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

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

Ezetimibe/Atorvastatin Teva 10 mg/20 mg film-coated tablets
Ezetimibe/Atorvastatin Teva 10 mg/40 mg film-coated tablets
Ezetimibe/Atorvastatin Teva 10 mg/80 mg film-coated tablets

Read the entire leaflet carefully before you start taking this medicine, because 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 must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

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

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

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol is mainly composed 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. This interruption of blood flow may 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.

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

Your doctor may prescribe this medicine if you are already taking atorvastatin and ezetimibe at the same dose as separate products. It should be taken in addition to your cholesterol-lowering diet if you have:

• high blood cholesterol levels (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.

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

Do not take Ezetimiba/Atorvastatina Teva

• 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 had 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 Teva if:

• you have severe respiratory insufficiency,
• you have previously had a stroke with intracranial haemorrhage, or have small accumulations of fluid in the brain due to previous strokes,
• you have kidney problems,
• your thyroid gland is underactive (hypothyroidism),
• you have had recurrent or unexplained muscle pain or discomfort, or have 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 have or have had myasthenia (a disease causing 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 called fusidic acid (used to treat bacterial infection). The combination of fusidic acid and medicines containing 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 immediately if you experience unexplained muscle pain, tenderness, or weakness while taking Ezetimiba/Atorvastatina Teva. This is because, although rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage.

It is known that 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. Additional tests or treatments may be needed to diagnose and manage this condition.

If any of the above circumstances apply to you (or you are unsure), consult your doctor or pharmacist before starting ezetimiba/atorvastatina, as your doctor may need to perform a blood test before starting 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 “Taking Ezetimiba/Atorvastatina Teva with other medicines”).

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

Taking Ezetimiba/Atorvastatina Teva with other medicines

Tell 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. 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:

• 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, 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),
• letermovir (a medicine used to prevent cytomegalovirus infection),
• 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 combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir,
• if you need to take oral fusidic acid temporarily to treat a bacterial infection, you must 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 ezetimibe/atorvastatin:

• oral contraceptives (medicines that prevent pregnancy),
• stiripentol (an anticonvulsant 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 Teva with food, drinks, 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 ezetimibe/atorvastatin.

Alcohol

Avoid excessive alcohol consumption while taking this medicine. For further 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 could become pregnant unless you are using reliable contraceptive methods. If you become pregnant while taking ezetimibe/atorvastatin, stop taking it immediately and inform your doctor.

Do not take ezetimibe/atorvastatin while breastfeeding.

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

Ezetimiba/Atorvastatina Teva contains lactose

The 10 mg/10 mg, 10 mg/20 mg, and 10 mg/40 mg film-coated tablets contain lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Ezetimiba/Atorvastatina Teva 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 Teva

Follow exactly the instructions for use of this medicine as given by your doctor.

Your doctor will determine the appropriate tablet strength for you, depending on your current treatment and your personal risk situation. If in doubt, consult your doctor or pharmacist again.

• Before starting ezetimibe/atorvastatin, you should already be on 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 once daily. The tablet should be taken with sufficient liquid (e.g., a glass of water).

When to take it

You may take ezetimibe/atorvastatin at any time of day. However, try to take your tablet at the same time every 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 Teva 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 Ezetimibe/Atorvastatin Teva

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

If you stop taking Ezetimibe/Atorvastatin Teva

Talk to your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any further questions about the use of this medicine or wish to discontinue treatment, 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, and take the tablets with you.

• severe allergic reactions causing swelling of the face, tongue, and throat, which may lead to severe breathing difficulties,
• 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, especially on the palms of the hands or soles of the feet, which may progress to blistering,
• muscle weakness, tenderness, rupture, muscle pain, or change in urine color to red-brown, and particularly if occurring together with a feeling of malaise or high temperature, which may indicate 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 associated with unexpected or unusual bleeding or bruising, as this may indicate liver disease.

Other possible adverse effects

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,
• pain in the pharynx and/or larynx,
• joint and/or hand or foot pain, back pain, muscle pain (myalgia), muscle spasms, joint swelling,
• elevations in certain blood tests of muscle function (CK),
• abnormal liver function test results, elevations in certain blood tests of liver function (transaminases),
• fatigue.

