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PACKAGE LEAFLET: 1. What is and Signs of an allergic reaction include: INFORMATION FOR THE USER what it is used for a rash, swallowing or breathing What oxybutynin is problems, swelling of your lips, face, Oxybutynin Hydrochloride The name of your medicine is Oxybutynin throat or tongue ✕ 3mg Tablets Hydrochloride 3mg Tablets (referred to as You have a rare muscle illness called oxybutynin throughout this leaflet). ‘Myasthenia gravis’ ✕ It contains a medicine called oxybutynin You have glaucoma (increased pressure in Read all of this leaflet carefully before the eye, sometimes sudden and painful you start taking this medicine hydrochloride. This belongs to two groups of medicines called ‘’ and with blurred vision or loss of vision) • Keep this leaflet. You may need to read ✕ ‘’. Your gut (stomach or intestine) is blocked, it again. perforated or not working properly • If you have any further questions, ask How oxybutynin works ✕ You have a severe form of a condition your doctor or pharmacist. It works by relaxing the muscles of the known as ‘ulcerative colitis’ • This medicine has been prescribed for bladder and stops sudden muscle ✕ You have a blockage that makes it you. Do not pass it on to others. It may contractions (spasms). This helps control difficult for you to pass water (urine) harm them, even if their symptoms are the release of water (urine). the same as yours. Do not take this medicine if any of the What oxybutynin is used for • If any of the side effects get serious, or above applies to you. If you are not sure, Oxybutynin can be used in adults and if you notice any side effects not listed talk to your doctor or pharmacist before children 5 years or older to treat: in this leaflet, please tell your doctor or taking oxybutynin. • Loss of control in passing water (urinary pharmacist. incontinence) In this leaflet: • Increased need or urgency to pass water Take special care with oxybutynin. 1. What oxybutynin is and what it is (urine) Check with your doctor or pharmacist used for • Night time bedwetting, when other before taking your medicine if: ▲ 2. Before you take oxybutynin treatments have not worked You have kidney or liver problems ▲ You are 65 years of age or older 3. How to take oxybutynin 2. Before you take oxybutynin ▲ The person taking this medicine is a 4. Possible side effects child (use is not recommended under 5. How to store oxybutynin Do not take this medicine and tell 5 years of age) 6. Further information your doctor if: ▲ You have an illness affecting the ✕ You are allergic (hypersensitive) to nerves called ‘autonomic neuropathy’ oxybutynin hydrochloride or any of the ▲ You have an overactive thyroid gland other ingredients in this medicine (‘Hyperthyroidism’) ▲ (listed in Section 6 Further You have heart disease or high Information) blood pressure 1 762512_NT. OXYBUTININ3MGRLV1GB.qxp_FORMAT210x170mm-RL-DBL.qxd25/06/202011:58Page2

▲ You have an irregular heart beat In particular, tell your doctor if you are amounts may pass into mothers’ milk. (palpitations) and/or increased or rapid taking any of the following: Breastfeeding while using oxybutynin is heart beat • Other or antimuscarinic therefore not recommended. ▲ You have an enlarged prostate gland medicines – such as some medicines for Ask your doctor or pharmacist for advice ▲ You have indigestion or heart burn irritable bowel syndrome, asthma or before taking any medicine if you are caused by a ‘hiatus hernia’ (where part incontinence, motion sickness or pregnant or breastfeeding. of your stomach pushes through the movement disorders associated with diaphragm) Parkinson’s disease Driving and using machines ▲ You have a raised body temperature or • Medicines used to make you feel sleepy You may feel drowsy or have blurred vision (sedatives) or if you are feeling sick fever while you are taking this medicine. If this ▲ (nausea) or have vertigo – such as You will be taking this medicine in a happens, do not drive or use any tools or prochlorperazine or hot climate machines. Oxybutynin can cause glaucoma (increased • Medicines used to treat certain mental pressure in the eye) please contact your illnesses such a , Important information about some of doctor immediately if you suffer any haloperidol or benperidol the ingredients of oxybutynin This medicine contains: blurred vision, loss of vision or have any (butyrophenones) • Lactose: If you have been told by your pain in the eye. • Medicines for depression – such as amitryptyline, or doctor that you cannot tolerate or digest Oxybutynin may reduce the amount of (“tricyclic ”) some sugars (have an intolerance to saliva resulting in tooth decay or fungal • Amantadine – used in Parkinson’s some sugars), talk to your doctor before infection of the mouth. disease or to treat and prevent some taking this medicine. If you are not sure if any of the above apply virus infections 3. How to take oxybutynin to you, talk to your doctor or pharmacist • L-dopa – used to treat Parkinson’s disease before taking oxybutynin. • Digoxin – used to treat heart problems. Always take oxybutynin exactly as your doctor • Medicines for stomach and bowel related has told you. You should check with your doctor or pharmacist if you are not sure. Taking other medicines problems - such as domperidone, Please tell your doctor or pharmacist if you metoclopromide or bethanechol Taking this medicine are taking or have recently taken any other Pregnancy and breastfeeding • Take this medicine by mouth medicines. This includes medicines you buy Talk to your doctor before taking this • Swallow the tablets with a glass of water without a prescription, including herbal medicine if • Do not give this medicine to children medicines. This is because oxybutynin can • You are pregnant, might become under 5 years old affect the way some other medicines work. pregnant or think you may be pregnant • If you feel the effect of your medicine is Also, some other medicines can affect the • You are breast-feeding or planning to too weak or too strong, do not change way oxybutynin works. breast feed. This is because small the dose yourself, but ask your doctor.

