nausea).
Common (may affect up to 1 in 10 people):
• shallow breathing
• exhaustion or lack of energy
• reduced heart function
• low blood pressure
• difficulty in sleeping
• changes in mood
• muscle weakness and pain
• dry mouth
• loss of co-ordination
• difficulty focusing and controlling eye movements
• skin rash
• excessive sweating
19 January 2018
PANTONE® GREEN C
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
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
Contents of the pack and other
What Baclofen tablets contains
• The active substance is baclofen.
• The other ingredients are lactose,
microcrystalline cellulose, sodium starch
glycolate and magnesium stearate.
What Baclofen tablets look like and contents of the
• Baclofen 10 mg Tablets are white, plain, flat
bevel-edged tablets. They are marked breakline
• 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
TEVA UK Limited, Eastbourne, BN22 9AG, UK
TEVA Gyógyszergyár Zrt. (TEVA Pharmaceutical
Works Private Limited Company), Debrecen,
Pallagi út 13, H-4042, Hungary
This leaflet was last revised in November 2017.
Page 2 of 4
THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE
Teva Pharmaceuticals Europe B.V
Meaning of Signature
Regulatory Affairs Approval
26-Jan-2018 03:12:42 PM
Page 4 of 4
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.