FESOTERODINE NORMON 8 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Fesoterodina Normon 8 mg prolonged-release tablets EFG

Fesoterodine fumarate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 Normon and what is it used for
2. What you need to know before you take Fesoterodina Normon
3. How to take Fesoterodina Normon
4. Possible side effects
5. Storage of Fesoterodina Normon
6. Contents of the pack and other information

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

Fesoterodina Normon 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 symptoms.

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

• inability to control when to urinate (urgency incontinence)
• sudden need to urinate (urgency)
• having to urinate more frequently than usual (increased urination frequency).

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

Do not take Fesoterodina Normon if:

• you are allergic to fesoterodine or any of the other ingredients of this medicine (listed in section 6) (see section 2, "Fesoterodina Normon contains lactose and fructose")
• you are unable to empty your bladder completely (urinary retention)
• your stomach empties slowly (gastric retention)
• you have a eye disease called narrow-angle glaucoma (increased eye pressure) that is not controlled (treated properly)
• you have excessive muscle weakness (myasthenia gravis)
• you have severe ulcerative colitis
• you have an abnormally long or dilated colon (toxic megacolon)
• you have severe liver problems
• 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

Fesoterodina may not always be suitable for you. Talk to your doctor before taking this medicine 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 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 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 you antibiotics

Heart problems: Tell your doctor if you have any of the following conditions:

• you have an ECG abnormality (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 can work and whether it would be safe for them.

Other medicines and Fesoterodina Normon

Tell your doctor or pharmacist if you are taking or have recently taken or may need to take other medicines. Your doctor will tell you if you can use Fesoterodina with other medicines.

Please tell 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 tell 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 dependence).

Pregnancy and breastfeeding

You should not take this medicine 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 fesoterodine.

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.

Driving and using machines

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

Fesoterodina Normon contains lactose and fructose

Fesoterodina Normon contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Fesoterodina Normon contains 72 mg of fructose per prolonged-release tablet.

3. How to take Fesoterodina Normon

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 of Fesoterodina Normon is one 4 mg tablet per day. Depending on how you respond to the medicine, 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. Fesoterodina Normon can be taken with or without food.

To help you remember to take your medicine, it may be more convenient to take it at the same time every day.

If you take more Fesoterodina Normon than you should

If you have taken more tablets than you should or if someone else has taken your tablets, 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 Normon

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 Normon

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

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 cause a higher risk of tooth decay. Therefore, you should brush your teeth habitually twice a day and visit a dentist in case of 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
• 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
• discomfort in the stomach
• gas (flatulence)
• difficulty emptying the bladder completely (urinary retention)
• delayed urination (urinary retardation)
• 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)

• hives
• confusion

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fesoterodina Normon

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 carton and blister, after "EXP". The expiry date is the last day of the month stated.

Do not store above 25°C.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Fesoterodina Normon

The active substance is fesoterodine fumarate.

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 (75:25), hypromellose, dibehenate of glycerol and talc.

Coating: Opadry II White 85F18422 (containing polyvinyl alcohol, titanium dioxide (E-171), macrogol 4000 and talc), indigo carmine lake (E-132) and talc.

Appearance of Fesoterodina Normon and contents of the pack

Fesoterodina Normon 8 mg prolonged-release tablets are dark blue, elliptical, biconvex and have F8 marked on one face.

Each pack contains 28 prolonged-release tablets.

Marketing authorisation holder and manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760, Tres Cantos

Madrid (Spain)

Date of last revision of this leaflet: February 2025

Other sources of information

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85912/P_85912.html.