EZETIMIBE/ATORVASTATIN SANDOZ 10 mg/80 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Ezetimibe/Atorvastatin Sandoz 10 mg/10 mg film-coated tablets

Ezetimibe/Atorvastatin Sandoz 10 mg/20 mg film-coated tablets

Ezetimibe/Atorvastatin Sandoz 10 mg/40 mg film-coated tablets

Ezetimibe/Atorvastatin Sandoz 10 mg/80 mg film-coated tablets

ezetimibe and atorvastatin

Read this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Ezetimibe/Atorvastatin Sandoz is and what it is used for

Ezetimibe/Atorvastatin Sandoz is a medicine that lowers high cholesterol levels. Ezetimibe/Atorvastatin Sandoz contains ezetimibe and atorvastatin.

Ezetimibe/atorvastatin is used in adults to lower the levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and a type of fat in the blood called triglycerides. It also raises the levels of "good" cholesterol (HDL cholesterol).

This medicine works by reducing cholesterol in two ways: by reducing the amount of cholesterol absorbed in the gut and by reducing the amount of cholesterol produced by the body.

Cholesterol is one of the fatty substances that can be found in the bloodstream. Your total cholesterol level 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 your arteries, forming plaques. Over time, this can lead to a narrowing of the arteries, which can reduce or block the flow of blood to vital organs such as the heart and brain. This blocking of the blood flow can lead to 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 found in the blood that can increase the risk of heart disease.

Your doctor may prescribe ezetimibe/atorvastatin for you if you are already taking atorvastatin and ezetimibe in the same dose, as a substitute treatment, in addition to your cholesterol-lowering diet, if you have:

• high levels of cholesterol in the blood (heterozygous or non-familial hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia),
• a hereditary disease (homozygous familial hypercholesterolemia) that increases the level of cholesterol in the blood.

Ezetimibe/atorvastatin does not help you lose weight.

2. What you need to know before you take Ezetimibe/Atorvastatin Sandoz

Do not take Ezetimibe/Atorvastatin Sandoz

• if you are allergic to atorvastatin, ezetimibe, 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 any unexplained abnormal blood test results indicating liver disease,
• if you are a woman who can become pregnant and are not using reliable contraceptive methods,
• if you are pregnant, trying to become pregnant, or are breastfeeding,
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before taking Ezetimibe/Atorvastatin Sandoz if:

• you have had a previous stroke with bleeding in the brain or have small amounts of fluid in the brain from previous strokes,
• you have kidney problems,
• your thyroid gland does not produce enough hormones (hypothyroidism),
• you have had recurring or unexplained muscle pains or a history of muscle problems,
• you have had muscle problems while taking other cholesterol-lowering medicines (e.g., other medicines containing "statins" or "fibrates"),
• you have or have had myasthenia gravis (a disease that causes muscle weakness) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the condition or trigger the onset of myasthenia gravis (see section 4),
• you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and atorvastatin/ezetimibe can cause serious muscle problems (rhabdomyolysis).
• you regularly drink large amounts of alcohol,
• you have a history of liver disease,
• you are over 70 years old.

Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness, or weakness while taking ezetimibe/atorvastatin. This is because muscle problems can be serious, including muscle breakdown causing kidney damage. Atorvastatin can cause muscle problems, and muscle problems have also been reported with ezetimibe.

Also, inform your doctor or pharmacist if you experience persistent muscle weakness. You may need to have tests and additional medications to diagnose and treat this problem.

Consult your doctor or pharmacist before taking Ezetimibe/Atorvastatin Sandoz

• if you have severe respiratory failure.

If you are in any of the above situations (or are unsure), consult your doctor or pharmacist before taking ezetimibe/atorvastatin, as your doctor will need to perform a blood test before starting your treatment and possibly during treatment to predict the risk of muscle side effects. The risk of muscle side effects, e.g., rhabdomyolysis (muscle breakdown), increases when certain medicines are taken at the same time (see section 2 "Other medicines and Ezetimibe/Atorvastatin Sandoz").

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

Tell your doctor about all your medical problems, including allergies.

Children and adolescents

Ezetimibe/atorvastatin is not recommended for children and adolescents.

Other medicines and Ezetimibe/Atorvastatin Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Fibrates (medicines used to lower cholesterol) should be avoided while taking ezetimibe/atorvastatin.

