Baclofen 10 Mg Tablets
s SANDOZ
SZ00000LT000
What you need to know about Baclofen Tablets
Your doctor has decided that you or your child need this medicine to help treat your condition.
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.
In this leaflet:
1. What Baclofen Tablets are, and what they are used for
2. Things to consider before you start to take Baclofen Tablets
3. How to take Baclofen Tablets
4. Possible side effects
5. How to store Baclofen Tablets
6. Further information
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.
Baclofen Tablets contain 10 mg of the active ingredient 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.
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.
2. Things to consider before you start to take Baclofen Tablets
Some people MUST NOT take Baclofen Tablets. Talk to your doctor if:
• you think you may be allergic to baclofen or to any of the other ingredients of the tablets, (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 Tablets:
• 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?
• Do you have an intolerance to wheat flour? (The tablets contain small amounts of wheat starch. They are suitable for people with coeliac disease, however if you have a wheat allergy (different from coeliac disease), you should not take this medicine.)
If the answer to any of these questions is YES, tell your doctor or pharmacist
because Baclofen Tablets 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 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. 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 Tablets. 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.
• Your doctor may want to give you a check up from time to time while you are taking Baclofen Tablets.
• 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 under 33 kg body weight.
3. How to take Baclofen Tablets
The doctor will tell you how many Baclofen Tablets to take and when to take them. 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.
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, mental disorders, feeling persecuted or convulsions (fits).
If you feel sick after taking Baclofen Tablets, you may find it helps 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 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.
Patients with kidney problems
You will probably be given a much lower dose. The doctor will decide what the dose should be.
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 many Baclofen Tablets, tell your doctor at once or contact your nearest hospital casualty department. Take your medicine with you.
4. Possible side effects
Baclofen Tablets are suitable for most people, but, like all medicines, they 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 heart beat.
Increase in blood sugar.
Symptoms caused by stopping treatment suddenly (see ‘3. How to take Baclofen Tablets’).
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 the Yellow Card
Scheme (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 all medicines out of the reach and sight of children.
Store the tablets below 25°C in a dry place.
Do not take the tablets after the expiry date which is printed on the outside of the pack.
If your doctor tells you to stop taking Baclofen Tablets, please take any which are left back to your pharmacist to be destroyed. Only keep them if the doctor
tells you to. Do not throw them away with your normal household water or waste. This will help to protect the environment.
6. Further information
Baclofen Tablets are white or pale yellow and contain 10 mg of the active ingredient, baclofen. They also contain the inactive ingredients silica, microcrystalline cellulose, magnesium stearate, povidone and wheat starch.
The tablets come in PVC blister packs of 84, 100 and 200 and containers of 84 and 200. Some of the pack sizes may not be marketed.
The product licence holder is Novartis Pharmaceuticals UK Limited,
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, England.
Baclofen Tablets are manufactured by Novartis Pharmaceuticals UK Limited, Wimblehurst Road, Horsham, West Sussex, RH12 5AB and Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, England.
Distributed by:
Sandoz Ltd, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR, UK.
This leaflet was revised in April 2015.
If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370.
Copyright Novartis Pharmaceuticals UK Limited
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