Ezetimibe/simvastatin Viatris 10 mg/40 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Ezetimibe/Simvastatin Viatris 10 mg/40 mg tablets EFG

ezetimibe / simvastatin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Ezetimibe/Simvastatin Viatris is and what it is used for

2. What you need to know before taking Ezetimibe/Simvastatin Viatris

3. How to take Ezetimibe/Simvastatin Viatris

4. Possible side effects

5. How to store Ezetimibe/Simvastatin Viatris

6. Contents of the pack and other information

1. What Ezetimiba/Simvastatina Viatris is and what it is used for

Ezetimiba/Simvastatina Viatris contains two active substances: ezetimibe and simvastatin.

Ezetimiba/simvastatin is used to reduce blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides. In addition, Ezetimiba/Simvastatina Viatris increases levels of "good" cholesterol (HDL cholesterol).

Ezetimiba/simvastatin works to reduce cholesterol in two ways. The active ingredient ezetimibe reduces the cholesterol absorbed through the gastrointestinal tract. The active ingredient simvastatin, which belongs to the statin group of medicines, inhibits the body's own production of cholesterol.

Cholesterol is one of the fatty substances found in the bloodstream. Total cholesterol is made up mainly of LDL and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of arteries and form 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. Interruption of blood flow may result in 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 type of fat in the blood that may increase the risk of heart disease.

Ezetimiba/simvastatin is used in patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.

Ezetimiba/simvastatin is used, together with a cholesterol-lowering diet, if you have:

• High levels of cholesterol in the blood (primary hypercholesterolemia [heterozygous familial and non-familial]) or high levels of fatty substances in the blood (mixed hyperlipidemia):

• That are not well controlled by a statin alone.

• For whom treatment with separate tablets of a statin and ezetimibe has been used.

• An inherited disease (homozygous familial hypercholesterolemia) that increases blood cholesterol levels. You may also receive other treatments.

• Heart disease: ezetimiba/simvastatin reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Ezetimiba/simvastatin does not help with weight loss.

2. What you need to know before taking Ezetimibe/Simvastatin Viatris

Do not take Ezetimibe/Simvastatin Viatris:

• 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 medicines 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), or medicines containing cobicistat (also used to treat HIV infections).
  • Boceprevir or telaprevir (used to treat hepatitis C virus infection).
  • Nefazodone (used to treat depression).
  • Gemfibrozil (used to lower cholesterol).
  • Cyclosporine (often used in organ transplant patients).
  • Danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus).
  • If you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) taken orally or by injection. The combination of fusidic acid and ezetimibe/simvastatin may cause serious muscle problems (rhabdomyolysis).

Do not take more than 10 mg/40 mg of ezetimibe/simvastatin if you are taking lomitapide (used to treat rare, severe genetic cholesterol disorders).

Consult your doctor if you are unsure whether your medicine is included in the list above.

Warnings and precautions

Tell your doctor or pharmacist before taking Ezetimibe/Simvastatin Viatris:

• About all your medical conditions, including allergies.
• If you have or have had myasthenia (a disease characterized by 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).
• If you consume large amounts of alcohol or have ever had liver disease, as ezetimibe/simvastatin may not be suitable for you.
• If you are scheduled for surgery. You may need to stop taking Ezetimibe/Simvastatin Viatris tablets for a short period.
• If you are of Asian origin, as you may require a different dose.

Your doctor should perform a blood test before you start taking ezetimibe/simvastatin and also if you develop any symptoms of liver problems while taking ezetimibe/simvastatin. This is to check liver function.

Your doctor may also wish to perform blood tests to monitor liver function after starting treatment with Ezetimibe/Simvastatin Viatris.

While taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. This risk increases if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

Talk to your doctor if you have a serious lung disease.

The combined use of ezetimibe/simvastatin and fibrates (certain medicines used to lower cholesterol) should be avoided, as the combination of ezetimibe/simvastatin with fibrates has not been studied.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, in rare cases, muscle problems can be serious—for example, muscle breakdown leading to kidney damage—and very rarely, deaths have occurred.

The risk of muscle breakdown is higher with higher doses of ezetimibe/simvastatin, especially the 10 mg/80 mg dose. The risk of muscle breakdown is also higher in certain patients.

Inform your doctor in the following situations:

• 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 or bezafibrate).
• You or close family members have a hereditary muscle disorder.
• You are of Asian origin.

Also inform your doctor or pharmacist if you have persistent muscle weakness. Additional tests and treatments may be needed for diagnosis and management.

Paediatric population

Ezetimibe/simvastatin is not recommended for children under 10 years of age.

Other medicines and Ezetimibe/Simvastatin Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including any of the following. Taking ezetimibe/simvastatin with any of the following medicines may increase the risk of muscle problems.

Do not take Ezetimibe/Simvastatin Viatris with:

• Fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will advise you when you can restart ezetimibe/simvastatin treatment. Taking Ezetimibe/Simvastatin Viatris with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Cyclosporine (often used in organ transplant patients).
• Danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus).
• Medicines containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections).
• Fibrates containing active substances such as gemfibrozil and bezafibrate (used to lower cholesterol).
• Erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections).
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infections).
• Hepatitis C antiviral agents such as boceprevir, telaprevir, elbasvir, grazoprevir, or glecaprevir/pibrentasvir (used to treat hepatitis C virus infection).
• Nefazodone (used to treat depression).
  • Medicines containing cobicistat (also used to treat HIV infections).
• Amiodarone (used to treat heart arrhythmias).
• Verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions).
• Lomitapide (used to treat rare, severe genetic cholesterol disorders).
  • Daptomycin (a medicine used to treat bacteremia and complicated skin and skin structure infections). Adverse effects affecting muscles may be increased when this medicine is taken during treatment with simvastatin (e.g., ezetimibe/simvastatin). Your doctor may decide that you should temporarily stop taking Ezetimibe/Simvastatin Viatris.
• 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 obtained without a prescription. In particular, inform your doctor if you are taking any of the following:

• Medicines containing active substances to prevent blood clotting, such as warfarin, fluindione, phenprocoumon, or acenocoumarol (anticoagulants).
• Colestipol (also used to lower cholesterol), as it affects how ezetimibe/simvastatin works.
• Fenofibrates (also used to lower cholesterol).
• Rifampicin (used to treat tuberculosis).
  • Ticagrelor (an antiplatelet medicine).

You should also talk to your doctor if you are taking niacin (nicotinic acid) or a product containing or related to it, such as acipimox (used to lower cholesterol), and if you are of Asian origin.

You should also inform any doctor who prescribes you a new medicine that you are taking ezetimibe/simvastatin.

Taking Ezetimibe/Simvastatin Viatris with food and drink

Grapefruit juice contains one or more components that alter the metabolism of certain medicines, including ezetimibe/simvastatin. Consumption of grapefruit juice should be avoided, as it may increase the risk of muscle problems.

Pregnancy and breastfeeding

Do not take ezetimibe/simvastatin if you are pregnant, trying to become pregnant, or think you might be pregnant. If you become pregnant while taking ezetimibe/simvastatin, stop taking it immediately and inform your doctor.

Do not take ezetimibe/simvastatin while breastfeeding, as it is unknown whether this medicine passes into breast milk.

Driving and using machines

Ezetimibe/simvastatin is not expected to affect your ability to drive or operate machinery. However, some people may feel dizzy after taking ezetimibe/simvastatin; if this happens to you, do not drive or operate machinery.

Ezetimibe/Simvastatin Viatris contains lactose monohydrate

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Ezetimiba/Simvastatina Viatris

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. Your doctor will determine the appropriate tablet dose for you, depending on your current treatment and your individual risk status.

If in doubt, consult your doctor or pharmacist again.

• Before starting ezetimiba/simvastatina, you must already be on a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking ezetimiba/simvastatina.

Adults

The recommended dose is one tablet of ezetimiba/simvastatina taken orally once daily in the evening.

The ezetimiba/simvastatina 10 mg/80 mg dose is only recommended for adult patients with very high cholesterol levels and a high risk of heart disease-related problems who have not achieved their cholesterol target with lower doses.

Use in adolescents (10 to 17 years of age)

The recommended dose is one tablet of ezetimiba/simvastatina taken orally once daily in the evening (the maximum dose should not exceed 10 mg/40 mg once daily).

• Take ezetimiba/simvastatina in the evening.
• You may take it with or without food.
• The tablets are not scored and must not be divided.

If your doctor has prescribed ezetimiba/simvastatina together with another cholesterol-lowering medicine containing the active substance colestyramine or any other bile acid sequestrant, you must take Ezetimiba/Simvastatina Viatris at least 2 hours before or 4 hours after taking these medicines.

If you take more Ezetimiba/Simvastatina Viatris than you should

If you take more ezetimiba/simvastatina tablets than prescribed, contact your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ezetimiba/Simvastatina Viatris

Do not take a double dose to make up for missed doses. Simply take your next dose of ezetimiba/simvastatina at the usual time the following day.

If you stop taking Ezetimiba/Simvastatina Viatris

Talk to your doctor before stopping treatment with this medicine, as your cholesterol levels may rise again.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately or go to the nearest hospital emergency department if you experience any of the following serious adverse effects; these effects are unknown (frequency cannot be estimated from available data) but may require medical attention:

• Unexplained muscle pain, tenderness or weakness, especially constant muscle weakness, muscle breakdown (which may affect up to 1 in 10,000 people). This is because, in rare cases, muscle problems can be serious—for example, muscle breakdown leading to kidney damage—and may become potentially life-threatening conditions.

• Allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing (requiring immediate treatment) (angioedema).

• Inflammation of the pancreas, often with severe abdominal pain.

• Gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea or vomiting).

• Skin rashes with redness, sometimes with target-like lesions (erythema multiforme), rashes that may occur on the skin or mouth ulcers (lichenoid drug eruptions), (which may affect up to 1 in 10,000 people).

