Label: information for the user

Ditropan5 mg tablets

oxibutinina hydrochloride

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Ditropan belongs to a group of medications called urinary antispasmodics.

This medication acts on the contractions of the bladder and delays the desire to urinate. It may be used to treat some types of incontinence and other urinary problems.

Ditropan may be used in children aged 5 years or older to treat:

• unintentional urine loss (urinary incontinence)
• an increased need or urgency to urinate
• unintentional urine loss at night, in combination with non-pharmacological treatment, when other treatments have not worked

Read carefully the following sections:

Do not take Ditropan

• if you are allergic to oxybutynin hydrochloride or any of the other ingredients of this medication (listed in section 6).
• if you have any urinary tract disease with possible urinary retention.
• if you have obstructive gastrointestinal disorders, intestinal atony (laxity) or paralytic ileus (functional intestinal obstruction).
• if you have toxic megacolon (persistent abnormal 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 shallow anterior chamber of the eye.
• if you have increased urination frequency and nocturia due to kidney or heart problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ditropan.

Be especially careful:

• 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 urinary retention, as it could worsen and cause urinary retention.
• if you have gastrointestinal disorders, as Ditropan may decrease gastrointestinal motility.
• if you have hiatal hernia/reflux esophagitis and/or are taking medications such as bisphosphonates, as they may cause or worsen esophagitis.
• if you have a urinary tract infection, as you should establish appropriate antibacterial treatment.
• if you are taking other anticholinergic medications.
• because Ditropan may worsen cognitive disorders, symptoms of benign prostatic hyperplasia (prostate enlargement) and tachycardia (increased heart rate). Therefore, use with caution in cases of hyperthyroidism (overactive thyroid gland), congestive heart failure, cardiac arrhythmia, coronary heart 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 drowsiness, and the consumption of alcohol may also increase drowsiness.
• because Ditropan may cause angle-closure glaucoma. Therefore, if you experience sudden loss of visual acuity or eye pain, contact your doctor immediately.
• because Ditropan may reduce saliva production, leading to tooth decay, gum inflammation, or oral fungal infections.
• if you are in a hot place or have a fever, you may experience heat exhaustion due to decreased sweating caused by this medication.

Older patients

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

Children

Children under 5 years old

This medication is not recommended for children under 5 years old.

Children 5 years old and older

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

Other medications and Ditropan

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Ditropan may affect the absorption of concomitantly administered medications.

Especially, inform your doctor if you are currently using 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 to treat Parkinson's disease)
• quinidine (used to treat heart problems)
• certains medications used to treat 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 gastrointestinal motility)
• bisphosphonates (used to treat osteoporosis)
• digitalis (used to stimulate the heart)

Ditropan and alcohol

The simultaneous use of Ditropan and alcohol may increase drowsiness.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Lactation

Ditropan passes into breast milk. Do not use this medication during lactation. If your doctor considers it necessary, breastfeeding will be interrupted.

Driving and operating machinery

Ditropan may cause drowsiness or blurred vision, so you should exercise caution when performing activities that require mental alertness, such as driving, operating machinery, or performing hazardous work while using this medication.

Abuse and dependence

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

Ditropan contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Ditropan contains sodium

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

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

Dosage

Adults

The recommended dose for adults is 3 tablets (15 mg of oxybutynin hydrochloride) per day, divided into three doses, although it may also be taken all at once at the end of the day for nighttime urinary problems. The dose may 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 in children under 5 years of age have not yet been established.

Children 5 years of age or older

A dose of 2 tablets (10 mg of oxybutynin hydrochloride) per day is recommended. At least 4 hours should pass between doses.

Older adults

In older adults, a dose of 2 tablets per day is usually sufficient.

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

Administration form

Remember to take your medication. Ditropan should be taken regularly as directed by your doctor throughout the treatment.

Ditropan is only indicated for oral use.

The tablet should be swallowed whole or may 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 too much Ditropan

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

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

If you forget to take Ditropan

In case of missed dose, wait for the next one. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Ditropan

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

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

Weakness, diarrhea, vomiting, taste disorder (disturbance of the sense of taste), flatulence (gas), states of confusion, atrial arrhythmia, nodal arrhythmia, supraventricular extrasystole, strong and irregular heartbeats, dry eyes, urinary retention, hematuria (presence of 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 hemorrhage), vulvovaginitis (inflammation of the vulva and vagina).

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

Phototoxicity (sensitivity to light), thrombocytopenia (reduction in the number of platelets).

Unknown frequency (cannot be estimated from available data):

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

Reporting of side effects

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

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

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the tablets have a different appearance (for example, if they change color).

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ditropan

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

Appearance of the product and content of the packaging

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 groove on one face and the engraving “OXB5” on the opposite face.

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Responsible for manufacturing

Sanofi Winthrop Industrie

Avenue Gustave Eiffel, 30-36

37100Tours

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

Last review date of this leaflet: June 2023.

Other sources of information

The detailed informationof this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.