Ditropan

Package Leaflet: Information for the User

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Ditropan, 5 mg, Tablets

Oxybutynin Hydrochloride

Before taking Ditropan, carefully read the leaflet contents, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if needed.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Ditropan and what is it used for
• 2. Important information before taking Ditropan
• 3. How to take Ditropan
• 4. Possible side effects
• 5. How to store Ditropan
• 6. Contents of the pack and other information

1. What is Ditropan and what is it used for

Ditropan is a tablet containing the active substance oxybutynin hydrochloride. The medicine has a relaxing effect on the smooth muscles of the urinary bladder in patients with symptoms of urinary bladder instability.

Ditropan is indicated for the relief of symptoms of urinary bladder instability, with disturbances of micturition in patients with a neurogenic bladder - hyperreflexia of the detrusor muscle (symptoms such as urgent urination, incontinence, difficulty urinating).

Ditropan may be used in children aged 5 years or older for the treatment of:

• loss of control over urination (incontinence),
• frequent urination or sudden urge to urinate,
• nocturnal enuresis, in combination with non-pharmacological therapy when other treatment methods have not been effective.

2. Important information before taking Ditropan

When not to take Ditropan:

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

Warnings and precautions

Before starting treatment with Ditropan, discuss it with your doctor or pharmacist.

• Ditropan should be used with caution if the patient has Parkinson's disease, autonomic nervous system neuropathy, and/or kidney or liver dysfunction. This is due to a higher risk of side effects after administration of the medicinal product.
• Ditropan may reduce the motility of the gastrointestinal tract. Therefore, caution should be exercised in patients with partial or complete intestinal obstruction, intestinal atony, or ulcerative colitis.
• Ditropan may exacerbate symptoms of tachycardia (including hyperthyroidism, congestive heart failure, arrhythmias, coronary heart disease, and hypertension), cognitive impairment, and symptoms of prostate hypertrophy.
• 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 in the first month of treatment or after dose adjustment.
• Ditropan may cause narrow-angle glaucoma. You should contact your doctor immediately if you experience a loss of vision or eye pain.
• Ditropan may reduce saliva production, which can lead to tooth decay, periodontal disease, or oral candidiasis.
• This medicine should be used with caution if the patient has a hiatal hernia with accompanying gastroesophageal reflux and/or during concomitant use of medications such as bisphosphonates, as Ditropan may cause or exacerbate esophagitis.
• Taking Ditropan in a hot climate or in a very warm room may cause heat stroke due to reduced sweating.
• In the case of a history of drug or substance abuse, Ditropan may cause dependence on the active substance oxybutynin.

If any of the above diseases apply to the patient, they should inform their doctor before starting treatment with Ditropan.

Elderly patients (including frail elderly patients)

Elderly patients should exercise caution when taking Ditropan, as they may be more sensitive to the side effects of this medicine and have a higher risk of cognitive impairment.

Children and adolescents

Children under 5 years of age

Ditropan is not recommended for use in children under 5 years of age.

Children aged 5 years and older

Ditropan should not be given to a child without prior consultation with a doctor. Children may be more sensitive to the side effects of Ditropan.

Ditropan and other medicines

Tell your doctor about all medicines you are taking, have recently taken, or plan to take.

Exercise caution when taking the following medicines with Ditropan:

• other anticholinergic medicines, such as amantadine (used to treat influenza and Parkinson's disease),
• other anticholinergic medicinal products used to treat Parkinson's disease (e.g., biperiden, levodopa),
• antihistamine medicines (used to treat allergy symptoms),
• antipsychotic medicines - used to treat mental disorders, such as schizophrenia (phenothiazine derivatives, butyrophenone derivatives, clozapine),
• quinidine, digitalis glycosides (used to treat arrhythmias),
• tricyclic antidepressants,
• atropine and its derivatives, such as atropine-like antispasmodic medicines,
• dipyridamole (a medicine that prevents blood clots),
• medicines used to treat dementia, such as donepezil, rivastigmine, galantamine (cholinesterase inhibitors),
• CYP3A inhibitors, including ketoconazole, itraconazole, or fluconazole, used to treat fungal infections, or erythromycin or other macrolide antibiotics used to treat bacterial infections,
• medicines for gastrointestinal disorders, such as domperidone, metoclopramide, or betanechol.

