Fesoterodine Alter 8 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Fesoterodine Alter 4 mg prolonged-release tablets EFG

Fesoterodine Alter 8 mg prolonged-release tablets EFG

Fesoterodine fumarate

Read the 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, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

Fesoterodine 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 Fesoterodine Alter

Do not take Fesoterodine Alter

• if you are allergic to fesoterodine or to any of the other ingredients of this medicine (listed in section 6) (see section 2, “Fesoterodine Alter contains fructose and lactose”)
• if you cannot completely empty your bladder (urinary retention)
• if your stomach empties slowly (gastric retention)
• if you have a narrow-angle glaucoma (an eye condition involving increased intraocular pressure) that is not controlled (adequately treated)
• if you have a condition causing excessive muscle weakness (myasthenia gravis)
• if you have severe ulcerative colitis (ulceration and inflammation of the colon)
• if you have an abnormally long or dilated colon (toxic megacolon)
• if you have severe liver problems
• if you have severe 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 taking Fesoterodine Alter.

Fesoterodine may not always be suitable for you. Speak with your doctor before taking fesoterodine if any of the following apply:

• if you have difficulty completely emptying your bladder (for example, due to an enlarged prostate)
• if you have ever experienced reduced intestinal motility or suffer from severe constipation
• if you are being treated for narrow-angle glaucoma (an eye condition)
• 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 that causes symptoms such as changes in blood pressure or disturbances in your bowel or sexual function
• 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 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 Fesoterodine Alter

Tell 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 you can use fesoterodine together with other medicines.

Please inform your doctor if you are taking any of the following medicines. Taking these medicines at the same time as fesoterodine may cause adverse effects such as dry mouth, constipation, difficulty completely emptying the bladder, 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 antipsychotics

Please tell 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 perforatum), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, or 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 treat depression), quinidine (used to treat arrhythmias), or 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 are planning 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 not known whether fesoterodine is excreted in breast milk; therefore, do not breastfeed while taking this medicine.

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.

Fesoterodine Alter contains fructose and lactose

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

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

3. How to take Fesoterodina Alter

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

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

You should 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 prescribed, 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, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Fesoterodina Alter

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 missed doses.

If you stop taking Fesoterodina Alter

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 this medicine.

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 may cause adverse effects, although not everyone will experience them.

Some adverse effects may be serious

• In rare cases, severe allergic reactions including angioedema may occur. You must stop taking this medicine 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 experience dry mouth. This effect is usually mild or moderate. It may increase the risk of dental caries. Therefore, you should routinely brush your teeth twice daily and consult 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
• altered taste sensation (dysgeusia)
• vertigo
• skin rash
• dry skin
• itching
• stomach discomfort
• gas (flatulence)
• difficulty completely emptying the bladder (urinary retention)
• delayed urination (hesitancy)
• 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fesoterodine 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 outer packaging and on the blister, following "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater 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 unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fesoterodina Alter

• The active substance is fumarate of fesoterodine.

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 components are:

Tablet core: fructose, spheres of monohydrate lactose-microcrystalline cellulose, hypromellose, glyceryl dibehenate, talc.

Tablet coating: poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc and indigo carmine (E132).

Appearance of the product and contents of the pack

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

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

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

Marketing Authorization 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 the most recent revision of this summary:

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