EZETIMIBE 10 mg/10 mg Коированная Таблетка

Содержание инструкции

1. EZETIMIBE E SIMVASTATINA ALMUS 10 mg/10 mg tablets, mg/20 mg tablets, mg/40 mg tablets
   1. What is EZETIMIBE E SIMVASTATINA ALMUS and what it is used for
2. EZETIMIBE and SIMVASTATIN ALMUS is used for patients who cannot keep under
   1. What you need to know before taking EZETIMIBE AND SIMVASTATIN ALMUS
3. EZETIMIBE E SIMVASTATINA ALMUS is not recommended in children under 10 years of age.
   1. How to take EZETIMIBE E SIMVASTATINA ALMUS
   2. Possible side effects
   3. How to store EZETIMIBE E SIMVASTATINA ALMUS
   4. Contents of the pack and other information
4. EZETIMIBE E SIMVASTATINA ALMUS 10 mg/10 mg tablets: light brown,
5. EZETIMIBE E SIMVASTATINA ALMUS 10 mg/20 mg tablets: light brown,
6. EZETIMIBE E SIMVASTATINA ALMUS 10 mg/40 mg tablets: light brown,

EZETIMIBE E SIMVASTATINA ALMUS 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 asit 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 ALMUS is and what it is used for
• 2. What you need to know before you take EZETIMIBE E SIMVASTATINA ALMUS
• 3. How to take EZETIMIBE E SIMVASTATINA ALMUS
• 4. Possible side effects
• 5. How to store EZETIMIBE E SIMVASTATINA ALMUS
• 6. Contents of the pack and other information

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

EZETIMIBE E SIMVASTATINA ALMUS contains the active ingredients ezetimibe and simvastatin.
EZETIMIBE E SIMVASTATINA ALMUS is a medicine used to reduce the level of total cholesterol,
“bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the
blood. In addition, EZETIMIBE E SIMVASTATINA ALMUS increases the levels of “good”
cholesterol (HDL cholesterol).
EZETIMIBE E SIMVASTATINA ALMUS 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
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 in the blood that can increase the risk of
heart disease.

EZETIMIBE and SIMVASTATIN ALMUS is used for patients who cannot keep under

control their cholesterol levels with diet alone. While taking this medicine you should still
follow a diet to lower cholesterol.
EZETIMIBE and SIMVASTATIN ALMUS is used as an adjunct to diet therapy to
lower cholesterol if you have:

• increased levels of cholesterol in the blood (primary hypercholesterolemia) [heterozygous familial and non-familial] 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 and SIMVASTATIN ALMUS reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

EZETIMIBE and SIMVASTATIN ALMUS does not help you lose weight.

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

Do not take EZETIMIBE AND SIMVASTATIN ALMUS if:

• you are allergic (hypersensitive) to ezetimibe, simvastatin, or any of the other ingredients of this medicine (listed in section 6)
• you currently have liver problems
• you are pregnant or breastfeeding
• you are taking any of the following medicines 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 undergoing organ transplantation)
• danazol (a hormone produced by humans used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus)
• you are taking or, within the last 7 days, have taken a medicine called fusidic acid (used to treat bacterial infection) orally or by injection. The combination of fusidic acid and EZETIMIBE AND SIMVASTATIN ALMUS may cause serious muscle problems (rhabdomyolysis) Do not take more than 10 mg/40 mg of EZETIMIBE AND SIMVASTATIN ALMUS 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
Tell your doctor or pharmacist before starting to take EZETIMIBE AND SIMVASTATIN
ALMUS:

• about all your medical conditions, including allergies
• if you drink significant amounts of alcohol or if you have ever had a liver disease. EZETIMIBE AND SIMVASTATIN ALMUS may not be suitable for you
• if you are going to have surgery. You may need to stop taking EZETIMIBE AND SIMVASTATIN ALMUS for a short period
• if you are Asian, because a different dose may be appropriate for you.

