Oxybutynin Hydrochloride Tablets 5mg
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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.
• 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 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.
In this leaflet:
1. What are Oxybutynin Hydrochloride Tablets and what are they 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
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. 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.
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 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).
Reduced saliva due to Oxybutynin Hydrochloride Tablets may increase dental caries or oral infection.
If you notice vision changes 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.
Taking other medicines:
Tell your doctor, or pharmacist if you are taking, have recently taken or plan to take any other medicines.
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 (eg. benperidol) or clozapine
• Medicines called Monoamine Oxidase Inhibitors (MAOIs) or tricyclic antidepressants used to treat depression (e.g. Isocarboxazid and moclobemide).
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.
Oxybutynin Hydrochloride Tablets and alcohol
These tablets can cause drowsiness which may be enhanced if you consume alcohol.
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 Tablets
Do not take these tablets if you have been told you have an intolerance to some sugars as these tablets contain lactose.
3. 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 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.
Children over 5 years 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.
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. 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.
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4. 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, double vision
• Glaucoma (increased pressure behind the eyes)
• Ringing in the ears
• Shaking
• Increased appetite
• Changes in your faeces, problems with the anus, inflammation of the stomach lining, narrowing of the oesophagus, hernia (bulge in the stomach wall), delay in emptying of the stomach (gastric atony), problems with the tongue including swelling Arthritis (inflammation of the joints)
Pelvic pain
Stiffness in the whole body Fever
Symptoms similar to those of flu such as headache, sore throat, fever
Suppression of milk in breast-feeding mothers.
Low blood pressure
Laryngitis (inflammation of the larynx), swelling of the larynx, problems with breathing, increase in the amount of mucus coughed up from the throat Changes in the urine, incontinence (leakage of urine) Increase in muscle tone and problems stretching the muscles
Genital disorders (in women), genital discharge General discomfort or uneasiness Irregular heart beat
Skin discolouration (ecchymosis), skin sensitive to light, hair disorders, skin rashes, small raised bumps on the skin, increased sweating
• Changes in your liver which will be picked up in a blood test
Uncommon side effects (less than 1 per 100 but more than 1 per 1000 patients):
Conjunctivitis (inflammation of part of the eye)
Acne, skin rashes and skin discolouration, nail disorders, Eczema, hair loss (Alopecia), reduction in sweating Migraine
Tingling or numbness in hands or feet, a feeling of ‘spinning' (vertigo)
Abnormal dreams, feeling anxious Hoarseness (voice change)
Difficulty swallowing, mouth ulcers, tongue or mouth inflammation,
Thirst
Muscle cramps, muscle pain
Breast pain (in men and women), inflammation of the vaginal lining
Anorexia (loss of appetite), dehydration Inflammation of the inside of the nose, hoarseness (changes in the voice), nosebleeds Shortness of breath Bloating of stomach
Urinary tract disorders, increase in the amount of times needed to urinate, blood or pus in the urine, increase in the need to urinate during the night, increase in the urgency to urinate
• Widening of the blood vessels (vasodilation)
• Pain, swelling
• Abnormal ECG results
Common side effects (less than 1 per 10 but more than 1 per 100 patients):
• Constipation, diarrhoea, feeling sick (nausea), being sick (vomiting), acid reflux, indigestion, wind (flatulence), abdominal pain or discomfort, taste disturbances
• Swelling to any part of the body
• Urinary disorders including inability to pass water (urinary retention), pain on urinating, difficulty starting to urinate, changes in the amount of urine produced
• Feeling sleepy or drowsy, headache, dizziness
• Dryness of the inside of the nose, throat or mouth, cough, sore or painful throat
• Palpitations (pounding or fluttering heart beat)
• Bronchitis (lung inflammation) or lung infections.
• Sinusitis (inflammation of the lining of the nose)
• Difficulty in sleeping, depression, feeling nervous, feeling confused
• Blurred vision, dry eyes including dry eye syndrome (Keratoconjunctivitis sicca)
• Dry skin, itching
• High blood pressure
• Urinary tract infections including cystitis
• Pain in the hands or feet, joint pain or back pain
• Weakness, tiredness
• Chest pain
Very common side effects (more than 1 per 10 patients)
• Dry mouth
Frequency unknown (frequency cannot be estimated from the available data)
• Not knowing where you are, feeling dizzy or impaired awareness (Disorientation)
• Heat stroke
• Pseudo-obstruction (where the intestines can't push food through) in patients who are at risk from intestinal disorders or who are taking other medicines which slow down how quickly the stomach works.
• Hallucinations (seeing or hearing things that aren't there)
• Night terrors
• Agitation, mental disorders, becoming dependent on Oxybutynin (in patients with drug abuse history)
• Convulsions (fits) may occur (children are at higher risk of these effects)
• Facial flushing (more marked in children than in adults)
• Falls
• Impotence or erectile dysfunction (in men)
• Changes in heart rhythm, including rapid heartbeat
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 your Oxybutynin Hydrochloride Tablets out of the reach and sight 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.
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.
6. 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 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.
O
LD
Marketing Authorisation Holder
Co-Pharma Limited Unit 4, Metro Centre,
Tolpits Lane, Watford, Herts.
UK, WD 18 9SS
This leaflet was last revised in March 2015.
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