Incoves

Italy
Brand name Incoves
Form tablets, film-coated
Active substance / Dosage
SOLIFENACIN SUCCINATE
Prescription type Prescription only
ATC code
G04BD08
Registration number 047442
Manufacturer LAMPUGNANI FARMACEUTICI SPA

Table of Contents

Patient Information Leaflet

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

Solifenacin succinate
Equivalent medicine
Please read all of 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, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 Incoves is and what it is used for

The active substance in Incoves belongs to the class of anticholinergic medicines. These medicines are used
to reduce the activity of an overactive bladder. This allows you to wait longer before needing to go to the
toilet and increases the amount of urine that your bladder can hold.
Incoves is used to treat the symptoms of a condition called overactive bladder. These symptoms
include: a sudden, strong urge to urinate with little or no warning, frequent urination, or leakage because you cannot reach the toilet in time.

2. What you need to know before using Incoves

Do not use Incoves:

  • If you have difficulty passing urine or completely emptying your bladder (urinary retention);
  • if you have a serious stomach or intestinal condition (including toxic megacolon, a complication associated with ulcerative colitis);
  • if you suffer from a muscle disorder called myasthenia gravis, which can cause extreme weakness of certain muscles;
  • if you have 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 have severe liver disease;
  • if you have severe kidney disease or moderate liver disease and, at the same time, are being treated with medicines that may reduce the elimination of solifenacin from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this applies.

Inform your doctor if you have or have previously had any of the conditions listed above before starting treatment with Incoves.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Incoves:

  • if you have problems emptying your bladder (= bladder obstruction) or difficulty passing urine (e.g. weak urine flow). The risk of urine accumulation in the bladder (urinary retention) is significantly increased;
  • if you have any obstruction of the digestive system (constipation);
  • if you are at risk of reduced motility of the digestive system (stomach and intestinal movements). Your doctor will have informed you if this applies;
  • if you suffer from severe kidney disease;
  • if you have moderate liver disease;
  • if you have stomach discomfort (hiatal hernia) or heartburn;
  • if you have a nervous system disorder (autonomic neuropathy).

Children and adolescents
Incoves must not be used in children or adolescents under 18 years of age.
Inform your doctor if you have or have previously had any of the conditions listed above before starting treatment with Incoves.
Before starting treatment with Incoves, your doctor will assess whether there are other underlying causes for your frequent need to urinate (e.g. heart failure (inadequate ability of the heart to pump blood) or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (a treatment against specific bacterial infections).
Other medicines and Incoves
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is particularly important that you inform your doctor if you are taking:

  • other anticholinergic medicines, as the effects and side effects of both medicines may be increased;
  • cholinergic agents, as they may reduce the effects of solifenacin;
  • medicines such as metoclopramide and cisapride, which increase gastrointestinal motility. Solifenacin may reduce their effect;
  • medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil and diltiazem, which reduce the rate of elimination of Incoves from the body;
  • drugs such as rifampicin, phenytoin and carbamazepine, which may increase the rate of elimination of solifenacin from the body;
  • drugs such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis).

Incoves with food and drinks
Incoves may be taken with or without food, according to your preference.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must not use Incoves during pregnancy unless clearly necessary.
Breastfeeding
Do not use Incoves while 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 must not drive or operate machinery.
Incoves contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to use Incoves

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
You must swallow the tablet whole with a small amount of liquid. This medicine can be taken with or without food, depending on your preference. Do not crush the tablets.
The usual dose is 5 mg once daily, unless your doctor has prescribed 10 mg once daily.
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, blurred vision, perception of things that do not exist (hallucinations), hyper-excitability, 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 your usual time, take it as soon as you remember, unless it is almost time for your 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 doubts about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you suffer an allergic attack or a severe skin reaction (e.g. development of blisters or peeling of the skin), you must inform your doctor or pharmacist immediately.
Angioedema (a skin allergy causing swelling of the tissue just beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate. If angioedema occurs, Incoves must be discontinued immediately and appropriate therapy and/or measures must be taken.
Other possible side effects of Incoves include:

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 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;
  • gastroesophageal reflux disease (acid reflux), dry throat;
  • dry skin;
  • difficulty in urination;
  • fatigue, fluid accumulation in the ankles (oedema).

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

  • accumulation of hardened faeces in the colon (faecal impaction);
  • urine retention 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 people)

  • hallucinations, confusion;
  • allergic skin rash.

Not known (frequency cannot be estimated from the available data)

  • decreased appetite, elevated blood potassium levels which may cause heart rhythm abnormalities;
  • increased intraocular pressure;
  • changes in the heart's electrical activity (ECG), irregular heartbeat, awareness of heartbeat, faster heartbeat;
  • voice disorder;
  • hepatic disorders;
  • muscle weakness;
  • renal disorders.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via 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 stated on the label after "EXP".
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not dispose of medicines 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 Incoves contains

  • The active substance 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: maize starch, lactose monohydrate, hypromellose, and magnesium stearate. Film coating: hypromellose, talc, titanium dioxide (E171), macrogol, and yellow iron oxide (E172).
  • The other components of Incoves 10 mg are: Tablet core: maize starch, lactose monohydrate, hypromellose, and magnesium stearate. Film coating: hypromellose, talc, titanium dioxide (E171), macrogol, and red iron oxide (E172).

Description of the appearance of Incoves and pack contents
Incoves 5 mg are yellow, round, convex, film-coated tablets.
Incoves 10 mg are light pink, round, convex, film-coated tablets.

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 Authorization Holder and Manufacturer
Marketing Authorization Holder
Lampugnani Farmaceutici S.p.A.
Via Gramsci 4
20014 Nerviano (MI), Italy

Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2
Abrunheira, 2710-089 Sintra
Portugal