Thursday, October 20, 2016

LIORESAL Tablets





LIORESAL Tablets 10 mg



(baclofen)




What you need to know about Lioresal Tablets


Your doctor has decided that you need this medicine to help treat your condition.



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.




In this leaflet:


  • 1. What Lioresal Tablets are, and what they are used for

  • 2. Things to consider before you start to take Lioresal Tablets

  • 3. How to take Lioresal Tablets

  • 4. Possible side effects

  • 5. How to store Lioresal Tablets

  • 6. Further information




What Lioresal Tablets are and what they are used for


Lioresal Tablets contain 10 mg of the active ingredient baclofen.


Baclofen is a muscle-relaxant drug. Lioresal Tablets are used to relieve muscle spasms which may occur as a result of certain illnesses affecting the nervous system including multiple sclerosis, motor neurone disease, cerebral palsy and meningitis, or following stroke or injuries to the head or spine.




Things to consider before you start to take Lioresal Tablets



Some people MUST NOT take Lioresal 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 Lioresal 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 Lioresal 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:


  • Medicines for depression, e.g. tricyclic antidepressants

  • Medicines for high blood pressure

  • Other drugs which also affect the kidney, e.g. ibuprofen

  • Medicines for Parkinson's disease

  • Medicines which slow down the nervous system, e.g. anti-histamines, sedatives, opiates for pain relief and anti-convulsants (anti-epileptic medicines).

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.




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 Lioresal 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 Lioresal Tablets.

  • If you are going to have an operation of any kind, make sure that the doctor knows that
    you are taking Lioresal Tablets.




How to take Lioresal Tablets


The doctor will tell you how many Lioresal 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 Lioresal 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 Lioresal Tablets suddenly. If the doctor decides to stop your treatment with Lioresal 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 Lioresal 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


  • The dosage depends on the weight of the child.

  • A starting dose of 0.3 mg / kg body weight a day is often used, preferably given in 4 divided doses. Therefore, tablets are not suitable for children who weigh less than 33 kg.

  • The usual daily doses are:


    Children aged 6 years -8 years: 30 - 40 mg
    Children over 8 years: up to 60 mg.



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 Lioresal Tablets, tell your doctor at once or contact your nearest hospital casualty department. Take your medicine with you.





LIORESAL Tablets Side Effects


Lioresal 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).




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.




How to store Lioresal 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 Lioresal 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.




Further information


Lioresal 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 blister packs of 84 and 100 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




Lioresal Tablets are made by




Novartis Pharma S.p.A

131 Via Provinciale Schito

Torre Annunziata

Italy




This leaflet was revised in July 2009.


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.


LIORESAL is a registered trade mark


Copyright Novartis Pharmaceuticals UK Limited





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