• Inflammation of the liver (which may cause yellowing of the skin and eyes, itching, dark urine or pale stools, tiredness or weakness, and loss of appetite).

• Liver failure.

• Breathing problems such as persistent cough and/or difficulty breathing or fever.

• A hypersensitivity reaction which may include the following: hypersensitivity (severe allergic reactions causing difficulty breathing or dizziness and requiring immediate treatment (anaphylaxis, which may affect 1 in 10,000 people), joint pain or swelling, inflammation of blood vessels, atypical bruising, skin rashes and swelling, hives, skin sensitivity to sunlight, fever, hot flushes, difficulty breathing, and general malaise, pseudolupus syndrome [skin rash, joint disorders, and effects on white blood cells]).

• Diabetes. This is more likely if you have high levels of sugars and fats in the blood, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine.

• Gynaecomastia (enlargement of breast glands in men), (which may affect up to 1 in 10,000 people).

Other possible adverse effects:

Common (may affect up to 1 in 10 people):

• Muscle pain.
• Increased blood levels in liver function tests (transaminases) and/or muscle function tests.

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

• Increased blood levels indicating liver function; increased blood uric acid levels; prolonged blood clotting time; presence of protein in urine; weight loss.
• Dizziness; headache; tingling sensation.
• Abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal swelling; diarrhoea; dry mouth; heartburn.
• Skin rash; itching; hives.
• Joint pain; muscle pain, tenderness, weakness or spasms; neck pain; pain in arms and legs; back pain.
• Unusual tiredness or weakness; fatigue; chest pain; swelling, especially of the hands and feet.
• Sleep disorders; difficulty sleeping.

Rare (may affect up to 1 in 1,000 people):

• Blurred vision; altered vision.

Frequency not known (frequency cannot be estimated from available data):

• Low red blood cell count (anaemia); reduced blood cell count, which may cause bruising/bleeding (thrombocytopenia).
• Numbness or weakness in arms and legs; poor memory, memory loss, confusion.
• Constipation.
• Hair loss.
• Muscle cramps; muscle inflammation; tendon problems, sometimes complicated by tendon rupture.
• Loss of appetite.
• Hot flushes; high blood pressure.
• Pain.
• Erectile dysfunction.
• Depression.
• Changes in certain blood tests measuring blood sugar levels.
• Inflammation of the stomach lining.
• Difficulty breathing.
• Cough.

Additional adverse effects reported with the use of some statins:

Frequency not known (cannot be estimated from available data):

• Sleep disorders, including nightmares.
• Sexual dysfunction.
• Myasthenia gravis (a condition causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a condition causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimibe/Simvastatin Viatris

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack, cardboard box, or bottle, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Bottles: Use within 100 days of opening.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimiba/Simvastatina Viatris

• The active substances are ezetimibe and simvastatin. Each tablet contains 10 mg of ezetimibe and 40 mg of simvastatin.
• The other components are: monohydrate lactose (see section 2 “Ezetimiba/Simvastatina Viatris contains monohydrate lactose”); monohydrate citric acid, butylated hydroxyanisole (E320), ascorbic acid (E300), sodium lauryl sulfate (E487), croscarmellose sodium, hypromellose (E464), microcrystalline cellulose, magnesium stearate.

Appearance of the product and contents of the pack

Ezetimiba/Simvastatina tablets are white to off-white, oval, biconvex tablets, marked with "M" on one side and "ES3" on the other.

Available in:

Blister packs:

14, 28, 30, 98 and 100 tablets

Calendar blister packs:

28 tablets

Perforated unit-dose blisters:

14 x 1, 28 x 1, 30 x 1 and 90 x 1 tablets

Plastic bottle with screw cap and aluminum seal, together with absorbent cotton, containing:

30, 100, 250 and 500 tablets

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1
Hungary

Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352
Germany

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorized in the European Economic Area member states under the following names:

Germany Ezetimib/Simvastatin Mylan 10 mg/40 mg Tabletten
Belgium Ezetimibe/Simvastatine Viatris 10 mg/40 mg tabletten
Cyprus Ezetimibe/Simvastatin Mylan 10 mg/40 mg Tablets
Spain Ezetimiba/Simvastatina Viatris 10 mg/40 mg comprimidos EFG
France EZETIMIBE/SIMVASTATINE VIATRIS 10/40 mg comprimé
Greece Ezetimibe/Simvastatin Mylan 10 mg/40 mg Tablets
Ireland Ezetimibe/Simvastatin 10 mg/40 mg Tablets
Italy Ezetimibe e Simvastatina Mylan
Luxembourg Ezetimibe/Simvastatine Viatris 10 mg/40 mg comprimés
Netherlands Ezetimibe/Simvastatine Mylan 10 mg/40 mg tabletten
Portugal Sinvastatina + Ezetimiba Mylan

Date of the most recent revision of this leaflet: June 2023

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/