Patient leaflet - Baclofen 5 mg / 5 ml oral solution
1. What Baclofen is and what it is used for
Baclofen contains 5 mg and 10 mg of the active ingredient baclofen.
Baclofen is a muscle-relaxant drug. Baclofen is used to reduce and relieve the excessive tension in your muscles (spasms) occurring in various illnesses such as cerebral palsy, multiple sclerosis, cerebrovascular accidents, spinal cord diseases and other nervous system disorders.
2. What you need to know before you take Baclofen
Some people MUST NOT take Baclofen.
Talk to your doctor 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.
You should also ask yourself these questions before taking Baclofen:
- Have you had a stroke?
- Do you have epilepsy?
- Do you suffer from any mental illness?
- Are you being treated for high blood pressure?
- Do you have Parkinson’s disease?
- Do you suffer from any liver, kidney or lung disease? • Do you have diabetes?
- Do you have difficulties in urinating?
- Are you pregnant or breast-feeding? (See section “Pregnancy and breast-feeding”).
- Do you have an intolerance to some sugars? (The solution contains sorbitol.)
- Do you have a history of drug abuse or dependence If the answer to any of these questions is YES, tell your doctor or pharmacist because Baclofen might not be the right medicine for you. Are you taking other medicines?
Some medicines can interfere with your treatment. Tell 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 that lower blood pressure including medicines used to treat 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).
Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.
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. Will there be any problems with driving or using machinery?
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.
Other special warnings
- Be careful when drinking alcohol - it may affect you more than usual. • 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.
- Your doctor may want to give you a check-up from time to time while you are taking Baclofen.
- If you are going to have an operation of any kind, make sure that the doctor knows that you are taking Baclofen.
- 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.
Baclofen contains
- Sodium: This medicine contains less than 1 mmol sodium (23mg) per 5ml, that is to say essentially ‘sodium free’.
- Sorbitol: This medicine contains 2750mg of Sorbitol in each 5 mL oral 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. • Propylene Glycol: This product also contains 3 mg of propylene glycol per 5 ml 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.
- Methyl para-hydroxybenzoate: may cause allergic reactions (possibly delayed)
- Propylene Glycol: This product also contains 3mg of propylene glycol per 5ml of dose. Coadministration with any substrate of alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates.
3. How to take Baclofen
The doctor will tell you how much Baclofen to take and when to take it. Always follow his/her instructions carefully. The dose will be on the pharmacist’s label. Check the label carefully. If you are not sure, ask your doctor or pharmacist.
The doctor will tell you the best time to take the medicine. Some people take it only at night or before doing a task such as washing, dressing, shaving, etc.
The final dose of Baclofen depends on how each person responds to the drug. You will be started on a low dose, and this will be increased gradually over a few days, under the supervision of the doctor, until you are having the dose which is right for you. If the starting dose is too high, or if the dose is increased too quickly, you may experience side effects, particularly if you are elderly, have kidney problems or have had a stroke. If you feel sick after taking Baclofen, you may find it helps to take it with food or a milk drink.
Adults
- The usual dose is 20 mg three times a day.
- The maximum daily dose is 100 mg.
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/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 2 mg/kg body weight. The maximum daily dose should not exceed 2 mg/kg/day. The maximum daily dose should not exceed 40 mg/day in children below 8 years old and 60 mg/day in children 8 years and older.
Please read this leaflet carefully before you start to take your medicine. It contains important information
Keep the leaflet in a safe place because you may want to read it again. If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even
if their symptoms seem to be the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
Patients with kidney problems
You will probably be given a much lower dose. The doctor will decide what the dose should be.
Route and method of administration
- 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.
Instructions for the use of syringe:
- 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).
What if you forget to take a dose?
If you forget to take a dose, take the next dose at the usual time. DO NOT take a double dose.
What if you take too much?
If you accidentally take too much Baclofen Solution, 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 and decrease in brain function (encephalopathy).
If you stop taking Baclofen
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, too much muscle tone, fast heart rate, fever, confusion, hallucinations, changes in mood and emotion, mental disorders, feeling persecuted or convulsions (fits).
4. Possible side effects
Baclofen is suitable for most people, but, like all medicines, it can sometimes cause side effects.
The side effects listed below have been reported:
More than 1 in 10 people have experienced:
Tiredness, sleepiness, nausea (feeling sick).
Up to 1 in 10 people have experienced:
Excessively weak limbs or feeling tired and exhausted, aching muscles Headache, dizziness or light-headedness
Breathing difficulties
Sleeplessness
Mood changes, confusion, hallucinations or nightmares Dry mouth
Problems with their eyes
Unsteadiness, trembling or other problems with muscle control Low blood pressure (fainting)
Stomach problems including retching, vomiting, constipation and
diarrhoea
Excessive sweating, rash
Increased need to pass urine or pain on passing urine. Up to 1 in 1,000 people have experienced:
Numbness or tingling in hands or feet
Increased muscle spasm
Disturbed sense of taste
Slurred or slow speech
Stomach ache
Liver problems
Difficulty in passing urine
Sexual problems in men, e.g. impotence
Convulsions (particularly in epileptics)
Very rarely (less than 1 in 10,000) people have experienced:
Hypothermia (low body temperature)
Other side-effects (how often they happen is not known)
Raised itchy rash (urticaria – also known as nettle rash or hives). Slow heartbeat.
Increase in blood sugar.
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)
Symptoms caused by stopping treatment suddenly (see ‘3. How to take Baclofen’).
If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to adjust the dose or give you a different medicine.
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, Website: 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.
5. How to store Baclofen
Keep this medicine out of the sight and reach of children. Store below 30°C.
Do not refrigerate
Do not take the solution after the expiry date which is printed on the outside of the pack. If your doctor tells you to stop taking Baclofen, please take any which is left back to your pharmacist to be destroyed. Only keep it if the doctor tells you to. Do not throw it away with your normal household water or waste. This will help to protect the environment.
6. Contents of the pack and other information
What Baclofen contains
- The active substance is Baclofen. Baclofen Oral Solution either contains 5 mg or 10 mg Baclofen per 5 mL.
- The other ingredients are: Methyl parahydroxybenzoate (E218), Sorbitol liquid (non-crystallising) (E420), Carmellose sodium (E466), Raspberry flavour, Water.
What Baclofen looks like and contents of the pack
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 1 ml oral syringe marked at volume of 0.05 ml, 0.06 ml, 0.07 ml, 0.08 ml, 0.09 ml up to 1 ml graduation marks with 28 mm adaptor and 10 ml oral syringe with 0.2 ml, 0.4 ml, 0.6 ml, 0.8 ml,1.0 ml up to 10.0 ml graduation marks and with 28 mm adaptor. Baclofen Oral Solution is supplied in bottles containing 300ml oral solution
Marketing Authorisation Holder
Novumgen Limited
20-22 Wenlock Road, London,
N1 7GU, United Kingdom
Manufacturer
Sciom Limited
Unit 4, Martinfield Business Centre,
Martinfield, Welwyn Garden City,
AL7 1HG, United Kingdom
This leaflet was last revised in Aug 2026.
Baclofen 10 mg/5 ml Oral Solution