DARIFENACIN 7.5 mg Tablets

Contents of the leaflet

1. Patient Information Leaflet: Patient Information
2. Darifenacin Aristo, 7.5 mg, prolonged-release tablets
3. Darifenacin Aristo, 15 mg, prolonged-release tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What is Darifenacin Aristo and what is it used for
   1. How Darifenacin Aristo works
   2. When Darifenacin Aristo is used
5. Important information before taking Darifenacin Aristo
   1. When not to take Darifenacin Aristo:
   2. Warnings and precautions
   3. Children and adolescents
   4. Darifenacin Aristo and other medicines
   5. Darifenacin Aristo with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
6. How to take Darifenacin Aristo
   1. How much Darifenacin Aristo to take
   2. Taking more Darifenacin Aristo than prescribed
   3. Missing a dose of Darifenacin Aristo
   4. Stopping treatment with Darifenacin Aristo
7. Possible side effects
   1. Some side effects may be serious
   2. Frequency not known (frequency cannot be estimated from the available data)
   3. Other side effects
   4. Very common (may affect more than 1 in 10 people)
   5. Common (may affect up to 1 in 10 people)
   6. Uncommon (may affect up to 1 in 100 people)
   7. Frequency not known (frequency cannot be estimated from the available data)
   8. Reporting side effects
8. How to store Darifenacin Aristo
9. Contents of the pack and other information
   1. What Darifenacin Aristo contains
   2. What Darifenacin Aristo looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet:

Patient Information Leaflet: Patient Information

Darifenacin Aristo, 7.5 mg, prolonged-release tablets

Darifenacin Aristo, 15 mg, prolonged-release tablets

Darifenacin

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

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

Table of Contents of the Leaflet

• 1. What is Darifenacin Aristo and what is it used for
• 2. Important information before taking Darifenacin Aristo
• 3. How to take Darifenacin Aristo
• 4. Possible side effects
• 5. How to store Darifenacin Aristo
• 6. Contents of the pack and other information

1. What is Darifenacin Aristo and what is it used for

How Darifenacin Aristo works

Darifenacin Aristo reduces the activity of an overactive bladder. This allows for longer intervals between visits to the toilet and increases the amount of urine the bladder can hold.

When Darifenacin Aristo is used

Darifenacin Aristo belongs to a group of medicines called antimuscarinics. It is used in adults for the symptomatic treatment of overactive bladder syndrome, such as: urgent need to urinate, frequent urination, and (or) when the patient is unable to reach the toilet in time and experiences urinary incontinence (urge incontinence).

2. Important information before taking Darifenacin Aristo

When not to take Darifenacin Aristo:

• if you are allergic to darifenacin or any of the other ingredients of this medicine (listed in section 6).
• if you have urinary retention (inability to empty the bladder).
• if you have gastric retention (difficulty emptying the stomach).
• if you have uncontrolled narrow-angle glaucoma (increased pressure in the eyes that is not being treated).
• if you have myasthenia gravis (a disease characterized by abnormal fatigue and weakness of certain muscles).
• if you have severe ulcerative colitis or toxic megacolon (acute dilation of the colon caused by infection or inflammation).
• if you have severe liver impairment.
• if you are taking medicines that strongly inhibit the activity of certain liver enzymes

such as cyclosporine (a medicine used in transplantation to protect against organ rejection or in other conditions, e.g., rheumatoid arthritis or atopic dermatitis), verapamil (a medicine that lowers blood pressure, regulates heart rhythm, and is used to treat angina pectoris), antifungal medicines (e.g., ketoconazole and itraconazole - see section "When not to take Darifenacin Aristo"), and certain antiviral medicines (e.g., ritonavir) - see section "Darifenacin Aristo and other medicines".

