FESOTERODINE STADA 8 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Fesoterodina Stada 4 mg prolonged-release tablets EFG

Fesoterodina Stada 8 mg prolonged-release tablets EFG

Fesoterodina fumarate

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

This medicine contains the active substance fesoterodine fumarate and is a treatment called an antimuscarinic, which reduces the activity of the overactive bladder and is used in adults to treat symptoms.

Fesoterodina treats the symptoms of an overactive bladder, such as:

• being unable to control when to urinate (urge incontinence)
• a sudden need to urinate (urgency)
• having to urinate more often than usual (increased urination frequency).

2. What you need to know before you take Fesoterodina Stada

Do not take Fesoterodina Stada if:

• you are allergic to fesoterodina, peanuts, soya or any of the other ingredients of this medicine (listed in section 6) (see section 2, “Fesoterodina Stada contains lactose and sodium”)
• you are unable to empty your bladder completely (urinary retention)
• your stomach empties slowly (gastric retention)
• you have a certain eye condition called narrow-angle glaucoma (increased eye pressure) that is not controlled (treated adequately)
• you have a condition called myasthenia gravis, which causes extreme weakness of the muscles
• you have severe ulcerative colitis
• you have a condition called toxic megacolon (an abnormally long or dilated colon)
• you have severe liver problems
• you have severe 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)

Warnings and precautions

Fesoterodina may not always be suitable for you. Talk to your doctor before taking this medicine in any of the following cases:

• if you have difficulty emptying your bladder completely (for example, due to an enlarged prostate)
• if you have ever suffered from decreased intestinal movement or have severe constipation
• if you are being treated for a certain eye condition 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 condition called autonomic neuropathy that causes symptoms such as changes in blood pressure or alterations in bowel 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 abnormal ECG (heart activity record) known as QT interval prolongation or if you are taking any medicine that is known to have this effect
• you have a slow heart rate (bradycardia)
• you have a heart condition 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 can work and whether it would be safe for them.

Taking Fesoterodina Stada with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or may need to take other medicines. Your doctor will tell you if you can use fesoterodina with other medicines.

Please inform your doctor if you are taking medicines from the list below. Taking these medicines at the same time as fesoterodina may cause side effects such as dry mouth, constipation, difficulty emptying the bladder completely or drowsiness more severe or frequent 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 inform 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 fesoterodina 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 fesoterodina 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 severe pain and drug addiction).

Pregnancy and breastfeeding

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

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

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.

Driving and using machines

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

Fesoterodina Stada contains lactose and sodium

Fesoterodina contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

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

3. How to take Fesoterodina Stada

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of 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 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. Fesoterodina 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 Fesoterodina Stada than you should

If you have taken more tablets than you should or if someone else has taken your tablets by mistake, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget 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 forgotten doses.

If you stop taking Fesoterodina Stada

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

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, severe allergic reactions may occur, including angioedema. You should stop taking fesoterodina and contact your doctor immediately 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, 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

? skin rash

? dry skin

? itching

? stomach discomfort

? gas (flatulence)

? difficulty emptying the bladder completely (urinary retention)

? delayed urination (urinary hesitancy)

? 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

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 national reporting system listed in the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fesoterodina Stada

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

For 4 mg:

Do not store above 30°C.

Keep the blister perfectly closed to protect it from moisture.

For 8 mg:

No special storage conditions are required.

Keep the blister perfectly closed to protect it 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 Fesoterodina Stada

? The active substance is fesoterodine fumarate.

Fesoterodina Stada 4 mg

Each prolonged-release tablet contains 4 mg of fesoterodine fumarate, equivalent to 3.1 mg of fesoterodina.

Fesoterodina Stada 8 mg

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

• The other ingredients are:

Core of the tablet: dibehenate of glycerol, hypromellose, talc, lactose monohydrate (see section 2, “Fesoterodina Stada contains lactose and sodium”), microcrystalline cellulose

Coating:

For 4 mg: polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylate, sodium lauryl sulfate (see section 2, “Fesoterodina Stada contains lactose and sodium”) and aluminum lake carmine indigo (E132).

For 8 mg: polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylate, sodium lauryl sulfate (see section 2, “Fesoterodina Stada contains lactose and sodium”), aluminum lake carmine indigo (E132) and red iron oxide (E172).

Appearance and packaging

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

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio Stada, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

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 under 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, comprimé à libération prolongée

Fesoterodine EG LP 8 mg, comprimé à libération prolongée

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, tabletten met verlengde afgifte

Fesoterodine CF 8 mg, tabletten met verlengde afgifte

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 tabletten met verlengde afgifte

Fesoterodine EG 8mg tabletten met verlengde afgifte

Luxembourg: Fesoterodine EG 4mg comprimés à libération prolongée

Fesoterodine EG 8mg comprimés à libération prolongée

Date of last revision of this leaflet:March 2021

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