Baclofen 10mg Tablets
Read all of this leaflet carefully before you or your child start using 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 or pharmacist.
- This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if their symptoms 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. ^
1. What Baclofen is and what it is used for
2. What you need to know before you take your medicine
3. How to take Baclofen
4. Possible side effects
5. How to store Baclofen
6. Content of the pack and other information
Baclofen 10 mg Tablets contain the active substance baclofen, which are a type of muscle relaxant.
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
Children and adolescents:
Baclofen tablets are not suitable for use in children under 33 kg body weight.
Other medicines and Baclofen:
Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines including medicines obtained without prescription:
Check with your doctor before taking these tablets if you are taking any of the following;
• Medicines for depression, e.g. tricyclic antidepressants, such as imipramine or amitriptyline
• Medicines for muscle relaxation e.g. tizanidine
• Morphine
• Lithium
• Medicines for high blood pressure
• Medicines for arthritis or pain, e.g. ibuprofen
• Levodopa and carbidopa (used to treat Parkinson's disease)
• Medicines which slow down the nervous system, e.g. anti-histamines, sedatives, opiates for pain relief or anti-convulsants.
Baclofen with food and drink
Swallow your tablets whole with a drink of water. If you feel sick after taking your tablets, you may find it helps to take them with milk or food.
Be very careful when drinking alcohol as it may affect you more than usual.
Pregnancy and breast-feeding
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 advise before taking this medicine.
Driving and using machines
Do not drive or operate machines if these tablets make you feel drowsy or cause blurred vision. Wait until the effects have worn off or contact your doctor.
Do not take these tablets if you:
• are allergic to Baclofen or any of the other ingredients of this medicine. (listed in section 6)
• have or have ever had, ulcers of the stomach or intestine.
Tell your doctor before taking these tablets if any of the above points apply to you.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Baclofen if you:
• suffer from liver, kidney or lung disease, kidney failure
• have epilepsy
• are being treated for high blood pressure
• have posture and balance problems
• have difficulties urinating/going for a wee
• suffer from mental illness
• suffer from Parkinson's disease
• are diabetic
• have breathing problems, or a disturbance of the blood circulation in your brain
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor if you are not sure. When you start taking these tablets the dosage will be increased gradually, usually every 3 days, starting with doses of 5-15 mg a day. The final dose depends on how you respond to treatment.
Use in Adults
The usual dose is 20 mg (two tablets) three times a day. However, some patients take them only at night or just before doing a task such as washing, dressing or shaving. The maximum daily dose is 100 mg. If you are in hospital you may be given a higher dose.
Renal impairment
If you have a kidney disease, your doctor will prescribe a lower dose of about 5 mg a day.
Elderly
Dosage may be reduced.
Use in Children (0 to <18 years)
Children's treatment is adjusted to their body weight. Children's treatment is usually starts with very low dose (approximately 0.3 mg/kg/day), in 2-4 divided doses (preferably in 4 doses). The dosage 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 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 60 mg/day may be given. Baclofen tablets are not suitable for use in children below 33 kg body weight.
Whilst you are taking Baclofen 10 mg Tablets, your doctor may want to take blood tests or give you a check-up from time to time.
If you take more Baclofen than you should:
If you take too many tablets, tell your doctor at once or contact your nearest hospital casualty department.
If you forget to take Baclofen
If you miss a dose do not take a double dose to make up for the one that you have missed.
If you stop taking Baclofen
You should not stop taking Baclofen Tablets suddenly.
If the doctor decides to stop your treatment with Tablets, the dose will be reduced gradually to prevent withdrawal symptoms such as;
• muscle spasms
• rapid heart rate
• fever
• confusion
• hallucinations
• mood changes
• convulsions (fits)
Ask your doctor how to reduce the dose gradually.
If you have any further questions on the use of this medicine, ask your doctor.
• urinating more often than usual (Pollakiuria)
• bladder weakness
• pain when urinating
Rare side effects (seen in more than 1 in 10,000 but less than 1 in 1,000 patients):
• numbness or tingling in hands or feet
• slurred speech
• changes in taste sensation (dysgeusia)
• convulsions
• pain in the stomach or abdomen
• liver function disorder
• being unable to urinate
• impotence
Very rare side effects (seen in less than 1 in 10,000 patients):
• low body temperature (hypothermia)
Other possible side effects
Some patients may experience a worsening of muscle stiffness, raised itchy skin rash/weals (urticaria), symptoms caused by stopping treatment suddenly (see section 3), Increase in blood sugar.
Reporting of side effects
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 Yellow card Scheme: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Like all medicines, this medicine can cause side effects, although not everybody gets them. They are normally mild and wear off after a few days treatment. If they become more severe or last for more than a few days tell your doctor.
Very common side effects (seen in more than 1 in 10 patients);
• feeling sleepy, calm, relaxed or having reduced awareness
• nausea (feeling sick)
• somnolence (desire to sleep more)
Common side effects (seen in more than 1 in 100 patients):
• light-headedness, dizziness or fainting
• confusion
• headache
• mood changes
• nightmares
• hallucinations
• tiredness or exhaustion
• insomnia (sleeplessness)
• dry mouth
• unsteadiness, trembling or other problems with muscle control
• breathing difficulties
• muscle pain or weakness
• constipation
• diarrhoea
• feeling or being sick (retching or vomiting)
• blurred or double vision
• low blood pressure
• slow heart rate
• increased sweating
• skin rash
Keep out of the sight and reach of children.
Store the tablets in the original package.
Do not use the medicine after the expiry date which can be found on the label after the letters “EXP”.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines which you no longer require. These measures will help protect the environment.
Baclofen 10 mg Tablets contain
The active ingredient in these tablets is Baclofen 10 mg. The inactive ingredients in these tablets are colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, povidone and maize starch.
Baclofen 10 mg Tablet looks like and contents of the pack
Baclofen 10 mg Tablets are round, white, scored tablets. They are supplied in packs of 50 or 84 tablets.
Marketing Authorisation Holder
Activase Pharmaceuticals Limited,
11 Boumpoulinas Street, 3rd Floor, P.C. 1060, Nicosia, Cyprus
Manufacturer
Edmond Pharma S.R.L.,
Via dei Giovi 131,20037, Paderno Dugnano (MI), Italy The leaflet was last revised in 08/2016.
A0030/O/PIL/A1