Uncommon: (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 levels),
• loss of appetite, weight gain,
• cough,
• fatigue or muscle weakness, neck pain, chest pain,
• hot flushes, high blood pressure,
• vomiting,
• belching,
• inflammation of the pancreas or liver,
• stomach acid reflux,
• inflammation of the stomach lining,
• dry mouth,
• skin redness, hives, rash, itching,
• hair loss,
• nightmares, difficulty sleeping,
• dizziness,
• numbness, tingling in fingers of hands and feet,
• altered sense of taste,
• amnesia,
• abnormal local sensations,
• blurred vision,
• ringing in the ears,
• general malaise, restlessness or pain,
• weakness,
• swelling, especially in the hands, ankles, and feet (edema),
• increased body temperature,
• 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,
• swelling of the deeper layers of skin tissue in the face, tongue, throat, abdomen, arms, or legs (angioedema),
• widespread rash with defined red spots or blistering or peeling skin, 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,
• unexpected bleeding or bruising,
• 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,
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

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 condition causing generalized muscle weakness which, in some cases, affects the muscles used for breathing), ocular myasthenia (a condition 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 sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• sexual dysfunction.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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 Teva

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

Do not use Ezetimibe/Atorvastatin Teva after the expiry date stated on the blister and on the packaging after CAD or 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 unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure, please 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 Teva

• The active substances are ezetimibe and atorvastatin.

Ezetimibe/Atorvastatin Teva 10 mg/10 mg:

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

Ezetimibe/Atorvastatin Teva 10 mg/20 mg:

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

Ezetimibe/Atorvastatin Teva 10 mg/40 mg:

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

Ezetimibe/Atorvastatin Teva 10 mg/80 mg:

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

• The other ingredients are:

Tablet core: microcrystalline cellulose 101; mannitol; calcium carbonate; sodium croscarmellose; hydroxypropylcellulose; polysorbate 80; yellow iron oxide (E172); magnesium stearate; povidone K29/32; sodium lauryl sulfate (see section 2 “Ezetimibe/Simvastatin Teva contains sodium”).

Coating

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

Monohydrate lactose (see section 2 “Ezetimibe/Simvastatin Teva contains lactose”); hypromellose 2910 (E464); titanium dioxide (E171); macrogol 4000 (E1521).

Ezetimibe/Atorvastatin Teva 10 mg/80 mg:

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

Appearance of Ezetimibe/Atorvastatin Teva and contents of the pack

Ezetimibe/Atorvastatin Teva 10 mg/10 mg tablets: white, round, biconvex, film-coated tablets with a diameter of approximately 8.1 mm.

Ezetimibe/Atorvastatin Teva 10 mg/20 mg tablets: white, oval, biconvex, film-coated tablets with a size of approximately 11.6 x 7.1 mm.

Ezetimibe/Atorvastatin Teva 10 mg/40 mg tablets: white, capsule-shaped, biconvex, film-coated tablets with a size of approximately 16.1 x 6.1 mm.

Ezetimibe/Atorvastatin Teva 10 mg/80 mg tablets: yellow, oblong, biconvex, film-coated tablets with a size of approximately 19.1 x 7.6 mm.

Pack sizes of 30 tablets in OPA/Al/PVC//Al blisters and packs of 30 tablets in perforated unit-dose OPA/Al/PVC//Al blisters.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturer

ELPEN Pharmaceutical Co. Inc.

Marathonos Ave. 95, Pikermi Attiki, 19009

Greece

Or

ELPEN Pharmaceutical Co. Inc.

Zapani, Block 1048, Keratea, 190 01

Greece

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Teva Pharma, S.L.U

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

Alcobendas 28108, Madrid (Spain)

This medicinal product is authorised in the Member States of the European Economic Area under 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: Cholezta 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mg filmtabletta

The Netherlands: Ezeat 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mg filmomhulde tabletten

Date of the most recent revision of this leaflet: March 2023

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