Toviaz

Package leaflet: Information for the user

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

fesoterodine fumarate
Read this entire leaflet carefully before 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including 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 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 belongs to a class of
medicines known as antimuscarinics, which reduce the activity of the overactive bladder and are used
in adults for the treatment of symptoms.
TOVIAZ treats symptoms of overactive bladder such as

• inability to control bladder emptying (urge incontinence)
• sudden need to empty the bladder (urinary urgency)
• 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, 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 empty your bladder completely (urinary retention)
• if your stomach empties slowly (gastric retention)
• if you have a condition of the eye called narrow-angle glaucoma (high pressure in the eye) that is not adequately controlled
• if you have severe muscle weakness (myasthenia gravis)
• if you have severe ulceration and inflammation of the colon (severe ulcerative colitis)
• if you have an abnormally 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 substances: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir, or nelfinavir (antiviral medicines for the treatment of AIDS), clarithromycin or telithromycin (used to treat bacterial infections), or nefazodone (used to treat depression).

Warnings and precautions
Fesoterodine may not be suitable for you. Speak to your doctor before taking TOVIAZ
if any of the following apply to you:

• if you have difficulty emptying your bladder completely (for example, 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 condition of the eye called narrow-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 causes symptoms such as changes in blood pressure or disturbances in intestinal or sexual function
• if you have a gastrointestinal disorder that affects the passage and/or digestion of food
• if you have heartburn or regurgitation
• if you have a urinary tract infection, your doctor may consider it necessary to prescribe antibiotics.

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

• an abnormality in your ECG (heart tracing) known as QT prolongation, or if you are taking a medicine that causes this abnormality
• a slow heartbeat (bradycardia)
• a heart condition called myocardial ischemia (reduced blood supply to the heart muscle), irregular heartbeat, or heart failure
• hypokalemia, which is a condition characterized by very 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 this medicine 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 advise you whether you can take TOVIAZ with other medicines.
Inform your doctor if you are taking any of the medicines listed below. Taking them together with fesoterodine may worsen side effects such as dry mouth, constipation, difficulty emptying the bladder completely, or drowsiness, or make them occur more frequently.

• medicines containing the active substance amantadine (used to treat Parkinson's disease)
• certain medicines used to increase gastrointestinal motility or to relieve stomach cramps or spasms, or to prevent traveler's illness, such as medicines containing metoclopramide
• certain medicines used to treat psychiatric conditions, such as antidepressants and antipsychotics.

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

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

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

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

TOVIAZ contains lactose and soybean oil
TOVIAZ contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor 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 exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended starting dose of TOVIAZ is one 4 mg tablet daily. Depending on your response to the medicine, your doctor may increase the dose up to one 8 mg tablet daily.
The tablet should be swallowed 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 medicine, it may be helpful to take it at the same time each day.

If you take more TOVIAZ than you should
If you have taken more tablets than prescribed, or if someone else has accidentally taken your tablets, contact your doctor or go to hospital immediately and show them the tablet pack.

If you forget to take TOVIAZ
If you forget to take a dose, take it as soon as you remember, but do not take more than one tablet per 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 first talking to your doctor, as symptoms of overactive bladder may return or worsen if you discontinue treatment with TOVIAZ.

If you have any questions 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 can be serious
Severe 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. It may increase the risk of dental caries. Therefore, you should brush your teeth regularly twice a day and consult your dentist if in doubt.
Common (may affect up to 1 in 10 people)

• Dry eyes
• Constipation
• Digestive problems (dyspepsia)
• Pressure or pain during bladder emptying (dysuria)
• Dizziness
• Headache
• Stomach ache
• Diarrhoea
• Feeling unwell (nausea)
• Sleep disorders (insomnia)
• Dry throat

Uncommon (may affect up to 1 in 100 people)

• Urinary tract infection
• Drowsiness
• Taste disturbances (dysgeusia)
• Vertigo
• Rash
• Dry skin
• Itching
• Uncomfortable feeling in the stomach
• Intestinal gas (flatulence)
• Difficulty completely emptying the bladder (urinary retention)
• Delayed passage of urine (hesitancy)
• Extreme tiredness (fatigue)
• Increased heart rate (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 people)

• Urticaria
• Confusion
• Numbness around the mouth (oral hypoesthesia)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed 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 stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Do not store above 25 °C.
Keep in the original packaging to protect from moisture.
Do not dispose of medicines via 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, 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.
Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc, soybean lecithin,
aluminium lake containing indigo carmine (E132).

Description of the appearance of TOVIAZ and contents of the pack
TOVIAZ 4 mg prolonged-release tablets are blue, oval-shaped, convex on both sides, film-coated,
and marked with the code 'FS' on one side.
TOVIAZ 8 mg prolonged-release tablets are blue, oval-shaped, convex on both sides, film-coated,
and marked with the code 'FT' on one side.
TOVIAZ is available in blisters containing 7, 14, 28, 30, 56, 84, 98 and 100 prolonged-release tablets.
Additionally, TOVIAZ is also available in HDPE bottles containing 30 or 90 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

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

België/Belgique/Belgien Lietuva
Luxembourg/Luxemburg Pfizer Luxembourg SARL, filialas Lietuvoje
Pfizer NV/SA Tel: +370 5 251 4000
Tél/Tel: +32 (0)2 554 62 11

България Magyarország
Пфайзер Люксембург САРЛ, Клон България Pfizer Kft.
Тел.: +359 2 970 4333 Tel.: +36 1 488 37 00

Česká republika Malta
Pfizer, spol. s.r.o. Vivian Corporation Ltd.
Tel: +420 283 004 111 Tel: +356 21344610

Danmark Nederland
Pfizer ApS Pfizer bv
Tlf.: +45 44 20 11 00 Tel: +31 (0)10 406 43 01

Deutschland Norge
PFIZER PHARMA GmbH Pfizer AS
Tel: +49 (0)30 550055-51000 Tlf: +47 67 52 61 00

Eesti Österreich
Pfizer Luxembourg SARL Eesti filiaal Pfizer Corporation Austria Ges.m.b.H.
Tel: +372 666 7500 Tel: +43 (0)1 521 15-0

Ελλάδα Polska
Pfizer Ελλάς A.E. Pfizer Polska Sp. z o.o.
Τηλ: +30 210 6785800 Tel.: +48 22 335 61 00

España Portugal
Pfizer, S.L. Laboratórios Pfizer, Lda.
Tel: +34 91 490 99 00 Tel: +351 21 423 5500

France România
Pfizer Pfizer Romania S.R.L.
Tél: +33 (0)1 58 07 34 40 Tel: +40 (0)21 207 28 00

Hrvatska Slovenija
Pfizer Croatia d.o.o. Pfizer Luxembourg SARL
Tel: +385 1 3908 777 Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Ireland Slovenská republika
Pfizer Healthcare Ireland Unlimited Company Pfizer Luxembourg SARL, organizačná zložka
Tel: +1800 633 363 (toll free) Tel: +421 2 3355 5500
Tel: +44 (0)1304 616161

Ísland Suomi/Finland
Icepharma hf. Pfizer Oy
Sími: +354 540 8000 Puh/Tel: +358(0)9 43 00 40

Italia Sverige
Pfizer S.r.l. Pfizer AB
Tel: +39 06 33 18 21 Tel: +46 (0)8 550 520 00

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

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

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