Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Ditropan, 5 mg, tablets
Oxybutynini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
If any adverse effects occur in the patient, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Ditropan is and what it is used for
Important information before taking Ditropan
How to take Ditropan
Possible side effects
How to store Ditropan
Contents of the pack and other information

1. What Ditropan is and what it is used for

Ditropan is a tablet formulation containing the active substance oxybutynin hydrochloride. Ditropan exerts a spasmolytic effect on the smooth muscles of the urinary bladder in patients with symptoms of bladder instability.
Ditropan is indicated for the relief of symptoms of urinary bladder instability and voiding disorders in patients with neurogenic bladder – detrusor hyperreflexia (symptoms such as urgent need to urinate, urinary incontinence, difficulty in urination).
Ditropan may be used in children aged 5 years and older for the treatment of:

loss of bladder control (urinary incontinence)
frequent urination or sudden urge to urinate
nocturnal enuresis, in combination with non-pharmacological therapy when other treatment methods have failed.

2. Important information before using Ditropan

When not to use Ditropan:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
in case of narrow-angle glaucoma or shallow anterior chamber of the eye,
in case of bladder outflow obstruction, when urinary retention may occur,
in case of partial or complete intestinal obstruction, paralytic ileus, intestinal atony,
in case of toxic megacolon,
in case of severe ulcerative colitis,
in case of myasthenia gravis.

Warnings and precautions
Before starting treatment with Ditropan, discuss this with your doctor or pharmacist.

Ditropan should be used with caution in patients with Parkinson's disease, autonomic neuropathy, and/or impaired kidney or liver function. This is due to an increased risk of adverse effects after administration of the medicinal product.
Ditropan may reduce gastrointestinal motility. Therefore, caution should be exercised in patients with partial or complete intestinal obstruction, intestinal atony, or ulcerative colitis.
Ditropan may exacerbate symptoms of tachycardia (and thus hyperthyroidism, congestive heart failure, cardiac arrhythmias, coronary artery disease, and hypertension), cognitive disturbances, and symptoms of benign prostatic hyperplasia.
The anticholinergic effect of Ditropan may cause symptoms such as hallucinations, agitation, disorientation, and drowsiness. The doctor may consider monitoring the patient's condition, especially during the first month of treatment or after dose adjustment.
Ditropan may cause narrow-angle glaucoma. Contact your doctor immediately if you experience loss of visual acuity or eye pain.
Ditropan may reduce saliva secretion, which may lead to dental caries, periodontitis, or oral candidiasis.
This medicine should be used with caution in patients with hiatal hernia associated with gastroesophageal reflux and/or when taking concomitant medications such as bisphosphonates, because Ditropan may cause or worsen esophagitis.
Taking Ditropan in hot climates or in very warm rooms may lead to heat stroke due to reduced sweating.
In patients with a history of drug or substance abuse, Ditropan may cause dependence on oxybutynin, the active substance contained in the medicine.

If any of the above conditions apply to the patient, inform the doctor before starting treatment with this medicine.
Elderly patients (including frail elderly patients)
Elderly patients should exercise caution when using Ditropan, as they may be more sensitive to adverse effects of this medicine and have an increased risk of cognitive disturbances.
Children and adolescents
Children under 5 years of age
Use of Ditropan is not recommended in children under 5 years of age.
Children aged 5 years and older
This medicine should not be given to a child without prior consultation with a doctor. Children may be more sensitive to adverse effects of Ditropan.
Ditropan with other medicines
Tell your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to use.
Exercise caution when using the following medicines concomitantly with Ditropan:

other anticholinergic medicines, such as amantadine (a medicine used in the treatment of influenza and Parkinson's disease),
other anticholinergic medicinal products used in the treatment of Parkinson's disease (e.g. biperiden, levodopa),
antihistamines (medicines used to treat allergy symptoms),
antipsychotic medicines – used in the treatment of psychiatric disorders, e.g. schizophrenia (phenothiazine derivatives, butyrophenone derivatives, clozapine),
quinidine, digitalis glycosides (used in the treatment of cardiac arrhythmias),
tricyclic antidepressants,
atropine and related compounds, such as atropine-like antispasmodics,
dipyridamole (a medicine preventing blood clot formation),
medicines used in the treatment of dementia, such as donepezil, rivastigmine, galantamine (cholinesterase inhibitors),
CYP3A inhibitors, including ketoconazole, itraconazole, or fluconazole used in the treatment of fungal infections, or erythromycin or other macrolide antibiotics used in the treatment of bacterial infections,
medicines for gastrointestinal disorders, such as domperidone, metoclopramide, or bethanechol.

