Oxibutininum Aflofarm

Package Leaflet: Information for the Patient

Oxybutyninum Aflofarm, 5 mg, Tablets

Oxybutynin Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Oxybutyninum Aflofarm and what is it used for
• 2. Important information 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 is Oxybutyninum Aflofarm and what is it used for

Oxybutyninum Aflofarm is a tablet that contains the active substance oxybutynin, which belongs to the group of anticholinergic medicines. The medicine has a relaxing effect on the smooth muscles of the urinary bladder in patients with symptoms of urinary bladder instability. Oxybutyninum Aflofarm is indicated for the relief of symptoms of urinary bladder instability, with urinary incontinence in patients with neurogenic bladder - hyperreflexia of the detrusor muscle (urgency, incontinence, difficulty urinating). Oxybutyninum Aflofarm may be used in children aged 5 years and older for the treatment of:

• loss of bladder control (urinary incontinence);
• requent urination or sudden urge to urinate (frequent urination of large amounts 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 oxybutynin 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 obstruction of the urinary outflow, in case urinary retention may occur;
• in case of partial or complete intestinal obstruction, paralytic ileus, or atony of the intestines (cessation of peristaltic movements of the intestines);
• 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 to take Oxybutyninum Aflofarm, the patient should discuss it with their doctor or pharmacist.

• Oxybutynin should be administered with caution to frail elderly patients, patients with Parkinson's disease, children, patients with autonomic nervous system neuropathy, patients with severe gastrointestinal motility disorders, and patients with renal or hepatic impairment. Patients in these groups are at increased risk of adverse reactions to the medicine.
• Anticholinergic medicines should be administered with caution to elderly patients, as they may cause cognitive impairment.
• Gastrointestinal disorders: anticholinergic medicines may decrease gastrointestinal motility, so they should be administered with caution to patients with partial or complete intestinal obstruction, intestinal atony, or ulcerative colitis.
• Oxybutynin may exacerbate tachycardia (which can also lead to hyperthyroidism, congestive heart failure, arrhythmias, coronary artery disease, and hypertension), cognitive impairment, and symptoms of benign prostatic hyperplasia.
• Anticholinergic effects on the central nervous system (CNS) (e.g., hallucinations, agitation, disorientation, drowsiness) have been reported; it is recommended to monitor the patient's condition, especially during the first few months of therapy or after increasing the dose; consideration should be given to discontinuing treatment or reducing the dose in case of anticholinergic effects on the CNS.
• Oxybutynin may cause narrow-angle glaucoma, so patients should be informed of the need to contact their doctor immediately in case of vision loss or eye pain.
• Oxybutynin may decrease saliva production, which can lead to tooth decay, periodontal disease, or oral candidiasis.
• Particular caution should be exercised in patients with hiatal hernia with accompanying gastroesophageal reflux and (or) taking medications such as bisphosphonates, as anticholinergic medicines may cause or exacerbate esophagitis.
• Administering oxybutynin to patients during heatwaves or in very hot environments may cause heat stroke due to decreased sweat production.
• Dependence on oxybutynin has been observed in patients with a history of drug or substance abuse. In case of any of the above-mentioned conditions, the patient should inform their doctor before starting treatment.

Children and adolescents

Oxybutynin is not recommended for use in children under 5 years of age. The safety of oxybutynin in this age group has not been established. Caution should be exercised when administering the medicine to children over 5 years of age, due to the possible increased sensitivity to the medicine, particularly in terms of adverse reactions from the nervous system and psychiatric disorders.

Oxybutyninum Aflofarm and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Caution should be exercised when co-administering oxybutynin with:
• other anticholinergic medicines, such as amantadine - a medicine used to treat influenza and Parkinson's disease,
• other anticholinergic medicines used to treat Parkinson's disease (e.g., biperiden, levodopa),
• antihistamine medicines - medicines used to treat allergy symptoms,
• antipsychotic medicines - used to treat mental disorders, e.g., schizophrenia (phenothiazine derivatives, butyrophenone derivatives, clozapine),
• quinidine, digitalis glycosides - used to treat arrhythmias,
• tricyclic antidepressants,
• atropine and its derivatives, such as atropine-based antispasmodic medicines,
• dipyridamole - a medicine that prevents blood clots.
• Due to decreased gastric motility, oxybutynin may affect the absorption of other medicines from the gastrointestinal tract, e.g., it may increase the absorption of digoxin (used to treat arrhythmias) and decrease the absorption of lidocaine (used for local anesthesia), paracetamol (a pain reliever), lithium salts (used to treat bipolar affective disorder), tetracyclines (antibiotics), phenylbutazone (an anti-inflammatory medicine), sulfamethoxazole, cotrimoxazole (antibiotics), and prolonged-release medicines.
• Oxybutynin is metabolized by the cytochrome P450 enzyme CYP 3A4. Concomitant administration of CYP 3A4 inhibitors (e.g., itraconazole, ketoconazole - antifungal medicines) may inhibit the metabolism of oxybutynin and increase its effect.
• Oxybutynin may reduce the effect of medicines that increase gastrointestinal motility (e.g., itopride).