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How much to take Your heart beat may become very fast, • Feeling sick, being sick Your doctor will decide the dose uneven or forceful. You may get breathing • Dry skin appropriate for you. problems or numbness or go into a coma. • Headache Adults If you forget to take oxybutynin • Somnolence (feeling drowsy or sleepy) • The usual starting dose is one 5mg If you forget a dose, take it as soon as you • Dizziness oxybutynin tablet two or three times remember it. However, if it is nearly time • Blurring of vision each day for the next dose, skip the missed dose. Common (affects 1 to 10 people in a 100) • Your doctor may decide to increase to Do not take a double dose to make up for • Dry eyes the maximum dose of 5mg four times a forgotten dose. • Diarrhoea each day If you stop taking oxybutynin • Vomiting Elderly Keep taking oxybutynin until your doctor • Flushing especially in children • The usual starting dose is one 3mg tells you to stop. Do not stop taking • Confusion tablet twice each day oxybutynin just because you feel better. Uncommon (affects 1 to 10 people in a 1,000) • Your doctor may decide to increase • Stomach pain this until you respond to the medicine 4. Possible side effects • Loss of appetite (anorexia) Children (over 5 years) Like all medicines, oxybutynin can cause • Difficulty in swallowing (dysphagia) • The starting dose is one 3mg tablet side effects, although not everybody gets Frequency unknown twice each day them. Children are at higher risk of the • Increased pressure in the eyes, sometimes • The usual dose is then one 5mg tablet effects. sudden and painful with blurred vision or twice each day loss of vision (glaucoma), enlargement of • Your doctor may decide to increase this Stop taking oxybutynin and see a doctor or go to a hospital straight away if: the pupil of the eye to one 5mg tablet two or three times each • Indigestion or heartburn (acid reflux) Frequency unknown day • Urinary tract infection • You have an allergic reaction. The signs • If you are giving it to a child to prevent • Increased, rapid or irregular heartbeat may include: a rash, swallowing or bedwetting, give the last dose just (palpitations) before bedtime breathing problems, swelling of your lips, face, throat or tongue. • Heat stroke If you take more oxybutynin than you • Difficulty passing water (urine) should • You feel reduced sweating, leading to overheating in hot environments • Agitation If you take more oxybutynin than you • Anxiety should, tell a doctor or go to a hospital Tell your doctor or pharmacist if any of • Becoming dependent on Oxybutynin casualty department straight away. Take the following side effects get serious or • Feeling excessively suspicious and the medicine pack with you. This is so the lasts longer than a few days: distrustful of others (paranoia) doctor knows what you have taken. Very common (affects more than 1 in 10 • Seeing or hearing things that are not Taking too much oxybutynin can be very people) there (hallucinations) dangerous. You may become very restless • Constipation • Drowsiness or excited, flush or get dizzy or lightheaded. • Dry mouth • Nightmares 3 762512_NT. OXYBUTININ3MGRLV1GB.qxp_FORMAT210x170mm-RL-DBL.qxd25/06/202011:58Page4

• Fits (convulsions) 6. Further Information • Depression What Oxybutynin 3mg Tablets contain • Itchy, lumpy rash (urticaria) • Each tablet contains 3mg of the active • Absence of sweating (hypohidrosis) substance oxybutynin hydrochloride • Skin that is more sensitive to the sun • The other ingredients are lactose, (photosensitivity) microcrystalline cellulose, calcium • Abnormal bloating/swelling together stearate and indigo carmine aluminium with pain and feeling or being sick lake (E132) (pseudo-obstruction) What oxybutynin looks like and contents Reporting of side effects of the pack If you get any side effects, talk to your • Oxybutynin 3mg Tablets are pale blue doctor or pharmacist. This includes any round tablets with OXB3 on one side. possible side effects not listed in this Supplied in blisters of 56 tablets. leaflet. You can also report side effects directly via the Yellow card Scheme at: Marketing Authorisation Holder and Manufacturer www.mhra.gov.uk/yellowcard. Marketing Authorisation Holder By reporting side effects you can help Zentiva Pharma UK Limited, provide more information on the safety 12 New Fetter Lane, London EC4A 1JP, of this medicine. United Kingdom Manufacturer 5. How to store oxybutynin Sanofi Winthrop Industrie, Keep this medicine in a safe place where 30-36 avenue Gustave Eiffel, children cannot see or reach it. 37000 Tours, France Do not use oxybutynin after the expiry date This leaflet does not contain all the which is stated on the label or carton after information about your medicine. If you EXP. The expiry date refers to the last day have any questions or are not sure about of that month. anything, ask your doctor or pharmacist. Store below 30°C. This leaflet was last revised in Medicines should not be disposed of via June 2020. wastewater or household waste. Ask your ‘Zentiva’ is a registered trademark pharmacist how to dispose of medicines © 2020 Zentiva. no longer required. These measures will help to protect the environment. 4 1065017710 - 762512 *762512*