Due to the reduced motility of the stomach, Ditropan may affect the absorption of other medicines from the gastrointestinal tract, e.g., it may increase the absorption of digoxin (used to treat arrhythmias) and reduce the absorption of lidocaine (used for local anesthesia), paracetamol (a pain reliever), lithium salts (used to treat bipolar affective disorder), tetracyclines (antibiotics), phenylbutazone (an anti-inflammatory medicine), sulfamethoxazole, cotrimoxazole (antibiotics), and prolonged-release medicines.

Ditropan with food, drink, and alcohol

Food does not affect the absorption of the medicine from the gastrointestinal tract.

Alcohol may enhance the drowsiness caused by anticholinergic medicines, such as oxybutynin.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Ditropan should only be used during pregnancy if it is absolutely necessary. The treating doctor will decide this.

Breastfeeding

Small amounts of oxybutynin pass into breast milk. It is not recommended to take Ditropan during breastfeeding.

Driving and using machines

Ditropan may cause drowsiness and blurred vision. If you experience these symptoms, do not drive, operate machinery, or perform tasks that may be hazardous.

Ditropan contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Ditropan contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Ditropan

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.

The tablet can be divided into equal doses.

Dosage

The exact dose will be determined individually by your doctor, although the recommended dose is usually as follows.

Adults

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

Elderly patients (including frail elderly patients)

The recommended dose is usually half a tablet 2 times a day. The dose can be increased to 1 tablet 2 times a day to achieve the desired clinical response, provided that the medicine is well tolerated.

Use in children

Children under 5 years of age

Ditropan is not recommended for use in children under 5 years of age.

Children aged 5 years and older

The usual recommended dose is 1 tablet of Ditropan 2 times a day. The dose can then be increased to 1 tablet 2 to 3 times a day.

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 and should be swallowed with a glass of water.

Overdose of Ditropan

Symptoms of overdose:

restlessness, agitation, mental disorders, circulatory disorders (flushing, decreased blood pressure, circulatory failure), respiratory failure, and in severe cases, paralysis and coma.

In the case of severe overdose, the patient should be hospitalized and monitored for cardiovascular function.

If you have taken more than the recommended dose of Ditropan, seek medical attention immediately.

Missed 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. If you are unsure, consult your doctor.

Stopping treatment with Ditropan

If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ditropan can cause side effects, although not everybody gets them.

The following side effects may occur when taking Ditropan:

Very common(more than 1 in 10 people):

constipation, nausea, dry mouth, headache, dizziness, drowsiness, blurred vision, dry skin.

Common(less than 1 in 10 people):

diarrhea, vomiting, altered consciousness (disorientation), dry eyes, urinary retention, flushing of the face, rapid or irregular heartbeat.

Uncommon(less than 1 in 100 people):

abdominal discomfort, anorexia, decreased appetite, difficulty swallowing.

Frequency not known(cannot be estimated from the available data):

urinary tract infections, gastroesophageal reflux, pseudo-obstruction in patients at high risk (elderly patients or patients with constipation and treated with other medicines that reduce intestinal motility), cognitive impairment, especially in elderly patients, seizures, drowsiness, agitation, anxiety, hallucinations, nightmares, paranoia, symptoms of depression, dependence on oxybutynin (in patients with a history of drug abuse), tachycardia (rapid heart rate), arrhythmias, heat stroke, increased intraocular pressure, angle-closure glaucoma, mydriasis, photophobia, decreased sweating, allergic reactions, such as: rash, urticaria (local changes in the form of blisters and redness on the skin), angioedema (an allergic reaction characterized by swelling and/or edema, mainly on the face and limbs), hypersensitivity, epistaxis, muscle disorders (muscle weakness, pain, cramps).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ditropan

Keep this medicine out of the 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 month.

Store in a temperature below 30°C.

Medicines should 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 (E 132), aluminum lake.

What Ditropan looks like and contents of the pack

Light blue, round, biconvex tablets with "OXB5" engraved on one side and a score line on the other side.

Packaging of 30 tablets in PVC/Aluminum blisters in a cardboard box.

For more detailed information, consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, 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 Avenue Gustave Eiffel

37100 Tours

France

Parallel importer:

Delfarma Sp. z o.o.

ul. Św. Teresy od Dzieciątka Jezus 111

91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.

ul. Św. Teresy od Dzieciątka Jezus 111

91-222 Łódź

Spanish export license number: 971812.1

Parallel import license number: 137/25

Date of leaflet approval: 10.04.2025