Fesoterodine Aurovitas 4 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fesoterodina Aurovitas 4 mg prolonged-release tablets EFG

Fesoterodina Aurovitas 8 mg prolonged-release tablets EFG

Fesoterodine fumarate

Read the entire leaflet carefully before you start 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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Fesoterodina Aurovitas is and what it is used for

2. What you need to know before taking Fesoterodina Aurovitas

3. How to take Fesoterodina Aurovitas

4. Possible side effects

5. Storage of Fesoterodina Aurovitas

6. Contents of the pack and other information

1. What Fesoterodine Aurovitas is and what it is used for

This medicine contains an active substance called fesoterodine fumarate and is an antimuscarinic treatment, which reduces the activity of the overactive bladder. It is used in adults to treat symptoms.

This medicine treats the symptoms of overactive bladder, such as:

• inability to control when to urinate (urgency urinary incontinence),
• sudden need to urinate (urgency),
• needing to urinate more often than usual (increased urinary frequency).

2. What you need to know before taking Fesoterodine Aurovitas

Do not take Fesoterodine Aurovitas:

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

Warnings and precautions

Fesoterodine may not always be suitable for you. Tell your doctor before starting this medicine if any of the following apply to you:

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

Heart problems: Tell your doctor if you have any of the following conditions:

• you have an abnormal ECG (electrocardiogram, a recording of the heart's activity) known as QT interval prolongation, or if you are taking any medicine known to cause this effect,
• your heart rate is slow (bradycardia),
• you have a heart condition such as myocardial ischaemia (reduced blood flow to the heart), irregular heartbeat, or heart failure,
• you have hypokalaemia, which is a condition characterized by abnormally low levels of potassium in the blood.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age, as it has not yet been established whether it is effective or safe for them.

Other medicines and Fesoterodine Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Your doctor will tell you whether you can use fesoterodine together with other medicines.

Please inform your doctor if you are taking any of the following medicines. Taking these medicines at the same time as fesoterodine may cause adverse effects such as dry mouth, constipation, difficulty emptying the bladder completely, or more severe or more frequent drowsiness than usual.

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

Please inform your doctor if you are taking any of the following medicines:

• medicines containing any of the following active substances, which may increase the metabolism of fesoterodine and thus reduce its effect: St. John’s wort (a herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among other conditions, to treat epilepsy),
• medicines containing any of the following active substances, which may increase fesoterodine levels in the blood: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir, or nelfinavir (antiviral medicines 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 help stop smoking or to treat depression), quinidine (used to treat arrhythmias), and cinacalcet (used to treat hyperparathyroidism),
• medicines containing the active substance methadone (used to treat severe pain and drug dependence).

Pregnancy, breastfeeding, and fertility

You must not take this medicine if you are pregnant, as the effects of fesoterodine during pregnancy and on the newborn are unknown.

It is not known whether fesoterodine is excreted in breast milk; therefore, do not breast-feed while taking this medicine.

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

Driving and using machines

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

Fesoterodine Aurovitas contains lactose and fructosa

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

Fructose

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

3. How to take Fesoterodine Aurovitas

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The recommended starting dose of this medicine is one 4 mg tablet per day. Depending on your response to the medicine, your doctor may prescribe a higher dose: one 8 mg tablet per day.

You should swallow the tablet whole with a glass of water. Do not chew the tablet. This medicine can be taken with or without food.

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

If you take more Fesoterodine Aurovitas than you should

If you have taken more tablets than you were instructed to take, or if someone else accidentally takes your tablets, contact your doctor or hospital immediately. Show them the tablet packaging.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Fesoterodine Aurovitas

If you forget to take a tablet, take it as soon as you remember, but do not take more than one tablet per day. Do not take a double dose to make up for a missed dose.

If you stop taking Fesoterodine Aurovitas

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some side effects can be serious

Serious allergic reactions, including angioedema, may rarely occur. You must stop taking this medicine and contact your doctor immediately if you develop swelling of the face, mouth, or throat, as it may be life-threatening.

Other adverse effects

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

You may notice dry mouth. This effect is usually mild or moderate. This may increase the risk of dental caries. 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,
• diarrhoea,
• malaise (nausea),
• difficulty sleeping (insomnia),
• dry throat.

Uncommon (may affect up to 1 in 100 people)

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

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

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Fesoterodine Aurovitas

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, following "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fesoterodina Aurovitas

• The active substance is fesoterodine fumarate.

Fesoterodina Aurovitas 4 mg prolonged-release tablets EFG

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

Fesoterodina Aurovitas 8 mg prolonged-release tablets EFG

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

• The other components are

Tablet core: Fructose, lactose monohydrate, microcrystalline cellulose, hypromellose, glyceryl dibehenate, talc.

Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, indigo carmine aluminium lake (E132).

Nature and content of the container

Fesoterodina Aurovitas 4 mg prolonged-release tablets EFG

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

Fesoterodina Aurovitas 8 mg prolonged-release tablets EFG

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

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

Only certain 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 medicinal product 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 the most recent review of this leaflet: April 2024

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