EZETIMIBE 10 mg/10 mg Coated Tablet

Зміст інструкції

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

Ezetimibe and SimvastatinaTeva B.V. 10mg/10mg tablets, 10mg/20mg tablets, 10mg/40mg 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 their symptoms are the same as yours, as 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 Ezetimibe and SimvastatinaTeva B.V. is and what it is used for
• 2. What you need to know before you take Ezetimibe and SimvastatinaTeva B.V.
• 3. How to take Ezetimibe and SimvastatinaTeva B.V.
• 4. Possible side effects
• 5. How to store Ezetimibe and SimvastatinaTeva B.V.
• 6. Contents of the pack and other information

1. What is Ezetimibe and SimvastatinaTeva B.V. and what is it used for

Ezetimibe and SimvastatinaTeva B.V. contains the active ingredients ezetimibe and simvastatin. Ezetimibe and
SimvastatinaTeva B.V. is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol) and fats called triglycerides in the blood.
In addition, Ezetimibe and SimvastatinaTeva B.V. increases levels of “good” cholesterol (HDL cholesterol).
Ezetimibe and SimvastatinaTeva B.V. 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 drugs called “statins”, inhibits the production of cholesterol made
by the body.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol is mainly made up 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 plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow 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 disease.
Triglycerides are another type of fat in the blood that can increase the risk of heart disease.
Ezetimibe and SimvastatinaTeva B.V. 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 and SimvastatinaTeva B.V. is used as an adjunct to diet 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 condition (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You may also be receiving other treatments.
• heart disease, Ezetimibe and SimvastatinaTeva B.V. reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

Ezetimibe and SimvastatinaTeva B.V. does not help with weight loss.

2. What you need to know before taking Ezetimibe and SimvastatinaTeva B.V.

Do not use Ezetimibe and SimvastatinaTeva B.V.:

• 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 develops outside the uterus).
• if you are taking or have taken in the last 7 days, orally or by injection, a medicine called fusidic acid (used to treat bacterial infections). The combination of fusidic acid and Ezetimibe and SimvastatinaTeva B.V. can cause serious muscle problems (rhabdomyolysis). Do not take more than 10 mg/40 mg of Ezetimibe and SimvastatinaTeva B.V. if you are taking lomitapide (used to treat a serious and rare genetic condition characterized by high cholesterol levels).

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 SimvastatinaTeva B.V.:

• telling them about all your medical conditions, including allergies.
• if you drink significant amounts of alcohol or if you have ever had a liver disease. In this case Ezetimibe and SimvastatinaTeva B.V. may not be suitable for you.
• if you are going to have surgery. You may need to stop taking Ezetimibe and SimvastatinaTeva B.V. for a short period
• if you are Asian, because a different dose may be appropriate for you. Your doctor will need to have a blood test before you start taking Ezetimibe and SimvastatinaTevaB.V. This test is to check if your liver is working properly.

Your doctor may prescribe blood tests to check your liver function even after
starting therapy with Ezetimibe and SimvastatinaTevaB.V..
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 severe lung disease.
The administration of Ezetimibe and SimvastatinaTeva B.V. with fibrates (some types of medicines
used to lower cholesterol) should be avoided as the use of Ezetimibe and
SimvastatinaTeva B.V. with fibrates has not been studied.

Contact your doctor immediately if you experience pain, tenderness or weakness in your muscles without
a specific cause, 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 injury is greater at higher doses of ezetimibe and simvastatin, in particular
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 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.

Also, tell your doctor or pharmacist if you have persistent muscle weakness. Further
tests and medicines may be needed for diagnosis and treatment of this condition.

Children and adolescents
The use of Ezetimibe and SimvastatinaTeva B.V. is not recommended in children under 10
years of age.

Other medicines and Ezetimibe and SimvastatinaTeva B.V.
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 SimvastatinaTeva B.V. with any of the following medicines may
increase the risk of muscle problems (some have already been mentioned above in the section “Do not use
Ezetimibe and SimvastatinaTeva B.V.”):

• If you need to take oral fusidic acid to treat a bacterial infection,you will need to temporarily stop using this medicine. Your doctorwill tell you when to safely restart Ezetimibe and SimvastatinaTevaB.V..Taking Ezetimibe and SimvastatinaTeva B.V. with fusidic acid can rarelycause weakness, tenderness or pain in your muscles (rhabdomyolysis).See more information about rhabdomyolysis in section 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 substance such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections)
• fibrates with active substances such as gemfibrozil and bezafibrate (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 serious and rare genetic condition characterized by high cholesterol levels)
• 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 medicine. 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 how Ezetimibe and SimvastatinaTevaB.V. 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 and SimvastatinaTeva B.V..

