TOVIAZ 4 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take TOVIAZ

Do not take TOVIAZ if:

• you are allergic to fesoterodine, peanuts, soya or any of the other ingredients of TOVIAZ (listed in section 6) (see section 2, "TOVIAZ contains lactose and soya oil")
• you are unable to empty your bladder completely (urinary retention)
• your stomach empties slowly (gastric retention)
• you have a eye disease 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 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

Fesoterodine may not always be suitable for you. Talk to your doctor before taking TOVIAZ 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 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 have heartburn or belching
• if you have a urinary tract infection, your doctor may need to prescribe you antibiotics

Heart problems: Tell 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 TOVIAZ with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. Your doctor will tell you whether you can use TOVIAZ with other medicines.

Please tell your doctor if you are taking medicines from the list 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 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 tell 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 thus 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 breast-feeding

You should not take TOVIAZ if you are pregnant, as the effects of fesoterodine on pregnancy and 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 breast-feeding, 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

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

TOVIAZ contains lactose and soya oil

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

TOVIAZ contains soya oil. Do not use this medicine if you are allergic to peanuts or soya.

3. How to take TOVIAZ

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended initial dose of TOVIAZ 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. TOVIAZ 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 TOVIAZ than you should

If you have taken more tablets than you should or if someone else has taken your tablets, contact your doctor or hospital immediately. Show them the pack of tablets.

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 taking TOVIAZ without talking to your doctor first, as the symptoms of an overactive bladder may return or worsen when you stop taking TOVIAZ.

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, serious allergic reactions including angioedema may occur. You should stop taking TOVIAZ and contact your doctor immediately if you develop swelling of the face, mouth or throat, as this can be life-threatening.

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
• discomfort in the stomach
• gas (flatulence)
• difficulty emptying the bladder completely (urinary retention)
• delayed urination (urinary hesitation)
• 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
• numbness around the mouth (oral hypoesthesia)

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 Appendix V. By reporting side 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 which is stated on the carton and blister after "EXP". The expiry date refers to the last day of the month stated.

Do not store above 25°C.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 ingredients are:

Core of the tablet: xylitol, lactose monohydrate, microcrystalline cellulose, hypromellose, glycerol dibehenate, talc.

Coating of the tablet: polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc, soya lecithin, carmine indigo lake (E132).

Appearance of the product and packaging contents

The TOVIAZ 4 mg prolonged-release tablets are light blue, oval, curved on both sides, with a film coating and with the letters "FS" engraved on one side.

The TOVIAZ 8 mg prolonged-release tablets are blue, oval, curved on both sides, with a film coating and with 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.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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

You can request more information about this medicine from the local representative of the marketing authorisation holder.

Date of last revision of this leaflet:

Other sources of information

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