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Patient Information Leaflet

Baclofen

5mg/5ml Oral Solution

This medicine will be called Baclofen Solution in this leaflet.

In this leaflet:

1.    What Baclofen Solution is and what it is used for

2.    Before you take Baclofen Solution

3.    How to take Baclofen Solution

4.    Possible side effects

5.    How to store Baclofen Solution

6.    Further information

1. What Baclofen Solution is and what it is used for

This oral solution contains the active ingredient baclofen which is a muscle relaxant. It works by relaxing the muscles and preventing spasms, cramping or tightening so reducing any pain and discomfort.

Your doctor has decided that you or your child needs this medicine to help treat your condition. Baclofen is used to reduce and relieve excessive tension in your muscles (spasms) occurring in various illnesses such as multiple sclerosis, cerebral palsy, cerebrovascular accidents, spinal cord diseases and other nervous system disorders. It is also used to relieve muscle spasms following injuries to the head or spine.

2. Before you take Baclofen Solution

Some people must not take this medicine. Do not take this medicine if:

•    You know you are allergic to baclofen or to any of the other ingredients. (These are listed in Section 6)

•    You have a peptic (stomach) ulcer.

You must be especially careful if:

•    You suffer from epilepsy, porphyria or diabetes

•    You have difficulty urinating (passing water)

•    You suffer from any liver, kidney or lung disease

•    You suffer from mental illness or depression

•    You suffer from Parkinson’s disease

•    You have problems with the blood circulation to your brain

•    You have ever had a peptic (stomach) ulcer

•    You are pregnant, trying to become pregnant or breast feeding

•    You are elderly

•    You have an intolerance to some sugars as this medicine contains maltitol.

If any of the conditions above apply to you, please discuss your treatment with your doctor before taking this medicine.

Taking other medicines:

Baclofen Solution can affect some other medicines you may be taking. Make sure your doctor knows if you are taking any of the following:

•    Any medicines to treat high blood pressure

•    Tricyclic antidepressants e.g. amitriptyline

•    Medicines which slow down the central nervous system e.g. anti-histamines, sedatives, opiates for pain relief, anti-convulsants

and alcohol

•    Nitrates e.g. glyceryl trinitrate used for angina

•    Diuretics (also known as water tablets) e.g. bendroflumethiazide

•    Ibuprofen or other NSAIDs (non-steroidal anti-inflammatory drugs) e.g. naproxen used to treat pain and inflammation

•    Lithium used to treat mental illness

•    Memantine used to treat dementia in Alzheimer’s disease

•    Levodopa and carbidopa to treat Parkinson’s disease.

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

Other special warnings

•    This medicine may affect your breathing. Your doctor may perform some tests to check your heart, lungs and blood are ok especially if you have heart/lung disease or breathing problems

•    Be careful when drinking alcohol if being treated with baclofen. Alcohol may make you feel more drowsy

•    This medicine contains sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217) which may cause allergic reactions (possibly delayed)

•    Do not stop taking this medicine suddenly.

Abrupt withdrawal may cause anxiety, confusion, hallucinations, changes in mood and emotion. Also convulsions (fits), muscle spasms, increased muscle rigidity, faster heart beat, high body temperature

•    In rare cases your doctor may perform some tests if you have liver disease or diabetes mellitus. This is to make sure no changes to these diseases have occurred. Your doctor will advise you when and how to reduce your dose gradually

•    If you are going to have an operation of any kind, including dental surgery, tell the doctor or dentist that you are taking baclofen.

Driving and using machinery

This medicine may make you feel drowsy, dizzy or cause blurred vision. If affected do not drive or operate machinery.

3. How to take Baclofen Solution

Shake the bottle well before you take this medicine. If you feel sick after taking this medicine, you may find it helps to take it with food or a milk drink.

This medicine has been given to you by your doctor, he/she will decide what dose you need to take. Always take the medicine exactly as the doctor has told you. The dose will be on the pharmacist’s label.

If you are not sure, ask your doctor or pharmacist. Carry on taking the medicine for as long as you have been told unless you have any problems. In that case, check with your doctor.

