MIBECOL 10 mg Tablets

Зміст інструкції

1. MIBECOL 10 mg tablets
   1. What is MIBECOL and what is it 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. Contents of the pack and other information

MIBECOL 10 mg tablets

Ezetimibe
Generic medicine

Read this leaflet carefully before you start 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. Do not pass it on to others even if their symptoms are the same as yours because 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 MIBECOL is and what it is used for
• 2. What you need to know before you take MIBECOL
• 3. How to take MIBECOL
• 4. Possible side effects
• 5. How to store MIBECOL
• 6. Contents of the pack and other information

1. What is MIBECOL and what is it used for

MIBECOL is a medicine used to reduce high cholesterol levels.
MIBECOL reduces the levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, MIBECOL increases the levels of “good” cholesterol (HDL cholesterol).
MIBECOL works by decreasing the absorption of cholesterol from the intestine.
MIBECOL adds to 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 the 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 building up 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 cannot control their cholesterol levels with diet alone. Follow a diet to reduce cholesterol while taking this medicine.
MIBECOL is used in addition to diet if you have:

• an increasing level of cholesterol in the blood (primary hypercholesterolemia [familial and non-familial heterozygous]) together with a statin, when the cholesterol level is not well controlled with a statin alone, or alone, when treatment with a statin is not appropriate or well tolerated.
• an inherited disease (familial homozygous hypercholesterolemia) that increases cholesterol levels in the blood. You will also be prescribed a statin and may also receive other 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 medicines that lower cholesterol, called statins, reduces the risk of heart attack, stroke, surgery to increase blood flow, or hospitalization for chest pain.

MIBECOL does not help with weight loss.

2. What you need to know before taking MIBECOL

Do not take MIBECOL:

• if you are allergic to the active ingredient 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.

• Tell your doctor about your medical conditions, including any allergies
• Your doctor will perform blood tests before starting therapy with MIBECOL 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 MIBECOL with a statin. If you suffer from moderate or severe liver problems, MIBECOL is not recommended.

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 between 6 and 17 years of age 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 in 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, tell your doctor if you are taking medicines containing any 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 MIBECOL
• fibrates (also used to reduce cholesterol)

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are 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 MIBECOL together with a statin if you are pregnant, trying to become pregnant or think you might be. If you become pregnant while taking MIBECOL with a statin, stop taking both medicines immediately and tell 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 if you are breastfeeding, as it is not known whether the medicines pass into breast milk. Do not take MIBECOL without a statin if you are breastfeeding. Ask your doctor for advice.

Driving and operating machinery
MIBECOL 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 MIBECOL.

MIBECOL contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take MIBECOL

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 MIBECOL, you must follow a diet to reduce cholesterol.
• You must continue to follow this diet while taking MIBECOL.

The recommended dose is one MIBECOL 10 mg tablet by mouth once a day.
Take MIBECOL at any time of the day. You can take it with or without food.
If your doctor has prescribed MIBECOL in combination 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 MIBECOL with another medicine to reduce cholesterol, containing the
active ingredient 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:
Inform your doctor or pharmacist.

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

If you stop taking MIBECOL:
Inform your doctor or pharmacist as your cholesterol may increase again.
If you have any further questions on 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 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 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, whichcan 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, diarrhoea, 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
• 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 the values of some liver function laboratory tests (transaminases)
• headache
• pain, tenderness or muscle weakness Uncommon (may affect up to 1 in 100 people):
• feeling of pins and needles
• dry mouth
• itching
• skin rash, urticaria
• 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 skin rash and urticaria, 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)
• feeling of pins and needles
• depression
• unusual fatigue or weakness
• shortness of breath

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 MIBECOL

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 MIBECOL contains
The active ingredient of MIBECOL is ezetimibe. Each 10 mg MIBECOL 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 MIBECOL and contents of the pack
MIBECOL 10 mg tablets are capsule-shaped tablets, from white to off-white, measuring
8 mm x 4 mm, with “713” imprinted on one side and smooth on the other.
MIBECOL is available in push-through or peelable blisters.
Pack sizes:
Blister: 30 tablets.

Marketing Authorisation Holder
SF Group S.r.l.,
Via Tiburtina, 1143
00156 Rome,
Italy

Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitza 2600
Bulgaria

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