Ezetimibe and atorvastatin Mylan: detailed information

Package leaflet: Information for the user

Ezetimibe and Atorvastatatin 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
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Ezetimibe and Atorvastatin Mylan is and what it is used for
What you need to know before taking Ezetimibe and Atorvastatin Mylan
How to take Ezetimibe and Atorvastatin Mylan
Possible side effects
How to store Ezetimibe and Atorvastatin Mylan
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 levels of cholesterol.
It contains ezetimibe and atorvastatin.
Ezetimibe and Atorvastatin Mylan is used in adults to lower total cholesterol levels,
"bad" cholesterol (LDL cholesterol) and blood fats called triglycerides. In addition,
it increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe and Atorvastatin Mylan works by reducing cholesterol in two ways. It reduces the cholesterol
absorbed in the digestive tract and the cholesterol produced by the body itself.
Cholesterol is one of several types of fat present in the bloodstream. Total cholesterol is
mainly composed of LDL 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 plaque buildup 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 buildup of
bad cholesterol in the arteries and protects against heart disease.
Triglycerides are another form of fat in the blood that may increase the risk of heart disease.
Ezetimibe and Atorvastatin Mylan is used in patients who cannot control their cholesterol levels through diet alone. While taking this medicine, you must follow a cholesterol-lowering diet.
Ezetimibe and Atorvastatin Mylan is used in addition to a cholesterol-lowering diet if you have:

high cholesterol levels in the blood (primary hypercholesterolemia [heterozygous familial and non-familial]) or high levels of fats in the blood (mixed hyperlipidemia): not adequately controlled with statin therapy alone; for which you have previously taken a statin and ezetimibe as separate tablets.
an inherited disease (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 improve blood flow to the heart, or hospitalization due to 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 liver disease;
if you have had unexplained abnormalities in blood tests related to liver function;
if you are a woman of childbearing age and you are not using a reliable method of contraception;
if you are pregnant, trying to become pregnant, or breastfeeding;
if you are taking the combination of glecaprevir/pibrentasvir for 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 previously had myasthenia (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4);
you have previously had a stroke with cerebral haemorrhage or have small pockets of fluid in the brain due to previous strokes;
you have kidney problems;
you have an underactive thyroid gland (hypothyroidism);
you have previously experienced unexplained or recurrent muscle pain, or have a personal or family history of muscle disorders;
you have previously had muscle problems during treatment with other lipid-lowering medicines (e.g., other "statins" or "fibrates");
you regularly consume large amounts of alcohol;
you have a history of liver disease;
you are over 70 years old;
if your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this product;
you are currently taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and Ezetimibe and Atorvastatin Mylan may lead to serious muscle problems (rhabdomyolysis).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness
while taking Ezetimibe and Atorvastatin Mylan. This is because, in rare cases, muscle problems can be severe, including muscle breakdown leading to kidney damage. Muscle-related problems are known to occur with atorvastatin, and cases have also been reported with ezetimibe.
Inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and treatment may be required.
Talk to your doctor or pharmacist before taking Ezetimibe and Atorvastatin Mylan:

if you suffer from severe respiratory insufficiency.

If any of these conditions apply to you (or you are unsure), consult your doctor or pharmacist before taking Ezetimibe and Atorvastatin Mylan, as your doctor may need to perform a blood test before and possibly during treatment to assess the risk of muscle-related side effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 “Other medicines and Ezetimibe and Atorvastatin Mylan”).
During treatment with this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You may be at increased risk of developing diabetes if you have high levels of sugar and fat in your blood, are overweight, or have high blood pressure.
Inform your doctor about all your medical conditions, including allergies.
The combined use of Ezetimibe and Atorvastatin Mylan with fibrates (medicines used to lower 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 those not requiring a prescription.

