FESOTERODINE STADA 4 mg PROLONGED-RELEASE TABLETS

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

Do not take Fesoterodina Stada if:

• you are allergic to fesoterodine, 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 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 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 if you 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 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 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
• your heart rate is slow (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 works and is 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 fesoterodine with other medicines.

Please inform your doctor if you are taking any of the medicines listed below. Taking these medicines at the same time as fesoterodine may cause side effects such as dry mouth, constipation, difficulty emptying the bladder completely or more severe or frequent drowsiness 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 fesoterodine 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 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 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 fesoterodine if you are pregnant, as the effects of fesoterodine on pregnancy and the newborn are unknown.

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

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

Fesoterodine 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

Fesoterodine contains lactose. If your doctor has told you that you have an intolerance to certain 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 the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended initial 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.

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 more convenient 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 ingested.

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 fesoterodine 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 fesoterodine 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 cause a higher 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 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 retardation)

? 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 to 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. Storing 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 refers to 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 fesoterodine.

Fesoterodina Stada 8 mg

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

• 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: Φεσοτεροδίνη STADA 4 mg δισκία παρατεταμένης αποδέσμευσης

Φεσοτεροδίνη STADA 8 mg δισκία παρατεταμένης αποδέσμευσης

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/