Baclofen 10mg/5ml Oral solution

• 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.

The name of your medicine is Baclofen 10mg/5ml Oral Solution but it will be referred to as ‘Baclofen’ throughout this leaflet.

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

• 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.

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.

There have been reports of reduction in brain function (encephalopathy) in some patients taking baclofen at prescribed doses, which resolved after stopping the medication. Symptoms include increased sleepiness, new onset of drowsiness, confusion, muscle jerks or coma. If you experience any of these symptoms, seek medical attention immediately. Your physician will decide whether baclofen has to be discontinued.

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.

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).

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

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.

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.

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.

Adults

• The usual dose is 10 ml (20 mg) three times a day.
• The maximum daily dose is 50 ml (100 mg) except if you are in hospital when a higher dose may be used.

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 per kg body weight per 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 mg and 2 mg per kg body weight per day. The total daily dose should not exceed a maximum of 20 ml (40 mg) per day in children below 8 years of age. In children over 8 years of age a maximum daily dose of 30 ml (60 mg) per day may be given.

In children under 8 years of age, or for individual doses less than 5 ml (10 mg), your doctor is likely to prescribe Baclofen 5mg/5ml Oral Solution.

Patients with kidney problems

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

• this medicinal product must be taken orally
• take this medicine with plenty of water, with or immediately after a meal to prevent upset stomach
• take this medicine regularly as advised by your doctor to obtain the maximum benefit
• use the measuring syringe provided in the pack to deliver the required dose.

a) Open the bottle: press the cap and turn it anticlockwise (figure 1). Separate the adaptor from the syringe (figure 2).

b) Insert the adaptor into the bottle neck (figure 3). Ensure it is properly fixed. Take the syringe and put it in the adaptor opening (figure 4).

c) Turn the bottle upside down. Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upwards in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C).

d) Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).

e) Empty the contents of the syringe into the patient’s mouth by pushing the piston to the bottom of the syringe (figure 7). The contents of the syringe should be emptied into the side cheek of the patient’s mouth to avoid a choking hazard. Close the bottle with the plastic screw cap. Wash the syringe with water (figure 8).

If you accidentally take too much Baclofen, tell your doctor at once or contact your nearest hospital casualty department. Take your medicine with you.

Signs of overdose are:

• Ringing in the ears.

If you forget to take a dose, take the next dose at the usual time. DO NOT take a double dose.

You should not stop taking Baclofen suddenly. If the doctor decides to stop your treatment with Baclofen, 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, mental disorders, feeling persecuted or convulsions (fits).

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 Website 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.

The active substance is baclofen.

Each 5ml of oral solution contains 10mg baclofen.

The other ingredients are methyl parahydroxybenzoate, carmellose sodium, liquid sorbitol, rasberry flavor [contains propylene glycol (E1520)] and purified water.

Baclofen is a clear pale yellow to yellow colour oral solution supplied in an amber glass bottle with tamper-evident child resistant plastic cap with a 1ml oral syringe with 0.01ml graduation and 10ml syringe with 0.25ml graduation and an syringe adaptor.

Baclofen is supplied in bottles containing 150ml oral solution.

Baclofen is sugar free.