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Package leaflet: Information for the user

Oxybutynin hydrochloride 2.5 mg tablets Oxybutynin hydrochloride 3 mg tablets Oxybutynin hydrochloride 5 mg tablets

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 symptoms 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.

In this leaflet:

1.    What Oybutynin hydrochloride tablets are and what they are used for

2.    What you need to know before you take Oxybutynin ^M 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 Oybutynin hydrochloride tablets are and what they are used for

Oxybutynin hydrochloride tablets belong to the group of spasm-relieving agents (a so-called spasmolytic).

Oxybutynin hydrochloride tablets act by reducing the muscle spasms of the bladder. It is these spasms that cause the feeling of having to urinate frequently, which in turn can lead to involuntary loss of urine. Oxybutynin relaxes the bladder muscle, so that the bladder can hold more urine and the frequent urge to urinate is reduced.

Oxybutynin hydrochloride tablets may be prescribed by the doctor for the treatment of the involuntary loss of urine as a result of an unstable or over-active bladder. In other words, when it is not possible to keep the urge to urinate and the frequent need to urinate normally under control.

2. What you need to know before you take Oxybutynin hydrochloride tablets

Do not take Oxybutynin hydrochloride tablets

•    if you are allergic to oxybutynin hydrochloride or any of the other ingredients of this medicine (listed in section 6).

•    if you have an eye condition with raised eyeball pressure (narrow angle glaucoma) or a shallow anterior eye chamber.

•    if you have a tendency to muscle weakness (myasthenia gravis).

•    if you have constriction in the gastrointestinal tract, sluggish bowel movements or constipation as a result of the complete absence of bowel peristalsis (paralytic ileus) or as a result of weakness of the bowel muscles (intestinal atony).

•    if you have difficulty in urinating as a result of obstruction of the urinary tract or as a result of enlargement of the prostate (prostatic hypertrophy).

•    if you have severe inflammation of the large bowel that is accompanied by ulcers (severe ulcerative colitis).

•    if you have acute inflammation of the wall of the large bowel with dilatation and ulcer formation in the mucous membrane (toxic megacolon).

Warnings and precautions

Talk to your doctor or pharmacist before taking

Oxybutynin hydrochloride tablets

•    in debilitated, elderly persons because there may be greater sensitivity to the effects of oxybutynin.

•    if you suffer from certain nerve diseases (autonomous neuropathy), reduced liver or kidney function, a rupture of the diaphragm with regurgitating gastric acid (hiatus hernia with reflux oesophagitis) or other severe gastrointestinal disorders.

•    if you have the symptoms of an overactive thyroid gland (hyperthyroidism), cardiovascular diseases, heart failure, disturbances of heart rhythm, raised blood pressure (hypertension) and enlarged prostate (prostatic hypertrophy).These symptoms may be intensified by the use of oxybutynin.

•    in the case of treatment of patients subject to a high environmental temperature or in cases of fever. There is the risk of a greatly increased body temperature (hyperpyrexia) due to a decrease in sweat production as a result of the use of oxybutynin.

•    because oxybutynin can cause a dry mouth. In cases of long-term use this can lead to an increased risk of the development of dental cavities (caries) or to abnormalities of the tooth pockets, oral Candida (a fungal infection) in the oral cavity or general discomfort caused by the reduced salivation. Careful oral hygiene is necessary.

•    in the case of a urinary tract infection during treatment, an adequate therapy with antibiotics has to be started.

•    if you suffer from frequent urination (pollakiuria), in the daytime or at night (nocturia), caused by a heart or kidney disease.

If any of the above warnings applies to you, or has done in the past, please ask your doctor for advice. Oxybutynin hydrochloride tablets should not be used in children under the age of 5.

Other medicines and Oxybutynin hydrochloride tablets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

An interaction with other medicines can occur when oxybutynin is used with the following medicines:

•    The effect may be potentiated by administration of other anticholinergic agents (a group of medicines to which oxybutynin belongs) or atropine and other parasympatholytic agents (medicines in eye drops for dilating the pupils, among other things).

•    By reducing the motility of the gastrointestinal tract, oxybutynin can influence the uptake of other medicines into the blood.

•    Anticholinergics and phenothiazines (medicines for mental disorders), amantadine (medicine for Parkinson's disease), butyrophenones (medicines for mental disorders), levodopa (medicine for Parkinson's disease), digitalis (medicine for heart failure), quinidine (medicine for disturbances of heart rhythm), and tricyclic antidepressants (medicines for severe depression). Caution should be exercised in cases of concomitant use of these agents with oxybutynin.

•    Certain anti-fungal agents (antimycotics) such as e.g. ketoconazole or itraconazole, and macrolide antibiotics, e.g. erythromycin. The effect of oxybutynin may increase.

•    Agents for nausea (metoclopramide and domperidone); the effect of oxybutynin may be reduced by these agents.

In this section, medicines are indicated with the name of the active substance or the group to which the substance belongs. Usually you know a medicine by its trade name. Therefore, check the pack or the package leaflet of the medicine that you are using in order to establish which substances are present, or ask your doctor or pharmacist for advice.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

During pregnancy, only take the product after consulting your doctor. Oxybutynin may only be used during pregnancy if the expected positive effect outweighs the risks of treatment.

Breast-feeding

Oxybutynin is excreted into the breast-milk in animals (rats). It is not known if the active substance is excreted into the breast-milk in humans. Oxybutynin hydrochloride tablets may only be used during lactation under the supervision of your doctor, if the expected positive effect outweighs the risks of treatment.

Driving and using machines

Oxybutynin hydrochloride tablets can cause drowsiness, dizziness and blurred vision, especially in combination with alcohol. You should take account of this when driving vehicles or operating machines.

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.

Pharma code 58

Age

5 - 9 years 9-12 years older than 12 years