Prospect: information for the patient

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

Ezetimiba and atorvastatina

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, or pharmacist, even if they do not appear in this prospect. See section 4.

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Ezetimiba/Atorvastatina Sandoz is a medication that reduces high levels of cholesterol. Ezetimiba/Atorvastatina Sandoz contains ezetimiba and atorvastatina.

Ezetimiba/atorvastatina is used in adults to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally, Ezetimiba/Atorvastatina Sandoz increases concentrations of "good" cholesterol (HDL cholesterol).

This medication acts by reducing cholesterol in two ways. It reduces the cholesterol absorbed in the digestive tract, as well as the cholesterol that your body produces on its own.

Cholesterol is one of the fatty substances found in the circulatory system. Your total cholesterol is composed mainly of LDL and HDL cholesterol.

LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of your arteries forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can make blood flow to vital organs such as the heart and brain slower or interrupted. This interruption of blood flow can trigger a heart attack or stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps prevent bad cholesterol from accumulating in the arteries and protects against heart disease.

Triglycerides are another type of fat present in your blood that can increase the risk of heart disease.

Your doctor may prescribe ezetimiba/atorvastatina if you are already taking atorvastatina and ezetimiba at the same dose, as a substitute treatment, in addition to your diet to reduce cholesterol if you have:

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

Ezetimiba/atorvastatina does not help you lose weight.

Do not takeEzetimiba/Atorvastatina Sandoz

• if you are allergic to atorvastatin, ezetimiba, or any of the other ingredients of this medicine (listed in section 6),
• if you have or have had a liver disease,
• if you have had any unexplained abnormal results in liver function blood tests,
• if you are a woman of childbearing age 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:

• ha suffered a previous stroke with intracranial hemorrhage, or has small fluid accumulations in the brain due to previous strokes,
• has kidney problems,
• has hypothyroidism (low thyroid function),
• has had recurrent or unexplained muscle pain or discomfort, or has a personal or family history of muscle problems,
• has experienced muscle problems during previous treatment with other lipid-lowering medicines (e.g., other "statin" or "fibrate" medicines),
• has or has had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4),
• is taking or has taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and atorvastatina/ezetimiba may cause severe muscle problems (rhabdomyolysis).
• consumes large amounts of alcohol regularly,
• has a history of liver disease,
• is over 70 years old.

Contact your doctor as soon as possible if you experience unexplained muscle pain, sensitivity, or muscle weakness while taking ezetimiba/atorvastatinaezetimiba/atorvastatina. This is because muscle problems can be severe, including muscle rupture causing kidney damage.It is known that atorvastatina causes muscle problems, and muscle problems have also been reported with ezetimiba.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medicines may be necessary to diagnose and treat this problem.

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

• if you have severe respiratory failure.

If you are in any of the above circumstances (or are unsure), consult your doctor or pharmacist before starting to take ezetimiba/atorvastatina, as your doctor will need to perform a blood test before starting your treatment, and possibly during it, to predict the risk of experiencing adverse muscle effects. It is known that the risk of experiencing adverse muscle effects, e.g., rhabdomyolysis (rupture of skeletal muscle damaged), increases when certain medicines are taken simultaneously (see section 2 “Other medicines and Ezetimiba/Atorvastatina Sandoz”).

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

Inform your doctor of all your medical problems, including allergies.

Children and adolescents

Ezetimiba/atorvastatina is not recommended for children and adolescents.

Other medicines and Ezetimiba/Atorvastatina Sandoz

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

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

There are some medicines that may modify the effect of ezetimiba/atorvastatina or whose effects may be affected by ezetimiba/atorvastatina (see section 3). This type of interaction could reduce the effectiveness of one or both medicines. On the other hand, it could also increase the risk or severity of adverse effects, including a serious condition in which muscle destruction occurs, known as “rhabdomyolysis”, which is described in section 4:

• ciclosporina (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),
• some 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),
• some 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 oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when you can restart the treatment with ezetimiba/atorvastatina. The use of this medicine with fusidic acid rarely may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• Other medicines that are known to interact with the combination Ezetimiba/Atorvastatina
• oral contraceptives (medicines that prevent pregnancy),
• estiripentol (an anticonvulsant medicine used to treat epilepsy),
• cimetidine (a medicine used to treat stomach acid and ulcers),
• phenazone (an analgesic),
• 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 Ezetimiba/Atorvastatina Sandoz with food and alcohol

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

Orange juice

Do not take more than one or two small glasses of orange juice per day, as large amounts of orange juice may alter the effects of the combined product.

Alcohol

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

Pregnancy, lactation, and fertility

Do not take ezetimiba/atorvastatina if you are pregnant, think you may be pregnant, or intend to become pregnant.

Do not take ezetimiba/atorvastatina if you can 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 may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Ezetimiba/atorvastatina is not expected to interfere with your ability to drive or operate machinery. 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 told you that you are intolerant 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; that is, it is essentially “sodium-free”

Follow exactly the administration instructions for this medication as indicated by your doctor. Your doctor will determine the appropriate dose per tablet for you, depending on your current treatment and personal risk situation. In case of doubt, consult your doctor or pharmacist again.

