EZETIMIBE 10 mg/10 mg Coated Tablet

Зміст інструкції

1. Ezetimibe and Simvastatina Alter 10 mg/10 mg tablets, Alter10 mg/20 mg tablets, Alter 10 mg/40 mg tablets
   1. What Ezetimibe and Simvastatina Alter is and what it is used for
   2. What you need to know before taking Ezetimibe and Simvastatina Alter
   3. How to take Ezetimibe and Simvastatina Alter
   4. Possible side effects
   5. How to store Ezetimibe and Simvastatina Alter
   6. Contents of the pack and other information

Ezetimibe and Simvastatina Alter 10 mg/10 mg tablets, Alter10 mg/20 mg tablets, Alter 10 mg/40 mg tablets

Ezetimibe/simvastatina
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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Ezetimibe and Simvastatina Alter is and what it is used for
• 2. What you need to know before you take Ezetimibe and Simvastatina Alter
• 3. How to take Ezetimibe and Simvastatina Alter
• 4. Possible side effects
• 5. How to store Ezetimibe and Simvastatina Alter
• 6. Contents of the pack and other information

1. What Ezetimibe and Simvastatina Alter is and what it is used for

Ezetimibe and Simvastatina Alter contains the active ingredients ezetimibe and simvastatin.
Ezetimibe and Simvastatina Alter 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. Furthermore, Ezetimibe and Simvastatina Alter increases the
levels of “good” cholesterol (HDL cholesterol).
Ezetimibe and Simvastatina Alter 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 the various 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 accumulate
in the walls of the arteries forming plaques. Over time, this
accumulation 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 a
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 and Simvastatina Alter is used for patients who cannot keep their cholesterol levels under
control with diet alone. While taking this
medicine, you should still follow a diet to lower cholesterol.
Ezetimibe and Simvastatina Alter 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): or that are not well controlled by a statin alone or for whom you have taken treatment with a statin and ezetimibe in separate tablets
• an inherited disease (familial homozygous hypercholesterolemia) that increases your cholesterol levels in the blood. You may also be treated with other treatments.
• a heart disease, Ezetimibe and Simvastatina Alter reduces the risk of heart attack, stroke, surgical procedures to increase blood flow or hospitalization for chest pain.

Ezetimibe and Simvastatina Alter does not help you lose weight.

2. What you need to know before taking Ezetimibe and Simvastatina Alter

Do not take Ezetimibe and Simvastatina Alter:

• 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: o itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections) o erythromycin, clarithromycin or telithromycin (used to treat infections) o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used to treat HIV infections) o boceprevir or telaprevir (used to treat hepatitis C virus infections) o nefazodone (used to treat depression) o cobicistat or gemfibrozil (used to lower cholesterol)

o cyclosporine (often used in patients who have undergone organ transplantation)
o 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, within the last 7 days, have taken a medicine called fusidic acid (used to treat bacterial infection) by mouth or by injection. The combination of fusidic acid and Ezetimibe and Simvastatina Alter may cause serious muscle problems (rhabdomyolysis).

Do not take more than 10 mg/40 mg of Ezetimibe and Simvastatina Alter 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 Simvastatina Alter
if:

• you suffer from any medical condition, including allergies.
• you consume significant amounts of alcohol or have ever had a liver disease. Ezetimibe and Simvastatina Alter may not be suitable for you.
• you are going to have surgery. You may need to stop taking Ezetimibe and Simvastatina Alter for a short period.
• you are Asian, because a different dose may be appropriate for you.

The doctor should have a blood test done before giving you Ezetimibe and
Simvastatina Alter and if you have symptoms of liver problems while taking
Ezetimibe and Simvastatina Alter. This test is done to check if your liver
is working properly.
The doctor may prescribe blood tests to check your liver function
after starting therapy with Ezetimibe and Simvastatina Alter.
During treatment with this medicine, your doctor will carefully monitor if you have
diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you
have high levels of sugars and fats in your blood, if you are overweight and have high
blood pressure.
Tell your doctor if you have a severe lung disease.
The combined use of Ezetimibe and Simvastatina Alter with fibrates (some types of
medicines to lower cholesterol) should be avoided as the use of Ezetimibe
and Simvastatina Alter with fibrates has not been studied.

