Leaflet: information for the user

Fesoterodine Aristo 8 mg prolonged-release tablets EFG

fesoterodine fumarate

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Fesoterodine Aristo

3. How to take Fesoterodine Aristo

4. Possible side effects

5. Storage of Fesoterodine Aristo

6. Contents of the pack and additional information

Fesoterodina contains 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 treats 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 if:

• You are allergic to fesoterodina or to any of the other components of fesoterodina (listed in section 6) (see section 2, “Fesoterodina contains lactose and sodium”)
• You cannot completely empty your urinary bladder (urinary retention)
• Your stomach empties slowly (gastroparesis)
• You have an eye disease called narrow-angle glaucoma (increased intraocular pressure), which is not controlled (adequately treated)
• You have excessive muscle weakness (myasthenia gravis)
• You have severe ulceration and inflammation of the colon (severe ulcerative colitis)
• You have a toxic megacolon (abnormally long or dilated colon)
• You have severe liver disease
• You have kidney problems or moderate to severe liver disease 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 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 be suitable for you.Talk to your doctorbefore taking fesoterodina in any of the following cases:

• If you have difficulty emptying your urinary bladder (e.g., due to an enlarged prostate);
• If you have ever experienced decreased bowel movements or have severe constipation;
• If you are being treated for a eye disease 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 disease called autonomic neuropathy that causes symptoms, such as changes in your blood pressure or alterations in your 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.

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

• You have an abnormal ECG (heart activity recording) 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 hypopotasemia, which is a manifestation of abnormally low levels of potassium in the blood.

Children and adolescents

Do not give this medication to children and adolescents under 18 years of age because it has not been established whether it works and if it is safe for them.

Other medications and Fesoterodina Aristo

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Your doctor will tell you if you can use fesoterodina 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 your urinary bladder, 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, 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 substance dependence)

Pregnancy and breastfeeding

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

Fesoterodina is not known to be excreted in breast milk; 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

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

Fesoterodina Aristo contains lactose and sodium

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended initial dose of fesoterodina is one 4 mg tablet per day. According to how you respond to the medication, 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 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 Aristo than you should

If you have taken more tablets than you were told to take or if someone else has accidentally taken your tablets, inform your doctor immediately or go to the nearest hospital emergency department. Show them the packaging 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 medication and the amount ingested.

If you forget to take Fesoterodina 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 compensate for missed doses.

If you interrupt treatment with Fesoterodina Aristo

Do not stop treatment with fesoterodina without first talking to your doctor, as overactive bladder symptoms may return or worsen when you stop treatment with fesoterodina.

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 fesoterodine and immediately contact your doctor 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 in doubt.

Common(may affect up to 1 in 10 people)

• Dry eyes
• Constipation
• Digestive problems (dyspepsia)
• Pain or discomfort while urinating (dysuria)
• Dizziness
• Headache
• Stomach pain
• Diarrhea
• Unpleasantness (nausea)
• Difficulty sleeping (insomnia)
• Dry throat

Uncommon(may affect up to 1 in 100 people)

• Urinary tract infection
• Drowsiness
• Difficulty tasting (dysgeusia)
• Dizziness
• Rash
• Dry skin
• Itching
• Discomfort in the stomach
• Gas (flatulence)
• Difficulty fully emptying the urinary bladder (urinary retention)
• Delay in urination (retardation)
• Intense fatigue (fatigue)
• Increased heart rate (tachycardia)
• Palpitations
• Liver problems
• Cough
• Dry nose
• Throat pain
• Acid reflux from the stomach
• Blurred vision

Rare(may affect up to 1 in 1,000 people)

• Urticaria
• Confusion
• Numbness around the mouth (oral hypoesthesia)

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 that does not appear in this prospectus. You can also report them directly through 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 packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unusedmedicines at the pharmacy's Sigrepoint. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Fesoterodine Aristo 8 mg prolonged-release tablets EFG

The active ingredient is fesoterodine fumarate.

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

The other ingredients are:

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

Tablet coating: Polyvinyl alcohol, talc, titanium dioxide (E171), monocaprilocaprylate of glycerol, sodium lauryl sulfate, aluminum lake of indigo carmine (E132), iron oxide red (E172).

Appearance of the product and contents of the package

The 8 mg tablets are blue, oval, biconvex, coated with a film of 13.1 x 6.6 mm, and engraved on one face with the number "8".

The tablets are presented in blister packs of OPA/Alu/PVC-Aluminum containing 10, 14, 28, 30, 56, 84, 90, or 100 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Responsible manufacturer

RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.

P.O. Box 3012, Industrial Area of Larissa

Larissa

41004 Greece

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

HungaryFesoterodine Aristo 8 mg retard tabletta

Czech RepublicFesoterodine Aristo

GermanyFesoterodin Aristo 8 mg

SpainFesoterodina Aristo 8 mg prolonged-release tablets EFG

ItalyFesoterodina Aristo

NetherlandsFesoterodine Aristo 8 mg tablets with prolonged release

PolandFesoterodine fumarate Aristo

SlovakiaFesoterodine Aristo 8 mg tablets with prolonged release

United KingdomFesoterodine fumarate Rontis 4mg prolonged-release tablets

IrelandFesoterodine Aristo

Last revision date of this leaflet:June 2024.

Further detailed and updated information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es