FESOTERODINE TEVA 8 mg PROLONGED-RELEASE TABLETS

2. What you need to know before taking Fesoterodina Teva

Do not take fesoterodine if:

• you are allergic to fesoterodine or any of the other components of this medication (listed in section 6) (see section 2, "Fesoterodina Teva contains lactose and sodium")
• you are unable to completely empty your urinary bladder (urinary retention)
• your stomach empties slowly (gastric retention)
• you have an 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 colon inflammation (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

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 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 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 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 Teva

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 containing 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 containing 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 containing any of the following active substances that may increase the metabolism of fesoterodine and, therefore, decrease its effect: St. John's Wort, rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used to treat epilepsy, among other conditions)
• Medications containing 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 containing the active substance methadone (used to treat severe pain and drug dependence)

Pregnancy, breast-feeding

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

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.

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 Teva contains lactose and sodium

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

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Fesoterodina Teva

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 of fesoterodine is one 4 mg tablet per day. Depending on your response 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 more convenient to take it at the same time every day.

If you take more fesoterodine 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 fesoterodine

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 fesoterodine

Do not stop taking fesoterodine without talking to your doctor first, as the symptoms of 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 experiences them.

Some side effects can be serious

Rarely, severe allergic reactions, including angioedema, may occur. Stop taking fesoterodine and contact your doctor immediately if you develop swelling in the face, mouth, or throat, as this 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, 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 hesitation)
• severe 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 side effects, consult your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fesoterodina Teva

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

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

Fesoterodina Teva 8 mg:

This medication does not require any special storage temperature

Keep the blister pack perfectly closed to protect it from moisture

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. If in doubt, 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 Fesoterodina Teva

The active substance is fesoterodine fumarate.

Fesoterodina Teva 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:

Core tablet: dibehenate of glycerol, hypromellose, talc, lactose monohydrate (see section 2 "Fesoterodina Teva contains lactose and sodium"), and microcrystalline cellulose

Coating: polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylate, sodium lauryl sulfate, aluminum lake indigo carmine (E132), and red iron oxide (E172)

Appearance and package contents

Fesoterodina Teva 8 mg prolonged-release tablets EFG

The 8 mg film-coated tablets are blue, oval, biconvex, and engraved with the number "8" on one side.

Fesoterodina Teva is available in packs of 10, 14, 20, 28, 30, 40, 42, 50, 56, 60, 70, 80, 84, 90, 98, 100 prolonged-release tablets in perforated and non-perforated OPA/Alu/PVC-Aluminum blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturer

Rontis Hellas, Medical and Pharmaceutical Products S.A.,

Larissa Industrial Area, P.O. Box 3012,

Larissa, 41 500,

Greece

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

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108, Madrid (Spain)

Date of last revision of this leaflet:June 2024

Other sources of information

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