TOVIAZ 8mg prolonged-release tablets

TOVIAZ is a so called antimuscarinic medicinal product which reduces the activity of an overactive bladder and treats the symptoms.

TOVIAZ treats the symptoms of an overactive bladder such as
-not being able to control when you empty your bladder (called urgency incontinence)-suddenly needing to empty your bladder (called urgency)
-having to empty your bladder more than usual (called increased urinary frequency)

Do not take TOVIAZ

• if you are allergic (hypersensitive) to fesoterodine or to peanut or soya or to any of the other ingredients of TOVIAZ (see section 2, ?Important information about some of the ingredients of TOVIAZ?)
• if you are not able to completely empty your bladder (urinary retention)
• if your stomach empties slowly (gastric retention)
• if you have an eye disease called narrow angle glaucoma (high pressure in the eye), which is not under control
• if you have excessive weakness of the muscles (myasthenia gravis)
• if you have ulceration and inflammation of the colon (severe ulcerative colitis)
• if you have an abnormally large or distended colon (toxic megacolon)
• if you have severe liver problems.

Take special care with TOVIAZ

Fesoterodine may not always be suitable for you. Talk to your doctor before you take TOVIAZ, if any of the following apply to you:

• if you have difficulties in completely emptying your bladder (for example due to prostate enlargement)
• if you ever experience decreased bowel movements or suffer from severe constipation
• if you are being treated for an eye disease called narrow angle glaucoma
• if you have serious kidney or liver problems, your doctor may need to adjust your dose-
• if you have a disease called autonomic neuropathy which you notice from symptoms such as changes in your blood pressure or disorders in the 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.

Heart problems: Talk to your doctor if you suffer from any of the following conditions

• you have an ECG (heart tracing) abnormality known as QT prolongation or you are taking any medicine known to cause this
• you have a slow heart rate (bradycardia)
• you suffer from heart disease such as myocardial ischaemia (reduced blood flow to the heart muscle), irregular heartbeat or heart failure
• you have abnormally low levels of potassium in your blood.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you do not have a prescription for. Your doctor will tell you whether you can take TOVIAZ with other medicines.

Please inform your doctor if you are taking medicines according to the following list. Concomitant treatment with fesoterodine may make side effects such as dry mouth, constipation, difficulty in completely emptying your bladder or drowsiness more serious or occur more often.

• medicines containing the active substance amantadine (used to treat Parkinson?s disease)
• certain medicines used to enhance gastrointestinal motility or to relieve stomach cramps or spasm and to prevent travel sickness
• certain medicines used to treat psychiatric diseases.

Please also inform your doctor if you are taking any of the following medicines:

• medicines containing any of the following active substances may increase the break-down of fesoterodine and thus decrease its effect: St. John?s Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy)
• medicines containing any of the following active substances may increase the blood levels of fesoterodine: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir or nelfinavir (antiviral medication for treating HIV), clarithromycin or telithromycin (used to treat bacterial infections) and nefazodone (used to treat depression)
• medicines containing the active substance methadone (used in the treatment of severe pain and abuse problems).

Taking TOVIAZ with food and drink

TOVIAZ can be taken with or without food. However, grapefruit juice should be avoided since grapefruit juice may alter the effect of the medicine.

Pregnancy and breast-feeding

You should not take TOVIAZ if you are pregnant, as the effects of fesoterodine on pregnancy and the unborn baby are not known. Tell your doctor if you are pregnant or planning to become pregnant.

It is not known whether fesoterodine is excreted into human milk; therefore, breast-feeding is not recommended during treatment with TOVIAZ.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

TOVIAZ can cause blurred vision, dizziness, and sleepiness. If you experience any of these effects, do not drive or use any tools or machines.

Important information about some of the ingredients of TOVIAZ

TOVIAZ contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
TOVIAZ contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

Always take TOVIAZ exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The recommended starting dose of TOVIAZ is one 4mg tablet a day. Based on how you respond to the medicine, your doctor may prescribe you a higher dose; one 8mg tablet a day.

You should swallow your tablet whole with a glass of water. Do not chew the tablet.

To help you remember to take TOVIAZ, you may find it 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 have been told to take, or if someone else accidentally takes your tablets, contact your doctor or hospital for advice immediately. Show them your pack of tablets.

If you forget to take TOVIAZ

If you forget to take a tablet, take your tablet as soon as you remember, but do not take more than one tablet in one day. Do not take a double dose to make up for a forgotten tablet.

If you stop taking TOVIAZ

Do not stop taking TOVIAZ without talking to your doctor, as your symptoms of overactive bladder may come back again or become worse once you stop taking TOVIAZ.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, TOVIAZ can cause side effects, although not everybody gets them.

