Package leaflet: Information for the user Oxybutynin hydrochloride 2.5mg/5ml Oral Solution
Read all of this leaflet you have a severe form of a Medicines used to make you feel carefully before you start condition known as ‘ulcerative sleepy (sedatives) or if you are taking this medicine colitis’ feeling sick (nausea) or have vertigo because it contains you have a blockage that makes - such as prochlorperazine or important information for it difficult for you to pass water chlorpromazine you. (urine). Medicines used to treat certain mental illnesses - such as clozapine, Keep this leaflet. You may need Do not take this medicine if any of phenothiazines, haloperidol or to read it again. the above applies to you. If you are benperidol (butyrophenones) If you have any further not sure, talk to your doctor or Medicines for depression - such as questions, ask your doctor or pharmacist before taking amitriptyline, imipramine or pharmacist. Oxybutynin. dosulepin (‘tricyclic antidepressants’) This medicine has been and lithium prescribed for you only. Do not Warnings and precautions Amantadine, biperiden, levodopa pass it on to others. It may harm Talk to your doctor or pharmacist - used in Parkinson’s disease or to them, even if their signs of illness before taking Oxybutynin if: treat and prevent some viral are the same as yours. infections If you get any side effects, talk to you are 65 years of age or older Aminopenicillins, tetracyclines, your doctor or pharmacist. This you have certain heart conditions sulfamethoxazole, cotrimoxazole - includes any possible side effects (deficiency congestive heart drugs used for inhibition of bacterial not listed in this leaflet. See failure, coronary heart disease) infections section 4. the person taking the medicine is Digoxin, quinidine, disopyramide, a child (use is not recommended procainamide and lidocaine - used to under 5 years of age) treat heart problems The name of your medicine is you have brain problems (such as Dipyridamole - used to treat Oxybutynin hydrochloride hallucinations, agitation, blood problems 2.5mg/5ml Oral Solution but it will confusion, drowsiness) Antihistamines - used to treat be referred to as Oxybutynin you have kidney or liver allergies throughout this leaflet. problems Paracetamol - used to treat pain you have bowel problems (such Phenylbutazone - used to treat What is in this leaflet as bowel obstruction, bowel inflammation
laziness, inflammation of bowel) Atropine and related compounds - 1. What Oxybutynin is and what you have neurological disorders drugs used for spasms of the it is used for (such as Parkinson's disease) digestive tract 2. What you need to know you have an illness affecting the before you take Oxybutynin nerves called ‘autonomic Oxybutynin with food, beverages 3. How to take Oxybutynin neuropathy’ and alcohol 4. Possible side effects you have eye problem (such as Alcohol may increase drowsiness 5. How to store Oxybutynin glaucoma) caused by oxybutynin. 6. Contents of the pack and you have an overactive thyroid other information gland (‘Hyperthyroidism’) Pregnancy, you have dental caries or a breast-feeding and
fungal infection in the mouth fertility 1. What Oxybutynin is and what you have heart disease or high it is used for blood pressure Talk to your doctor before taking
you have an irregular heart beat this medicine if: Oxybutynin contains a medicine (palpitations) and/or increased or called oxybutynin hydrochloride. rapid heart beat You are pregnant, think you may This belongs to two groups of you have an enlarged prostate be pregnant or are planning to medicines called ‘anticholinergics’ gland have a baby and ‘antispasmodics’. you have indigestion or heart You are breast-feeding or It works by relaxing the muscles of burn caused by a ‘hiatus hernia’ planning to breast-feed. This is the bladder and stops sudden (where part of your stomach because small amounts may pass muscle contractions (spasms). This pushes through the diaphragm) into mothers’ milk. Breast helps control the release of water feeding while using Oxybutynin is (urine). you have a raised body temperature or fever therefore not recommended you will be taking this medicine Oxybutynin can be used in in a hot climate adults and children 5 years or Driving and using machines
older to treat: You may feel drowsy or have blurred Children and adolescents vision while you are taking this Do not give this medicine to children loss of control in passing water medicine. If this happens, do not under the age of 5 years. (urinary incontinence) drive or use any tools or machines.
increased need or urgency to If you are not sure if any of the pass water (urine) above applies to you, talk to your night time bedwetting, when Oxybutynin contains: doctor or pharmacist before taking other treatments have not Oxybutynin. worked Sorbitol (E420): This medicine Other medicines and contains 896mg sorbitol in each 5ml You must talk to a doctor if you do Oxybutynin dose which is equivalent to not feel better or if you feel worse. 179.2mg/ml . Sorbitol is a source of fructose. If your doctor has told you 2. What you need to know Tell your doctor or pharmacist if you that you (or your child) have an before you take Oxybutynin are taking, have recently taken or intolerance to some sugars or if you
might take any other medicines. have been diagnosed with hereditary Do not take Oxybutynin This includes medicines obtained fructose intolerance (HFI), a rare if: without a prescription, including genetic disorder in which a person
herbal medicines. cannot break down fructose, talk to you are allergic to oxybutynin your doctor before you (or your child) hydrochloride or any of the other This is because Oxybutynin can take or receive this medicine. Sorbitol ingredients of this medicine affect the way some medicines may cause gastrointestinal discomfort (listed in section 6). work. Also some medicines can and mild laxative effect. affect the way Oxybutynin work. Methyl parahydroxybenzoate Signs of an allergic reaction include: In particular, tell your doctor if (E218): may cause allergic a rash, swallowing or breathing you are taking any of the reactions (possibly delayed). problems, swelling of your lips, face, following: throat or tongue. Sodium: This medicine contains less than 1 mmol sodium (23 mg) per 5ml Other anticholinergic or you have a rare muscle illness dose, that is to say essentially antimuscarinic medicines - such as called ‘Myasthenia gravis’ 'sodium-free'. some medicines for irritable bowel you have increased pressure in syndrome, asthma or incontinence, the eye (glaucoma) Propylene glycol (E1520): This motion sickness or movement your gut (stomach or intestine) is medicine contains 15.5mg disorders associated with blocked, perforated or not propylene glycol in each 5ml dose Parkinson's disease working properly which is equivalent to 3.1mg/ml.