Some medicines may alter the effect of Ezetimibe and Atorvastatin Mylan, or their effect may be altered by Ezetimibe and Atorvastatin Mylan (see section 3). Such interactions could reduce the effectiveness of one or both medicines. Alternatively, they could increase the risk or severity of side effects, including the serious condition of muscle breakdown known as "rhabdomyolysis" described in section 4:

cyclosporine (a medicine often used in organ transplant patients);
erythromycin, clarithromycin, telithromycin, fusidic acid**, rifampicin (medicines used to treat bacterial infections);
ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines used to treat fungal infections);
gemfibrozil, other fibrates, nicotinic acid and its derivatives, colestipol, cholestyramine (medicines used to regulate lipid levels);
certain calcium channel blockers used for angina or high blood pressure, e.g., amlodipine, diltiazem;
digoxin, verapamil, amiodarone (medicines used 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);
certain 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 oral fusidic acid to treat a bacterial infection,
you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart
treatment with Ezetimibe and Atorvastatin Mylan. Taking this medicine with fusidic acid may rarely
lead to muscle weakness, tenderness, or pain (rhabdomyolysis). For further 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 painkiller);
antacids (indigestion remedies containing aluminium or magnesium);
warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines to prevent blood clots);
colchicine (used to treat gout);
St. John’s wort (a herbal remedy used for 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 per day, as large quantities of grapefruit juice may alter the effects of Ezetimibe and Atorvastatin Mylan.
Alcohol
Avoid drinking excessive amounts of 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 there is any chance you could become pregnant, unless you are using reliable contraceptive measures. If you become pregnant while taking Ezetimibe and Atorvastatin Mylan, stop taking it immediately and inform 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 established.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Ezetimibe and Atorvastatin Mylan 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 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 certain sugars, contact your doctor 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 Atorvastatina Mylan

Take this medicine exactly as directed by your doctor. Your doctor will determine the appropriate tablet dosage for you, based on your current treatment and your individual risk status.
If you have any doubts, consult your doctor or pharmacist.
Before starting to take Ezetimibe and Atorvastatina Mylan, you must follow a cholesterol-lowering diet.
While taking this medicine, you must continue to follow this low-cholesterol diet.
The recommended dose is one tablet of Ezetimibe and Atorvastatina Mylan taken orally once daily.
Take this medicine at any time of day. You may take it with or without food.
If your doctor has prescribed Ezetimibe and Atorvastatina Mylan together with colestyramine or any other bile acid sequestrant (cholesterol-lowering medicines), you must take Ezetimibe and Atorvastatina Mylan at least 2 hours before or 4 hours after taking the bile acid sequestrant.

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

If you forget to take Ezetimibe and Atorvastatina Mylan
Do not take a double dose; on the following day simply take your usual dose of Ezetimibe and Atorvastatina Mylan at the regular time.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ezetimibe and Atorvastatin Mylan can cause side effects, although not
everyone experiences them.
If you experience any of the following side effects or serious symptoms, stop taking the tablets
immediately and contact your doctor right away or go to the nearest hospital emergency department.

Severe allergic reaction causing swelling of the face, tongue, and throat, which may cause severe breathing difficulties;
serious illness with severe peeling and swelling of the skin, blistering rash 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 develop into blisters;
muscle weakness, tenderness, pain, or tearing, or red-brown discoloration of urine, and particularly if you also feel unwell or have a high fever—this may be due to abnormal muscle damage, which can be life-threatening and lead to kidney problems;
lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).

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

diarrhoea;
muscle pain.

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

influenza;
depression; difficulty sleeping; sleep disorder;
dizziness; headache; tingling sensation;
slow heartbeat;
hot flush;
shortness of breath;
abdominal pain; abdominal swelling; constipation; indigestion; flatulence; frequent bowel movements; stomach inflammation; nausea; stomach discomfort; stomach disorder;
acne; urticaria;
joint pain; back pain; leg cramps; muscle fatigue, spasms, or weakness; pain in arms and legs;
unusual weakness; feeling tired or unwell; swelling, especially in the ankles (oedema);
increases in certain 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 may cause difficulty breathing or swallowing (requiring immediate treatment);
raised red rash, sometimes with target-shaped lesions;
liver problems;
cough;
heartburn;
reduced appetite; loss of appetite;
high blood pressure;
skin rash and itching; allergic reactions including skin rash and urticaria;
tendon injury;
gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting);
inflammation of the pancreas, often with severe abdominal pain;
reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopenia);
inflammation of the nasal passages; nosebleeds;
neck pain; pain; chest pain; sore throat;
increases and decreases in blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully);
nightmares;
numbness or tingling in fingers and toes;
reduced 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 body temperature;
positive urine tests for white blood cells;
blurred vision; visual disturbances;
gynaecomastia (breast enlargement in men);
myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing) (frequency not known);
ocular myasthenia (a disease causing weakness of the eye muscles) (frequency not known).