Ezetimibe and SimvastatinaTeva B.V. with food and drink
Grapefruit juice contains one or more substances that alter the metabolism of some medicines,
including Ezetimibe and SimvastatinaTevaB.V..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 SimvastatinaTeva B.V. if you are pregnant. If you become pregnant during
therapy with Ezetimibe and SimvastatinaTeva B.V., stop taking it immediately and contact your
doctor. Ezetimibe and SimvastatinaTeva B.V. should not be used during breastfeeding as it is
not known whether the medicine passes into breast milk.

Driving and using machines
Ezetimibe and SimvastatinaTeva B.V. is not expected to affect your ability to drive or
operate machinery. However, you should be aware that some people may
experience dizziness after taking Ezetimibe and SimvastatinaTevaB.V..

Ezetimibe and SimvastatinaTeva B.V. contains lactose.
The tablets of Ezetimibe and SimvastatinaTeva B.V. contain a sugar called lactose. If your
doctor has told you that you have an intolerance to some sugars, contact them before taking this
medicine.

3. How to take Ezetimibe and SimvastatinaTeva B.V.

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

• Before starting to take Ezetimibe and SimvastatinaTeva B.V., you should already have followed a diet to lower cholesterol levels.
• During treatment with Ezetimibe and SimvastatinaTeva B.V. 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).

The 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.
Take Ezetimibe and SimvastatinaTeva B.V. in the evening. You can take it with or without food.
If your doctor has prescribed Ezetimibe and SimvastatinaTeva B.V. with another medicine to lower
cholesterol containing the active ingredient colestiramina or any other bile acid sequestrant, you must take Ezetimibe and SimvastatinaTeva B.V. at least 2 hours before or 4 hours after taking
the bile acid sequestrant.

If you take more Ezetimibe and SimvastatinaTeva B.V. than you should
Contact your doctor or pharmacist.

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

If you stop taking Ezetimibe and SimvastatinaTeva B.V.
Consult your doctor or pharmacist as your cholesterol may increase again.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ezetimibe and simvastatinaTeva BV
can cause side effects, although not everybody gets them.
The following side effects have been reported: 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 side effects have been reported as uncommon (may affect up to 1 in
100 people):

• increases in blood test values regarding liver function; increases in the levels of uric acid in the blood; increases in the time it takes for 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; pain, tenderness, weakness or muscle 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 disorders; difficulty falling asleep

In addition, the following side effects have been reported in people taking the combination
of ezetimibe and simvastatin 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 that 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 medical treatment (angioedema), a severe allergic reaction causing 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 blood vessels, abnormal bruising, skin rashes and swelling, skin sensitivity to the sun, fever, hot flushes, shortness of breath and feeling unwell, a set of symptoms like lupus (which include skin rash, joint problems, and effects on white blood cells))
• pain, tenderness; weakness or cramps in muscles; muscle injury; tendon problems, sometimes complicated by tendon rupture
• decreased appetite
• hot flushes; high blood pressure
• pain
• erectile dysfunction
• depression
• alteration of some values of the blood tests regarding 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.
• constant muscle pain, tenderness or weakness that does not go away after stopping treatment with Ezetimibe and SimvastatinaTeva B.V. (frequency not known: cannot be estimated from available data).

Contact your doctor immediately if you experience pain, tenderness and weakness in muscles without a
specific cause, as 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, 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 and SimvastatinaTeva B.V.

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 cardboard box or on the
bottle or on the blisters 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. Contents of the pack and other information

What Ezetimibe and SimvastatinaTeva B.V. 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 ingredients are:

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

Pigment mixture:lactose monohydrate, yellow iron oxide (E172), red iron oxide (E172) and
black iron oxide (E172).

Description of the appearance of Ezetimibe and SimvastatinaTeva B.V. and contents of the pack
Ezetimibe and SimvastatinaTeva B.V. 10 mg/10 mg tablets are light brown,
mottled, round with a diameter of 6 mm, biconvex and with “511” imprinted on one side.
Ezetimibe and SimvastatinaTeva B.V. 10mg/20mg tablets are light brown,
mottled, round with a diameter of 8 mm, biconvex and with “512” imprinted on one side.
Ezetimibe and SimvastatinaTeva B.V. 10mg/40mg tablets are light brown,
mottled, round with a diameter of 10 mm, biconvex and with “513” imprinted on one side.
Packs:
Blister packs:
10mg/10mg
14, 28, 30, 98 and 100 tablets
10mg/20mg
28, 30, 90, 98 and 100 tablets.
10mg/40mg
28, 30, 90, 98 and 100 tablets.
HDPE tablet container:
10mg/10mg
30 and 100 tablets
10mg/20mg
30, 90 and 100 tablets
10mg/40mg
30 and 90 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.,
Swensweg 5,
2031 GA Haarlem,
Netherlands

Manufacturer
Balkanpharma-Dupnitsa AD, 3 Samokovsko ShosseStreet, Dupnitsa, 2600, Bulgaria