Leaflet: Information for the User

Fesoterodine Stada 4 mg prolonged-release tablets EFG

Fesoterodine Stada 8 mg prolonged-release tablets EFG

Fesoterodine fumarate

Read this leaflet carefully before you start taking the 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. Do not give it to others, even if they have the same symptoms, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Fesoterodine Stada

3.How to take Fesoterodine Stada

4.Possible side effects

5.Storage of Fesoterodine Stada

6.Contents of the pack and additional information

This medication contains an active ingredient called fesoterodine fumarate and is a treatment for the so-called antimuscarinics, which reduce the activity of an overactive bladder and is used in adults to treat symptoms.

Fesoterodine treats the symptoms of an 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 Fesoterodina Stada if:

- is allergic to fesoterodine, peanuts, soy, or any of the other components of this medication (including those listed in section 6) (see section 2, “Fesoterodina Stada contains lactose and sodium”)

-cannot completely empty the urinary bladder (urinary retention)

-has a slow stomach emptying (gastroparesis)

-has a narrow-angle glaucoma (increased eye pressure) that is not controlled (adequately treated)

-has myasthenia gravis (severe muscle weakness)

-has a severe ulcerative colitis (inflammation of the colon)

-has a toxic megacolon (abnormally long or dilated colon)

-has a severe liver problem

-has a kidney problem or moderate to severe liver problem and is 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 for HIV), clarithromycin or telithromycin (used to treat bacterial infections), and nefazodone (used to treat depression)

Warnings and precautions

Fesoterodine may not be suitable for you.Consult your doctorbefore taking this medication in any of the following cases:

-if you have difficulty emptying the urinary bladder (e.g., due to an enlarged prostate)

-if you have experienced a decrease in bowel movements or have severe constipation

-if you are being treated for a 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 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 have heartburn or belching

-if you have a urinary tract infection, your doctor may need to prescribe antibiotics

Cardiac problems:inform your doctorif you have any of the following conditions:

-has an ECG anomaly known as prolonged QT interval or is taking any medication that is known to cause this effect

-has a slow heart rate (bradycardia)

-has a heart disease such as myocardial ischemia (reduced blood flow to the heart), irregular heartbeats, or heart failure

-has 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 its safety and efficacy have not been established in this age group.

Taking Fesoterodina Stada with other medications

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take other medications. Your doctor will tell you if you can use fesoterodine with other medications.

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

-medications that contain the active ingredient amantadine (used to treat Parkinson's disease)

-some 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

-some medications used to treat psychiatric disorders, such as antidepressants and neuroleptics

Please indicate to 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 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)

-medications that contain any of the following active ingredients that may increase fesoterodine levels in the blood: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir, or nelfinavir (antiviral medications for HIV), 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 intense pain and substance dependence)

Pregnancy and breastfeeding

You should not take fesoterodine if you are pregnant, as its effects on pregnancy and the newborn are unknown.

Fesoterodine is unknown to be excreted in breast milk; therefore, do not breastfeed during treatment with fesoterodine.

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

Driving and operating machinery

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

Fesoterodina Stada contains lactose and sodium

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

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

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

The recommended initial dose of fesoterodina is one 4 mg tablet per day. Depending on how you respond to the medication, 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. Fesoterodina can be taken with or without food.

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

If you take more Fesoterodina Stada than you should

If you have taken more tablets than you were told to take or if someone else has accidentally taken your tablets, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Fesoterodina Stada

If you have forgotten to take a tablet, take it as soon as you remember, but do not take more than one tablet in a day. Do not take a double dose to make up for missed doses.

If you interrupt treatment with Fesoterodina Stada

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

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 may occur, including angioedema. Stop taking fesoterodine and immediately contact your doctor if you develop swelling in the face, mouth, or throat.

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, 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)

?difficulty urinating (dysuria)

?dizziness

?headache

?stomach pain

?diarrhea

?nausea

?difficulty sleeping (insomnia)

?dry throat

Less common(may affect up to 1 in 100 people)

?urinary tract infection

?drowsiness

?difficulty tasting (dysgeusia)

?dizziness

?skin rash

?dry skin

?itching

?stomach discomfort

?gas (flatulence)

?difficulty fully emptying the bladder (urinary retention)

?delayed urination (retardation)

?intense fatigue

?increased heart rate (tachycardia)

?palpitations

?liver problems

?cough

?dryness in the nose

?throat pain

?acid reflux from the stomach

?blurred vision

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

?hives

?confusion

Reporting 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 themdirectly through the national notification system included in the Spanish System for Pharmacovigilance of Medicines for Human Use: 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 carton and on the blister pack, after “CAD”. The expiration date is the last day of the month indicated.

