EZETIMIBE 10 mg/10 mg Coated Tablet

Зміст інструкції

1. EZETIMIBE E SIMVASTATINA EG 10 mg/10 mg tablets, mg/20 mg tablets, mg/40 mg tablets
   1. What is EZETIMIBE E SIMVASTATINA EG and what is it used for
   2. What you need to know before taking EZETIMIBE AND SIMVASTATIN EG
   3. How to take EZETIMIBE AND SIMVASTATIN EG
   4. Possible side effects
   5. How to store EZETIMIBE E SIMVASTATINA EG
   6. Package contents and other information

EZETIMIBE E SIMVASTATINA EG 10 mg/10 mg tablets, mg/20 mg tablets, mg/40 mg tablets

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 they have the same symptoms as you, as it may 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 EZETIMIBE E SIMVASTATINA EG is and what it is used for
• 2. What you need to know before you take EZETIMIBE E SIMVASTATINA EG
• 3. How to take EZETIMIBE E SIMVASTATINA EG
• 4. Possible side effects
• 5. How to store EZETIMIBE E SIMVASTATINA EG
• 6. Contents of the pack and other information

1. What is EZETIMIBE E SIMVASTATINA EG and what is it used for

EZETIMIBE E SIMVASTATINA EG is a medicine that is used to decrease the levels of
total cholesterol, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides in the
blood. In addition, EZETIMIBE E SIMVASTATINA EG increases the levels of "good" cholesterol (HDL
cholesterol).
EZETIMIBE E SIMVASTATINA EG contains the active ingredients ezetimibe and simvastatin.
EZETIMIBE E SIMVASTATINA EG works in two ways to lower cholesterol. The active ingredient
ezetimibe reduces the cholesterol absorbed in the digestive tract. The active ingredient simvastatin, which belongs
to the class of "statins", inhibits the production of cholesterol synthesized by the body.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol is
mainly composed of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of the arteries
forming plaques. Over time, this buildup in the form of plaque can lead to a
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 disease.
Triglycerides are another form of fat present in the blood that can increase the risk of heart
disease.
EZETIMIBE E SIMVASTATINA EG is used for patients who cannot control their cholesterol levels with
diet alone. While taking this medicine, you should still follow a diet to lower cholesterol.
EZETIMIBE E SIMVASTATINA EG is used as an adjunct to diet to lower
cholesterol if you have:

• increased levels of cholesterol in the blood (primary hypercholesterolemia [familial and non- familial heterozygous]) or high levels of fats in the blood (mixed hyperlipidemia):
• which are not well controlled by a statin alone,
• for which you have taken treatment with a statin and ezetimibe in separate tablets;
• an inherited disease (homozygous familial hypercholesterolemia) that increases your cholesterol levels in the blood. You may also be receiving other treatments;
• a heart disease, EZETIMIBE E SIMVASTATINA EG reduces the risk of heart attack, stroke, surgical procedures to increase blood flow, or hospitalization for chest pain.

EZETIMIBE E SIMVASTATINA EG does not help with weight loss.

2. What you need to know before taking EZETIMIBE AND SIMVASTATIN EG

Do not take EZETIMIBE AND SIMVASTATIN EG:

• if you are allergic to ezetimibe, simvastatin or any of the other ingredients of this medicine (listed in section 6);
• if you currently have liver problems;
• if you are pregnant or breastfeeding;
• if you are taking any medicine(s) containing one or more of the following active substances:
• itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections),
• erythromycin, clarithromycin or telithromycin (used to treat infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used to treat HIV infections),
• boceprevir or telaprevir (used to treat hepatitis C virus infections),
• nefazodone (used to treat depression),
• cobicistat,
• gemfibrozil (used to lower cholesterol),
• cyclosporine (often used in patients who have undergone organ transplantation),
• danazol (a hormone produced by man used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus);
• if you are taking or have taken, within the last 7 days, a medicine called fusidic acid (used to treat bacterial infection) by mouth or by injection. The combination of fusidic acid and EZETIMIBE AND SIMVASTATIN EG can cause serious muscle problems (rhabdomyolysis);
• do not take more than 10 mg/40 mg of EZETIMIBE AND SIMVASTATIN EG if you are taking lomitapide (used to treat a severe and rare genetic condition of cholesterol). Ask your doctor for advice if you are not sure whether the medicine you are taking is among those listed above.

