Tovedeso 3,5 mg comprimidos de liberacion prolongada

Prospect: information for the patient

Tovedeso 3.5 mg prolonged-release tablets

Tovedeso 7 mg prolonged-release tablets

Desfesoterodine, succinate

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Tovedeso contains an active ingredient called desfesoterodine succinate, and is a treatment of the so-called antimuscarinics, which reduce the activity of the overactive bladder and is used in adults to treat symptoms.

Tovedeso treats the symptoms of overactive bladder, such as:

• not being able 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 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 empty your bladder completely (urinary retention)
• if your stomach empties slowly (gastroparesis)
• if you have a narrow-angle glaucoma (increased intraocular pressure) that is not controlled (adequately treated)
• if you have myasthenia gravis (severe muscle weakness)
• if you have severe ulcerative colitis (inflammation and ulceration of the colon)
• if you have a toxic megacolon (abnormally long or dilated colon)
• if you have severe liver disease
• if 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) (See other medications and Tovedeso)

Warnings and precautions

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

• if you have difficulty emptying your bladder completely (e.g., due to an enlarged prostate)
• if you have ever experienced a decrease in bowel movements or if you have severe constipation
• if you are being treated for a condition called narrow-angle glaucoma
• if you have severe kidney or liver disease, 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 the intestine or sexual function
• if you have a gastrointestinal disease that affects the passage and/or digestion of food
• if you experience 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:

• if you have a known ECG abnormality called prolonged QT interval or if you are taking any medication that is known to cause this effect
• if you have a slow heart rate (bradycardia)
• if you have a heart condition such as myocardial ischemia (reduced blood flow to the heart), irregular heartbeats, or heart failure
• if 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 because it has not been established whether it works and whether it is safe for them.

Other medications and Tovedeso

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 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 produce adverse effects such as dry mouth, constipation, difficulty emptying the bladder completely, 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 inform 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 desfesoterodine 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 the levels of desfesoterodine 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 addiction problems)

Pregnancy and lactation

If you are pregnant or breastfeeding, 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.

The excretion of desfesoterodine in human milk is unknown; therefore, do not breastfeed during treatment with Tovedeso.

Driving and operating machinery

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

Tovedeso contains lactose

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

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

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

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

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

If you take more Tovedeso than you should

If you have taken more tablets than you were told to take or if someone else accidentally takes your tablets, contact your doctor or hospital immediately. Show them the packaging of the tablets.immediatelywith your doctor or hospital. 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 forgot 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 the missed doses.

If you interrupt treatment with Tovedeso

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

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

Like all medicines, this medicine may 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 shouldstop 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 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
• nausea
• difficulty sleeping (insomnia)
• dry throat

Uncommon(may affect up to 1 in 100 people)

• urinary tract infection
• drowsiness
• difficulty tasting (dysgeusia)
• dizziness
• skin rash
• dry skin
• itching
• feeling of discomfort in the stomach
• gas (flatulence)
• difficulty emptying the bladder completely (urinary retention)
• delayed urination (retardation)
• intense 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)

• hives
• confusion
• numbness around the mouth (hypoaesthesia oral)

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 leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Usehttp://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 on the blister after “CAD”. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

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

Appearance of the product and contents of the package

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

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

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B,

1st floor, Alcobendas,

28108 Madrid (Spain)

Responsible 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 by contacting the local representative of the marketing authorization holder:

Laboratorios Gebro Pharma, S.A.

Av. Tibidabo, 29

08022 Barcelona

Spain

Last review date of this leaflet:June 2024

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