Oxybutyninum aflofarm

Package leaflet: Information for the user

Oxybutyninum Aflofarm, 5 mg, tablets
oxybutynini hydrochloridum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Oxybutyninum Aflofarm is and what it is used for
2. What you need to know before taking Oxybutyninum Aflofarm
3. How to take Oxybutyninum Aflofarm
4. Possible side effects
5. How to store Oxybutyninum Aflofarm
6. Contents of the pack and other information

1. What Oxybutyninum Aflofarm is and what it is used for

Oxybutyninum Aflofarm is available in tablet form and contains the active substance oxybutynine, which belongs to a group of medicines called anticholinergics. The medicine exerts a spasmolytic effect on the smooth muscles of the urinary bladder in patients with symptoms of unstable bladder. Oxybutyninum Aflofarm is indicated for the relief of symptoms of unstable bladder with voiding disorders in patients with neurogenic bladder - detrusor hyperreflexia (urgency, urinary incontinence, difficulty in passing urine).

Oxybutyninum Aflofarm 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 (frequent passage of large volumes of urine);
• nocturnal enuresis, when other treatment methods have not been effective.

2. Important information before taking Oxybutyninum Aflofarm

When not to take Oxybutyninum Aflofarm

• if the patient is allergic to oxybutynine hydrochloride 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, intestinal atony (cessation of intestinal peristalsis);
• in case of toxic megacolon;
• in case of severe ulcerative colitis;
• in case of myasthenia gravis (excessive, rapid muscle fatigue).

Warnings and precautions
Before starting treatment with Oxybutyninum Aflofarm, discuss this with your doctor or
pharmacist.

• Oxybutynine should be administered with caution in debilitated elderly patients, patients with Parkinson's disease, children, patients with autonomic neuropathy, patients with severe gastrointestinal motility disorders, and patients with impaired renal or hepatic function. Patients in these groups are at increased risk of adverse reactions following administration of the drug.
• Anticholinergic drugs should be used cautiously in elderly patients, as they may cause cognitive impairment.
• Gastrointestinal disorders: anticholinergic drugs may reduce gastrointestinal motility; therefore, they should be administered cautiously in patients with partial or complete intestinal obstruction, intestinal atony, or ulcerative colitis.
• Oxybutynine may exacerbate tachycardia (including hyperthyroidism, congestive heart failure, cardiac arrhythmias, coronary artery disease, and hypertension), cognitive disturbances, and symptoms of mild benign prostatic hyperplasia.
• Central nervous system (CNS) anticholinergic effects (e.g. hallucinations, agitation, disorientation, drowsiness) have been reported; patients should be monitored, especially during the first few months of therapy or after dose escalation; consider discontinuing treatment or reducing the dose if CNS anticholinergic effects occur.
• Oxybutynine may precipitate narrow-angle glaucoma; patients should therefore be informed of the need to contact a doctor immediately if they experience blurred vision or eye pain.
• Oxybutynine may reduce salivary secretion, which may lead to dental caries, periodontitis, or oral candidiasis.
• Extreme caution is required in patients with hiatal hernia associated with gastroesophageal reflux and/or those concurrently taking medications such as bisphosphonates, as anticholinergic drugs may cause or exacerbate esophagitis.
• Administration of oxybutynine during hot weather or in very warm environments may result in heat stroke due to decreased sweating.
• Oxybutynine dependence has been observed in patients with a history of drug or substance abuse. If any of the above conditions are present, inform your doctor before starting treatment.

Children and adolescents
The use of oxybutynine is not recommended in children under 5 years of age. The safety of oxybutynine has not been established in this age group.
Caution should be exercised when administering the drug to children over 5 years of age due to possible increased sensitivity to the drug's effects, particularly regarding adverse reactions affecting the nervous system and psychiatric disturbances.

Oxybutyninum Aflofarm with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Exercise caution when using the following drugs concomitantly with oxybutynine:

• other anticholinergic drugs, such as amantadine – used in the treatment of influenza and Parkinson's disease;

• other anticholinergic drugs used in the treatment of Parkinson's disease (e.g. biperiden, levodopa);

• antihistamines – used to treat allergy symptoms;

• antipsychotics – used in the treatment of psychiatric disorders, e.g. schizophrenia (phenothiazine derivatives, butyrophenone derivatives, clozapine);

• quinidine, digitalis glycosides – used in the treatment of cardiac arrhythmias;

• tricyclic antidepressants;

• atropine and related compounds, such as atropine-based antispasmodics;

• dipyridamole – a drug preventing blood clot formation.

• Due to reduced gastric motility, oxybutynine may affect the absorption of other drugs from the gastrointestinal tract; for example, it may increase the absorption of digoxin (used in the treatment of cardiac arrhythmias) and decrease the absorption of lidocaine (used for local anesthesia), paracetamol (analgesic), lithium salts (used in the treatment of bipolar affective disorder), tetracyclines (antibiotics), phenylbutazone (anti-inflammatory drug), sulfamethoxazole, cotrimoxazole (antibiotics), and drugs with prolonged release.

