VYTORIN 10 mg Tablet

Зміст інструкції

1. VYTORIN 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mg tablets
   1. What is VYTORIN and what is it used for
   2. What you need to know before taking VYTORIN
   3. How to take VYTORIN
   4. Possible side effects
   5. How to store VYTORIN
   6. Package Contents and Other Information

VYTORIN 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mg tablets

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

1. What is VYTORIN and what is it used for

VYTORIN contains the active ingredients ezetimibe and simvastatin.
VYTORIN is a medicine used to lower total cholesterol levels, “bad” cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. In addition,
VYTORIN increases levels of “good” cholesterol (HDL cholesterol).
VYTORIN 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 buildup in the form of plaque can
lead to 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.
VYTORIN 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.
VYTORIN 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 whom 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.

VYTORIN does not help with weight loss.

2. What you need to know before taking VYTORIN

Do not take VYTORIN if:

• you are allergic to ezetimibe, simvastatin or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information);
• you currently have liver problems;
• you are pregnant or breastfeeding;
• 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), or cobicistat, or gemfibrozil (used to lower cholesterol), ○ cyclosporine (often used in patients who have had an organ transplant), ○ danazol (an artificial hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus);
• you are taking or have taken, in the last 7 days, a medicine called fusidic acid (a medicine used to treat bacterial infection) by mouth or by injection. The combination of fusidic acid and VYTORIN can cause serious muscle problems (rhabdomyolysis). Do not take more than 10 mg/40 mg of VYTORIN 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:

• about all of your medical conditions, including allergies;
• if you drink large amounts of alcohol or if you have ever had liver disease. In this case VYTORIN may not be suitable for you;
• if you are going to have surgery. You may need to stop taking VYTORIN tablets for a short period;
• if you are Asian, because a different dose may be appropriate for you.

Your doctor should have a blood test before starting you on VYTORIN and if you have symptoms of
liver problems while taking VYTORIN. This test is done to see if your liver is working properly.
Your doctor may also prescribe blood tests to check your liver function after starting
treatment with VYTORIN.
During treatment with this medicine, your doctor will carefully monitor you to see 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 administration of VYTORIN with fibrates (some types of medicines to lower cholesterol)
should be avoided as the use of VYTORIN with fibrates has not been studied.

Contact your doctor immediately if you experience pain, tenderness or weakness in your muscles for
no known reason, as muscle problems can, rarely, be serious and lead to muscle tissue damage that causes kidney damage and very rarely cases of
death.
The risk of muscle damage is greater at higher doses of VYTORIN, particularly with the 10 mg/80 mg dose. The risk of muscle damage 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 ever had muscle problems during treatment with 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.

Also, tell your doctor or pharmacist if you have persistent muscle weakness. Further tests and medicines may be needed to diagnose and treat this condition.

Children and adolescents
The use of VYTORIN is not recommended in children under 10 years of age.

Other medicines and VYTORIN
Tell your doctor if you are taking, have recently taken or might take any other
medicine with any of the following active substances. Taking VYTORIN 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 VYTORIN if”):

• 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 it is safe to start treatment with VYTORIN again. Taking VYTORIN with fusidic acid can rarely lead to 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 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);
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia). It is possible that the side effects affecting the muscles may be greater when this medicine is taken during treatment with simvastatin (e.g., VYTORIN). Your doctor may decide to stop you from taking VYTORIN for a period of time,
• high doses (1 gram 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 substance to prevent blood clots, such as warfarin, fluindione, phenprocoumon or acenocoumarol (anticoagulants);
• cholestyramine (also used to lower cholesterol) as it affects how VYTORIN works;
• fenofibrate (also used to lower cholesterol);
• rifampicin (used to treat tuberculosis);
• ticagrelor (antiplatelet medicine).

You should also tell any doctor who is prescribing you new medicines that you are
taking VYTORIN.

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

Pregnancy and breastfeeding
Do not use VYTORIN if you are pregnant, are planning to become pregnant or
suspect you may be pregnant. If you become pregnant while taking VYTORIN, stop
immediately and contact your doctor. VYTORIN should not be used during
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
VYTORIN is not expected to affect your ability to drive or operate
machinery. However, be aware that some people have experienced dizziness after taking
VYTORIN.