Use in adults:

The dosage is increased gradually, usually every 3 days starting with doses of 5-15 mg (5-15 ml) a day. The final dose depends on how you respond.

Baclofen is usually taken three times a day. However, some patients take it only at night or just before doing a specific task such as washing, dressing, shaving etc.

The usual doses are as follows:

20 mg (four 5 ml spoonfuls) three times a day. Your doctor may increase the maximum daily dose slowly to 100 mg (100 ml) if required. If you are in hospital, a higher dose may be required.

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 0.3mg/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 40mg/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.

If you have kidney problems a low dose of 5 mg (one 5 ml spoonful) daily is recommended.

If you take more medicine than you should:

You should contact your doctor or go to the nearest hospital casualty department straightaway. Take your medicine or the pack with you so that the doctor knows what you have taken.

If you forget to take a dose of Baclofen Solution:

If you miss a dose don’t worry. Do not take a double dose to make up for a forgotten dose, just take the next dose at the usual time.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These occur mainly at the start of treatment, if the dose is increased too quickly, if too large a dose is used or in elderly patients. Effects often last only a short time and usually disappear when the dose is reduced. They are not usually severe enough to stop you taking this medicine.

If any of the following occur contact your doctor

immediately:

•    Swelling of the face or throat, as this may mean you have a serious allergic reaction to this medicine.

The following other side-effects have been reported:

Very common effects (that could happen to more

than 1 in 10 people):

Sedation, sleepiness and feeling sick.

Common effects (that could happen to more than 1 in

100 people, but less than 1 in 10 people):

•    Breathing difficulties

•    Hallucinations (seeing or hearing things that are not real), feeling tired or exhausted, difficulty in sleeping, nightmares, anxiety, agitation, confusion, mood swings

•    Convulsions (fits), light-headedness, dizziness, headache

•    Muscle weakness or pain, unsteadiness, trembling

•    Blurred vision, problems focusing your eyes, rapid involuntary eyeball movements

•    Slow heart rate, low blood pressure

•    Retching, vomiting, constipation, diarrhoea, dry mouth

•    Increased sweating, rash, itching, fever

•    Passing large volumes of urine, bedwetting, difficulty or pain in passing water.

Rare effects (that could happen to more than 1 in

10.000    people, but less than 1 in 1,000 people):

•    Tingling or numbness in the hands or feet, slurred speech, abnormal sense of taste

•    Stomach pain

•    Changes in blood sugar or blood levels of certain liver enzymes

•    Inability to urinate

•    Inability to develop or maintain an erection.

Very rare effects (that could happen to less than 1 in

10.000    people):

•    Hypothermia (abnormally low body temperature).

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or 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.

5. How to store Baclofen Solution

Keep out of the sight and reach of children.

Do not store above 25°C. Store in the original container in order to protect the medicine from light. Do not refrigerate or freeze.

Discard 28 days after opening.

Do not use the medicine after the expiry date shown on the carton or label.

If your doctor tells you to stop taking the medicine, please take any unused medicine back to your pharmacist to be destroyed.

6. Further Information

Ingredients

Each 5 ml of medicine contains 5 mg of the active ingredient, baclofen. The other ingredients are sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), raspberry flavour (containing flavourings, propylene glycol and maltol), carmellose sodium, liquid maltitol (E965), citric acid, sodium citrate and purified water.

What the medicine looks like

The medicine is a clear, almost colourless solution with a raspberry odour. It is supplied to your pharmacist in bottles containing 300 ml.

Product licence holder and manufacturer

Product Licence holder: Dalkeith Laboratories Ltd.,

2 Park Street, Woburn, Bedfordshire, MK17 9PG. UK Manufactured by Thorpe Laboratories Ltd.,

Golf Road Industrial Estate, Mablethorpe,

Lincolnshire, LN12 1NB. UK

Product Licence Number:

PL 17496/0024

Date of revision: May 2015.

If you would like the leaflet in a different format, please contact the licence holder at the above address.    4039/2