Contact your doctor if you experience arm or leg weakness that worsens with activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
Possible side effects reported with some statins

sexual difficulties;
depression;
respiratory problems including persistent cough and/or shortness of breath or fever;
diabetes. This is more likely if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine;
persistent muscle pain, tenderness, or weakness, particularly if you also feel unwell or have a high temperature that does not resolve after stopping ezetimibe/atorvastatin (frequency not known).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist. You can also report side effects directly via 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 Atorvastatin Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and packaging after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via 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 and Atorvastatin Mylan contains
The active substances are ezetimibe and atorvastatin.
Each film-coated tablet of Ezetimibe and Atorvastatin Mylan 10 mg/10 mg contains 10 mg of
ezetimibe and 10 mg of atorvastatin (as trihydrate calcium).
Each film-coated tablet of Ezetimibe and Atorvastatin Mylan 10 mg/20 mg contains 10 mg of
ezetimibe and 20 mg of atorvastatin (as trihydrate calcium).
Each film-coated tablet of Ezetimibe and Atorvastatin Mylan 10 mg/40 mg contains 10 mg of
ezetimibe and 40 mg of atorvastatin (as trihydrate calcium).
Each film-coated tablet of Ezetimibe and Atorvastatin Mylan 10 mg/80 mg contains 10 mg of
ezetimibe and 80 mg of atorvastatin (as trihydrate calcium).
The other components are:
Tablet core: microcrystalline cellulose, mannitol, calcium carbonate, sodium croscarmellose,
hydroxypropylcellulose, polysorbate 80, yellow iron oxide (E172), magnesium stearate,
povidone K29/32 and sodium lauryl sulfate.
Ezetimibe and Atorvastatin Mylan 10 mg/10 mg, 10 mg/20 mg and 10 mg/40 mg film-coated tablets
Tablet coating: monohydrate lactose (see section 2 “Ezetimibe and Atorvastatin Mylan contains lactose”), hypromellose 2910, titanium dioxide (E171) and macrogol 4000.
Ezetimibe and Atorvastatin 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 Atorvastatin Mylan and contents of the pack
Ezetimibe and Atorvastatin Mylan 10 mg/10 mg film-coated tablets
White, round, biconvex film-coated tablets with a diameter of approximately 8.1 mm.
Ezetimibe and Atorvastatin Mylan 10 mg/20 mg film-coated tablets
White, ovaloid, biconvex film-coated tablets with dimensions of approximately 11.6 × 7.1 mm.
Ezetimibe and Atorvastatin 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 Atorvastatin 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 Atorvastatin 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 Atorvastatin Mylan 10 mg/80 mg film-coated tablets
Preformed blisters containing 30 film-coated tablets, 60 film-coated tablets or multiple packs containing 90 (2 packs of 45) or 100 (2 packs of 50) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

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 authorised in the European Economic Area countries under the following names:
France EZETIMIBE/ATORVASTATINE VIATRIS 10 mg/10 mg, comprimé pelliculé
EZETIMIBE/ATORVASTATINE VIATRIS 10 mg/20 mg, comprimé pelliculé
EZETIMIBE/ATORVASTATINE VIATRIS 10 mg/40 mg, comprimé pelliculé
EZETIMIBE/ATORVASTATINE VIATRIS 10 mg/80 mg, comprimé pelliculé

Germany Ezetimib/Atorvastatin Viatris 10 mg/10 mg, Filmtabletten
Ezetimib/Atorvastatin Viatris 10 mg/20 mg, Filmtabletten
Ezetimib/Atorvastatin Viatris 10 mg/40 mg, Filmtabletten
Ezetimib/Atorvastatin Viatris 10 mg/80 mg, Filmtabletten

Italy Ezetimibe e Atorvastatina Mylan

Netherlands Ezetimibe/Atorvastatine Viatris 10 mg/10 mg, filmomhulde tabletten
Ezetimibe/Atorvastatine Viatris 10 mg/20 mg, filmomhulde tabletten
Ezetimibe/Atorvastatine Viatris 10 mg/40 mg, filmomhulde tabletten
Ezetimibe/Atorvastatine Viatris 10 mg/80 mg, filmomhulde tabletten