Toviaz 8 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

TOVIAZ 4 mg prolonged-release tablets

TOVIAZ 8 mg prolonged-release tablets

Fesoterodine 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What TOVIAZ is and what it is used for

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

TOVIAZ 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 taking TOVIAZ

Do not take TOVIAZ if:

• you are allergic to fesoterodine, peanut, soy, or any of the other ingredients of TOVIAZ (listed in section 6) (see section 2, “TOVIAZ contains lactose and soybean oil”)
• you cannot completely empty your bladder (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 muscle disorder called myasthenia gravis
• you have severe ulcerative colitis (inflammation and ulceration of the colon)
• you have an abnormally enlarged or elongated 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 TOVIAZ if any of the following apply to you:

• if you have difficulty completely emptying your bladder (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, which causes symptoms such as changes in your blood pressure or disturbances in your 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 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 activity) known as QT prolongation, or if you are taking any medicine 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, 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.

Taking TOVIAZ with other medicines

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 TOVIAZ 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 completely emptying the bladder, or more severe or frequent drowsiness than usual.

• medicines containing the active ingredient amantadine (used to treat Parkinson's disease)
• certain medicines used to increase gastrointestinal motility or to relieve stomach cramps or spasms, and medicines used to prevent motion sickness, such as those containing 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 containing any of the following active substances, which may increase the metabolism of fesoterodine and thus 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 treat depression), quinidine (used to treat arrhythmias), and cinacalcet (used to treat hyperparathyroidism)
• medicines containing the active ingredient methadone (used to treat severe pain and drug dependence)

Pregnancy and breastfeeding

You must not take TOVIAZ 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 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 medicine.

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 soybean oil

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

TOVIAZ contains soybean oil. Do not use this medicine if you are allergic to peanut or soy.

3. How to take TOVIAZ

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

The recommended starting dose of TOVIAZ is one 4 mg tablet per day. Depending on your response 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. TOVIAZ may 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 each day.

If you take more TOVIAZ than you should

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

If you forget to take TOVIAZ

If you forget 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 TOVIAZ

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

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 may cause adverse effects, although not everyone will experience them.

Some adverse effects may be serious

Serious allergic reactions, including angioedema, may rarely occur. You must stop taking TOVIAZ and contact your doctor immediately if you develop swelling of the face, mouth or throat, as this may 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 cavities. Therefore, you should regularly brush your teeth twice a day and visit a dentist if in doubt.

Common (may affect up to 1 in 10 people)

• Dry eyes
• Constipation
• Digestive disturbances (dyspepsia)
• Pain or discomfort when urinating (dysuria)
• Dizziness
• Headache
• Stomach pain
• Diarrhea
• Feeling unwell (nausea)
• Difficulty sleeping (insomnia)
• Dry throat

Uncommon (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 emptying the bladder completely (urinary retention)
• Delay in 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)

• Hives (urticaria)
• Confusion
• Numbness around the mouth (oral hypoesthesia)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of TOVIAZ

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

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

Do not store above 25 °C.

Keep in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Empty section

Composition of TOVIAZ

• The active substance 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, monohydrate lactose, microcrystalline cellulose, hypromellose, glyceryl dibehenate, talc.

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

Appearance of the product and contents of the pack

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

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

TOVIAZ is available in blister packs containing 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 certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer:

Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg im Breisgau
Germany

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

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.eu游戏副本.europa.eu.