Fesoterodine Teva 8 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fesoterodine Teva 8 mg prolonged-release tablets EFG

fesoterodine fumarate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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 could 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.

Contents of the leaflet

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

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

Fesoterodine Teva contains an active substance called fesoterodine fumarate and is a treatment belonging to the class of antimuscarinic agents, which reduce the activity of the overactive bladder and is used in adults to treat symptoms.

Fesoterodine treats the symptoms of overactive bladder, such as:

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

2. What you need to know before starting to use Fesoterodine Teva

Do not take fesoterodine if:

• you are allergic to fesoterodine or to any of the other ingredients of this medicine (listed in section 6) (see section 2, “Fesoterodine Teva contains lactose and sodium”)
• you cannot empty your bladder completely (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 excessive muscle weakness (myasthenia gravis)
• you have severe ulceration and inflammation of the colon (severe ulcerative colitis)
• you have an abnormally enlarged or dilated colon (toxic megacolon)
• you have severe liver problems
• you have severe 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), or nefazodone (used to treat depression).

Warnings and precautions

Fesoterodine may not always be suitable for you. Talk to your doctor before taking Fesoterodine if any of the following apply to you:

• if you have difficulty emptying your bladder completely (e.g., due to an enlarged prostate)
• if you have ever had reduced intestinal movements 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 abnormal ECG (electrocardiogram, a recording of the heart's electrical 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 is effective or safe for them.

Other medicines and Fesoterodine Teva

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

Please inform your doctor if you are taking any of the following medicines. Taking these medicines together with fesoterodine may cause adverse effects such as dry mouth, constipation, difficulty emptying the bladder completely, or more severe or more 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 fesoterodine 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 fesoterodine 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

It is not known whether fesoterodine is excreted in breast milk; therefore, do not breastfeed during treatment with fesoterodine.

Driving and using machines

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

Fesoterodine Teva contains lactose and sodium

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Fesoterodine Teva

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

The recommended starting dose of fesoterodine is one 4 mg tablet per day. Depending on how you respond to the medicine, 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. Fesoterodine can be taken with or without food.

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

If you take more fesoterodine 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 fesoterodine

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 fesoterodine

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

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 may be serious

Severe allergic reactions, including angioedema, may rarely occur. You must stop taking fesoterodine and contact your doctor immediately if you develop swelling of the face, mouth or throat, as this could 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. This may increase the risk of dental caries. 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 when urinating (dysuria)
• dizziness
• headache
• stomach pain
• diarrhoea
• malaise (nausea)
• difficulty sleeping (insomnia)
• dry throat

Uncommon (may affect up to 1 in 100 people):

• urinary tract infection
• somnolence
• difficulty tasting (dysgeusia)
• vertigo
• skin rash
• dry skin
• itching
• sensation of stomach discomfort
• gas (flatulence)
• difficulty completely emptying the urinary bladder (urinary retention)
• delayed urination (hesitancy)
• 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):

• urticaria
• confusion
• numbness around the mouth (oral hypoesthesia)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fesoterodina Teva

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

Do not use this medicine after the expiry date stated on the blister and on the carton after “EXP”. The expiry date is the last day of the month indicated.

Fesoterodina Teva 8 mg:

This medicine does not require any special storage temperature.

Keep the blister pack tightly closed to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to your pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fesoterodine Teva

The active substance is fesoterodine fumarate.

Fesoterodine Teva 8 mg prolonged-release tablets EFG

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

The other components are:

Tablet core: glyceryl dibehenate, hypromellose, talc, lactose monohydrate (see section 2 "Fesoterodine Teva contains lactose and sodium"), and microcrystalline cellulose.

Coating: polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylocaprate, sodium lauryl sulfate, indigo carmine aluminium lake (E132), and red iron oxide (E172).

Appearance of the product and contents of the pack

Fesoterodine Teva 8 mg prolonged-release tablets EFG

The 8 mg film-coated prolonged-release tablets are blue, oval-shaped, biconvex, and marked on one side with the number "8".

Fesoterodine Teva is available in packs containing 10, 14, 20, 28, 30, 40, 42, 50, 56, 60, 70, 80, 84, 90, 98, or 100 prolonged-release tablets in perforated and non-perforated blisters made of OPA/Alu/PVC-Aluminium.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

Manufacturer responsible for manufacturing:

Rontis Hellas, Medical and Pharmaceutical Products S.A.,

Larissa Industrial Area, P.O. Box 3012,

Larissa, 41 500,

Greece

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

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid (Spain)

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

Other sources of information

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