Package leaflet: Information for the user

Oxybutynin STADA 5 mg, tablet

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 STADA is and what it is used for 2. What you need to know before you take Oxybutynin STADA 3. How to take Oxybutynin STADA 4. Possible side effects 5. How to store Oxybutynin STADA 6. Contents of the pack and other information

1. What Oxybutynin STADA is and what it is used for

Oxybutynin STADA belongs to a group of medicines called anticholinergics and spasmolytics.

Certain types of muscles in your bladder wall (detrusor muscles) increase your urge to urinate when they spasm (contract). Oxybutynin STADA relaxes these muscles and it is therefore used to help control your bladder function.

Oxybutynin STADA is used to treat overactive bladder conditions with the symptoms:  urinating too often, or the feeling that you need to urinate too often  urinary incontinence (when you cannot control when you urinate)

Oxybutynin STADA can be used in children 5 years 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

2. What you need to know before you take Oxybutynin STADA

DO NOT take Oxybutynin STADA  If you are allergic to oxybutynin hydrochloride or any of the other ingredients of this medicine (listed in section 6).  If you have increased pressure in the eye (glaucoma)  If you have a blockage that makes it difficult for you to pass urine  If your gut (stomach or intestine) is blocked  If your intestinal activity is decreased  If you suffer from severe inflammatory disease of the large intestine or toxic megacolon (a sudden widening of your lower bowel)  If you suffer from myasthenia gravis. This is a disease which causes muscle weakness.  If you are a child under 5 years of age.

Warnings and precautions Talk to your doctor or pharmacist before taking Oxybutynin STADA.

Check with your doctor or pharmacist before taking your medicine if:  The person taking the medicine is a child (use is not recommended under 5 years of age)

Ask your doctor before you start to take Oxybutynin STADA. This is especially important if any of the conditions or illnesses listed below applies to you. You should also talk to your doctor if you have suffered from any of these conditions in the past. These conditions include:  a disease of the nervous system. For example: o multiple sclerosis (a disease affecting the brain and spinal cord) o autonomic neuropathy. This is a disease of the autonomic nervous system. The autonomic nervous system is that part of the nervous system that controls your internal organs. These nerves are not under your conscious control and function automatically.  Parkinson disease and/or if your perception is impaired. Under these conditions, oxybutynin may trigger side effects which affect the nervous system.  a damaged midriff associated with reflux disease or any other severe diseases of the bowels  impaired liver and/or kidney function  hyperthyroidism (an overactive thyroid)  heart disease or heart failure  a fast heartbeat (tachycardia) or an irregular heartbeat (arrhythmia)  high blood pressure (hypertension)  an enlarged prostate gland  fever (high body temperature)  you are 65 years of age or older

Take care if you are working or living in a very hot environment. Oxybutynin STADA causes you to sweat less and this may cause heatstroke.

Long-term use Oxybutynin STADA also causes you to produce less saliva. Long-term use can lead to problems in your mouth such as:  caries (rotten teeth)  diseases of the gums (e.g. periodontal disease)  general discomfort as a consequence of too less saliva  thrush

You should be aware that you may get a urinary tract infection during treatment. If you think you are getting an infection you should see your doctor.

Your doctor will check your eye-sight and the pressure inside your eyes (intraocular pressure) regularly during therapy. If you have the feeling that your eyes cannot focus properly or your vision is suddenly impaired, please talk to you doctor immediately!

You should not take Oxybutynin STADA as a treatment for stress or for incontinence caused by stress (when you cannot control your urge to urinate). If you treat a child or you are elderly you may be more sensitive to Oxybutynin STADA. Your doctor may give you a reduced dose (see section 3 for further information on the dosage of Oxybutynin).

Children Oxybutynin, the active ingredient of Oxybutynin STADA, must not be given to children under 5 years old (see “DO NOT take Oxybutynin STADA”).

