TOVIAZ 4 mg Extended-Release Tablet

Зміст інструкції

1. TOVIAZ 4 mg prolonged-release tablets, 8 mg prolonged-release tablets
   1. What is TOVIAZ and what is it 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. Package contents and other information

TOVIAZ 4 mg prolonged-release tablets, 8 mg prolonged-release tablets

fesoterodine fumarate

Read this leaflet carefully before you start taking this medicine as 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What TOVIAZ is and what it is used for
• 2. What you need to know before you take 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 is TOVIAZ and what is it used for

TOVIAZ contains an active substance called fesoterodine fumarate and belongs to the class of
medicines known as antimuscarinics which reduce the activity of an overactive bladder and are used
in adults for the treatment of symptoms.
TOVIAZ treats the symptoms of an overactive bladder such as

• inability to control bladder emptying (urgency incontinence)
• a sudden need to empty the bladder (urinary urgency)
• the need to empty the bladder more often than usual (increased urinary frequency)

2. What you need to know before taking TOVIAZ

Do not take TOVIAZ:

• if you are allergic to fesoterodine, to peanuts or soy or to any of the other ingredients of this medicine (listed in section 6) (see section 2, “TOVIAZ contains lactose and soybean oil”)
• if you are unable to completely empty your bladder (urinary retention)
• if your stomach empties slowly (gastric retention)
• if you suffer from an eye disease called closed-angle glaucoma (high pressure in the eye) that is not sufficiently under control
• if you have excessive muscle weakness (myasthenia gravis)
• if you have an ulceration and inflammation of the colon (severe ulcerative colitis)
• if you have an enlarged or distended colon (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 ingredients: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir or nelfinavir (an antiviral medicine for the treatment of AIDS), 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 conditions apply to you:

• if you have difficulty completely emptying your bladder (for example due to an enlarged prostate)
• if you have ever suffered from a reduction in bowel movements or if you suffer from severe constipation
• if you are being treated for an eye disease called closed-angle glaucoma
• if you have severe liver or kidney problems, your doctor may need to adjust the dose of the medicine
• if you have a condition called autonomic neuropathy which manifests with symptoms such as changes in blood pressure or disturbances of 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 consider it necessary to prescribe you some antibiotics.

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

• you have an abnormality in the ECG (heart tracing) known as prolonged QT interval or are taking a medicine that causes such an abnormality
• you have a slowed heartbeat (bradycardia)
• you suffer from a heart disease called myocardial ischemia (reduced blood supply to the heart muscle), irregular heartbeat or heart failure
• if you have hypokalaemia, which is a manifestation of very low levels of potassium in the blood

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, because it has not
yet been established whether it is effective and safe for them.

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 if you can take TOVIAZ with other medicines.
Tell your doctor if you are taking any of the medicines listed below. Taking them at the same time as fesoterodine may worsen effects such as dry mouth, constipation,
difficulty emptying your bladder or drowsiness, or make them occur more frequently.

• medicines containing amantadine as the active ingredient (used to treat Parkinson's disease)
• some medicines used to increase gastrointestinal motility or to relieve cramps or spasms in the stomach and to prevent traveler's disease, such as medicines containing metoclopramide.
• some medicines used to treat mental illnesses, such as antidepressants and antipsychotics.

Also tell your doctor if you are taking any of the following medicines:

• the medicines containing any of the following active ingredients may increase the degradation of fesoterodine and therefore reduce its effect: St. John's wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among other indications, for the treatment of epilepsy)
• the medicines containing any of the following active ingredients may increase the levels of fesoterodine in the blood: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir or nelfinavir (antiviral medicines used to treat AIDS), 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 for the treatment of depression), quinidine (used to treat arrhythmias) and cinacalcet (used to treat hyperparathyroidism)
• medicines containing the active ingredient methadone (used for the treatment of severe pain and for addiction problems).

Pregnancy and breastfeeding
Do not take TOVIAZ if you are pregnant, because the effects of fesoterodine on pregnancy and the fetus
are unknown.
It is not known whether fesoterodine is excreted in breast milk; therefore, you should not breastfeed during
treatment with TOVIAZ.
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
TOVIAZ can cause blurred vision, dizziness and drowsiness. Do not drive or use tools or
machinery if you experience any of these effects.

TOVIAZ contains lactose and soybean oil
TOVIAZ contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact
them before taking this medicine.
TOVIAZ contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.