There are some medicines that can affect the way ezetimibe/atorvastatin works or that ezetimibe/atorvastatin can affect. This type of interaction could reduce the effectiveness of one or both medicines or increase the risk or severity of side effects, including a serious condition called "rhabdomyolysis," which is described in section 4:

• cyclosporin (a medicine often 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, derivatives, colestipol, colestyramine (medicines used to regulate lipid levels),
• certain calcium channel blockers used to treat angina or high blood pressure, e.g., amlodipine, diltiazem,
• digoxin, verapamil, amiodarone (medicines that regulate heart rhythm),
• medicines used to treat HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS),
• certain medicines used to treat 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 fusidic acid by mouth to treat a bacterial infection, you will need to stop using this medicine temporarily. Your doctor will tell you when you can restart treatment with ezetimibe/atorvastatin. The use of this medicine with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• Other medicines that are known to interact with the combination Ezetimibe/Atorvastatin
• oral contraceptives (medicines that prevent pregnancy),
• stiripentol (an anticonvulsant medicine used to treat epilepsy),
• cimetidine (a medicine used to treat stomach acid and peptic ulcers),
• phenazone (a pain reliever),
• antacids (medicines used to treat indigestion that contain aluminum or magnesium),
• warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines that prevent blood clotting),
• colchicine (used to treat gout),
• St. John's Wort (a medicine used to treat depression).

Taking Ezetimibe/Atorvastatin Sandoz with food and alcohol

See section 3 for instructions on how to take Ezetimibe/Atorvastatin Sandoz. Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice can affect the way the combined product works.

Alcohol

Avoid excessive alcohol consumption while taking this medicine. For more details, see section 2 "Warnings and precautions".

Pregnancy, breastfeeding, and fertility

Do not take ezetimibe/atorvastatin if you are pregnant, think you may be pregnant, or are planning to become pregnant.

Do not take ezetimibe/atorvastatin if you can become pregnant, unless you use reliable contraceptive methods. If you become pregnant while taking ezetimibe/atorvastatin, stop taking it immediately and inform your doctor.

Do not take ezetimibe/atorvastatin if you are breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Ezetimibe/atorvastatin is not expected to affect your ability to drive or use machines. However, it should be noted that some people experience dizziness after taking ezetimibe/atorvastatin. If you feel dizzy after taking this medicine, do not drive or use machinery.

Ezetimibe/Atorvastatin Sandoz contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Ezetimibe/Atorvastatin Sandoz contains sodium

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

3. How to take Ezetimibe/Atorvastatin Sandoz

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

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

How much to take

The recommended dose is one ezetimibe/atorvastatin tablet per day, preferably at the same time every day. The tablet should be taken with a sufficient amount of liquid (e.g., a glass of water).

When to take it

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

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

If you take more Ezetimibe/Atorvastatin Sandoz than you should

Consult your doctor or pharmacist.

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

If you forget to take Ezetimibe/Atorvastatin Sandoz

Do not take a double dose to make up for forgotten doses. Take the normal dose at the usual time the next day.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• Severe allergic reactions that cause swelling of the face, tongue, and throat and can cause great difficulty breathing
• Severe disease whose symptoms are intense exfoliation and skin inflammation, blister formation on the skin, mouth, eyes, genitals, and fever; skin rash with pink or red spots, especially on the palms of the hands or soles of the feet, which can lead to blisters
• Weakness, sensitivity, rupture, or muscle pain, change in urine color to reddish-brown, and especially if it occurs at the same time, feeling of discomfort or high temperature that may be caused by abnormal muscle destruction that can be potentially fatal and trigger kidney problems
• Lupus-like syndrome (which includes skin rash, joint disorders, and effects on blood cells)

Consult your doctor as soon as possible if you experience problems associated with the unexpected or unusual appearance of bleeding or bruising, as this fact may indicate liver disease.

Other Possible Side Effects When Taking Ezetimibe/Atorvastatin Sandoz

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

• Nasal passage inflammation, sore throat, nosebleeds,
• Allergic reactions,
• Increased blood glucose level, diabetic patients should monitor their blood glucose level,
• Headache,
• Nausea, constipation, flatulence, diarrhea, indigestion, abdominal pain,
• Pain in the pharynx and/or larynx,
• Pain in the joints and/or hands or feet, back pain, muscle pain (myalgia), muscle spasms, joint swelling,
• Increased levels in some blood tests to evaluate muscle function (creatine kinase (CK)),
• Abnormal results in liver function tests, increased levels in some blood tests to evaluate liver function (transaminases),
• Fatigue,

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

• Swelling due to an allergic reaction
• Reduced blood glucose level, diabetic patients should monitor their blood glucose level,
• Lack of appetite, weight gain,
• Cough,
• Muscle weakness, neck pain, chest pain,
• Hot flashes, high blood pressure,
• Vomiting, belching, pancreas and liver inflammation, stomach acid, inflammation of the stomach lining, dry mouth,
• Redness of the skin, hives, skin rash, itching, hair loss,
• Nightmares, difficulty sleeping,
• Dizziness, numbness, loss of taste, amnesia, abnormal local sensations,
• Blurred vision,
• Ringing in the ears,
• General feeling of discomfort, restlessness, or pain,
• Weakness,
• Increased gamma-glutamyl transferase enzyme
• Positive urine test for white blood cells

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

• Reduction in blood platelets,
• Inflammation of the lower layer of skin tissue on the face, tongue, throat, abdomen, arms, or legs (angioedema),
• Widespread rash in the form of delimited red spots or rash with blisters or skin peeling, particularly around the mouth, nose, eyes, and genitals due to an allergic reaction,
• Inflammation of the skeletal muscle, tendon inflammation sometimes complicated by rupture, muscle weakness due to loss of skeletal muscle fibers.
• Visual disturbances,
• Yellowish discoloration of the skin and the whites of the eyes.