Due to reduced gastric motility, Ditropan may affect the absorption of other medicines from the gastrointestinal tract; for example, it may increase the absorption of digoxin (used in the treatment of cardiac arrhythmias) and decrease the absorption of lidocaine (used in local anesthesia), paracetamol (an analgesic), lithium salts (used in the treatment of bipolar affective disorder), tetracyclines (antibiotics), phenylbutazone (an anti-inflammatory medicine), sulfamethoxazole, cotrimoxazole (antibiotics), and medicines with prolonged release.
Ditropan with food, drink, and alcohol
Food does not affect the absorption of the medicine from the gastrointestinal tract.
Alcohol may intensify drowsiness caused by anticholinergic medicines such as oxybutynin.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Pregnancy
Ditropan may be used during pregnancy only if its use is absolutely necessary. This decision will be made by the attending physician.
Breastfeeding
Small amounts of oxybutynin pass into breast milk. Use of Ditropan is not recommended during breastfeeding.
Driving and operating machinery
Ditropan may cause drowsiness and blurred vision. If these symptoms occur, driving, operating machinery, or performing potentially hazardous activities is not recommended.
Ditropan contains lactose
If your doctor has diagnosed an intolerance to certain sugars, contact your doctor before taking this medicine.
Ditropan contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Ditropan

This medicine should always be taken as prescribed by the physician. In case of doubt, consult your doctor.
The tablet may be divided into equal doses.

Dosage
The exact dosage will be individually determined by the physician, although the following doses are generally recommended.

Adults
The usual recommended dose is 1 tablet of Ditropan 2 to 3 times daily. Do not exceed the maximum dose of 4 tablets per day.

Elderly patients (including frail elderly patients)
The usual recommended dose is half a tablet twice daily. The dose may be increased to 1 tablet twice daily to achieve an adequate clinical response, provided the medicine is well tolerated.

Use in children
Children under 5 years of age
Use of this medicine is not recommended.

Children aged 5 years and older
The usual recommended dose is 1 tablet of Ditropan twice daily. The dose may then be increased to 1 tablet 2 to 3 times daily.
Do not exceed the maximum dose of 3 tablets per day.

If you feel that the effect of Ditropan is too strong or too weak, consult your doctor.

Method of administration
The tablets are intended for oral use. They have an unpleasant taste, so they should be taken with a glass of water.

Taking more Ditropan than recommended
Symptoms of overdose:
restlessness, excitement, mental disturbances, circulatory disorders (flushing, decreased blood pressure, circulatory failure), respiratory failure, and in severe cases paralysis and coma.
In case of severe overdose, the patient should be hospitalized and cardiovascular function monitored.
If you have taken more than the recommended dose, contact your doctor or pharmacist immediately.

Missing a dose of Ditropan
If you miss a dose, take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose. In case of doubt, consult your doctor.

Stopping Ditropan treatment
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although they do not occur in everyone.
The following adverse reactions may occur during treatment with this medicine:
Very common (occurs in more than 1 in 10 people):
constipation, nausea, dry mouth, headache, dizziness, drowsiness, blurred vision, dry skin.
Common (occurs in less than 1 in 10 people):
diarrhea, vomiting, disturbances in consciousness (disorientation), dry eyes, urinary retention,
flushing of the face, strong heartbeat which may be fast or irregular.
Uncommon (occurs in less than 1 in 1,000 people):
feeling of discomfort in the abdominal cavity, loss of appetite, decreased appetite, difficulty swallowing.
Frequency not known (cannot be estimated from available data):
urinary tract infections, gastroesophageal reflux, pseudointestinal obstruction in patients at increased risk (elderly patients or patients with constipation and those treated with other medicines reducing intestinal peristalsis), cognitive disorders especially in elderly patients, convulsions, somnolence, excitation, anxiety, hallucinations, nightmares, paranoia, symptoms of depression, dependence on oxybutynin (in patients with a history of drug abuse), tachycardia (accelerated heart rate), cardiac arrhythmia, heat stroke, increased intraocular pressure, development of narrow-angle glaucoma, pupil dilation, photosensitivity, decreased sweating, allergic reactions such as: rash, urticaria (local skin lesions in the form of blisters and erythema), angioedema (an allergic reaction manifested by swelling and/or puffiness mainly in the face and limbs), hypersensitivity, nosebleeds, muscular disorders (muscle weakness, pain, cramps).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Ditropan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store in the original packaging. Store at a temperature below 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Ditropan contains

The active substance is oxybutynin chloride 5 mg.
The other ingredients are: lactose, microcrystalline cellulose, calcium stearate, aluminium lake with indigo carmine.

What Ditropan looks like and contents of the pack
Light blue, round, biconvex tablets imprinted with the code "OXB5" on one side and a division line on the other.
Packaged in PVC/Aluminium blisters containing 30 tablets, presented in a cardboard outer container.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in France, the country of export:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer:
Fidelio Healthcare Limburg GmbH, Mundipharmastrasse 2, 65549 Limburg an der Lahn, Germany
Sanofi Winthrop Industrie, 30-36, Avenue Gustave Eiffel, 37100 Tours, France
Delpharm Dijon, 6, Boulevard de l’Europe, 21800 Quetigny, France

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in France, the country of export: 34009 327 307 5 9
327 307-5

Parallel Import Licence Number: 456/16