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Active substance: BACLOFEN

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Baclofen Tablets 10 mg

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 or pharmacist.
• 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 or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet

1. What Baclofen is and what it is used for
2.  hat you need to know before you take
3. How to take Baclofen
4. Possible side effects
5. How to store Baclofen
6. Contents of the pack and other


1. What Baclofen is and what it is
used for
Baclofen Tablets contain the active substance
baclofen, which is a muscle-relaxant drug.
Baclofen is used to reduce and relieve the
excessive tension in your muscles (spasms)
occurring in various illnesses such as cerebral
palsy, multiple sclerosis, cerebrovascular
accidents, spinal cord diseases and other
nervous system disorders.

2. What you need to know before
you take Baclofen
Do not take Baclofen:

• if you are allergic to baclofen or any of the
other ingredients of this medicine (listed
in section 6). Signs of an allergic reaction
include rash, itching and swelling of the
face, lips, throat or tongue
• if you have ever had a stomach ulcer.

Warnings and precautions

Talk to your doctor or pharmacist before
taking Baclofen:
• if you suffer from a mental disorder
• if you suffer from liver or kidney disease
• if you have breathing difficulties or
lung disease
• if you have diabetes as your doctor may
want to monitor your condition
• if you have suffered from a stroke
• if you suffer from epilepsy
• if you have difficulty urinating (urinary
• if you suffer from Parkinson’s disease
• if you being treated for high blood
• if you are pregnant or breast-feeding.
If you are going to have an operation
when you will have a general anaesthetic,
tell the doctor or dentist that you are
taking Baclofen.
Your doctor may do regular blood tests to
monitor your liver function.

Children and adolescents

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

Other medicines and Baclofen

Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
You must tell your doctor if you are already
taking any of the following medicines:
• other medicines to relax muscles
e.g. tizanidine
• medicines to treat mood disorders such
as lithium or tricyclic depressants such
as amitriptyline
• medicines for high blood pressure
e.g. diltiazem
• medicines which affect the kidney,
e.g. ibuprofen
• medicines for Parkinson’s disease
e.g. levodopa and carbidopa
• medicines which slow down the
nervous system, such as anti-histamines
(e.g. promethazine), sedatives
(e.g. temazepam), opiates for pain relief
(e.g. morphine, fentanyl) and anti-epileptic
medicines (e.g. carbamazepine).

Baclofen with alcohol

Do not drink alcohol whilst taking Baclofen.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think
you may be pregnant or planning to have
a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Do not take Baclofen during pregnancy
unless your doctor tells you otherwise.
Although very small amounts of Baclofen
pass into breast milk, your doctor will discuss
with you whether you should breast-feed
whilst taking this medicine.

Driving and using machines

Some people may feel drowsy and/or dizzy
or have problems with their eyes while they
are taking these tablets. If this happens, you
should not drive or do anything that requires
you to be alert (such as operating tools or
machinery) until these effects have worn off.

Baclofen contains lactose

This medicine contains lactose, which is
a type of sugar. If you have been told by
your doctor that you have an intolerance
to some sugars, contact your doctor before
taking this medicine.

3. How to take Baclofen
Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
You will be started on a low dose and this
will be increased gradually over a few days,
under the supervision of doctor, until you are
having the dose which is right for you.
If the starting dose is too high, or if the dose
is increased too quickly, you may experience
side effects, particularly if you are elderly,
have kidney problems or have had a stroke.


The recommended dose is 5 mg Baclofen
(half a tablet) 3 times a day for 3 days, then
• 10 mg Baclofen (1 tablet) 3 times a day for
the next 3 days, then
• 15 mg Baclofen (one and half tablets)
3 times a day for 3 days, then
• 20 mg Baclofen (2 tablets) 3 times a day
for the next 3 days.
The maximum daily dose is 100 mg except
if you are in hospital when a higher dose
may be used.

Elderly patients

Elderly patients will usually start with a
smaller daily dose of Baclofen.

Patients with kidney problems

You will probably be given a much lower
dose. The doctor will decide what the dose
should be.

