Toviaz

Основна информация

  • Търговско наименование:
  • Toviaz
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Toviaz
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Urologicals
  • Терапевтична област:
  • Urinary Bladder, Overactive
  • Терапевтични показания:
  • Treatment of the symptoms (increased urinary frequency and / or urgency and / or urgency incontinence) that may occur in patients with overactive-bladder syndrome.
  • Каталог на резюме:
  • Revision: 23

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/000723
  • Дата Оторизация:
  • 20-04-2007
  • EMEA код:
  • EMEA/H/C/000723
  • Последна актуализация:
  • 06-05-2020

Доклад обществена оценка

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Canary Wharf

London E14 4HB

United Kingdom

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

EMA/84670/2012

EMEA/H/C/000723

EPAR summary for the public

Toviaz

fesoterodine

This is a summary of the European public assessment report (EPAR) for Toviaz. It explains how the

Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in

favour of granting a marketing authorisation and its recommendations on the conditions of use for

Toviaz.

What is Toviaz?

Toviaz is a medicine containing the active substance fesoterodine. It is available as prolonged-release

4 mg tablets and 8 mg tablets. Prolonged-release means that fesoterodine is released slowly from the

tablet over a few hours.

What is Toviaz used for?

Toviaz is used in adults with overactive bladder syndrome to treat the symptoms of the disease:

increased urinary frequency (need to urinate frequently), urgency (sudden urge to pass urine), and

urgency incontinence (sudden lack of control over urination).

The medicine can only be obtained with a prescription.

How is Toviaz used?

The recommended starting dose of Toviaz is 4 mg once a day. The tablets are swallowed whole with a

glass of water and must not be chewed. The patient normally gets the full effect of the treatment after

two to eight weeks. Based upon individual response, the dose may be increased to 8 mg once daily.

The dose of Toviaz must be adjusted, or the medicine not used at all, in patients with problems with

their kidneys or liver, depending on whether they are also receiving ‘CYP3A4 inhibitors’, a group of

medicines that may affect the way Toviaz is broken down in the body. See the summary of product

characteristics (also part of the EPAR) for full details.

How does Toviaz work?

The active substance in Toviaz, fesoterodine, is an anticholinergic medicine. It blocks some receptors

in the body, the muscarinic receptors. In the bladder, this causes the muscles that push urine out of

the bladder to relax, leading to an increase in the capacity of the bladder and to changes in the way

the bladder muscles contract as the bladder fills up. This helps Toviaz to prevent unwanted urination.

How has Toviaz been studied?

The two main studies involved 1,964 patients with overactive bladder syndrome and compared Toviaz

(4 or 8 mg a day) with placebo (a dummy treatment). One of the studies also compared Toviaz with

tolterodine (another medicine used in overactive bladder syndrome). The main measure of

effectiveness was the change in the number of times the patients needed to urinate in a 24-hour

period after 12 weeks of treatment.

What benefit has Toviaz shown during the studies?

Toviaz was more effective than placebo and as effective as tolterodine in reducing the number of times

the patients urinated in a 24-hour period. Before treatment, patients needed to urinate about 12 times

in 24 hours. This number was reduced by 1.74 and 1.86 with the 4 mg dose of Toviaz and by 1.94 with

the 8 mg dose. The reductions seen in patients taking placebo and tolterodine were 1.02 and 1.69,

respectively.

What is the risk associated with Toviaz?

The most common side effect with Toviaz (seen in more than 1 patient in 10) is dry mouth. For the full

list of all side effects reported with Toviaz, see the package leaflet.

Toviaz must not be used in people who are hypersensitive (allergic) to fesoterodine, to any of the other

ingredients, to peanut or to soya. Toviaz must also not be used in patients with:

urinary retention (difficulty in passing urine);

gastric retention (when the stomach does not empty properly);

uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment);

myasthenia gravis (a disease of the nerves causing muscle weakness);

severe hepatic impairment (severe liver disease);

severe ulcerative colitis (severe inflammation of the large intestine causing ulceration and

bleeding);

toxic megacolon (a very serious complication of colitis).

