Prospect: Information for the user

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

Ezetimiba/Atorvastatina Teva 10 mg/20 mg film-coated tablets Ezetimiba/Atorvastatina Teva 10 mg/40 mg film-coated tablets Ezetimiba/Atorvastatina Teva 10 mg/80 mg film-coated tablets

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 for you, and you must 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 do not appear in this prospect. See section 4.

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

2. What you need to know before starting to take Ezetimiba/Atorvastatina Teva

3. How to take Ezetimiba/Atorvastatina Teva

4. Possible adverse effects

5. Storage of Ezetimiba/Atorvastatina Teva

6. Contents of the package and additional information

Ezetimiba/Atorvastatina Teva is a medication that lowers high levels of cholesterol. This medication contains ezetimiba and atorvastatina.

Ezetimiba/Atorvastatina is used in adults to lower total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides that circulate in the blood. Additionally, Ezetimiba/Atorvastatina increases the 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.

Ezetimiba/Atorvastatina is used in patients who cannot control their cholesterol levels solely with diet. While taking this medication, you should follow a diet to reduce cholesterol.

Your doctor may prescribe this medication if you are already taking atorvastatina and ezetimiba at the same dose, as separate products. You must take it in addition to your diet to reduce cholesterol if you have:

• high levels of cholesterol in the blood (primary heterozygous and homozygous familial and non-familial hypercholesterolemia) or high levels of fat in the blood (mixed hyperlipidemia)

Ezetimiba/Atorvastatina Teva does not help you lose weight.

Do not takeEzetimiba/Atorvastatina Teva

• 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 who may become pregnant and is 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 Teva if:

• you have severe respiratory failure,
• you have had a previous stroke with intracranial hemorrhage, or have small fluid accumulations in the brain due to previous strokes,
• you have kidney problems,
• your thyroid gland has low activity (hypothyroidism),
• you have had recurrent or unexplained muscle pain or discomfort or a personal or family history of muscle problems,
• you have experienced muscle problems during previous treatment with other lipid-lowering medicines (e.g. other medicines containing "statins" or "fibrates"),
• if you have or have 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),
• you are taking or have taken in the last 7 days a medicine called fusidic acid (used for the treatment of bacterial infections) by mouth or injection. The combination of fusidic acid and medicines containing atorvastatin/ezetimiba may cause severe muscle problems (rhabdomyolysis),
• you regularly consume large amounts of alcohol,
• you have a history of liver disease,
• you are over 70 years old.

Contact your doctor immediately if you experience unexplained muscle pain, sensitivity or weakness while taking Ezetimiba/Atorvastatina Teva.This is because, in rare cases, muscle problems can be severe, including muscle degradation and causing kidney damage.

It is known that atorvastatin can cause muscle problems and muscle problems have also been reported with ezetimiba.

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

If any of the above circumstances apply to you (or you 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 muscle adverse effects. It is known that the risk of experiencing muscle adverse effects, e.g. rhabdomyolysis (destruction of skeletal muscle), increases when certain medicines are taken simultaneously (see section 2 “Taking Ezetimiba/Atorvastatina Teva with other medicines”).

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, being overweight and having 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.

Taking Ezetimiba/Atorvastatina Teva with other medicines

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. 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 is destroyed, known as “rhabdomyolysis”, which is described in section 4:

• ciclosporin (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, niacin, cholestyramine, colestipol (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),
• letermovir (a medicine that helps prevent citomegalovirus infection),
• 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,ledipasvir/sofosbuvir,
• if you have to take fusidic acid orally to treat a bacterial infection, you will temporarily have to 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 for stomach acid and ulcers),
• phenazone (a painkiller),
• antacids (medicines for the treatment of indigestion that contain aluminium or magnesium),
• warfarin, phenprocoumon, acenocoumarol or fluindione (medicines that prevent blood clotting),
• colchicine (used to treat gout),
• St. John's Wort (a medicine for treating depression).

Taking Ezetimiba/Atorvastatina Teva with food, drinks and alcohol

See section 3 for instructions on how to take Ezetimiba/Atorvastatina. 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 ezetimiba/atorvastatina.

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 ezetimiba/atorvastatina if you are pregnant, think you may be pregnant or intend to become pregnant.

Do not take ezetimiba/atorvastatina if you may 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 use machines. However, some people may experience dizziness after taking ezetimiba/atorvastatina. If you feel dizzy after taking this medicine, do not drive or use machinery.

Ezetimiba/Atorvastatina Teva contains lactose

The 10 mg/10 mg, 10 mg/20 mg and 10 mg/40 mg coated tablets contain lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Ezetimiba/Atorvastatina Teva 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. The tablet should be taken with a sufficient amount of liquid (e.g., a glass of water).

When to take it

You can take ezetimiba/atorvastatina at any time of the day. However, try to take your tablet at the same time every day. You can take it with or without food.

If your doctor has prescribed ezetimiba/atorvastatina along with cholestyramine or any other bile acid sequestrant (medications 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 Teva 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 Teva

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 interrupt treatment with Ezetimiba/Atorvastatina Teva

Talk to your doctor or pharmacist because your cholesterol may increase again.

If you have any other questions about the use of this medication or wish to discontinue treatment, 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 and bring the tablets with you.

