TOVEDESO 7 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Tovedeso

Do not take Tovedeso:

• if you are allergic to desfesoterodine, fesoterodine or any of the other ingredients of this medicine (including those listed in section 6) (see section 2, Tovedeso contains lactose)
• if you cannot empty your urinary bladder completely (urinary retention)
• if your stomach empties slowly (gastric retention)
• if you have an 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 ulceration and inflammation of the colon (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 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) (See other medicines 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 (for example, due to an enlarged prostate)
• if you have ever suffered from decreased intestinal movement or if you have severe constipation
• if you are being treated for an 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 suffer from heartburn or belching
• if you have a urinary tract infection, your doctor may need to prescribe you antibiotics

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

• you have an ECG abnormality (heart activity record) 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 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 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 Tovedeso

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

Please tell your doctor if you are taking medicines from the list below. Taking these medicines 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 than usual.

• 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 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)
• medicines that contain 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 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 intense pain and drug dependence).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 some sugars, consult them before taking this medicine.

3. How to take Tovedeso

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask 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 medicine, 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 medicine, 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, contact your doctor or hospital immediately. 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 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 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, serious allergic reactions, including angioedema, can occur. You should stop taking Tovedeso and contact your doctor immediatelyif you develop swelling in the face, mouth or throat, as this can put your life at risk.

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 can 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 via the Spanish Pharmacovigilance System for Human Use http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tovedeso

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 pack and on the blister after “EXP”. The expiry date is the last day of the month shown.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Tovedeso

• The active substance 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 Red Iron Oxide (E132).

Appearance and packaging

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

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

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