Ditropan

Package Leaflet: Information for the User

Ditropan, 5 mg, Tablets

Oxybutynin Hydrochloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 pack 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 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-drug therapy when other treatment methods have not been effective.

2. Important information before taking Ditropan

When not to take Ditropan:

• if you are 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, intestinal atony,
• 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 you have Parkinson's disease, autonomic nervous system neuropathy, and/or kidney or liver dysfunction. This is due to the increased risk of side effects after administration of the medicinal product.
• Ditropan may decrease 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. Your doctor may consider monitoring your 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 decrease saliva production, which can lead to tooth decay, periodontal disease, or oral candidiasis.
• This medicine should be used with caution if you have a hiatal hernia with accompanying gastroesophageal reflux and/or are 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 decreased sweat production.
• 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 conditions apply to you, inform your 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
Do not give this medicine to a child without consulting 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 heart rhythm disorders),
• 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 decreased gastric motility, Ditropan may affect the absorption of other medicines from the gastrointestinal tract, e.g., may increase the absorption of digoxin (used to treat heart rhythm disorders) and decrease 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 plan to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
Ditropan should only be used during pregnancy if absolutely necessary. Your 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, talk to 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, contact your doctor or pharmacist 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 the missed dose. If you are unsure, consult your doctor.

Stopping treatment with Ditropan

If you have any further questions about taking this medicine, ask 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, consciousness disorders (disorientation), dry eyes, urinary retention, flushing, 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, glaucoma, mydriasis, decreased 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 you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Urzad Rejestracji Produktow Leczniczych, Wyrobów Medycznych i Produktow Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather 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 the original packaging. Store 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 anhydrous, microcrystalline cellulose, calcium stearate, indigo carmine.

What Ditropan looks like and contents of the pack

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/Al blisters in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
e-mail: [email protected]
Manufacturer
Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel
37100 Tours
France
Fidelio Healthcare Limburg GmbH
Mundipharmastraße 2
65549 Limburg an der Lahn
Germany

Date of last revision of the leaflet: 07/2023