Leaflet: information for the user

Fesoterodine fumarate 8 mg prolonged-release EFG tablets

fesoterodine fumarate

Read this leaflet carefully before you start taking this medicine, because 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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Fesoterodina cinfa 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 cinfa 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 Fesoterodina cinfa:

• If you are allergic to fesoterodina or to any of the other components of this medication (listed in section 6) (see section 2, “Fesoterodina cinfa contains lactose and sodium”).
• If you cannot empty your urinary bladder completely (urinary retention).
• If your stomach empties slowly (gastroparesis).
• If you have a narrow-angle glaucoma (increased intraocular pressure) that is not controlled (adequately treated).
• If you have a severe weakness of the muscles (myasthenia gravis).
• If you have a severe ulceration and inflammation of the colon (severe ulcerative colitis).
• If you have a toxic megacolon (abnormally long or dilated colon).
• If you have a severe liver problem.
• If you have a kidney problem or a moderate to severe liver problem 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

Consult your doctor or pharmacist before starting to take fesoterodina.

Fesoterodina may not be suitable for you at all times.Inform your doctorbefore taking fesoterodina in any of the following cases:

• If you have difficulty emptying your urinary bladder completely (for example, due to an enlarged prostate);
• If you have ever experienced a decrease in bowel movements or if you have severe constipation;
• If you are receiving treatment for a condition 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 condition called autonomic neuropathy that causes symptoms such as changes in your blood pressure or alterations in your intestine or sexual function;
• If you have a gastrointestinal disease that affects the passage and/or digestion of food;
• If you experience heartburn or belching;
• If you have a urinary tract infection, your doctor may need to prescribe antibiotics.

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

• You have an ECG abnormality known as prolonged QT interval or if you are taking any medication that is known to produce 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 hypopotasemia, which is a manifestation of abnormally low levels of potassium in the blood.

Children and adolescents

Do not give this medication to children and adolescents under 18 years of age because its safety and efficacy have not been established in this age group.

Other medications and Fesoterodina cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Your doctor will tell you if you can use fesoterodina with other medications.

Please inform your doctor if you are taking medications from the list below. Taking these medications at the same time as fesoterodina may produce adverse effects such as dry mouth, constipation, difficulty emptying your urinary bladder completely, or more severe or frequent drowsiness.

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

Please also inform your doctor if you are taking any of the following medications:

• Medications that contain any of the following active ingredients that may increase the metabolism of fesoterodina and, therefore, reduce its effect: St. John's Wort (hypericum, plant-based medication), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy);
• Medications that contain any of the following active ingredients that may increase fesoterodina 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 to treat depression), quinidine (used to treat arrhythmias), and cinacalcet (used to treat hyperparathyroidism);
• Medications that contain the active ingredient methadone (used to treat severe pain and addiction problems).

Pregnancy and breastfeeding

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

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

The safety of fesoterodina during breastfeeding is unknown; therefore, do not breastfeed during treatment with fesoterodina.

Driving and operating machinery

Fesoterodina 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 told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Fesoterodina cinfa contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult 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 medication, your doctor may prescribe a higher dose; one 8 mg tablet per day.

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 medication, it may be easier to take it at the same time every day.

If you take more Fesoterodine cinfa than you should

If you have taken more tablets than you were told to take or if someone else has accidentally taken your tablets, 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 forgot to take Fesoterodine 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 missed doses.

If you interrupt treatment with Fesoterodine cinfa

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 medicines, this medicine may cause side effects, although not everyone will experience them.

Some side effects can be serious

In rare cases, severe allergic reactions including angioedema may occur. Stop taking fesoterodine and immediately contact your doctor if you develop swelling in 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 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
• Unpleasantness (nausea)
• Difficulty sleeping (insomnia)
• Dry throat

Uncommon(may affect up to 1 in 100 people)

• Urinary tract infection
• Drowsiness
• Difficulty tasting (dysgeusia)
• Dizziness
• Rash
• Dry skin
• Itching
• Discomfort in the stomach
• Gas (flatulence)
• Difficulty completely emptying the urinary bladder (urinary retention)
• Delay in urinating (difficulty initiating urination)
• Intense fatigue (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)

• Urticaria
• Confusion

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for 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 medicine.

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

Do not use this medication after the expiration date that appears on the packaging and in the blister pack, after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Fesoterodine Cinfa Composition

• The active ingredient is fesoterodine fumarate. 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, lactose monohydrate (see section 2 “Fesoterodine Cinfa contains lactose and sodium”)/microcrystalline cellulose, hypromellose, and talc.

Covering: polyvinyl alcohol, talc, titanium dioxide (E-171), monocaprilocaprato of glycerol (Type I), sodium laurilsulfate, aluminum carmine lake (E-132) and iron oxide red.

Product Appearance and Packaging Contents

Prolonged-release tablets of blue color, oval, biconvex, coated with a film and marked on one face with the number “8”.

Fesoterodine Cinfa is available in OPA/Alu/PVC-Alu blister packs in containers that contain10, 14, 20, 28, 30, 40, 42, 50, 56, 60, 70, 80, 84, 90, 98 and 100prolonged-release tablets.

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Cinfa, S.A

Carretera Olaz-Chipi, 10. Industrial Area Areta

31620 Huarte (Navarra) – Spain

Responsible Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.

Larissa Industrial Area, P.O. Box 3012,

Larissa, 41 500, Greece

or

Cinfa, S.A

Carretera Olaz-Chipi, 10.Industrial Area Areta

31620 Huarte (Navarra) – Spain

Last Review Date of this Leaflet: 04/2021

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your 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