Baclofen 10 mg Tablets

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

• If you are allergic to baclofen or any of the other ingredients of this medicine (listed in Section 6).
• If you have ever had a stomach ulcer.
• Warnings and precautions:
• Talk to your doctor or pharmacist before taking Baclofen:
• if you have suffered from a stroke
• if you suffer from epilepsy
• if you suffer from any mental illness
• if you are being treated for high blood pressure
• if you suffer from Parkinson’s Disease
• if you suffer from any liver, kidney or lung disease
• if you have diabetes
• if you have difficulty urinating (urinary retention)
• if you are pregnant or breast-feeding.
• if you have a history of drug abuse or dependence.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, and herbal preparations.

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Other medicines to relax muscles e.g. tizanidine
• Medicines to treat mood disorders e.g. lithium or tricyclic antidepressants such as amitriptyline.
• Medicines for high blood pressure e.g. diltiazem
• Other drugs which affect the kidney, e.g. ibuprofen
• Medicines for Parkinson’s Disease e.g. levodopa orcarbidopa
• Medicines which slow down the nervous system e.g.anti-histamines such as promethazine, sedatives suchas temazepam, opiates for pain relief such as morphineand anti-convulsants (anti-epileptic medicines such ascarbamazepine)

Ask your doctor or pharmacist for advice before taking this medicine.

You should not take Baclofen during pregnancy unless your doctor advises you to do so. Tell your doctor if you are pregnant, or planning to become pregnant .If you have to take Baclofen during pregnancy, your unborn baby will also be exposed to Baclofen. After birth your baby may develop withdrawal symptoms such as convulsions (symptoms of withdrawal are described in the section “If you stop taking Baclofen Tablets”).

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.

Some people may feel drowsy and/or dizzy or have problems with their eyes while they are taking BaclofenTablets. 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.

Other special warnings

• Be careful when drinking alcohol – it may affect you more than usual.
• Some people being treated with baclofen have had thoughts of harming or killing themselves or have triedto kill themselves. Most of these people also haddepression, had been using alcohol excessively or were prone to having thoughts of killing themselves.
• If you have thoughts of harming or killing yourself at any time, speak to your doctor straightaway or go to a hospital. Also, ask a relative or close friend to tell you if they are worried about any changes in your behaviour and ask them to read this leaflet.
• Your doctor may want to give you a check-up from time to time while you are taking Baclofen Tablets.
• If you are going to have an operation of any kind, make sure that the doctor knows that you are taking Baclofen Tablets.

Baclofen Tablets are not suitable for use in children under33 kg body weight.

• The usual dose is 20 mg (2 tablets) three times a day.
• The maximum daily dose is 100 mg (10 tablets) except if you are in hospital when a higher dose may be used.

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 2mg/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 60mg/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.

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

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

You should not stop taking Baclofen Tablets suddenly. If the doctor decides to stop your treatment with Baclofen Tablets, the dose will be reduced gradually to prevent withdrawal symptoms such as muscle spasms and increased muscle rigidity, fast heart rate, fever, confusion, hallucinations, changes in mood and emotion, mentaldisorders, feeling persecuted or convulsions (fits).

Very Common: may affect more than 1 in 10 people

• Tiredness, sleepiness, nausea (feeling sick).

Common: may affect up to 1 in 10 people

• Excessively weak limbs or feeling tired and exhausted, aching muscles
• Headache, dizziness or light-headedness
• Breathing difficulties
• Sleeplessness
• Mood changes, confusion, hallucinations or nightmares
• Dry mouth
• Problems with their eyes
• Unsteadiness, trembling or other problems with muscle control
• Low blood pressure (fainting)
• Stomach problems including retching, vomiting, constipation and diarrhoea
• Excessive sweating, rash
• Increased need to pass urine or pain on passing urine.

Rare: may affect up to 1 in 1,000 people

• Numbness or tingling in hands or feet
• Increased muscle spasm
• Disturbed sense of taste
• Slurred or slow speech
• Stomach ache
• Liver problems
• Difficulty in passing urine
• Sexual problems in men, e.g. impotence
• Convulsions (particularly in epileptics).

Very rare: may affect up to 1 in 10,000 people

• Hypothermia (low body temperature)

Not known: frequency cannot be estimated from the available data

• Raised, itchy rash (urticaria – also known as nettle rashor hives).
• Slow heart beat.
• Increase in blood sugar.
• Trouble breathing during sleep (sleep apnoea syndrome)
• Symptoms caused by stopping treatment suddenly (see‘3. How to take Baclofen Tablets’).

If any of the symptoms become troublesome, or if younotice anything else not mentioned here, please go and see your doctor, He/She may want to adjust the dose or give you a different medicine.

If you get any side effects, talk to your doctor, pharmacistor nurse. 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

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

The active ingredient is Baclofen (10mg).

The other ingredients are: Microcrystalline Cellulose, Pregelatinised Starch, Maize Starch and Magnesium Stearate

Baclofen 10mg Tablets are white, round, flat, uncoated tablets with a breakline on one side and plain on the other side.

The tablet can be divided into equal doses.

They are available in PVC/PVdC and aluminium blister packs of 28, 84 and 100 tablets.

Not all pack sizes may be marketed.