FESOTERODINE NORMON 4 mg PROLONGED-RELEASE TABLETS

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 cannot empty your urinary bladder completely (urinary retention)
• your stomach empties slowly (gastric retention)
• you have an 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 ulceration and inflammation of the colon (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 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 for treating 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 urinary bladder completely (for example, due to prostate enlargement)
• 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 suffer from 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 ECG abnormality (heart activity record) known as QT interval prolongation or if you are taking any medication that is known to cause 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 inform your doctor if you are taking medications from the list below. Taking these medications 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.

• medications containing the active ingredient amantadine (used to treat Parkinson's disease).
• certain medications used to increase gastrointestinal motility or to relieve stomach cramps or spasms, such as medications containing 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 containing 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)
• medications 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 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 treat depression), quinidine (used to treat arrhythmias), and cinacalcet (used to treat hyperparathyroidism).
• medications containing the active ingredient methadone (used to treat intense 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 plan to become pregnant, consult your doctor or pharmacist before using 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 operate 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 certain 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 easier 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 other questions about the use of this medicine, 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 may occur, including angioedema. 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
• skin rash
• dry skin
• itching
• stomach discomfort
• gas (flatulence)
• difficulty emptying the bladder completely (urinary retention)
• delayed urination (urinary retardation)
• intense 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 Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This 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 4 mg of fesoterodine fumarate, equivalent to 3.1 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 4 mg prolonged-release tablets are blue, elliptical, biconvex, and have F4 marked on one side.

Each pack contains 28 prolonged-release tablets.

Marketing authorization 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 about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es.

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85913/P_85913.html