FESOTERODINE ARISTO 8 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Fesoterodine Aristo

Do not take Fesoterodine if:

• you are allergic to fesoterodine or any of the other ingredients of fesoterodine (listed in section 6) (see section 2, “Fesoterodine contains lactose and sodium”)
• you cannot empty your bladder completely (urinary retention)
• your stomach empties slowly (gastric retention)
• you have a certain eye condition called narrow-angle glaucoma (increased eye pressure), which is not well-controlled (treated)
• 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 or 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

Fesoterodine may not always be suitable for you. Talk to your doctor before taking fesoterodine 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 movement or have severe constipation
• if you are being treated for a certain eye 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 bowel 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

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

• you have an abnormal heart rhythm (ECG) 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 condition such as myocardial ischemia (reduced blood flow to the heart), irregular heartbeats, or heart failure
• you have low potassium levels in the blood (hypokalemia)

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 works and is safe for them.

Other medicines and Fesoterodine Aristo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor will tell you whether you can use fesoterodine with other medicines.

Please inform 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.

• 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 thus 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 fesoterodine 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

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

Fesoterodine Aristo contains lactose and sodium

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially, “sodium-free”.

3. How to take Fesoterodine Aristo

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The recommended initial dose of fesoterodine 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.

Swallow the tablet whole with a glass of water. Do not chew the tablet. Fesoterodine 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 Fesoterodine Aristo than you should

If you have taken more tablets than you should or if someone else has taken your tablets, tell your doctor immediately or go to the nearest hospital emergency department. Show them the pack of 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 taken.

If you forget to take Fesoterodine Aristo

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 Fesoterodine Aristo

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

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 fesoterodine 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
• rash
• dry skin
• itching
• stomach discomfort
• gas (flatulence)
• difficulty emptying the bladder completely (urinary retention)
• delayed urination (urinary hesitation)
• extreme 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
• numbness around the mouth (oral hypoesthesia)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use 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 Aristo

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 shown.

This medicine does not require any special storage conditions.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fesoterodine Aristo 8 mg prolonged-release tablets EFG

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: Dibehenate of glycerol, hypromellose, talc, lactose monohydrate (“See section 2: Fesoterodine Aristo contains lactose and sodium”), microcrystalline cellulose.

Coating of the tablet: Polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylate, sodium lauryl sulfate, aluminum lake of carmine (E132), red iron oxide (E172).

Appearance and packaging

The 8 mg tablets are blue, oval, biconvex, film-coated, 13.1 x 6.6 mm in size, and engraved with the number "8" on one side.

The tablets are packaged in OPA/Alu/PVC-Aluminum blisters containing 10, 14, 28, 30, 56, 84, 90, or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.

Larissa Industrial Area, P.O. Box 3012,

Larissa, 41 500 Greece

You can obtain further information on this medicine from the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Hungary Fesoterodine Aristo 8 mg retard tabletta

Czech Republic Fesoterodine Aristo

Germany Fesoterodin Aristo 8 mg

Spain Fesoterodina Aristo 8 mg prolonged-release tablets EFG

Italy Fesoterodina Aristo

Netherlands Fesoterodine Aristo 8 mg tabletten met verlengde afgifte

Poland Fesoterodine fumarate Aristo

Slovakia Fesoterodine Aristo 8 mg tablety s predlženým uvolnovaním

United Kingdom Fesoterodine fumarate Rontis 4mg prolonged-release tablets

Ireland Fesoterodine Aristo

Date of last revision of this leaflet:June 2024.

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