Contact your doctor immediately if you experience muscle pain, tenderness or
unexplained muscle weakness, as muscle problems can, rarely,
be serious and lead to muscle tissue damage that causes kidney damage;
very rarely, deaths have occurred.
The risk of muscle damage is greater at higher doses of Ezetimibe and Simvastatina
Alter, particularly with the 10/80 mg dose. The risk of muscle damage is greater
also 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 ever had 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.

Always inform your doctor or pharmacist even if you have a persistent muscle weakness.
Further tests and medicines may be needed for the diagnosis and treatment
of this condition.

Children and adolescents
The use of Ezetimibe and Simvastatina Alter is not recommended in children under the age of
10 years.

Other medicines and Ezetimibe and Simvastatina Alter
Tell your doctor if you are taking, have recently taken or might take
any other medicine with any of the following active substances. Taking
Ezetimibe and Simvastatina Alter with any of the following medicines may increase
the risk of muscle problems (some have already been mentioned above in the “Do not
take Ezetimibe and Simvastatina Alter” section):

• if you need to take fusidic acid orally to treat a bacterial
  infection you will need to temporarily stop taking this medicine. Your doctor will tell you when you can safely start taking
  Ezetimibe and Simvastatina Alter again. Taking Ezetimibe and Simvastatina Alter
  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 substance such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections)
• fibrates with active substances 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)
• antiviral agents for hepatitis C such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection)
• nefazodone (used to treat depression)
• medicines with the active substance 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 substance 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 Simvastatina Alter works
• fenofibrate (also used to lower cholesterol)
• rifampicin (used to treat tuberculosis).

You should also tell any doctor who is prescribing you new medicines
that you are taking Ezetimibe and Simvastatina Alter.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become
pregnant, ask your doctor or pharmacist for advice before
taking this medicine.
Do not take Ezetimibe and Simvastatina Alter if you are pregnant, suspect you are
or are planning to become pregnant. If you become pregnant while taking Ezetimibe and
Simvastatina Alter, stop taking it immediately and contact your doctor. Do not
take Ezetimibe and Simvastatina Alter if you are breastfeeding, as it is
not known whether the medicine passes into breast milk.

Driving and using machines
Ezetimibe and Simvastatina Alter is not expected to affect your ability to
drive or operate machinery. However, you should be aware that some people
have experienced dizziness after taking Ezetimibe and Simvastatina Alter.

Ezetimibe and Simvastatina Alter contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.

3. How to take Ezetimibe and Simvastatina Alter

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 exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• Before starting to take Ezetimibe and Simvastatina Alter you must have already followed a diet to lower cholesterol levels.
• During treatment with Ezetimibe and Simvastatina Alter you must continue to follow this diet to lower cholesterol.

Adults: the dose is 1 tablet of Ezetimibe and Simvastatina Alterorally once a day.

Use in adolescents(10 to 17 years of age): the dose is 1 tablet of Ezetimibe and Simvastatina Alterorally once a day (do not exceed a maximum dose of 10 mg/40 mg once a day).
The 10 mg/80 mg dose of Ezetimibe and Simvastatina Alter 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.
Take Ezetimibe and Simvastatina Alter in the evening. You can take it with or without food.
If your doctor has prescribed Ezetimibe and Simvastatina Alter with another medicine to lower cholesterol containing the active ingredient ezetimibe or any other bile acid sequestrant, you must take Ezetimibe and Simvastatina Alter at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe and Simvastatina Alter than you should
Contact your doctor or pharmacist.

If you forget to take Ezetimibe and Simvastatina Alter
Do not take a double dose to make up for the missed tablet, just take your normal dose of Ezetimibe and Simvastatina Alter the next day at the usual time.

