EZETIMIBE 10 mg/10 mg Coated Tablet

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1. EZETIMIBE and SIMVASTATIN DOC Generici 10 mg/10 mg tablets, mg/20 mg tablets, mg/40 mg tablets, mg/80 mg tablets
   1. What is EZETIMIBE and SIMVASTATINA DOC Generici and what it is used for
2. EZETIMIBE and SIMVASTATINA DOC Generici is used for patients who cannot keep
3. EZETIMIBE and SIMVASTATINA DOC Generici is used as an adjunct to diet therapy to
   1. What you need to know before taking EZETIMIBE and SIMVASTATIN DOC Generics
   2. How to take EZETIMIBE and SIMVASTATINA DOC Generici
   3. Possible side effects
   4. How to store EZETIMIBE E SIMVASTATINA DOC Generici
   5. Package Contents and Other Information

EZETIMIBE and SIMVASTATIN DOC Generici 10 mg/10 mg tablets, mg/20 mg tablets, mg/40 mg tablets, mg/80 mg tablets

Generic medicine

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

1. What is EZETIMIBE and SIMVASTATINA DOC Generici and what it is used for

EZETIMIBE and SIMVASTATINA DOC Generici 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 and SIMVASTATINA DOC Generici increases
the levels of "good" cholesterol (HDL cholesterol).
EZETIMIBE and SIMVASTATINA DOC Generici contains the active ingredients ezetimibe and simvastatin.
EZETIMIBE and SIMVASTATINA DOC Generici 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 composed mainly 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 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 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 DOC Generici 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 DOC Generici is used as an adjunct to diet therapy to

lower cholesterol if you have:

• increased cholesterol levels 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 SIMVASTATINA DOC Generici reduces the risk of heart attack, stroke, surgical procedures to increase blood flow, or hospital admission for chest pain

EZETIMIBE and SIMVASTATINA DOC Generici does not help with weight loss.

2. What you need to know before taking EZETIMIBE and SIMVASTATIN DOC Generics

Do not take EZETIMIBE and SIMVASTATIN DOC Generics:

• 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 of the following medicines containing one or more of the following active substances: itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections) or erythromycin, clarithromycin or telithromycin (used to treat infections) or HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used to treat HIV infections) or boceprevir or telaprevir (used to treat hepatitis C virus infections) or nefazodone (used to treat depression) or cobicistat or gemfibrozil (used to lower cholesterol) or cyclosporine (often used in patients who have undergone organ transplantation) or 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, in the last 7 days, or have been given a medicine called fusidic acid (used to treat bacterial infection) orally or by injection. The combination of fusidic acid and EZETIMIBE and SIMVASTATIN DOC Generics may lead to a serious muscle problem (rhabdomyolysis)
• do not take more than 10 mg/40 mg of EZETIMIBE and SIMVASTATIN DOC Generics 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 taking EZETIMIBE and SIMVASTATIN DOC
Generics:

• if you have any medical condition, including allergies.
• if you drink significant amounts of alcohol or have ever had a liver disease. In this case EZETIMIBE and SIMVASTATIN DOC Generics may not be suitable for you.
• if you are going to have surgery. You may need to stop taking EZETIMIBE and SIMVASTATIN DOC Generics for a short period.
• if you are Asian, because a different dose may be suitable for you

The doctor must have a blood test done before giving you EZETIMIBE and
SIMVASTATIN DOC Generics. This test is done to see how well your liver is working.
The doctor may also have a blood test done to check if your liver is working well
after you have started taking EZETIMIBE and SIMVASTATIN DOC Generics.
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 serious lung disease.
The combined use of EZETIMIBE and SIMVASTATIN DOC Generics with fibrates (some types of
medicines to lower cholesterol) should be avoided as the use of EZETIMIBE and
SIMVASTATIN DOC Generics with fibrates has not been studied.

Contact your doctor immediately if you experience muscle pain, tenderness or weakness
that is unexplained. This is because 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 diagnosis and treatment of this condition.
The risk of muscle injury is greater at higher doses of EZETIMIBE and SIMVASTATIN
DOC Generics, 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 DOC Generics is not recommended in children under
the age of 10 years.

