BACLOFEN 5 MG / 5ML ORAL SOLUTION - patient leaflet, side effects, dosage

Baclofen

5mg/5ml Oral Solution Baclofen

This medicine will be called Baclofen Solution in this leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• 2. What you need to know before you take Baclofen Solution

• 3. How to take Baclofen Solution

• 4. Possible side effects

• 5. How to store Baclofen Solution

• 6. Contents of the pack and other 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. what you need to know before you take baclofen solution

Do not take Baclofen Solution if:

• You are allergic to baclofen or any of the other ingredients of this medicine (listed in section 6)
• You have a peptic (stomach) ulcer.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking this medicine 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 elderly
• You have a history of alcoholism, you 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.

Other medicines and Baclofen Solution

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines especially:

• 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.

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

Tests

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.

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.

Baclofen Solution with alcohol

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

• This medicine contains sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217) which may cause allergic reactions (possibly delayed).
• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product, as it contains liquid maltitol (E965). May have a mild laxative effect. Calorific value 2.3 kcal/g maltitol.
• This medicine contains 6.23mg propylene glycol (E1520) per 5ml which is equivalent to 1.246mg/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.
• This medicine contains 5.51 mg of sodium per 5ml dose, ie. less than 1 mmol sodium (23mg) per 5ml, that is to say essentially “sodium free”.

3. how to take baclofen solution

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Use in adults:

The starting dose is 5mg (one 5 ml spoonful) three times daily for three days and will be increased gradually every three days depending 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.

Continued, please turn over.

The recommended doses are as follows:

20mg (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 and adolescents (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.

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.

If you take more Baclofen Solution 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. Signs of overdose include drowsiness, breathing difficulties, changes in consciousness or coma. Also muscle weakness or spasm, confusion, hallucinations, agitation, fits, reflex problems, vision problems, enlargement of blood vessels, low or high blood pressure, slow, fast or irregular heartbeat, low body temperature, feeling or being sick, diarrhoea, excessive saliva production, increased blood levelsofa liver enzyme, muscle injury, ringing in the ears.

If you forget to take 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.

If you stop taking Baclofen Solution

You should not stop taking Baclofen Solution suddenly. If the doctor decides to stop your treatment with Baclofen Solution, 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 have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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 (may affect more than 1 in 10 people):

• Sedation, sleepiness and feeling sick.

Common (may affect up to 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 (may affect up to 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 (may affect up to 1 in 10,000 people):

• Hypothermia (abnormally low body temperature).

Not known (frequency cannot be estimated from the available data):

• Trouble breathing during sleep (sleep apnoea syndrome)
• Slow heart beat
• Symptoms caused by stopping treatment suddenly (see section 3 “How to take”/lf you stop taking”).

5. how to store baclofen solution

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Do not freeze.

Store in the original container in order to protect the medicine from light.

Discard 28 days after opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Baclofen Solution contains

The active substance is baclofen. Each 5 ml of solution contains 5 mg of 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. (See also end of section 2 “Baclofen Solution contains”).

What Baclofen Solution looks like and contents of the pack

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Dalkeith Laboratories Ltd., 2 Park Street, Woburn, Bedfordshire, MK17 9PG, UK.

Manufacturer: Thorpe Laboratories Ltd., Golf Road Industrial Estate, Mablethorpe, Lincolnshire, LN12 1NB, UK.

This leaflet was last revised in October 2021.

If you would like the leaflet in a different format, please contact the marketing authorisation holder at the above address.

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