Prospect: information for the patient

Fesoterodine Alter 4 mg prolonged-release EFG tablets

Fesoterodine Alter 8 mg prolonged-release EFG tablets

Fesoterodine, fumarate

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must 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 not listed in this prospect. See section 4.

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.

Fesoterodine 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 Alter

• if you are allergic to fesoterodina or any of the other components of this medication (listed in section 6) (see section 2, “Fesoterodina Alter contains fructose and lactose”)
• if you are unable to completely empty your urinary bladder (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 myasthenia gravis (severe muscle weakness)
• if you have severe ulcerative colitis (inflammation and ulceration of the colon)
• if you have a toxic megacolon (abnormally long or dilated colon)
• if you have severe liver disease
• if you have kidney problems or moderate to severe liver disease 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 Alter.

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

• if you have difficulty emptying your urinary bladder (e.g., 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 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 blood pressure or alterations in the 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.

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

• you have a known ECG abnormality called 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 condition 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 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 Alter

Inform your doctor or pharmacist if you are taking or 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 the urinary bladder, 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 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 fesoterodina and, therefore, reduce its effect: St. John's Wort (hypericum), 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 lactation

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.

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

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 Alter contains fructose and lactose

If your doctor has indicated that you (or your child) have a condition that makes you intolerant to certain sugars, or if you 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 medication.

This medication contains lactose. If your doctor has indicated that you are intolerant to certain sugars, consult with them before taking this medication.

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 is one 4 mg fesoterodina tablet per day. Depending on how you respond to the medication, your doctor may prescribe a higher dose; one 8 mg fesoterodina 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 Alter than you should

If you have taken more tablets than you were told to take or if someone else has taken your tablets by mistake, 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication 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 missed doses.

If you interrupt treatment with Fesoterodina Alter

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

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 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 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
• Feeling of discomfort in the stomach
• Gas (flatulence)
• Difficulty emptying the bladder completely (urinary retention)
• Delay in urinating (retardation)
• 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 prospectus. You can also report them directly through the Spanish System for the 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 on the blister, 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. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Fesoterodina Alter

• The active principle is fumarate of fesoterodina.

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

Fesoterodina Alter 8 mg: Each prolonged-release tablet contains 8 mg of fumarate of fesoterodina, equivalent to 6.2 mg of fesoterodina.

• The other components are:

Tablet core: fructosa, lactose monohydrate-celulose microcrystalline spheres, hypromellose, dibehenato of glycerol, talc.

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

Appearance of the product and content of the container

Fesoterodina Alter 4 mg: Film-coated tablets, 13.1 x 6.0 mm, blue, eliptical, biconvex, with the engraving “F4” on one of the faces.

Fesoterodina Alter 8 mg: Film-coated tablets, 13.1 x 6.0 mm, dark blue, eliptical, biconvex, with the engraving “F8” on one of the faces.

Fesoterodina Alter is available in aluminum-aluminum blisters, in containers that contain 28 tablets.

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

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

Last review date of this leaflet:

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