TOVIAZ - Fesoterodine fumarate uses, dose and side effects

TOVIAZ contains an active substance called fesoterodine fumarate and is a so-called antimuscarinic treatment that reduces the activity of an overactive bladder and is used in adults to treat the symptoms.

TOVIAZ treats the symptoms of an overactive bladder, such as

not being able to control bladder emptying (urge incontinence)
having to suddenly empty the bladder (urging)
having to empty the bladder more often than normal (increased bladder emptying frequency).

What you need to know before you use TOVIAZ

Do not take TOVIAZ

if you are allergic to fesoterodine, peanuts, soy, or any of the other ingredients of TOVIAZ (listed in section 6) (see section 2, “TOVIAZ contains lactose and soybean oil”)
if you cannot 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 the control
if you have severe muscle weakness ( myasthenia gravis )
if you have ulcers 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 medicines used to treat 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 difficulty emptying your bladder (for example due to prostate enlargement)
if you ever experience reduced bowel movements or suffer from severe constipation
if you are being treated for an eye disease called narrow-angle glaucoma
if you have severe kidney or liver disease, your doctor may need to adjust your dose
if you have a disease called autonomic neuropathy that manifests itself as changes in your blood pressure, or disturbances in bowel function or sexual function
if you have a gastrointestinal disease that affects the passage of food and/or digestion
if you have heartburn or belch
If you have a urinary tract infection, your doctor may need to prescribe antibiotics.

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

if you have an abnormality seen on the EKG (heart test) called QT prolongation or if you are taking any medicines that cause this
if you have slow heart rhythm ( bradycardia )
if you suffer from a heart condition such as myocardial ischemia (reduced blood flow to the heart muscle), irregular heartbeat, or heart failure
if you have hypokalaemia, which is an expression of abnormally low levels of potassium in your blood.

Children and young people

Do not give this medicine to children and adolescents under 18 years of age, as it has not yet been established whether it works for them or 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 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 can make side effects such as dry mouth, constipation, difficulty emptying the bladder, and drowsiness more severe or common.

medicines containing the active substance amantadine (used to treat Parkinson’s disease )
certain medicines used to improve gastrointestinal motility and relieve stomach cramps or spasms and prevent motion sicknesses such as medicines containing metoclopramide,
certain medicines for the treatment of mental illnesses, such as antidepressants and neuroleptics.

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

medicines containing any of the following active substances can increase the breakdown of fesoterodine and thus reduce its effect: St. John’s wort (natural medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among other things, to treat epilepsy )
medicines that contain 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 to treat HIV ), clarithromycin or telithromycin (used to treat bacterial infections), nefazodone (used to treat depression), fluoxetine or paroxetine (used to treat depression and 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 to treat severe pain and addiction problems).

Pregnancy, breastfeeding, and fertility

You should not take TOVIAZ if you are pregnant because it is not known what effects fesoterodine has during pregnancy and on the fetus.

It is not known whether fesoterodine passes into breast milk. Therefore, do not breastfeed during treatment with TOVIAZ.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving ability and use of machinery

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

TOVIAZ contains lactose and soybean oil

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

TOVIAZ contains soybean oil. If you are allergic to peanuts or soya, you should not use this medicine.

HOW TO TAKE TOVIAZ

Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.

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

You should swallow the tablet whole with a glass of water. Do not chew the tablet. TOVIAZ can be taken with or without food.

It may be easier to remember to take your medicine if you take the tablet at the same time each day.

If you have taken too much TOVIAZ

If you have taken more tablets than your doctor has told you to, or if someone else has taken your tablets by mistake, contact your doctor or hospital immediately for advice. Show the medicine package.

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 per 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 talking to your doctor because overactive bladder symptoms may return or worsen if you stop taking TOVIAZ.

If you have any further questions about this medicine, ask your doctor or pharmacist.

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 occurred in rare cases. You should stop taking TOVIAZ and contact your doctor immediately if you develop swelling of the face, mouth, or throat.

Other side effects are

Very common (may affect more than 1 in 10 users)

You may experience dry mouth. This side effect is usually mild or moderate. This can lead to a greater risk of caries. You should therefore regularly brush your teeth twice a day and visit a dentist if you are unsure.

Common (may affect more than 1 in 10 users)

dry eyes
constipation
indigestion ( dyspepsia )
resistance or pain during bladder emptying ( dysuria )
dizziness
headache
stomach ache
diarrhea
nausea
difficulty sleeping (insomnia)
dry throat.

Uncommon (may affect more than 1 in 100 users)

urinary tract infection
sleepiness ( somnolence )
taste changes ( dysgeusia )
dizziness
rash
dry skin
itching
discomfort in the stomach
gas formation ( flatulence )
difficulty emptying the bladder completely ( urinary retention )
starting difficulties during bladder emptying
extreme fatigue
increased heart rate ( tachycardia )
palpitation
liver problems
cough
nasal dryness
sore throat
acid reflux
blurred vision

Rare (may affect more than 1 in 1,000 users)

hives
confusion

HOW TOVIAZ SHOULD BE STORED

Keep this medicine out of the sight and reach of children.

Use before the expiry date stated on the carton and the blister after “EXP”. The expiration date is the last day of the specified month.

Store at a maximum of 25 °C.

Store in the original packaging, moisture-sensitive.

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

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

Other ingredients are:

Tablet core: xylitol, lactose monohydrate, microcrystalline cellulose, hypromellose, glycerol behenate, talc.

Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc, soy lecithin, indigo carmine aluminum lake (E132).

Appearance and package sizes of the medicine

TOVIAZ 4 mg prolonged-release tablets are light blue, oval, biconvex, film-coated, and embossed on one side with the letters ‘FS’.

TOVIAZ 8 mg prolonged-release tablets are blue, oval, biconvex, film-coated, and embossed on one side with the letters ‘FT’.

TOVIAZ is sold in blister packs of 7, 14, 28, 30, 56, 84, 98, or 100 prolonged-release tablets. TOVIAZ is also sold in plastic cans (HDPE) of 30 or 90 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing Authorisation Holder:

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer:

R – Pharm Germany GmbH

Heinrich-Mack-Str. 35, 89257 Illertissen

Germany

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

79090 Freiburg