• Oxybutynine is metabolized by cytochrome P450 isoenzyme CYP3A4. Concomitant use of CYP3A4 inhibitors (e.g. itraconazole, ketoconazole – antifungal agents) may inhibit oxybutynine metabolism and increase its effects.

• Oxybutynine may reduce the efficacy of drugs that enhance gastrointestinal motility (e.g. itopride).

Concomitant use of oxybutynine with cholinesterase inhibitors may reduce the effectiveness of cholinesterase inhibitors.

Oxybutyninum Aflofarm with food and alcohol
Food does not affect the absorption of the drug from the gastrointestinal tract.
Alcohol may intensify drowsiness caused by anticholinergic drugs such as Oxybutyninum Aflofarm.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Oxybutynine may be used during pregnancy only if absolutely necessary.
Small amounts of oxybutynine pass into human milk. The use of the drug during breastfeeding is not recommended.

Driving and operating machinery
Oxybutynine may cause drowsiness and blurred vision. If these symptoms occur, driving, operating machinery, or performing potentially hazardous activities is not recommended.

Oxybutyninum Aflofarm contains lactose
The medicine contains 149.2 mg of lactose per tablet.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking the medicine.

3. How to take Oxybutyninum Aflofarm

This medicine should always be taken as directed by the physician. In case of doubt, consult your
doctor.
Use in adults
The usual recommended dose is 1 tablet 2 to 3 times daily. Do not exceed the maximum dose of
4 tablets per day.
Use in elderly patients (including frail elderly patients)
2.5 mg (half a tablet) twice daily. The dose may be increased to 5 mg (1 tablet) twice daily
to achieve an appropriate clinical response, provided the medicine is well tolerated.
Use in children under 5 years of age
Use of this medicine is not recommended.
Use in children over 5 years of age
Usually, 1 tablet twice daily is recommended. The dose may then be increased to
1 tablet 3 times daily.
Do not exceed the maximum dose of 3 tablets per day.
The tablet may be divided into equal doses.
Taking more Oxybutyninum Aflofarm than recommended
Symptoms of oxybutynin overdose include: psychiatric disturbances (anxiety, agitation up to
psychotic behaviour), circulatory disturbances (flushing, decreased blood pressure, circulatory
failure), respiratory failure, and in severe cases, paralysis and coma.
If more than the recommended dose has been taken, consult a doctor immediately.
In case of severe overdose, the patient should be hospitalized and cardiovascular function monitored.
Missed dose of Oxybutyninum Aflofarm
If a dose is missed, take it as soon as possible, unless it is almost time for the next dose.
Do not take a double dose or doses in close succession to make up for a missed dose.
In case of doubt, consult your doctor.
Stopping Oxybutyninum Aflofarm
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should contact a doctor immediately or go to the nearest hospital emergency department
if the patient experiences any of the following symptoms, as urgent medical care may be required:

• allergic reactions such as angioedema (an allergic reaction causing swelling and/or puffiness mainly affecting the face, tongue, throat and limbs), rash, urticaria (localized skin lesions characterized by blisters and erythema).

The following adverse reactions may also occur during treatment with this medicine:
Very common (affects more than 1 in 10 people):

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

Common (affects 1 to 10 in 100 people):

• diarrhoea,
• vomiting,
• disturbances in consciousness (disorientation),
• reduced tear production,
• urinary retention,
• sudden flushing,
• strong heartbeat which may be fast or irregular.

Rare (affects 1 to 10 in 10,000 people):

• discomfort in the abdominal cavity,
• loss of appetite,
• decreased appetite,
• difficulty swallowing.

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

• urinary tract infections,
• gastroesophageal reflux,
• pseudo-obstruction in patients at increased risk (elderly patients, patients with constipation, and patients treated with other medicines reducing intestinal peristalsis),
• cognitive disorders in elderly patients,
• convulsions,
• excitation,
• anxiety,
• hallucinations,
• nightmares,
• paranoia,
• symptoms of depression,
• dependence (in patients with a history of drug abuse),
• tachycardia (increased heart rate),
• cardiac arrhythmias,
• heat stroke,
• increased intraocular pressure,
• acute narrow-angle glaucoma,
• pupillary dilation,
• photophobia,
• decreased sweating,
• hypersensitivity.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store the medicine Oxybutyninum Aflofarm

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What Oxybutyninum Aflofarm contains

• The active substance is oxybutynin hydrochloride in a dose of 5 mg.
• The other ingredients are: monohydrate lactose, lactose, microcrystalline cellulose, magnesium stearate.

What Oxybutyninum Aflofarm looks like and contents of the pack
The medicine is in the form of a round, biconvex, uncoated tablet of white colour with a single-sided
division line.
The tablets are packed in blisters made of PVC/PVDC/Aluminium foil and placed in a cardboard box.
The packaging contains 10, 30 or 60 tablets.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. (42) 22-53-100
Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów