DARIFENACIN ARISTO 15 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Darifenacina Aristo 15 mg prolonged-release tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Darifenacina Aristo and what is it used for
2. What you need to know before taking Darifenacina Aristo
3. How to take Darifenacina Aristo
4. Possible side effects
5. Storage of Darifenacina Aristo
6. Package contents and additional information

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

How darifenacina works

Darifenacina reduces the activity of the overactive bladder. This allows you to wait longer before urinating and increases the amount of urine you can hold in your bladder.

What darifenacina is used for

Darifenacina belongs to a class of medications that relax the bladder muscles. It is used in adults to treat symptoms of an overactive bladder, such as sudden urgency to urinate, frequent need to urinate, or inability to hold urine until reaching the bathroom (urge incontinence).

2. What you need to know before taking Darifenacina Aristo

Do not take darifenacina:

• if you are allergic to darifenacina or any of the other components of this medication (listed in section 6);
• if you have urinary retention (difficulty emptying the bladder);
• if you have gastric retention (problems emptying the stomach);
• if you have uncontrolled narrow-angle glaucoma (increased eye pressure that is not being treated properly);
• if you have myasthenia gravis (a disease that causes unusual fatigue and weakness of some muscles);
• if you have severe ulcerative colitis or toxic megacolon (acute dilation of the colon due to a complication of an infection or inflammation);
• if you have severe liver problems;
• if you are taking medications that strongly inhibit the activity of certain liver enzymes, such as cyclosporine (a medication used in transplants to prevent organ rejection or in other conditions, such as rheumatoid arthritis or atopic dermatitis), verapamil (a medication to lower blood pressure, correct heart rhythm, or treat angina pectoris), antifungal medications (e.g., ketoconazole and itraconazole), and some antiviral medications (e.g., ritonavir), see section "Other medications and darifenacina".

Warnings and precautions

Consult your doctor before starting to take this medication.

• if you have autonomic neuropathy (nerve damage that affects the communication between the brain and internal organs, muscles, skin, and blood vessels to regulate vital functions, including heart rate, blood pressure, and intestinal function) – your doctor will have informed you if you have this disease;
• if you have a condition where one or more abdominal organs ascend to the thorax through an opening in the diaphragm, causing heartburn and frequent belching;
• if you have difficulty urinating and a weak urine flow;
• if you have significant constipation (2 or fewer bowel movements per week);
• if you have an alteration of intestinal motility;
• if you have a gastrointestinal obstructive disorder (any obstruction of the passage of gastric or intestinal contents, such as a narrowing of the pylorus, the lower part of the stomach) – your doctor will have informed you if you have this disease;
• if you are taking medications that can cause or worsen esophageal inflammation, such as oral bisphosphonates (a type of medication that prevents bone loss and is used to treat osteoporosis);
• if you are receiving treatment for narrow-angle glaucoma;
• if you have liver problems;
• if you have a urinary tract infection or other kidney problems;
• if you have an overactive muscle that controls bladder emptying and can cause involuntary loss of urine (a disease known as detrusor hyperreflexia) - your doctor will inform you if you have this disease;
• if you have heart disease.

If you are in any of these situations, inform your doctor before taking this medication.

During treatment with darifenacina, inform your doctor immediately and stop taking darifenacina if you experience swelling of the face, lips, tongue, and/or throat (signs of angioedema).

Children and adolescents

Darifenacina is not recommended in children and adolescents (<18 years).

Other medications and darifenacina

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription. This is especially important if you are taking any of the following medications, as your doctor will need to adjust your dose of darifenacina and/or the other medication:

• certain antibiotics (e.g., erythromycin, clarithromycin, telithromycin, and rifampicin);
• antifungal medications (e.g., ketoconazole and itraconazole - see section "Do not take darifenacina", fluconazole, terbinafine);
• medications used to reduce the activity of the immune system, for example, after an organ transplant (e.g., cyclosporine - see section "Do not take darifenacina");
• antiviral medications (e.g., ritonavir - see section "Do not take darifenacina"),
• antipsychotic medications (e.g., thioridazine);
• certain antidepressants (e.g., imipramine and paroxetine);
• certain anticonvulsants (carbamazepine, barbiturates);
• certain medications used to treat heart problems (e.g., verapamil - see section "Do not take darifenacina" - flecainide, digoxin, and quinidine);
• certain medications used to treat stomach problems (e.g., cimetidine);
• other antimuscarinic medications (e.g., tolterodine, oxybutynin, and flavoxate).

Also, inform your doctor if you are taking products that contain St. John's Wort.

Taking darifenacina with food and beverages

Food does not affect darifenacina. Grapefruit juice may interact with darifenacina. Inform your doctor if you are taking grapefruit juice regularly.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Darifenacina is not recommended during pregnancy.

Darifenacina should be taken with caution during breastfeeding.

Driving and using machines

Darifenacina may cause effects such as dizziness, blurred vision, sleep problems, or drowsiness. If you experience any of these symptoms while taking darifenacina, consult your doctor about a dose change or alternative treatment. Do not drive or use machines if you experience these symptoms. For darifenacina, these adverse effects have been reported as uncommon (see section 4).

3. How to take Darifenacina Aristo

Follow your doctor's instructions for taking darifenacina exactly. Consult your doctor or pharmacist if you have any questions. If you think the effect of darifenacina is too strong or too weak, tell your doctor or pharmacist.

How much darifenacina to take

The recommended initial dose, including patients over 65 years of age, is 7.5 mg per day. Depending on your response to darifenacina, your doctor may increase your dose to 15 mg per day, two weeks after starting treatment.

These doses are suitable for people with mild liver problems or people with kidney problems.

Take darifenacina tablets once a day with liquid, approximately at the same time every day.

The tablets can be taken with or without food. Swallow the tablet whole. Do not chew, break, or crush it.

If you take more darifenacina than you should

If you have taken more tablets than prescribed, or if someone else has taken your tablets by accident, you should go to your doctor or hospital immediately. When seeking medical advice, make sure to bring this package leaflet and your tablets to show the doctor. People who have taken an overdose may experience dry mouth, constipation, headache, indigestion, and nasal dryness. Overdose with darifenacina can cause serious symptoms that require emergency treatment in a hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take darifenacina

If you forget to take darifenacina at the usual time, take it as soon as you remember, unless it is time for the next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking darifenacina

Your doctor will tell you how long to take darifenacina. Do not stop treatment early because you do not see an immediate effect. Your bladder will need some time to adapt. Complete the treatment cycle prescribed by your doctor. If you have not noticed any effect by then, consult your doctor.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. The side effects caused by darifenacina are usually mild and temporary.

Some side effects can be serious

Unknown frequency (cannot be estimated from 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, indigestion, discomfort, dry eyes, dry nose.

Uncommon (may affect up to 1 in 100 people)

Fatigue, accidental injury, swelling of the face, high blood pressure, diarrhea, flatulence, mouth ulceration, increased liver enzymes (indicating abnormal liver function), swelling including swelling of the hands, ankles, or feet, dizziness, insomnia, drowsiness, strange thoughts, runny nose (rhinitis), cough, difficulty breathing, dry skin, itching, rash, sweating, vision changes including blurred vision, taste changes, urinary tract infection or changes, impotence, vaginal discharge and itching, bladder pain, inability to empty the bladder.

Frequency not known (cannot be estimated from available data)

Depressive mood/disorders, hallucinations.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Darifenacina Aristo

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the carton, blister, and bottle after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Darifenacina Aristo

The active ingredient is darifenacina. Each tablet contains 15 mg of darifenacina (as hydrobromide).

The other ingredients are:

Tablet core:anhydrous calcium hydrogen phosphate (E341(ii)), hypromellose (E464), and magnesium stearate (E470b).

Coating:hypromellose (E464), titanium dioxide (E171), macrogol, and talc (E553b).

Appearance of the product and package contents

The 15 mg prolonged-release tablets are peach-colored, round, biconvex, film-coated, and have a diameter of 8 mm.

They are available in blister packs of 14, 28, 49, and 98 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

You can request more information about this medication from the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

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

Netherlands Darifenacine Aristo 15 mg tabletten met verlengde afgifte

Germany Darifenacin Aristo 15 mg Retardtabletten

Czech Republic Darifenacin Aristo

Italy Darifenacina Aristo 15 mg compresse a rilascio prolungato

Portugal Darifenacina Aristo 15 mg Comprimido de libertação prolongada

Poland Darifenacin Aristo 15 mg tabletki o przedluzonym uwalnianiu

Spain Darifenacina Aristo 15 mg comprimidos de liberación prolongada EFG

Date of last revision of this package leaflet:February 2022

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/