FESOTERODINE ALTER 8 mg PROLONGED-RELEASE TABLETS

Introduction

Patient Information Leaflet

Fesoterodina Alter 4 mg prolonged-release tablets EFG

Fesoterodina Alter 8 mg prolonged-release tablets EFG

Fesoterodina, fumarate

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

• Keep this 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 it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

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

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

This medication contains the active ingredient fesoterodina fumarate and is a treatment called antimuscarinics, which reduce the activity of the overactive bladder and is used in adults to treat symptoms.

Fesoterodina treats symptoms of an overactive bladder, such as:

• inability to control when to urinate (urge incontinence)
• sudden need to urinate (urgency)
• need to urinate more frequently than usual (increased urination frequency)

2. What you need to know before taking Fesoterodina Alter

Do not take Fesoterodina Alter

• if you are allergic to fesoterodina or any of the other components of this medication (listed in section 6) (see section 2, "Fesoterodina Alter contains fructose and lactose")
• 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 (treated properly)
• if you have excessive muscle weakness (myasthenia gravis)
• if you have severe colitis (severe colon inflammation)
• 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 that contain 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

Consult your doctor or pharmacist before starting to take Fesoterodina Alter.

Fesoterodina may not always be suitable for you. Talk to your doctor before taking fesoterodina in any of the following cases:

• if you have difficulty completely emptying your urinary bladder (e.g., due to prostate enlargement)
• if you have suffered from decreased intestinal movements or have severe constipation
• if you are being treated for 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 intestinal function or sexual function
• if you have a gastrointestinal disease that affects the passage and/or digestion of food
• if you have heartburn or belching
• if you have a urinary tract infection, your doctor may need to prescribe antibiotics.

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

• you have an ECG abnormality known as QT interval prolongation or are taking any medication that is known to cause this effect
• you have a slow heart rate (bradycardia)
• you have 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 is effective and safe for them.

Other medications and Fesoterodina Alter

Tell your doctor or pharmacist if you are taking or 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 emptying the bladder, or more severe or frequent drowsiness.

• medications that contain the active ingredient amantadine (used to treat Parkinson's disease)
• certain medications used to increase gastrointestinal motility or to relieve stomach cramps or spasms, such as medications that contain 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 that contain any of the following active substances that may increase the metabolism of fesoterodina and, therefore, decrease its effect: St. John's Wort (hypericum), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy)
• medications that contain 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 that contain the active ingredient methadone (used to treat intense pain and drug dependence)

Pregnancy and breastfeeding

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.

You should not take fesoterodina 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.

Driving and using machines

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

Fesoterodina Alter contains fructose and lactose

If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

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

3. How to take Fesoterodina Alter

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended initial dose is one 4 mg fesoterodina tablet per day. Depending on your response to the medication, your doctor may prescribe a higher dose; one 8 mg fesoterodina 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 Alter 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 Alter

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 taking Fesoterodina Alter

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

If you have any other questions 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, including angioedema, can occur. Stop taking this medication and contact your doctor immediately if you develop swelling in the face, mouth, or throat.

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, 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
• nausea
• difficulty sleeping (insomnia)
• dry throat

Uncommon(may affect up to 1 in 100 people)

• urinary tract infection
• drowsiness
• difficulty tasting (dysgeusia)
• vertigo
• rash
• dry skin
• itching
• stomach discomfort
• gas (flatulence)
• difficulty emptying the bladder (urinary retention)
• delayed urination (urinary hesitancy)
• extreme 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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are 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 help provide more information on the safety of this medication.

5. Storage of Fesoterodina Alter

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

Do not use this medication after the expiration date stated on the package and blister, 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 in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Fesoterodina Alter

• The active ingredient is fesoterodina fumarate.

Fesoterodina Alter 4 mg: Each prolonged-release tablet contains 4 mg of fesoterodina fumarate, equivalent to 3.1 mg of fesoterodina.

Fesoterodina Alter 8 mg: Each prolonged-release tablet contains 8 mg of fesoterodina fumarate, equivalent to 6.2 mg of fesoterodina.

• The other components are:

Tablet core: fructose, lactose monohydrate-microcrystalline cellulose spheres, hypromellose, dibehenate, talc.

Tablet coating: poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, and carmine indigo (E132).

Appearance of the product and package contents

Fesoterodina Alter 4 mg: film-coated tablets, 13.1 x 6.0 mm, blue, elliptical, biconvex, with the engraving "F4" on one side.

Fesoterodina Alter 8 mg: film-coated tablets, 13.1 x 6.0 mm, dark blue, elliptical, biconvex, with the engraving "F8" on one side.

Fesoterodina Alter is available in aluminum-aluminum blisters, in packages containing 28 tablets.

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo 6

28760 Tres Cantos, Madrid

Spain

Or

Laboratorios Liconsa, S.A.

Avda. Miralcampo 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Date of the last revision of this leaflet:

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