Other medicines and EZETIMIBE and SIMVASTATIN DOC Generics
Tell your doctor if you are taking, have recently taken or might take any other
medicines with any of the following active substances. Taking EZETIMIBE and
SIMVASTATIN DOC Generics 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 DOC Generics"):
o 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
takingEZETIMIBE and SIMVASTATIN DOC Generics again.
Taking EZETIMIBE and SIMVASTATIN DOC Generics with fusidic acid can, in rare
cases, lead to muscle weakness or pain (rhabdomyolysis). For more information
on rhabdomyolysis see also section 4 of this leaflet
o cyclosporine (often used in patients receiving an organ transplant)
o danazol (an artificial hormone that is used for the treatment of endometriosis, a
condition in which the lining of the uterus grows outside the uterus)
o medicines with an active substance such as itraconazole, ketoconazole, fluconazole,
posaconazole or voriconazole (used to treat fungal infections)
o fibrates with active substances such as gemfibrozil and bezafibrato (used to reduce cholesterol)
o erythromycin, clarithromycin or telithromycin (used to treat bacterial infections)
o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to
treat AIDS)
o boceprevir or telaprevir (used to treat hepatitis C virus infections)
o nefazodone (used to treat depression)
o medicines with the active substance cobicistat
o amiodarone (used to treat an irregular heartbeat)
o verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease or other heart conditions)
o lomitapide (used to treat a severe and rare genetic condition of cholesterol
o high doses (1 g or more per day) of niacin or nicotinic acid (also used to lower
cholesterol)
o colchicine (used to treat gout).

You should also inform any doctor who is prescribing you new medicines that you are
taking EZETIMIBE and SIMVASTATIN DOC Generics.

EZETIMIBE and SIMVASTATIN DOC Generics with food and drink
Grapefruit juice contains one or more substances that alter the metabolism of some medicines,
including EZETIMIBE and SIMVASTATIN DOC Generics. 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 DOC Generics if you are pregnant, if
you suspect you are pregnant or are planning to become pregnant. If you become pregnant during therapy with EZETIMIBE and
SIMVASTATIN DOC Generics, stop taking it immediately and contact your doctor. Do
not take EZETIMIBE and SIMVASTATIN DOC Generics if you are breastfeeding, because
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 DOC Generics 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 SIMVASTATIN DOC Generics.

EZETIMIBE and SIMVASTATIN DOC Generics contains lactose
The tablets of EZETIMIBE and SIMVASTATIN DOC Generics contain a sugar, the
lactose. If your doctor has told you that you are intolerant to some sugars, contact your doctor before
taking this medicine.

EZETIMIBE and SIMVASTATIN DOC Generics contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially
‘sodium-free’.

3. How to take EZETIMIBE and SIMVASTATINA DOC Generici

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 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 and SIMVASTATINA DOC Generici, you must be following a diet to lower cholesterol levels.
• During treatment with EZETIMIBE and SIMVASTATINA DOC Generici, you must continue to follow this diet to lower cholesterol.

Adults: the dose is 1 tabletof EZETIMIBE and SIMVASTATINA DOC Generici orally once a
day.
Adolescents (10 to 17 years of age): the dose is 1 tabletof EZETIMIBE and SIMVASTATINA
DOC Generici orally once a day (a maximum dose of 10
mg/40 mg once a day should not be exceeded).
The dose of EZETIMIBE and SIMVASTATINA DOC Generici 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 SIMVASTATINA DOC
Generici, your doctor may prescribe you other tablets containing ezetimibe/simvastatin.
Take EZETIMIBE and SIMVASTATINA DOC Generici in the evening. You can take it with or without food.
If your doctor has prescribed EZETIMIBE and SIMVASTATINA DOC Generici with another
medicine to lower cholesterol containing the active ingredient colestyramine or any other
bile acid sequestrant, you must take EZETIMIBE and SIMVASTATINA DOC Generici
at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more EZETIMIBE and SIMVASTATINA DOC Generici than you should:
Contact your doctor or pharmacist.

If you forget to take EZETIMIBE and SIMVASTATINA DOC Generici:
Do not take a double dose to make up for a missed tablet, just take
the normal dose of EZETIMIBE and SIMVASTATINA DOC Generici the next day at the usual
time.

