DITROPAN 5 мг КоATED таблетки

Содержание инструкции

1. Ditropan 5 mg tablets
   1. What is Ditropan and what is it 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

Ditropan 5 mg tablets

oxibutynin hydrochloride

Read this leaflet carefully before you start to use this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take Ditropan
• 3. How to use 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 contains oxybutynin which belongs to a class of medicines called “antispasmodics
urinary”.
Ditropan is indicated:

• for the treatment of some urinary problems (urinary disturbances resulting from detrusor bladder hyperactivity, such as unstable bladder and neurogenic bladder),
• difficulty in retaining urine (loss of urinary control) if you are an elderly person, with problems with the blood vessels of the brain (neuro-vascular deterioration based on arteriosclerosis), or if you suffer from diabetes,
• nocturnal incontinence (enuresis),
• involuntary incontinence with or without urge to urinate,
• very frequent emission of small amounts of urine (non-obstructive pollakiuria) during the day and night,
• constant feeling of needing to urinate (tenesmus),
• bladder spasms,
• in association with other medicines for the treatment of cystitis of various origins (even after radiation therapy) and for the treatment of some inflammations of the prostate (chronic prostatitis),
• for disorders of psychosomatic origin of urine production, such as frequent emission of small amounts of urine (pollakiuria) and severe pain in the lower abdomen (cystalgia based on neuro-erethism). Ditropan is indicated in children over 5 years of age for:
• difficulty in retaining urine (urinary incontinence),
• urgent and frequent need to urinate due to bladder alterations (conditions of unstable bladder due to idiopathic detrusor hyperactivity or neurogenic bladder disorders, detrusor hyperactivity),
• loss of urine during sleep (nocturnal enuresis associated with detrusor hyperactivity) associated with non-pharmacological treatments and after failure of other treatments.

2. What you need to know before taking Ditropan

Do not take Ditropan

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6),
• if you suffer from certain diseases of the urinary tract (uropathy due to obstruction which may precipitate into urinary retention),
• if you suffer from a blockage (obstruction) partial or total of the stomach or intestine (gastrointestinal tract),
• if you suffer from severe problems with the intestine (intestinal atony, paralytic ileus, mega-colon, toxic mega-colon),
• if you suffer from a severe inflammatory disease of the intestine called “ulcerative colitis”,
• if you suffer from severe muscle weakness (myasthenia gravis),
• if you suffer from high pressure in the eye (narrow-angle glaucoma or shallow anterior chamber),
• if you have problems with the circulatory and heart system in the presence of acute bleeding (unstable cardiovascular conditions).

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

• if it is for a weak elderly person and if it is for children because these patients may be more sensitive to the undesirable effects of this medicine,
• if you have a disease of the nervous system (neuropathy affecting the autonomic nervous system) such as Parkinson's disease,
• if you have serious problems with the functioning of the stomach and intestines (gastrointestinal) with impaired liver function or kidney damage,
• if you are an elderly person because it may cause problems with decreased learning and memory ability (cognitive impairment),
• if you have problems at the level of the stomach and intestines such as a blockage in the stomach or intestines (gastrointestinal obstruction), decreased functioning of the intestine (intestinal atony) and an inflammatory disease of the intestine called “ulcerative colitis”. If you suffer from “ulcerative colitis” Ditropan may cause a cancellation of the functioning of the intestine and lead to serious complications (paralytic ileus, trigger or worsen a toxic megacolon),
• if you suffer from an increased heart rate (tachycardia), excessive thyroid function (hyperthyroidism), heart disease (coronary heart disease, congestive heart failure), heart rhythm disturbances (cardiac arrhythmia), increased blood pressure (hypertension), attention, memory, perception and reasoning disorders (cognitive disorders) and disorders of a prostate disease called “prostate hypertrophy”,
• if you suffer from a stomach hernia (hiatal hernia), reflux (gastroesophageal reflux) and/or if you are taking medicines (such as bisphosphonates) that can cause or worsen inflammation of the esophagus (esophagitis).

