ИНКОВЕС 5 MG Film-coated tablets

Содержание инструкции

1. Incoves 5 mg, film-coated tablets, 10 mg, film-coated tablets
   1. What is Incoves and what is it used for
   2. What you need to know before using Incoves
   3. How to use Incoves
   4. Possible side effects
   5. How to store Incoves
   6. Contents of the pack and other information

Incoves 5 mg, film-coated tablets, 10 mg, film-coated tablets

Solifenacin succinate
Generic medicine

Read this leaflet carefully before you start to use 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, pharmacist or nurse.
• 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 may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Incoves and what is it used for

The active substance of Incoves belongs to the class of anticholinergics. These medications are used
to reduce the activity of an overactive bladder. This allows you to wait longer before having the
need to go to the bathroom and increase the amount of urine that your bladder can hold.
Incoves is used to treat the symptoms of a condition defined as overactive bladder. These symptoms
include: a strong and sudden urge to urinate without prior warning, frequent urination, or
wetting yourself because you cannot reach the bathroom in time.

2. What you need to know before using Incoves

Do not use Incoves:

• If you have an impediment to urination or complete emptying of the bladder (urinary retention);
• if you have a serious problem with your stomach or intestines (including toxic megacolon, a complication associated with ulcerative colitis);
• if you suffer from a muscle disease called myasthenia gravis, which can cause extreme weakness of some muscles;
• if you suffer from increased intraocular pressure with gradual loss of vision (glaucoma);
• if you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6);
• if you are undergoing renal dialysis;
• if you suffer from a severe liver disease;
• if you suffer from a severe kidney disease or a moderately severe liver disease and, at the same time, are being treated with drugs that can reduce the elimination of solifenacin from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Tell your doctor if you have or have had any of the conditions described above before starting treatment
with Incoves.

Warnings and precautions
Consult your doctor, pharmacist or nurse before using Incoves:

• if you have problems emptying the bladder (= bladder obstruction) or if you have difficulty passing urine (for example, weak urine flow). The risk of urine accumulating in the bladder (urinary retention) is much higher;
• if you have any obstruction of the digestive system (constipation);
• if you are at risk of low motility of the digestive system (movements of the stomach and intestines). Your doctor will have informed you if this is the case;
• if you suffer from a severe kidney disease;
• if you have a moderately severe liver disease;
• if you have stomach pain (hiatal hernia) or heartburn.
• if you have a nervous disorder (autonomic neuropathy).

Children and adolescents
Incoves should not be used in children or adolescents under the age of 18 years.
Tell your doctor if you have or have had any of the conditions mentioned above before starting
treatment with Incoves.
Before starting treatment with Incoves, your doctor will assess whether there are other causes underlying
your need to urinate frequently (e.g. heart failure (insufficient ability of the heart to pump blood) or kidney disease). If you have a urinary tract infection, your doctor will prescribe you an antibiotic (a treatment for certain bacterial infections).

Other medicines and Incoves
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
It is particularly important that you tell your doctor if you are taking:

• other anticholinergic medicines, the effects and side effects of both medicines may be enhanced;
• cholinergics, as they may reduce the effects of solifenacin;
• medicines, such as metoclopramide and cisapride, that speed up the digestive system. Solifenacin may reduce their effect;
• medicines, such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil and diltiazem, which decrease the rate of elimination of Incoves from the body;
• drugs, such as rifampicin, phenytoin and carbamazepine, as they may increase the rate of elimination of solifenacin from the body;
• drugs, such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Incoves with food and drink
Incoves can be taken with or without food, depending on your
preference.

Pregnancy and breastfeeding
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.
Pregnancy
You should not use Incoves if you are pregnant, unless it is clearly necessary.
Breastfeeding
Do not use Incoves if you are breastfeeding, as solifenacin may pass into breast milk.

Driving and using machines
Solifenacin may cause blurred vision and sometimes drowsiness or fatigue. If you experience any
of these side effects, you should not drive vehicles or use machines.

Incoves contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine.