Very Rare (may affect up to 1 in 10,000 people):

• Anaphylactic shock due to allergic reaction,
• Hearing loss,
• Liver failure,
• Increased breast size in males

Frequency Not Known (cannot be estimated from the available data):

• Allergic reaction, including rash and swelling of the lower layers of the skin,
• Shortness of breath, gallbladder inflammation, gallstones
• Physical weakness and loss of strength, loss of muscle tissue due to autoimmune antibodies.
• Depression
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).

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

In addition, the following adverse effects have been reported during the post-marketing of some statins (medicines used to reduce cholesterol):

• Difficulty breathing, 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, you are overweight, and you have high blood pressure.
• Sexual dysfunction.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ezetimibe/Atorvastatin Sandoz

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

Do not use this medicine after the expiration date that appears on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Store in the original packaging. This medicine does not require any special storage temperature.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ezetimibe/Atorvastatin Sandoz

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

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

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

Ezetimibe/Atorvastatin Sandoz 10 mg/80 mg film-coated tablets: 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, mannitol, calcium carbonate, sodium croscarmellose, hydroxypropylcellulose, polysorbate 80, yellow iron oxide (E172), magnesium stearate, povidone, sodium lauryl sulfate.

Tablet coating

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

Opadry white OY-L28900 consisting of: lactose monohydrate, hypromellose 2910 (E464), titanium dioxide (E171), macrogol 4000 (E1521).

Ezetimibe/Atorvastatin Sandoz 10 mg/80 mg:

DrCoat FCUconsisting of: hypromellose 2910, titanium dioxide (E171), talc (E553b), macrogol 400, yellow iron oxide (E172).

Appearance of the Product and Package Contents

Ezetimibe/Atorvastatin Sandoz 10 mg/10 mg film-coated tablets

White, round, biconvex film-coated tablets with a diameter of approximately 8.1 mm.

Ezetimibe/Atorvastatin Sandoz 10 mg/20 mg film-coated tablets

White, oval, biconvex film-coated tablets with dimensions of approximately 11.6 x 7.1 mm.

Ezetimibe/Atorvastatin Sandoz 10 mg/40 mg film-coated tablets

White, capsule-shaped, biconvex film-coated tablets with dimensions of approximately 16.1 x 6.1 mm

Ezetimibe/Atorvastatin Sandoz 10 mg/80 mg film-coated tablets

Yellow, oblong, biconvex film-coated tablets with dimensions of approximately 19.1 x 7.6 mm

Ezetimibe/Atorvastatin Sandoz 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg film-coated tablets:

Packaging of 10, 30, 90, and 100 film-coated tablets in OPA/AL/PVC/AL blisters

Packaging of 10 x 1, 30 x 1, 90 x 1, and 100 x 1 film-coated tablets in perforated OPA/AL/PVC/AL unit-dose blisters

Ezetimibe/Atorvastatin Sandoz 10 mg/80 mg film-coated tablets:

Packaging of 10, 30, multi-packs of 90 (2 packs of 45 x 1), and 100 (2 packs of 50 x 1) film-coated tablets in OPA/AL/PVC/AL blisters.

Packaging of 10 x 1, 30 x 1, multi-packs of 90 x 1 (2 packs of 45 x 1), and 100 x 1 (2 packs of 50 x 1) film-coated tablets in OPA/AL/PVC/AL blisters.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

ELPEN Pharmaceutical Co. Inc.

Marathonos Ave 95

Pikermi Attiki, 19009

Greece

or

Lek Pharmaceuticals d.d

Verovskova 57

1526 Ljubljana

Slovenia

or

ELPEN Pharmaceutical Co. Inc.

Zapani, Block 1048

Keratea, 190 01

Greece

This medicine is authorized in the Member States of the European Economic Area with the following names:

Slovakia: Tulip Plus 10 mg/20 mg

Tulip Plus 10 mg/40 mg

Hungary: Ezetimibe/Atorvastatin Sandoz 10 mg/40 mg filmtabletta

Ezetimibe/Atorvastatin Sandoz 10 mg/80 mg filmtabletta

Ezetimibe/Atorvastatin Sandoz 10 mg/10 mg filmtabletta

Ezetimibe/Atorvastatin Sandoz 10 mg/20 mg filmtabletta

Poland: Tulip combo

Spain: Ezetimiba/Atorvastatina Sandoz 10 mg/10 mg film-coated tablets

Ezetimiba/Atorvastatina Sandoz 10 mg/20 mg film-coated tablets

Ezetimiba/Atorvastatina Sandoz 10 mg/40 mg film-coated tablets

Ezetimiba/Atorvastatina Sandoz 10 mg/80 mg film-coated tablets

Date of the Last Revision of this Prospectus:April 2023

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