Warnings and precautions

Before starting treatment with Darifenacin Aristo, discuss with your doctor:

• if you have autonomic nervous system neuropathy (nerve damage affecting communication between the brain and internal organs, muscles, skin, and blood vessels, regulating vital functions, including heart rate, blood pressure, and bowel function) - your doctor will inform you if you have such a diagnosis.
• if you have a condition where one or more organs in the abdominal cavity have moved up into the chest through an opening in the diaphragm, causing heartburn and frequent belching.
• if you have difficulty urinating or urinate with a weak stream.
• if you experience severe constipation (2 or fewer bowel movements per week).
• if you have a disorder of gastrointestinal motility.
• if you have intestinal obstruction (any disorder of the passage of intestinal or stomach contents, such as pyloric stenosis, lower stomach) - your doctor should inform you about its presence.
• if you are taking medicines that may cause or worsen esophageal inflammation, such as oral bisphosphonates (a group of medicines that protect against bone loss, used to treat osteoporosis).
• if you are being treated for narrow-angle glaucoma.
• if you have liver impairment.
• if you have urinary tract infections or other kidney function disorders.
• if you have an overactive bladder muscle that controls bladder emptying, which may cause involuntary urination (a condition called detrusor overactivity) - your doctor will inform you if you have this disease.
• if you have heart disease.

If you have any of these conditions, inform your doctor before taking Darifenacin Aristo.
During treatment with Darifenacin Aristo, immediately inform your doctor and stop taking Darifenacin Aristo if you experience facial, lip, tongue, and (or) throat swelling (symptoms of angioedema).

Children and adolescents

Darifenacin Aristo is not recommended for use in children and adolescents (under 18 years of age).

Darifenacin Aristo and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription. This is especially important if you are taking any of the following medicines, as your doctor may need to change the dose of Darifenacin Aristo and (or) other medicines:

• certain antibiotics (e.g., erythromycin, clarithromycin, telithromycin, and rifampicin),
• antifungal medicines (e.g., ketoconazole and itraconazole - see section "When not to take Darifenacin Aristo", fluconazole, terbinafine),
• medicines used to reduce the activity of the immune system, e.g., after organ transplantation (e.g., cyclosporine - see section "When not to take Darifenacin Aristo"),
• antiviral medicines (e.g., ritonavir - see section "Darifenacin Aristo"),

• antipsychotic medicines (e.g., thioridazine),
• certain antidepressant medicines (e.g., imipramine and paroxetine), certain antiepileptic medicines (e.g., carbamazepine, barbiturates),
• certain medicines used to treat heart conditions (e.g., verapamil - see section "When not to take Darifenacin Aristo", flecainide, digoxin, and quinidine),
• certain medicines used to treat stomach disorders (e.g., cimetidine),
• other antimuscarinic medicines (e.g., tolterodine, oxybutynin, and flavoxate).

You should also inform your doctor about taking medicines containing St. John's Wort.

Darifenacin Aristo with food and drink

Food intake does not affect the action of Darifenacin Aristo. Grapefruit juice may interact with Darifenacin Aristo. Inform your doctor about regular consumption of grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Darifenacin Aristo is not recommended during pregnancy.
Caution is advised when taking Darifenacin Aristo during breastfeeding.

Driving and using machines

Darifenacin Aristo may cause side effects such as dizziness, blurred vision, insomnia, or drowsiness. If you experience any of these side effects while taking Darifenacin Aristo, consult your doctor for advice on changing the dose or using an alternative treatment method. If you experience these side effects, do not drive or operate machinery. With darifenacin, these effects occurred not very often (see section 4).

3. How to take Darifenacin Aristo

Always take Darifenacin Aristo exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. If you feel that the effect of Darifenacin Aristo is too strong or too weak, ask your doctor or pharmacist.

How much Darifenacin Aristo to take

The recommended initial dose of the medicine is 7.5 mg once daily, also for patients over 65 years of age. Depending on the response to treatment, your doctor may increase the dose of Darifenacin Aristo to 15 mg once daily, two weeks after starting treatment.
These doses can be used in patients with mild liver or kidney impairment.
Take Darifenacin Aristo once daily, with a liquid, preferably at the same time each day.
The tablet can be taken with or without food. Swallow the tablet whole. Do not chew, divide, or crush it.

Taking more Darifenacin Aristo than prescribed

If you have taken more tablets than prescribed or if someone else has taken your tablets, immediately consult your doctor or go to the nearest hospital.
When seeking medical attention, it is important to have this leaflet and any remaining tablets from the packaging with you, so you can show them to the doctor. People who have taken more than the prescribed dose may experience dry mouth, constipation, headache, nausea, and dryness of the nasal mucosa. Overdose of Darifenacin Aristo may cause severe symptoms that require emergency hospital treatment.