Concomitant administration of oxybutynin with cholinesterase inhibitors may decrease the efficacy of cholinesterase inhibitors.

Oxybutyninum Aflofarm with food and alcohol

Food does not affect the absorption of the medicine from the gastrointestinal tract. Alcohol may enhance the sedative effect of anticholinergic medicines, such as Oxybutyninum Aflofarm.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Oxybutynin may be used during pregnancy only if its use is absolutely necessary. Small amounts of oxybutynin pass into breast milk. The use of the medicine is not recommended during breastfeeding.

Driving and operating machinery

Oxybutynin may cause drowsiness and blurred vision. If these symptoms occur, the patient should not drive, operate machinery, or perform tasks that may be hazardous.

Oxybutyninum Aflofarm contains lactose

The medicine contains 149.2 mg of lactose in each tablet. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Oxybutyninum Aflofarm

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor.

Administration in adults

The recommended dose is 1 tablet 2 to 3 times a day. The maximum dose should not be exceeded - 4 tablets per day.

Administration in elderly patients (including frail elderly patients)

2.5 mg (half a tablet) 2 times a day. The dose can be increased to 5 mg (1 tablet) 2 times a day to achieve the desired clinical response, provided that the medicine is well tolerated.

Administration in children under 5 years of age

The use of the medicine is not recommended.

Administration in children over 5 years of age

The recommended dose is 1 tablet 2 times a day. The dose can then be increased to 1 tablet 3 times a day. The maximum dose should not be exceeded - 3 tablets per day. The tablet can be divided into equal doses.

Taking a higher dose of Oxybutyninum Aflofarm than recommended

Symptoms of oxybutynin overdose include: psychiatric disorders (anxiety, agitation up to psychotic behavior), circulatory disorders (flushing, decreased blood pressure, circulatory failure), respiratory failure, and in severe cases, paralysis and coma. In case of overdose, the patient should immediately consult their doctor. In case of severe overdose, the patient should be hospitalized and their cardiovascular system should be monitored.

Missing a dose of Oxybutyninum Aflofarm

In case of missing a dose, the patient should take it as soon as possible, unless it is almost time for the next dose. The patient should not take a double dose or doses at short intervals to make up for the missed dose. In case of doubts, the patient should consult their doctor.

Stopping treatment with Oxybutyninum Aflofarm

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Oxybutyninum Aflofarm can cause side effects, although not everybody gets them.

The patient should immediately contact their doctor or go to the emergency department of the nearest hospital if they experience any of the following symptoms, as they may require urgent medical attention:

• allergic reactions, such as angioedema (an allergic reaction characterized by swelling and (or) edema, mainly on the face, tongue, and throat, as well as limbs), rash, urticaria (local changes in the form of blisters and redness on the skin).

The following side effects may also occur during treatment with Oxybutyninum Aflofarm:
Very common(occurring in more than 1 in 10 people):

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

Common(occurring in 1 to 10 people in 100):

• diarrhea,
• vomiting,
• disorders of consciousness (disorientation),
• decreased tear production,
• urinary retention,
• flushing;
• palpitations, which can be rapid or irregular.

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

• abdominal discomfort,
• anorexia,
• decreased appetite,
• difficulty swallowing.

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

• urinary tract infections,
• gastroesophageal reflux,
• pseudo-obstruction in patients at high risk (elderly patients or patients with constipation and treated with other medicines that reduce intestinal peristalsis),
• cognitive impairment in elderly patients,
• seizures,
• agitation,
• anxiety,
• hallucinations,
• nightmares,
• paranoia,
• symptoms of depression,
• dependence (in patients with a history of drug abuse),
• tachycardia (rapid heart rate),
• arrhythmias (irregular heart rhythm),
• heat stroke,
• increased intraocular pressure,
• narrow-angle glaucoma,
• pupil dilation,
• photophobia,
• decreased sweat production,
• hypersensitivity.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Oxybutyninum Aflofarm

The medicine should be stored out of sight and reach of children. Store in a temperature 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 month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Oxybutyninum Aflofarm contains

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

What Oxybutyninum Aflofarm looks like and what the pack contains

The medicine is a round, biconvex, uncoated tablet, white in color, with a single dividing line on one side. The tablets are packaged in PVC/PVDC/Aluminum blisters and a cardboard box. The pack contains 10, 30, or 60 tablets.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Phone: (42) 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów

Date of last revision of the leaflet: