CORINTUS 10 mg Tablet

Зміст інструкції

1. Corintus 10 mg tablets
   1. What is CORINTUS and what is it used for
   2. What you need to know before taking CORINTUS
   3. How to take CORINTUS
   4. Possible side effects
   5. How to store CORINTUS
   6. Contents of the pack and other information

Corintus 10 mg tablets

Ezetimibe
Generic medicine

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours, 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 CORINTUS is and what it is used for
• 2. What you need to know before you take CORINTUS
• 3. How to take CORINTUS
• 4. Possible side effects
• 5. How to store CORINTUS
• 6. Contents of the pack and other information

1. What is CORINTUS and what is it used for

CORINTUS is a medicine used to reduce high cholesterol levels.
CORINTUS reduces the levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, CORINTUS increases the levels of “good” cholesterol (HDL cholesterol).
CORINTUS works by decreasing the absorption of cholesterol from the intestine.
CORINTUS joins the cholesterol-lowering effects of statins, a group of medicines that work by reducing the production of cholesterol by the body itself.
Cholesterol is one of many fatty substances found in the bloodstream. Total cholesterol is mainly composed of LDL and HDL cholesterol.
LDL cholesterol is often called “bad” because it can build up in the walls of arteries forming plaques. Over time, this plaque can lead to narrowing of the arteries. This narrowing can slow down or block the flow of blood to vital organs such as the heart and brain. This blockage of blood flow can cause a heart attack or stroke.
HDL cholesterol is often called “good” cholesterol because it helps prevent bad cholesterol from accumulating in the arteries and protects against heart attacks.
Triglycerides are another form of fat in the blood that can increase the risk of heart disease.
It is used in patients who are unable to control their cholesterol levels through diet alone. Follow a diet to reduce cholesterol while taking this medicine.
CORINTUS is used in addition to diet if you have:

• increasing cholesterol levels in the blood (primary hypercholesterolemia [heterozygous familial and non-familial]) together with a statin, when cholesterol levels are not well controlled with a statin alone or alone, when treatment with a statin is not appropriate or well tolerated.
• an inherited condition (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You will also be prescribed a statin and may also receive other therapy.
• An inherited condition (homozygous sitosterolemia, also known as phytosterolemia) that increases levels of plant sterols in the blood.

If you suffer from heart disease, CORINTUS in combination with medicines that reduce cholesterol, called statins, reduces the risk of heart attack, stroke, surgery to increase blood flow, or hospitalization for chest pain.
CORINTUS does not help with weight loss.

2. What you need to know before taking CORINTUS

medicinal product.

Do not take CORINTUS:

• if you are allergic to the active ingredient ezetimibe or to any of the other ingredients of this medicinal product (listed in section 6).

Do not take CORINTUS together with a statin if:

• you currently have liver problems
• you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking CORINTUS.

• Inform your doctor about your medical conditions, including allergies
• Your doctor will perform blood tests before starting therapy with CORINTUS together with a statin. This is to check your liver function.
• Your doctor may also want to perform blood tests to check how your liver is functioning after you have started taking CORINTUS with a statin.

If you suffer from moderate or severe liver problems, CORINTUS is not recommended.
The safety and efficacy of CORINTUS administered in combination with fibrates, medicines that reduce cholesterol, have not been established.

Children and adolescents
Do not give this medicine to children and adolescents between 6 and 17 years of age unless prescribed by a specialist, as there is limited safety and efficacy data. Do not give this medicine to children under 6 years of age as there is no information in this age group.

Other medicines and CORINTUS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking medicines containing one of the following active ingredients:

• cyclosporine (often used in patients with organ transplantation)
• medicines with an active ingredient that prevents blood clotting, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants)
• cholestyramine (also used to reduce cholesterol), as it affects the mechanism of action of CORINTUS
• fibrates (also used to reduce cholesterol)

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take CORINTUS together with a statin if you are pregnant, trying to become pregnant or think you may be pregnant. If you become pregnant while taking CORINTUS with a statin, stop taking both medicines immediately and inform your doctor. There is no experience with the use of CORINTUS without a statin during pregnancy. If you are pregnant, consult your doctor before taking CORINTUS.
Do not take CORINTUS with a statin if you are breastfeeding, as it is not known whether the medicines pass into breast milk. Do not take CORINTUS without a statin if you are breastfeeding. Ask your doctor for advice.