• Severe allergic reactions that cause swelling of the face, tongue, and throat and may cause great difficulty breathing,
• Severe disease whose symptoms are intense peeling and inflammation of the skin, blistering of 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 blistering,
• Weakness, sensitivity, muscle rupture, muscle pain, or urine color change 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 may 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 may be indicative of liver disease.

Other possible side effects

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 pain,
• Joint pain and/or hand or foot pain, back pain, muscle pain (myalgia), muscle spasms, joint swelling,
• Elevations in some blood tests of muscle function (CK),
• Abnormal results of liver function tests, elevations in some blood tests of 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,
• Fatigue or muscle weakness, neck pain, chest pain,
• Palpitations, high blood pressure,
• Vomiting,
• Belching,
• Pancreatitis or hepatitis inflammation,
• Acid reflux,
• Stomach membrane inflammation,
• Dry mouth,
• Skin redness, urticaria, skin rash, itching,
• Hair loss,
• Nightmares, difficulty sleeping,
• Dizziness,
• Numbness,Numbness in the fingers of the hands and feet,
• Alteration of taste,
• Amnesia,
• Abnormal local sensations,
• Blurred vision,
• Tinnitus,
• General feeling of discomfort, restlessness, or pain,
• Weakness,
• Swelling, especially in the hands, ankles, and feet (edema),
• Increased temperature,
• Increased gamma-glutamyl transferase liver enzyme,
• Positive urine test for white blood cells.

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

• Reduced blood platelets,
• Inflammation of the lower layer of skin tissue 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,
• Unexpected bleeding or bruising,
• 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,
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Unknown frequency (cannot be estimated from available data):

• Allergic reaction, including rash and swelling of the lower skin layers,
• Shortness of breath, inflammation of the gallbladder, 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 the arms or legs that worsens after periods of activity, double vision, 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. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medicine,
• Sexual dysfunction.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. 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 use Ezetimiba/Atorvastatina Teva after the expiration date that appears on the blister and on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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 point of 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 Teva

• The active ingredients are ezetimiba and atorvastatina.

Ezetimiba/Atorvastatina Teva 10 mg/10 mg:

Each film-coated tablet contains 10 mg of ezetimiba and 10 mg of atorvastatina (as atorvastatina calcium trihydrate).

Ezetimiba/Atorvastatina Teva 10 mg/20 mg:

Each film-coated tablet contains 10 mg of ezetimiba and 20 mg of atorvastatina (as atorvastatina calcium trihydrate).

Ezetimiba/Atorvastatina Teva 10 mg/40 mg:

Each film-coated tablet contains 10 mg of ezetimiba and 40 mg of atorvastatina (as atorvastatina calcium trihydrate).

Ezetimiba/Atorvastatina Teva 10 mg/80 mg:

Each film-coated tablet contains 10 mg of ezetimiba and 80 mg of atorvastatina (as atorvastatina calcium trihydrate).

• The other ingredients are:

Core of the tablet:microcrystalline cellulose 101; mannitol; calcium carbonate; sodium croscarmellose; hydroxypropylcellulose; polisorbate 80; yellow iron oxide (E172); magnesium stearate; povidone K29/32; sodium lauryl sulfate (see section 2 “Ezetimiba/Simvastatina Teva contains sodium”).

Coating

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

Lactose monohydrate (see section 2 “Ezetimiba/Simvastatina Teva contains lactose”); hypromellose 2910 (E464); dioxide of titanium (E171); macrogol 4000 (E1521).

Ezetimiba/Atorvastatina Teva 10 mg/80 mg:

Hypromellose 2910 (E464); dioxide of titanium (E171); talc (E553b); macrogol 4000 (E1521); yellow iron oxide (E172).

Appearance ofEzetimiba/Atorvastatina Tevaand contents of the package

Ezetimiba/Atorvastatina Teva 10 mg/10 mg tablets: film-coated white, round, biconvex tablets, approximately 8.1 mm in diameter.

Ezetimiba/Atorvastatina Teva 10 mg/20 mg tablets: film-coated white, oval, biconvex tablets, approximately 11.6 x 7.1 mm in size.

Ezetimiba/Atorvastatina Teva 10 mg/40 mg tablets: film-coated white, capsule-shaped, biconvex tablets, approximately 16.1 x 6.1 mm in size.

Ezetimiba/Atorvastatina Teva 10 mg/80 mg tablets: film-coated yellow, oblong, biconvex tablets, approximately 19.1 x 7.6 mm in size.

Packages of 30 tablets in OPA/Al/PVC//Al blisters and of 30 tablets in perforated OPA/Al/PVC//Al blisters for single-dose use.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer responsible

ELPEN Pharmaceutical Co. Inc.

Marathonos Ave. 95, Pikermi Attiki, 19009

Greece

Or

ELPEN Pharmaceutical Co. Inc.

Zapani, Block 1048, Keratea, 190 01

Greece

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas 28108, Madrid (Spain)

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

Spain:Ezetimiba/Atorvastatina Teva 10 mg/ 10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/ 80 mg film-coated tablets

Hungary:Cholezta10 mg/ 10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/ 80 mgfilmtabletta

Netherlands:Ezeat10 mg/ 10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/ 80 mgfilmomhulde

tabletten

Last revision date of this leaflet:March 2023

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/