ARIONTE 4 mg Tabletki O Przedłużonym Uwalnianiu

Treść ulotki

1. Arionte 4 mg prolonged-release tablets, 8 mg prolonged-release tablets
   1. What is Arionte and what is it used for
   2. What you need to know before taking Arionte
   3. How to take Arionte
   4. Possible side effects
   5. How to store Arionte
   6. Contents of the pack and other information

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

fesoterodine fumarate
Generic medicine

Read 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 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 Arionte is and what it is used for
• 2. What you need to know before you take Arionte
• 3. How to take Arionte
• 4. Possible side effects
• 5. How to store Arionte
• 6. Contents of the pack and other information

1. What is Arionte and what is it used for

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

Do not take Arionte:

• if you are allergic to fesoterodine or any of the other ingredients of Arionte (listed in section 6) (see section 2, “Arionte contains lactose”);
• 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 controlled;
• 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 Arionte,
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 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 Arionte
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 Arionte 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 one 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 one 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 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 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
You should not take Arionte if you are pregnant, because the effects of fesoterodine on pregnancy and the fetus are not
known.
It is not known whether fesoterodine is excreted in breast milk; therefore you should not breastfeed during
treatment with Arionte.
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

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

Arionte contains lactose and sodium
Arionte contains lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact
them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet,
which is essentially “sodium-free”.

3. How to take Arionte

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended initial dose of Arionte 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. Arionte
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 Arionte 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 hospital. Show them the packaging
of the tablets.

If you forget to take Arionte
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 Arionte
Do not stop taking Arionte without first talking to your doctor, as the symptoms of overactive bladder
may return or worsen if you stop treatment with Arionte.
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.
li manifestino.

Some side effects may be serious
Severe allergic reactions including angioedema have rarely occurred. Stop taking Arionte
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 can 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 tension or pain during urination (dysuria)
• dizziness
• headache
• stomach pain
• 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
• skin rash
• dry skin
• itching
• unpleasant stomach sensation
• intestinal gas (flatulence)
• difficulty emptying the bladder completely (urinary retention)
• delayed urination (delayed micturition)
• extreme fatigue (asthenia)
• 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 people)

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Arionte

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.

Arionte4 mgprolonged-release tablets
Do not store at a temperature above 30 °C.
Store in the original package to protect from moisture.

Arionte 8 mg prolonged-release tablets
This medicine does not require any particular storage temperature.
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. Contents of the pack and other information

What Arionte contains

• The active ingredient is fesoterodine fumarate.

Arionte4 mg prolonged-release tablets
Each prolonged-release tablet contains 4 mg of fesoterodine fumarate corresponding to 3.1 mg
of fesoterodine.

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

• Other ingredients are:

Arionte 4 mg prolonged-release tablets
Tablet core: glyceryl dibehenate, hypromellose, talc, lactose monohydrate (see paragraph 2
“Arionte contains lactose and sodium”)/microcrystalline cellulose.
Coating: polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylocaprate, sodium
lauryl sulfate (see paragraph 2 “Arionte contains lactose and sodium”), aluminium lake containing
indigo carmine (E132).
Arionte 8 mg prolonged-release tablets
Tablet core: glyceryl dibehenate, hypromellose, talc, lactose monohydrate (see paragraph 2
“Arionte contains lactose and sodium”)/microcrystalline cellulose.
Coating: polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylocaprate, sodium
lauryl sulfate (see paragraph 2 “Arionte contains lactose and sodium”), aluminium lake containing
indigo carmine (E132), Iron oxide red (E172).

Description of the appearance of Arionte and contents of the pack
Arionte 4 mg prolonged-release tablets are film-coated tablets, azure, oval,
biconvex, with the number “4” imprinted on one side.
Arionte 8 mg prolonged-release tablets are film-coated tablets, blue, oval,
biconvex, with the number “8” imprinted on one side.
Arionte is available in packs of 14 and 28 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome

Manufacturer
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larissa Industrial Area,
Larissa, 41500, Greece

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Hungary: Arionte 4 mg prolonged-release tablets, Arionte 8 mg prolonged-release
Italy: Arionte