Ditropan

Package leaflet: Information for the patient

Ditropan 5 mg tablets

oxybutynin chloride
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Ditropan is and what it is used for
2. What you need to know 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 Ditropan is and what it is used for

Ditropan contains oxybutynin, which belongs to a class of medicines called "urinary antispasmodics".
Ditropan is indicated:

• for the treatment of certain urinary problems (micturition disorders due to overactive bladder muscle, such as unstable bladder and neurogenic bladder),
• difficulty in controlling urination (impaired micturition control) in elderly patients, in those with cerebrovascular disorders (neurovascular deterioration of arteriosclerotic origin), or in patients suffering from diabetes,
• nocturnal incontinence (enuresis),
• involuntary incontinence with or without urge to urinate,
• frequent passage of small amounts of urine (non-obstructive pollakiuria) during day and night,
• persistent urge to urinate (tenesmus),
• bladder spasms,
• in combination with other medicines for the treatment of cystitis of various origins (including radiation-induced cystitis) and for the treatment of certain prostate inflammations (chronic prostatitis),
• for psychosomatic urinary disorders, such as frequent passage of small amounts of urine (pollakiuria) and severe pain in the lower abdomen (neuro-irritable bladder pain). Ditropan is indicated in children above 5 years of age for:
• difficulty in controlling urination (urinary incontinence),
• urgent and frequent need to urinate due to bladder abnormalities (conditions of unstable bladder due to idiopathic bladder overactivity or neurogenic bladder disorders, detrusor overactivity),
• loss of urine during sleep (nocturnal enuresis associated with detrusor overactivity), in combination with non-pharmacological treatments and after failure of other therapies.

2. What you need to know before taking Ditropan

Do not take Ditropan

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if you suffer from certain urinary tract diseases (obstructive uropathy that may lead to urinary retention),
• if you suffer from partial or complete blockage (obstruction) of the stomach or intestine (gastrointestinal tract),
• if you suffer from severe intestinal problems (intestinal atony, paralytic ileus, megacolon, toxic megacolon),
• if you suffer from a severe inflammatory bowel disease called "ulcerative colitis",
• if you suffer from severe muscle weakness (myasthenia gravis),
• if you suffer from increased pressure in the eye (narrow-angle glaucoma or shallow anterior chamber),
• if you have circulatory and heart problems associated with acute bleeding (unstable cardiovascular conditions).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ditropan.
Ditropan should be used with caution:

• in frail elderly patients and in children, as these patients may be more sensitive to the undesirable effects of this medicine,
• if you have a nervous system disorder (neuropathy of the autonomic nervous system), such as Parkinson's disease,
• if you have severe gastrointestinal problems with impaired liver function or kidney damage,
• if you are elderly, as it may cause problems with learning and memory (cognitive decline),
• if you have stomach or intestinal problems such as blockage of the stomach or intestine (gastrointestinal obstruction), reduced intestinal function (intestinal atony), or an inflammatory bowel disease called "ulcerative colitis". If you suffer from "ulcerative colitis", Ditropan could cause a complete loss of intestinal function and lead to serious complications (paralytic ileus, triggering or worsening of toxic megacolon),
• if you suffer from increased heart rate (tachycardia), overactive thyroid (hyperthyroidism), heart diseases (coronary heart disease, congestive heart failure), irregular heart rhythm (cardiac arrhythmia), high blood pressure (hypertension), disturbances in attention, memory, perception, and reasoning (cognitive disorders), or disorders related to a prostate condition called "benign prostatic hyperplasia",
• if you suffer from a hiatal hernia, gastroesophageal reflux, and/or if you are taking medicines (such as bisphosphonates) that may cause or worsen esophageal inflammation (esophagitis).

If you take Ditropan when the ambient temperature is high, you may experience heat stroke
(fever and collapse due to reduced sweating).
Diarrhea may be an early sign of intestinal blockage (incomplete intestinal obstruction),
especially if you have undergone an "ileostomy" or "colostomy". In such cases,
treatment with Ditropan is not appropriate and could be harmful.
Your doctor will monitor you closely, especially during the first few months after starting therapy or after
an increase in dose, because this medicine may affect the Nervous System (anticholinergic effects),
for example: hallucinations, agitation, confusion, drowsiness.
Your doctor may consider stopping the treatment or reducing the dose if you experience these effects (central nervous system anticholinergic effects).
Ditropan may increase intraocular pressure (narrow-angle glaucoma); contact your doctor immediately if you experience sudden loss of visual detail (decreased visual acuity) or eye pain.
Ditropan may reduce saliva production, which can lead to dental caries, weakening of the supporting tissues of the teeth (periodontitis), or mouth infections (oral candidiasis).
Dependence on Ditropan has been observed in patients with a history of substance or medication abuse.

Children
The use of Ditropan is not recommended in children under 5 years of age.
In children over 5 years of age, Ditropan should be used with caution, as these patients may be more sensitive to the undesirable effects of this medicine, particularly those affecting the Nervous System and psychiatric reactions. (See possible side effects.)

