Toviaz 4 mg comprimidos de liberacion prolongada

Prospecto: Information for the User

TOVIAZ 4mg prolonged-release tablets

TOVIAZ 8mg prolonged-release tablets

Fesoterodine fumarate

Read this prospectus carefully before starting to take the medicine, because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribedonlyto you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• Ifyou experienceadverse effects, consult your doctor or pharmacist,evenifthe adverse effects do not appearin this prospectus. See section 4.

1.What is TOVIAZ and for what it is used

2.What you need to knowbeforestarting to take TOVIAZ

3.How to take TOVIAZ

4.Possible adverse effects

5.Storage of TOVIAZ

6.Contents of the package and additional information

TOVIAZ 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.

TOVIAZ 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 TOVIAZ if:

• You are allergic to fesoterodine, peanuts, soy, or any of the other components of TOVIAZ(listed in section 6)(see section2, “TOVIAZ contains lactose and soy oil”)
• You are unable to completely empty your bladder (urinary retention)
• You have delayed stomach emptying (gastroparesis)
• You have a narrow-angle glaucoma (increased eye pressure) that is not controlled (adequately treated)
• You have myasthenia gravis (severe muscle weakness)
• You have severe ulcerative colitis (inflammation and ulceration of the colon)
• You have a toxic megacolon (abnormally long or dilated colon)
• You have severe liver disease
• You have kidney problems or moderate to severe liver disease and are taking medications that contain any of the following active substances: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir, or nelfinavir (used to treat HIV infection), clarithromycin or telithromycin (used to treat bacterial infections), and nefazodone (used to treat depression)

Warnings and precautions

Fesoterodine may not be suitable for you.Talk to your doctorbefore takingTOVIAZin any of the following cases:

• If you have difficulty emptying your bladder completely (for example, due to an enlarged prostate)
• If you have ever experienced decreased bowel movements or have severe constipation
• If you are being treated for a condition 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 blood pressure or alterations in your intestines or sexual function
• If you have a gastrointestinal disease that affects the passage and/or digestion of food
• If you experience 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:

• You have a known ECG abnormality called prolonged QT interval or are taking any medication that is 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 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 medication to children and adolescents under 18years of age because its safety and effectiveness have not been established in this age group.

TOVIAZ with other medications

Inform your doctor or pharmacist if you are taking or have recently takenor may need to takeother medications.Your doctor will tell you if you can useTOVIAZwith 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 bladder completely, or more severe or frequent drowsiness.

• Medications that contain the active ingredient amantadine (used to treat Parkinson's disease)
• Certain 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
• Certain medications used to treat psychiatric disorders, such as antidepressants and neuroleptics

Please inform 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 (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 to treat depression), quinidine (used to treat arrhythmias), and cinacalcet (used to treat hyperparathyroidism)
• Medications that contain the active ingredient methadone (used to treat severe pain and addiction)

Pregnancy and breastfeeding

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

The excretion of fesoterodine in breast milk is unknown; therefore, do not breastfeed during treatment with TOVIAZ.

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

Driving and operating machinery

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

TOVIAZ contains lactose and soy oil

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

TOVIAZ contains soy oil. Do not use this medication if you are allergic to peanuts or soy.

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 TOVIAZ 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.

Swallow the tablet whole with a glass of water. Do not chew the tablet. TOVIAZ 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 TOVIAZ than you should

If you have taken more tablets than you were told to take or if someone else has accidentally taken your tablets, contact your doctor or hospital immediately. Show them the packaging of the tablets.

If you forget to take TOVIAZ

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 TOVIAZ

Do not stop taking TOVIAZ without first talking to your doctor, as symptoms of overactive bladder may return or worsen when you stop taking TOVIAZ.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

Some side effects can be serious

In rare cases, severe allergic reactions can occur, including angioedema. You should stop taking TOVIAZ and immediately contact your doctor if you develop swelling in the face, mouth, or throat,as it can be life-threatening.

Other side effects

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

You may notice dry mouth. This effect is usually mild or moderate. This can increase the risk of tooth decay. Therefore, you should brush your teeth regularly twice a day and visit a dentist if in doubt.

Common(can affect up to 1 in 10 people)

• Dry eyes
• Constipation
• Digestive problems (dyspepsia)
• Pain or discomfort while urinating (dysuria)
• Dizziness
• Headache
• Stomach pain
• Diarrhea
• Unpleasantness (nausea)
• Difficulty sleeping (insomnia)
• Dry throat

Uncommon(can affect up to 1 in 100 people)

• Urinary tract infection
• Drowsiness
• Difficulty tasting (dysgeusia)
• Dizziness
• Rash
• Dry skin
• Itching
• Discomfort in the stomach
• Gas (flatulence)
• Difficulty emptying the bladder completely (urinary retention)
• Delay in urinating (retardation)
• Intense fatigue (fatigue)
• Increased heart rate (tachycardia)
• Palpitations
• Liver problems
• Cough
• Dry nose
• Throat pain
• Acid reflux from the stomach
• Blurred vision

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

• Urticaria
• Confusion
• Numbness around the mouth (oral hypoesthesia)

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 them directly through thenational notification system included in Appendix V. By reporting side effects, you can contribute to providing more information about 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, after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medication that you no longer need. In this way, you will help protect the environment.

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TOVIAZ Composition

• The active ingredient is fesoterodine fumarate.

TOVIAZ 4 mg

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

TOVIAZ 8 mg

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

• The other components are:

Tablet core: xylitol, lactose monohydrate, microcrystalline cellulose, hypromellose, glycerol dibehenate, talc.

Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc, soy lecithin, aluminium lake carmine (E132).

Product appearance and packaging contents

TOVIAZ 4 mg prolonged-release tablets are light blue, oval, curved on both sides, with a film-coated surface and the letters “FS” engraved on one side.

TOVIAZ 8 mg prolonged-release tablets are blue, oval, curved on both sides, with a film-coated surface and the letters “FT” engraved on one side.

TOVIAZ is available in blister packs of 7, 14, 28, 30, 56, 84, 98, and 100 prolonged-release tablets. TOVIAZ is also available in HDPE bottles containing 30 or 90 prolonged-release tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturer:

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

For more information about this medicine, please contact the local representative of the marketing authorization holder.

Last review date of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.