Patient leaflet - Baclofen 10 mg tablets
1. What Baclofen Tablets are and what they are used for 2. What you need to know before you take Baclofen Tablets 3. How to take Baclofen Tablets
- 4. Possible side effects
- 5. How to store Baclofen Tablets
- 6. Contents of the pack and other information
- 1. What Baclofen Tablets are and what are they used for
Baclofen Tablets contain 10 mg of the active substance baclofen. Baclofen is a muscle-relaxant drug. Baclofen Tablets are 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 Tablets
Do NOT take Baclofen Tablets:
Ÿ If you are allergic to baclofen or any of the other ingredients of this medicine (listed in Section 6).
Ÿ If you have ever had a stomach ulcer.
Ÿ Warnings and precautions:
Ÿ Talk to your doctor or pharmacist before taking Baclofen: Ÿ if you have suffered from a stroke
Ÿ if you suffer from epilepsy
Ÿ if you suffer from any mental illness
Ÿ if you are being treated for high blood pressure
Ÿ if you suffer from Parkinson’s Disease
Ÿ if you suffer from any liver, kidney or lung disease
Ÿ if you have diabetes
Ÿ if you have difficulty urinating (urinary retention)
Ÿ if you are pregnant or breast-feeding.
Ÿ if you have a history of drug abuse or dependence.
Other medicines and Baclofen tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, and herbal preparations.
Tell your doctor or pharmacist if you are taking any of the following medicines:
Ÿ Other medicines to relax muscles e.g. tizanidine
Ÿ Medicines to treat mood disorders e.g. lithium or tricyclic antidepressants such as amitriptyline.
Ÿ Medicines for high blood pressure e.g. diltiazem
Ÿ Other drugs which affect the kidney, e.g. ibuprofen
Ÿ Medicines for Parkinson’s Disease e.g. levodopa orcarbidopa Ÿ Medicines which slow down the nervous system e.g.anti-histamines such as promethazine, sedatives suchas temazepam, opiates for pain relief such as morphineand anti-convulsants (anti-epileptic medicines such ascarbamazepine)
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking this medicine. You should not take 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 Tablets”).
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.
Driving and using machines
Some people may feel drowsy and/or dizzy or have problems with their eyes while they are taking BaclofenTablets. If this happens, you should not drive or do anything that requires you to be alert (such as operating
Package leaflet: Information for the patient
(Baclofen) Baclofen 10mg Tablets
tools or machinery) until these effects have worn off.
Other special warnings
Ÿ Be careful when drinking alcohol – it may affect you more than usual. Ÿ Some people being treated with baclofen have had thoughts of harming or killing themselves or have triedto kill themselves. Most of these people also haddepression, had been using alcohol excessively or were prone to having thoughts of killing themselves.
Ÿ 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.
Ÿ Your doctor may want to give you a check-up from time to time while you are taking Baclofen Tablets.
Ÿ If you are going to have an operation of any kind, make sure that the doctor knows that you are taking Baclofen Tablets.
Children and adolescents
Baclofen Tablets are not suitable for use in children under33 kg body weight.
3. How to take Baclofen tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The doctor will tell you the best time to take this 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 has a
stroke.
If you feel sick after taking Baclofen Tablets, it may help to take them
with food or a milk drink.
Adults
- The usual dose is 20 mg (2 tablets) three times a day.
- The maximum daily dose is 100 mg (10 tablets) 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/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 40 mg/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. Baclofen Tablets are not suitable for use
in children below 33 kg body weight. Other forms of this medicine may
be more suitable for children, ask 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.
If you forget to take Baclofen tablets
If you forget to take a dose, take the next dose at the usual time. DO NOT
take a double dose to make up for a forgotten dose.
If you take more Baclofen than you should
If you take more Baclofen than you have been prescribed, contact your doctor or local hospital immediately. Take the medicine with you. If you stop taking Baclofen tablets
You should not stop taking Baclofen Tablets suddenly. If the doctor
decides to stop your treatment with Baclofen Tablets, 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, mentaldisorders, feeling
persecuted or convulsions (fits).
If you have any further questions on the use of thismedicine, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side-effects,although not everybody gets them.
The side effects listed below have been reported:
Very Common: may affect more than 1 in 10 people
- Tiredness, sleepiness, nausea (feeling sick).
Common: may affect up to 1 in 10 people
Ÿ Excessively weak limbs or feeling tired and exhausted, aching muscles Ÿ Headache, dizziness or light-headedness
Ÿ Breathing difficulties
Ÿ Sleeplessness
Ÿ Mood changes, confusion, hallucinations or nightmares Ÿ Dry mouth
Ÿ Problems with their eyes
Ÿ Unsteadiness, trembling or other problems with muscle control Ÿ Low blood pressure (fainting)
Ÿ Stomach problems including retching, vomiting, constipation and diarrhoea
Ÿ Excessive sweating, rash
Ÿ Increased need to pass urine or pain on passing urine.
Rare: may affect up to 1 in 1,000 people
Ÿ Numbness or tingling in hands or feet
Ÿ Increased muscle spasm
Ÿ Disturbed sense of taste
Ÿ Slurred or slow speech
Ÿ Stomach ache
Ÿ Liver problems
Ÿ Difficulty in passing urine
Ÿ Sexual problems in men, e.g. impotence
Ÿ Convulsions (particularly in epileptics).
Very rare: may affect up to 1 in 10,000 people
Ÿ Hypothermia (low body temperature)
Not known: frequency cannot be estimated from the available data
Ÿ Raised, itchy rash (urticaria – also known as nettle rashor hives). Ÿ Slow heart beat.
Ÿ Increase in blood sugar.
Ÿ Trouble breathing during sleep (sleep apnoea syndrome) Ÿ Symptoms caused by stopping treatment suddenly (see‘3. How to take Baclofen Tablets’).
If any of the symptoms become troublesome, or if younotice 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, pharmacistor 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 tablets
- Keep out of the sight and reach of children.
- Do not take after the expiry date which is stated on thecontainer label and on the carton. The expiry date refers to the last day of that month. • Store below 25°C.
- Do not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.
6. Contents of the pack and other information What Baclofen Tablets contain
The active ingredient is Baclofen (10mg).
The other ingredients are: Microcrystalline Cellulose, Pregelatinised Starch, Maize Starch and Magnesium Stearate
What Baclofen Tablets look like and contents of the pack
Baclofen 10mg Tablets are white, round, flat, uncoated tablets with a breakline on one side and plain on the other side.
The tablet can be divided into equal doses.
They are available in PVC/PVdC and aluminium blister packs of 28, 84 and100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Flamingo Pharma (UK) Ltd.
1st Floor, Kirkland House,
11-15 Peterborough Road,
Harrow, Middlesex,
HA1 2AX, UK.
Manufacturer
Flamingo Pharma (UK) Ltd.
The Bloc, 38 Springfield Way,
Anlaby, Hull, HU 10 6RJ,
United Kingdom.
This leaflet was last revised in August 2026.
Other sources of information:
To listen to or request a copy of this leaflet in braille, large print, CD or audio please contact the MAH on above address.
Please be ready to give the following information:
Product name: Baclofen 10 mg Tablets
Reference number: PL 43461/0214
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