If you stop taking EZETIMIBE and SIMVASTATINA DOC Generici:
Consult your doctor or pharmacist because your cholesterol may increase again.
If you have any questions about the use of this medicine, consult 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 DOC Generici).
The following side effects have been reported as common (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 side effects have been reported as uncommon (may affect up to 1 in 100 people):
or increases in blood test values relating to liver function; increases in blood uric acid levels; increases in the time it takes for the blood to clot;
presence of protein in the urine; decrease in body weight
or dizziness; headache; sensation of tingling
or abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal bloating; diarrhea;
dry mouth; heartburn
or skin rash; itching; hives
or joint pain; muscle pain; sensitivity; weakness or spasms; neck pain;
arm or leg pain; back pain
or unusual fatigue or weakness; feeling tired; chest pain; swelling,
especially of the hands and feet
or 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 substances ezetimibe or simvastatin:
or reduced number of red blood cells (anemia); decrease in the number of blood cells, which can cause bruising/bleeding (thrombocytopenia)
or loss of sensation or weakness in the arms and legs; poor memory; memory loss; confusion
or breathing problems including persistent cough and/or shortness of breath or fever
or constipation
or inflammation of the pancreas often with severe abdominal pain
or 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)
or hair loss; raised, red skin rash, sometimes with target-like lesions
(erythema multiforme)
or 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 severe allergic reaction that causes difficulty breathing or
dizziness (anaphylaxis, which can affect up to 1 in 10,000, and anaphylactic reactions),
joint pain or inflammation of blood vessels, unusual bruising, skin rashes and swelling, skin sensitivity to the sun, fever,
hot flashes, shortness of breath and feeling unwell, a set of symptoms like lupus (which
include skin rash, joint problems, and effects on white blood cells).
or muscle pain; sensitivity; weakness or muscle cramps; muscle injuries; tendon problems, sometimes complicated by tendon rupture.
or loss of appetite
or hot flashes; high blood pressure
or pain
or erectile dysfunction
or depression
or changes in some values of the blood analysis relating to liver function
Further possible side effects reported with some statins:
or sleep disturbances, including nightmares
or sexual difficulties
or diabetes. This is more likely if you have high blood sugar and fat levels, if you are overweight and have high blood pressure. Your doctor will monitor you during
treatment with this medicine.
or muscle pain, tenderness or weakness that is constant and may not disappear after
stopping treatment with EZETIMIBE and SIMVASTATINA DOC Generici (frequency
not known: cannot be estimated based on available data).

Immediately contact your doctor if you experience unexplained muscle pain, tenderness and muscle weakness. This is because muscle problems can, rarely, be serious and
lead to muscle tissue damage that causes kidney damage; very
rarely, deaths 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 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 DOC Generici

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 and on the blister after the
writing "EXP". The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
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. Package Contents and Other Information

What EZETIMIBE E SIMVASTATINA DOC Generici 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. Each tablet contains 10 mg of
ezetimibe and 80 mg of simvastatin.
The other ingredients are: Tablet core:lactose monohydrate, hypromellose,
sodium croscarmellose, microcrystalline cellulose, ascorbic acid, anhydrous citric acid,
butylhydroxyanisole, propyl gallate, magnesium stearate. Coloring mixture:lactose monohydrate, iron
oxide yellow (E 172), iron oxide red (E 172), iron oxide black (E 172).

Description of the appearance of EZETIMIBE E SIMVASTATINA DOC Generici and package contents
EZETIMIBE E SIMVASTATINA DOC Generici 10 mg/10 mg tablets: light brown,
mottled, round tablets, 6 mm in diameter, biconvex, smooth on one side and with “511”
engraved on the other side
EZETIMIBE E SIMVASTATINA DOC Generici 10 mg/20 mg tablets: light brown,
mottled, round tablets, 8 mm in diameter, biconvex, smooth on one side and with “512”
engraved on the other side
EZETIMIBE E SIMVASTATINA DOC Generici 10 mg/40 mg tablets: light brown,
mottled, round tablets, 10 mm in diameter, biconvex, smooth on one side and with “513”
engraved on the other side
EZETIMIBE E SIMVASTATINA DOC Generici 10 mg/80 mg tablets: light brown,
mottled, capsule-shaped tablets, measuring 17.5x7.55 mm, biconvex, smooth on one side and
with “515” engraved on the other side
Packages: blister packs of 30 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici Srl
Via Turati 40
20121 Milano

Manufacturer
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitza 2600
Bulgaria
Special Product’s Line S.p.A
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR)
Italy

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Denmark: Ezetimib/Simvastatin Doc Generici
Italy: EZETIMIBE e SIMVASTATINA DOC Generici