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Buspirone 5Mg and 10Mg Tablets Package leaflet: Information for the patient Buspirone 5mg and 10mg tablets Read all of this leaflet carefully before you start Other medicines and Buspirone tablets taking this medicine because it contains important Tell your doctor or pharmacist if you are taking, information for you. have recently taken or might take any other medicines, • Keep this leaflet. You may need to read it again. especially: • If you have any further questions, ask your doctor or • monoamine-oxidase inhibitors (MAOIs) such as pharmacist. phenelzine, tranylcypromine (for depression) • This medicine has been prescribed for you only. Do • St. John’s Wort, nefazodone, L-tryptophan, fluvoxamine, not pass it on to others. It may harm them, even if trazodone (for depression) • selective serotonin re-uptake inhibitors (SSRIs) e.g. their signs of illness are the same as yours. fluoxetine, paroxetine (for depression) • If you get any side effects, talk to your doctor or • serotonin norepinephrine re-uptake inhibitors (SNRIs) e.g. pharmacist. This includes any possible side effects duloxetine, venlafaxine not listed in this leaflet. See section 4. • tricyclic antidepressants e.g. amitriptyline, clomipramine • haloperidol, lithium (for mental illness) What is in this leaflet • calcium channel blockers such as diltiazem, verapamil (to 1 What Buspirone tablets are and what they treat high blood pressure) • rifampicin (to treat tuberculosis) are used for • triptan drugs e.g. sumatriptan (to treat migraine) 2 What you need to know before you • tramadol (a painkiller) take Buspirone tablets • baclofen (a muscle relaxant) • lofexidine (to manage drug withdrawal) 3 How to take Buspirone tablets • nabilone (to treat nausea and vomiting) 4 Possible side effects • antihistamines (to treat allergic reactions) 5 How to store Buspirone tablets • erythromycin, itraconazole, linezolid (to treat infections) • benzodiazepines e.g. nitrazepam or temazepam or 6 Contents of the pack and other another common sedative or hypnotic medicine information • diltiazem (to treat angina) • digoxin (to treat heart failure) • phenobarbital, phenytoin, carbamazepine (to treat 1 What Buspirone tablets are and what they epilepsy) are used for • cimetidine (to treat stomach ulcers) Buspirone tablets belong to a group of medicines called • diazepam (to treat anxiety) anxiolytics. These medicines work on the central nervous • warfarin (to treat blood clots). system, altering levels of chemicals in the brain. Buspirone tablets may be used for the: Buspirone tablets with food, drink and alcohol • short term management of anxiety disorders Talk to your doctor before eating or drinking products • relief of symptoms of anxiety with or without symptoms containing grapefruit juice, whilst taking Buspirone of depression. tablets. You should not drink alcohol whilst taking Buspirone tablets. 2 What you need to know before you take Pregnancy and breast-feeding Buspirone tablets If you are pregnant or breast-feeding, think you may be Do not take Buspirone tablets if you: pregnant or are planning to have a baby, ask your doctor or • are allergic to buspirone hydrochloride or any of the pharmacist for advice before taking this medicine. other ingredients of this medicine (listed in section 6) • are pregnant or breast-feeding Buspirone should not be given to a pregnant or breast- • have epilepsy feeding mother as it is not known if it affects the growth • have severely impaired liver or kidney function. of the unborn or breast-fed baby. Ask your doctor or pharmacist for advice before taking any medicine. Warnings and precautions Talk to your doctor or pharmacist before taking Buspirone Driving and using machines tablets if you have: Buspirone tablets may make you feel drowsy or dizzy. • had impaired liver or kidney function in the past Make sure you are not affected before you drive or operate • been prescribed a benzodiazepine e.g. nitrazepam or machinery. temazepam or another common sedative or hypnotic The medicine can affect your ability to drive as it may make medicine. You should be gradually withdrawn from these you sleepy or dizzy. medicines before taking Buspirone tablets • Do not drive while taking this medicine until you • depression or other conditions that are treated with know how it affects you. antidepressants. The use of these medicines together with • It is an offence to drive if this medicine affects your ability buspirone can lead to serotonin syndrome, a potentially to drive. life-threatening condition (see “Other medicines and • However, you would not be committing an Buspirone tablets”) offence if: • acute narrow-angle glaucoma - The medicine has been prescribed to treat a • myasthenia gravis, a disorder characterised by muscle medical or dental problem and weakness, difficulty chewing or swallowing and slurred - You have taken it according to the instructions speech given by the prescriber or in the information • have had drug dependence. provided with the medicine and - It was not affecting your ability to drive safely Continued top of next column BBBB1045 Continued over page Buspirone 5mg & 10mg Tablets PIL - UK approved for print/date Item number: BBBB1045 Colours Non Printing Colours 1. 