Use in children and adolescents

Children’s treatment is adjusted to their
body weight. Children’s treatment usually
starts with a 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. Other forms of this
medicine may be more suitable for children,
ask your doctor or pharmacist.

How to take the tablets

You should take the tablets with food or a
milk drink, especially if you feel sick when
you take them. Baclofen may be taken just
at night-time to help painful night cramps or
approximately 1 hour before doing specific
tasks such as washing or physiotherapy,
which are helped by taking Baclofen. Your
doctor will tell you what is best for you.

If you take more Baclofen than
you should

If you take more Baclofen than you have
been prescribed, contact your doctor
or local hospital immediately. Take the
medicine with you.

If you forget to take Baclofen

If you forget to take a dose, take the next
dose at the usual time. Do not take a double
dose to make up for a forgotten dose.

If you stop taking Baclofen

Do not stop taking Baclofen suddenly
unless your doctor tells you. If you stop
taking your Baclofen Tablets without
gradually reducing the dose you may
suffer from unpleasant side effects such
as muscle spasms and increased muscle
rigidity, fast heart rate, fever, hallucinations,
changes in mood and emotion, confusion,
mental disorders, feeling persecuted or
convulsions (fits).
If you have any further questions on the
use of this medicine, ask your doctor
or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody
gets them.
If you have breathing difficulties, stop
using baclofen and tell your doctor or go
to your nearest hospital emergency room
immediately as you may need urgent
medical treatment

Other side effects include:

5. How to store Baclofen
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the carton after
“EXP”. The expiry date refers to the last day
of that month.
Store in a dry place below 25°C. Protect
from light.
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. Content of the pack and
other information
What Baclofen contains

• The active substance is baclofen. Each
tablet contains 10 mg of baclofen.
• The other ingredients are microcrystalline
cellulose, lactose monohydrate, calcium
phosphate, silica, magnesium stearate and
sodium starch glycollate.

Very Common (may affect more than 1 in
10 people)
• drowsiness
• sleepiness
• feeling sick.

What Baclofen looks like and contents of
the pack

Common (may affect up to 1in 10 people)
• dry mouth
• headache, dizziness or light-headedness
• fatigue
• excessively weak limbs or feeling tired and
exhausted, aching muscles
• unsteadiness, trembling or other problems
with muscle control
• confusion, depression
• mood changes with extreme excitement,
• hallucinations (seeing or feeling or
hearing things that are not really there) or
• low blood pressure (fainting)
• stomach upset including retching,
vomiting, diarrhoea or constipation
• sleeplessness
• skin rash, excessive sweating
• rapid, uncontrollable movements of the
eyes or other eyesight problems
• pain when passing urine or passing more
urine than normal

Baclofen Tablets are available in containers
of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56,
60, 84, 90, 100, 112, 120, 168, 180, 250 or
500 tablets and in blister packs of 5, 7, 10,
14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100,
112, 120, 168 and 180 tablets.

Baclofen tablets are flat bevelled edge
tablets marked “BN” breakline “10” on one
side and “G” on the reverse.

Not all pack sizes may be marketed.
Marketing Authorisation Holder: Mylan,
Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer: Gerard Laboratories,
35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13 Eire
This leaflet was last revised in 12/2013.

Rare (may affect up to 1 in 1,000 people)
• numbness or pins and needles in hands
or feet
• increased muscle spasm
• slurred or slow speech
• disturbed sense of taste
• stomach pain
• difficulty passing urine,
• problems getting or keeping an erection
• liver problems. Your doctor may do regular
blood tests to monitor your liver function
Very rarely (may affect up to 1 in
10,000 people)
• low body temperature (hypothermia).
Not known (frequency cannot be
estimated from available data)
• raised, itchy rash (‘nettle rash’)
• slow heart beat
• increase in blood sugar
• symptoms caused by stopping
treatment suddenly (see ‘How to take
Baclofen Tablets’)
If have epilepsy you may experience more
convulsions than usual.
If you are elderly or if you have mental
problems or you have suffered from a
stroke, the side effects may be more serious.

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 By reporting
side effects, you can help provide more
information on the safety of this medicine.


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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.