PACKAGE LEAFLET:

INFORMATION FOR THE USER

OXYBUTYNIN HYDROCHLORIDE TABLETS 2.5 mg and 5 mg

[Oxybutynin Hydrochloride]

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Oxybutynin Hydrochloride Tablets are and what they are used for

2.    What you need to know before you take Oxybutynin Hydrochloride Tablets

3.    How to take Oxybutynin Hydrochloride Tablets

4.    Possible side effects

5.    How to store Oxybutynin Hydrochloride Tablets

6.    Contents of the pack and other information

1.    WHAT OXYBUTYNIN HYDROCHLORIDE TABLETS ARE AND WHAT THEY ARE USED FOR

Oxybutynin relaxes and prevents spasms (contractions) of the muscle of the bladder, and helps to control the release of urine.

Oxybutynin Hydrochloride Tablets are used to treat the following in adults:

•    Loss of control in passing urine (urinary incontinence)

•    Increased need or urgency to pass urine

•    Problems passing urine due to multiple sclerosis and spina bifida.

Oxybutynin Hydrochloride Tablets can be used in children 5 years and 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 HYDROCHLORIDE TABLETS

Do not take Oxybutynin Hydrochloride Tablets If you:

•    Are allergic (hypersensitive) to oxybutynin or any of the ingredients of Oxybutynin Hydrochloride Tablets, see section 6 for ingredients

•    Have myasthenia gravis (muscle weakness)

•    Suffer with glaucoma (high pressure and pain in the eyes)

•    Have a blocked urinary tract causing a poor flow of urine

•    Have severe ulcerative colitis (a form of inflammatory bowel disease)

•    Have toxic megacolon (dilated colon accompanied by fever and abdominal pain)

•    Have diseases of the intestine (gut) including obstructions of the bowel

•    Have porphyria which is a disorder of the skin and nervous system.

Warnings and precautions

Talk to your doctor or pharmacist before taking Oxybutynin Hydrochloride Tablets if you suffer from:

•    Diseases of the nervous system (autonomic neuropathy) such as those with Parkinson’s disease

•    Liver or kidney problems

•    Severe diarrhoea or constipation

•    An overactive thyroid

•    Heart disease, heart failure, a fast or irregular heart beat

•    Cognitive disorders such as amnesia, dementia, and delirium

•    An enlarged prostate gland

•    Diseases of the oesophagus (food pipe) including a hiatus hernia, or if you are taking medicines (e.g. bisphosphonates) that could worsen oesophagitis (inflamed oesophagus)

•    High blood pressure

•    A fever or are in a hot environment as Oxybutynin Hydrochloride Tablets may reduce the amount you sweat and this may increase your chance of heat stroke.

Check with your doctor or pharmacist before taking this medicine if:

•    The person taking this medicine is a child (use is not recommended under 5 years of age).

•    You are 65 years of age or older

Reduced saliva due to Oxybutynin Hydrochloride Tablets may increase dental caries or oral infection.

If you notice vision changes or suffer from any pain in the eye whilst using Oxybutynin Hydrochloride Tablets tell your doctor who may do a vision test.

Oxybutynin Hydrochloride Tablets may affect your central nervous system. If you have hallucinations, agitation, confusion or sleepiness you should tell your doctor.

Other medicines and Oxybutynin Hydrochloride Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially any of the following:

•    Other medicines to treat urinary disorders such as propiverine or tolterodine

•    Any other medicines which act in the same way as Oxybutynin, these are called anticholinergic medicines. Examples include atropine used in glaucoma, hyoscine for nausea

•    Medicines to stop vomiting such as phenothiazines e.g. prochlorperazine

•    Medicines to treat Parkinson’s disease such as amantadine, levodopa or benzotropine mesylate

•    Medicines called anticholinesterases used for Alzheimer’s disease (e.g memantine)

•    Medicines to treat heart conditions such as digitalis (digoxin)

•    Antihistamines used for allergies

•    Medicines to treat psychotic disorders including schizophrenia such as butyrophenones (eg. benperidol) or clozapine

•    Medicines used to correct disturbances in the rhythm of the heart such as Quinidine.

•    Medicines called Monoamine Oxidase Inhibitors (MAOIs) or tricyclic antidepressants used to treat depression (e.g. Isocarboxazid and moclobemide).

•    Medicines to prevent blood clots such as dipyridamole

Oxybutynin Hydrochloride Tablets and alcohol

These tablets can cause drowsiness which may be enhanced if you consume alcohol.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Your doctor will decide whether you need to take this medicine during pregnancy and whether it is safe to do so. You should not breast-feed whilst taking oxybutynin as it passes into your milk.

Driving and using machines:

As Oxybutynin Hydrochloride Tablets may cause drowsiness or blurred vision in some people, do not drive or operate machinery, if affected.

Oxybutynin Hydrochloride Tablets contain Lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

3. HOW TO TAKE OXYBUTYNIN HYDROCHLORIDE TABLETS

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults

The usual initial dose is 5mg two or three times a day.

