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1. Ezetimibe and Atorvastatin Mylan 10 mg/10 mg film-coated tablets, mg/20 mg film-coated tablets, mg/40 mg film-coated tablets, mg/80 mg film-coated tablets
   1. What Ezetimibe and Atorvastatin Mylan is and what it is used for
   2. What you need to know before taking Ezetimibe and Atorvastatin Mylan
   3. How to take Ezetimibe and Atorvastatin Mylan
   4. Possible side effects
   5. How to store Ezetimibe and Atorvastatina Mylan
   6. Package contents and other information

Ezetimibe and Atorvastatin Mylan 10 mg/10 mg film-coated tablets, mg/20 mg film-coated tablets, mg/40 mg film-coated tablets, mg/80 mg film-coated tablets

ezetimibe/atorvastatin
Generic medicine
Read this leaflet carefully before you start 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 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 and Atorvastatin Mylan is and what it is used for
• 2. What you need to know before you take Ezetimibe and Atorvastatin Mylan
• 3. How to take Ezetimibe and Atorvastatin Mylan
• 4. Possible side effects
• 5. How to store Ezetimibe and Atorvastatin Mylan
• 6. Contents of the pack and other information

1. What Ezetimibe and Atorvastatin Mylan is and what it is used for

Ezetimibe and Atorvastatin Mylan is a medicine used to reduce high cholesterol levels.
It contains ezetimibe and atorvastatin.
Ezetimibe and Atorvastatin Mylan is used in adults to lower levels of total cholesterol,
“bad” cholesterol (LDL cholesterol) and fats called triglycerides in the blood. It also,
increases levels of “good” cholesterol (HDL cholesterol).
Ezetimibe and Atorvastatin Mylan works by reducing cholesterol in two ways. It reduces cholesterol
absorbed in the digestive tract and the cholesterol that the body produces on its own.
Cholesterol is one of many fats in the bloodstream. Total cholesterol is
mainly made up of LDL and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can build up on the walls of the
arteries forming plaques. Over time, this build-up of plaque can lead to narrowing of the
arteries, which in turn 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 the build-up of
bad cholesterol 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 Atorvastatin Mylan is used in patients who are unable to control their cholesterol levels with diet alone. While taking this medicine, you must follow a
low-cholesterol diet.
Ezetimibe and Atorvastatin Mylan is used in addition to a low-cholesterol diet if you
have:

• a high level of cholesterol in the blood (primary hypercholesterolemia [heterozygous familial and non-familial]) or high levels of fats in the blood (mixed hyperlipidemia): not well controlled with statin therapy alone; for which you have used a statin and ezetimibe as separate tablets.
• an inherited condition (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You may also receive other treatments.
• heart disease. Ezetimibe and Atorvastatin Mylan reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

Ezetimibe and Atorvastatin Mylan does not help with weight loss.

2. What you need to know before taking Ezetimibe and Atorvastatin Mylan

Do not take Ezetimibe and Atorvastatin Mylan

• if you are allergic to ezetimibe, atorvastatin or any of the other ingredients of this medicine (listed in section 6);
• if you have or have ever had a disease that affects the liver;
• if you have had unexplained abnormalities in blood tests related to liver function;
• if you are a woman of childbearing potential and not using reliable contraception;
• if you are pregnant, trying to become pregnant or breastfeeding;
• if you are using glecaprevir/pibrentasvir combination in the treatment of Hepatitis C.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ezetimibe and Atorvastatin Mylan if:

• you have or have had myasthenia (a condition that causes generalized muscle weakness that affects in some cases the muscles used for breathing) or ocular myasthenia (a condition that causes weakness of the eye muscles), as statins can sometimes worsen the condition or lead to the appearance of myasthenia (see section 4);
• you have had a previous stroke with cerebral hemorrhage or have small pockets of fluid in the brain due to previous strokes;
• you have problems with your kidneys;
• you have an underactive thyroid gland (hypothyroidism);
• you have had recurrent or unexplained muscle pain, a personal or family history of muscle problems;
• you have had previous muscle problems while taking other lipid-lowering medicines (for example, other “statins” or “fibrates”);
• you regularly consume large amounts of alcohol;
• you have a history of liver disease;
• you are over 70 years of age;
• if your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product;
• you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) orally or by injection. The combination of fusidic acid and Ezetimibe and Atorvastatin Mylan can lead to serious muscle problems (rhabdomyolysis).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness during taking Ezetimibe and Atorvastatin Mylan.This is because in rare
cases muscle problems can be severe, including muscle breakdown with
resulting kidney damage. Atorvastatin is known to cause muscle problems and cases of muscle problems have also been reported with ezetimibe.
Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further
tests and medications may be needed to diagnose and treat this condition.
Talk to your doctor or pharmacist before taking Ezetimibe and Atorvastatin Mylan:

• if you suffer from severe respiratory failure.

