Patient leaflet - Oxybutynin Hydrochloride tablets 5 mg
1.What Oxybutynin Tablets are and what they are used for
The active substance in Oxybutynin Tablets is oxybutynin hydrochloride. This is one of a group of medicines called anticholinergics or antispasmodics. It increases the volume of the bladder by relaxing the muscle of the bladder wall, and helps to control the release of urine. It is used to treat the following conditions:
Adults:
- Loss of control in passing water (urinary incontinence), urgency and frequency in patients unable to control their bladder
- Neurogenic bladder disorders (lack of bladder control caused by problems with the nervous system or spinal cord)
Children over 5 years:
Oxybutynin Hydrochloride Tablets can be used in children 5 years or older to treat: ■ Loss of control in passing urine (urinary incontinence)
- Increased need or urgency to pass urine
- Night time bedwetting, when other treatments have not worked
2.What you need to know before you take Oxybutynin Tablets
Do not take Oxybutynin Tablets:
- if you are allergic (hypersensitive) to oxybutynin hydrochloride or any of the other ingredients of Oxybutynin Tablets (listed in section 6, Contents of the pack and other information). Signs of an allergic reaction include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
- if you have a blockage that makes it difficult to pass water (urine)
- if you have diseases or obstructions of the stomach or intestine (gut), including bowel obstruction or no bowel movement
- if you have a severe form of a condition known as ulcerative colitis
- if you have a condition called myasthenia gravis (a muscle weakening disease) ■ if you have glaucoma (increased pressure in the eye, sometimes sudden and painful with blurred vision or loss of vision)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Oxybutynin Tablets: ■ if you have kidney or liver disease
- if you are 65 years of age or older
- if the person taking this medicine is a child (use is not recommended under 5 years of age) ■ if you have an illness affecting the nerves called autonomic neuropathy
- if you have an overactive thyroid gland (hyperthyroidism)
- if you have heart disease, heart failure or high blood pressure
- if you have an irregular heartbeat (palpitations) and/or increased or rapid heart beat ■ if you have an enlarged prostate gland
- if you have indigestion or heartburn caused by a hiatus hernia
- if you have raised body temperature or fever
- if you will be taking this medicine in a hot climate
Oxybutynin can cause glaucoma (increased pressure in the eye). Please contact your doctor immediately if you suffer any blurred vision, loss of vision or have any pain in the eye. Oxybutynin may reduce the amount of saliva resulting in tooth decay, gum disease or fungal infection of the mouth.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist. Other medicines and Oxybutynin Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Oxybutynin Tablets can affect the way some other medicines work. Also some other medicines can affect the way Oxybutynin Tablets work.
In particular, tell your doctor if you are taking any of the following:
- other anticholinergic or antimuscarinic medicines such as some medicines for irritable bowel syndrome, asthma or incontinence, motion sickness or movement disorders associated with Parkinson’s disease
- medicines used to make you feel sleepy (sedatives) or if you are feeling sick (nausea) or have vertigo, such as prochlorperazine or chlorpromazine
- medicines used to treat certain mental illnesses such as clozapine, phenothiazines, haloperidol or benperidol (butyrophenones)
- medicines used to treat depression such as amitriptyline, imipramine or dosulepin (tricyclic antidepressants)
- amantadine used in Parkinson’s disease or to treat and prevent some viral infections ■ levodopa or biperiden, used to treat Parkinson’s disease
- digitalis, digoxin and quinidine, used to treat heart problems
- medicines for stomach and bowel related problems such as domperidone, metoclopramide or bethanechol
- antihistamines used to relieve allergy symptoms
- medicines containing atropine or related compounds like atropinic antispasmodics and dipyridamole.
Oxybutynin Tablets with alcohol
If you take alcohol while taking these tablets, you may become very drowsy. Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine as oxybutynin should not be used during pregnancy unless clearly necessary.
When oxybutynin is used during breast-feeding, a small amount is excreted in the mother’s milk. Use of Oxybutynin Tablets while breast-feeding is therefore not recommended. Driving and using machines
Oxybutynin Tablets can sometimes cause blurred vision, drowsiness or dizziness. If this happens, do not drive or use any tools or machines. If you are unsure, speak to your doctor or pharmacist. Oxybutynin Tablets contain Lactose
If you have been told by your doctor that you are intolerant to some sugars, contact your doctor before taking this medicine.
3.How to take Oxybutynin Tablets
Always take Oxybutynin Tablets exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The tablets should be swallowed with plenty of water or other fluid, with or without food. Adults: The usual dose is 5 mg two or three times a day. Your doctor may increase this to a maximum dose of 5 mg four times a day.