Warnings and precautions
Talk to your doctor or pharmacist before taking EZETIMIBE AND SIMVASTATIN EG if:

• you suffer from any medical condition, including allergies;
• you drink significant amounts of alcohol or have ever had liver disease. EZETIMIBE AND SIMVASTATIN EG may not be suitable for you;
• you are going to have surgery. You may need to stop taking EZETIMIBE AND SIMVASTATIN EG for a short period;
• you are Asian, because a different dose may be appropriate for you.

The doctor must have a blood test done before giving you EZETIMIBE AND SIMVASTATIN
EG. This test is done to check if your liver is functioning properly.
The doctor may prescribe a blood test to check if your liver is working well after you have
started taking EZETIMIBE AND SIMVASTATIN EG.
During treatment with this medicine, your doctor will carefully monitor whether you have diabetes or are at risk
of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in
your blood, if you are overweight and have high blood pressure.
Tell your doctor if you have a serious lung disease.
The combined use of EZETIMIBE AND SIMVASTATIN EG with fibrates (some types of medicines to
lower cholesterol) should be avoided as the use of EZETIMIBE AND SIMVASTATIN EG with
fibrates has not been studied.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness, as muscle problems can, rarely, be serious and lead to muscle tissue damage that causes kidney damage; very rarely, deaths have occurred.
Always inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and medicines may be needed for the diagnosis and treatment of this condition.
The risk of muscle injury is greater at higher doses of EZETIMIBE AND SIMVASTATIN EG,
particularly with the 10 mg/80 mg dose. The risk of muscle injury is also greater in some patients.
Tell your doctor if any of the following conditions apply to you:

• you have kidney problems;
• you have thyroid problems;
• you are 65 years of age or older;
• you are female;
• you have previously experienced muscle problems while taking cholesterol-lowering medicines called "statins" (such as simvastatin, atorvastatin, and rosuvastatin) or fibrates (such as gemfibrozil and bezafibrato);
• you or your close family members have a hereditary muscle disease.

Children and adolescents
The use of EZETIMIBE AND SIMVASTATIN EG is not recommended in children under 10 years of age.

Other medicines and EZETIMIBE AND SIMVASTATIN EG
Tell your doctor if you are taking, have recently taken or might take any other medicines
containing any of the following active substances. Taking EZETIMIBE AND SIMVASTATIN EG with any
of the following medicines may increase the risk of muscle problems (some have already been mentioned above in the section "Do not take EZETIMIBE AND SIMVASTATIN EG"):

• if you need to take fusidic acid orally to treat a bacterial infection you musttemporarily stop taking this medicine. Your doctor will tell you when you can safely start taking EZETIMIBE AND SIMVASTATIN EG again. Taking EZETIMIBE ANDSIMVASTATIN EG with fusidic acid can, in rare cases, lead to muscle weakness or pain(rhabdomyolysis). For more information on rhabdomyolysis, see also section 4;
• cyclosporine (often used in patients receiving an organ transplant);
• danazol (an artificial hormone used for the treatment of endometriosis, a condition in which the lining of the uterus grows outside the uterus);
• medicines with an active ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections);
• fibrates with active ingredients such as gemfibrozil and bezafibrato (used to reduce cholesterol);
• erythromycin, clarithromycin or telithromycin (used to treat bacterial infections);
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat AIDS);
• boceprevir or telaprevir (used to treat hepatitis C virus infections);
• nefazodone (used to treat depression);
• medicines with the active ingredient cobicistat;
• amiodarone (used to treat an irregular heartbeat);
• verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease or other heart conditions);
• lomitapide (used to treat a severe and rare genetic cholesterol condition);
• high doses (1 g or more per day) of niacin or nicotinic acid (also used to lower cholesterol);
• colchicine (used to treat gout).

In addition to the medicines listed above, tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including those available without a prescription. In
particular, tell your doctor if you are taking any of the following:

• medicines with an active ingredient to prevent blood clots, such as warfarin, fluindione, phenprocoumone or acenocoumarol (anticoagulants);
• cholestyramine (also used to lower cholesterol) as it affects the way EZETIMIBE AND SIMVASTATIN EG works;
• fenofibrate (also used to lower cholesterol);
• rifampicin (used to treat tuberculosis).

You should also inform any doctor who is prescribing you new medicines that you are taking
EZETIMIBE AND SIMVASTATIN EG.

