Baclofen 5mg/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 the medicine is Baclofen 5mg/5ml Oral Solution but 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 are allergic to baclofen or any of the other ingredients of this medicine (listed in section 6)

Do not take baclofen if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking baclofen.

Talk to your doctor or pharmacist before taking Baclofen:

• If you have disturbance of the blood circulation in your brain
• If you suffer from epilepsy
• If you suffer from any mental illness such as schizophrenia, psychosis, depressive or manic disorders or confusional states
• If you have high blood pressure
• If you have Parkinson’s disease
• If you suffer from any liver, kidney or lung disease
• If you have diabetes
• If you have difficulties in urinating
• If 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 have a disease of your blood pigment called “Porphyria”
• If you have ever had an ulcer in your stomach or gut
• you are pregnant and taking baclofen during pregnancy*,
  *Your newborn may have convulsions and other symptoms related to sudden stop of treatment just after delivery. Your doctor may need to give your newborn small doses of baclofen and gradually reduce the dose to control and prevent the symptoms. This recommendation for newborns is based on a limited number of case reports in the literature.
• Talk to your doctor or pharmacist before giving Baclofen to a child under the age of one year

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 any of the above apply to you (or 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 medicine. This includes medicines obtained without a prescription, including herbal medicines. This is because baclofen can affect the way some other medicines work. Also some other medicines can affect the way baclofen works. In particular tell your doctor or pharmacist if you are taking any of the following medicines:

• Other medicines to relax muscles e.g. tizanidine
• antidepressants e.g. tricyclic antidepressants and monoamine oxidase inhibitors
• medicines that lower blood pressure including medicines used to treat high blood pressure
• other drugs which affect the kidney e.g. ibuprofen
• medicines used to treat Parkinson’s disease
• medicines which slow down the nervous system e.g. anti-histamines, opiate pain killers, sedatives and anti-convulsant (some of these can be bought over the counter)
• medicines for diabetes such as insulin – your doctor may need to increase your dose
• lithium – for mood problems.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking baclofen.

• Your doctor may want to give you a check up from time to time while you are being treated with baclofen, especially if you have diabetes or any liver problems.
• If you are going to have an operation of any kind, make sure that your doctor knows you are being treated with baclofen.

Always tell your doctor or pharmacist about all the medicines you are taking. This includes medicines you have bought yourself as well as medicines on prescription from your doctor.

You should not drink alcohol during your treatment with baclofen – it may affect you more than usual.

If you are in one of these groups, you may experience more side effects. Therefore, your doctor will keep you under appropriate surveillance and may adapt the dose of baclofen you take.

Talk to your doctor before taking this medicine if you are pregnant or might become pregnant. You should not use baclofen during pregnancy unless your doctor advises you to do so. If you have to take baclofen during pregnancy, your baby may have convulsions and other symptoms related to sudden stop of treatment just after delivery. Talk to your doctor before taking this medicine if you are breast-feeding. Baclofen passes into mother’s milk but in small amounts and no effects on your baby are expected.

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.

Methyl parahydroxybenzoate (E218): May cause allergic reactions (possibly delayed).

Sorbitol (E420): This medicine contains 1925mg sorbitol in each 5ml dose which is equivalent to 385mg/ml. 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.

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

Propylene glycol (E1520): This medicine contains 6.675mg propylene glycol in each 5ml dose which is equivalent to 1.335mg/ml. 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 starting dose for adults is 15 ml (15 mg) a day, preferably taken in 3 divided doses. The dose is then gradually increased until the best results are obtained, this may be between 30 ml (30 mg) to 80 ml (80 mg) a day, taken in 2 to 4 divided doses.
• Your doctor may even decide to give you a higher dose.

Children (0 < 18 years)

The dose for a child is based on their body weight. The usual starting dose is 0.3 mg for each kilogram of body weight a day, in 2 to 4 divided doses (preferably in 4 doses). The daily dose is then gradually increased until it becomes sufficient for the child’s individual requirements. This may be between 0.75 mg and 2 mg for each kilogram of body weight.