Very common side effects (more than one in 10 patients)
You may get a dry mouth. This effect is usually mild or moderate. This may lead to a greater risk of dental caries. Therefore, you should brush your teeth regularly with fluoride toothpaste twice daily.

Common side effects between one in 100 patients and one in 10 patientsdry eyeconstipationtrouble digesting food dyspepsiastraining or pain when emptying the bladder dysuriadizzinessheadachepain in the stomachdiarrhoeafeeling sick nauseadifficulty sleeping insomnia

dry throa

Uncommon side effects occuring in 1 in 1,000 to 1 in 100 patients urinary tract infectionsleepiness somnolencedifficulty tasting dysgeusiavertigorashdry skinitchingan uncomfortable feeling in the stomachwind flatulencedifficulty in completely emptying the bladder urinary retentiondelay in passing urine urinary hesitationextreme tiredness fatigueincreased heart beat tachycardiapalpitationsliver problemscoughnasal drynessthroat painstomach acid refluxblurred visio

Rare side effects

-angioedema
-urticaria
-confusion

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use TOVIAZ after the expiry date which is stated on the carton and the blister after ?EXP?. The expiry date refers to the last day of that month.

Do not store above 25-C.

Store in the original package in order 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. These measures will help to protect the environment.

What TOVIAZ contains

The active substance is fesoterodine fumarate

TOVIAZ 4mg

1 prolonged-release tablet contains 4mg fesoterodine fumarate, equivalent to 3.1mg of fesoterodine. TOVIAZ 8mg
1 prolonged-release tablet contains 8mg fesoterodine fumarate, equivalent to 6.2mg of fesoterodine.

-The other ingredients are:
The tablet core: xylitol, lactose monohydrate, microcrystalline cellulose, hypromellose, glycerol dibehenate, talc.
The coating: polyvinyl alcohol, titanium dioxide, macrogol, talc, soya lecithin, indigo carmine aluminium lake (E132)

What TOVIAZ looks like and contents of the pack

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

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

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

Please note that not all the above pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Manufacturer

Pfizer Manufacturing Deutschland GmbH
Heinrich Mack Str. 35
89257 Illertissen
Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België Belgique BelgienPfizer S.A. N.V.TélTel 32 02 554 62 11 LuxembourgLuxemburgPfizer S.A.TélTel 32 02 554 62 1

, . 359 2 970 4333 MagyarországPfizer Kft. Tel. 36 1 488 37 00

eská republikaPfizer s.r.o. Tel 420-283-004-111 Malta V.J. Salomone Pharma Ltd.Tel 356 21 22 01 7

DanmarkPfizer ApSTlf 45 44 20 11 00 NederlandPfizer bvTel 31 010 406 43 0

DeutschlandPfizer Pharma GmbHTel 49 030 550055 51000 NorgePfizer ASTlf 47 67 52 61 0

EestiPfizer Luxembourg SARL, Eesti filiaalTel 372 6 405 328 ÖsterreichPfizer Corporation Austria Ges.m.b.H.Tel 43 01 521 15-

Pfizer Hellas A.E. 30 210 6785800 PolskaPfizer Polska Sp. z o.o. Tel. 48 22 335 61 0

EspañaPfizer S.A.Tel 34 91 490 99 00 PortugalLaboratórios Pfizer, Lda. Tel 351 21 423 550

FrancePfizerTél 33 01 58 07 34 40 RomâniaPfizer România S.R.L.Tel 40 021 207 28 0

IrelandPfizer Healthcare IrelandTel 1800 633 363 toll freeTel 44 01304 616161 SlovenijaPfizer Luxembourg SARL, Pfizer, podrunica za svetovanje s podroja farmacevtske dejavnosti, LjubljanaTel 386 01 52 11 40

ÍslandIcepharma hf.Sími 354 540 8000 Slovenská republikaPfizer Luxembourg SARL, organizaná zlokaTel 42123355 550

ItaliaPfizer Italia S.r.l.Tel 39 06 33 18 21 SuomiFinlandPfizer OyPuhTel 35809 43 00 4

GEO. PAVLIDES ARAOUZOS LTD 35722818087 Sverige Pfizer ABTel 46 08 550 520 0

LatvijaPfizer Luxembourg SARL, filile LatvijTel 371 670 35 775 United KingdomPfizer LimitedTel 44 01304 61616

Lietuva

Pfizer Luxembourg SARL, filialas Lietuvoje
Tel. +3705 2514000

This leaflet was last revised on{MM/YYYY}.