1. Originator: S.Anson Dimensions: 210x120 Black Origination Date: 26.03.2021 Min Body Text Size: 7pt 2. 2. Revision Date: 01.04.2021 Supplier: Alkaloida 3. 3. Revised By: S.Anson 4. 5. Proof Round Technical Date sent: n/a 6. 4 Approval Date received: n/a [email protected] Cartons and label leaflets only (labels only when specified) German GTIN 14 (incorporating PZN): * 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 Talk to your doctor or pharmacist if you are not sure Other side effects: whether it is safe for you to drive while taking this medicine. Very common: may affect more than 1 in 10 people • Dizziness, headache, sleepiness Buspirone tablets contain lactose If you have been told by your doctor that you have an Common: may affect up to 1 in 10 people intolerance to some sugars, contact your doctor before • Nervousness, difficulty in sleeping, disturbance taking this medicinal product. in attention, depression, confused state, sleeping problems, anger, excitement, pins and needles, 3 How to take Buspirone tablets tingling, blurred vision, abnormal coordination, Always take this medicine exactly as your doctor or tremor, ringing or buzzing in the ears, racing heart pharmacist has told you. Check with your doctor or (abnormally fast heart rhythm), chest pain, blocked pharmacist if you are not sure. nose, sore throat, feeling and being sick, stomach pain, dry mouth, diarrhoea, constipation, cold sweats, Swallow the tablets with water, at the same time each rash, pain in the muscles, tendons, ligaments and bone, day. Buspirone tablets should be taken consistently with mental and physical tiredness or without food. Rare: may affect up to 1 in 1,000 people The recommended dose is: • Bruising, itchy skin rash caused by allergic Adults (including the elderly) reaction- pale or red irregular raised patches with severe The usual starting dose is 5mg two to three times a day, itching (hives) which may be increased every two to three days. The usual Very rare: may affect up to 1 in 10, 000 people dose you will be maintained on is 15mg to 30mg a day in divided doses. The maximum daily dosage should not • Feeling that the mind is separated from the body, effect exceed 60mg per day. on your lability, extrapyramidal disorder (tremor, slurred speech, restlessness (akathisia), dystonia (affecting Use in children and adolescents posture – muscle spasm of the neck, shoulders or body)), Buspirone tablets are not recommended for use in children anxiety, distress, muscle rigidity, difficulty controlling or adolescents under the age of 18. movement/jerky movements, disorder affecting posture (muscle spasm of neck, shoulders and body), total or Patients with liver or kidney problems – Your doctor will partial memory loss, lack of muscle control, co-ordination, prescribe a lower dose if you have liver or kidney problems. difficulty in controlling movements, tremor, stiffness and shuffling, restless leg syndrome, restlessness, difficulty If you take more Buspirone tablets than you passing water, over production of breast milk. should If you (or someone else) swallow too many tablets at Reporting of side effects the same time, or if you think a child has swallowed any, If you get any side effects, talk to your doctor, pharmacist contact your nearest hospital casualty department or or nurse. This includes any possible side effects not listed in tell your doctor immediately. Symptoms of an overdose this leaflet. You can also report side effects directly via the include feeling or being sick, headache, dizziness, Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or drowsiness, ringing or buzzing in the ears, restlessness, search for MHRA Yellow Card in the Google Play or Apple restriction of the pupils, stomach problems, slow heart App Store. beat, low blood pressure, fits and extrapyramidal By reporting side effects you can help provide more symptoms (difficulty in speaking or swallowing, loss of information on the safety of this medicine. balance control, mask-like face, shuffling walk, stiffness of arms and legs, trembling or shaking of hands or fingers). 5 How to store Buspirone tablets If you forget to take Buspirone tablets Keep this medicine out of the sight and reach of children. Do not take a double dose to make up for a forgotten Do not use Buspirone tablets after the expiry date which is dose. If you forget to take a dose, take it as soon as you stated on the carton after EXP. remember it and then take the next dose at the right time. The expiry date refers to the last day of that month. Do not store above 25°C. Store in the original container.
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