VYTORIN contains lactose
VYTORIN tablets contain a sugar called lactose. If you have been
diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.

VYTORIN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say essentially
“sodium-free”.

3. How to take VYTORIN

Your doctor will determine the appropriate tablet dosage for you, based on your current treatment and your
risk profile.
The tablets do not have a score 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 VYTORIN, you should already have followed a diet to lower your cholesterol levels.
• During treatment with VYTORIN you should continue to follow this diet to lower cholesterol.

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

If you take more VYTORIN than you should:

• Contact your doctor or pharmacist.

If you forget to take VYTORIN:

• Do not take a double dose to make up for the missed tablet, just take your normal dose of VYTORIN the next day at the usual time.

If you stop taking VYTORIN:

• Consult 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, VYTORIN can cause side effects, although not everybody gets them
(see section 2, What you need to know before you take VYTORIN).
The following common side effects have been reported (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 uncommon side effects have been reported (may affect up to 1 in
100 people):

• increases in blood test values regarding liver function; increases in uric acid levels 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; sensation of tingling,
• 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 disorder; difficulty falling asleep.

In addition, the following side effects have been reported in people taking VYTORIN 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 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),
• blurred vision and impaired vision (which can affect up to 1 in
• 1,000),
• skin rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions) (which can 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, flushing, shortness of breath and feeling of

unwell, lupus-like symptoms (including skin rash, joint problems and effects on white blood cells). A very rare serious allergic reaction (which can affect up to 1 in 10,000) that causes difficulty breathing or dizziness and
requires immediate treatment (anaphylaxis) can occur,

• pain, tenderness, weakness or cramps in muscles; muscle injury; muscle rupture (which can affect up to 1 in 10,000); tendon problems, sometimes complicated by tendon rupture,
• gynecomastia (enlargement of the breasts in men) (which can affect up to 1 in 10,000),
• decreased appetite,
• hot flushes; high blood pressure,
• pain,
• erectile dysfunction,
• depression,
• alteration of some blood test values 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 sugar and fat 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, which may not disappear after stopping treatment with VYTORIN (frequency not known).

Contact your doctor immediately if you experience muscle pain, tenderness or weakness of
unknown cause, as muscle problems can, rarely, be serious and lead to muscle tissue damage that causes kidney damage and very rarely cases of
death.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. By reporting side effects you can help provide more information on the safety of this
medicine.

web: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can contribute to providing more information about the safety of this medicine.

5. How to store VYTORIN

• 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 the wording "Exp".
• Do not store VYTORIN tablets at a temperature above 30°C.

Blisters: store in the original package to protect the medicine from moisture and light.
Bottles: keep the bottles tightly closed to protect the medicine from moisture and light.
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 VYTORIN contains
The active ingredients of VYTORIN are ezetimibe and simvastatin. Each tablet contains 10 mg of
ezetimibe and 10 mg, 20 mg, 40 mg or 80 mg of simvastatin.
The other ingredients are: butylated hydroxyanisole, citric acid monohydrate, sodium croscarmellose,
hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propyl gallate.

Description of the appearance of VYTORIN and package contents
VYTORIN tablets are capsule-shaped off-white tablets with the code
“311”, “312”, ”313” or ”315” on one side. The tablets have no score line and should not
be divided.
Packs:
7, 10, 14, 28, 30, 50, 56, 84, 90, 98, multi-pack containing 98 (2 packs of 49), 100 or 300
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Neopharmed Gentili S.p.A.
Via San Giuseppe Cottolengo, 15

• 20143 – Milan, Italy

Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Netherlands
Schering-Plough Labo NV
Industriepark 30
Heist-op-den-Berg, 2220, Belgium

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
VYTORIN in Germany, Italy, Portugal and Spain.
INEGY in Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal,
Slovakia, Slovenia, Spain, Sweden and United Kingdom.
GOLTOR in Germany and Italy.