Arionte

Patient Information Leaflet

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

fesoterodine fumarate
Equivalent medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 Arionte is and what it is used for

Arionte 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.
Arionte treats the symptoms of overactive bladder such as

• loss of control during 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 Arionte

Do not take Arionte:

• if you are allergic to fesoterodine or to any of the other ingredients of Arionte (listed in section 6) (see section 2, "Arionte contains lactose");
• if you are unable to empty your bladder completely (urinary retention);
• if your stomach empties slowly (gastric retention);
• if you have a type of eye disease called closed-angle glaucoma (high pressure in the eye) that is not adequately controlled;
• if you have excessive muscle weakness (severe myasthenia gravis);
• if you have 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 always be suitable for you. Talk to your doctor before taking Arionte
if any of the following apply to you:

• if you have difficulty emptying your bladder completely (e.g. due to an enlarged prostate);
• if you have ever suffered from reduced intestinal movements or have 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 causes symptoms such as changes in blood pressure or disturbances in intestinal or sexual function;
• if you have a gastrointestinal disease that affects the passage and/or digestion of food;
• if you have heartburn or burping;
• if you have a urinary tract infection, your doctor may consider it necessary to prescribe some 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 you are taking a medicine that causes this abnormality;
• a slow heart rate (bradycardia);
• a heart disease 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 Arionte
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 Arionte together 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 amantadine as the active ingredient (used to treat Parkinson's disease).
• Some medicines used to increase gastrointestinal motility or to relieve stomach cramps or spasms, or to prevent traveler's illness, such as medicines containing metoclopramide.
• Some medicines used to treat psychiatric disorders, such as antidepressants and neuroleptics.

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 used in 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 methadone (used to treat severe pain and addiction problems).

Pregnancy and breastfeeding
You must not take Arionte if you are pregnant, because the effects of fesoterodine on pregnancy and the unborn child are unknown.
It is not known whether fesoterodine is excreted in breast milk; therefore, you must not breastfeed during treatment with Arionte.
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

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

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

3. How to take Arionte

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose of Arionte 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. Arionte can 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 Arionte 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. Show them the tablet packaging.

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 per day. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Arionte
Do not stop taking Arionte without first talking to your doctor, because symptoms of overactive bladder may return or worsen if you stop treatment with Arionte.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
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 may increase the risk of tooth decay. 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)
• Excessive strain or pain during bladder emptying (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
• Rash
• Dry skin
• Itching
• Unpleasant stomach sensation
• Intestinal gas (flatulence)
• Difficulty completely emptying the bladder (urinary retention)
• Delayed urination (delayed micturition)
• Extreme tiredness (asthenia)
• 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, consult your doctor or pharmacist. You may also report side effects directly via 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 stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Arionte 4 mg prolonged-release tablets
Do not store above 30 °C.
Store in the original packaging to protect from moisture.
Arionte 8 mg prolonged-release tablets
This medicine does not require any special storage temperature.
Store in the original packaging to protect from moisture.
Do not dispose of any medicine 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 Arionte contains

• The active substance is fesoterodine fumarate.

Arionte 4 mg prolonged-release tablets
Each prolonged-release tablet contains 4 mg of fesoterodine fumarate, equivalent to 3.1 mg of fesoterodine.
Arionte 8 mg prolonged-release tablets
Each prolonged-release tablet contains 8 mg of fesoterodine fumarate, equivalent to 6.2 mg of fesoterodine.

• Other components are:

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

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

Marketing Authorization Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome, Italy

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

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