If any of these conditions apply to you (or you are not sure), talk to your doctor or
pharmacist before taking Ezetimibe and Atorvastatin Mylan because your doctor will need to perform a
blood test before and possibly during treatment to predict the risk of muscle-related side
effects. It is known that the risk of muscle-type side effects, such as
rhabdomyolysis, increases when certain medicines are taken together (see
section 2 “Other medicines and Ezetimibe and Atorvastatin Mylan”).
During treatment with this medicine your doctor will carefully monitor you if you have diabetes or are
at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high
levels of sugars and fats in your blood, if you are overweight and if you have high blood pressure.
Tell your doctor about all of your medical conditions, including allergies.
The combined use of Ezetimibe and Atorvastatin Mylan and fibrates (medicines to reduce cholesterol)
should be avoided as it has not been studied.

Children and adolescents
Ezetimibe and Atorvastatin Mylan is not recommended for children and adolescents.

Other medicines and Ezetimibe and Atorvastatin Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines obtained without a prescription.
There are some medicines that can change the effect of Ezetimibe and Atorvastatin Mylan or their effect can be changed by Ezetimibe and Atorvastatin Mylan (see section 3). This
type of interaction could reduce the effectiveness of one or both medicines. Alternatively, it could
increase the risk or severity of side effects, including the important condition of
muscle breakdown known as “rhabdomyolysis” described in section 4:

• cyclosporine (a medicine often used in patients undergoing organ transplantation);
• erythromycin, clarithromycin, telithromycin, fusidic acid**, rifampicin (medicines for bacterial infections);
• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines for fungal infections);
• gemfibrozil, other fibrates, nicotinic acid, derivatives, colestipol, colestyramine (medicines to regulate lipid levels);
• some calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem;
• digoxin, verapamil, amiodarone (medicines to regulate heart rhythm);
• medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir etc. (medicines for AIDS);
• some medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir;
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia).

**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 it will be
safe to restart treatment with Ezetimibe and Atorvastatin Mylan. Taking this
medicine with fusidic acid can rarely lead to weakness, tenderness or pain
muscular (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.**
Other medicines known to interact with Ezetimibe and Atorvastatin Mylan:

• oral contraceptives (medicines to prevent pregnancy);
• stiripentol (an anticonvulsant medicine for epilepsy);
• cimetidine (a medicine used for heartburn and peptic ulcer);
• phenazone (a pain reliever);
• antacids (indigestion products containing aluminum or magnesium);
• warfarin, phenprocoumon, acenocoumarol or fluindione (medicines to prevent blood clots);
• colchicine (used to treat gout);
• St John's wort (a medicine for the treatment of depression).

Ezetimibe and Atorvastatin Mylan with food, drinks and alcohol
See section 3 for instructions on how to take Ezetimibe and Atorvastatin Mylan. Pay
attention to the following:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice a day, as large amounts
of grapefruit juice can change the effects of Ezetimibe and Atorvastatin Mylan.

Alcohol
Avoid drinking too much alcohol while taking this medicine. For details see section 2
“Warnings and precautions”.

Pregnancy and breastfeeding
Do not take Ezetimibe and Atorvastatin Mylan if you are pregnant, trying to become pregnant or think you
might be pregnant. Do not take this medicine if you might become pregnant unless
you are using reliable contraceptive measures. If you become pregnant while taking Ezetimibe and
Atorvastatin Mylan, stop taking it immediately and tell your doctor.
Do not take Ezetimibe and Atorvastatin Mylan if you are breastfeeding.
The safety of this medicine during pregnancy and breastfeeding has not yet been demonstrated.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Ezetimibe and Atorvastatin Mylan is not expected to interfere with the ability to drive or operate vehicles and
machinery. However, you should be aware that some people may experience
dizziness after taking this medicine.

Ezetimibe and Atorvastatin Mylan 10 mg/10 mg, 10 mg/20 mg and 10 mg/40 mg contains lactose
If your doctor has diagnosed you with an intolerance to some sugars, contact him before taking
this medicine.

