Oxybutynin Hydrochloride 5mg Tablets
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DITROPAN® 5mg TABLETS/ OXYBUTYNIN HYDROCHLORIDE 5mg TABLETS (Oxybutynin Hydrochloride)
Patient Information Leaflet
This product is known by the above names, but will usually be referred to as Ditropan Tablets throughout this leaflet. Another strength (2.5mg) is also available.
Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.
In this leaflet:
1. What Ditropan Tablets are and what they are used for
2. Before you take Ditropan Tablets
3. How to take Ditropan Tablets
4. Possible side effects
5. How to store Ditropan Tablets
6. Further information
1. What Ditropan Tablets are and what they are used for What Ditropan Tablets are
Ditropan Tablets contain a medicine called oxybutynin hydrochloride. This belongs to two groups of medicines called ‘anticholinergics', and ‘antispasmodics'.
How Ditropan Tablets work
It works by relaxing the muscles of the bladder and stops sudden muscle contractions (spasms). This helps to control the release of water (urine).
What Ditropan Tablets are used for
Ditropan Tablets can be used in adults and children 5 years or older to treat:
• Loss of control in passing water (urinary incontinence)
• Increased need or urgency to pass water (urine)
• Night time bedwetting, when other treatments have not worked
2. Before you take Ditropan Tablets Do not take this medicine and tell your doctor if:
• You are allergic (hypersensitive) to oxybutynin hydrochloride, or any of the other ingredients of Ditropan Tablets (listed in Section 6 Further Information). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• You have a rare muscle illness called 'myasthenia gravis'
• You have increased pressure in the eye (glaucoma)
• Your gut (stomach or intestine) is blocked, perforated or not working properly
• You have a severe form of a condition known as ‘ulcerative colitis'
• You have a blockage that makes it difficult for you to pass water (urine)
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Ditropan Tablets.
Take special care with Ditropan Tablets
Check with your doctor or pharmacist before taking your medicine if:
• You have kidney or liver problems
• You are 65 years of age or older
• The person taking the medicine is a child (use is not recommended under 5 years of age)
• You have an illness affecting the nerves called ‘autonomic neuropathy'
• You have an overactive thyroid gland (‘Hyperthyroidism')
• You have heart disease or high blood pressure
• You have an irregular heart beat (palpitations) and/or increased or rapid heart beat
• You have an enlarged prostate gland
• You have indigestion or heart burn caused by a ‘hiatus hernia' (where part of your stomach pushes through the diaphragm)
• You have a raised body temperature or fever
• You will be taking this medicine in a hot climate
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Ditropan Tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Ditropan Tablets can affect the way some other medicines work. Also, some medicines can affect the way Ditropan 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 for depression - such as amitriptyline, imipramine or dosulepin (‘tricyclic antidepressants')
• Amantadine - used in Parkinson's disease or to treat and prevent some virus infections
• L-dopa - used to treat Parkinson's disease
• Digoxin - used to treat heart problems
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if
• You are pregnant, might become pregnant or think you may be pregnant
• You are breast-feeding or planning to breast feed. This is because small amounts may pass into mothers' milk. Breastfeeding while using oxybutynin is therefore not recommended.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
You may feel drowsy or have blurred vision while you are taking this medicine. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Ditropan Tablets
This medicine contains:
• Lactose. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
3. How to take Ditropan Tablets
A
Always take Ditropan Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the tablets with a glass of water
• Do not give this medicine to children under 5 years old
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
How much to take
Your doctor will decide the dose appropriate for you.
Adults
• The usual dose is one 5mg tablet two or three times each day
• Your doctor may decide to increase to the maximum dose of 5mg four times each day
Elderly
• The usual dose is one 2.5mg tablet twice each day
• Your doctor may decide to increase this to 5mg twice each day
Children (over 5 years)
• The usual dose is one 2.5mg tablet twice each day
• Your doctor may decide to increase this to one 5mg tablet two or three times each day
• If you are giving it to a child to prevent bedwetting, give the last dose just before bedtime
If you take more Ditropan Tablets than you should
If you take more Ditropan Tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so that the doctor knows what you have taken.
Taking too many Ditropan 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 Ditropan Tablets
If you forget 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 Ditropan Tablets
Keep taking Ditropan Tablets until your doctor tells you to stop. Do not stop taking Ditropan Tablets just because you feel better.
4. Possible Side Effects
Like all medicines, Ditropan Tablets can cause side effects, although not everybody gets them. Children are at higher risk of the side effects.
Stop taking Ditropan 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:
• Blurring of vision, increased pressure in the eyes (glaucoma), enlargement of the pupil of the eye, dry eyes
• Diarrhoea or constipation
• Feeling sick, being sick or stomach pain
• Indigestion or heartburn (acid reflux)
• Dry mouth
• Loss of appetite (anorexia)
• Agitation
• Headache
• Dizziness, drowsiness or confusion
• Seeing or hearing things that are not there (hallucinations)
• Nightmares
• Fits (convulsions)
• Increased, rapid or irregular heartbeat (palpitations)
• Difficulty passing water (urine)
• Facial flushing especially in children
• Dry skin, rash or skin that is more sensitive to the sun
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.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Ditropan Tablets
• Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to the last day of that month.
• Ditropan 5mg tablets/Oxybutynin Hydrochloride 5mg tablets should be stored in a dry place below 25°C and they should be kept in their original blister packaging.
• Keep all medicines out of the sight and reach of children.
• If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
• If the tablets become discoloured or show any other signs of deterioration, you should consult your pharmacist who will advise you what to do.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
Your medicine is called Ditropan 5mg tablets/Oxybutynin Hydrochloride 5mg tablets. Each tablet contains 5mg of the active ingredient, oxybutynin hydrochloride in a pale blue, bi-convex tablet with a breakline on one side and ‘OXB 5' on the reverse.
Ditropan 5mg tablets/Oxybutynin Hydrochloride 5mg tablets also contain the following: lactose, microcrystalline cellulose, calcium stearate and indigotine aluminium lake (E132).
Ditropan 5mg tablets/Oxybutynin Hydrochloride 5mg tablets are available as blister packs of 60, 90 and 120 tablets.
POM PL No: 6464/0451
This product is manufactured by Laboratoires Synthelabo France, Ave. Gustav Eiffel Tours, Cedex 37000, France and is procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 24.03.2014
Ditropan is a registered trademark of Hoechst Marion Roussel Inc.
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