Baclofen 10Mg Tablets

Package leaflet: Information for the patient Baclofen 10mg tablets

Read all of this leaflet carefully before you If you have thoughts of harming or killing yourself at any time, speak start taking this medicine because it contains to your doctor straightaway or go to a hospital. Also, ask a relative or important information for you. close friend to tell you if they are worried about any changes in your • Keep this leaflet. You may need to read it again. behaviour and ask them to read this leaflet. • If you have any further questions, ask your Children and adolescents doctor, pharmacist or nurse. Baclofen tablets are not suitable for use in children under 33kg body • This medicine has been prescribed for you only. weight. Do not pass it on to others. It may harm them, Other medicines and Baclofen Tablets even if their signs of illness are the same as yours. Some medicines can interfere with your treatment. Tell your doctor • If you get any side effects, talk to your doctor, or pharmacist if you are taking any of the following: pharmacist or nurse. This includes any possible • Other medicines to relax muscles e.g. tizanidine side effects not listed in this leaflet. See section 4. • Medicines to treat mood disorders such as lithium or tricyclic antidepressants such as amitriptyline • Medicines for high blood pressure e.g. diltiazem What is in this leaflet: • Other drugs which also affect the kidney, e.g. ibuprofen 1 What Baclofen tablets are and what they • Medicines for Parkinson’s disease e.g. levodopa or carbidopa are used for • Medicines which slow down the nervous system, e.g. anti- histamines such as promethazine, 2 What you need to know before you take • Sedatives such as temazepam, opiates for pain relief such as Baclofen Tablets morphine and anti-convulsants (antiepileptic medicines such as 3 How to take Baclofen Tablets carbamazepine). 4 Possible side effects Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as 5 How to store Baclofen Tablets medicines on prescription from your doctor. 6 Contents of the pack and other Pregnancy and breast-feeding information Pregnancy: Ask your doctor or pharmacist for advice before taking any medicine. 1 What Baclofen tablets are and what they are used You should not take Baclofen tablets during pregnancy unless your for doctor advises you to do so. Tell your doctor if you are pregnant, or Baclofen is a muscle-relaxant drug. Baclofen Tablets are used to planning to become pregnant. reduce and relieve the excessive tension in your muscles (spasms) If you have to take Baclofen tablets during pregnancy, your unborn occurring in various illnesses such as cerebral palsy, multiple baby will also be exposed to Baclofen. After birth your baby may sclerosis, cerebrovascular accidents, spinal cord diseases and other develop withdrawal symptoms such as convulsions (symptoms nervous system disorders. of withdrawal are described in the section “If you stop taking Baclofen tablets”). 2 What you need to know before you take Baclofen Breastfeeding: Tablets Only a very small amount of baclofen passes into breast milk. Your Do not take Baclofen tablets if you doctor will discuss with you whether you should breast-feed whilst • are allergic to baclofen or to any of the other ingredients of this taking Baclofen tablets. medicine (listed in section 6) Driving and using machines • have ever had a stomach ulcer Some people may feel drowsy and/or dizzy or have problems with Warnings and precautions their eyes while they are taking Baclofen tablets. If this happens, you Talk to your doctor or pharmacist before taking Baclofen tablets if should not drive or do anything that requires you to be alert (such as you: operate tools or machinery) until these effects have worn off. • have had a stroke Other special warnings • have epilepsy • Be careful when drinking alcohol - it may affect you more than • suffer from any mental illness usual. • are being treated for high blood pressure • Your doctor may want to give you a check up from time to time • have Parkinson’s disease while you are taking Baclofen tablets. • suffer from any liver, kidney or lung disease • If you are going to have an operation of any kind, make sure that • have diabetes the doctor knows that you are taking Baclofen Tablets. • have difficulties urinating • are pregnant or breast-feeding Baclofen tablets contain lactose • have a history of alcoholism, or you drink alcohol to excess or you If you have been told that you have intolerance to some sugars, have a history of drug abuse or dependence contact your doctor before taking this medicine. Some people being treated with baclofen have had thoughts Tests of harming or killing themselves or have tried to kill themselves. If you are diabetic or have liver disease your doctor may take regular Most of these people also had depression, had been using alcohol blood tests, as Baclofen tablets may cause certain blood levels to rise. excessively or were prone to having thoughts of killing themselves. Continued top of next column Continued over page