Your doctor must have a blood test before you start taking EZETIMIBE AND
SIMVASTATIN ALMUS and if you have symptoms of liver problems while taking
EZETIMIBE AND SIMVASTATIN ALMUS. This test is done to check if your liver is working
properly.
Your doctor may also want to have blood tests to check that your
liver is working properly after you have started taking EZETIMIBE AND SIMVASTATIN
ALMUS.
During treatment with this medicine, your doctor will carefully monitor that you do not
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 ALMUS with fibrates (some types of medicines
to lower cholesterol) should be avoided as the use of EZETIMIBE AND SIMVASTATIN
ALMUS with fibrates has not been studied.

Contact your doctor immediately if you experience muscle pain, tenderness or weakness
that is unexplained, as muscle problems can, rarely, be serious and
lead to muscle tissue damage that causes kidney damage and very
rarely cases of death have occurred.
The risk of muscle damage is greater at higher doses of EZETIMIBE AND SIMVASTATIN
ALMUS, particularly with the 10 mg/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 bezafibrate)
• you or your close family members suffer from an inherited muscle disease.

Tell your doctor or pharmacist if you experience persistent muscle weakness.
Further examinations and medicines may be necessary for the diagnosis and treatment of
this condition.

Children and adolescents

EZETIMIBE E SIMVASTATINA ALMUS is not recommended in children under 10 years of age.

Other medicines and EZETIMIBE E SIMVASTATINA ALMUS
Tell your doctor if you are taking, have recently taken, or might take any other medicine with any of the following active ingredients. Taking EZETIMIBE E SIMVASTATINA ALMUS 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 E SIMVASTATINA ALMUS” section).

• if you need to take fusidic acid by mouth 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 E SIMVASTATINA ALMUS again. Taking EZETIMIBE E SIMVASTATINA ALMUS and fusidic acid can rarely lead to weakness, tenderness, or muscle pain (rhabdomyolysis). For more information on rhabdomyolysis, see paragraph 4.
• cyclosporine (often used in patients receiving an organ transplant)
• danazol (an artificial hormone used to treat endometriosis, a condition in which the lining of the uterus develops 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 bezafibrate (used to reduce cholesterol)
• erythromycin, clarithromycin, telithromycin (used to treat bacterial infections)
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat AIDS)
• antiviral agents against hepatitis C such as boceprevir or telaprevir, elbasvir or grazoprevir (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 condition of cholesterol)
• daptomycin (a drug used to treat complicated skin and soft tissue infections and bacteremia). It is possible that adverse effects on the muscles may be greater when this drug is taken during treatment with simvastatin (e.g. EZETIMIBE E SIMVASTATINA ALMUS). Your doctor may decide to have you stop EZETIMIBE E SIMVASTATINA ALMUS for a period.
• 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 or have recently taken 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, phenprocoumon or acenocoumarol (anticoagulants)

• cholestyramine (also used to lower cholesterol) as it affects how EZETIMIBE E SIMVASTATINA ALMUS works
• fenofibrate (also used to lower cholesterol)
• rifampicin (used to treat tuberculosis).

You should also inform any doctor who is prescribing you a new medicine that you are taking EZETIMIBE E SIMVASTATINA ALMUS.

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

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

Driving and using machines
It is not expected that EZETIMIBE E SIMVASTATINA ALMUSwill interfere with your ability to drive or operate machinery. However, you should be aware that some people have experienced dizziness after taking EZETIMIBE E SIMVASTATINA ALMUS.

EZETIMIBE E SIMVASTATINA ALMUS contains lactose
EZETIMIBE E SIMVASTATINA ALMUS tablets contain a sugar called lactose.
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially ‘sodium-free’.

3. How to take EZETIMIBE E SIMVASTATINA ALMUS

Your doctor will determine the appropriate tablet dosage for you, based on your current treatment and your personal risk profile.
The tablets have no break line and must not be divided.
Take this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.

• Before starting to take EZETIMIBE E SIMVASTATINA ALMUS, you should already have been following a diet to lower your cholesterol levels.
• During treatment with EZETIMIBE E SIMVASTATINA ALMUS you should continue to follow this diet to lower cholesterol.

Adults: the dose is 1 tabletorally once a day.
Adolescents (10 to 17 years): the dose is 1 tabletorally 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 E SIMVASTATINA ALMUS 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 E SIMVASTATINA ALMUS in the evening. You can take it with or without food.
If your doctor has prescribed EZETIMIBE E SIMVASTATINA ALMUS with another medicine to lower cholesterol containing the active ingredient ezetimibe or any other bile acid sequestrant, you must take EZETIMIBE E SIMVASTATINA ALMUS at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more EZETIMIBE E SIMVASTATINA ALMUS than you should
Contact your doctor or pharmacist.

