BACLOFEN TABLETS 10 MG

Active substance: BACLOFEN

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170 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Children and adolescents:
Baclofen tablets are not suitable for use in children under
33 kg body weight.

TBC

(Baclofen)

Please read this product information carefully before
you or your child is given Baclofen since it contains
important information.
• 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. Do not pass
it on to others. It may harm them, even if their
symptoms are the same as yours
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Baclofen is and what it is used for
2. Before you take Baclofen
3. How to take Baclofen
4. Possible side effects
5. How to store Baclofen
6. Further information.

The daily dose may be taken divided up in to more than
three doses, or 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.

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.

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

You must tell your doctor if you are already taking any
of the following medicines:
• antidepressants such as Clomipramine, Amytriptiline
or Dothiepin as muscle relaxant effect can increase
• medicine to help lower blood pressure as your
doctor may want to monitor your blood pressure
• Ibuprofen (usually for arthritis or pain relief),
Levodopa and Carbidopa for Parkinson's Disease,
Fentanyl or other medicines acting on the central
nervous system as sedative effects can increase
• Lithium as Baclofen can increase your restlessness.

TBC

BACLOFEN TABLETS
10 mg

Taking Baclofen with food and drink - You should take
the tablets with food or a drink of milk, especially if you
feel sick when you take them. Do not drink alcohol
whilst taking Baclofen.

1. WHAT BACLOFEN IS AND WHAT IT IS USED FOR

Patients with special requirements - Patients with
kidney problems or having haemodialysis or some
patients with spasticity associated with the brain will
need a smaller daily dose of Baclofen.

Pregnancy and breast-feeding - Ask your doctor or
pharmacist for advice before taking any medicine. Do
not take Baclofen within your pregnancy, unless your
doctor tells you otherwise. Although only small amounts
of baclofen pass into breast milk, contact your doctor
before breast-feeding.

Do not take Baclofen if:
• you are allergic to baclofen or any of the other
ingredients of Baclofen
• you have a stomach ulcer.

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.

3. HOW TO TAKE BACLOFEN

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 worsening of spasticity, anxiety,
hallucinations, changed behaviour, confusion, fits or
palpitations.

Always take Baclofen exactly as your doctor has told you.
You should check with your doctor or pharmacist if you
are not sure. Your doctor will adjust the dose of Baclofen
so that it is the most appropriate for you.

Very rarely your body temperature may fall. If you have
epilepsy you may experience more convulsions than
usual.
If you are elderly or if you have mental problems the side
effects may be more serious.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE BACLOFEN
Keep out of the reach and sight of children. Do not use
Baclofen 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.
6. FURTHER INFORMATION
What Baclofen contains - The active substance is
baclofen. Each tablet contains 10 mg of baclofen. The
other ingredients are microcrystalline cellulose, lactose,
calcium phosphate, silica, magnesium stearate and
sodium starch glycollate.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Baclofen can cause side effects,
although not everybody gets them.

Marketing Authorisation Holder: Mylan, Potters Bar,
Hertfordshire, EN6 1TL. United Kingdom.

Very common side effects (that affect more than
1 person in 10) mainly occur at the start of treatment and
may weaken after a short period of treatment or when
your doctor adjusts the dose: • drowsiness • feeling sick.

Adults - The usual starting 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.
After gradual increasing of your dose the usual daily
dose is 60 mg Baclofen (2 tablets three times a day). Your
doctor may increase the dose prescribed up to 100 mg
Baclofen per day or sometimes more if you
are in hospital.
00000000

What Baclofen looks like and contents of the pack Your medicine is in the form of a tablet. 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. Not
all pack sizes may be marketed.

Manufacturer: Gerard Laboratories, 35/36 Baldoyle
Industrial Estate, Grange Road, Dublin 13, Eire.

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

This leaflet was last revised in: 01/2013

Mylan Version Number - 08
17-DEC-2012

Job No. 37006659v2

09-JAN-2013

product category BACLOFEN
market UK 2012
packing site Gerard
product Baclofen 10mg Tab x84

Black
artwork code 10004679
superseded code 10003232

component type Leaflet

Dimensions Cutter
MA no. 04569/0158
new/revised Revised

change control ref. TBC
Marketing
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barcode N/A
dimensions

Customer (if applicable)
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font & point size Myriad Pro Regular 8pt

pharma code N/A

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Myriad Pro Bold 17pt

170 mm x 240 mm
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00000000 10004679

TBC

You must tell your doctor before taking your medicine if:
• you have taken a medicine containing baclofen
before and had an unusual or allergic reaction to it
such as a rash, itching, swelling of the face, lips,
throat or tongue
• you suffer from a mental disorder, especially if you
are taking Lithium
• you suffer from liver or kidney disease
• you have breathing difficulties or lung disease
• you have diabetes as your doctor may want to
monitor your condition
• you have recently suffered from a stroke
• you suffer from epilepsy
• you have difficulty urinating (urinary retention).

If you forget to take Baclofen - If you forget to take
Baclofen, take it as soon as you remember unless it is
nearly time for your next dose. Do not take a double
dose to make up for a forgotten dose, just carry on as
usual.

TBC

Important information about some of the ingredients
of Baclofen - This medicine contains 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.

2. BEFORE YOU TAKE BACLOFEN

Driving and using machines - Do not drive or operate
machinery or equipment if you feel drowsy whilst taking
Baclofen.

If you take more Baclofen than you should - If you take
more Baclofen than you have been prescribed, contact
your doctor immediately. Symptoms of overdose may
include muscle weakness, vomiting, feeling sick,
drowsiness, hallucinations, confusion, dilated or pinpoint
pupils, weak or shallow breathing, fainting and coma.

Rare side effects (that affect less than 1 person in 1,000
but more than 1 in 10,000): • pins and needles, difficulty
speaking, loss of taste • stomach pain, difficulty passing
urine, problems getting or keeping an erection • an
alteration in liver function tests may also occur. Your
doctor may do regular blood tests to monitor your liver
function.

240 mm

Your doctor has decided that you or your child needs this
medicine to help treat your condition.
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.

Use in children (0 to <18 years)
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.

Common side effects (that affect less than 1 person in 10
but more than 1 in 100): • dry mouth • dizziness and
light-headedness especially when standing • shortness
of breath or palpitations or fatigue • extreme tiredness,
blurred vision • confusion, depression, shaking • extreme
excitement, hallucinations (seeing or feeling or hearing
things that are not really there) or nightmares • excessive
muscle weakness or muscle pain • headache • stomach
upset, being sick, diarrhoea or constipation
• sleeplessness • skin rash, excessive sweating • rapid,
uncontrollable movements of the eyes • pain when
passing urine or passing more urine than normal.

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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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