If you have been treated for 6 weeks and you feel no improvement, tell your doctor. Your doctor will decide if you should continue taking baclofen. If you have questions about how long to take baclofen, talk to your doctor or pharmacist.

Patients with kidney problems

If you have kidney disease, a lower dose of 5 ml (5 mg) a day is used. If you are not sure how much medicine to take, ask your doctor or pharmacist.

This medicinal product must be taken orally.

Use the measuring syringes provided in the pack to deliver the required dose.

a) Open the bottle: press the cap and turn it anticlockwise (figure 1).

b) Separate the adaptor from the syringe (figure 2). 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 millilitres (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). 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 so that people can see what you have taken.

Signs of overdose are:

• unusual muscle weakness (too little muscle tone) or sudden contraction of your muscles
• drowsiness
• excessive salivation
• feeling sick (nausea), being sick (vomiting) or diarrhoea
• difficulty in breathing
• fits (convulsions)
• loss of consciousness
• abnormally low body temperature
• feeling confused or agitated
• hallucinations
• blurred vision
• poor or absent reflexes
• high or low blood pressure
• slow, fast or irregular heart beat
• trouble breathing during sleep (sleep apnoea)
• pain in muscles, fever and dark urine (rhabdomyolysis)
• ringing in the ears.

If you have kidney disease and have accidentally taken more baclofen than your doctor has prescribed, you may experience neurological symptoms of overdose (e.g. drowsiness, feeling confused, hallucinations).

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 treatment suddenly. If the doctor decides to stop your treatment, the dose will be reduced gradually to prevent withdrawal symptoms such as muscle spasms and increased muscle rigidity, too much muscle tone, fast heartbeat, high body temperature, pain in muscles, fever and dark urine fever, confusion, seeing things that are not really there (hallucinations), changes in mood and emotion, mental disorders, feeling persecuted or convulsion (fits).

Stop taking baclofen and tell your doctor straight away if you notice the following symptoms:

• breathing difficulties
• shortness of breath at rest or with activity, swelling in the legs and tiredness (signs of decreased cardiac output)
• feeling confused, extremely happy or depressed
• loss of coordination affecting balance and walking, limb and eye movements or speech (signs of ataxia)
• trembling
• nightmares or hallucinations
• problems with eyesight
• low blood pressure (fainting)
• skin rash and hives
• urinary incontinence, problems when urinating or a sudden decrease in urine
• seizures
• abdominal pain, yellowing of the skin or eyes and tiredness (signs of liver problems).
• slow heart beat
• symptoms following sudden discontinuation of the medicine (drug withdrawal syndrome) as explained above in Section 3 (if you stop taking baclofen)

If you experience any of the above, stop taking baclofen and tell your doctor straight away.

Very common: may affect more than 1 in 10 people

• tiredness

Common: may affect up to 1 in 10 people

• feeling lethargic (having no energy)
• headache, dizziness or light-headedness
• insomnia
• being sick, retching, constipation or diarrhoea
• dry mouth
• weakness or pain in your muscles
• excessive sweating.

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

• slurred speech
• a change in the way things taste
• tingling hands or feet
• sexual problems in men e.g. impotence

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

• increased blood sugar
• raised, itchy rash (urticaria - also known as nettle rash or hives)
• slow heart beat
• trouble breathing during sleep (sleep apnoea syndrome)
• swelling of the ankles, feet or lower legs
• swelling face
• allergic reaction (hypersensitivity)
• hair loss
• sexual difficulties
• reduction in brain function (encephalopathy)

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 5mg baclofen.

The other ingredients are methyl parahydroxybenzoate (E218), sorbitol liquid (non-crystallising) (E420), carmellose sodium (E466), raspberry flavour (contains propylene glycol (E1520)) and purified water.

Baclofen is clear, pale yellow to yellow coloured oral solution with raspberry flavour supplied in an amber glass bottle with a tamper-evident child resistant plastic cap.

The pack also contains a 1ml oral syringe with 0.01ml graduation marks and 10ml oral syringe with 0.25ml graduation marks and a syringe adaptor.

Baclofen Oral Solution is supplied in bottles containing 300ml oral solution.

POM