FESOTERODINE ALTER 4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Fesoterodina Alter 4 mg prolonged-release tablets EFG

Fesoterodina Alter 8 mg prolonged-release tablets EFG

Fesoterodina, fumarate

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

This medicine contains the active substance fesoterodine fumarate and is a treatment called an antimuscarinic, which reduces the activity of the overactive bladder and is used in adults to treat the symptoms.

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

• being unable to control when to urinate (urge incontinence)
• a sudden need to urinate (urgency)
• having to urinate more often than usual (increased frequency of urination).

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

Do not take Fesoterodina Alter

• if you are allergic to fesoterodine or any of the other ingredients of this medicine (listed in section 6) (see section 2, “Fesoterodina Alter contains fructose and lactose”)
• if you cannot empty your bladder completely (urinary retention)
• if your stomach empties slowly (gastric retention)
• if you have a eye disease called narrow-angle glaucoma (increased eye pressure) that is not controlled (treated properly)
• if you have excessive muscle weakness (myasthenia gravis)
• if you have 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 that contain 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) and nefazodone (used to treat depression).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fesoterodina Alter.

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

• if you have difficulty emptying your bladder completely (for example, due to an enlarged prostate)
• if you have ever suffered from decreased intestinal movements or if you have severe constipation
• if you are being treated for a eye disease 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 disease called autonomic neuropathy that causes symptoms such as changes in blood pressure or alterations in bowel or sexual function
• if you have a gastrointestinal disease that affects the passage and/or digestion of food
• if you suffer from heartburn or belching
• if you have a urinary tract infection, your doctor may need to prescribe you antibiotics.

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 Alter

Tell your doctor or pharmacist if you are taking or have recently taken or may need to 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 more severe or frequent drowsiness 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 indicate to 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), 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 this medicine.

Driving and using machines

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

Fesoterodina Alter contains fructose and lactose

If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine.

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

3. How to take Fesoterodina Alter

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

The recommended initial dose is one 4 mg fesoterodine tablet per day. Depending on how you respond to the medicine, your doctor may prescribe a higher dose; one 8 mg fesoterodine tablet per day.

Swallow the tablet whole with a glass of water. Do not chew the tablet. This medicine 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 Alter than you should

If you have taken more tablets than you should or if someone else has taken your tablets by mistake, contact your doctor or hospital immediately. Show them the package of the 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 Alter

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 Alter

Do not stop taking fesoterodine without talking to your doctor first, as the symptoms of overactive bladder may return or worsen when you stop taking this medicine.

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, severe allergic reactions including angioedema may occur. You should stop taking this medicine and contact your doctor immediately 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 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 (urinary hesitation)
• 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)

• urticaria
• 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fesoterodina Alter

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 packaging and on the blister, after “EXP”. The expiry date is the last day of the month stated.

Do not store above 25°C.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and 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 Alter

• The active substance is fesoterodine fumarate.

Fesoterodina Alter 4 mg: Each prolonged-release tablet contains 4 mg of fesoterodine fumarate, equivalent to 3.1 mg of fesoterodine.

Fesoterodina Alter 8 mg: 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: fructose, lactose monohydrate-microcrystalline cellulose spheres, hypromellose, dibehenate of glycerol, talc.

Coating of the tablet: poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc and carmine indigo (E132).

Appearance of the product and contents of the pack

Fesoterodina Alter 4 mg: film-coated tablets, 13.1 x 6.0 mm, blue, elliptical, biconvex, with the engraving “F4” on one side.

Fesoterodina Alter 8 mg: film-coated tablets, 13.1 x 6.0 mm, dark blue, elliptical, biconvex, with the engraving “F8” on one side.

Fesoterodina Alter is available in aluminum-aluminum blisters, in packs containing 28 tablets.

Marketing authorisation holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo 6

28760 Tres Cantos, Madrid

Spain

Or

Laboratorios Liconsa, S.A.

Avda. Miralcampo 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Date of last revision of this leaflet

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