FESOTERODINE TEVA 4 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Fesoterodina Teva

Do not take fesoterodine if:

• you are allergic to fesoterodine or any of the other ingredients of this medicine (listed in section 6) (see section 2, "Fesoterodina Teva contains lactose and sodium")
• you cannot empty your bladder completely (urinary retention)
• your stomach empties slowly (gastric retention)
• you have a certain 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 medicines that contain 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), 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 emptying your bladder completely (for example, due to an enlarged prostate)
• if you have ever suffered from decreased intestinal movement or if you have severe constipation
• if you are being treated for a certain 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 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 you antibiotics.

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

• you have an abnormal ECG (heart activity record) known as QT interval prolongation or if you are taking any medicine 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 heartbeat, 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 medicine to children and adolescents under 18 years of age because it has not been established whether it works and is safe for them.

Other medicines and Fesoterodina Teva

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

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

• Medicines that contain the active substance amantadine (used to treat Parkinson's disease).
• Certain medicines used to increase gastrointestinal motility or to relieve stomach cramps or spasms, such as medicines that contain metoclopramide.
• Certain medicines used to treat psychiatric disorders, such as antidepressants and antipsychotics.

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

• Medicines 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)
• Medicines 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 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 quit smoking or treat depression), quinidine (used to treat arrhythmias), and cinacalcet (used to treat hyperparathyroidism).
• Medicines that contain the active substance methadone (used to treat severe pain and drug addiction).

Pregnancy, breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Fesoterodine 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 medicine.

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

3. How to take Fesoterodina Teva

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended initial dose of fesoterodine is one 4 mg tablet per day. Depending on how you respond to the medicine, 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. Fesoterodine 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 Fesoterodina Teva than you should

If you have taken more tablets than you should or if someone else has taken your tablets, contact your doctor or hospital immediately. Show them the pack 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 medicine and the amount ingested.

If you forget to take Fesoterodina Teva

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 Teva

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious

Rarely, severe allergic reactions may occur, including angioedema. You should 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 may increase the risk of tooth decay. Therefore, you should brush your teeth regularly, twice a day, and visit a dentist if you have any doubts.

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 completely (urinary retention)
• delayed urination (urinary retardation)
• 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)

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

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fesoterodina Teva

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

Do not use this medicine after the expiry date which is stated on the blister and carton after "EXP". The expiry date is the last day of the month shown.

Fesoterodina Teva 4 mg:

Do not store above 30°C.

Keep the blister perfectly closed to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fesoterodina Teva

The active substance is fesoterodine fumarate.

Fesoterodina Teva 4 mg prolonged-release tablets EFG

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

The other ingredients are:

Core of the 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, and aluminum lake crimson (E132)

Appearance and packaging

Fesoterodina Teva 4 mg prolonged-release tablets EFG

The 4 mg film-coated tablets are light blue, oval, biconvex, and engraved with the number "4" 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 obtain further information on this medicine 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 on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es