Ezetimibe/atorvastatin Cinfa 10 mg/20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ezetimibe/Atorvastatin cinfa 10 mg/10 mg film-coated tablets EFG

Ezetimibe/Atorvastatin cinfa 10 mg/20 mg film-coated tablets EFG

Ezetimibe/Atorvastatin cinfa 10 mg/40 mg film-coated tablets EFG

Ezetimibe/Atorvastatin cinfa 10 mg/80 mg film-coated tablets EFG

Read the 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

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

Ezetimiba/atorvastatina 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 increases levels of "good" cholesterol (HDL cholesterol).

Ezetimiba/atorvastatina works by reducing cholesterol in two ways. It reduces cholesterol absorbed in the gastrointestinal tract as well as cholesterol produced by your body.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol 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 plaque buildup can cause narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This interruption in 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 them from 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 a cholesterol-lowering diet.

Ezetimiba/atorvastatina is used, together with a cholesterol-lowering diet, if you have:

• high blood levels of cholesterol (primary hypercholesterolemia [heterozygous familial and non-familial]) or high blood levels of fatty substances (mixed hyperlipidemia):

• that are not well controlled with a statin alone

• for whom a statin and ezetimibe have been used as separate tablets

• a hereditary disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You may also receive other treatments.

• heart disease; ezetimiba/atorvastatina reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Ezetimiba/atorvastatina does not help you lose weight.

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

Do not take Ezetimiba/Atorvastatina cinfa

• if you are allergic to ezetimibe, atorvastatin, or any of the other ingredients of this medicine (listed in section 6),
• if you have or have ever had liver disease,
• if you have had unexplained abnormal results in blood tests assessing liver function,
• 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 ezetimibe/atorvastatin

• if you have previously had a stroke with intracranial hemorrhage, or have small accumulations of fluid in the brain due to prior strokes,
• if you have kidney problems,
• if your thyroid gland has low activity (hypothyroidism),
• if you have experienced recurrent or unexplained muscle pain or discomfort, or have a personal or family history of muscle disorders,
• if you have previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g., other medicines containing "statins" or "fibrates"),
• if you regularly consume large amounts of alcohol,
• if you have a history of liver disease,
• if you are over 70 years old,
• if your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine,
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness that, 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),
• if you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) taken orally or by injection. The combination of fusidic acid and ezetimibe/atorvastatin may cause serious muscle problems (rhabdomyolysis).

Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness, or muscle weakness while taking ezetimibe/atorvastatin. This is because, although rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage. It is known that atorvastatin may 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 ezetimibe/atorvastatin

• if you have severe respiratory failure.

If you are in any of the above situations (or are unsure), consult your doctor before starting ezetimibe/atorvastatin, as your doctor will need to perform a blood test before starting and possibly during treatment with ezetimibe/atorvastatin to assess your risk of developing muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, e.g., rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 “Taking Ezetimibe/Atorvastatina cinfa with other medicines”).

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.

The combined use of ezetimibe/atorvastatin and fibrates (certain medicines to lower cholesterol) should be avoided, as the combination of ezetimibe/atorvastatin with fibrates has not been studied.

Children

Ezetimibe/atorvastatin is not recommended in children and adolescents.

Other medicines and Ezetimiba/Atorvastatina cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those available without a prescription.

There are some medicines that may alter the effect of ezetimibe/atorvastatin, or whose effects may be affected by ezetimibe/atorvastatin (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 disorder 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 ezetimibe/atorvastatin. Using this medicine with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4

• Other medicines known to interact with ezetimibe/atorvastatin
• 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 (a painkiller),
• antacids (medicines for indigestion containing aluminum or magnesium),
• warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines that prevent blood clots),
• colchicine (used to treat gout),
• St. John’s wort (a herbal medicine used to treat depression).

Taking Ezetimiba/Atorvastatina cinfa with food and alcohol

See section 3 for instructions on how to take ezetimibe/atorvastatin. 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 and breastfeeding

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

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.

The safety of ezetimibe/atorvastatin during pregnancy and breastfeeding has not been established. Consult your doctor or pharmacist before taking 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 may experience dizziness after taking ezetimibe/atorvastatin.

Ezetimiba/Atorvastatina cinfa contains sodium

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

Ezetimiba/Atorvastatina cinfa 10 mg/10 mg, 10 mg/20 mg, and 10 mg/40 mg contain lactose

If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Ezetimiba/Atorvastatina cinfa

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the appropriate tablet dose for you, depending on your current treatment and your individual risk situation.

? Before starting ezetimiba/atorvastatina, you should already be following a cholesterol-lowering diet.

? You must continue this cholesterol-lowering diet while taking ezetimiba/atorvastatina.

What dose to take

The recommended dose is one tablet of ezetimiba/atorvastatina taken once daily by mouth.

Method of administration

Take ezetimiba/atorvastatina at any time of day. You may take it 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 cinfa than you should

In case of overdose or accidental ingestion, consult 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 cinfa

Do not take a double dose to make up for missed doses; the next day, take your usual dose of ezetimiba/atorvastatina at the regular time.

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 with symptoms of extensive 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 blisters

• muscle weakness, tenderness, pain, or rupture, or 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 associated with unexpected or unusual bleeding or bruising, as this may indicate liver disease.

The following adverse effects have been observed frequently (may affect up to 1 in 10 patients):

• diarrhea,
• muscle pain.