Other medicines and Ditropan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effects of Ditropan may be influenced by, or may influence, the following medicines:

• medicines belonging to the same class as Ditropan (anticholinergics), as they may increase certain effects (anticholinergic effects) of Ditropan,
• medicines with the same activity as Ditropan (anticholinergic activity), such as amantadine and other antiparkinsonian medicines (biperiden, levodopa), antihistamines (used for allergies), antipsychotics (used for mental disorders) such as phenothiazines, butyrophenones, clozapine, medicines used for certain heart conditions (quinidine, digitalis), medicines used for depression (tricyclic antidepressants), the medicine called "atropine" and related compounds such as "atropine-like antispasmodics" and "dipyridamole",
• medicines that inhibit a substance responsible for the metabolism of Ditropan in the body (cytochrome P450 isoenzyme CYP3A4), as they may inhibit the metabolism of Ditropan and increase exposure to this medicine,
• medicines that stimulate intestinal motility (prokinetics), as Ditropan may block the effect of these medicines,
• medicines that inhibit a body substance called "cholinesterase" (cholinesterase inhibitors), as Ditropan may reduce their action.

Ditropan normally does not interfere with the following medicines: phenobarbital (used for seizures), phenytoin (used for epilepsy), warfarin (used for blood coagulation), phenylbutazone (used for inflammation), tolbutamide (used for diabetes).
By reducing gastric motility, Ditropan may affect the absorption of other medicines.

Ditropan and alcohol
Do not consume alcohol with Ditropan, as alcohol may increase the drowsiness caused by Ditropan.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take Ditropan during pregnancy unless your doctor considers it strictly necessary.

Breastfeeding
Ditropan may pass into breast milk.
Do not use Ditropan if you are breastfeeding.

Driving and using machines
Ditropan may cause drowsiness or blurred vision. Take this into account if you need to drive, operate machinery, or perform hazardous tasks.

Important information about some excipients
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Ditropan

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use in adults:
The recommended dose is
1 tablet of 5 mg two or three times daily.
The maximum recommended dose is 1 tablet four times a day.
Use in children and adolescents
For children over 5 years of age:
The recommended dose is
1 tablet of 5 mg twice daily.
The maximum recommended dose is 1 tablet three times a day.
If you take more Ditropan than you should
If you take more Ditropan than you should, you may experience:

• an increase in adverse effects on the nervous system, such as: agitation, excitement up to psychotic behaviour,
• circulatory disturbances, such as flushing, decreased blood pressure and severe circulatory disorders (circulatory failure),
• severe respiratory problems (respiratory failure), paralysis and coma.

If you experience any of these symptoms, consult your doctor immediately, who will provide appropriate treatment.
In case of accidental ingestion/overdose of Ditropan, contact your doctor immediately or go to the nearest hospital.
If you forget to take Ditropan
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about the use of Ditropan, consult your doctor or pharmacist.

4. Possible side effects

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

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

• constipation,
• nausea,
• dry mouth,
• dizziness,
• headache,
• drowsiness,
• dry skin,
• blurred vision.

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

• diarrhoea,
• vomiting,
• confusion,
• dry eyes,
• problems when urinating or urinary retention,
• hot flushes,
• flushing,
• strong heartbeat, which may be fast or irregular.

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

• abdominal discomfort,
• anorexia,
• decreased appetite,
• swallowing difficulties (dysphagia).

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• urinary tract infection,
• gastroesophageal reflux,
• sensation of bloating,
• pseudo-intestinal obstruction in at-risk individuals (elderly or patients with constipation and treated with other medicines that reduce intestinal function),
• agitation,
• anxiety,
• hallucinations,
• nightmares,
• paranoia,
• cognitive disorders in the elderly,
• depressive disorders,
• oxibutynin dependence in patients with a history of substance or medicine abuse,
• cognitive disorders,
• seizures,
• vertigo,
• insomnia,
• increased heart rate (tachycardia),
• changes in heart rhythm (arrhythmia),
• heat stroke,
• blurred vision,
• pupil dilation,
• increased eye pressure (intraocular pressure, closed-angle glaucoma),
• paralysis of the ciliary muscle (cycloplegia),
• allergic or intolerance reactions (idiosyncratic reactions) of the skin to medicines such as urticaria, skin rashes, swelling of the face, hands and feet, lips, tongue or throat (angioedema), or other skin disorders,
• abnormally reduced sweating (hypohidrosis),
• generalized allergic reactions (hypersensitivity),
• impotence,
• cessation of lactation,
• weakness,
• nosebleeds (epistaxis),
• muscle disorders presenting as muscle weakness, muscle pain (myalgia) and/or muscle spasms.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide 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 pack after "Exp". The expiry date refers to the last day of that month.
Store below 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ditropan contains

• The active substance is oxybutynin chloride. Each tablet contains 5 mg of oxybutynin chloride.
• The other ingredients are: anhydrous lactose, microcrystalline cellulose, calcium stearate.

Description of the appearance of Ditropan and contents of the pack
Ditropan is available as tablets.

• Carton pack containing 30 tablets of 5 mg

Marketing Authorization Holder
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany
Manufacturer
Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel, Tours (France)