Oxybutynin Hydrochloride Tablets 2.5mg
PACKAGE LEAFLET: INFORMATION FOR THE USER
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, pharmacist or nurse.
• 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 becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse. This includes any possible side effect not listed in the leaflet, see section 4.
• have a blocked urinary tract (causing a poor flow of urine)
• have a condition called myasthenia gravis (a muscle weakening disease)
• have untreated glaucoma (high pressure and pain in the eyes)
• have problems with your blood pressure
• have severe form of a condition known as ulcerative colitis.
• if you are pregnant or breast-feeding.
Your medicine is called Oxybutynin Hydrochloride Tablets 2.5 mg and 5 mg
They will be referred to as Oxybutynin Tablets throughout this leaflet for ease.
What is in this leaflet:
|T| What Oxybutynin Tablets are and what they are used for
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Oxybutynin Tablets if any of the following apply to you:
• an overactive thyroid gland (a gland in your neck)
• heart disease, heart failure, fast or irregular heartbeat
• high blood pressure
• an enlarged prostate gland (in men)
• hiatus hernia
• reflux oesophagitis (a condition affecting the food pipe)
• raised body temperature
• taking this medicine in a hot climate
• have an illness affecting the nerves called autonomic neuropathy
• have kidney or liver disease.
• are 65 years of age or older
• have dental caries,as long term use can lead to an increase risk of tooth decay, gum disease or fungal infection
|2 What you need to know before you take Oxybutynin Tablets
13 How to take Oxybutynin Tablets
14 Possible side effects
M”5| How to store Oxybutynin Tablets |6 Contents of the pack and other information.
T| What Oxybutynin Tablets are and what they are used for
The active substance in Oxybutynin Tablets is oxybutynin hydrochloride This is one of a group of medicines called anticholinergics or antispasmodics It increases the volume of the bladder by relaxing the muscle of the bladder wall, and helps to control the release of urine.
Children
Check with your doctor pharmacist or nurse before taking your medicine if:
The person taking this medicine is a child (use is not recommended under 5 years of age).
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist
It is used to treat the following conditions:
Adults:
• Loss of control in passing water (urinary incontinence), urgency and frequency in patients unable to control their bladder
• Neurogenic bladder disorders (lack of bladder control caused by problems with the nervous system or spinal cord)
Children over 5years:
Oxybutynin Hydrochloride Tablets can be used in children 5years 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
What you need to know before you take Oxybutynin Tablets
Do not take Oxybutynin Tablets if you
• are allergic (hypersensitive) to oxybutynin hydrochloride or any of the ingredients of Oxybutynin Tablets (see section 6, Contents of the pack and other information, for a list of ingredients) Signs of an allergic reaction include, a rash, swallowing or breathing problems, swelling of your lips, face throat or tongue.
• have diseases or obstructions of the intestine (gut), including bowel obstruction or no bowel movement
Other medicines and Oxybutynin Tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines or might take any other medicine. This includes medicines you buy without prescription.
In particular, interaction with any of the following may alter the effect of the medicine:
• amantadine (used in Parkinson's disease or to treat and prevent some viral infections)
• levodopa or biperiden (used to treat Parkinson's disease)
• digitalis, digoxin and quinidine (used to treat heart problems)
• medicines to treat depression such as amitriptyline, imipramine or dosulepin (tricyclic antidepressants)
• medicines used to make you feel sleepy (sedatives) or if you are feeling sick (nausea) or have vertigo, such as prochlorperazine or chlorpromazine
• medicines used to treat certain mental illnesses -such as clozapine,phenothiazines, haloperidol or benperidol (butyrophenones)
• other medicines called anticholinergic or antimuscarinic medicines such as some medicines for irritable bowel syndrome, asthma or incontinence, motion sickness or movement disorders associated with Parkinson's disease
• antihistamines used to relieve allergy symptoms
• medicines containing atropine or related compounds like atropinic antispasmodics and dipyridamole.
Oxybutynin Tablets with food, drink and alcohol
Oxybutynin Tablets should be swallowed with plenty of water, with or without food. If you take alcohol while taking these tablets, you may become very drowsy.
Continued top of next column 50853010 AAAH8783
Pregnancy and breast-feeding
You should not take Oxybutynin Tablets if you are pregnant or breast-feeding.
If you are planning to become pregnant or suspect you might be pregnant, talk to your doctor before taking your tablets.
Ask your doctor or pharmacist for advice before taking any medicine.
Continued over page
Driving and using machines
Oxybutynin Tablets can sometimes cause blurred vision, drowsiness or dizziness.
If you get any of these symptoms do not drive or use any tools or machines until they go away. If you are unsure, speak to your doctor or pharmacist.
Oxybutynin Tablets contain Lactose
If you have been told by your doctor that you are intolerant to some sugars and have to avoid them, contact your doctor before taking this medicine.