The following adverse effects have been observed uncommonly (may affect up to 1 in 100 patients):

• flu,
• depression; sleep problems; sleep disorder,
• dizziness; headache; tingling sensation,
• slow heart rate,
• hot flushes,
• choking sensations,
• abdominal pain; bloating; constipation; indigestion; flatulence; frequent bowel movements; stomach inflammation; nausea; stomach discomfort; gastric distress,
• acne; hives,
• joint pain; back pain; leg muscle cramps; muscle fatigue, spasms, or weakness; pain in arms and legs,
• unusual weakness; feeling of tiredness or malaise; swelling, especially in the ankles (edema),
• increased levels in certain liver or muscle function tests (CK) in laboratory blood tests,
• weight gain.

The following adverse effects have been reported with unknown frequency (frequency cannot be estimated from available data):

• myasthenia gravis (a disease causing generalized muscle weakness that, in some cases, affects muscles used for breathing),
• ocular myasthenia (a disease causing 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 or drooping eyelids, difficulty swallowing, or difficulty breathing.

Additionally, the following adverse effects have been reported in people taking ezetimibe/atorvastatin tablets, or ezetimibe or atorvastatin tablets alone:

• allergic reactions including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (requiring immediate medical treatment),
• red skin rash, sometimes target-shaped,
• liver problems,
• cough,
• heartburn,
• decreased appetite; loss of appetite,
• high blood pressure,
• skin rash and itching; allergic reactions including skin rash and hives,
• tendon injury,
• gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, or vomiting),
• inflammation of the pancreas, often accompanied by severe abdominal pain,
• decreased blood cell counts, which may lead to bruising/bleeding (thrombocytopenia),
• nasal inflammation; nosebleeds,
• neck pain; chest pain; sore throat,
• increased or decreased blood sugar levels (if you have diabetes, you should closely monitor your blood glucose levels),
• nightmares,
• numbness or tingling in fingers or toes,
• decreased sensitivity to pain or touch,
• disturbance of taste; dry mouth,
• memory loss,
• ringing in the ears and/or head; hearing loss,
• vomiting,
• burping,
• hair loss,
• high temperature,
• presence of white blood cells in urine tests,
• blurred vision; visual disturbances,
• gynecomastia (enlargement of the breast in men).

Possible adverse effects observed with some statins

• sexual dysfunction,
• depression,
• respiratory problems, including persistent cough and/or choking sensations or fever,
• diabetes. This is more likely if you have high levels of blood sugar and fats, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• persistent muscle pain, tenderness, or weakness, and especially if occurring together with a feeling of malaise or high temperature, which may not resolve after stopping ezetimibe/atorvastatin treatment (frequency not known).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, 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 cinfa

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

Do not use this medicine after the expiry date stated on the packaging and blister pack, after “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 any unused medicines and their packaging to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Ezetimibe/Atorvastatin cinfa

The active substances are ezetimibe and atorvastatin. Each film-coated tablet contains 10 mg of ezetimibe and 10 mg, 20 mg, 40 mg, or 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other components (excipients) are:

Tablet core:

Mannitol, sodium croscarmellose, povidone, sodium lauryl sulfate, magnesium stearate, microcrystalline cellulose, calcium carbonate, hydroxypropylcellulose, polysorbate 80, and yellow iron oxide (E-172).

Tablet coating:

Ezetimibe/Atorvastatin cinfa 10 mg/10 mg, 10 mg/20 mg, and 10 mg/40 mg

Opadry White (hypromellose, macrogol, titanium dioxide (E-171), and monohydrate lactose)

Ezetimibe/Atorvastatin cinfa 10 mg/80 mg

DrCoat FCU (hypromellose, titanium dioxide (E-171), talc, macrogol, yellow iron oxide (E-172))

Appearance of the product and contents of the pack

Ezetimibe/Atorvastatin cinfa 10 mg/10 mg: white, round, biconvex, film-coated tablets, approximately 8.1 mm in diameter.

Ezetimibe/Atorvastatin cinfa 10 mg/20 mg: white, oval, biconvex, film-coated tablets, approximately 11.6 x 7.1 mm in size.

Ezetimibe/Atorvastatin cinfa 10 mg/40 mg: white, capsule-shaped, biconvex, film-coated tablets, approximately 16.1 x 6.1 mm in size.

Ezetimibe/Atorvastatin cinfa 10 mg/80 mg: yellow, oblong, biconvex, film-coated tablets, approximately 19.1 x 7.6 mm in size.

Pack sizes:

Blister packs of OPA/Al/PVC//Al containing 30 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

ELPEN Pharmaceutical Co. Inc.

Marathonos Avenue 95, Pikermi, Attiki,

190 09, Greece

ELPEN Pharmaceutical Co. Inc.

Zapani, Block 1048, Keratea,

190 01, Greece

Date of the most recent revision of this leaflet: October 2024

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

Ezetimibe/Atorvastatin cinfa 10 mg/10 mg film-coated tablets EFG

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/89581/P_89581.html

QR code link: https://cima.aemps.es/cima/dochtml/p/89581/P_89581.html

Ezetimibe/Atorvastatin cinfa 10 mg/20 mg film-coated tablets EFG

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/89582/P_89582.html

QR code link: https://cima.aemps.es/cima/dochtml/p/89582/P_89582.html

Ezetimibe/Atorvastatin cinfa 10 mg/40 mg film-coated tablets EFG

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/89583/P_89583.html

QR code link: https://cima.aemps.es/cima/dochtml/p/89583/P_89583.html

Ezetimibe/Atorvastatin cinfa 10 mg/80 mg film-coated tablets EFG

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/89584/P_89584.html

QR code link: https://cima.aemps.es/cima/dochtml/p/89584/P_89584.html