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

If you stop taking EZETIMIBE E SIMVASTATINA ALMUS
Contact your doctor or pharmacist because 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 everyone will experience them (see section 2).
The following undesirable effects have been reported:

• muscle pain
• increased values in laboratory tests concerning liver function (transaminases) and/or muscles (CK).

The following undesirable effects are uncommon (may affect up to 1 in 100 people):

• increases in the values of blood tests concerning liver function; increases in uric acid levels in the blood; increases in the time required for blood coagulation; presence of proteins in the urine; decrease in body weight
• dizziness; headache; sensation of tingling
• abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal bloating;

diarrhea; dryness of the mouth; heartburn

• skin rash; itching; hives
• joint pain; muscle pain; sensitivity; weakness or spasms; neck pain; arm or 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 both ezetimibe and simvastatin or medicines containing the active ingredients ezetimibe or simvastatin:

• reduction in the 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-shaped lesions (erythema multiforme)
• blurred vision and impaired vision (may affect up to 1 in 1,000)
• 1,000)
• skin rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions) (which may affect up to 1 in 10,000)
• hypersensitivity reactions including some of the following: allergic reactions including swelling of the face, lips, tongue and/or throat that can cause difficulty breathing or swallowing and requires immediate treatment (angioedema), pain or inflammation of the joints, inflammation of blood vessels, unusual bruising, skin rashes and swelling, skin sensitivity to the sun, fever, hot flushes, shortness of breath and feeling unwell, lupus-like symptoms (which include skin rash, joint problems, and effects on white blood cells). A severe allergic reaction (which may affect up to 1 in 10,000) causing difficulty breathing or dizziness and requiring immediate treatment (anaphylaxis)
• muscle pain; sensitivity, weakness or cramps, muscle injury, muscle rupture (which may affect up to 1 in 10,000); tendon problems, sometimes complicated by tendon rupture
• gynecomastia (breast enlargement in men) (which may affect up to 1 in 10,000)
• decreased appetite
• hot flushes; high blood pressure
• pain
• erectile dysfunction
• depression
• alteration of some values in the blood tests concerning 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 ALMUS (frequency not known).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness and weakness.
This is because muscle problems can, rarely, be serious and lead to muscle tissue damage that causes kidney damage; and very rare cases of death have occurred.
Reporting of side effects
If you get any side effects, 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:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store EZETIMIBE E SIMVASTATINA ALMUS

Keep this medicine out of the sight and reach of children.
Do not use EZETIMIBE E SIMVASTATINA ALMUS after the expiry date which is stated on the
pack or on the blister after the wording "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. Contents of the pack and other information

What EZETIMIBE E SIMVASTATINA ALMUS contains
The active ingredients are ezetimibe and simvastatin. Each tablet contains 10 mg of ezetimibe
and 10 mg, 20 mg, 40 mg of simvastatin.
The other excipients 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 (E172), red iron oxide (E172) and
black iron oxide (E172).

Description of the appearance of EZETIMIBE E SIMVASTATINA ALMUS and contents of the pack

EZETIMIBE E SIMVASTATINA ALMUS 10 mg/10 mg tablets: light brown,

mottled, round tablet with a diameter of 6 mm, biconvex, smooth on one side and with “511” imprinted
on the other.

EZETIMIBE E SIMVASTATINA ALMUS 10 mg/20 mg tablets: light brown,

mottled, round tablet with a diameter of 8 mm, biconvex, smooth on one side and with “512” on the other.

EZETIMIBE E SIMVASTATINA ALMUS 10 mg/40 mg tablets: light brown,

mottled, round tablet with a diameter of 10 mm, biconvex, smooth on one side and with “513” on the other.
Package: 30 tablets
Not all package sizes may be marketed.

Marketing Authorisation Holder
Almus S.r.l.
Via Cesarea, 11/10

• 16121 - Genoa (GE) 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 with the
following designation
Denmark: NELSTATINE
Italy: EZETIMIBE E SIMVASTATINA ALMUS