Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Ditropan, 5 mg, tablets
Oxybutynini hydrochloridum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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 pack 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 exerts 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 and voiding disorders in patients with neurogenic bladder - detrusor hyperreflexia (symptoms such as urgent need to urinate, 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, when urinary retention may occur,
in case of partial or complete intestinal obstruction, paralytic ileus, or 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 following administration of the medicinal product.
Ditropan may reduce gastrointestinal motility. Therefore, caution is advised in patients with partial or complete intestinal obstruction, intestinal atony, or ulcer游戏副本

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. This dose may be increased to 1 tablet twice daily to achieve an appropriate 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 and should therefore be taken with a glass of water.

Taking more Ditropan than recommended
Symptoms of overdose:
anxiety, agitation, psychiatric disturbances, circulatory disturbances (flushing, decreased arterial blood pressure, circulatory failure), respiratory failure, and in severe cases paralysis and coma.
In case of severe overdose, hospitalize the patient and monitor cardiovascular function.
If you take more than the recommended dose, 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 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 (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,
facial flushing, strong heartbeat which may be fast or irregular.
Uncommon (occurs in less than 1 in 1,000 people):
feeling of discomfort in the abdominal cavity, loss of appetite, decreased appetite, difficulty swallowing.
Frequency not known (cannot be estimated based on available data):
urinary tract infections, gastroesophageal reflux, pseudointestinal obstruction in patients in the high-risk group (elderly patients or patients with constipation and treated with other medicines reducing intestinal peristalsis), cognitive disorders especially in elderly patients, convulsions, somnolence, agitation, anxiety, hallucinations, nightmares, paranoia, symptoms of depression, dependence on oxybutynin (in patients with history of drug abuse), tachycardia (increased heart rate), cardiac arrhythmias, heat stroke, increased intraocular pressure, development of narrow-angle glaucoma, pupil dilation, photophobia, decreased sweating, allergic reactions such as: rash, urticaria (local skin lesions in the form of blisters and erythema), angioedema (an allergic reaction manifested by swelling and (or) puffiness, mainly in the face and limbs), hypersensitivity, nosebleeds, muscle 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, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects allows collecting further information on the safety of using 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.
Store in the original packaging to protect from light.
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 package 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, aluminium lake.

What Ditropan looks like and contents of the pack
Light blue, round, biconvex tablets, embossed with the code "OXB5" on one side and a break line on the other.
Packaged in PVC/Aluminium blisters, pack size: 30 tablets, contained in a cardboard carton.
For further information, please contact the responsible party or the parallel importer.
Responsible party in Portugal, country of export:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer:
Sanofi Winthrop Industrie
30-36, Avenue Gustave Eiffel
37100 Tours, France
Laboratórios Vitória, S.A.
Rua Elias Garcia, 28 - Venda Nova
2700-327 Amadora, Portugal
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 authorization number in Portugal, country of export: 8782516
Parallel import licence number: 93/25