Other medicines and Oxybutynin STADA Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Take special care with Oxybutynin STADA if you are also taking any of the following medicines:  amantadine and other drugs used in Parkinson’s disease (e.g. biperiden, levodopa)  antihistamines (medicines used for allergies e.g. hayfever)  antipsychotics (e.g. phenothiazines, butyrophenones, clozapine)  quinidine (for the treatment of heart problems or used as an antimalarial drug)  digitalis glycosides (for the treatment of heart problems)  tricyclic antidepressants (used for depression)  atropine and related compounds (used for treatment in stomach disorders such as irritable bowel syndrome)  dipyridamole (used to thin your blood)  antifungal medicines (e.g. ketoconazole, itraconazole)  antibiotics called “macrolides” (e.g. erythromycin)  medicines, that can cause or exacerbate inflammation of the gullet (oesophagitis) such as bisphosphonates (used to treat bone diseases)

Oxybutynin may alter the effect of other drugs because it reduces the movement of the guts. Also, the use of this medicine together with other medicines may alter the effect of oxybutynin.

Oxybutynin may also decrease the effect of drugs which affect the bowel movement (e.g. cisapride, metoclopramide, domperidone).

Oxybutynin STADA and alcohol Oxybutynin may cause drowsiness or blurred vision. Drowsiness may be increased by consumption of alcohol.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Oxybutynin STADA during the first three months of pregnancy. Your doctor may prescribe Oxybutynin STADA from the fourth month of pregnancy if he thinks that it is clearly necessary.

Do not take Oxybutynin STADA if you are breast-feeding. Oxybutynin may reach your baby through the breast milk.

Driving and using machines Oxybutynin STADA may influence your reaction times and affect your eye-sight. You may feel drowsy or have blurred vision while you are taking this medicine. This will affect your ability to drive, use machines and perform hazardous work or work without a firm physical support. This may especially be the case at the start of treatment, when increasing the dose, switching medication or drinking alcohol at the same time. Do not drive, use machines or work without a firm support if you notice any side-effects that influence your reaction time or affect your eye-sight.

Oxybutynin STADA contains lactose Oxybutynin STADA tablets contain milk sugar (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 STADA

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

Dosage: Your doctor will decide how much Oxybutynin STADA you should take depending on your condition. You should be given the lowest effective dose.

The recommended dose is:

Adults You should start your treatment with 2.5 mg (a half tablet) of Oxybutynin STADA three times a day (equal to 1 ½ tablets a day).

Your dose should be increased over time to one Oxybutynin STADA 5 mg tablet two to three times a day (equal to 10-15 mg per day).

Take your daily dose in 2 or 3 divided doses. Do not take the tablets in more than 4 divided doses.

The maximum daily dose for adults is 4 tablets (equivalent to 20 mg of oxybutynin)

Older people You should start your treatment with half an Oxybutynin STADA 5 mg tablet two times a day (equal to 1 tablet a day or 5 mg per day).

A dose of one Oxybutynin STADA 5 mg tablet two times a day should be enough to treat your medical condition.

Children over 5 years old The treatment of children should be started with half an Oxybutynin STADA 5 mg tablet two times a day (equal to 1 tablet or 5 mg per day). After that, your doctor will decide how much your child should take. This depends on the body weight.

Age Daily dose 5-9 years 2.5 mg three times a day 9-12 years 5 mg two times a day 12 years and older (bodyweight over 38 kg) 5 mg three times a day

Children should not take more than 3 tablets a day (equivalent to 15 mg of oxybutynin).

Method of administration Swallow your tablets whole with a drink of water.

Duration of treatment Your doctor will tell you for how long you should take Oxybutynin STADA.

If you take more Oxybutynin STADA than you should If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice.

If you forget to take Oxybutynin STADA If you forget to take a dose of Oxybutynin STADA, just take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop using Oxybutynin STADA Do not stop or change your treatment before talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The evaluation of the side effects is based on the following frequencies:

Serious side effects:

Stop taking Oxybutynin STADA and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:  Swelling of the face, lips or throat, which makes it difficult to swallow or breathe, as well as itching and rashes. This could be a sign of a severe allergic reaction to Oxybutynin STADA.

