Fesoterodine Normon 8 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fesoterodine Normon 8 mg prolonged-release tablets EFG

Fesoterodine fumarate

Read the entire leaflet carefully before you start taking this medicine, because 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 other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Fesoterodine Normon contains an active substance called fesoterodine fumarate and is a treatment belonging to a class of medicines known as antimuscarinics, which reduce the activity of the overactive bladder. It is used in adults to treat symptoms.

Fesoterodine Normon 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 Fesoterodina Normon

Do not take Fesoterodina Normon if:

• you are allergic to fesoterodine or to any of the other ingredients of this medicine (listed in section 6) (see section 2, “Fesoterodina Normon contains lactose and fructose”)
• you cannot completely empty your urinary bladder (urinary retention)
• your stomach empties slowly (gastric retention)
• you have a type of eye disease called narrow-angle glaucoma (increased eye pressure) that is not controlled (adequately treated)
• you have a condition causing excessive muscle weakness (myasthenia gravis)
• you have 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 containing any of the following active substances: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir, or nelfinavir (antiviral medicines to treat HIV infection), clarithromycin or telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression).

Warnings and precautions

Fesoterodine may not always be suitable for you. Talk to your doctor before taking this medicine if any of the following apply to you:

• if you have difficulty completely emptying your urinary bladder (for example, due to an enlarged prostate)
• if you have ever had reduced intestinal movements or suffer from severe constipation
• if you are being treated for a type of eye disease called narrow-angle glaucoma
• 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 your blood pressure or disturbances in your bowel or sexual function
• if you have a gastrointestinal disease 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:

• you have an abnormal ECG (electrocardiogram, a recording of the heart's activity) known as QT interval prolongation, or if you are taking any medicine known to cause 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 condition characterized by abnormally low levels of potassium in the blood

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age, as it has not yet been established whether it is effective or safe for them.

Other medicines and Fesoterodina Normon

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 together with fesoterodine may cause adverse effects such as dry mouth, constipation, difficulty completely emptying the urinary 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, and those used to prevent travel sickness, such as medicines containing 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 containing any of the following active substances, which may increase the metabolism of fesoterodine and therefore reduce its effect: St. John’s wort (Hypericum perforatum), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among other conditions, to treat epilepsy)
• medicines containing any of the following active substances, which 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 stop smoking or to treat depression), quinidine (used to treat arrhythmias), and cinacalcet (used to treat hyperparathyroidism)
• medicines containing the active substance methadone (used to treat severe pain and in drug dependency treatment)

Pregnancy and breastfeeding

You should not take this medicine if you are pregnant, as the effects of fesoterodine in pregnancy and on the newborn infant are unknown.

It is not known 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and use of machines

This medicine may cause blurred vision, dizziness, and somnolence. 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 informed you of an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Fesoterodina Normon

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

The recommended starting 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 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Fesoterodina Normon

If you forget to take a tablet, take it as soon as you remember, but do not take more than one tablet per day. Do not take a double dose to make up for forgotten doses.

If you stop taking Fesoterodina Normon

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

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 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. You must stop taking this medicine and contact your doctor immediately if you develop swelling of the face, mouth, or throat.

Other side effects

Very common (may affect more than 1 in 10 people):

You may experience dry mouth. This effect is usually mild or moderate. This may increase the risk of dental caries. Therefore, you should regularly brush your teeth twice a day and visit 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
• diarrhea
• malaise (nausea)
• difficulty sleeping (insomnia)
• dry throat

Uncommon (may affect up to 1 in 100 people):

• urinary tract infection
• somnolence
• difficulty tasting (dysgeusia)
• vertigo
• skin rash
• dry skin
• itching
• sensation of stomach discomfort
• gas (flatulence)
• difficulty completely emptying the urinary bladder (urinary retention)
• delay in 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You may also report them directly through the Spanish System of Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fesoterodine 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 on the blister pack, after "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 located at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fesoterodina Normon

The active substance is fumarate of fesoterodine.

Each prolonged-release tablet contains 8 mg of fesoterodine fumarate, equivalent to 6.2 mg of fesoterodine.

The other components are:

Tablet core: fructose, monohydrate lactose/microcrystalline cellulose (75:25), hypromellose, glyceryl dibehenate 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 tablets marked with "F8" 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 the most recent review of this leaflet: February 2025

Other sources of information

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

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