DITROPAN 5 mg TABLETS

2. What you need to know before you take Ditropan

Read the following sections carefully:

Do not take Ditropan

• if you are allergic to oxybutynin hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you have any urinary tract disease with possible urinary retention.
• if you have gastrointestinal disorders of an obstructive type, intestinal atony (laxity) or paralytic ileus (functional intestinal obstruction).
• if you have toxic megacolon (abnormal constant dilation of the large intestine).
• if you have severe ulcerative colitis (a disease that causes chronic diarrhea).
• if you have myasthenia gravis (muscle weakness).
• if you have glaucoma (increased eye pressure) or a shallow anterior chamber of the eye.
• if you have increased urinary frequency and urinate more at night due to kidney or heart problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ditropan.

Special care should be taken:

• if you have Parkinson's disease because you have a higher risk of adverse reactions to the product.
• if you have autonomic neuropathy (neurological disease).
• if you have any intestinal disease (including intestinal obstruction), liver or kidney problems.
• if you have clinically significant vesical obstruction, as it may worsen and cause urinary retention.
• if you have gastrointestinal disorders, as Ditropan may decrease gastrointestinal motility.
• if you have hiatal hernia/gastroesophageal reflux and/or are taking medications such as bisphosphonates, as they may cause or worsen esophagitis.
• if you have a urinary tract infection, as appropriate antibacterial treatment should be instituted.
• if you are taking other anticholinergic medications.
• because Ditropan may worsen cognitive disorders, symptoms of prostatic hyperplasia (enlargement of the prostate) and tachycardia (increased heart rate). Therefore, it should be used with caution in cases of hyperthyroidism (overactive thyroid gland), congestive heart failure, cardiac arrhythmia (heart rhythm disorders), coronary artery disease, and hypertension (high blood pressure).
• because Ditropan may produce anticholinergic effects on the nervous system, e.g., hallucinations, agitation, sleep disorders, confusion, blurred vision, and somnolence, and alcohol consumption may also increase somnolence.
• because Ditropan may cause angle-closure glaucoma. If you experience sudden loss of visual acuity or eye pain, contact a doctor immediately.
• because Ditropan may reduce saliva production, leading to the formation of dental caries, gum inflammation, or fungal infections in the mouth.
• if you are in a place with very high temperatures or have a fever, you may feel heat exhaustion due to decreased sweating caused by this medication.

Elderly patients

Ditropan should be used with caution in elderly patients because they have a higher risk of experiencing adverse reactions and due to the risk of cognitive decline.

Children

Children under 5 years of age

The use of this medication is not recommended in children under 5 years of age.

Children aged 5 years and older

Children in this age group have a higher risk of experiencing adverse reactions to the product.

Other medicines and Ditropan

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Ditropan may affect the absorption of concomitantly administered medications.

Especially, inform your doctor if you are currently taking any of the following medications:

• phenothiazines, butyrophenones, clozapine (used in mental illnesses)
• medications used to treat dementia, e.g., donepezil, rivastigmine, galantamine, or tacrine (cholinesterase inhibitors)
• tricyclic antidepressants (used to treat depression)
• antihistamines (used to treat allergies)
• amantadine, biperiden, levodopa (used for Parkinson's disease)
• quinidine (used to treat heart problems)
• certain medications used for fungal infections (e.g., ketoconazole and fluconazole) or certain antibiotics such as erythromycin
• atropine and related compounds (used to prevent muscle contractions)
• other anticholinergic medications
• dipyridamole (used to prevent thrombus formation)
• prokinetics (used to increase digestive tract movements)
• bisphosphonates (used to treat osteoporosis)
• digitalis (used to stimulate the heart)

Ditropan with alcohol

The simultaneous use of Ditropan and alcohol may increase somnolence.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

If you are pregnant or suspect you may be pregnant while taking Ditropan, you must inform your doctor immediately. It is recommended not to take this medicine during pregnancy, unless your doctor considers it necessary.

Breastfeeding

Ditropan passes into breast milk. The use of this medicine is not recommended during breastfeeding. If your doctor considers it necessary, breastfeeding will be interrupted.

Driving and using machines

Ditropan causes somnolence or blurred vision, so you should be careful when performing activities that require a state of mental alertness, such as driving, operating machinery, or performing hazardous work while using this medicine.

Abuse and dependence

Dependence on oxybutynin has been observed in patients with a history of substance abuse or dependence (see section 4).

Ditropan contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Ditropan contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per unit dose; it is essentially "sodium-free".

