Package leaflet: Information for the user

FESOTERODINE DOC 4 mg prolonged-release tablets, 8 mg prolonged-release tablets

Generic medicine
Please read this 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, consult 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 you, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What FESOTERODINE DOC is and what it is used for
What you need to know before taking FESOTERODINE DOC
How to take FESOTERODINE DOC
Possible side effects
How to store FESOTERODINE DOC
Contents of the pack and other information

1. What FESOTERODINE DOC is and what it is used for

FESOTERODINE DOC 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 to treat symptoms.
FESOTERODINE DOC treats the 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 should know before taking FESOTERODINE DOC:

Do not take FESOTERODINE DOC:

if you are allergic to fesoterodine, fructose, or any of the other components of FESOTERODINE DOC (listed in section 6) (see section 2, FESOTERODINE DOC contains lactose and fructose)
if you are unable to completely empty your bladder (urinary retention)
if your stomach empties too slowly (gastric retention)
if you have a condition of the eye called closed-angle glaucoma (high pressure in the eye) that is not adequately controlled
if you have severe muscle weakness (myasthenia gravis)
if you have severe ulcerative colitis (ulceration and inflammation of the colon)
if you have 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. Talk to your doctor before taking
FESOTERODINE DOC
if any of the following apply to you:

if you have difficulty completely emptying your bladder (e.g., due to an enlarged prostate)
if you have ever experienced reduced intestinal motility or suffer from severe constipation
if you are being treated for a condition of the eye 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 intestinal or sexual dysfunction
if you have a gastrointestinal disorder 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 prescribing antibiotics. Heart problems: speak with your doctor if you have any of the following conditions
you have an abnormal ECG (heart tracing) known as QT prolongation, or you are taking a medicine that causes this abnormality
you have a slow heart rate (bradycardia)
you have a heart condition called myocardial ischemia (reduced blood supply to the heart muscle), irregular heartbeat, or heart failure
if you have hypokalemia, a condition characterized by 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, as it has not yet been established whether it is effective and safe for them.
Other medicines and FESOTERODINE DOC
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 FESOTERODINE DOC 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 completely emptying the bladder, or drowsiness, or make them occur more frequently.

medicines containing amantadine (used to treat Parkinson's disease)
certain medicines used to increase gastrointestinal motility or relieve stomach cramps or spasms, or to prevent traveler's illness, such as medicines containing metoclopramide
certain medicines used to treat psychiatric disorders, such as antidepressants and neuroleptics. Inform your doctor also 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 for the treatment of 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 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 FESOTERODINE DOC 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 must not breastfeed during treatment with FESOTERODINE DOC.
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
FESOTERODINE DOC may cause blurred vision, dizziness, and drowsiness. Do not drive or operate tools or machinery if you experience any of these effects.
FESOTERODINE DOC contains lactose and fructose
FESOTERODINE DOC contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Fructose
This medicine contains 72 mg of fructose per tablet. Fructose may cause dental decay.

3. How to take FESOTERODINE DOC

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended starting dose of FESOTERODINE DOC 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 must be swallowed whole with a glass of water. Do not chew the tablet.
FESOTERODINE DOC 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 FESOTERODINE DOC than you should
If you have taken more tablets than prescribed for you, 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 FESOTERODINE DOC
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 FESOTERODINE DOC
Do not stop taking FESOTERODINE DOC without first talking to your doctor, as symptoms of overactive bladder may return or worsen if you stop treatment with FESOTERODINE DOC.

If you have any doubts 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 can be serious
Severe allergic reactions, including angioedema, have rarely occurred. Stop taking
FESOTERODINE DOC and contact your doctor immediately if you develop swelling of the face, mouth or
throat.
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 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)
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 emptying the bladder completely (urinary retention)
Delayed urination (delayed micturition)
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

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 at https://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 FESOTERODINE DOC

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.
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 FESOTERODINA DOC contains
The active substance is fesoterodine fumarate.
FESOTERODINA DOC 4 mg
Each prolonged-release tablet contains 4 mg of fesoterodine fumarate, equivalent to 3.1 mg of fesoterodine.
FESOTERODINA DOC 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: Fructose, monohydrate lactose, microcrystalline cellulose, hypromellose, glyceryl dibehenate, talc.
Film coating: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, aluminium lake containing indigo carmine (E132).

Description of the appearance of FESOTERODINA DOC and the contents of the pack
FESOTERODINA DOC 4 mg prolonged-release tablets are film-coated, elliptical, biconvex, blue tablets, approximately 6 mm in diameter, with "F4" printed on one side and flat on the other side.
FESOTERODINA DOC 8 mg prolonged-release tablets are film-coated, elliptical, biconvex, blue tablets, approximately 6 mm in diameter, with "F8" printed on one side and flat on the other side.
FESOTERODINA DOC is available in blisters of 14 or 28 prolonged-release tablets.
Please note that not all pack sizes mentioned above may be marketed.

Marketing Authorization Holder:
DOC Generici Srl
Via Turati 40 - 20121 Milan, Italy

Manufacturers:
Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6, Tres Cantos - 28760 Madrid, Spain.
Laboratorios Liconsa, S.A.
Avda. Miralcampo, Nº 7, Pol. Ind. Miralcampo - 19200 Azuqueca de Henares - Guadalajara, Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: FESOTERODINA DOC
Ireland: Fesoterodine Doc, prolonged release tablets