Baclofen Tablets Bp 10mg
6504
PACKAGE LEAFLET: INFORMATION FOR THE USER
Baclofen 10mg tablets
Read all of this leaflet carefully before you start taking 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 or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
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.
Please read this product information carefully before you or your child is given Baclofen since it contains important information.
1. WHAT BACLOFEN TABLETS ARE AND WHAT THEY ARE USEDFOR
Baclofen belongs to a group of medicines called anti-spasticity agents, which are used to relax muscles.
Your doctor has decided that you or your child needs this medicine to hel p treat you r cond ition.
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 TABLETS
Do not take Baclofen tablets if you:
• are hypersensitive (allergic) to baclofen or any of the other ingredients in these tablets (See section 6).
• have a stomach ulcer Warnings and precautions:
Talk to your doctor, or pharmacist or nurse before taking this medicine if you have any of the following:
• depression or a mental disorder, especially if you are taking lithium
• liver or kidney disease
• breathing difficulties or lung disease
• high blood pressure and are being treated with antihypertensive medicines
• suffered from stomach ulcers in the past
• Parkinson's Disease
• diabetes, as your doctor may wantto monitoryour condition
• recently suffered from a stroke
• epilepsy
• difficulty urinating (urinary retention)
• pregnant, intend to become pregnant or are breastfeeding.
Other medicines and Baclofen tablets:
If taken with some other medicines the effects of Baclofen Tablets or the effects of other medicines may be changed. Please check with your doctor if you are taking any of the following:
• other medicines to relax muscles e.g tizanidine
• antidepressants such as clomipramine, amitriptyline or lithium
• medicine to help lower blood pressure, as your doctor may want to monitoryour blood pressure
• Other drugs which also affect the kidney, e.g. ibuprofen (usually for arthritis or pain relief)
• levodopa and carbidopa for Parkinson's Disease (as taking these together may cause mental confusion, hallucinations, agitation)
• If you are due to have an operation requiring a general anaesthetic, make sure you tell the doctor that you are taking baclofen.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Baclofen tablets with food and drink:
Do not drinkalcohol whilst taking Baclofen Tablets.
You should take the tablets with food or a drink of milk, especially if you feel sick when you take them.
Children and adolescents:
Baclofen tablets are not suitable for use in children under 33 kg body weight.
Pregnancy and breast-feeding:
Ask your doctorfor advice before taking any medicine.
If you are pregnant, intend to become pregnant or are breast feeding speak to your doctor.
Baclofen should only be used during pregnancy, if considered strictly necessary, especially during the first three months.
Driving and using machines:
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 the effects have worn off.
Important information about some of the ingredients of Baclofen tablets:
Baclofen tablets contain lactose; do not take if you have been told by your doctor that you have an intolerance to some sugars.
3. HOWTO TAKE BACLOFEN TABLETS
Always take Baclofen tablets exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.
You should take the tablets with food or a drink of milk, especially if you feel sick when you take them.
Adults
The usual initial dose is 5 mg baclofen three times a day for three days. Then 10mg baclofen three times a day for the next three days. Then 15mg baclofen three times a day for three days, followed by 20mg baclofen three times a day for the next three days.
The usual daily dose thereafter is 60mg baclofen (two tablets three times a day). Your doctor may increase the dose prescribed up to 100mg baclofen per day or sometimes more if you are in hospital.
The daily dose may be taken divided up in to three doses, or it may be taken just at night time to help painful night cramp, or it may be taken approximately 1 hour before doing specific tasks such as washing, dressing or physiotherapy, which are helped by taking baclofen. Your doctor will tell you what is best foryou.
Elderly
Elderly patients will usually start with a smaller dally dose of baclofen. Use in 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 0.3mg/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 40mg/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.
If you take more Baclofen tablets than you should:
An overdose of this medicine may be harmful. If you or someone else, have taken too much of your medicine tell your doctor or pharmacist, or go to the nearest hospital casualty department immediately. Take your medicine with you.
If you forget to take Baclofen tablets:
If you forget to take a dose at the right time, take it as soon as you remember, then go one as before. Do not take a double dose to make upforaforgotten dose.
If you stop taking Baclofen tablets:
Do not stop taking baclofen suddenly unless your doctor tells you to. If you stop taking your Baclofen Tablets without gradually reducing the dose you may suffer from unpleasant side effects such as worsening of spasticity, anxiety, delusions, hallucinations, changed behaviour, hyperactivity, abnormally high body temperatures, confusion, abnormal muscle movements, convulsions or palpitations.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Baclofen Tablets can cause side effects, although not everybody gets them.
The side effects listed below have been reported:
More than 1 in 10 people have experienced:
Tiredness, sleepiness, nausea (feeling sick).
Uptol 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.
Uptol in 1,000 people have experienced:
Numbness or tingling in hands orfeet 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,itchyrash(urticaria-alsoknownasnettlerashorhives).
• Slow heart beat.
• Increase in blood sugar.
Symptoms caused by stopping treatment suddenly (see '3. How to take Baclofen Tablets').
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 at: www.mhra.aov.uk/vellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOWTO STORE BACLOFEN TABLETS
Keep out of the sight and reach of children.
Do not use the medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Baclofen tablets contain:
Each tablet contains 10mg of the active ingredient Baclofen.
Each tablet also contains microcrystalline cellulose, lactose, calcium hydrogen phosphate, colloidal anhydrous silica, magnesium stearate and sodium starch glycollate.
What Baclofen tablets look like and the contents of the pack
Baclofen Tablets are round and white with the markings "BN" and "10" on one side with a breakline and plain on the reverse.
The tablets are supplied in packs of 84 tablets.
Marketed Authorisation Holder and Manufacturer Co-Pharma Ltd.
Unit 4, Metro Centre, Tolpits Lane,
Watford, Herts, WD189SS
This leaflet was last revised in May 2016.
