Prospect: information for the patient

Fesoterodine Teva 8 mg prolonged-release tablets EFG

fesoterodine fumarate

Read this prospect carefully before starting to use this medication, because

it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Fesoterodina Teva contains an active ingredient called fesoterodine fumarate and is a treatment for the so-called antimuscarinics, which reduce the activity of overactive bladder and is used in adults to treat symptoms.

Fesoterodina treats the symptoms of overactive bladder, such as:

• not being able to control when to urinate (urge incontinence)
• the sudden need to urinate (urgency)
• having to urinate more frequently than usual (increased urinary frequency)

Do not take fesoterodine if:

• You are allergic to fesoterodine or any of the other ingredients in this medicine (listed in section 6)(see section2, “Fesoterodine Teva contains lactose and sodium”)
• You cannot empty your bladder completely (urinary retention)
• Your stomach empties slowly (gastroparesis)
• You have a narrow-angle glaucoma (increased eye pressure) that is not controlled (adequately treated)
• You have myasthenia gravis (severe muscle weakness)
• You have a severe ulcerative colitis (inflammation of the colon)
• You have a toxic megacolon (abnormally long or dilated colon)
• You have a severe liver problem
• You have a kidney problem or a moderate or severe liver problem 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 (medicines used to treat HIV infection), clarithromycin or telithromycin (used to treat bacterial infections), and nefazodone (used to treat depression)

Warnings and precautions

Fesoterodine may not be suitable for you.Talk to your doctorbefore takingFesoterodinein any of the following cases:

• If you have difficulty emptying your bladder completely (e.g., due to an enlarged prostate)
• If you have ever had a decrease in bowel movements or if you have severe constipation
• If you are being treated for a 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 condition 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 have heartburn or belching
• If you have a urinary tract infection, your doctor may need to prescribe antibiotics

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

• You have an abnormal ECG (heart activity recording) known as prolonged QT interval 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 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 medicine to children and adolescents under 18years of age because it has not yet been established whether it works and if it would be safe for them.

Other medicines and Fesoterodine Teva

Inform your doctor or pharmacist if you are taking or have recently takenor may need to takeother medicines.Your doctor will tell you if you can usefesoterodine 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 produce side effects such as dry mouth, constipation, difficulty emptying the bladder completely, or more severe or more frequent drowsiness.

• Medicines that contain the active ingredient amantadine (used to treat Parkinson's disease)
• Certain medicines used to increase gastrointestinal motility or to relieve stomach cramps or spasms, and those that prevent motion sickness, such as medicines that contain metoclopramide
• Certain medicines used to treat psychiatric disorders, such as antidepressants and neuroleptics

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

• Medicines that contain any of the following active ingredients that may increase the metabolism of fesoterodine and, therefore, reduce 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 ingredients that may increase fesoterodine levels in the blood: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir, or nelfinavir (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 to treat depression), quinidine (used to treat arrhythmias), and cinacalcet (used to treat hyperparathyroidism)
• Medicines that contain the active ingredient methadone (used to treat severe pain and addiction problems)

Pregnancy,breastfeeding

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

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

The excretion of fesoterodine in breast milk is unknown; therefore, do not breastfeed during treatment with fesoterodine.

Driving and operating machines

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

Fesoterodine Teva contains lactose and sodium

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

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

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

The recommended initial dose of fesoterodine is one 4 mg tablet per day. Your doctor may prescribe a higher dose, one 8 mg tablet per day, depending on your response to the medication.

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 medication, it may be easier 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 were told to take or if someone else has taken your tablets by mistake, contact your doctor or hospital immediately. Show them the packaging of the tablets.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take fesoterodine

If you forget 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 missed doses.

If you interrupt treatment with fesoterodine

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

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Some side effects can be serious

In rare cases, severe allergic reactions may occur, including angioedema. Stop taking fesoterodine and immediately contact your doctor if you develop swelling in your 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 in doubt.

Common(may affect up to 1 in 10 people)

• dry eyes
• constipation
• digestive problems (dyspepsia)
• pain or discomfort while 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)
• dizziness
• skin rash
• dry skin
• itching
• feeling of discomfort in the stomach
• gas (flatulence)
• difficulty emptying the bladder completely (urinary retention)
• delayed urination (retardation)
• intense fatigue
• increased heart rate (tachycardia)
• palpitations
• liver problems
• cough
• dry nose
• throat pain
• acid reflux from the stomach
• 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 type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the blister pack and on the box after “CAD or EXP”. The expiration date is the last day of the month indicated.

Fesoterodine Teva 8 mg:

This medication does not require any special storage temperature

Keep the blister pack perfectly closed to protect it from moisture

Medicines should not be thrown down the drains or in the trash.Dispose of the containers and medicines that you no longer need at the SIGRE collection point at the pharmacy.In case of doubt,ask your pharmacist how to dispose ofthe containers and medicines that you no longerneed.This will help protect the environment.

Composition of Fesoterodina Teva

The active ingredient 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:

Tablet core: dibehenato 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),monocaprilocaprato of glycerol, sodium lauryl sulfate, aluminum lake of indigo carmine (E132) and iron oxide red (E172)

Appearance of the product and contents of the packaging

Fesoterodina Teva 8 mg prolonged-release tablets EFG

The coated tablets of 8 mg are blue, oval, biconvex, and on one face are engraved with the number “8”.

Fesoterodina Teva is available in packaging 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 blisters of OPA/Alu/PVC-Aluminum.

Only some sizes of packaging may be commercially marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Responsible for manufacturing:

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

Larissa Industrial Area, P.O. Box 3012,

Larissa, 41 500,

Greece

For further information about this medicinal product, please contact 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)

Last revision date of this leaflet:June 2024

Other sources of information

The detailed information about this medicinal product is available on the website of theSpanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es