Ditropan

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Ditropan, 5 mg, tablets

Oxybutynin hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. 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 packaging and other information

1. What is Ditropan and what is it used for

Ditropan is available in tablet form and contains 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 in urination 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-drug therapy when other treatment methods have not been effective.

2. Important information before taking Ditropan

When not to take Ditropan:

Warnings and precautions

Before starting treatment with Ditropan, the patient should discuss it with their 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 the increased risk of side effects after taking the medicine.
• 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 hyperplasia.
• The anticholinergic effect of Ditropan may cause symptoms such as hallucinations, excitement, disorientation, and drowsiness. The doctor may consider monitoring the patient's condition, especially in the first month of treatment or after adjusting the dose.
• Ditropan may cause narrow-angle glaucoma. The patient should contact their doctor immediately if they experience a loss of visual acuity 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 is taking 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 sweat production.
• In cases of a history of drug or substance abuse, Ditropan may cause dependence on the active substance oxybutynin.

If any of the above conditions 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

This medicine 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

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Caution should be exercised when taking the following medicines with Ditropan:

• other anticholinergic medicines, such as amantadine (used to treat influenza and Parkinson's disease),
• other anticholinergic medicines 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-based 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 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 enhance the feeling of drowsiness caused by anticholinergic medicines, such as oxybutynin.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

Pregnancy

Ditropan may be used during pregnancy only if its use is absolutely necessary. The attending physician 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 these symptoms occur, the patient should not drive vehicles, operate machines, or perform potentially hazardous activities.

Ditropan contains lactose

If the doctor has determined that the patient has an intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Ditropan

This medicine should always be taken as directed by the doctor. If there are any doubts, the patient should consult their doctor.

The tablet can be divided into equal doses.

Dosage

The exact dose will be determined individually by the doctor, although the following doses are generally recommended.

Adults

The usual recommended dose is 1 Ditropan tablet 2 to 3 times a day. The maximum dose should not be exceeded - 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 Ditropan tablet 2 times a day. The dose can then be increased to 1 tablet 2 to 3 times a day.

The maximum dose should not be exceeded - 3 tablets per day.

If the patient feels that the effect of Ditropan is too strong or too weak, they should consult their doctor.

Method of administration

The tablets are intended for oral use. They have an unpleasant taste and should be swallowed with a glass of water.

Taking a higher dose of Ditropan than recommended

Symptoms of overdose:

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

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

If a higher dose of Ditropan than recommended is taken, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Ditropan

If a dose of Ditropan is missed, the patient should take it as soon as possible, unless it is almost time for the next dose. A double dose should not be taken to make up for the missed dose. If there are any doubts, the patient should consult their doctor.

Stopping treatment with Ditropan

If the patient has any further doubts about taking this medicine, they should consult their 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, consciousness disorders (disorientation), dry eyes, urinary retention, flushing of the face, rapid or irregular heartbeat.

Uncommon(less than 1 in 1,000 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, excitement, 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, glaucoma, mydriasis, hypersensitivity to light, reduced sweat production, 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 any side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. 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.

Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Ditropan

The medicine should be stored 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 specified month.

Store at a temperature below 30°C.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ditropan contains

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

What Ditropan looks like and what the packaging contains

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

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

For more detailed information, the patient should contact 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:

Sanofi Winthrop Industrie

30 Avenue Gustave Eiffel

37100 Tours

France

Parallel importer:

InPharm Sp. z o.o.

ul. Strumykowa 28/11

03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.

ul. Chełmżyńska 249

04-458 Warsaw

Marketing authorization number in Spain, the country of export:971812.1

Parallel import authorization number: 346/24

Date of leaflet approval: 26.09.2024