• Before starting to take ezetimiba/atorvastatina, you must be following a diet to reduce cholesterol.
• You will need to continue with this cholesterol-reducing diet while taking ezetimiba/atorvastatina.

How much to take

The recommended dose is one tablet of ezetimiba/atorvastatina once a 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 ezetimiba/atorvastatina at any time of the day. You can take it with or without food.

If your doctor has prescribed ezetimiba/atorvastatina along with colestiramine or any other bile acid sequestrant (medicines that reduce cholesterol levels), you should 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Ezetimiba/Atorvastatina Sandoz

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

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

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

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

• Severe allergic reactions that cause swelling of the face, tongue, and throat and may cause severe difficulty breathing
• Severe disease whose symptoms are intense peeling 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 may lead to blisters
• Weakness, sensitivity, muscle rupture or pain, change in urine color to brown-red, and especially if it occurs at the same time, feeling unwell or high temperature that may be caused by abnormal muscle destruction that can be potentially fatal and trigger kidney problems
• Lupus-like disease 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 may be indicative of liver disease.

Other possible side effects when taking Ezetimiba/Atorvastatina Sandoz

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

• Nasal congestion, sore throat, nosebleeds,
• Allergic reactions,
• Increased blood glucose levels, diabetic patients should control their blood glucose levels,
• Headache,
• Nausea, constipation, flatulence, diarrhea, indigestion, abdominal pain,
• Sore throat and/or larynx,
• Joint pain 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),
• Abnormal results in liver function tests, increased levels in some blood tests to evaluate liver function (transaminases),
• Fatigue,

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

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

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

• Reduced platelet count,
• Inflammation of the lower layer of the skin on the face, tongue, throat, abdomen, arms, or legs (angioedema),
• Generalized rash in the form of red spots or rash with blisters or skin peeling, particularly around the mouth, nose, eyes, and genitals due to an allergic reaction,
• Muscle skeletal inflammation, tendon inflammation sometimes complicated by rupture, muscle weakness due to loss of skeletal muscle fibers.
• Visual disturbances,
• Yellowing of the skin and white of the eyes.

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

• Anaphylactic shock due to allergic reaction,
• Loss of hearing,
• Liver insufficiency,
• Increased size of male breasts

Frequency unknown (cannot be estimated from available data):

• Allergic reaction, including rash and swelling of the lower skin layers,
• Shortness of breath, inflammation of the bile duct, gallstones
• Physical weakness and loss of strength, muscle tissue loss due to autoimmune antibodies.
• Depression
• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenia ocular (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 eyelid drooping, difficulty swallowing or difficulty breathing.

In addition, the following side effects have been reported during post-marketing surveillance 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 blood sugar and fat levels, are overweight, and have high blood pressure.
• Sexual dysfunction.

Reporting of side effects

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

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

Do not usethis medicationafter 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 medication does not require any special storage temperature.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Ezetimiba/Atorvastatina Sandoz

Ezetimiba/Atorvastatina Sandoz10 mg/10 mg film-coated tablets:each film-coated tablet contains 10 mg of ezetimiba and 10 mg of atorvastatina (as atorvastatina calcium trihydrate).

Ezetimiba/Atorvastatina Sandoz 10 mg/20 mg film-coated tablets:each film-coated tablet contains 10 mg of ezetimiba and 20 mg of atorvastatina (as atorvastatina calcium trihydrate).

Ezetimiba/Atorvastatina Sandoz 10 mg/40 mg film-coated tablets:each film-coated tablet contains 10 mg of ezetimiba and 40 mg of atorvastatina (as atorvastatina calcium trihydrate).

Ezetimiba/Atorvastatina Sandoz 10 mg/80 mg film-coated tablets:each film-coated tablet contains 10 mg of ezetimiba and 80 mg of atorvastatina (as atorvastatina calcium trihydrate).

The other components are:

Core of the tablet:

Microcrystalline cellulose 101, mannitol, calcium carbonate, croscarmellose sodium, hydroxypropylcellulose, polisorbate 80, yellow iron oxide (E172), magnesium stearate, povidone, sodium lauryl sulfate.

Coating of the tablet

Ezetimiba/Atorvastatina 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).

Ezetimiba/Atorvastatina Sandoz 10 mg/80 mg:

DrCoat FCUconsisting of: hypromellose 2910,dióxido de titanio (E171),talco (E553b), macrogol 400, yellow iron oxide (E172).

Appearance of the product and contents of the package

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

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

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

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

Ezetimiba/Atorvastatina 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.

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

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

Ezetimiba/Atorvastatina Sandoz 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg film-coated tablets:

Blister packs of 10, 30, 90, and 100 film-coated tablets in OPA/AL/PVC/AL.

Blister packs of 10 x 1, 30 x 1, 90 x 1, and 100 x 1 film-coated tablets in perforated OPA/AL/PVC/AL.

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

Blister packs 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.

Blister packs 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.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

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 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

Last review date of this leaflet:April 2023

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