3. How to use Incoves

Take this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
You must swallow the tablet whole with a little liquid. The medicine can be taken with or without food, as
preferred. Do not crush the tablets.
The usual dose is 5 mg per day, unless your doctor has prescribed you to take 10 mg
per day.

If you take more Incoves than you should
If you have taken too much Incoves or if a child has accidentally taken Incoves, contact
your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness,
drowsiness and blurred vision, perceiving things that do not exist (hallucinations), hyperactivity, seizures
(convulsions), difficulty breathing, increased heart rate (tachycardia), urine retention
in the bladder (urinary retention) and dilated pupils (mydriasis).

If you forget to take Incoves
If you forget to take a dose at the usual time, take it as soon as you remember, unless it is
time to take the next dose. Never take more than one dose per day. If in doubt, always consult
your doctor or pharmacist.

If you stop taking Incoves
If you stop taking Incoves, your overactive bladder symptoms may return or worsen.
Always consult your doctor if you are considering stopping treatment.
If you have any questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you should experience an allergic reaction or a severe skin reaction (e.g. appearance of blisters or
skin peeling), you should inform your doctor or pharmacist immediately.
Angioedema (skin allergy that causes swelling of the tissue just below the skin surface) with obstruction of the airways (difficulty breathing) has been reported in some patients treated
with solifenacin succinate. In case of angioedema, Incoves must be discontinued immediately and appropriate therapy and/or suitable measures must be adopted.
Incoves may cause the following other side effects:
Very common (may affect more than 1 in 10 people)

• dry mouth.

Common (may affect up to 1 in 10 people)

• blurred vision;
• constipation, nausea, indigestion with symptoms such as abdominal bloating, abdominal pain, belching, nausea, heartburn (dyspepsia), stomach discomfort.

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection;
• drowsiness;
• altered taste perception (dysgeusia);
• dry (irritated) eyes;
• dry nose;
• reflux disease (gastro-esophageal reflux), dry throat;
• dry skin;
• difficulty urinating;
• fatigue, fluid retention in the ankles (edema).

Rare (may affect up to 1 in 1,000)

• accumulation of a large amount of hardened stool in the colon (fecal impaction);
• retention of urine in the bladder due to inability to empty the bladder (urinary retention);
• dizziness, headache;
• vomiting;
• itching, rash.

Very rare (may affect up to 1 in 10,000)

• hallucinations, confused state;
• allergic skin rash. Not known (frequency cannot be estimated from available data)
• decreased appetite, high levels of potassium in the blood which can cause abnormal heart rhythm;
• increased intraocular pressure;
• changes in the electrical activity of the heart (ECG), irregular heartbeat, awareness of your heartbeat, faster heartbeat;
• voice disorder;
• liver disorders;
• muscle weakness;
• kidney disorders.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Incoves

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 label after “EXP”.
The expiry date refers to the last day of that month.
This medicinal product does not require any particular storage conditions.
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 Incoves contains

• The active ingredient is solifenacin succinate. Incoves 5 mg: Each film-coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin. Incoves 10 mg: Each film-coated tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacin.
• The other components of Incoves 5 mg are: Tablet core: corn starch, lactose monohydrate, hypromellose and magnesium stearate. Tablet coating: hypromellose, talc, titanium dioxide (E171), macrogol and yellow iron oxide (E172).
• The other components of Incoves 10 mg are: Tablet core: corn starch, lactose monohydrate, hypromellose and magnesium stearate. Tablet film coating: hypromellose, talc, titanium dioxide (E171), macrogol and red iron oxide (E172). Description of the appearance of Incoves and contents of the packIncoves 5 mg are film-coated tablets, yellow in colour, round and convex. Incoves 10 mg are film-coated tablets, light pink in colour, round and convex.

Incoves 5 mg film-coated tablets are supplied in blisters, containing 30 tablets.
Incoves 10 mg film-coated tablets are supplied in blisters, containing 20 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Lampugnani Farmaceutici S.p.A.
Via Gramsci 4
20014 Nerviano (MI)
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2
Abrunheira, 2710-089 Sintra
Portugal