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

3. How to take Ezetimibe and Atorvastatin Mylan

Take this medicine following the doctor's instructions exactly. The doctor will determine the appropriate tablet dosage for you, based on your current treatment and your personal risk status.
If you have any doubts, consult your doctor or pharmacist.
Before starting to take Ezetimibe and Atorvastatin Mylan, you must follow a diet to reduce
cholesterol.
During the intake of this medicine, you must continue to follow this cholesterol-lowering diet.
The recommended dose is one tablet of Ezetimibe and Atorvastatin Mylan orally once a
day.
Take this medicine at any time of the day. You can take it with or without
meals.
If your doctor has prescribed Ezetimibe and Atorvastatin Mylan together with colestyramine or any other
bile acid sequestrant (medicines to lower cholesterol), you must take Ezetimibe and
Atorvastatin Mylan at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe and Atorvastatin Mylan than you should
Contact your doctor or pharmacist.

If you forget to take Ezetimibe and Atorvastatin Mylan
Do not take a double dose; the next day simply take the normal amount of
Ezetimibe and Atorvastatin Mylan at the usual time.
If you have any doubts about the use of this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ezetimibe and Atorvastatin Mylan can cause side effects, although not everyone gets them.

If you experience any of the following side effects or serious symptoms, stop
taking the tablets and immediately inform your doctor or go to the nearest hospital emergency room.

• Severe allergic reaction causing swelling of the face, tongue and throat that can cause severe difficulty breathing;
• serious illness with severe peeling and blistering of the skin, formation of blisters on the skin, mouth, eyes, genitals and fever; skin rash with pink-red patches especially on the palms of the hands or soles of the feet, which may form blisters;
• muscle weakness, tenderness, pain or rupture or reddish-brown discoloration of the urine and especially, if at the same time you feel unwell or have a high fever, this may be caused by abnormal muscle damage that can be life-threatening and lead to kidney problems;
• lupus-like syndrome (including rash, joint disease and effects on blood cells).

You should consult your doctor as soon as possible if you experience unexpected or unusual bleeding or bruising problems, as this may suggest a liver disorder.
Common side effects (may affect up to 1 in 10 people):

• diarrhea;
• muscle pain.

Uncommon side effects (may affect up to 1 in 100 people):

• flu;
• depression; difficulty sleeping; sleep disorder;
• dizziness; headache; tingling sensation;
• slow heartbeat;
• hot flush;
• shortness of breath;
• abdominal pain; abdominal bloating; constipation; indigestion; flatulence; frequent bowel movements; inflammation of the stomach; nausea; stomach discomfort; stomach upset;
• acne; hives;
• joint pain; back pain; leg cramps; muscle fatigue, spasms or weakness; pain in the arms and legs;
• unusual weakness; feeling tired or unwell; swelling, especially in the ankles (edema);
• increases in some laboratory blood tests related to liver or muscle function (CK);
• weight gain.

In addition, the following side effects have been reported in people taking
ezetimibe/atorvastatin or ezetimibe or atorvastatin tablets:

• allergic reactions including swelling of the face, lips, tongue and/or throat which can cause difficulty breathing or swallowing (requiring immediate treatment);
• raised, red skin rash, sometimes with target-like lesions;
• liver problems;
• cough;
• heartburn;
• decreased appetite; loss of appetite;
• high blood pressure;
• skin rash and itching; allergic reactions including rash and hives;
• tendon injury;
• gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting);
• inflammation of the pancreas, often with severe abdominal pain;
• reduction in the number of blood cells, which can cause bruising/bleeding (thrombocytopenia);
• inflammation of the nasal cavities; nosebleeds;
• neck pain; pain; chest pain; sore throat;
• increases and decreases in blood sugar levels (if you have diabetes you should continue to carefully monitor your blood sugar levels);
• nightmares;
• numbness or tingling in the fingers of the hands and feet;
• decreased sensitivity to pain or touch;
• altered sense of taste; dry mouth;
• memory loss;
• ringing in the ears and/or head; hearing loss;
• vomiting;
• belching;
• hair loss;
• increased temperature;
• urine tests positive for white blood cells;
• blurred vision; visual disturbances;
• gynecomastia (increase in breast volume in men);
• myasthenia gravis (a disease that causes generalized muscle weakness, including in some cases the muscles used during breathing) (frequency not known);
• ocular myasthenia (a disease that causes weakness of the eye muscles) (frequency not known).

See your doctor if you experience weakness in your arms or legs that gets worse after periods of
activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.
Possible side effects reported with some statins

• sexual difficulties;
• depression;
• breathing problems including persistent cough and/or shortness of breath or fever;
• diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine;
• constant muscle pain, tenderness or weakness and especially if, at the same time, you feel unwell or have a high temperature that may not go away after stopping ezetimibe/atorvastatin (frequency not known).