Elderly: The usual dose is 2.5 mg twice a day. Your doctor may increase this to 5 mg twice a day. Use in Children
Children over 5 years: The usual dose is 2.5 mg twice a day. Your doctor may increase the dose to 5 mg two or three times a day. If you are giving it to a child to prevent bedwetting, give the last dose just before bedtime.
Children under 5 years: Not recommended.
Sometimes your doctor may reduce your dose, especially when you have been taking your tablets for some time.
If you take more Oxybutynin Tablets than you should
If you accidentally take more than your prescribed dose, contact a doctor or your nearest hospital casualty department immediately. Take this leaflet and the pack with you. This is so the doctor knows what you have taken.
Taking too many Oxybutynin Tablets can be very dangerous. You may become very restless or excited, flushed or get dizzy or light headed. Your heart beat may become very fast, uneven or forceful. You may get breathing problems or numbness or go into a coma. If you forget to take Oxybutynin Tablets
If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. If you stop taking Oxybutynin Tablets
Keep taking your medicine until your doctor tells you to stop. Do not stop taking Oxybutynin Tablets just because you feel better.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4.Possible side effects
Like all medicines, Oxybutynin Tablets can cause side effects, although not everybody gets them. Children are at higher risk of the effects.
Stop taking Oxybutynin Tablets and see a doctor or go to a hospital straight away if:
- you have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
- you feel reduced sweating, leading to overheating in hot environments Tell your doctor or pharmacist if any of the following side effects get serious or last longer than a few days.
Very common (may affect more than 1 in 10 people):
- Headache
- Dizziness
- Dry mouth which can lead to tooth decay, gum disease or oral thrush
- Constipation
- Feeling sick
- Dry skin
- Somnolence (feeling drowsy or sleepy)
- Blurring of vision
Common (may affect up to 1 in 10 people):
- Flushing, especially in children
- Diarrhoea
- Vomiting
- Dry eyes
- Confusion
- A forceful heartbeat that may be rapid or irregular
Uncommon (may affect up to 1 in 100 people):
- Loss of appetite (anorexia)
- Abdominal discomfort
- Difficulty swallowing
Not known (frequency cannot be estimated from the available data):
- Urinary tract infection
- Indigestion or heartburn (acid reflux)
- Abdominal pain and bloating which may be accompanied by feeling or being sick, difficulty with swallowing, diarrhoea or constipation, depending on the part of the gut affected (pseudo-obstruction)
- Agitation
- Anxiety
- Seeing or hearing things that are not there (hallucinations)
- Nightmares
- Feeling excessively suspicious and distrustful of others (paranoia)
- Depression
- Becoming dependant on Oxybutynin Tablets
- Fits (convulsions)
- Increased pressure in the eyes sometimes sudden and painful with blurred vision or loss of vision (glaucoma)
- Dilation of pupil (mydriasis)
- Increased heartbeat (tachycardia)
- Irregular heartbeat (arrhythmia)
- Heat stroke
- Itchy, lumpy rash (urticaria)
- Absence of sweating (hypohidrosis)
- Difficulty passing water (urine)
- Drowsiness
- Mental health disorders
- Skin that is more sensitive to the sun (photosensitivity)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.How to store Oxybutynin Tablets
Keep this medicine out of the sight and reach of children.
Do not use Oxybutynin Tablets after the expiry date which is stated on the carton and blister strip. The expiry date refers to the last day of that month.
Store below 25°C. Store in the original package.
Do not use Oxybutynin Tablets if the tablets show visible signs of deterioration. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6.Contents of the pack and other information
What Oxybutynin Tablets contain
The active substance is oxybutynin hydrochloride. Each 2.5 mg tablet contains 2.5 mg oxybutynin hydrochloride. Each 5 mg tablet contains 5 mg oxybutynin hydrochloride. The other ingredients are crospovidone, cellulose microcrystalline, lactose monohydrate, magnesium stearate and indigo carmine aluminium lake (E132).
What Oxybutynin Tablets look like and contents of the pack
Oxybutynin Hydrochloride Tablets are light blue circular tablets, marked ‘OXB 2.5’ or ‘OXB 5’ on one side with a breakline on the reverse. The tablets can be divided into equal halves. They are packed in blister strips and supplied in cartons of 20, 28, 30, 56, 60, 84 and 120 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW, United Kingdom. Manufacturer
Niche Generics Limited, Unit 1, Waterloo Farm Courtyard, Stotfold Road, Arlesey, SG15 6XP, United Kingdom.