If you stop taking Ezetimibe and Simvastatina Alter
Contact your doctor or pharmacist because your cholesterol may increase 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 will experience them
(see section 2. What you need to know before taking Ezetimibe and Simvastatina Alter).
The following undesirable effects have been reported as common (may affect up to 1
in 10 people):

• muscle pain
• increases in blood test values regarding liver function (transaminases) and/or muscles (CK)

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

• increases in blood test values regarding liver function; increases in blood uric acid levels; increases in the time it takes for blood to clot; presence of protein in the urine; decrease in body weight
• dizziness; headache; sensation of tingling
• 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 undesirable effects have been reported in people taking
the ezetimibe/simvastatin combination or medicines containing the active ingredients ezetimibe
or simvastatin:

• lowering of the number of red blood cells (anemia); decrease in the number of blood cells, which can cause bruising/bleeding (thrombocytopenia)
• loss of sensitivity 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 in

breathing or swallowing and requires immediate treatment (angioedema), a
severe allergic reaction that causes difficulty breathing or dizziness
(anaphylaxis, which can affect up to 1 in 10,000 and anaphylactic reactions), pain or inflammation of the joints, inflammation of the
blood vessels, abnormal bruising, skin rashes and swelling,
skin sensitivity to the sun, fever, hot flushes, shortness of breath and
feeling unwell, a collection of symptoms like lupus (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 flashes; high blood pressure
• pain
• erectile dysfunction
• depression
• alteration of some values of the blood analysis regarding the function of the liver.

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 and may not disappear after stopping treatment with this medicine (frequency not known).

Contact your doctor immediately if you experience muscle pain, sensitivity and
unexplained muscle weakness. This is because muscle problems can,
rarely, be serious and lead to muscle tissue damage that causes kidney damage; very rare cases of death have occurred.
Reporting of side effects
If you get any side effect, 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
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 and Simvastatina Alter

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
Do not use this medicine after the expiry date which is stated on the package, bottle or blister after “Exp.”.
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 Ezetimibe and Simvastatina Alter contains

• The active ingredients are ezetimibe and simvastatin. Each tablet contains 10 mg of ezetimibe and 10 mg, 20 mg or 40 mg of simvastatin.
• The other ingredients are: Tablet core: lactose monohydrate, hypromellose, sodium croscarmellose, microcrystalline cellulose, ascorbic acid, anhydrous citric acid, butylated hydroxyanisole (E320), 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 and Simvastatina Alter and contents of the pack
Ezetimibe and Simvastatina Alter 10 mg/10 mg are light brown, mottled,
round tablets, 6 mm in diameter, biconvex, with “511” inscribed on one side
Ezetimibe and Simvastatina Alter 10 mg/20 mg are light brown, mottled,
round tablets, 8 mm in diameter, biconvex, with “512” inscribed on one side
Ezetimibe and Simvastatina Alter 10 mg/40 mg are light brown, mottled,
round tablets, 10 mm in diameter, biconvex, with “513” inscribed on one side
Blisters in OPA/aluminum/PVC with aluminum foil and/or HDPE bottles with
desiccant. Pack sizes:
10 mg/10 mg: 28 and 30 tablets.
10 mg/20 mg: 28, 30 and 90 tablets.
10 mg/40 mg: 28, 30 and 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder
Laboratori Alter S.r.l.
Via Egadi 7 – 20144 Milan

Manufacturer
Balkanpharma-Dupnitsa AD
3 SamokovskoShosse Street, Dupnitsa, 2600 – Bulgaria

This medicinal product is authorized in the Member States of the European Economic
Area under the following denominations:
France EZETIMIBE/SIMVASTATINE ALTER, comprimé
Italy Ezetimibe e Simvastatina Alter compresse
Spain Ezetimiba/Simvastatina Alter comprimidos EFG
More detailed information on this medicinal product is available on the AIFA website
www.agenziafarmaco.gov.it