FESOTERODINA 4 mg Extended-Release Tablet

Зміст інструкції

1. FESOTERODINA DOC 4 mg prolonged-release tablets, 8 mg prolonged-release tablets
   1. What is FESOTERODINA DOC and what is it used for
   2. What you need to know before taking FESOTERODINA DOC:
   3. How to take FESOTERODINA DOC
   4. Possible side effects
   5. How to store FESOTERODINA DOC
   6. Package contents and other information

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

Generic medicine

Read this leaflet carefully before taking this medicine as 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 they have the same symptoms as you, 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 FESOTERODINA DOC is and what it is used for
• 2. What you need to know before you take FESOTERODINA DOC
• 3. How to take FESOTERODINA DOC
• 4. Possible side effects
• 5. How to store FESOTERODINA DOC
• 6. Contents of the pack and other information

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

FESOTERODINA DOC contains an active ingredient called fesoterodine fumarate and belongs to the
class of medicines called antimuscarinics which reduce the activity of the overactive bladder and are
used in adults for the treatment of symptoms.
FESOTERODINA 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 need to know before taking FESOTERODINA DOC:

Do not take FESOTERODINA DOC:

• if you are allergic to fesoterodine or fructose or to any of the other ingredients of FESOTERODINA DOC (listed in section 6) (see section 2, FESOTERODINA DOC contains lactose and fructose)
• 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 ulcer 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
FESOTERODINA DOC
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 in 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 some 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 heart rate (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 the age of 18 years, because it has not yet
been established whether it is effective and safe for them.

Other medicines and FESOTERODINA DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. The doctor will tell you if you can take FESOTERODINA DOC 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 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 cramps or spasms in the stomach and to prevent traveler's sickness, 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:
• medicines containing any 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).
• medicines containing any 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 to treat 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 to treat severe pain and addiction problems).

Pregnancy and breastfeeding
You should not take FESOTERODINA 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 should not breastfeed during treatment
with FESOTERODINA DOC.
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

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

FESOTERODINA DOC contains lactose and fructose
FESOTERODINA DOC contains lactose. If your doctor has diagnosed you with intolerance to some
sugars, contact him before taking this medicine.
Fructose
This medicine contains 72 mg of fructose per tablet. Fructose can damage teeth.

3. How to take FESOTERODINA DOC

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

If you forget to take FESOTERODINA DOC
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 FESOTERODINA DOC
Do not stop taking FESOTERODINA DOC without first talking to your doctor, as the symptoms
of overactive bladder may return or worsen if you stop treatment with
FESOTERODINA DOC.
If you have any doubts 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.
manifest.

Some side effects may be serious
Serious allergic reactions including angioedema have occurred rarely. Stop taking
FESOTERODINA DOC and contact your doctor immediately if you experience 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 cause an
increased 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 tension 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 -
• skin rash -
• dry skin -
• itching -
• unpleasant sensation in the stomach -
• 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)
• hives -
• confusion -

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through 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 FESOTERODINA DOC

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 pack and blister after “Exp”. The
expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
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 the
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FESOTERODINA DOC contains
The active ingredient is fesoterodine fumarate.

FESOTERODINA DOC 4 mg
Each prolonged-release tablet contains 4 mg of fesoterodine fumarate corresponding to 3.1 mg of
fesoterodine.

FESOTERODINA DOC 8 mg
Each prolonged-release tablet contains 8 mg of fesoterodine fumarate corresponding to 6.2 mg of
fesoterodine.
The other ingredients are:
Tablet core: Fructose, lactose monohydrate, microcrystalline cellulose, hypromellose, glycerol 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 package contents
The 4 mg prolonged-release tablets of FESOTERODINA DOC are film-coated
elliptical, biconvex, blue tablets, approximately 6 mm in diameter with "F4" imprinted on one side and plain on the other side.
The 8 mg prolonged-release tablets of FESOTERODINA DOC are film-coated
elliptical, biconvex, blue tablets, approximately 6 mm in diameter with "F8" imprinted on one side and plain on the other side.
FESOTERODINA DOC is available in blisters of 14 or 28 prolonged-release tablets.
Please note that not all of the above-mentioned pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following
names:
Italy: FESOTERODINA DOC
Ireland: Fesoterodine Doc, prolonged release tablets