FESOTERODINE AUROVITAS 8 mg PROLONGED-RELEASE TABLETS

2. What you need to know before taking Fesoterodina Aurovitas

Do not take Fesoterodina Aurovitas:

• if you are allergic to fesoterodina, fructose, or any of the other components of this medication (listed in section 6) (see section 2, “Fesoterodina Aurovitas contains lactose and fructose”),
• if you cannot completely empty your urinary bladder (urinary retention),
• if your stomach empties slowly (gastric retention),
• if you have an eye disease called narrow-angle glaucoma (increased eye pressure) that is not controlled,
• if you have excessive muscle weakness (myasthenia gravis),
• if you have ulceration and inflammation of the colon (severe ulcerative colitis),
• if you have an abnormally long or dilated colon (toxic megacolon),
• if you have severe liver problems,
• if you have kidney problems or moderate to severe liver problems and are taking medications containing any of the following active substances: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir, or nelfinavir (antiviral medications used to treat HIV infection), clarithromycin or telithromycin (used to treat bacterial infections), and nefazodone (used to treat depression).

Warnings and precautions

Fesoterodina may not always be suitable for you. Inform your doctor before starting to take this medication in any of the following cases:

• if you have difficulty completely emptying your urinary bladder (e.g., due to prostate enlargement),
• if you have ever suffered from decreased intestinal movements or have severe constipation,
• if you are being treated for an eye disease called narrow-angle glaucoma,
• if you have severe kidney or liver problems, as your doctor may need to adjust the dose you receive,
• if you have a disease called autonomic neuropathy that causes symptoms such as changes in blood pressure or alterations in the intestine or sexual function,
• if you have a gastrointestinal disease that affects the passage and/or digestion of food,
• if you suffer from heartburn or belching,
• if you have a urinary tract infection, your doctor may need to prescribe you antibiotics.

Cardiac problems: Inform your doctor if you have any of the following conditions:

• you have an ECG anomaly (heart activity record) known as QT interval prolongation or if you are taking any medication that is known to cause this effect,
• your heart rate is slow (bradycardia),
• you have a heart disease such as myocardial ischemia (reduced blood flow to the heart), irregular heartbeats, or heart failure,
• you have hypokalemia, which is a manifestation of abnormally low potassium levels in the blood.

Children and adolescents

Do not give this medication to children and adolescents under 18 years of age, as it has not been established whether it can work and be safe for them.

Other medications and Fesoterodina Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. Your doctor will tell you if you can use fesoterodina with other medications.

Please inform your doctor if you are taking medications from the list below. Taking these medications at the same time as fesoterodina may cause side effects such as dry mouth, constipation, difficulty completely emptying the urinary bladder, or more severe or frequent drowsiness than usual.

• medications containing the active ingredient amantadine (used to treat Parkinson's disease),
• certain medications used to increase gastrointestinal motility or to relieve stomach cramps or spasms, and those that prevent travel sickness, such as medications containing metoclopramide,
• certain medications used to treat psychiatric disorders, such as antidepressants and neuroleptics.

Please indicate to your doctor if you are taking any of the following medications:

• medications containing any of the following active substances that may increase the metabolism of fesoterodina and, therefore, decrease its effect: St. John's Wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy),
• medications containing any of the following active substances that may increase fesoterodina levels in the blood: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir, or nelfinavir (antiviral medications used to treat HIV infection), clarithromycin or telithromycin (used to treat bacterial infections), nefazodone (used to treat depression), fluoxetine or paroxetine (used to treat depression or anxiety), bupropion (used to quit smoking or treat depression), quinidine (used to treat arrhythmias), and cinacalcet used to treat hyperparathyroidism),
• medications containing the active ingredient methadone (used to treat severe pain and drug addiction).

Pregnancy, breastfeeding and fertility

You should not take this medication if you are pregnant, as the effects of fesoterodina on pregnancy and the newborn are unknown.

It is unknown whether fesoterodina is excreted in breast milk; therefore, do not breastfeed during treatment with this medication.

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

Driving and using machines

This medication may cause blurred vision, dizziness, and drowsiness. If you experience any of these effects, do not drive or operate tools or machines.

Fesoterodina Aurovitas contains lactose and fructose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Fructose

This medication contains 72 mg of fructose per tablet. Fructose may damage teeth.

3. How to take Fesoterodina Aurovitas

Follow your doctor's instructions for taking this medication exactly. If in doubt, consult your doctor or pharmacist again.

The recommended initial dose of this medication is one 4 mg tablet per day. Depending on how you respond to the medication, your doctor may prescribe a higher dose; one 8 mg tablet per day.

