Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Ditropan, 5 mg, tablets
Oxybutynini hydrochloridum
Please read 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, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual only. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What is Ditropan and what is it 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 is Ditropan and what is it 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 unstable bladder and voiding disorders in patients with neurogenic bladder – detrusor hyperreflexia (symptoms such as urgency, 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 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 where 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 forms of 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 worsen symptoms of tachycardia (and thus hyperthyroidism, congestive heart failure, cardiac arrhythmias, coronary artery disease, and hypertension), cognitive disorders, and symptoms of benign prostatic hyperplasia.
The anticholinergic effect of Ditropan may cause symptoms such as hallucinations, agitation, disorientation, and drowsiness. The physician may consider monitoring the patient's condition, especially during the first month of treatment or after dose adjustment.
Ditropan may cause narrow-angle glaucoma. Immediate medical advice should be sought in case of sudden 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, as Ditropan may cause or exacerbate 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 the active ingredient oxybutynin contained in the medicine.

If any of the above conditions apply to the patient, the doctor should be informed before starting treatment with the medicine.
Elderly patients (including frail elderly patients)
Elderly individuals should exercise caution when using Ditropan, as they may be more susceptible to adverse effects of this medicine and have an increased risk of cognitive disorders.
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 susceptible to adverse effects of Ditropan.
Ditropan with other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines planned for use.
Caution is advised when using the following medicines concomitantly with Ditropan:

other anticholinergic medicines, such as amantadine (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),
antipsychotics – 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 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),
gastrointestinal medicines such as domperidone, metoclopramide, or betanechol.

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 (analgesic), lithium salts (used in the treatment of bipolar affective disorder), tetracyclines (antibiotics), phenylbutazone (anti-inflammatory drug), sulfamethoxazole, cotrimoxazole (antibiotics), and drugs with prolonged release.
Ditropan, 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 the doctor has diagnosed intolerance to certain sugars in the patient, contact the 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 your doctor. If in doubt, consult your doctor.
The tablet may be divided into equal doses.

Dosage
The exact dose will be individually determined by your doctor, 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 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, psychiatric disturbances, circulatory disturbances (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 or someone else has taken more than the recommended dose, seek immediate medical advice from a doctor or pharmacist.

If you forget to take 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. If in doubt, consult your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects 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):
abdominal discomfort, loss of appetite, decreased appetite, difficulty swallowing.
Frequency not known (cannot be estimated from available data):
urinary tract infections, gastroesophageal reflux, pseudo-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 (increased heart rate), cardiac arrhythmias, heat stroke, increased intraocular pressure, acute angle-closure glaucoma, mydriasis (pupil dilation), photophobia (sensitivity to light), decreased sweating, allergic reactions such as: rash, urticaria (localized skin lesions with blisters and redness), angioedema (an allergic reaction characterized by swelling and/or puffiness, mainly affecting the face and limbs), hypersensitivity, nosebleeds, muscular disorders (muscle weakness, pain, cramps).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, telephone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects 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.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ditropan contains

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

What Ditropan looks like and contents of the pack
Light blue, round, biconvex tablets with the imprint "OXB5" on one side and a division line on the other.
Pack of 30 tablets packed in PVC/Aluminum blisters within a cardboard box.
For further information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation Holder in Spain, country of export:
Cheplapharm Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer:
Sanofi Winthrop Industrie
30 Avenue Gustave Eiffel
37100 Tours
France
Fidelio Healthcare Limburg GmbH
Mundipharmastraße 2
65549 Limburg an der Lahn
Germany

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in Spain, country of export: 971812.1
Parallel Import Licence Number: 248/25