FESOTERODINE EDIST 8 mg PROLONGED-RELEASE TABLETS

2. What you need to know before taking Fesoterodina Edest

Do not take Fesoterodina Edest if:

• you are allergic to fesoterodine, peanuts, soy, or any of the other components of Fesoterodina Edest (listed in section 6) (see section 2, "Fesoterodina Edest contains lactose and soy lecithin")
• you are unable to completely empty your urinary bladder (urinary retention)
• your stomach empties slowly (gastric retention)
• you have a eye disease called narrow-angle glaucoma (increased eye pressure) that is not controlled (treated properly)
• you have excessive muscle weakness (myasthenia gravis)
• you have severe ulceration and inflammation of the colon (severe ulcerative colitis)
• you have an abnormally long or dilated colon (toxic megacolon)
• you have severe liver problems
• 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 fesoterodine.

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 ever suffered from decreased intestinal movement or have severe constipation
• if you are being treated for a 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 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 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 is effective and safe for them.

Other medications and Fesoterodina Edest

Tell your doctor or pharmacist if you are taking or have recently taken or may need to take other medications. Your doctor will tell you if you can use fesoterodine with other medications.

Please inform your doctor if you are taking medications from the list below.

Taking these medications at the same time as fesoterodine may cause side effects such as dry mouth, constipation, difficulty emptying the bladder, or more severe or frequent drowsiness.

• medications that contain the active substance 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 antipsychotics

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 fesoterodine 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 fesoterodine 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 substance methadone (used to treat severe pain and drug dependence)

Pregnancy and breastfeeding

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

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

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

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

Fesoterodina Edest contains lactose and soy lecithin

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.

This medication contains soy lecithin. Do not use this medication if you are allergic to peanuts or soy.

3. How to take Fesoterodina Edest

Follow your doctor's instructions for taking this medication exactly.

If in doubt, consult your doctor or pharmacist again.

The recommended initial dose of fesoterodine 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. Fesoterodina 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 Edest 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 Edest

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 Edest

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

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, may occur. You should stop taking fesoterodine 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 may 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
• 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
• discomfort in the stomach
• gas (flatulence)
• difficulty emptying the bladder (urinary retention)
• delayed urination (urinary hesitation)
• extreme 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

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 Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fesoterodina Edest

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

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

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Fesoterodina Edest

• The active substance is fesoterodine fumarate.

Fesoterodina Edest 4mg prolonged-release tablets EFG:

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

Fesoterodina Edest 8mg prolonged-release tablets EFG:

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

• The other components (excipients) are:

Core of the tablet:silicon dioxide, microcrystalline cellulose, hypromellose, lactose, and magnesium stearate.

Coating of the 4 mg tablet:poly(vinyl alcohol), titanium dioxide (E171), talc, soy lecithin, yellow iron oxide (E172), and xanthan gum.

Coating of the 8 mg tablet:poly(vinyl alcohol), titanium dioxide (E171), talc, soy lecithin, carmine indigo (E132), and xanthan gum.

Appearance of the product and package contents

Fesoterodina Edest 4mg prolonged-release tablets EFG:

The 4 mg tablets are yellow, oval-shaped, 13.2 mm long, and 6.65 mm wide, film-coated, and have the letters "FI" engraved on one side and are smooth on the other.

Fesoterodina Edest 8mg prolonged-release tablets EFG:

The 8 mg tablets are blue, oval-shaped, 13.2 mm long, and 6.65 mm wide, film-coated, and have the letters "F II" engraved on one side and are smooth on the other.

Fesoterodina Edest 4 mg and 8 mg are packaged in aluminum-aluminum blisters in a cardboard box containing 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Intas Third Party Sales 2005 S.L.

Calle Moll de Barcelona S/N

Edificio World Trade Center

08039 – Barcelona

Spain

Manufacturer

Laboratori Fundació Dau

C/ C, 12-14 Pol. Industrial Zona Franca

08040, Barcelona,

Spain

Date of the last revision of this package leaflet: March 2023

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.