Package Insert: Information for the Patient

Fesoterodine Normon 4 mg Extended-Release TabletsEFG

Fesoterodine Fumarate

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Fesoterodine Normon and how is it used

2. What you need to know before starting to take Fesoterodine Normon

3. How to take Fesoterodine Normon

4. Possible adverse effects

5. Storage of Fesoterodine Normon

6. Contents of the package and additional information

Fesoterodina Normoncontains 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.

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

• being unable 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 Normon if:

• You are allergic to fesoterodina or to any of the other components of this medication(including those listed in section 6)(see section2, “Fesoterodina Normon contains lactose and fructose”)
• You cannot completely empty your bladder (urinary retention)
• Your stomach empties slowly (gastroparesis)
• You have a narrow-angle glaucoma (increased eye pressure) that is not controlled (adequately treated)
• You have a severe muscle weakness (myasthenia gravis)
• You have a severe ulceration and inflammation of the colon (severe ulcerative colitis)
• You have a toxic megacolon (abnormally long or dilated colon)
• You have a severe liver problem
• You have a kidney problem or a moderate or severe liver problem 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 HIV infection), clarithromycin or telithromycin (used to treat bacterial infections), and nefazodone (used to treat depression)

Warnings and precautions

Fesoterodina may not be suitable for you.Consult your doctorbefore taking this medication 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 experienced a decrease in bowel movements or if you have severe constipation
• If you are being treated for a 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

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

• You have a heart rhythm abnormality known as prolonged QT interval 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 medication to children and adolescents under 18 years of age because its safety and effectiveness have not been established in this age group.

Other medications and Fesoterodina Normon

Inform your doctor or pharmacist if you are taking or have taken recentlyor may need to takeother medications.Your doctor will tell you if you can useFesoterodina 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 bladder completely, 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 during travel, 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 breastfeeding

You should not take this medication if you are pregnant, as the effects of fesoterodina on pregnancy and the newborn are unknown.

The excretion of fesoterodina in breast milk is unknown; therefore, do not breastfeed during treatment with fesoterodina.

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.

Driving and operating machinery

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

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 medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor.Consult your doctor or pharmacist again if you are unsure.

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

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 medication, 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 were instructed to take or if someone else has accidentally taken your tablets, 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication 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 missed doses.

If you interrupt treatment with Fesoterodina Normon

Do not stop treatment with Fesoterodina Normon without first speaking with your doctor, as symptoms of overactive bladder may return or worsen when treatment with Fesoterodina Normon is interrupted.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can 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, brush your teeth regularly twice a day and visit a dentist if in doubt.

Common(may affect up to 1 in 10 people)

Uncommon(may affect up to 1 in 100 people)

• urinary tract infection
• drowsiness
• difficulty tasting (dysgeusia)
• dizziness
• skin rash
• dry skin
• itching
• feeling of discomfort in the stomach
• gas (flatulence)
• difficulty emptying the bladder completely (urinary retention)
• delayed urination (retardation)
• intense fatigue (fatigue)
• increased heart rate (tachycardia)
• palpitations
• liver problems
• cough
• dryness in the 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 experienceany type of side effect, consult your doctor or pharmacist, even if it is a possibleside effect that does not appear in this prospectus.You can also report them directlythrough the Spanish System for 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 carton and on the blister, after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines that you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Fesoterodina Normon

The active principle is fumarate of fesoterodina.

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

The other components are:

Tablet core: fructosa, lactose monohydrate/microcrystalline cellulose (75:25), hypromellose, glyceryl dibehenate, and talc.

Covering: Opadry II White 85F18422 (containing polyvinyl alcohol, titanium dioxide (E-171), macrogol 4000, and talc), indigotin lacquer (E-132), and talc.

Appearance of Fesoterodina Normon and contents of the packaging

Fesoterodina Normon 4 mg prolonged-release tablets are blue, elliptical, biconvex, and have F4 marked on one face.

Each package contains 28 prolonged-release tablets.

Holder of the marketing authorization and responsible manufacturer

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6

28760, Tres Cantos

Madrid (Spain)

Last review date of this leaflet: February 2025

Other sources of information

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

You can access detailed and updated information about this medication 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