Very common (may affect more than 1 user in 10 people):  dry mouth  dizziness  headache  drowsiness (somnolence)  difficult, incomplete, or infrequent stool (constipation)  feeling sick (nausea)  dry skin

Common (may affect up to 1 to 10 people):  confusion  aching tummy, stomach cramps (abdominal discomfort)  indigestion (dyspepsia)  a feeling of “spinning” (vertigo)  blurred vision  enlarged pupils (mydriasis)  dry eyes  skin redness and flushing (sudden reddening of the face)  problems with urinating  inability to urinate (urinary retention)  loose stool (diarrhoea)  being sick (vomiting)

Uncommon (may affect up to 1 to 100 people):  loss of appetite (anorexia)  not knowing where you are (disorientation)  passivity  mental or physical tiredness (fatigue)  light sensitivity  too rapid heartbeat (tachycardia)  difficulty swallowing (dysphagia)

Rare (may affect up to 1 to 1,000 people):  heartburn  concentration and behavioural disorders  feeling your heartbeat (heart palpitations)  irregular heartbeat (arrhythmia)

Very rare (may affect up to 1 in 10,000 people):  fits (convulsions)  an eye disease causing high pressure inside the eye (glaucoma)  allergic (hypersensitivity) skin reactions: o redness (erythema) o rash o hives (urticaria) o your skin may be more sensitive to sunlight (photosensitivity)  swelling of the skin, lips or tongue (angio-oedema)  difficulty getting or keeping an erection (impotence)  heat stroke

Not known (frequency cannot be estimated from the available data):  seeing or hearing things that are not there (hallucinations)  restlessness (agitation)  fearfulness  nightmares  a feeling that others wish to persecute you (paranoia)  symptoms of depression  dependence (in patients with history of drug or substance abuse)  inflammation of the food pipe due to acid reflux (gastroesophageal reflux disease)  disorder of gut motility (pseudo-obstruction) in patients at risk (older people or patients with congestion and treated with other medicinal products that decrease gut motility)  urinary tract infection  severe allergic reactions (hypersensitivity)  difficulty remembering (cognitive disorder) (in older people)  high pressure in the eye (ocular hypertension)  sweating less than normal (hypohidrosis)

Reducing your dose may decrease the risk of suffering from the above mentioned side effects.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via {to be completed nationally: the national reporting system listed in Appendix V}. By reporting side effects, you can help provide more information on the safety of this medicine. 5. How to store Oxybutynin STADA

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

Keep your tablets in the original package.

Do not use this medicine after the expiry date which is stated on the carton and blister pack after EXP. The expiry date refers to the last day of that month.

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 STADA contains

The active substance is oxybutynin hydrochloride.

One Oxybutynin STADA 5 mg tablet contains 5 mg of oxybutynin hydrochloride.

The other ingredients are:  powdered cellulose  lactose monohydrate  magnesium stearate  talc

What Oxybutynin STADA, tablet looks like and contents of the pack Oxybutynin STADA 5 mg tablets are white, round tablets, scored on both sides and marked “OBC5” on one side.

Oxybutynin STADA is available in PVC/aluminium blister packs containing 10, 20, 28, 30, 50, 56, 60, 90, 100, 250, 300 or 500 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder: [to be completed nationally]

Manufacturer: STADA Arzneimittel AG, Stadastraße 2-18, 61118 Bad Vilbel, Germany or

Sanico N.V. Veedijk 59, Industriezone 4, 2300 Turnhout, Belgium or

Centrafarm Services B.V. Nieuwe Donk 9 4870 Ac Etten Leur, The Netherlands or STADA Arzneimittel GmbH Muthgasse 36 A-1190 Wien, Austria

This medicinal product is authorised in the Member States of the EEA under the following names: AT Detrusan 5 mg – Tabletten BE Oxybutynine EG 5 mg, tabletten DE Oxybutynin STADA 5 mg Tabletten IT Oxybutynine EG 5 mg LU Oxybutynine EG 5 mg NL Oxybutynine HCl CF 5 mg

This leaflet was last revised in 02/2015.