Driving and operating machinery
CORINTUS is not expected to interfere with the ability to drive or operate machinery.
However, you should be aware that some people may experience dizziness after taking CORINTUS.

CORINTUS contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this medicine.

3. How to take CORINTUS

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Continue to take other medicines to reduce cholesterol unless your doctor tells you to
stop.

• Before starting therapy with CORINTUS, you must follow a diet to reduce cholesterol.
• You must continue to follow this diet while taking CORINTUS.

The recommended dose is one CORINTUS 10 mg tablet by mouth once a day.
Take CORINTUS at any time of the day. You can take it with or without food.
If your doctor has prescribed CORINTUS in association with a statin, both medicines
can be taken at the same time. In this case, read the dosage instructions in the package
leaflet of that particular medicine.
If your doctor has prescribed CORINTUS with another medicine to reduce cholesterol, containing
the active ingredient colestyramine or any other medicine that contains a bile acid
sequestrant, you must take CORINTUS at least 2 hours before or 4 hours after taking the bile
acid sequestrant.

If you take more CORINTUS than you should:
Inform your doctor or pharmacist.

If you forget to take CORINTUS:
Do not take a double dose to make up for the missed tablet, take the normal
amount of CORINTUS the next day at the same time.

If you stop taking CORINTUS:
Inform your doctor or pharmacist as your cholesterol may increase again.
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 everyone gets them.

Stop taking CORINTUS and contact your doctor or go immediately to the nearest emergency room if you experience any of the following symptoms:

• unexplained muscle pain, tenderness or weakness. This is because, in rare cases, muscle problems, including muscle tissue injury, leading to kidney damage, can be serious and become a potentially life-threatening condition.
• Allergic reactions, including swelling of the face, lips, tongue and/or throat, which can cause difficulty breathing or swallowing.

The following side effects have been reported when used alone:
Common (may affect up to 1 in 10 people):

• abdominal pain, diarrhea, flatulence
• feeling tired

Uncommon (may affect up to 1 in 100 people):

• increases in the values of some laboratory tests related to the liver (transaminases) and/or muscle function (CK)
• cough
• indigestion, heartburn
• nausea
• joint pain, muscle spasms, neck pain
• pain
• chest pain
• decreased appetite
• hot flushes
• elevated blood pressure

In addition, when used with a statin, the following side effects have been reported:
Common (may affect up to 1 in 10 people):

• increases in the values of some liver function laboratory tests (transaminases)
• headache
• pain, tenderness or muscle weakness

Uncommon (may affect up to 1 in 100 people):

• tingling sensation
• dry mouth
• itching
• rash, hives
• back pain
• muscle weakness
• pain in arms and legs
• unusual fatigue or weakness
• swelling, especially in hands and feet.

When used with fenofibrates, the following common side effects have been reported(may affect up to 1 in 10 people):

• abdominal pain.

In addition, with the general use of the medicine, the following side effects have been reported:

• dizziness
• muscle pain
• liver problems
• allergic reactions including rash and hives, raised red skin rash, sometimes with target-like lesions (erythema multiforme)
• pain, tenderness or muscle weakness, muscle tissue injury
• gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting)
• inflammation of the pancreas often with severe abdominal pain
• constipation
• reduction in blood cell count, which can cause bruising/bleeding (thrombocytopenia)
• tingling sensation
• depression
• unusual fatigue or weakness
• shortness of breath

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store CORINTUS

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 package, blister or
container after Exp. The expiry date refers to the last day of that month.
This medicine 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 CORINTUS contains
The active ingredient of CORINTUS is ezetimibe. Each 10 mg CORINTUS tablet contains 10
mg of ezetimibe.
The other excipients are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, sodium
lauryl sulfate, magnesium stearate, hypromellose and crospovidone.

Description of the appearance of CORINTUS and contents of the pack
CORINTUS 10 mg tablets are capsule-shaped tablets, from white to off-white, of
size 8 mm x 4 mm, with “713” imprinted on one side and smooth on the other.
CORINTUS is available in blister packs.
Pack sizes:
Blister: 30 tablets.

Marketing Authorisation Holder
EBERLIFE FARMACEUTICI S.p.A.
Via G. Porzio snc
80143 Napoli
Italy

Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitza 2600
Bulgaria
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
IT: Corintus