This dose may be increased to a maximum of 5mg four times a day.

Elderly

Initially 2.5mg twice a day increased to 5mg twice a day according to response.

Use in children (over 5 years) and adolescents Urinary incontinence:

The usual dose is 2.5mg twice a day. This may be increased to 5mg two or three times a day.

Bed wetting:

The usual dose is 2.5mg twice a day, increased to 5mg two or three times a day, with the last dose given before bedtime.

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Children under 5 years

Not recommended.

The dose recommendations given above are a guideline only. Your doctor may prescribe a different dose.

If you take more Oxybutynin Hydrochloride Tablets than you should:

An overdose of this medicine may be harmful. Symptoms of overdose include restlessness, excitement, abnormal behaviour, flushing, fall in blood pressure, problems with your circulation, breathing problems, paralysis and coma. If you or someone else, have taken too much of your medicine tell your doctor or pharmacist, or go to the nearest hospital casualty department immediately.

If you forget to take Oxybutynin Hydrochloride Tablets:

If you forget to take a dose at the right time, take it as soon as you remember, then go on as before. However you must take care not to take two doses at the same time.

Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions:

If you experience an allergic reaction which may include symptoms such as swelling of the face, neck, throat or body, a rash which may be itchy or difficulty breathing; stop taking the tablets and contact your doctor immediately.

If you experience any of the following contact your doctor immediately:

•    Increased bruising, bleeding, nose bleeds or frequent infections

•    Change in your vision such as blurred vision or double vision.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

Very common (affects more than 1 in 10 people)

•    Constipation

•    Nausea

•    Dry mouth

•    Dry skin

•    Headache

•    Somnolence (feeling drowsy or sleepy)

•    Dizziness

•    Blurring of vision

Common (affects 1 to 10 people in 100 people)

•    Dry eyes

•    Diarrhoea

•    Being sick (vomiting)

•    Confusion

•    Flushing especially in children

•    Difficulty emptying the bladder (Urinary retention)

Uncommon (affects 1 to 10 people in a 1,000)

•    Stomach pain

•    Loss of appetite

•    Anorexia

•    Difficulty in swallowing (dysphagia)

Frequency unknown

•    Increased pressure in the eyes sometimes sudden and painful with blurred vision or loss of vision (glaucoma)

•    Indigestion or heartburn (acid reflux)

•    Urinary tract infection

•    Heat stroke

•    Difficulty passing water (urine)

•    Agitation

•    Anxiety

•    Becoming dependent on Oxybutynin Hydrochloride Tablets

•    Feeling excessively suspicious and distrustful of others

•    Mental Health disorders

•    Seeing or hearing things that are not there (hallucinations)

•    Drowsiness

•    Nightmares

•    Fits (convulsions)

•    Depression

•    Increased heart beat (tachycardia)

•    Irregular heart beat (arrhythmia)

•    Dilation of pupil (mydriasis)

•    Itchy, lumpy rash (urticaria)

•    Absence of sweating (hypohidrosis)

•    Skin that is more sensitive to the sun (photosensitivity)

•    Disorientation

•    Severe impairment in the ability of the intestines to push food through (pseudo-obstruction)

If you get any of these side effects, please consult your doctor as he may decrease your dose to reduce the effects.

The following may be detected in blood tests performed by your doctor

•    Changes in the number blood cells or platelets

•    Increased blood sugar

•    Increase or decrease in blood pressure

•    Inflammation of a vein under the skin

•    Changes in the hormone, chemical and enzyme levels in the body.

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 OXYBUTYNIN HYDROCHLORIDE TABLETS

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use Oxybutynin Hydrochloride Tablets after the expiry date which is stated on the label.

The expiry refers to the last day of that month.

Do not use Oxybutynin Hydrochloride Tablets if you notice visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Oxybutynin Hydrochloride Tablets contain

The active substance(s) is Oxybutynin Hydrochloride/ Oxybutynin Chloride BP/Ph.Eur

The other ingredients are: Lactose monohydrate, Microcrystalline cellulose, Calcium stearate, Indigo carmine (aluminium lake) E132

What Oxybutynin Hydrochloride Tablets look like and contents of the pack

Description: Oxybutynin Hydrochloride Tablets 2.5 mg:

Blue, biconvex, uncoated capsule-shaped tablets, marked “OB” scoreline “2.5” on one side and plain on the other side. Oxybutynin Hydrochloride Tablets 5 mg: Blue, round, biconvex, uncoated tablets, marked “OB” breakline “5” on one side and plain on the other side.

Contents of pack: Blister pack containing 56 or 84 tablets.

7 tablets in a blister, 8 or 12 blisters in a carton.

Marketing Authorisation Holder

Co-Pharma Limited Unit 4, Metro Centre,

Tolpits Lane, Watford, Herts.

UK, WD 18 9SS

This leaflet was last revised in July 2016.

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