BACLOFEN TABLETS BP 10MG
Active substance: BACLOFEN
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Baclofen 10mg tablets
Read all of this leaflet carefully before you start taking this medicine 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice 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. Before you 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 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 USED FOR 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 help treat your condition. Baclofen is used to reduce and relieve the excessive tension in your muscles (spasms) occurring in various illnesses such as cerebral palsy, multiple scelrosis, cerebrovascular accidents, spinal cord diseases and other nervous system disorders. 2. 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. have a stomach ulcer Take special care with Baclofen tablets: 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 suffered from stomach ulcers in the past Parkinson's Disease diabetes, as your doctor may want to monitor your condition recently suffered from a stroke epilepsy difficulty urinating (urinary retention) pregnant, intend to become pregnant or are breast feeding Taking other medicines: 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: antidepressants such as clomipramine, amitriptyline or lithium medicine to help lower blood pressure, as your doctor may want to monitor your blood pressure 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 drink alcohol 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 doctor for 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: Do not drive or operate machinery if you feel drowsy or your alertness is reduced whilst taking these tablets. 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. HOW TO 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
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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 for you. Elderly Elderly patients will usually start with a smaller daily 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. 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 up for a forgotten 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. Some commonly occurring side effects include: drowsiness (including during daytime) feeling sick If you get any of these side effects, please consult your doctor as he may decrease your dose to reduce the effects. Other side effects which occur less frequently include: dry mouth, dizziness and light-headedness heart and lung disorders, low blood pressure shortness of breath or palpitations fatigue or extreme tiredness, sleeplessness (insomnia), confusion, headache, itchy, red skin rash retching, vomiting, slight diarrhoea or constipation Other side effects which occur rarely include: abdominal pain, extreme excitement, depression, hallucinations (seeing or hearing things that are not really there) or nightmares agitation, excessive muscle weakness and muscle pain, shaking, tingling of the limbs or hands and feet, increased muscle spasticity, difficulty walking, co-ordination problems, convulsions visual disturbances (including involuntary eye movements), changes in taste sensation, excessive sweating, difficulty or a change in frequency of urination an alteration in liver function tests or hypothermia. 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. 5. HOW TO STORE BACLOFEN TABLETS Keep out of the reach and sight 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 25C. 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. FURTHER 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, WD18 9SS This leaflet was last approved in 02/2011
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Front side printing 2 of 2
Baclofen 10mg tablets
Read all of this leaflet carefully before you start taking this medicine 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice 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. Before you 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 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 USED FOR 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 help treat your condition. Baclofen is used to reduce and relieve the excessive tension in your muscles (spasms) occurring in various illnesses such as cerebral palsy, multiple scelrosis, cerebrovascular accidents, spinal cord diseases and other nervous system disorders. 2. 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. have a stomach ulcer Take special care with Baclofen tablets: 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 suffered from stomach ulcers in the past Parkinson's Disease diabetes, as your doctor may want to monitor your condition recently suffered from a stroke epilepsy difficulty urinating (urinary retention) pregnant, intend to become pregnant or are breast feeding Taking other medicines: 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: antidepressants such as clomipramine, amitriptyline or lithium medicine to help lower blood pressure, as your doctor may want to monitor your blood pressure 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 drink alcohol 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 doctor for 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: Do not drive or operate machinery if you feel drowsy or your alertness is reduced whilst taking these tablets. 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. HOW TO 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
150 x 410 mm
Front side printing 1 of 2
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 for you. Elderly Elderly patients will usually start with a smaller daily 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. 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 up for a forgotten 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. Some commonly occurring side effects include: drowsiness (including during daytime) feeling sick If you get any of these side effects, please consult your doctor as he may decrease your dose to reduce the effects. Other side effects which occur less frequently include: dry mouth, dizziness and light-headedness heart and lung disorders, low blood pressure shortness of breath or palpitations fatigue or extreme tiredness, sleeplessness (insomnia), confusion, headache, itchy, red skin rash retching, vomiting, slight diarrhoea or constipation Other side effects which occur rarely include: abdominal pain, extreme excitement, depression, hallucinations (seeing or hearing things that are not really there) or nightmares agitation, excessive muscle weakness and muscle pain, shaking, tingling of the limbs or hands and feet, increased muscle spasticity, difficulty walking, co-ordination problems, convulsions visual disturbances (including involuntary eye movements), changes in taste sensation, excessive sweating, difficulty or a change in frequency of urination an alteration in liver function tests or hypothermia. 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. 5. HOW TO STORE BACLOFEN TABLETS Keep out of the reach and sight 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 25C. 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. FURTHER 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, WD18 9SS This leaflet was last approved in 02/2011
150 x 410 mm
Front side printing 2 of 2
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