3. How to take TOVIAZ

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
The recommended starting dose of TOVIAZ is one 4 mg tablet daily. Based on your
response to the medicine, your doctor may increase the dose up to one 8 mg tablet daily.
The tablet must be swallowed whole with a glass of water. Do not chew the tablet.
TOVIAZ can be taken with or without food.
To remember to take your medicine, it may be helpful to take the medicine every day at the same
time.

If you take more TOVIAZ than you should
If you have taken more tablets than you have been prescribed, or if someone else has accidentally
taken your tablets, seek immediate medical attention or go to the hospital and 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 a day. Do not take a double dose to make up for a missed tablet.

If you stop taking TOVIAZ
Do not stop taking TOVIAZ without first talking to your doctor, as the symptoms of
overactive bladder may return or worsen if you stop treatment with TOVIAZ.
If you have any doubts about 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 may be serious
Serious allergic reactions including angioedema have occurred rarely. Stop taking
TOVIAZ and contact your doctor immediately if you experience swelling of the face, mouth or
throat, as this could be life-threatening.

Other side effects
Very common(may affect more than 1 in 10 people)
Dry mouth may occur. This effect is usually mild or moderate. This may cause an increased risk
of tooth decay. Therefore, you should brush your teeth regularly twice a day and see your
dentist if in doubt.

Common(may affect up to 1 in 10 people)

• dry eyes
• constipation
• digestive problems (dyspepsia)
• excessive strain or pain when emptying the bladder (dysuria)
• dizziness
• headache
• stomach ache
• diarrhoea
• feeling unwell (nausea)
• sleep disturbances (insomnia)
• dry throat

Uncommon(may affect up to 1 in 100 people)

• urinary tract infection
• drowsiness
• taste disturbances (dysgeusia)
• vertigo
• skin rash
• dry skin
• itching
• unpleasant stomach sensation
• intestinal gas (flatulence)
• difficulty emptying the bladder completely (urinary retention)
• delayed urination (micturition hesitation)
• extreme tiredness (fatigue)
• fast heartbeat (tachycardia)
• palpitations
• liver problems
• cough
• dry nose
• sore throat
• acid reflux into the stomach
• blurred vision

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

• hives
• confusion
• numbness around the mouth (oral hypoesthesia)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the
national reporting system listed in Annex 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 package and blister after
“Exp.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C.
Store in the original package to protect from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TOVIAZ contains

• The active substance is fesoterodine fumarate.

TOVIAZ 4 mg
Each prolonged-release tablet contains 4 mg of fesoterodine fumarate corresponding to 3.1 mg
of fesoterodine.

TOVIAZ 8 mg
Each prolonged-release tablet contains 8 mg of fesoterodine fumarate corresponding to 6.2 mg
of fesoterodine.

• The other ingredients are:

Tablet core: xylitol, lactose monohydrate, microcrystalline cellulose, hypromellose,
glycerin dibehenate, talc.
Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc, soybean lecithin,
aluminum lake containing indigo carmine (E132).

Description of the appearance of TOVIAZ and package contents
TOVIAZ 4 mg prolonged-release tablets are light blue, oval-shaped, with a curved
exterior on both sides, film-coated and have the letters ‘FS’ imprinted on one side.
TOVIAZ 8 mg prolonged-release tablets are blue, oval-shaped, with a curved
exterior on both sides, film-coated and have the letters ‘FT’ imprinted on one side.
TOVIAZ is available in blisters 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.
Not all 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
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany
For further information on this medicine, contact the local representative of the marketing
authorization holder:

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Lietuva
Pfizer Luxembourg SARL, filialas Lietuvoje
Tel: +370 5 251 4000

България
Пфайзер Люксембург САРЛ, Клон България
Тел.: +359 2 970 4333

Magyarország
Pfizer Kft.
Tel.:+ 36 1 488 37 00

Česká republika
Pfizer, spol. sr.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 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.
Τ  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
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

France
Pfizer
Tél: +33 (0)1 58 07 34 40

România
Pfizer Romania 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 AB
Tel: +46 (0)8 550 520 00

Κύπρος
Pfizer Ελλάς A.E. (Cyprus Branch)
Τηλ: +357 22817690

United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0)1304 616161

Latvija
Pfizer Luxembourg SARL, filiāle Latvijā
Tel: +371 670 35 775

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