Corintus

Patient Information Leaflet: Information for the Patient

Corintus 10 mg tablets

Ezetimibe
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as 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

1. What CORINTUS is and what it is 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

1. What CORINTUS is and what it is used for

CORINTUS is a medicine used to reduce high levels of cholesterol.
CORINTUS reduces levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and
fatty substances called triglycerides in the blood. In addition, CORINTUS increases levels of
"good" cholesterol (HDL cholesterol).
CORINTUS works by reducing cholesterol absorption in the intestine.
CORINTUS complements the cholesterol-lowering effects of statins, a group of medicines that
act by reducing the body's own production of cholesterol.
Cholesterol is one of many fatty substances found in the bloodstream. Total cholesterol is
composed mainly of LDL and HDL cholesterol.
LDL cholesterol is often called "bad" because it can accumulate 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 blood flow 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 building up in the arteries, thus protecting against heart attacks.
Triglycerides are another form of fat in the blood that may increase the risk of heart disease.
CORINTUS is used in patients who cannot control their cholesterol levels through diet alone. Follow a cholesterol-lowering diet while taking this medicine.
CORINTUS is used in addition to diet if you have:

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

If you have heart disease, CORINTUS, in combination with cholesterol-lowering medicines called statins, reduces the risk of heart attack, stroke, surgery to improve blood flow, or hospitalization for chest pain.
CORINTUS does not help with weight loss.

2. What you need to know before taking CORINTUS

If you are taking CORINTUS together with a statin, read the package leaflet of that specific
medicine.
Do not take CORINTUS:

• if you are allergic to the active substance ezetimibe or to any of the other ingredients of this medicine (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 condition, including any allergies.
• Your doctor will perform blood tests before starting treatment with CORINTUS together with a statin. These tests are to check how well your liver is functioning.
• Your doctor may also carry out further blood tests to monitor liver function after you have started taking CORINTUS with a statin.

CORINTUS is not recommended if you have moderate or severe liver problems.
The safety and efficacy of CORINTUS when taken in combination with fibrates, medicines that reduce cholesterol, have not been established.
Children and adolescents
Do not give this medicine to children and adolescents aged 6 to 17 years unless prescribed by a specialist, as there is limited information on safety and efficacy. Do not give this medicine to children under 6 years of age, as there is no information available for 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, inform your doctor if you are taking medicines containing any of the following active substances:

• ciclosporine (often used in patients who have had an organ transplant)
• medicines containing active substances that prevent blood clotting, such as warfarin, fencoumon, acenocoumarol or phenindione (anticoagulants)
• colestyramine (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, think you may be pregnant, planning a pregnancy, or 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 might 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 while breastfeeding. Ask your doctor for advice.
Driving and using machines
CORINTUS is not expected to affect the ability to drive or use machines.
However, you should be aware that some people may experience dizziness after taking CORINTUS.
CORINTUS 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 take CORINTUS

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.
Continue taking any other cholesterol-lowering medicines unless your doctor tells you to stop.

• Before starting treatment with CORINTUS, you must follow a cholesterol-lowering diet.
• You must continue this diet while taking CORINTUS.

The recommended dose is one 10 mg CORINTUS tablet by mouth once daily.
Take CORINTUS at any time of day. You may take it with or without food.
If your doctor has prescribed CORINTUS together with a statin, both medicines may be taken at the same time. In this case, read the dosing instructions in the package leaflet of that specific medicine.
If your doctor has prescribed CORINTUS with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing 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 your usual dose of CORINTUS at the usual time the next day.

If you stop taking CORINTUS:
Inform your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any questions 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 damage, may occur and lead to kidney damage; these conditions can be serious and potentially life-threatening.
• Allergic reactions, including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing.

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

• abdominal pain, diarrhoea, flatulence
• feeling of tiredness

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

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

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

• increases in liver function laboratory test values (transaminases)
• headache
• muscle pain, tenderness or 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 tiredness or weakness
• swelling, especially in hands and feet

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

• abdominal pain

In addition, with 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 rash sometimes with target-like lesions (erythema multiforme)
• muscle pain, tenderness or weakness, muscle tissue damage
• gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting)
• inflammation of the pancreas, often with severe abdominal pain
• constipation
• reduction in blood cell count, which may cause bruising/bleeding (thrombocytopenia)
• tingling sensation
• depression
• unusual tiredness or weakness
• shortness of breath

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 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 stated on the carton, blister, or container after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 CORINTUS contains
The active substance of CORINTUS is ezetimibe. Each 10 mg tablet of CORINTUS contains 10 mg of ezetimibe.
The other excipients are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate, hypromellose and crospovidone.
Description of the appearance of CORINTUS and package contents
CORINTUS 10 mg tablets are capsule-shaped, white to off-white tablets, 8 mm x 4 mm in size, imprinted with "713" on one side and smooth on the other.
CORINTUS is available in press-through or peelable blisters.
Pack sizes:
Blister: 30 tablets.
Marketing Authorization 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 authorized in the European Economic Area Member States under the
following names:
IT: Corintus