Missing a dose of Darifenacin Aristo

If you forget to take Darifenacin Aristo at the usual time, take it as soon as possible, unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Darifenacin Aristo

Your doctor will tell you how long the treatment with Darifenacin Aristo will last.
Do not stop treatment too early because of the lack of immediate effect of the medicine.
The bladder needs some time to adapt to the treatment. You should complete the course prescribed by your doctor. If the treatment does not produce noticeable results, discuss this with your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Darifenacin Aristo can cause side effects, although not everybody gets them.
The side effects of Darifenacin Aristo are usually mild and temporary.

Some side effects may be serious

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

Severe allergic reactions, including: swelling, mainly of the face and neck (angioedema).

Other side effects

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

Dry mouth, constipation.

Common (may affect up to 1 in 10 people)

Headache, abdominal pain, nausea, vomiting, dry eyes, dryness of the nasal mucosa.

Uncommon (may affect up to 1 in 100 people)

Feeling tired, accidental injury, facial swelling, high blood pressure, diarrhea, bloating with gas, oral mucosal ulceration, increased liver enzyme activity (indicating abnormal liver function), swelling including swelling of the hands, ankles, or feet, dizziness, insomnia, drowsiness, impaired thinking, runny nose (rhinitis), cough, shortness of breath, dry skin, itching, rash, sweating, vision disturbances including blurred vision, taste disturbances, kidney and urinary tract disorders, impotence, vaginal discharge and vaginal itching, bladder pain, inability to empty the bladder.

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

Depressed mood and (or) mood changes, hallucinations.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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, you can help provide more information on the safety of this medicine.

5. How to store Darifenacin Aristo

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
• There are no special precautions for storage of the medicinal product.
• Do not use if you notice signs of damage or deterioration of the packaging.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Darifenacin Aristo contains

Darifenacin Aristo, 7.5 mg, prolonged-release tablets

• The active substance is darifenacin. Each prolonged-release tablet contains 7.5 mg of darifenacin (as darifenacin hydrobromide).
• The other ingredients are: Tablet core:calcium hydrogen phosphate, hypromellose 2208, magnesium stearate Coating:hypromellose 2910, titanium dioxide, macrogol 4000, and talc.

Darifenacin Aristo, 15 mg, prolonged-release tablets

• The active substance is darifenacin. Each prolonged-release tablet contains 15 mg of darifenacin (as darifenacin hydrobromide).
• The other ingredients are: Tablet core:calcium hydrogen phosphate, hypromellose 2208, magnesium stearate Coating:hypromellose 2910, titanium dioxide, macrogol 6000, talc, yellow iron oxide (E 172), red iron oxide (E 172).

What Darifenacin Aristo looks like and contents of the pack

Darifenacin Aristo, 7.5 mg, prolonged-release tablets are white to almost white, round, biconvex, film-coated tablets with "7.5" engraved on one side and a diameter of 8 mm.
Darifenacin Aristo, 15 mg, prolonged-release tablets are light orange, round, biconvex, film-coated tablets with a diameter of 8 mm.
Tablets are available in blisters containing 14, 28, 49, or 98 prolonged-release tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw
tel. +48 22 855 40 93

Manufacturer

Aristo Pharma GmbH
Wallenroder Straße 8–10
13435 Berlin
Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic
Darifenacin Aristo
Spain
Darifenacina Aristo, 7.5 mg, 15 mg, Comprimidos de liberación prolongada
Netherlands
Darifenacine Aristo, 7.5 mg, 15 mg, tabletten met verlengde afgifte
Germany
Darifenacin Aristo, 7.5 mg, 15 mg, Retardtabletten
Poland
Darifenacin Aristo
Portugal
Darifenacina Aristo, 7.5 mg, 15 mg, Comprimido de libertação prolongada
United Kingdom
Darifenacin Aristo, 7.5 mg, 15 mg, Prolonged-released tablets
Italy
Darifenacina Aristo, 7.5 mg, 15 mg, compresse a rilascio prolungato

Date of last revision of the leaflet: