Tovedeso 7 mg prolonged-release tablets

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Tovedeso 3.5 mg prolonged-release tablets

Tovedeso 7 mg prolonged-release tablets

Desfesoterodine, succinate

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

Leaflet contents

1. What Tovedeso is and what it is used for
2. What you need to know before taking Tovedeso
3. How to take Tovedeso
4. Possible side effects
5. How to store Tovedeso
6. Contents of the pack and other information

1. What Tovedeso is and what it is used for

Tovedeso contains an active substance called desmopressin succinate, and is an antimuscarinic treatment that reduces the activity of the overactive bladder. It is used in adults to treat symptoms.

Tovedeso treats symptoms of overactive bladder, such as:

• being unable to control when to urinate (urge incontinence)
• a sudden need to urinate (urgency)
• needing to urinate more frequently than usual (increased urinary frequency).

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 ingredients of this medicine (listed in section 6) (see section 2, Tovedeso contains lactose)
• you cannot completely empty your urinary bladder (urinary retention)
• your stomach empties slowly (gastric retention)
• you have a type of eye disease called narrow-angle glaucoma (increased eye pressure) that is not controlled (adequately treated)
• you have a condition causing severe muscle weakness (myasthenia gravis)
• you have 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 problems or moderate to severe liver problems and are taking medicines containing 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 if any of the following apply to you:

• if you have difficulty completely emptying your bladder (e.g., due to an enlarged prostate)
• if you have ever experienced reduced intestinal motility or suffer from severe constipation
• if you are being treated for a type of eye disease called narrow-angle glaucoma
• if you have severe kidney or liver problems, as your doctor may need to adjust your dose
• if you have a condition called autonomic neuropathy that causes symptoms such as changes in your blood pressure or disturbances in your bowel or sexual function
• if you have a gastrointestinal disease affecting the passage and/or digestion of food
• if you suffer from heartburn or burping
• 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 abnormality on your ECG (electrocardiogram, a recording of your heart's activity) known as QT interval prolongation, or if you are taking any medicines known to cause this effect
• your heart rate is slow (bradycardia)
• you have a heart condition such as myocardial ischemia (reduced blood flow to the heart), irregular heartbeat, or heart failure
• you have hypokalemia, which is a condition characterized by abnormally low levels of potassium in the blood

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age, as it has not yet been established whether it would be effective or safe for them.

Other medicines and Tovedeso

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

Please inform your doctor if you are taking any of the following medicines. Taking these medicines together with desfesoterodine may cause adverse effects such as dry mouth, constipation, difficulty completely emptying the bladder, or more severe or frequent drowsiness than usual.

• medicines containing the active substance amantadine (used to treat Parkinson's disease)
• certain medicines used to increase gastrointestinal motility or to relieve stomach cramps or spasms, or to prevent travel sickness, such as medicines containing 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 containing any of the following active substances, which 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)
• medicines containing any of the following active substances, which 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 help quit smoking or to treat depression), quinidine (used to treat arrhythmias), and cinacalcet (used to treat hyperparathyroidism)
• medicines containing the active substance 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 medicine.

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

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

Driving and use of machines

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 informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Tovedeso

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended starting dose of Tovedeso is one 3.5 mg tablet per day. Depending on your response to the medicine, 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 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 were told to take, or if someone else accidentally takes your tablets, contact your doctor or hospital immediately. Show them the tablet packaging.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Tovedeso

If you forget 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 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some adverse effects can be serious

Serious allergic reactions, including angioedema, may rarely occur. You must stop taking Tovedeso and contact your doctor immediately if you develop swelling of the face, mouth or throat, as this may be life-threatening.

Other adverse effects

Very common (may affect more than 1 in 10 people):

You may experience dry mouth. This effect is usually mild or moderate. It may increase the risk of dental caries. Therefore, you should routinely brush your teeth twice daily and consult a dentist if in doubt.

Common (may affect up to 1 in 10 people)

• Dry eyes
• Constipation
• Digestive disturbances (dyspepsia)
• Pain or discomfort when urinating (dysuria)
• Dizziness
• Headache
• Stomach pain
• Diarrhea
• Feeling unwell (nausea)
• Difficulty sleeping (insomnia)
• Dry throat

Uncommon (may affect up to 1 in 100 people)

• Urinary tract infection
• Drowsiness
• Difficulty tasting (dysgeusia)
• Dizziness (vertigo)
• Skin rash
• Dry skin
• Itching
• Stomach discomfort
• Gas (flatulence)
• Difficulty completely emptying the urinary bladder (urinary retention)
• Delay in urination (urination delay)
• Severe tiredness (fatigue)
• Increased heart rate (tachycardia)
• Palpitations
• Liver problems
• Cough
• Dry nose
• Sore throat
• Acid reflux from the stomach
• Blurred vision

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

• Hives (urticaria)
• Confusion
• Numbness around the mouth (oral hypoesthesia)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es . By reporting adverse 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 stated on the packaging and blister after "EXP". The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This 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 components are: microcrystalline cellulose, povidone, hypromellose 2208, Microcelac 100, magnesium stearate, hypromellose 2910, glycerol, titanium dioxide (E171), and aluminium lake of indigo carmine (E132).

Appearance of the product and contents of the pack

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

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

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

Only certain 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

For further information about this medicinal product, contact the local representative of the Marketing Authorization Holder:

Laboratorios Gebro Pharma, S.A.
Av. Tibidabo, 29
08022 Barcelona
Spain

Date of the most recent review of this leaflet: June 2024

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