If you take Ditropan when the ambient temperature is high, you may experience heatstroke
(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” operation. In this case, the
treatment with Ditropan is not appropriate and may be harmful.
The doctor will monitor you carefully, especially in the first few months after starting therapy or after
increasing the dose, because it may have effects on the Nervous System (anticholinergic effects),
for example: hallucinations, agitation, confusion, drowsiness.
The doctor may consider interrupting therapy or reducing the dose in
case you experience these effects (anticholinergic effects on the CNS).
Ditropan can cause an increase in eye pressure (narrow-angle glaucoma); contact
your doctor immediately if you have a sudden loss of the ability to see details
(decreased visual acuity) or have eye pain.
Ditropan can decrease saliva production, which can lead to tooth decay, weakening of
tooth support tissues (periodontitis) or mouth infections (oral candidiasis).
Dependence on Ditropan has been observed in patients with a history of substance or
drug 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 to the undesirable effects
on 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 influence the following medicines:

• medicines belonging to the same class as Ditropan (anticholinergics), because they may increase some effects (anticholinergic effects) of Ditropan,
• medicines that have the same activity as Ditropan (anticholinergic activity), such as amantadine and other anti-Parkinson's medicines (biperiden, levodopa), antihistamines (used for allergies), antipsychotics (used for mental disorders) such as phenothiazines, butyrophenones, clozapine, medicines used for some heart disorders (quinidine, digitalis), medicines used for depression (tricyclic antidepressants), a medicine called “atropine” and related compounds such as “atropinic antispasmodics” and “dipiridamol”,
• medicines that inhibit a substance responsible for the transformation of Ditropan in the body (cytochrome P450 isoenzyme CYP 3A4), because they may inhibit the transformation of Ditropan and increase exposure to this medicine,
• medicines that stimulate the functioning of the intestine (prokinetics), because Ditropan may block the effect of these medicines,
• medicines that inhibit a substance in the body called “cholinesterase” (cholinesterase inhibitors), because Ditropan may decrease their action.

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

Ditropan with alcohol
Do not drink alcohol together with Ditropan because alcohol can increase the drowsiness caused by Ditropan.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take Ditropan if you are pregnant, 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 can cause drowsiness or blurred vision, keep this in mind if you need to
drive vehicles, use machines or perform dangerous 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 following exactly the instructions of 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 a day.
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 a day.
The maximum recommended dose is 1 tablet three times a day.

If you use more Ditropan than you should
If you use more Ditropan than you should, you may experience:

• an increase in undesirable effects on the Nervous System such as agitation, excitement up to psychotic behavior,
• circulatory disorders, such as hot flashes, decreased blood pressure and severe circulatory alterations (circulatory failure),
• severe respiratory problems (respiratory failure), paralysis and coma.

If you should experience these disorders, consult your doctor who will administer the appropriate treatment.
In case of accidental ingestion/intake of an excessive dose of Ditropan, immediately notify
your doctor or go to the nearest hospital.

If you forget to take Ditropan
Do not take a double dose to make up for a missed 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 everybody 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 eye,
• problems when urinating or urinary retention ,
• hot flushes,
• redness,
• strong heartbeat that may be fast or irregular.

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

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

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

• urinary tract infection,
• gastro-oesophageal reflux,
• feeling of fullness,
• pseudo-obstruction of the intestine in people at risk (elderly or patients with constipation and treated with other medicines that decrease intestinal function),
• agitation,
• anxiety,
• hallucinations,
• nightmares,
• paranoia,
• cognitive impairment in the elderly,
• depressive disorders,
• dependence on oxibutynin in patients with a history of substance or medicine abuse,
• cognitive disorders,
• convulsions,
• vertigo,
• insomnia,
• increased heart rate (tachycardia),
• heart rhythm disturbances (arrhythmia),
• heatstroke,
• blurred vision,
• pupil dilation,
• increased eye pressure (intraocular hypertension, angle-closure glaucoma),
• paralysis of the ciliary muscle (cycloplegia),
• allergic or intolerance reactions (idiosyncrasies) of the skin to medicines such as hives, redness (rash), swelling of the face, hands and feet, lips, tongue or throat (angioedema) or other skin disorders,
• abnormally reduced sweating (hypohidrosis),
• generalised allergic reactions (hypersensitivity),
• impotence,
• suppression of lactation,
• weakness,
• nosebleeds (epistaxis),
• muscle conditions that manifest as muscle weakness, muscle pain (myalgia) and/or muscle spasms

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
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 that is stated on the pack after “Exp”. The expiry
date refers to the last day of that month.
Store at a temperature below 30 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ditropan contains

• The active ingredient is oxibutynin hydrochloride. One tablet contains 5 mg of oxibutynin hydrochloride.
• The other ingredients are :anhydrous lactose, microcrystalline cellulose, calcium stearate.

Description of the appearance of Ditropan and contents of the pack
Ditropan is presented in the form of tablets

• pack of 30 tablets containing 5 mg

Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Manufacturer
Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel, Tours (France)