Oxybutynin Hydrochloride 5mg Tablets
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Oxybutynin Hydrochloride 2.5mg and 5mg Tablets |
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In this leaflet:
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What this medicine is and what it is used for |
Possible side effects | |
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Before you take |
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How to store |
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How to take |
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Further information |
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 questions or are not sure about anything ask your doctor or pharmacist.
■ This medicine has been prescribed for you personally 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Oxybutynin hydrochloride belongs to a group of medicines called anticholinergics and antispasmodics.
It works by relaxing the muscles of the bladder and stops sudden muscle contractions (spasms). This helps control the release of urine.
Oxybutynin Tablets can be used in adults to treat the following:
■ Loss of control in passing urine (urinary incontinence).
■ Increased need or urgency to pass urine
Oxybutynin Tablets can be used in children 5 years or older to treat the following:
■ 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 you take
Do not take Oxybutynin Tablets and tell your doctor
if:
■ You are allergic (hypersensitive) to oxybutynin hydrochloride or any of the other ingredients (listed in Section 6 'Further information')
■ You have a problem with your gut (stomach or intestine) and it is blocked, perforated or not working properly, especially if you are elderly or unwell
■ You have a form of inflammatory bowel disease which can cause abdominal pain, bloody diarrhoea, fever and weight loss (ulcerative colitis) or sudden widening of the colon, which causes abdominal pain, fever or shock (toxic megacolon)
■ You have a blockage which makes it difficult to pass urine
■ You have a muscle weakness problem (myasthenia gravis)
■ You have increased pressure in the eye and it is untreated (glaucoma)
■ You have an unstable heart due to a sudden loss of blood (acute haemorrhage)
■ You are breast feeding
Take special care
Check with your doctor or pharmacist before taking
Oxybutynin Tablets if:
■ You have liver or kidney problems
■ You have obstructions of the stomach or intestines
■ You have indigestion or heart burn caused by a 'hiatus hernia' (where part of the stomach pushes through the diaphragm)
■ You have damaged nerves, which can affect the way internal organs work (autonomic neuropathy)
■ You are taking this medicine in a hot climate as Oxybutynin Tablets can decrease your ability to sweat and may cause fever or heat stroke
■ You have the following conditions, as the symptoms may become worse:
- overactive thyroid gland
- heart disease
- heart failure
- irregular or increased heart beat
- high blood pressure
- enlarged prostate gland
■ The person taking the medicine is a child (use is not recommended under 5 years of age)
■ You are elderly, frail (weak or in poor health) or a child, as you may be more sensitive to the effects of Oxybutynin Tablets
Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
In particular, tell your doctor if you are taking any of the following:
■ Other anticholinergic medicines, such as some medicines for irritable bowel syndrome, asthma, incontinence, motion sickness or movement disorders associated with Parkinson's disease
■ Amantadine, for Parkinson's disease and to prevent some virus infections
■ Levodopa, for Parkinson's disease
■ Phenothiazines, butyrophenones, clozapine and haloperidol, used to treat certain mental problems
■ Digoxin, used to treat heart problems
■ Tricyclic antidepressants for depression e.g. amitriptyline, imipramine, dosulepin
Taking with alcohol
If you drink alcohol while taking these tablets, you may become very drowsy.
Pregnancy and breast-feeding
If you are pregnant, might become pregnant or think you are pregnant; you should not take this medicine unless your doctor tells you to.
If you are breast-feeding you should not take this medicine as small amounts may pass in to your milk.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machinery
You may feel drowsy or have blurred vision whilst taking Oxybutynin Tablets. If this happens, do not drive or operate machinery.
Important information about some of the ingredients of Oxybutynin Tablets
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.
continued.
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Always take Oxybutynin Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
■ These tablets are for oral administration
■ The tablets should be swallowed with plenty of water or other fluid
If your doctor increases your dose this may be done slowly to minimise side effects, such as a dry mouth.
Once your condition is under control, your doctor may give you a lower maintenance dose.
Usual dose
Adults: The usual dose is 2.5mg or 5mg taken two or three times a day.
This may be increased to a maximum dose of 5mg four times a day.
Elderly patients (over 80 years): The usual dose is 2.5mg or 5mg twice a day as the drug can remain in the body for longer.
Children over 5 years: The usual dose is 2.5mg to 5mg taken twice a day.
The dose may be increased to 5mg three times a day.
Nocturnal enuresis (bedwetting): The usual dose is 5mg taken two or three times a day. The last dose should be given just before bedtime.
Children under 5 years: This medicine is not recommended.
If you have taken more Oxybutynin Tablets than you should
If you accidentally take more Oxybutynin Tablets than you should, contact your doctor or go to the nearest hospital casualty department immediately. Take this medicine pack with you. This is so the doctor knows what you have taken.
Symptoms of an overdose may include feeling restless or excited, behaviour changes, flushing, feeling dizzy or light-headed (due to a fall in blood pressure), very fast or uneven heartbeat, difficulty breathing, being unable to move your body and loss of consciousness.
If you forget to take Oxybutynin Tablets
If you forget to take a dose, take it as soon as you remember and then go on as before. 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.
Indigestion or heart burn (acid reflux)
Stomach pain Difficulty passing urine Drowsiness Headache Dizziness Fits (convulsions)
Feeling agitated
Seeing or hearing things that are not real (hallucinations)
Nightmares Difficulty sleeping Feeling restless Feeling disorientated Feeling of weakness Feeling your heart beat (palpitation)
Faster heart beat Irregular heart beat
Flushing and flushing of the face (especially in children)
■ Loss of weight
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of reach and sight of children.
Do not take this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
Store your medicine in the original package below 25°C, in a dry place.
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.
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What Oxybutynin Tablets contain:
■ Active ingredient: Each Oxybutynin Hydrochloride Tablet contains 2.5mg or 5mg of oxybutynin hydrochloride
■ Other ingredients: crospovidone, microcrystalline cellulose, lactose monohydrate, magnesium stearate and indigo carmine aluminium lake (E132).
What Oxybutynin Tablets look like and the contents
of the pack:
The tablets are light blue and marked: OXB 2.5 or
OXB 5 and have a break line on the reverse
They are packed in blister strips and supplied in
cartons of 20, 28, 30, 56, 60, 84 or 120 tablets.
Not all pack sizes may be marketed
Like all medicines, Oxybutynin Tablets may cause side effects, although not everyone gets them.
Stop taking Oxybutynin Tablets and see a doctor or go to a hospital immediately if you have the following allergic reactions:
■ Swelling of the face or throat
■ Rash, itchy rash
Other possible side effects
■ Increased sensitivity of eyes and skin to sunlight
■ Dry skin
■ Decreased sweating
■ Blurred vision
■ Enlargement of the pupil (mydriasis)
■ Dry eyes
■ Increased pressure in the eyes (possible onset of glaucoma)
■ Constipation
■ Diarrhoea
■ Dry mouth
■ Feeling or being sick (nausea/vomiting)
Marketing Authorisation Holder & Manufacturer:
Tillomed Laboratories Ltd 3 Howard Road, Eaton Socon,
St Neots, Cambridgeshire,
PE198ET UK
Product licence numbers:
Oxybutynin Hydrochloride 2.5mg Tablets PL 11311/0136
Oxybutynin Hydrochloride 5mg Tablets PL 11311/0137
Date of approval: May 2011
Till-Ver.4.1sa