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3. How to take Oxybutynin 4. Possible side effects 5. How to store Oxybutynin
Always take this medicine exactly as Like all medicines, this medicine can ► Keep this medicine out of the sight your doctor has told you. Check with cause side effects, although not and reach of children. your doctor or pharmacist if you are everybody gets them. ► Do not use this medicine after not sure. the expiry date which is stated on the carton and bottle label after Stop taking Oxybutynin The recommended doses are given EXP. The expiry date refers to and contact your doctor below. These may be changed by the last day of that month. immediately if you develop your doctor: ► Do not store above 25°C. the following symptoms: ► Discard 30 days after first opening. Adults ► You have an allergic reaction. Store in the original packaging after The signs may include: a rash, first opening. The usual dose is 5mg (10ml) swallowing or breathing ► ► Do not use this medicine if you two or three times a day problems, swelling of your lips, notice that the solution becomes ► Your doctor may decide to face, throat or tongue discoloured or shows any signs of increase to the maximum dose of ► You feel reduced sweating, deterioration. Seek the advice of 5mg (10ml) four times a day leading to overheating in hot your pharmacist. environments ► Do not throw away any medicines Elderly via wastewater or household Other side effects: waste. Ask your pharmacist how ► The usual dose is 2.5mg (5ml) to throw away medicines you no twice a day Very common: may affect more longer use. These measures will ► Your doctor may decide to than 1 in 10 people help protect the environment. increase this to 5mg (10ml) twice a day Dry mouth, constipation, nausea Dizziness, headache, drowsiness 6. Contents of the pack and Children (over 5 years) Dry skin other information
► The usual dose is 2.5mg (5ml) Common: may affect up to 1 in What Oxybutynin contains twice a day 10 people The active substance is oxybutynin ► Your doctor may decide to hydrochloride. increase this to 5mg (10ml) two Diarrhoea, vomiting or three times a day Confusional state Each 5ml oral solution contains 2.5mg ► If you are giving it to a child to Dry eyes oxybutynin hydrochloride. prevent bedwetting, give the last Inability or difficulty in passing water (urine) dose just before bedtime The other ingredients are citric acid Flushing monohydrate (E330), sodium citrate
Method of administration (E331), liquid sorbitol (non- Uncommon: may affect up to 1 crystallising (E420), glycerol ► For oral use only in 100 people (E422), methyl ► Use the 2.5-5ml double-ended parahydroxybenzoate (E218), spoon supplied in the pack to Stomach pain, loss of appetite raspberry flavor (containing measure the required dose (see (anorexia), decrease appetite, propylene glycol (E1520)) and figure below). difficulty in swallowing purified water. ► Swallow the solution. (dysphagia) ► Wash the spoon with clean water after taking every dose. Not known: cannot be estimated What Oxybutynin looks like and from the available data contents of the pack 2.5-5ml double-ended Spoon Oxybutynin is a clear, colourless oral A bladder infection (Urinary tract solution with raspberry odour and infection) supplied in amber glass bottles with Indigestion or heartburn (acid tamper evident child resistant plastic reflux) cap and with a 2.5-5ml double Fits (convulsions) ended spoon for measuring the dose. Agitation Seeing or hearing things that are not there (hallucinations) Oxybutynin hydrochloride If you take more Oxybutynin Nightmares 2.5mg/5ml oral solution is supplied than you should Increased, rapid or irregular in bottles containing 100ml and Contact your nearest hospital heartbeats (palpitation) 150ml solution. casualty department or tell your Blurring of vision, enlargement of doctor immediately. Take the the pupil of the eye, increased Not all pack sizes may be marketed. medicine pack with you. This is so pressure in the eyes (glaucoma), the doctor knows what you have dry eyes Marketing Authorisation Holder: taken. Rash or skin that is more sensitive to the sun Thame Laboratories, Unit 4, Bradfield Road, Taking too much Oxybutynin can be Anxiety very dangerous. You may become Ruislip, Middlesex, Feeling excessive suspicious and very restless or excited, flushed or HA4 0NU, UK distrustful of others get dizzy or light-headed. Your heart Mental Health disorders beat may become very fast, uneven Manufacturer: or forceful. You may get breathing Delpharm Bladel B.V. problems or numbness or go into a Reporting of side effects Industrieweg 1, coma. If you get any side effects, talk to 5531 AD, Bladel, your doctor or pharmacist. This Netherlands includes any possible side effects POM If you forget to take Oxybutynin not listed in this leaflet. You can If you forget a dose, take it as soon also report side effects directly via as you remember it. However, if it is the Yellow Card Scheme Website: This leaflet was last revised in 01/2020. nearly time for the next dose, skip www.mhra.gov.uk/yellowcard or the missed dose. search for MHRA Yellow Card in the Google Play or Apple App Store. Do not take a double dose to make By reporting side effects you can up for a forgotten dose. help provide more information on the safety of this medicine. If you stop taking Oxybutynin Keep taking Oxybutynin until your doctor tells you to stop. Do not stop taking Oxybutynin just because you feel better. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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