Toviaz must not be given to patients with moderate liver or moderate to severe kidney disease at the

same time as strong CYP3A4 inhibitor medicines. These include medicines such as ketoconazole and

itraconazole (used to treat fungal infections), atazanavir, indinavir, nelfinavir, ritonavir and saquinavir

(medicines used in HIV-positive patients), clarithromycin and telithromycin (antibiotics), and

nefazodone (used to treat depression).

Toviaz

EMA/84670/2012

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Toviaz

EMA/84670/2012

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Why has Toviaz been approved?

The CHMP decided that Toviaz’s benefits are greater than its risks and recommended that it be given

marketing authorisation.

Other information about Toviaz

The European Commission granted a marketing authorisation valid throughout the European Union for

Toviaz on 20 April 2007.

The full EPAR for Toviaz can be found on the Agency’s website: ema.europa.eu/Find medicine/Human

medicines/European Public Assessment Reports. For more information about treatment with Toviaz,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 02-2012.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

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 further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm

them, even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What TOVIAZ is and what it is used for

What you need to know before you take TOVIAZ

How to take TOVIAZ

Possible side effects

How to store TOVIAZ

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 a so called

antimuscarinic treatment which reduces the activity of an overactive bladder and it is used in adults

to treat 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 often than usual (called increased urinary frequency)

2.

What you need to know before you take TOVIAZ

Do not take TOVIAZ:

if you are allergic to fesoterodine or to peanut or soya or to any of the other ingredients of

TOVIAZ (listed in section 6) (see section 2, “TOVIAZ contains lactose and soya oil”)

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.

if you have 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 medicine

for treating HIV), 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, 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.

if you have an infection of the urinary tract, your doctor may need to prescribe some

antibiotics

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 hypokalaemia, which is a manifestation of abnormally low levels of potassium in

your blood.

Children and adolescents

Do not give this medicine to children and adolescents below 18 years of age because it is yet to be

established whether it would work for them and whether it would be safe.

Other medicines and TOVIAZ

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. 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. Taking them

at the same time as 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 like medicines containing metoclopramide.

certain medicines used to treat psychiatric diseases, like anti-depressives and neuroleptics.

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 medicine for treating HIV),

clarithromycin or telithromycin (used to treat bacterial infections), nefazodone (used to treat

depression), fluoxetine or paroxetine (used to treat depression or anxiety), bupropion (used

for smoking cessation or to treat depression), quinidine (used to treat arrhythmias) and

cinacalcet (used to treat hyperparathyroidism).

medicines containing the active substance methadone (used in the treatment of severe pain

and abuse problems).

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.

It is not known whether fesoterodine is excreted into human milk; therefore, do not breast-feed

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 can cause blurred vision, dizziness, and sleepiness. If you experience any of these effects,

do not drive or use any tools or machines.

TOVIAZ contains lactose and soya oil

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 medicinal product.

TOVIAZ contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

3.

How to take TOVIAZ

Always take this medicine exactly as your doctor has told you. Check with your doctor or

pharmacist if you are not sure.

The recommended starting dose of TOVIAZ is one 4 mg tablet a day. Based on how you respond to

the medicine, your doctor may prescribe you a higher dose; one 8 mg tablet a day.

You should swallow your 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, 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 medicine, 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 could be serious

Serious allergic reactions including angioedema occurred rarely. You should stop taking TOVIAZ

and contact your doctor immediately if you develop swelling of the face, mouth or throat.

Other side effects

Very common

(may affect more than 1 in 10 people)

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 twice daily and see a dentist when in

doubt.

Common

(may affect up to 1 in 10 people)

dry eye

constipation

trouble digesting food (dyspepsia)

straining or pain when emptying the bladder (dysuria)

dizziness

headache

pain in the stomach

diarrhoea

feeling sick (nausea)

difficulty sleeping (insomnia)

dry throat

Uncommon

(may affect up to 1 in 100 people)

urinary tract infection

sleepiness (somnolence)

difficulty tasting (dysgeusia)

vertigo

rash

dry skin

itching

an uncomfortable feeling in the stomach

wind (flatulence)

difficulty in completely emptying the bladder (urinary retention)

delay in passing urine (urinary hesitation)

extreme tiredness (fatigue)

increased heart beat (tachycardia)

palpitations

liver problems

cough

nasal dryness

throat pain

stomach acid reflux

blurred vision

Rare

(may affect up to 1 in 1,000 people)

urticaria

confusion

Reporting of side effects

If you get 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.