EZETIMIBE AND SIMVASTATIN EG with food and drink
Grapefruit juice contains one or more substances that alter the metabolism of some medicines, including
EZETIMIBE AND SIMVASTATIN EG. Consumption of grapefruit juice should be avoided, as it may
increase the risk of muscle problems.

Pregnancy and breastfeeding
Do not take EZETIMIBE AND SIMVASTATIN EG if you are pregnant, if you suspect you might be
pregnant or if you are planning to become pregnant. If you become pregnant during treatment with EZETIMIBE AND SIMVASTATIN EG,
stop taking it immediately and contact your doctor. Do not take EZETIMIBE AND SIMVASTATIN
EG if you are breastfeeding, as it is not known whether the medicine passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
EZETIMIBE AND SIMVASTATIN EG is not expected to affect your ability to drive or
use machines. However, you should be aware that some people have experienced dizziness after taking
EZETIMIBE AND SIMVASTATIN EG.

EZETIMIBE AND SIMVASTATIN EG contains lactose and sodium
EZETIMIBE AND SIMVASTATIN EG tablets contain a sugar called lactose. If you have been
diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially ‘sodium-free’

3. How to take EZETIMIBE AND SIMVASTATIN EG

The doctor will determine the appropriate tablet dosage for you, based on your current treatment and your personal
risk profile.
The tablets do not have a break line and should not be divided.
Take this medicine following the instructions of your doctor or pharmacist exactly as given. If you
have any doubts, ask your doctor or pharmacist.

• Before starting to take EZETIMIBE AND SIMVASTATIN EG, you should be following a diet to lower cholesterol levels.
• During treatment with EZETIMIBE AND SIMVASTATIN EG, you should continue to follow this diet to lower cholesterol. Adults: the dose is 1 tabletorally once a day. Adolescents (10 to 17 years of age): the dose is 1 tabletorally once a day (a maximum dose of 10 mg/40 mg once a day should not be exceeded).

A dose of ezetimibe and simvastatin 10 mg/80 mg is recommended only in adult patients with very high cholesterol levels and at high risk for heart disease who have not reached their ideal cholesterol level with lower doses.
If the optimal dosage cannot be achieved with EZETIMIBE AND SIMVASTATIN EG, your doctor may
prescribe other tablets containing ezetimibe/simvastatin.
Take EZETIMIBE AND SIMVASTATIN EG in the evening. You can take it with or without food.
If your doctor has prescribed EZETIMIBE AND SIMVASTATIN EG with another medicine to lower your
cholesterol containing the active ingredient colestyramine or any other bile acid sequestrant, you must
take EZETIMIBE AND SIMVASTATIN EG at least 2 hours before or 4 hours after taking the bile acid
sequestrant.

If you take more EZETIMIBE AND SIMVASTATIN EG than you should
Contact your doctor or pharmacist.

If you forget to take EZETIMIBE AND SIMVASTATIN EG
Do not take a double dose to make up for a missed tablet, just take your usual dose of EZETIMIBE AND SIMVASTATIN EG the next day at the usual time.

If you stop taking EZETIMIBE AND SIMVASTATIN EG
Contact 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
(see section 2).
The following common side effects have been reported (may affect up to 1 in 10 people):

• muscle pain;
• increases in blood test values relating to liver function (transaminases) and/or muscles (CK).

The following uncommon side effects have been reported (may affect up to 1 in 100 people):

• increases in blood test values relating to liver function; increases in uric acid levels in the blood; increases in the time it takes for the blood to clot; presence of protein in the urine; decrease in body weight;
• dizziness; headache; tingling sensation;
• abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal bloating; diarrhea; dry mouth; heartburn;
• skin rash; itching; hives;
• joint pain; muscle pain; sensitivity; weakness or spasms; neck pain; arm and leg pain; back pain;
• unusual fatigue or weakness; feeling tired; chest pain; swelling, especially of the hands and feet;
• sleep disorder; difficulty falling asleep.

