Oxybutynin Hydrochloride Tablets 5mg
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OXYBUTYNIN HYDROCHLORIDE TABLETS 2.5 mg AND 5 mg
(Oxybutynin Hydrochloride)
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 no 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.
IN THIS LEAFLET
1. What Oxybutynin Hydrochloride Tablets are and what they are used for
2. 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. Further information
OWHAT 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:
• 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 • Children with night time bedwetting caused by problems with the spinal cord.
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 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.
Take special care with Oxybutynin Hydrochloride Tablets
If you suffer from any of the following you should tell your doctor before taking this medicine:
• diseases of the nervous system • liver or kidney problems • severe diarrhoea or constipation • an overactive thyroid • heart disease, heart failure, a fast or irregular heart beat • an enlarged prostate gland • diseases of the oesophagus (food pipe) including a hiatus hernia • high blood pressure • a fever or are in a hot environment as oxybutynin tablets may reduce the amount you sweat and this may increase your chance of heat stroke.
Reduced saliva due to oxybutynin tablets may increase dental caries or oral infection.
If you notice vision changes whilst using oxybutynin tablets tell your doctor who may do a vision test.
Taking other medicines:
If taken with some other medicines the effects of Oxybutynin Tablets or the effects of other medicines may be changed. Please check with your doctor if you are taking 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 used to relieve sickness such as metoclopramide and domperidone
• 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)
• Medicines which dissolve in the mouth such as glyceryl trinitrate as your saliva production may be reduced
• Medicines used to treat fungal infections (e.g. ketoconazole and itraconazole)
• Antihistamines used for allergies
• Medicines to treat psychotic disorders including schizophrenia such as butyrophenones (e.g. benperidol) or clozapine
• Medicines called Monoamine Oxidase Inhibitors (MAOIs) or tricyclic antidepressants used to treat depression (e.g. Isocarboxazid and moclobemide).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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.
Important information about some of the ingredients of Oxybutynin Hydrochloride Tablets
Do not take these tablets if you have been told you have an intolerance to some sugars as these tablets contain lactose.
©HOW TO TAKE OXYBUTYNIN HYDROCHLORIDE TABLETS
Always take Oxybutynin Hydrochloride Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults
The usual initial dose is 5 mg two or three times a day. This dose may be increased to a maximum of 5 mg four times a day.
Elderly
Initially 2.5 mg twice a day increased to 5 mg twice a day according to response.
Children over 5 years Urinary incontinence:
The usual dose is 2.5 mg twice a day. This may be increased to 5 mg two or three times a day.
Bedwetting:
The usual dose is 2.5 mg twice a day, increased to 5 mg two or three times a day, with the last dose given before bedtime.
Children under 5 years
Not recommended.
The dose recommendations given above are a guideline only. Your doctor may prescribe a different dose.
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If you take more Oxybutynin Hydrochloride Tablets than you should:
An overdose of this medicine may be harmful.
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.
^ POSSIBLE SIDE EFFECTS
Like all medicines, Oxybutynin Hydrochloride Tablets 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.
Rare side effects (less than 1 per 1000 but more than 1 per 10 000 patients):
• Eyes sensitive to light
• Glaucoma (increased pressure behind the eyes)
• Ringing in the ears
• Double vision
• Alopecia (hair loss)
• Skin sensitive to light
• Convulsions (fits) may occur (children are at higher risk of these effects)
• Shaking
• Hallucinations (seeing or hearing things that aren't there)
• Increased appetite
• Hernia (bulge in the abdominal wall)
• Disorder of the gut, which may show as diarrhoea, constipation or changes in your faeces, you may also experience stomach pains
• Arthritis (inflammation of the joints)
• Back pain, pelvic pain, joint pain
• Stiffness in the whole body
• Genital discharge
• Fever
• Symptoms similar to those of flu such as headache, sore throat, fever
• Impotence or erectile dysfunction (in men)
• Suppression of milk in breast feeding mothers.
Uncommon side effects (less than 1 per 100 but more than 1 per 1000 patients):
• Loss of appetite
• Facial flushing (more marked in children than in adults)
• Conjunctivitis (inflammation in part of the eye)
• Dry skin, skin rashes, which may be red or itchy or skin discolouration
• Eczema (skin disorder)
• Nail disorders
• Reduced or increased sweating
• Acne
• Blood in the urine
• Headache or migraine
• Tingling or numbness in hands or feet
• Depression or changes to your mental state
• Difficulty in sleeping or abnormal dreams (including nightmares and night terrors)
• Mouth ulcers, tongue or mouth inflammation
• Hoarseness (voice change)
• Difficulty swallowing
• Vomiting (being sick)
• Thirst
• Chest pain
• Dehydration
• Muscle tightness, stiffness, cramps or pain in arms and legs
• Breast pain (in men and women)
• Inflammation of the vaginal mucosa (lining)
• Cough.
Common side effects (less than 1 per 10 but more than 1 per 100 patients):
• Dry mouth
• Dry eyes
• Constipation
• Nausea
• Abdominal discomfort or pain
• Problems urinating such as increased urinating and waking in the night
• Swelling to any part of the body
• Urinary retention (unable to pass water) or urinary tract infections such as cystitis
• Dizziness or Vertigo (a feeling of dizziness or 'spinning')
• Drowsiness or tiredness
• Confusion, anxiety, agitation or nervousness
• Dryness of the inside of the nose, throat or mouth
• Sore or painful throat or laryngitis (inflammation of the larynx)
• Diarrhoea
• Taste disturbances
• Flatulence (wind)
• Acid reflux or indigestion
• Changes in heart beat (palpitations or change in heart rhythm) including rapid heartbeat
• Bronchitis (lung inflammation) or lung infections.
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 of blood cells
• 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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
HOW TO STORE OXYBUTYNIN HYDROCHLORIDE TABLETS
Keep your Oxybutynin Hydrochloride Tablets out of the reach and sight of children.
Do not store above 30°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. Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
^ FURTHER 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 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, 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 approved in 01/2011.
TPWTl
1008970
87212-T
TEVA UK LIMITED