TOVEDESO 3.5 mg PROLONGED-RELEASE TABLETS

2. What you need to know before taking Tovedeso

Do not take Tovedeso:

• if you are allergic to desfesoterodine, fesoterodine, or any of the other components of this medication (listed in section 6) (see section 2, Tovedeso contains lactose)
• if you cannot completely empty your urinary bladder (urinary retention)
• if your stomach empties slowly (gastric retention)
• if you have a eye disease called narrow-angle glaucoma (increased eye pressure) that is not controlled (treated properly)
• if you have excessive muscle weakness (myasthenia gravis)
• if you have severe ulcerative colitis
• if you have an abnormally long or dilated colon (toxic megacolon)
• if you have severe liver problems
• if 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 used to treat HIV infection), clarithromycin or telithromycin (used to treat bacterial infections), and nefazodone (used to treat depression) (See other medications and Tovedeso)

Warnings and precautions

Desfesoterodine may not always be suitable for you. Talk to your doctor before taking Tovedeso in any of the following cases:

• if you have difficulty emptying your urinary bladder completely (e.g., due to prostate enlargement)
• if you have suffered from decreased intestinal movement or 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 intestinal function 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 doctor if you have any of the following conditions:

• you have an ECG abnormality known as QT interval prolongation or are taking any medication that is known to cause this effect
• you have a slow heart rate (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, as it has not been established whether it is effective and safe for them.

Other medications and Tovedeso

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication. Your doctor will tell you if you can take Tovedeso with other medications.

Please inform your doctor if you are taking medications from the list below. Taking these medications at the same time as desfesoterodine may cause side effects such as dry mouth, constipation, difficulty emptying the bladder completely, or more severe or frequent drowsiness.

• 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 inform 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 desfesoterodine 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 desfesoterodine 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 severe pain and drug dependence)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

It is unknown whether desfesoterodine is excreted in human milk; therefore, do not breastfeed during treatment with Tovedeso.

Driving and using machines

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

Tovedeso contains lactose

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

3. How to take Tovedeso

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

The recommended initial dose of Tovedeso is one 3.5 mg tablet per day. Depending on how you respond to the medication, your doctor may prescribe a higher dose; one 7 mg tablet per day.

Swallow the tablet whole with a glass of water. Do not chew the tablet. Tovedeso can be taken with or without food.

To help you remember to take your medication, it may be easier if you take it at the same time every day.

If you take more Tovedeso than you should

If you have taken more tablets than you should or if someone else has taken your tablets by accident, contact your doctor or hospital immediately. Show them the package 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 medication and the amount ingested.

If you forget to take Tovedeso

If you have forgotten 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 Tovedeso

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Some side effects can be serious

Rarely, severe allergic reactions, including angioedema, may occur. You should stop taking Tovedeso and contact your doctor immediatelyif you develop swelling in the face, mouth, or throat, as this can be life-threatening.

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 disorders (dyspepsia)
• pain or discomfort while 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
• discomfort in the stomach
• gas (flatulence)
• difficulty emptying the bladder completely (urinary retention)
• delayed urination (urinary hesitancy)
• 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Tovedeso

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the package and blister after "EXP". The expiration date is the last day of the month indicated.

Store below 30°C. Keep in the original packaging to protect from moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Tovedeso

• The active ingredient is desfesoterodine succinate

Tovedeso 3.5 mg.Each prolonged-release tablet contains 3.5 mg of desfesoterodine succinate, equivalent to 2.6 mg of desfesoterodine.

Tovedeso 7 mg.Each prolonged-release tablet contains 7 mg of desfesoterodine succinate, equivalent to 5.2 mg of desfesoterodine.

The other ingredients are: microcrystalline cellulose, povidone, hypromellose 2208, Microcelac 100, magnesium stearate, hypromellose 2910, glycerol, titanium dioxide (E171), and aluminum lake carmine (E132).

Appearance and package contents

Tovedeso 3.5 mg prolonged-release tablets are film-coated, oval, biconvex tablets, light blue in color, with dimensions of 11.6 mm x 6.35 mm and marked with "3.5" on one side.

Tovedeso 7 mg prolonged-release tablets are film-coated, oval, biconvex tablets, blue in color, with dimensions of 11.6 mm x 6.35 mm and marked with "7" on one side.

Tovedeso is available in blister packs of 14, 28, 56, 84, 98, 100, and 112 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B,

1st floor, Alcobendas,

28108 Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3,

Blaubeuren, Baden-Wuerttemberg

89143 Germany

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25

Zagreb

10000 Croatia

You can request more information about this medication from the local representative of the marketing authorization holder:

Laboratorios Gebro Pharma, S.A.

Av. Tibidabo, 29

08022 Barcelona

Spain

Date of last revision of this leaflet:June 2024

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