Mibecol

Patient Information Leaflet: Information for the patient

MIBECOL 10 mg tablets

Ezetimibe
Equivalent medicine
Please 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. 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 MIBECOL is and what it is used for
2. What you need to know before taking MIBECOL
3. How to take MIBECOL
4. Possible side effects
5. How to store MIBECOL
6. Package contents and other information

1. What MIBECOL is and what it is used for

MIBECOL is a medicine used to reduce high levels of cholesterol.
MIBECOL lowers levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fats in the blood called triglycerides. In addition, MIBECOL increases levels of "good" cholesterol (HDL cholesterol).
MIBECOL works by reducing the absorption of cholesterol by the intestine.
MIBECOL complements the cholesterol-lowering effects of statins, a group of medicines that work by reducing the body's own production of cholesterol.
Cholesterol is one of many fatty substances found in the bloodstream. Total cholesterol is made up 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.
It is used in patients who are unable to control their cholesterol levels through diet alone. Follow a cholesterol-lowering diet while taking this medicine.
MIBECOL is used in addition to diet when 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 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, MIBECOL 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.

MIBECOL does not help with weight loss.

2. What you need to know before taking MIBECOL

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

• 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 MIBECOL 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 MIBECOL.

• Inform your doctor about your medical condition, including any allergies
• Your doctor will perform blood tests before starting treatment with MIBECOL together with a statin. These tests are to check how well your liver is functioning.
• Your doctor may also want to carry out blood tests to monitor liver function after you start taking MIBECOL with a statin. MIBECOL is not recommended if you have moderate or severe liver problems.

The safety and efficacy of MIBECOL 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 aged 6 to 17 years unless prescribed by a specialist, as there is limited data 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 MIBECOL
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:

• cyclosporine (often used in patients who have had an organ transplant)
• medicines with an active substance that prevents blood clotting, such as warfarin, fenprocoumon, acenocoumarol, or fluindione (anticoagulants)
• colestyramine (also used to reduce cholesterol), as it affects the mechanism of action of MIBECOL
• fibrates (also used to reduce cholesterol)

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take MIBECOL together with a statin if you are pregnant, trying to become pregnant, or think you could be pregnant. If you become pregnant while taking MIBECOL with a statin, stop taking both medicines immediately and inform your doctor. There is no experience with the use of MIBECOL without a statin during pregnancy. If you are pregnant, consult your doctor before taking MIBECOL.
Do not take MIBECOL with a statin while breastfeeding, as it is not known whether the medicines pass into breast milk. Do not take MIBECOL without a statin while breastfeeding. Consult your doctor.
Driving and using machines
MIBECOL is not expected to affect the ability to drive or use machines.
However, you should bear in mind that some people may experience dizziness after taking MIBECOL.
MIBECOL contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take MIBECOL

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Continue taking your other cholesterol-lowering medicines unless your doctor tells you to stop.

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

The recommended dose is one 10 mg MIBECOL tablet taken by mouth once daily.
Take MIBECOL at any time of day. You may take it with or without food.
If your doctor has prescribed MIBECOL 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 MIBECOL together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant, you must take MIBECOL at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more MIBECOL than you should:
Tell your doctor or pharmacist.

If you forget to take MIBECOL:
Do not take a double dose to make up for the missed tablet. Take your usual dose of MIBECOL at the usual time the next day.

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

If you have any doubts about how to use 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.
Stop taking MIBECOL 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 damage to muscle tissue, leading to kidney injury, 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 blood 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 with a statin, the following side effects have been reported:

Common (may affect up to 1 in 10 people):

• increases in blood test values related to liver function (transaminases)
• headache
• muscle pain, tenderness or weakness

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

• tingling sensation
• dry mouth
• itching
• skin rash, hives
• back pain
• muscle weakness
• pain in arms and legs
• unusual tiredness 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 general use of the medicine, the following side effects have been reported:

• dizziness
• muscle pain
• liver problems
• allergic reactions including skin rash and hives, raised red rash, sometimes with target-shaped 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 get any side effects, 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 MIBECOL

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 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 MIBECOL contains
The active substance of MIBECOL is ezetimibe. Each 10 mg MIBECOL tablet 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 MIBECOL and package contents
MIBECOL 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 plain on the other.
MIBECOL is available in press-through or peelable blisters.
Pack sizes:
Blister: 30 tablets.
Marketing Authorization Holder
SF Group S.r.l.,
Via Tiburtina, 1143
00156 Rome,
Italy
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600
Bulgaria
This medicinal product is authorized in the Member States of the European Economic Area under the following names: