Ezetimibe/atorvastatin Sandoz Farmacéutica 10 mg/10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Ezetimibe/Atorvastatin Sandoz Farmacéutica 10 mg/10 mg

film-coated tablets EFG

Ezetimibe/Atorvastatin Sandoz Farmacéutica 10 mg/20 mg

film-coated tablets EFG

Ezetimibe/Atorvastatin Sandoz Farmacéutica 10 mg/40 mg

film-coated tablets EFG

Ezetimibe/Atorvastatin Sandoz Farmacéutica 10 mg/80 mg

film-coated tablets EFG

ezetimibe/atorvastatin

Read the entire leaflet carefully before you start taking this medicine, as 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 others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Ezetimibe/Atorvastatin Sandoz Farmacéutica is and what it is used for
2. What you need to know before taking Ezetimibe/Atorvastatin Sandoz Farmacéutica
3. How to take Ezetimibe/Atorvastatin Sandoz Farmacéutica
4. Possible side effects
5. How to store Ezetimibe/Atorvastatin Sandoz Farmacéutica
6. Contents of the pack and other information

1. What Ezetimiba/Atorvastatina Sandoz Farmacéutica is and what it is used for

Ezetimiba/Atorvastatina Sandoz Farmacéutica is a medicine that lowers high cholesterol levels. Ezetimiba/Atorvastatina Sandoz Farmacéutica contains ezetimibe and atorvastatin.

Ezetimibe/atorvastatin is used in adults to lower total cholesterol levels, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, ezetimibe/atorvastatin increases levels of "good" cholesterol (HDL cholesterol).

Ezetimibe/atorvastatin works by reducing cholesterol in two ways: it reduces the cholesterol absorbed in the gastrointestinal tract as well as the cholesterol produced by the body itself.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol consists mainly of LDL and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries, forming plaques. Over time, this plaque buildup can cause narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This interruption in blood flow can trigger 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 present in your blood that may increase the risk of heart disease.

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

Ezetimibe/atorvastatin is used in addition to your diet to lower cholesterol if you have:

• high cholesterol levels in the blood (primary hypercholesterolemia [heterozygous familial and non-familial]) or high levels of fat in the blood (mixed hyperlipidemia)
• that is not well controlled with a statin alone,
• who has previously taken a statin and ezetimibe in separate tablets,
• a hereditary disease (homozygous familial hypercholesterolemia) that increases cholesterol levels in your blood. You may also receive other treatments,
• heart disease. Ezetimibe/atorvastatin reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Ezetimibe/atorvastatin does not help you lose weight.

2. What you need to know before taking Ezetimiba/Atorvastatina Sandoz Farmacéutica

Do not take Ezetimiba/Atorvastatina Sandoz Farmacéutica if:

• you are allergic to ezetimibe, atorvastatin, or to any of the other ingredients of this medicine (listed in section 6),
• you have or have ever had a liver disease,
• you have had unexplained abnormal results in blood tests assessing liver function,
• you are a woman who could become pregnant and are not using reliable contraceptive methods,
• you are pregnant, trying to become pregnant, or breastfeeding,
• you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before starting ezetimiba/atorvastatina if:

• you have previously suffered a stroke with intracranial haemorrhage, or have small accumulations of fluid in the brain due to prior strokes,
• you have kidney problems,
• you have low thyroid gland activity (hypothyroidism),
• you have experienced recurrent or unexplained muscle pain or discomfort, or have a personal or family history of muscle disorders,
• you have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g., other medicines containing "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 diagnosed you with intolerance to certain sugars, contact your doctor before taking this medicine,
• 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),
• you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and atorvastatin/ezetimibe may cause serious muscle problems (rhabdomyolysis).

Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness, or weakness while taking ezetimiba/atorvastatina. This is because, although rarely, muscle problems can be severe, including muscle breakdown leading to kidney damage. Atorvastatin is known to cause muscle problems, and muscle-related adverse events have also been reported with ezetimibe.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Consult your doctor or pharmacist before starting ezetimiba/atorvastatina:

• if you suffer from severe respiratory insufficiency.

If you are in any of the above situations (or are unsure), consult your doctor or pharmacist before starting ezetimiba/atorvastatina, as your doctor may need to perform blood tests before and possibly during treatment to assess your risk of developing muscle-related adverse effects. The risk of muscle-related adverse effects, e.g., rhabdomyolysis (breakdown of damaged skeletal muscle), is known to increase when certain medicines are taken concomitantly (see section 2 “Other medicines and Ezetimiba/Atorvastatina Sandoz Farmacéutica”).

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

Inform your doctor about all your medical conditions, including allergies.

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

Children

Ezetimiba/atorvastatina is not recommended for use in children and adolescents.

Other medicines and Ezetimiba/Atorvastatina Sandoz Farmacéutica

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those available without a prescription.

Some medicines may alter the effect of ezetimiba/atorvastatina, or their effects may be altered by ezetimiba/atorvastatina (see section 3). Such interactions could reduce the effectiveness of one or both medicines. They could also increase the risk or severity of adverse effects, including a serious condition involving muscle breakdown known as “rhabdomyolysis”, described in section 4:

• cyclosporine (a medicine commonly used in 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 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 that regulate heart rhythm),
• medicines used in the treatment of HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat 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 skin structure infections and bacteremia).

**If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when you can restart treatment with ezetimiba/atorvastatina. Rarely, using this medicine with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

• Other medicines known to interact with ezetimiba/atorvastatina:
• oral contraceptives (medicines to prevent pregnancy),
• stiripentol (an anticonvulsant medicine used to treat epilepsy),
• cimetidine (a medicine used for stomach acidity and peptic ulcers),
• phenazone (an analgesic),
• antacids (medicines for indigestion containing aluminium or magnesium),
• warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines that prevent blood clotting),
• colchicine (used to treat gout),
• St. John’s wort (a herbal medicine used to treat depression).

Taking Ezetimiba/Atorvastatina Sandoz Farmacéutica with food and alcohol

See section 3 for instructions on how to take ezetimiba/atorvastatina. Please note 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 ezetimiba/atorvastatina.

Alcohol

Avoid excessive alcohol consumption while taking this medicine. For further details, see section 2 “Warnings and precautions”.

Pregnancy and breastfeeding

Do not take ezetimiba/atorvastatina if you are pregnant, think you may be pregnant, or are planning to become pregnant. Do not take ezetimiba/atorvastatina if you could become pregnant unless you are using reliable contraceptive methods. If you become pregnant while taking ezetimiba/atorvastatina, stop taking it immediately and inform your doctor.

Do not take ezetimiba/atorvastatina if you are breastfeeding.

The safety of ezetimiba/atorvastatina during pregnancy and breastfeeding has not been established.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

Ezetimiba/atorvastatina is not expected to affect your ability to drive or operate machinery. However, bear in mind that some people may experience dizziness after taking ezetimiba/atorvastatina.

Ezetimiba/Atorvastatina 10mg/10mg, 10mg/20mg and 10 mg/40 mg

Ezetimiba/Atorvastatina Sandoz Farmacéutica contains lactose

The tablets of Ezetimiba/Atorvastatina Sandoz Farmacéutica contain a sugar called lactose. If your doctor has diagnosed you with intolerance to certain sugars, consult your doctor before taking this medicine.

Ezetimiba/Atorvastatina Sandoz Farmacéutica contains sodium

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

3. How to take Ezetimibe/Atorvastatin Sandoz Farmacéutica

Follow exactly the instructions for use of this medicine as indicated by your doctor. Your doctor will determine the appropriate tablet dose for you, depending on your current treatment and your individual risk situation. If in doubt, consult your doctor or pharmacist again.

• Before starting to take ezetimibe/atorvastatin, you must already be following a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking ezetimibe/atorvastatin.

How much to take

The recommended dose is one tablet of ezetimibe/atorvastatin taken orally once daily.

When to take it

Take ezetimibe/atorvastatin at any time of day. You may take it with or without food.

If your doctor has prescribed ezetimibe/atorvastatin together with colestyramine or any other bile acid sequestrant (medicines that reduce cholesterol levels), you must take ezetimibe/atorvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe/Atorvastatin Sandoz Farmacéutica than you should

Contact your doctor or pharmacist.

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

If you forget to take Ezetimibe/Atorvastatin Sandoz Farmacéutica

Do not take a double dose to make up for missed doses. Take your next dose at the usual time on the following day.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

If you experience any of the following serious adverse effects or symptoms, stop taking your tablets immediately and contact your doctor right away, or go to the nearest hospital emergency department.

• severe allergic reactions causing swelling of the face, tongue, and throat, which may lead to severe difficulty breathing,
• a serious illness characterized by extensive skin peeling and inflammation, blistering of the skin, mouth, eyes, or genitals, and fever; skin rash with pink or red spots, especially on the palms of the hands or soles of the feet, which may progress to blistering,
• muscle weakness, tenderness, pain, or rupture, change in urine color to red-brown, and especially if occurring together with a feeling of malaise or high temperature, which may be due to abnormal muscle breakdown that can be potentially life-threatening and may trigger kidney problems,
• lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).

Consult your doctor as soon as possible if you experience unexpected or unusual bleeding or bruising, as this may indicate liver disease.

The following common adverse effects have been reported (may affect up to 1 in 10 people):

• diarrhea,
• muscle pain.

The following uncommon adverse effects have been reported (may affect up to 1 in 100 people):

• influenza-like illness,
• depression, trouble sleeping, sleep disorders,
• dizziness, headache, tingling sensation,
• slow heart rate,
• hot flushes,
• difficulty breathing,
• abdominal pain, bloating, constipation, indigestion, flatulence, frequent bowel movements, stomach inflammation, nausea, stomach discomfort, gastrointestinal discomfort,
• acne, urticaria,
• joint pain, back pain, leg cramps, muscle fatigue, muscle spasms or weakness, pain in arms and legs,
• unusual weakness, feeling of tiredness or malaise, swelling, especially in the ankles (edema),
• increased levels in certain liver or muscle function tests (CK) in laboratory blood tests,
• weight gain.

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

• 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-like lesions,
• liver problems,
• cough,
• heartburn,
• decreased appetite, loss of appetite,
• high blood pressure,
• skin rash and itching, allergic reactions including skin rash and urticaria,
• tendon disorders,
• gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting),
• inflammation of the pancreas, often with severe abdominal pain,
• reduced blood cell counts, which may cause bruising/bleeding (thrombocytopenia),
• nasal inflammation, 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,
• change in taste sensation, 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,
• gynecomastia (breast enlargement in men).

Possible adverse effects observed with some statins:

• sexual difficulties,
• depression,
• respiratory problems such as persistent cough and/or difficulty breathing or fever,
• diabetes. This is more likely if you have high levels of blood sugar and fats, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• muscle pain, tenderness, or weakness that is persistent and particularly if, at the same time, you feel unwell or have a high fever that does not resolve after stopping [ezetimibe/atorvastatin] (frequency not known),
• myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing),
• ocular myasthenia (a disease 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 type of 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/Atorvastatin Sandoz Farmacéutica

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimibe/Atorvastatin Sandoz Farmacéutica

Ezetimibe/Atorvastatin Sandoz Farmacéutica 10 mg/10 mg: each film-coated tablet contains 10 mg of ezetimibe and 10 mg of atorvastatin (as atorvastatin calcium trihydrate).

Ezetimibe/Atorvastatin Sandoz Farmacéutica 10 mg/20 mg: each film-coated tablet contains 10 mg of ezetimibe and 20 mg of atorvastatin (as atorvastatin calcium trihydrate).

Ezetimibe/Atorvastatin Sandoz Farmacéutica 10 mg/40 mg: each film-coated tablet contains 10 mg of ezetimibe and 40 mg of atorvastatin (as atorvastatin calcium trihydrate).

Ezetimibe/Atorvastatin Sandoz Farmacéutica 10 mg/80 mg: each film-coated tablet contains 10 mg of ezetimibe and 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other components are:

Tablet core:

Microcrystalline cellulose 101 (E460), mannitol (E421), calcium carbonate (E170), croscarmellose sodium (E468), hydroxypropylcellulose (E463), polysorbate 80 (E433), yellow iron oxide (E172), magnesium stearate (E470b), povidone K29/32 (E1201), sodium lauryl sulfate (E487).

Tablet coating:

Ezetimibe/Atorvastatin Sandoz Farmacéutica 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg:

Opadry White OY-L28900 consisting of:

Monohydrate lactose,

Hypromellose 2910 (E464),

Titanium dioxide (E171),

Macrogol 4000 (E1521).

Ezetimibe/Atorvastatin Sandoz Farmacéutica 10 mg/80 mg: DrCoat FCU consisting of:

Hypromellose 2910,

Titanium dioxide (E171),

Talc (E553b),

Macrogol 400,

Yellow iron oxide (E172).

Appearance of the product and contents of the pack

Ezetimibe/Atorvastatin Sandoz Farmacéutica 10 mg/10 mg:

White, round, biconvex film-coated tablets, approximately 8.1 mm in diameter.

Ezetimibe/Atorvastatin Sandoz Farmacéutica 10 mg/20 mg:

White, oval, biconvex film-coated tablets, approximately 11.6 x 7.1 mm in size.

Ezetimibe/Atorvastatin Sandoz Farmacéutica 10 mg/40 mg:

White, capsule-shaped, biconvex film-coated tablets, approximately 16.1 x 6.1 mm in size.

Ezetimibe/Atorvastatin Sandoz Farmacéutica 10 mg/80 mg:

Yellow, oblong, biconvex film-coated tablets, approximately 19.1 x 7.6 mm in size.

Ezetimibe/Atorvastatin Sandoz Farmacéutica 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg:

Packs of 30, 90 and 100 film-coated tablets in OPA/Al/PVC//Al blisters.

Packs of 30x1, 90x1 and 100x1 film-coated tablets in single-dose pre-cut blisters OPA/Al/PVC//Al.

Ezetimibe/Atorvastatin Sandoz Farmacéutica 10 mg/80 mg:

Packs of 30, multiple packs of 90 (2 packs of 45) and 100 (2 packs of 50) film-coated tablets in OPA/Al/PVC//Al blisters.

Packs of 30x1, multiple packs of 90x1 (2 packs of 45x1) and 100x1 (2 packs of 50x1) film-coated tablets in OPA/Al/PVC//Al blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

ELPEN Pharmaceutical Co. Inc.

Marathonos Avenue 95

Pikermi Attiki, 19009

Greece

or

Lek Pharmaceuticals d.d

Verovskova ulica 57

1526 Ljubljana

Slovenia

or

ELPEN Pharmaceutical Co. Inc.

Zapani, Block 1048,

Keratea, 190 01

Greece

Date of the most recent revision of this leaflet: March 2024

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