In addition, the following side effects have been reported in people taking the ezetimibe/simvastatin combination or medicines containing the active ingredients ezetimibe or simvastatin:

• reduced number of red blood cells (anemia); decrease in the number of blood cells, which can cause bruising/bleeding (thrombocytopenia);
• loss of sensation or weakness in the arms and legs; poor memory; memory loss; confusion;
• breathing problems including persistent cough and/or shortness of breath or fever;
• constipation;
• inflammation of the pancreas often with severe abdominal pain;
• inflammation of the liver with the following symptoms: yellowing of the skin and eyes; itching; dark urine or pale stools; feeling tired or weak; loss of appetite; liver failure; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea and vomiting);
• hair loss; raised, red skin rash, sometimes with target-like lesions (erythema multiforme);
• a hypersensitivity reaction that included some of the following characteristics: hypersensitivity (allergic reactions including swelling of the face, lips, tongue and/or throat that can cause difficulty breathing or swallowing and requires immediate treatment (angioedema), a very rare serious allergic reaction that causes difficulty breathing or dizziness (anaphylaxis);, pain or inflammation of the joints, inflammation of the blood vessels, unusual bruising, skin rashes and swelling, skin sensitivity to the sun, fever, hot flushes, shortness of breath and feeling unwell, a lupus-like syndrome (which includes skin rash, joint problems, and effects on white blood cells)), muscle pain; sensitivity; weakness or muscle cramps; muscle injury; tendon problems, sometimes complicated by tendon rupture;
• decreased appetite;
• hot flushes; high blood pressure;
• pain;
• erectile dysfunction;
• depression;
• alteration of some values in blood tests relating to liver function.

Further possible side effects reported with some statins:

• sleep disturbances, including nightmares;
• sexual difficulties;
• diabetes. This is more likely if you have high levels of sugars and fats in your blood, if you are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine;
• muscle pain, tenderness or weakness that is constant that may not disappear after stopping treatment with EZETIMIBE AND SIMVASTATIN EG (frequency not known: cannot be estimated from the available data).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or muscle weakness.
This is because muscle problems can, rarely, be serious and lead to muscle tissue damage that causes kidney damage; very rarely, cases of death have occurred.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at: http://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 EZETIMIBE E SIMVASTATINA EG

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 pack or container after
"Exp.". The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water 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 EZETIMIBE E SIMVASTATINA EG contains
The active ingredients are ezetimibe and simvastatin.
Each tablet contains 10 mg of ezetimibe and 10 mg of simvastatin.
Each tablet contains 10 mg of ezetimibe and 20 mg of simvastatin.
Each tablet contains 10 mg of ezetimibe and 40 mg of simvastatin
The other ingredients are:

Tablet core:lactose monohydrate, hypromellose, sodium croscarmellose, microcrystalline cellulose,
ascorbic acid, anhydrous citric acid, butylated hydroxyanisole, propyl gallate, magnesium stearate.

Coloring mixture:lactose monohydrate, yellow iron oxide (E 172), red iron oxide (E 172), black iron
oxide (E 172).

Description of the appearance of EZETIMIBE E SIMVASTATINA EG and package contents
EZETIMIBE E SIMVASTATINA EG 10 mg/10 mg are light brown, mottled, round tablets, 6
mm in diameter, biconvex, with “511” inscribed on one side.
EZETIMIBE E SIMVASTATINA EG 10 mg/20 mg are light brown, mottled, round tablets, 8
mm in diameter, biconvex, with “512” inscribed on one side.
EZETIMIBE E SIMVASTATINA EG 10 mg/40 mg are light brown, mottled, round tablets, 10
mm in diameter, biconvex, with “513” inscribed on one side.
Packages
Blister packs:
[10 mg/10 mg]
Packs: 14, 28, 30, 50, 98 and 100 tablets.
[10 mg/20 mg; 10 mg/40 mg]
Packs: 28, 30, 50, 98 and 100 tablets.
HDPE bottle:
100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia 6, 20136 Milano

Manufacturers
Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitza 2600 – Bulgaria
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel – Germany
STADA Arzneimittel GmbH, Muthgasse 36/2 1190 Wien – Austria
Centrafarm Services B.V., Nieuwe Donk 9, NL- 4879 AC Etten-Leur – Netherlands
Clonmel Healthcare Ltd., Waterford Road Clonmel, Co. Tipperary – Ireland

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
AT Ezetimib/Simvastatin STADA
BE Ezetimibe/Simvastatine EG
CZ Ezetimib/Simvastatin STADA
DE Ezetimib/Simvastatin AL
DK Ezetimib/Simvastatin STADA
ES Ezetimiba/Simvastatina STADA
FR EZETIMIBE/SIMVASTATINE EG
IE Ezetimibe/Simvastatin Clonmel
IT Ezetimibe e Simvastatina EG
LU Ezetimibe/Simvastatine EG
NL Ezetimibe/Simvastatine CF
PT Sinvastatina + Ezetimiba Ciclum
SI Ezetimib/simvastatin STADA