How to store 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 the blister after

“EXP”. The expiry date refers to the last day of that month.

Do not store above 25

Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how

to throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What TOVIAZ contains

The active substance is fesoterodine fumarate.

TOVIAZ 4 mg

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

fesoterodine.

TOVIAZ 8 mg

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

fesoterodine.

The other ingredients are:

The tablet core: xylitol, lactose monohydrate, microcrystalline cellulose, hypromellose, glycerol

dibehenate, talc.

The coating: polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc, soya lecithin, indigo

carmine aluminium lake (E132).

What TOVIAZ looks like and contents of the pack

TOVIAZ 4 mg 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 8 mg prolonged-release tablets are blue, oval, curved outwards on both sides, film-coated

tablets, and engraved on one side with the letters ‘FT’.

TOVIAZ

is available in blister packs of

7, 14, 28, 30, 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 and Manufacturer

Marketing Authorisation Holder:

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturer:

-

Pharm Germany GmbH

Heinrich

-

Mack

-

Str. 35, 89257 Illertissen

Germany

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

79090 Freiburg

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België /Belgique / Belgien

Pfizer S.A./ N.V.

Tél/Tel: +32 (0)2 554 62 11

Luxembourg/Luxemburg

Pfizer S.A.

Tél/Tel: +32 (0)2 554 62 11

България

Пфайзер Люксембург САРЛ, Клон България

Тел.: +359 2 970 4333

Magyarország

Pfizer Kft.

Tel.: + 36 1 488 37 00

Česká Republika

Pfizer PFE, spol. s r.o.

Tel: +420 283 004 111

Malta

Vivian Corporation Ltd.

Tel: +356 21344610

Danmark

Pfizer ApS

Tlf: +45 44 20 11 00

Nederland

Pfizer bv

Tel: +31 (0)10 406 43 01

Deutschland

Pfizer Pharma GmbH

Tel: +49 (0)30 550055 51000

Norge

Pfizer Norge AS

Tlf: +47 67 52 61 00

Eesti

Pfizer Luxembourg SARL Eesti filiaal

Tel: +372 666 7500

Österreich

Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15-0

Ελλάδα

Pfizer Ελλάς A.E.

λ: +30 210 6785800

Polska

Pfizer Polska Sp. z o.o.

Tel.: +48 22 335 61 00

España

Pfizer S.L.

Tel: +34 91 490 99 00

Portugal

Pfizer Biofarmacêutica, Sociedade Unipessoal Lda

Tel: +351 21 423 5500

France

Pfizer

Tél: +33 (0)1 58 07 34 40

România

Pfizer România S.R.L.

Tel: +40 (0)21 207 28 00

Hrvatska

Pfizer Croatia d.o.o.

Tel: +385 1 3908 777

Slovenija

Pfizer Luxembourg SARL, Pfizer, podružnica za

svetovanje s področja farmacevtske dejavnosti,

Ljubljana

Tel: + 386 (0)1 52 11 400

Ireland

Pfizer Healthcare Ireland

Tel: 1800 633 363 (toll free)

Tel: +44 (0)1304 616161

Slovenská republika

Pfizer Luxembourg SARL, organizačná zložka

Tel: +421–2–3355 5500

Ísland

Icepharma hf.

Sími: + 354 540 8000

Suomi/Finland

Pfizer Oy

Puh/Tel: +358(0)9 43 00 40

Italia

Pfizer S.r.l.

Tel: +39 06 33 18 21

Sverige

Pfizer Innovations AB

Tel: +46 (0)8 550 520 00

Κύπρος

Pfizer Ελλάς A.E. (Cyprus Branch)

Τηλ: +357 22 817690

United Kingdom

Pfizer Limited

Tel: +44 (0)1304 616161

Latvija

Pfizer Luxembourg SARL, filiāle Latvijā

Tel: +371 670 35 775

Lietuva

Pfizer Luxembourg SARL, filialas Lietuvoje

Tel. +3705 2514000

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.