Reporting of side effects
If you get any side effect, talk to 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 and Atorvastatina Mylan

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 label and on the packaging
after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Ezetimibe and Atorvastatina Mylan contains
The active ingredients are ezetimibe and atorvastatin.
Each film-coated tablet of Ezetimibe and Atorvastatina Mylan 10 mg/10 mg contains 10 mg of
ezetimibe and 10 mg of atorvastatin (as calcium trihydrate).
Each film-coated tablet of Ezetimibe and Atorvastatina Mylan 10 mg/20 mg contains 10 mg of
ezetimibe and 20 mg of atorvastatin (as calcium trihydrate).
Each film-coated tablet of Ezetimibe and Atorvastatina Mylan 10 mg/40 mg contains 10 mg of
ezetimibe and 40 mg of atorvastatin (as calcium trihydrate).
Each film-coated tablet of Ezetimibe and Atorvastatina Mylan 10 mg/80 mg contains 10 mg of
ezetimibe and 80 mg of atorvastatin (as calcium trihydrate).
The other ingredients are:

Tablet core: microcrystalline cellulose, mannitol, calcium carbonate, croscarmellose
sodium, hydroxypropylcellulose, polysorbate 80, yellow iron oxide (E172), magnesium stearate,
povidone K29/32 and sodium lauryl sulfate.
Ezetimibe and Atorvastatina Mylan 10 mg/10 mg, 10 mg/20 mg and 10 mg/40 mg film-coated tablets

Tablet coating:lactose monohydrate (see section 2 “Ezetimibe and Atorvastatina
Mylan contains lactose”), hypromellose 2910, titanium dioxide (E171) and macrogol 4000.
Ezetimibe and Atorvastatina Mylan 10 mg/80 mg film-coated tablets

Tablet coating:hypromellose 2910, titanium dioxide (E171), talc, macrogol 400 and yellow iron
oxide (E172).

Description of the appearance of Ezetimibe and Atorvastatina Mylan and package contents
Ezetimibe and Atorvastatina Mylan 10 mg/10 mg film-coated tablets
White, round, biconvex film-coated tablets with a diameter of approximately 8.1 mm.
Ezetimibe and Atorvastatina Mylan 10 mg/20 mg film-coated tablets
White, ovoid, biconvex film-coated tablets with dimensions of approximately 11.6 × 7.1 mm.
Ezetimibe and Atorvastatina Mylan 10 mg/40 mg film-coated tablets
White, capsule-shaped, biconvex film-coated tablets with dimensions of approximately
16.1 × 6.1 mm.
Ezetimibe and Atorvastatina Mylan 10 mg/80 mg film-coated tablets
Yellow, oblong, biconvex film-coated tablets with dimensions of approximately 19.1 × 7.6 mm.
Ezetimibe and Atorvastatina Mylan 10 mg/10 mg, 10 mg/20 mg and 10 mg/40 mg film-coated
tablets
Preformed blisters containing 30, 60, 90 or 100 tablets.
Ezetimibe and Atorvastatina Mylan 10 mg/80 mg film-coated tablets
Preformed blisters containing 30 film-coated tablets, 60 film-coated tablets or
multipacks containing 90 (2 packs of 45) or 100 (2 packs of 50) tablets.
Not all pack sizes may be marketed.

Marketing authorization holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan

Manufacturer
ELPEN Pharmaceutical Co. Inc., Marathonos Ave. 95, Pikermi Attiki, 19009, Greece.
ELPEN Pharmaceutical Co. Inc., Zapani, Block 1048, Keratea, 190 01, Greece.

This medicinal product is authorized in the Member States of the European Economic Area with the
following denominations:
France EZETIMIBE/ATORVASTATINE VIATRIS 10 mg/10 mg, film-coated tablet
EZETIMIBE/ATORVASTATINE VIATRIS 10 mg/20 mg, film-coated tablet
EZETIMIBE/ATORVASTATINE VIATRIS 10 mg/40 mg, film-coated tablet
EZETIMIBE/ATORVASTATINE VIATRIS 10 mg/80 mg, film-coated tablet
Germany Ezetimib/Atorvastatin Viatris 10 mg/10 mg, film-coated tablets
Ezetimib/Atorvastatin Viatris 10 mg/20 mg, film-coated tablets
Ezetimib/Atorvastatin Viatris 10 mg/40 mg, film-coated tablets
Ezetimib/Atorvastatin Viatris 10 mg/80 mg, film-coated tablets
Italy Ezetimibe e Atorvastatina Mylan
Netherlands Ezetimibe/Atorvastatine Viatris 10 mg/10 mg, film-coated tablets
Ezetimibe/Atorvastatine Viatris 10 mg/20 mg, film-coated tablets
Ezetimibe/Atorvastatine Viatris 10 mg/40 mg, film-coated tablets
Ezetimibe/Atorvastatine Viatris 10 mg/80 mg, film-coated tablets