Oxybutynin Hydrochloride Tablets 5mg
TEXT FOR NON-MARKETED PACKS
PIL FOR
OXYBUTYNIN HYDROCHLORIDE TABLETS 5mg 84’s
PATIENT INFORMATION LEAFLET Oxybutynin Hydrochloride Tablets 5mg
Please read this leaflet carefully before you start to take your medicine. It tells you some of the more important things you should know. If you want to know more, or you are not sure about anything, ask your doctor or pharmacist.
What's in your medicine
Oxybutynin Hydrochloride Tablets contain 5mg of the active ingredient oxybutynin hydrochloride. They are identified by the following markings.
White tablets
They also contain: cellulose, lactose, magnesium stearate, E553.
Oxybutynin Hydrochloride Tablets are available in pack sizes of 84s.
Oxybutynin Hydrochloride is one of a group of medicines called antimuscarinic agents.
Marketing Authorisation holder
Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.
Manufacturer
Rottendorf Pharma GmbH, Ennigerloh, Germany.
About your medicine
The name of your medicine is Oxybutynin Hydrochloride which is the generic (common) name. Your doctor may have given you this medicine before from another company and it may have looked slightly different. Both brands will do the same job.
Oxybutynin Hydrochloride Tablets may be used to:
• help decrease muscle spasms of the bladder and the urge to pass water caused by these spasms.
Your doctor may sometimes prescribe them for other purposes - ask your doctor for information. 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.
Before taking your medicine
Make sure you have told your doctor if you:
• are pregnant, plan to become pregnant or are breast-feeding
• are sensitive to any of the ingredients in the tablets
• have a urinary tract blockage or problems with urination
• have muscle weakness (myasthenia gravis)
• have glaucoma
• have a blockage of the gastrointestinal tract or any other intestinal or stomach problems
• have heart, kidney or liver disease
• have disease of the nervous system
• have an over active thyroid gland
• have an enlarged prostatic gland
• have a hiatus hernia
• are a child (use is not recommended under 5 years of age)
• are taking other medicines such as amantadine, anticholinergic agents, butyrophenones, digitalis, levodopa, phenothiazines, tricyclic antidepressants and including any that you can buy without prescription.
If you see another doctor or go into hospital, let them know what medicines you are taking.
Important information about some of the ingredients of Oxybutynin Hydrochloride 5mg
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Taking your medicine
Your doctor has decided the dose which is best for you. Always follow your doctor's instructions exactly, and those on the pharmacy label. If you do not understand anything, ask your doctor or pharmacist.
The usual dosage(s) are described below:
Age group
Adults:
Elderly:
Children over 5 years of age:
Children under 5 years of age:
Dosage
5mg two to four times daily.
Initially 2.5mg twice daily, can be increased to 5mg twice a day.
2.5mg twice daily, can be increased to 5mg three times a day.
The last dose should be given before bedtime. Not recommended.
These tablets should be taken as instructed - after meals, followed by a glass of water. Continue to take them for as long as your doctor tells you to, it may be dangerous to stop without their advice.
If you forget to take a dose, take another as soon as you remember and then your next dose at the usual time. Never take two doses at the same time.
If you are elderly, it is particularly important to take this medicine exactly as directed by the doctor.
If you see another doctor or go into hospital, let them know what medicine you are taking.
If you accidentally take more than your prescribed dose, contact your nearest hospital casualty department, or tell your doctor, immediately. Take any remaining tablets and the container with you.
After taking your medicine
Like many medicines, oxybutynin may occasionally cause side-effects in some patients, particularly when you first start taking it. These may include blurred vision, dry mouth, headache, dizziness, depression, flushing or redness of the face, hesitant urination. Other side-effects may occur, such as feeling sick, stomach upset, constipation or diarrhoea.
You may experience problems such as dry skin, skin rash or increased sensitivity to sunlight.
Rarely you may feel restless, confused, disorientated, have fits or hallucinations (where you may see and hear things which do not exist), these side-effects are more likely to occur in children than adults. You should consult your doctor if these are troublesome or continue.
If you get irregular heart beats or any other unusual effects, tell your doctor immediately and seek advice. Warning: May cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.
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.
Storing your medicine
Do not use the tablets after the expiry date shown on the product packaging. Do not store above 25°C, store in a dry place, protected from light and in the original packaging. Keep out of the sight and reach of children.
Remember, this medicine is for you only. Never give it to anyone else. It may harm them, even if their symptoms are the same as yours. Unless your doctor tells you to, do not keep medicines that you no longer need - give them back to your pharmacist for safe disposal.
Leaflet prepared: November 2014
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