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 further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including those not listed in this leaflet, tell 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 package and other information

1. What Ditropan is and what it is used for

Ditropan is a tablet containing the active substance oxybutynini hydrochloridum. The medicine
has a spasmolytic effect on the smooth muscles of the urinary bladder in patients with symptoms
of unstable bladder.
Ditropan is indicated for the relief of symptoms of unstable bladder, with micturition disorders in patients with neurogenic bladder – detrusor hyperreflexia (symptoms such as urgency, urinary incontinence, difficulty in passing urine).
Ditropan may be used in children aged 5 years and older in the treatment of:

loss of control over urination (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 urinary 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 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 renal or hepatic function, due to an increased risk of adverse effects.
Ditropan may reduce gastrointestinal motility. Therefore, caution is advised 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 arterial 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 a doctor immediately if blurred vision or eye pain occurs.
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 concomitantly taking medications such as bisphosphonates, as 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 lead to dependence on the active ingredient oxybutynin.

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 susceptible to adverse effects of this medicine and have an increased risk of cognitive disturbances.
Children and adolescents
Children under 5 years of age
The 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 the adverse effects of Ditropan.
Ditropan with other medicines
Inform your doctor about all medicines currently 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 (used in the treatment of influenza and Parkinson's disease),
other anticholinergic medicines 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 antispasmodic anticholinergics,
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 medications 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 for local anesthesia), paracetamol (analgesic), lithium salts (used in the treatment of bipolar affective disorder), tetracyclines (antibiotics), phenylbutazone (anti-inflammatory medicine), sulfamethoxazole, cotrimoxazole (antibiotics), and medicines 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 her 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. The 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 the patient with an intolerance to certain sugars, contact the doctor before taking this medicine.

3. How to use Ditropan

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor.
The tablet may be divided into equal doses.

Dosage
The exact dosage 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 have taken more than the recommended dose, seek medical advice immediately from your doctor or pharmacist.

Missed dose of Ditropan
If you miss a dose, take it as soon as possible, unless it is almost time for your 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 will experience them.
The following adverse effects may occur during treatment with this medicine:
Very common (affects more than 1 in 10 people):
constipation, nausea, dry mouth, headache, dizziness, drowsiness, blurred vision, dry skin.
Common (affects less than 1 in 10 people):
diarrhoea, vomiting, disturbances of consciousness (disorientation), dry eyes, urinary retention,
facial flushing, palpitations which may be rapid or irregular.
Uncommon (affects less than 1 in 1,000 people):
abdominal discomfort, loss of appetite, decreased appetite, difficulty in swallowing.
Frequency not known (cannot be estimated from the available data):
urinary tract infections, gastro-oesophageal reflux, paralytic ileus in patients in the high-risk group (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 (localised skin lesions in the form of blisters and erythema), angioedema (an allergic reaction characterised by swelling and/or puffiness mainly in the face and extremities), hypersensitivity, nosebleeds, muscle disorders (muscle weakness, pain, cramps).
Reporting of adverse effects
If any adverse effects occur, including any adverse effects 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, Tel.: +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 the 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 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 packaging and other information

What Ditropan contains

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

What Ditropan looks like and contents of the pack
White, round tablets.
Pack size: 30 tablets in PVC/Aluminium blisters, packed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Greece, country of export:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer:
Sanofi Winthrop Industrie
Tours, France
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Greece, country of export: 45745/14-07-2020
Parallel Import Licence Number: 80/24