Fesoterodine CINFA 4 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fesoterodina cinfa 4 mg prolonged-release tablets EFG

fesoterodine fumarate

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do 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 adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Fesoterodina cinfa is and what it is used for
2. What you need to know before taking Fesoterodina cinfa
3. How to take Fesoterodina cinfa
4. Possible adverse effects
5. How to store Fesoterodina cinfa
6. Contents of the pack and other information

1. What Fesoterodina cinfa is and what it is used for

Fesoterodina cinfa contains an active substance called fesoterodine fumarate and is an antimuscarinic treatment that reduces the activity of the overactive bladder. It is used in adults to treat symptoms.

Fesoterodina cinfa treats the symptoms of overactive bladder, such as:

• inability to control when to urinate (urge incontinence)
• sudden need to urinate (urgency)
• needing to urinate more frequently than usual (increased urinary frequency).

2. What you need to know before taking Fesoterodina cinfa

Do not take Fesoterodina cinfa:

• If you are allergic to fesoterodine or to any of the other ingredients of this medicine (listed in section 6) (see section 2, “Fesoterodina cinfa contains lactose and sodium”).
• If you are unable to empty your bladder completely (urinary retention).
• If your stomach empties slowly (gastric retention).
• If you have a type of eye disease called narrow-angle glaucoma (increased eye pressure) that is not controlled (adequately treated).
• If you have a condition causing excessive muscle weakness (myasthenia gravis).
• If you have ulceration and inflammation of the colon (severe ulcerative colitis).
• If you have an abnormally long or dilated colon (toxic megacolon).
• If you have severe liver problems.
• If you have kidney problems or moderate to severe liver problems and are taking medicines containing 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), or nefazodone (used to treat depression).

Warnings and precautions

Talk to your doctor or pharmacist before starting fesoterodine.

Fesoterodine may not be suitable for everyone. Inform your doctor before taking fesoterodine if any of the following apply to you:

• if you have difficulty emptying your bladder completely (e.g., due to an enlarged prostate);
• if you have ever experienced reduced intestinal motility or suffer from severe constipation;
• if you are being treated for a type of eye disease called narrow-angle glaucoma;
• if you have severe kidney or liver problems, as your doctor may need to adjust your dose;
• if you have a condition called autonomic neuropathy causing symptoms such as changes in blood pressure, intestinal disturbances, or sexual dysfunction;
• if you have a gastrointestinal disorder affecting the passage and/or digestion of food;
• if you suffer from heartburn or burping;
• if you have a urinary tract infection, your doctor may need to prescribe antibiotics.

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

• a known ECG (electrocardiogram) abnormality called QT interval prolongation, or if you are taking any medicine known to cause this effect;
• a slow heart rate (bradycardia);
• a heart condition such as myocardial ischemia (reduced blood flow to the heart), irregular heartbeat, or heart failure;
• hypokalemia, which is a condition characterized by abnormally low levels of potassium in the blood.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as it has not yet been established whether it is effective or safe for them.

Other medicines and Fesoterodina cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Your doctor will advise you whether fesoterodine can be used together with other medicines.

Please inform your doctor if you are taking any of the following medicines. Taking these medicines together with fesoterodine may cause adverse effects such as dry mouth, constipation, difficulty emptying the bladder completely, or more severe or more frequent drowsiness than usual.

• Medicines containing the active substance amantadine (used to treat Parkinson's disease).
• Certain medicines used to increase gastrointestinal motility or to relieve stomach cramps or spasms, or to prevent travel sickness, such as medicines containing 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 containing any of the following active substances that may increase the metabolism of fesoterodine and thus reduce its effect: St. John’s wort (hypericum, a herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy);
• medicines 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 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 help quit smoking or to treat depression), quinidine (used to treat arrhythmias), and cinacalcet (used to treat hyperparathyroidism);
• medicines containing the active substance methadone (used to treat severe pain and drug dependence).

Pregnancy and breastfeeding

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

You must not take fesoterodine if you are pregnant, as the effects of fesoterodine during pregnancy and on 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 machinery.

Fesoterodina cinfa contains lactose

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

Fesoterodina cinfa contains sodium

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

3. How to take Fesoterodina cinfa

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended starting dose of fesoterodine is one 4 mg tablet daily. Depending on your response to the medication, your doctor may prescribe a higher dose: one 8 mg tablet daily.

You should 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 cinfa than you should

If you have taken more tablets than you were told to take, or if someone else accidentally takes your tablets, contact your doctor or hospital immediately. Show them the tablet packaging.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Fesoterodina cinfa

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 forgotten doses.

If you stop taking Fesoterodina cinfa

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some adverse effects may be serious

Rarely, severe allergic reactions including angioedema may occur. You must stop taking fesoterodine and contact your doctor immediately if you develop swelling of the face, mouth or throat.

Other adverse 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 dental caries. Therefore, you should regularly brush your teeth twice daily 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
• diarrhoea
• malaise (nausea)
• difficulty sleeping (insomnia)
• dry throat

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection
• somnolence
• difficulty tasting (dysgeusia)
• vertigo
• skin rash
• dry skin
• itching
• sensation of stomach discomfort
• gas (flatulence)
• difficulty completely emptying the urinary bladder (urinary retention)
• delayed urination (difficulty initiating micturition)
• severe tiredness (fatigue)
• increased heart rate (tachycardia)
• palpitations
• liver problems
• cough
• dry nose
• sore throat
• acid reflux from the stomach
• blurred vision

Rare (may affect up to 1 in 1,000 people)

• urticaria
• confusion

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fesoterodine cinfa

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

Do not use this medicine after the expiry date stated on the packaging and on the blister, after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fesoterodina cinfa

• The active substance is fumarate of fesoterodine. Each prolonged-release tablet contains 4 mg of fesoterodine fumarate, equivalent to 3.1 mg of fesoterodine.
• The other components are:

Tablet core: glyceryl dibehenate, hypromellose, talc and monohydrate lactose (see section 2 “Fesoterodina cinfa contains lactose and sodium”)/microcrystalline cellulose.

Coating: polyvinyl alcohol, talc, titanium dioxide (E-171), glyceryl monocaprylocaprate (Type I), sodium lauryl sulfate and indigo carmine aluminum lake (E-132).

Appearance of the product and contents of the pack

Prolonged-release tablets, light blue in colour, oval-shaped, biconvex, film-coated, marked with the number “4” 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.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 the most recent revision of this leaflet: 04/2021

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/86136/P_86136.html

QR code to: https://cima.aemps.es/cima/dochtml/p/86136/P_86136.html