Oxybutynin 2.5mg Tablets
Patient Information Leaflet
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 further questions, please ask your doctor or your pharmacist.This medicine has been prescribed for you only and you should 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 get serious, or if you notice any side effects not listed in this leaflet, please talk to your doctor or pharmacist. See section 4.
In this leaflet:
1. What Oxybutynin is and what it is used for
2. What you need to know before you take Oxybutynin
3. How to use Oxybutynin
4. Possible side effects
5. How to store Oxybutynin
6. Contents of the pack and other Information
1. What Oxybutynin is and what it is used for
Some people have difficulty in controlling their bladder. Oxybutynin is an example of an antispasmodic medicine. Medicines like this relax the muscle of the bladder and can be helpful in helping you to control your bladder.
Oxybutynin 2.5mg 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 Do not take Oxybutynin 2.5mg tablets:
• If you are allergic to the active substance oxybutynin or to any of the other ingredients listed above
• If you suffer from ulcerative colitis, inflammatory bowel disease, disease of the intestine, including obstructions of the bowel
• If you have difficulty in passing water (poor stream)
• If you suffer from myasthenia gravis (a muscle disease)
• If you suffer from glaucoma (raised pressure in the eye)
Warnings and precautions
Tell your doctor before you start to take Oxybutynin 2.5mg tablets if you suffer from one of the following conditions:
• Psychological illness (mental disturbance).
• Parkinson’s disease
• Heart disease, heart failure, fast or irregular heart beats.
• Diabetes
• Depression
• Prostate problems
• Liver or kidney problems
• Indigestion or heart bum caused by hernia
• Raised body temperature or fever
• An overactive thyroid gland
• Disease of the nervous system eg. Motor neurone disease.
Please consult your doctor, even if these statements were applicable to you at any time in the past.
Check with your doctor or pharmacist before taking your medicine if:
- The person taking the medicine is a child (use is not recommended under 5 years of age)
- You are 65 years of age or older.
- You will be taking medicine in a hot climate.
Pregnancy, breast-feeding and fertility
Ask your doctor for advice before taking oxybutynin.
Breast feeding
Do not take oxybutynin while you are breast-feeding.
Driving and using machines
This medicine can sometimes cause blurred vision, drowsiness or dizziness (see the section “Possible side effects” below). You should not plan to drive or operate machinery until you are sure that you are not affected by this. If you are affected, do not drive or operate machinery during treatment with oxybutynin.
Important information about some of the ingredients of Oxybutynin
Patients who are intolerant to lactose should note that Oxybutynin tablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Other medicines and Oxybutynin
Tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines:
• 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, such as benzhexol, atropine, procyclidine and ipratropium.
• Medicines used to make you feel sleepy (sedatives) or if you are feeling sick (nausea) or have vertigo - such as prochlorperazine or chlorpromazine, thioridazine.
• Medicines used to treat certain mental illnesses - such as clozapine, phenothiazines haloperidol or benperidol (butyrophenones)
• Medicines for depression - such as amitriptyline, imipramine, prothiaden 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
3. How to use Oxybutynin
Swallow the tablets whole with a sufficient amount of fluid e.g. a glass of water.
Adults: The usual adult dose is 5mg two or three times a day. Occasionally, 5 mg four times a day is required. In the elderly the drug can remain in the body for longer, so 2.5mg twice a day is usually enough to start with, although this can be increased to 5mg twice a day.
Children under 5 years:
Not recommended
Children over 5 years:
Neurogenic bladder (lack of control caused by problems with spinal cord):
The usual dose is 2.5mg twice a day which may be increased to 5mg two or three times a day.
Noctural enuresis (bedwetting):
The usual dose is 2.5mg twice a day which may be increased to 5mg two or three times a day. The last dose should be given just before bedtime.
All the dose recommendations given above are a guideline only. Your doctor may prescribe a different dose.
If you take more tablets than you should:
If you follow these instructions on how to take your medicine you should not be at risk of taking too much Oxybutynin. If you do take too much medicine, the side effects (see the section “Possible side effects” below) may become more intense than normal and you may have difficulty breathing or moving. If you think you have taken too much or if you suddenly feel unwell you should ring your doctor or the nearest casualty department immediately.
If you forget to take Oxybutynin
Do not worry if you accidentally forget to take a dose of Oxybutynin. Simply take your next dose at the usual time and then carry on as normal.
4. Possible side effects
Like most medicines, oxybutynin may cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people)
constipation, nausea, dry mouth, dizziness, headache, sleepiness, dry skin, feeling sick, stomach pains, there is no need to tell your doctor unless it is causing you a problem.
Common (may affect up to 1 in 10 people)
diarrhoea, vomiting, confusional state, dry eyes, flushing of the face (especially in children) and difficulty in passing water, an inability to pass water or to empty the bladder
Uncommon (may affect up to 1 in 100 people)
abdominal discomfort, anorexia, decreased appetite, difficulty in swallowing or any other unpleasant side effects then you should tell your doctor.
Not known (cannot be estimated from the available data)
urinary tract infection, heartburn, restlessness, anxiety, hallucinations, nightmares, paranoid thoughts, diminished sweating, disorientation, memory problems especially in elderly, faster heartbeat, heartbeat irregularities, heat stroke, angle closure glaucoma, dilation of pupils, ocular hypertension, blurred vision, urticaria, skin reactions including rash, a more severe allergic reaction called
angioedema, hypersensitivity and photosensitivity and convulsions may occur during therapy with oxybutnin. Children may be more liable to such effects and if they occur you should seek medical advice immediately.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist. 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 Oxybutnin
Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Store in the original package in order to protect from light and moisture.
Do not use Oxybutynin tablets after the expiry date shown on the blister and label.
Remember this medicine is only for you. Never give it to anybody else, even if their symptoms are the same as yours.
6. Contents of the pack and other Information What Oxybutynin 2.5mg Tablets contain
The active ingredient is oxybutynin hydrochloride 2.5mg.
Other ingredients are lactose monohydrate, powdered cellulose, talc and magnesium stearate. What Oxybutynin 2.5mg Tablets look like and contents of pack Oxybutynin 2.5mg tablets come in a pack size of 84 tablets.
Marketing autorising holder and Manufacturer
Marketing authorisation holder:
ratiopharm GmbH, Graf-Arco-Str. 3, D-89079 Ulm, Germany
Manufacturer:
Merckle GmbH, Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren, Germany
This leaflet applies only to Oxybutynin tablets, but it does not contain all the information known about your medicine. If you have any questions or are not sure about anything ask your doctor or pharmacist.
This leaflet was revised in May 2014
REG0075141 Version 1.20 Approved Page 4 of 5