Do not take Baclofen if:

• you think you may be allergic to baclofen or to any of the other ingredients of the solution (these are listed at the end of the leaflet)
• you have ever had a stomach ulcer.

Warnings and precautions

Talk to your doctor or pharmacist before taking Baclofen if:

• you have had a stroke
• you suffer from epilepsy
• you suffer from any mental illness
• you are being treated for high blood pressure
• you have Parkinson’s disease
• you suffer from any liver, kidney or lung disease
• you have diabetes
• you have difficulties in urinating
• you are pregnant or breast-feeding (see section “Pregnancy and breast-feeding”)
• you have a history of alcoholism, your drink alcohol to excess or you have a history of drug abuse or dependence.

Some people being treated with baclofen have had thoughts of harming or killing themselves or have tried to kill themselves. Most of these people also had depression, 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.

If you are going to have an operation of any kind, make sure that the doctor knows that you are taking this medicine. Your doctor may want to give you a check up from time to time while you are taking baclofen.

Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Baclofen.

Other medicines and Baclofen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Talk to your doctor or pharmacist if you are taking any of the following:

• other medicines to relax muscles e.g. tizanidine
• medicines to treat mood disorders such as lithium or tricyclic antidepressants such as amitriptyline
• medicines for high blood pressure e.g. diltiazem
• other drugs which also affect the kidney e.g. ibuprofen
• medicines for Parkinson’s disease e.g. levodopa or carbidopa
• medicines which slow down the nervous system, e.g. anti-histamines such as promethazine, sedatives such as temazepam, opiates for pain relief such as morphine and anti-convulsants (anti-epileptic medicines such as carbamazepine).

Baclofen with alcohol

Alcohol should be consumed with caution when taking Baclofen, as effects of alcohol may be increased.

Pregnancy and breast-feeding

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

You should not use 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”)

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.

Driving and using machines

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

Baclofen contains:

This medicine contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).

This medicine also contains 1925mg sorbitol (E420) in 5ml of solution. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

This medicine also contains 8.1mg sodium (main component of cooking/table salt) in 5ml of dose. This is equivalent to 0.41% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine also contains 6.675mg propylene glycol (E1520) per 5ml of dose. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.