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

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

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 the entire 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 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet Contents

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

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

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

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

This medicine works by reducing cholesterol in two ways: it reduces cholesterol absorbed in the gastrointestinal tract and also reduces cholesterol produced by your body.

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 lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Such blockage 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.

Your doctor may prescribe ezetimibe/atorvastatin if you are already taking atorvastatin and ezetimibe at the same dose as a replacement therapy, in addition to your diet, to lower cholesterol if you have:

• high blood levels of cholesterol (primary heterozygous familial and non-familial hypercholesterolemia) or high blood levels of fatty substances (mixed hyperlipidemia),
• a hereditary condition (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood.

Ezetimibe/atorvastatin does not help you lose weight.

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

Do not take Ezetimiba/Atorvastatina 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 unexplained abnormal results in liver function blood tests,
• if you are a woman who could become pregnant and are not using reliable contraceptive methods,
• 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

Consult your doctor or pharmacist before starting to take Ezetimiba/Atorvastatina Sandoz if:

• you have previously had a stroke with intracranial hemorrhage, or have small accumulations of fluid in the brain due to previous strokes,
• you have kidney problems,
• you have low thyroid activity (hypothyroidism),
• you have had recurrent or unexplained muscle pain or discomfort, or a personal or family history of muscle disorders,
• you have previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g., other medicines containing "statins" or "fibrates"),
• 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 a medicine containing fusidic acid (used to treat bacterial infection) by mouth or injection. The combination of fusidic acid and atorvastatin/ezetimibe may cause serious muscle problems (rhabdomyolysis).
• you regularly consume large amounts of alcohol,
• you have a history of liver disease,
• you are over 70 years of age.

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 serious, including muscle breakdown leading to kidney damage. Atorvastatin is known to cause muscle problems, and muscle problems 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 to take Ezetimiba/Atorvastatina Sandoz

• if you suffer from severe respiratory failure.

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 a blood test before starting treatment, and possibly during treatment, to assess your risk of experiencing muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, e.g., rhabdomyolysis (breakdown of damaged skeletal muscle), increases when certain medicines are taken concomitantly (see section 2 “Other medicines and Ezetimiba/Atorvastatina Sandoz”).

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

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

Children and adolescents

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

Other medicines and Ezetimiba/Atorvastatina Sandoz

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

Fibrates (medicines used to lower cholesterol) should be avoided while taking ezetimiba/atorvastatina.

Some medicines may alter the effect of ezetimiba/atorvastatina or their effects may be affected by ezetimiba/atorvastatina (see section 3). Such interactions could reduce the effectiveness of one or both medicines. Alternatively, they could 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 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, cholestyramine (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 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. Using this medicine with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• Other medicines known to interact with the combination Ezetimiba/Atorvastatina

• oral contraceptives (medicines that 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 with food and alcohol

See section 3 for instructions on how to take Ezetimiba/Atorvastatina Sandoz. 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 this combination product.

Alcohol

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

Pregnancy, breastfeeding, and fertility

Do not take ezetimiba/atorvastatina if you are pregnant, think you might 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.

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

Driving and using machines

Ezetimiba/Atorvastatina Sandoz is not expected to affect your ability to drive or use machines. However, some people may experience dizziness after taking ezetimiba/atorvastatina. If you feel dizzy after taking this medicine, do not drive or operate machinery.

Ezetimiba/Atorvastatina Sandoz contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, contact him before taking this medicine.

Ezetimiba/Atorvastatina Sandoz contains sodium

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

3. How to take Ezetimiba/Atorvastatina Sandoz

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

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

How much to take

The recommended dose is one ezetimiba/atorvastatina tablet once daily, preferably at the same time each day. The tablet should be taken with a sufficient amount of liquid (e.g., a glass of water).

When to take it

Take ezetimiba/atorvastatina at any time of day. It may be taken with or without food.

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

If you take more Ezetimiba/Atorvastatina Sandoz than you should

Consult 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 Ezetimiba/Atorvastatina Sandoz

Do not take a double dose to make up for the missed dose. Take your next dose at the usual time 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 can cause adverse effects, although not everyone will experience them.

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

• Severe allergic reactions causing swelling of the face, tongue, and throat, which may cause severe difficulty breathing
• A serious illness characterized by severe skin peeling and inflammation, blistering of the skin, mouth, eyes, genitals, and fever; skin rash with pink or red spots, particularly on the palms of the hands or soles of the feet, which may progress to blistering
• Muscle weakness, tenderness, rupture, or pain, 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 lead to 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 problems related to unexpected or unusual bleeding or bruising, as this may indicate liver disease.

Other possible side effects when taking Ezetimiba/Atorvastatina Sandoz

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

• Nasal passage inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels; diabetic patients should monitor their blood glucose levels
• Headache
• Nausea, constipation, flatulence, diarrhea, indigestion, abdominal pain
• Pharyngeal and/or laryngeal pain
• Joint and/or hand or foot pain, back pain, muscle pain (myalgia), muscle spasms, joint swelling
• Increase in certain blood tests assessing muscle function (creatine kinase [CK])
• Abnormal liver function test results, increase in certain blood tests assessing liver function (transaminases)
• Fatigue

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

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

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

• Reduction in blood platelets
• Inflammation of the deeper layers of skin tissue in the face, tongue, throat, abdomen, arms, or legs (angioedema)
• Widespread rash with well-defined red spots or blistering or peeling skin rash, particularly around the mouth, nose, eyes, and genitals due to an allergic reaction
• Inflammation of skeletal muscle, tendon inflammation sometimes complicated by rupture, muscle weakness due to loss of skeletal muscle fibers
• Visual disturbances
• Yellowing of the skin and whites of the eyes (jaundice)

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

• Anaphylactic shock due to allergic reaction
• Hearing loss
• Liver failure
• Enlargement of male breasts

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

• Allergic reaction, including rash and swelling of the deeper layers of the skin
• Shortness of breath, inflammation of the gallbladder, gallstones
• Physical weakness and loss of strength, loss of muscle tissue due to autoimmune antibodies
• Depression
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects 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.

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

• Difficulty breathing, including persistent cough and/or shortness of breath or fever
• Diabetes: this is more likely if you have high levels of blood sugar and fats, are overweight, and 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 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

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.

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

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

6. Package contents and other 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 FCU consisting of: hypromellose 2910, titanium dioxide (E171), talc (E553b), macrogol 400, yellow iron oxide (E172).

Appearance of the medicinal product and contents of the pack

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:

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

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

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

Pack sizes 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.

Pack sizes 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.

Only certain pack 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 medicinal product is authorized in the European Economic Area member states under 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 comprimidos recubiertos con película

Ezetimiba/Atorvastatina Sandoz 10 mg/20 mg comprimidos recubiertos con película

Ezetimiba/Atorvastatina Sandoz 10 mg/40 mg comprimidos recubiertos con película

Ezetimiba/Atorvastatina Sandoz 10 mg/80 mg comprimidos recubiertos con película

Date of the most recent review of this summary: April 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/