3. How to take Ditropan

Follow the administration instructions of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

Adults

The recommended dose in adults is 3 tablets (15 mg of oxybutynin hydrochloride) per day, divided into three doses, although they can also be taken together at the end of the day in case of nocturnal urinary problems. The dose can be increased to 4 tablets (20 mg of oxybutynin hydrochloride) per day and also reduced to a lower maintenance dose.

Use in children and adolescents

Children under 5 years of age

The safety and efficacy of Ditropan have not been established in children under 5 years of age.

Children aged 5 years and older

A dose of 2 tablets (10 mg of oxybutynin hydrochloride) per day is recommended. There should be at least 4 hours between each dose.

Elderly patients

In elderly patients, a dose of 2 tablets per day is usually sufficient.

If you think the effect of Ditropan is too strong or too weak, consult your doctor or pharmacist.

Method of administration

Remember to take your medicine. Ditropan should be taken regularly according to your doctor's instructions throughout the treatment.

Ditropan is indicated for oral use only.

The tablet should be swallowed whole or can be broken and taken with a large amount of liquid to ensure passage through the esophagus. The taste of the tablets is not pleasant.

If you take more Ditropan than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you have taken too much Ditropan, you may experience some symptoms, e.g., restlessness, excitement, psychotic behavior, flushing, decreased blood pressure, respiratory problems, paralysis, and coma.

If you forget to take Ditropan

In case of forgetting a dose, wait for the next one. Do not take a double dose to make up for the forgotten doses.

If you stop taking Ditropan

If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Very common side effects (may affect more than 1 in 10 people):

Dry mouth, constipation, nausea, dizziness, somnolence, blurred vision, difficulty urinating, dry skin, headache.

Common side effects (may affect up to 1 in 10 people):

Asthenia, diarrhea, vomiting, dysgeusia (disorder of taste), flatulence (gas), confusion, atrial arrhythmia, nodal arrhythmia, supraventricular extrasystole, strong heartbeats that can be rapid or irregular, dry eyes, urinary retention, hematuria (blood in the urine), nocturia (need to urinate at night), pyuria (presence of leukocytes in the urine), pharyngitis (inflammation of the pharynx), skin redness.

Uncommon side effects (may affect up to 1 in 100 people):

Abdominal discomfort, anorexia (loss of appetite), decreased appetite, dysphagia (difficulty swallowing), cough, epistaxis (nasal bleeding), vulvovaginitis (inflammation of the vulva and vagina).

Rare side effects (may affect up to 1 in 1,000 people):

Photosensitivity (sensitivity to light), thrombocytopenia (reduction in platelet count).

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

Gastroesophageal reflux, gastritis, pseudo-obstruction in at-risk patients (in elderly patients or patients with constipation and being treated with other medications that decrease intestinal motility), hallucinations, agitation, convulsions, anxiety, nightmares, paranoia (distrust, delusions), cognitive disorders, especially in elderly patients, symptoms of depression, and dependence on oxybutynin (in patients with a history of substance abuse or dependence), tachycardia (increased heart rate), arrhythmia, angle-closure glaucoma (increased intraocular pressure), mydriasis (pupil dilation), intraocular hypertension, urinary tract infection, adverse reactions such as generalized cutaneous erythema, urticaria, angioedema (generalized inflammation of feet, hands, throat, lips, and respiratory tract), skin rash, hypohidrosis (decreased sweat production), heat stroke, hypersensitivity, muscular disorders (pain, cramps, or weakness).

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Ditropan

Keep this medicine out of the sight and reach of children.

Store in the original package. Store below 30 °C.

Do not use this medicine after the expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

Do not use this medicine if you notice that the tablets have a different appearance (e.g., if they change color).

Medicines should not be disposed of via wastewater or household waste. Return the packages and medicines you no longer need to the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ditropan

• The active ingredient is oxybutynin hydrochloride. Each tablet contains 5 mg of oxybutynin hydrochloride.
• The other ingredients (excipients) are: lactose, aluminum lake indigo (E132), microcrystalline cellulose, and calcium stearate.

Appearance of the product and contents of the pack

Ditropan is presented in the form of tablets. Each package contains 60 tablets. The tablets are round, biconvex, light blue in color with a central score line on one face and the engraving "OXB5" on the opposite face.

Marketing authorization holder and manufacturer

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

Sanofi Winthrop Industrie

Avenue Gustave Eiffel, 30-36

37100 Tours

France

or

Fidelio Healthcare Limburg GmbH

Mundipharmastraße 2

65549 Limburg an der Lahn

Germany

Local representative

Laboratorios Rubió, S.A.

Industria, 29

Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Date of the last revision of this leaflet: June 2023.

Other sources of information

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.