For 4 mg:

Do not store at a temperature above 30°C.

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

For 8 mg:

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fesoterodine Stada

?The active ingredient is fumarate of fesoterodine.

Fesoterodine Stada 4 mg

Cada comprimido de liberación prolongada contiene 4 mg de fumarato de fesoterodina, equivalentes a 3,1 mg de fesoterodina.

Fesoterodine Stada 8 mgg

Cada comprimido de liberación prolongada contiene 8 mg de fumarato de fesoterodina, equivalentes a 6,2 mg de fesoterodina.

• The other components are:

Core of the tablet:dibehenato de glicerol, hipromelosa, talco, lactosa monohidrato (see section 2, “Fesoterodine Stada contains lactose and sodium”), celulosa microcristalina

Coating:

For 4 mg: alcohol polivinílico, talco, dióxido de titanio (E171), monocaprilocaprato de glicerol, laurilsulfato de sodio (see section 2, “Fesoterodine Stada contains lactose and sodium”) and laca de aluminio carmín índigo (E132).

For 8 mg: alcohol polivinílico, talco, dióxido de titanio (E171), monocaprilocaprato de glicerol, laurilsulfato de sodio (see section 2, “Fesoterodine Stada contains lactose and sodium”), laca de aluminio carmín índigo (E132) and óxido de hierro, rojo (E172).

Appearance of the product and contents of the package

The prolonged-release tablets of Fesoterodine Stada 4 mg are light blue, oval, biconvex, film-coated, 13 x 7 mm, and have the number “4” engraved on one side.

The prolonged-release tablets of Fesoterodine Stada 8 mg are blue, oval, biconvex, film-coated, 13 x 7 mm, and have the number “8” engraved on one side.

Fesoterodine is available in packages of 14, 28, 30, 56, 84, 90, 100 tablets in OPA/Alu/PVC-Al perforated and non-perforated blisters or in packages of 14x1, 28x1, 30x1, 56x1, 84x1, 90x1 and 100x1 tablets in OPA/Alu/PVC-Al single-dose blisters.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Laboratorio Stada, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer responsible

Rontis Hellas Medical and Pharmaceutical Products S.A.

P.O. Box 3012 Larisa Industrial Area,

Larisa, 41004,

Greece

or

Stada Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel, Co. Tipperary,

Ireland

or

Centrafarm Services B.V., Netherlands

Nieuwe Donk 9

4879 AC Etten-Leur

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Fesoterodin AL 4 mg Retardtabletten

Fesoterodin AL 8 mg Retardtabletten

Denmark:Fesoterodine STADA

Spain:Fesoterodina STADA 4 mg prolonged-release tablets EFG

Fesoterodina STADA 8 mg prolonged-release tablets EFG

Finland:Fesoterodine STADA 4 mg depottabletti

Fesoterodine STADA 8 mg depottabletti

France:Fesoterodine EG LP 4 mg, prolonged-release tablet

Fesoterodine EG LP 8 mg, prolonged-release tablet

Ireland:Fesoterodine Clonmel 4 mg prolonged-release tablets

Fesoterodine Clonmel 8 mg prolonged-release tablets

Iceland:Fesoterodine STADA 4 mg forðatöflur

Fesoterodine STADA 8 mg forðatöflur

Netherlands:Fesoterodine CF 4 mg, tablets with prolonged release

Fesoterodine CF 8 mg, tablets with prolonged release

Sweden:Fesoterodine STADA 4 mg depottablett

Fesoterodine STADA 8 mg depottablett

Greece:Φεσοτεροδ?νη STADA 4 mg δισκ?α παρατεταμ?νης αποδ?σμευσης

Φεσοτεροδ?νη STADA 8 mg δισκ?α παρατεταμ?νης αποδ?σμευσης

Belgium:Fesoterodine EG 4mg tablets with prolonged release

Fesoterodine EG 8mg tablets with prolonged release

Luxembourg:Fesoterodine EG 4mg prolonged-release tablets

Fesoterodine EG 8mg prolonged-release tablets

Last review date of this leaflet:March 2021

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