Prospecto:Information for the Patient

Fesoterodine Aurovitas 4 mg prolonged-release tablets EFG

Fesoterodine Aurovitas 8 mg prolonged-release tablets EFG

Fesoterodine, fumarate

Read this prospectus carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctororpharmacist.

-This medicine has been prescribedonlyto you, and you must not give it to other people even if they havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this prospectus. See section 4.

1.What is Fesoterodine Aurovitas and what is it used for

2.What you need to knowbeforestarting totake Fesoterodine Aurovitas

3.How to take Fesoterodine Aurovitas

4.Possible adverse effects

5Storage of Fesoterodine Aurovitas

6.Contents of the package and additional information

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

This medication treats the symptoms of an 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 Aurovitas:

• if you are allergic to fesoterodine, fructose or any of the other ingredients of this medication (listed in section 6) (see section 2, “Fesoterodina Aurovitas contains lactose and fructose”),
• if you cannot completely empty your bladder (urinary retention),
• if your stomach empties slowly (gastroparesis),
• if you have a narrow-angle glaucoma (increased eye pressure) that is not controlled,
• if you have a severe muscle weakness (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 or 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

Fesoterodine may not be suitable for you.Inform your doctorbefore starting to take this medicationin any of the following cases:

• if you have difficulty emptying your 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 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 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 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:

• if you have a known ECG anomaly called prolonged QT interval or if you are taking any medication that is known to cause this effect,
• if your heart rate is slow (bradycardia),
• if you have a heart disease such as myocardial ischemia (reduced blood flow to the heart), irregular heartbeats or heart failure,
• if you have hypokalemia, which is a manifestation of abnormally low potassium levels in the blood.

Children and adolescents

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

Other medications and Fesoterodina Aurovitas

Inform your doctor or pharmacist if you aretaking,havetakenrecentlyor may need to takeany other medication.Your doctor will tell you if you can use fesoterodine with other medications.

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

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

Please indicate to 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 fesoterodine and, therefore, reduce its effect: St. John's Wort (herbal medicine), 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 fesoterodine 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, lactation and fertility

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

Fesoterodine is unknown to be excreted in breast milk; therefore, do not breastfeed during treatment with this medication.

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

Driving and operating machines

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

Fesoterodina Aurovitas contains lactose and fructose

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

Fructose

This medication contains 72 mg of fructose per tablet. Fructose may damage teeth.

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

The recommended initial dose of this medication 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.

Swallow the tablet whole with a glass of water. Do not chew the tablet. This medication 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 Fesoterodina Aurovitas 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 forget to take Fesoterodina Aurovitas

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 Fesoterodina Aurovitas

Do not stop treatment with fesoterodina without first talking to your doctor, as symptoms of overactive bladder may return or worsen when treatment with this medication 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 including angioedema may occur. You should stop taking this medication and immediately contact your doctor if you develop swelling in the face, mouth, or throat, as it may put your life at risk.

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.

Rarely common(may affect up to 1 in 100 people)

• urinary tract infection,
• drowsiness,
• difficulty tasting (dysgeusia),
• vertigo,
• 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)

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

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 prospectus. You can also report them directly through theSpanish System of Pharmacovigilance ofmedicaments for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

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

Do not store above 25 °C.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of through drains or in the trash.Deposit containers and unused medications at the SIGRE collection pointat the pharmacy.Ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Fesoterodine Aurovitas

• The active ingredient is fesoterodine fumarate.

Fesoterodine Aurovitas 4 mg prolonged-release tablets EFG

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

Fesoterodine Aurovitas 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: Fructose, lactose monohydrate, microcrystalline cellulose, hypromellose, glycerol dibehenate, talc.

Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, aluminium lake indigo carmine (E132).

Appearance of the product and contents of the package

Fesoterodine Aurovitas 4 mg prolonged-release tablets EFG

The 4 mg tablets are blue, eliptical, biconvex, film-coated, approximately 6 mm in diameter, and have the letters “F4” engraved on one face and smooth on the other face.

Fesoterodine Aurovitas 8 mg prolonged-release tablets EFG

The 8 mg tablets are dark blue, eliptical, biconvex, film-coated, approximately 6 mm in diameter, and have the letters “F8” engraved on one face and smooth on the other face.

Fesoterodine Aurovitas is available in blister packs of10, 14, 28, 30, 56, 84, 98 or 100 prolonged-release tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

Laboratorios Liconsa S.A.

Avenida Miralcampo 7,

Industrial Estate Miralcampo

Azuqueca de Henares

19200 Guadalajara

Spain

or

Laboratorios Normon S.A.

Ronda Valdecarrizo 6,

28760 Tres Cantos

Madrid

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Spain:Fesoterodine Aurovitas 4 mg prolonged-release tablets EFG

Fesoterodine Aurovitas 8 mg prolonged-release tablets EFG

France:FESOTERODINE ARROW LP 4 mg, prolonged-release tablet

FESOTERODINE ARROW LP 8 mg, prolonged-release tablet

Ireland:Fesoterodine Liconsa 4mg prolonged-release tablets

Fesoterodine Liconsa 8mg prolonged-release tablets

Last review date of thisleaflet: April 2024

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)