^ How to take Oxybutynin Tablets
Always take Oxybutynin Tablets exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The tablets should be swallowed with plenty of water or other fluid, with or without food.
Adults: The recommended dose is 2.5 to 5 mg swallowed two or three times a day. Occasionally, 5 mg four times a day is required.
Elderly (over 80 years): The recommended dose is 2.5 to 5 mg swallowed two or three times a day, however, as the drug can remain in the body for longer in elderly patients, 2.5 to 5 mg twice a day is usually sufficient.
Use in Children
Children over 5 years: The recommended dose is 2.5 to 5 mg swallowed twice a day. Your doctor might decide to increase the dose to three times a day if needed.
Nocturnal enuresis (nighttime bedwetting): The usual dose is 5 mg swallowed two or three times a day. The last dose should be given just before bedtime.
Children under 5 years: Not recommended.
Sometimes your doctor may reduce your dose, especially when you have been taking your tablets for some time.
If you take more Oxybutynin Tablets than you should
If you accidentally take more than your prescribed dose, contact a doctor or your nearest hospital casualty department immediately. Take this leaflet and the pack with you. This is so the doctor knows what you have taken.
Taking too many Oxybutynin tablets can be very dangerous. You may become very restless or excited, flushed or get dizzy or light headed .Your heart beat may become very fast, uneven or forceful. You may get breathing problems or numbness or go into a coma.
Uncommon: (may affect up to 1 in 100 people)
Loss of appetite (anorexia)
Abdominal discomfort Difficulty swallowing
Not known: (frequency cannot be estimated from the available data)
Urinary tract infection Indigestion or heartburn (acid reflux)
Abdominal pain and bloating which may be accompanied by feeling or being sick, difficulty with swallowing, diarrhoea or constipation, depending on the part of the gut affected (pseudo-obstruction)
Agitation
Anxiety
Seeing things that are not there (hallucinations)
Nightmares
Feeling excessively suspicious and distrustful of others (paranoia)
Depression
Becoming dependent on Oxybutynin Tablets Fits (convulsions)
Blurring of vision or sudden loss of vision, increased pressure in the eyes (glaucoma), pain the eyes, enlargement of the pupil of the eye, or dry eyes Increased, rapid or irregular heartbeat (palpitations)
Heat stroke
Itchy, lumpy rash (urticaria)
Absence of sweating (hypohidrosis)
Allergic reaction, the signs may include a rash, swallowing or breathing problems, swelling of the lips face throat or tongue
Reporting of side effects
If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse. This includes any possible side effect 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.
3| How to store Oxybutynin Tablets
Keep out of the sight and reach of children.
Do not use Oxybutynin Tablets after the expiry date which is stated on the carton and blister strip. The expiry date refers to the last day of that month.
If you forget to take Oxybutynin Tablets
If you forget to take a dose, take it as soon as you remember it. 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 tablet.
If you stop taking Oxybutynin Tablets
Keep taking your medicine until your doctor tells you to stop. Do not stop taking Oxybutynin just because you feel better.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, Oxybutynin Tablets can cause side effects, although not everybody gets them. Children are at higher risk of the effects.
Stop taking Oxybutynin Tablets and see a doctor or go to a hospital straight away if:
• You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• You feel reduced sweating, leading to overheating in hot environments
Tell your doctor or pharmacist if any of the following side effects get serious or last longer that a few days Very common: (may affect more than 1 in 10 people)
Headache
Dizziness, drowsiness or confusion
Dry mouth which can lead to tooth decay, gum disease or oral thrush.
Constipation Feeling sick
Dry skin, rash or skin that is more sensitive to the sun.
Common: (may affect up to 1 in 10 people)
Facial flushing especially in children
Diarrhoea
Vomiting
Difficulty passing water (urine)
Dry eyes Confusion
Continued top of next column 50853010 AAAH8783
Store below 25°C. Store in the original package. Do not use Oxybutynin Tablets if the tablets show 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 to protect the environment.
_6| Contents of the pack and other information
What Oxybutynin Tablets contain
The active substance is oxybutynin hydrochloride. Each 2.5 mg tablet contains 2.5 mg oxybutynin hydrochloride.
Each 5 mg tablet contains 5 mg oxybutynin hydrochloride.
The other ingredients are crospovidone, cellulose, microcrystalline, lactose monohydrate,
magnesium stearate and indigo carmine aluminium lake (E132).
What Oxybutynin Tablets look like and contents of the pack
Oxybutynin Hydrochloride Tablets are light blue tablets, marked OXB or OxB with a breakline on the reverse.
2.5 5
They are packed in blister strips and supplied in cartons of 20, 28, 30, 56, 60, 84 and 120 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Niche Generics Limited,
1 The Cam Centre,
Wilbury Way,
Hitchin,
Herts SG4 0TW,
United Kingdom.
This leaflet was last revised in June 2015