148x210 Leaflet Reel Fed Profile (BST) Baclofen BP Tablets 10mg x 84 (UK) Baclofen 10mg 84 Tablets PIL UK JDE No.: 50995157 approved for print/date Item number: BBBA9608 Colours Non Printing Colours 1. Black 1. Profile Dimensions: 148x210 (Reel Fed) Originator: M.Doak Dimensions: 148 x 210mm 2. 2. Origination Date: 04/11/2020 Min Body Text Size: 7pt Component: Leaflet for Blisters Revision Date: Supplier: Accord Barnstaple 3. 3. Revised By: 4. Pharmacode: 5. 4063 Proof Round Technical Date sent: N/A 6. 1 Approval Date received: Date Sent: 07/10/20 [email protected] Technologist: T.Hull Cartons and label leaflets only (labels only when specified) German GTIN 14 (incorporating PZN): N/A Technically Approved * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 12.02.2020 3 • Mood changes, confusion, hallucinations or nightmares How to take Baclofen Tablets • Dry mouth Your doctor will tell you how many Baclofen Tablets to take and when to • Problems with their eyes take them. Always follow his/her instructions carefully. The dose will be • Unsteadiness, trembling or other problems with muscle control on the pharmacist’s label. Check the label carefully. If you are not sure, ask • Low blood pressure (fainting) your doctor or pharmacist. • Stomach problems including retching, vomiting, constipation and The doctor will tell you the best time to take the medicine. Some people diarrhoea take it only at night or before doing a task such as washing, dressing, • Excessive sweating, rash shaving, etc. • Increased need to pass urine or pain on passing urine. The final dose of Baclofen depends on how each person responds to the Rare (may affect up to 1 in 1,000 people): drug. You will be started on a low dose, and this will be increased gradually • Numbness or tingling in hands or feet over a few days, under the supervision of the doctor, until you are having • Increased muscle spasm the dose which is right for you. If the starting dose is too high, or if the • Disturbed sense of taste dose is increased too quickly, you may experience side effects, particularly • Slurred or slow speech if you are elderly, have kidney problems or have had a stroke. • Stomach ache If you feel sick after taking Baclofen Tablets, you may find it helps to take • Liver problems them with food or a milk drink. • Difficulty in passing urine Adults • Sexual problems in men, e.g. impotence • The usual dose is 20 mg (2 tablets) three times a day. • Convulsions (particularly in epileptics). • The maximum daily dose is 100 mg (10 tablets) except if you are in hospital when a higher dose may be used. Very rare (may affect up to 1 in 10,000 people): • Hypothermia (low body temperature). Children (0 to < 18 years) Children’s treatment is adjusted to their body weight. Children’s treatment Not known (frequency cannot be estimated from the available data): usually starts with a very low dose (approximately 0.3 mg/kg/day), in • Raised, itchy rash (urticaria – also known as nettle rash or hives). 2-4 divided doses (preferably in 4 doses). The dosage is then gradually • Slow heart beat. increased until it becomes sufficient for the child’s individual requirements, • Increase in blood sugar. this may be between 0.75 and 2 mg/kg body weight. • Trouble breathing during sleep (sleep apnoea syndrome) The total daily dose should not exceed a maximum of 40 mg/day in • Symptoms caused by stopping treatment suddenly (see section 3 ’How children below 8 years of age. to take Baclofen Tablets’). In children over 8 years of age a maximum daily dose of 60 mg/day may If any of the symptoms become troublesome, or if you notice be given. anything else not mentioned here, please go and see your doctor. He/ Baclofen Tablets are not suitable for use in children below 33 kg body she may want to adjust the dose or give you a different medicine. weight. Reporting of side effects Patients with kidney problems If you get any side effects, talk to your doctor, pharmacist or nurse. This You will probably be given a much lower dose. The doctor will decide includes any possible side effects not listed in this leaflet. You can also what the dose should be. report side effects directly via the Yellow Card Scheme at: If you take more Baclofen tablets than you should www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the If you accidentally take too many Baclofen Tablets, tell your doctor at once Google Play or Apple App Store. or contact your nearest hospital casualty department. Take your medicine By reporting side effects you can help provide more information on the with you. Signs of an overdose include drowsiness, breathing difficulties, safety of this medicine. changes in consciousness or coma (unrousable unconsciousness). Also muscle weakness or spasm, confusion, hallucinations, agitation, fits, 5 How to store Baclofen Tablets low blood pressure, slow heart beat, feeling or being sick, diarrhoea, Keep this medicine out of the sight and reach of children. excessive saliva production, reflex problems. Store below 25°C and protected from light. If you forget to take Baclofen tablets Do not use Baclofen tablets after the expiry date stated on If you forget to take a dose, take the next dose at the usual time. DO NOT the carton after Exp. The expiry date refers to the last day of take a double dose. that month. Do not throw away any medicines via wastewater or If you stop taking Baclofen tablets household waste. Ask your pharmacist how to throw away You should not stop taking Baclofen Tablets suddenly. If the doctor medicines you no longer use. These measures will help decides to stop your treatment with Baclofen Tablets, the dose will be protect the environment reduced gradually to prevent withdrawal symptoms such as muscle spasms and increased muscle rigidity, fast heart rate, fever, confusion, 6 hallucinations, changes in mood and emotion, mental disorders, feeling Contents of the pack and other Information persecuted or convulsions (fits). What Baclofen tablets contain If you have any further questions on the use of this medicine, ask your • The active substance (the ingredient that makes the tablet doctor, pharmacist or nurse. work) is baclofen. Each tablet contains 10mg of the active ingredient • The other ingredients are lactose, pregelatinised maize 4 Possible Side Effects starch, maize starch, magnesium stearate, water. Baclofen Tablets are suitable for most people, but, like all medicines, they can sometimes cause side effects. What Baclofen tablets look like and contents of the pack The side effects listed below have been reported: Baclofen Tablets 10mg are white to off-white, circular, Very common (may affect more than 1 in 10 people): biconvex uncoated tablets impressed “C” on one face, and the • Tiredness, sleepiness, nausea (feeling sick). identifying letters “B” “L” on either side of a central division line on the reverse. Common (may affect up to 1 in 10 people): • Excessively weak limbs or feeling tired and exhausted, aching muscles Pack size is: 84 tablets. • Headache, dizziness or light-headedness Marketing Authorisation Holder and • Breathing difficulties Manufacturer • Sleeplessness Accord, Barnstaple, EX32 8NS, UK. Continued top of next column 50995157 BBBA9608 This leaflet was last revised in November 2020