FESOTERODINE CINFA 8 mg PROLONGED-RELEASE TABLETS

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

Do not take Fesoterodina Cinfa:

Warnings and precautions

Consult your doctor or pharmacist before starting to take fesoterodine.

Fesoterodine may not always be suitable for you. Inform your doctor before taking fesoterodine in any of the following cases:

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 have 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 18 years of age because it has not been established whether it works and is safe for them.

Other medicines and Fesoterodina Cinfa

Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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 drowsiness more severe or frequent 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 neuroleptics

Please also inform 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, plant-based medicine), 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 and breastfeeding

If you are pregnant or breastfeeding, 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 Cinfa contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Fesoterodina Cinfa contains sodium

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

3. How to take Fesoterodina Cinfa

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

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 Cinfa

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 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, serious allergic reactions including angioedema may occur. You should stop taking fesoterodine and contact your doctor immediately if you develop swelling of 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 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
• stomach discomfort
• gas (flatulence)
• difficulty emptying the bladder completely (urinary retention)
• delayed urination (difficulty starting urination)
• 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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. 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 the 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 Cinfa

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 carton and blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Store in the original package to protect 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 Cinfa

• The active substance is fesoterodine fumarate. Each prolonged-release tablet contains 8 mg of fesoterodine fumarate, equivalent to 6.2 mg of fesoterodine.
• The other ingredients are:

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

Coating: polyvinyl alcohol, talc, titanium dioxide (E-171), glycerol monocaprylate (Type I), sodium lauryl sulfate, aluminum carmine lake (E-132) and red iron oxide.

Appearance and packaging of the product

Prolonged-release tablets are blue, oval, biconvex, film-coated and marked with the number "8" on one side.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.

Larissa Industrial Area, P.O. Box 3012,

Larissa, 41 500, Greece

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of last revision of this leaflet: 04/2021

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/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/86137/P_86137.html

QR code to: https://cima.aemps.es/cima/dochtml/p/86137/P_86137.html