Swallow the tablet whole with a glass of water. Do not chew the tablet. This medication can be taken with or without food.

To help you remember to take your medication, it may be easier to take it at the same time every day.

If you take more Fesoterodina Aurovitas than you should

If you have taken more tablets than you should or if someone else has taken your tablets by accident, contact your doctor or hospital immediately. Show them the package of tablets.

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 Fesoterodina Aurovitas

If you have forgotten to take a tablet, take it as soon as you remember, but do not take more than one tablet in a day. Do not take a double dose to make up for forgotten doses.

If you stop treatment with Fesoterodina Aurovitas

Do not stop treatment with fesoterodina without talking to your doctor first, as the symptoms of overactive bladder may return or worsen when you stop treatment with this medication.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Some side effects can be serious

Rarely, severe allergic reactions may occur, including angioedema. You should stop taking this medication and contact your doctor immediately if you develop swelling in the face, mouth, or throat, as it can be life-threatening.

Other side effects

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

You may notice dry mouth. This effect is usually mild or moderate. This can increase the risk of tooth decay. Therefore, you should brush your teeth regularly, twice a day, and visit a dentist if in doubt.

Common(may affect up to 1 in 10 people)

• dry eyes,
• constipation,
• digestive disorders (dyspepsia),
• pain or discomfort when urinating (dysuria),
• dizziness,
• headache,
• stomach pain,
• diarrhea,
• discomfort (nausea),
• difficulty sleeping (insomnia),
• dry throat.

Uncommon(may affect up to 1 in 100 people)

• urinary tract infection,
• drowsiness,
• difficulty tasting (dysgeusia),
• vertigo,
• skin rash,
• dry skin,
• itching,
• stomach discomfort,
• gas (flatulence),
• difficulty completely emptying the urinary bladder (urinary retention),
• delayed urination (urination delay),
• intense fatigue (fatigue),
• increased heart rate (tachycardia),
• palpitations,
• liver problems,
• cough,
• dry nose,
• sore throat,
• acid reflux,
• blurred vision.

Rare(may affect up to 1 in 1,000 people)

• hives,
• confusion,
• numbness around the mouth (oral hypoesthesia).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Fesoterodina Aurovitas

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the carton and blister pack, after “EXP”. The expiration date is the last day of the month indicated.

Do not store above 25 °C.

Keep in the original packaging to protect from moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Fesoterodina Aurovitas

• The active ingredient is fesoterodina fumarate.

Fesoterodina Aurovitas 4 mg prolonged-release tablets EFG

Each prolonged-release tablet contains 4 mg of fesoterodina fumarate equivalent to 3.1 mg of fesoterodina.

Fesoterodina Aurovitas 8 mg prolonged-release tablets EFG

Each prolonged-release tablet contains 8 mg of fesoterodina fumarate equivalent to 6.2 mg of fesoterodina.

• The other components are

Core of the tablet: Fructose, lactose monohydrate, microcrystalline cellulose, hypromellose, glycerol dibehenate, talc.

Coating of the tablet: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, aluminum lacquer carmine (E132).

Appearance of the product and package contents

Fesoterodina Aurovitas 4 mg prolonged-release tablets EFG

The 4 mg tablets are blue, elliptical, biconvex, film-coated, approximately 6 mm in diameter, and have the letters “F4” engraved on one side and are smooth on the other side.

Fesoterodina Aurovitas 8 mg prolonged-release tablets EFG

The 8 mg tablets are dark blue, elliptical, biconvex, film-coated, approximately 6 mm in diameter, and have the letters “F8” engraved on one side and are smooth on the other side.

Fesoterodina Aurovitas is available in blister packs of 10, 14, 28, 30, 56, 84, 98, or 100 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Laboratorios Liconsa S.A.

Avenida Miralcampo 7,

Polígono Industrial Miralcampo

Azuqueca de Henares

19200 Guadalajara

Spain

or

Laboratorios Normon S.A.

Ronda Valdecarrizo 6,

28760 Tres Cantos

Madrid

Spain

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

Spain: Fesoterodina Aurovitas 4 mg prolonged-release tablets EFG

Fesoterodina Aurovitas 8 mg prolonged-release tablets EFG

France: FESOTERODINE ARROW LP 4 mg, prolonged-release tablet

FESOTERODINE ARROW LP 8 mg, prolonged-release tablet

Ireland: Fesoterodine Liconsa 4mg prolonged-release tablets

Fesoterodine Liconsa 8mg prolonged-release tablets

Date of last revision of this leaflet: April 2024

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/)