Ezetimibe/atorvastatin Kern Pharma 10 mg/40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ezetimibe/Atorvastatin Kern Pharma 10 mg/10 mg film-coated tablets EFG

Ezetimibe/Atorvastatin Kern Pharma 10 mg/20 mg film-coated tablets EFG

Ezetimibe/Atorvastatin Kern Pharma 10 mg/40 mg film-coated tablets EFG

Ezetimibe/Atorvastatin Kern Pharma 10 mg/80 mg film-coated tablets EFG

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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Ezetimiba/atorvastatina is used in adults to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain blood fats called triglycerides. In addition, ezetimiba/atorvastatina increases levels of "good" cholesterol (HDL cholesterol).

Ezetimiba/atorvastatina works by reducing cholesterol in two ways: by decreasing the cholesterol absorbed in the digestive tract and by reducing the cholesterol that your body produces on its own.

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. 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 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.

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 fats (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 condition (homozygous familial hypercholesterolemia), which increases blood cholesterol levels. You may also receive other treatments.
• heart disease, because 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 Ezetimibe/Atorvastatin Kern Pharma

Do not take Ezetimibe/Atorvastatin Kern Pharma

• 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 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

Talk to your doctor or pharmacist before starting ezetimibe/atorvastatin

• if you have previously had a stroke with intracranial haemorrhage, or have small accumulations of fluid in the brain due to previous strokes,
• if you have kidney problems,
• if your thyroid gland is underactive (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 during treatment 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 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),
• if 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).

Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness, or 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 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 and treatments may be needed to diagnose and manage this condition.

Talk to your doctor or pharmacist before starting ezetimibe/atorvastatin if you have severe respiratory insufficiency.

If you are in any of the above situations (or are unsure), consult your doctor before starting ezetimibe/atorvastatin, as your doctor may need to perform blood tests 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, increases when certain medicines are taken concomitantly (see section 2 “Taking Ezetimibe/Atorvastatin Kern Pharma with other medicines”).

While taking this medicine, your doctor will monitor whether you have diabetes or are at 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.

Tell 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 has not been studied.

Children and adolescents

Ezetimibe/atorvastatin is not recommended for use in children and adolescents.

Other medicines and Ezetimibe/Atorvastatin Kern Pharma

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

Some medicines may affect the action of ezetimibe/atorvastatin, or their effects may be altered by ezetimibe/atorvastatin (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**, and rifampicin (medicines used to treat bacterial infections),
• ketoconazole, itraconazole, voriconazole, fluconazole, and posaconazole (medicines used to treat fungal infections),
• gemfibrozil, other fibrates, nicotinic acid, derivatives, colestipol, and 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, and 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 combinations elbasvir/grazoprevir and ledipasvir/sofosbuvir,
• letermovir (a medicine used to help prevent cytomegalovirus disease),
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria).

** If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when you can restart ezetimibe/atorvastatin treatment. 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 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 aluminium 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 Ezetimibe/Atorvastatin Kern Pharma 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 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

Do not take this medicine if you are pregnant, trying to become pregnant, or think you might be 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.

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, bear in mind that some people may experience dizziness after taking ezetimibe/atorvastatin.

Ezetimibe/Atorvastatin Kern Pharma 10 mg/10 mg, 10 mg/20 mg and 10 mg/40 mg contain lactose

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

Ezetimibe/Atorvastatin Kern Pharma contains sodium

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

3. How to take Ezetimibe/Atorvastatin Kern Pharma

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. 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 to take ezetimibe/atorvastatin, you should already be on a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking ezetimibe/atorvastatin.

What dose to take

The recommended dose is one tablet of ezetimibe/atorvastatin once daily by oral administration.

Method of administration

Take ezetimibe/atorvastatin at any time of 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 Kern Pharma 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 Kern Pharma

Do not take a double dose to make up for missed doses; on the following day, take your usual dose of ezetimibe/atorvastatin at the usual 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 right away, 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, or 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, especially if accompanied by a feeling of malaise or high temperature, which may be due to abnormal muscle breakdown that could 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.

Common adverse effects (may affect up to 1 in 10 patients):

• diarrhea,
• muscle pain.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• flu-like illness,
• depression; sleep disturbances; sleep disorders,
• 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.

Rare adverse effects (may affect up to 1 in 1,000 patients):

• skin rash or mouth ulcers (drug-induced lichenoid reaction),
• purple-colored skin lesions (signs of blood vessel inflammation, vasculitis).

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects 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.

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 count, 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 hands and feet,
• decreased sensitivity to pain or touch,
• altered sense of taste; dry mouth,
• memory loss,
• ringing in the ears and/or head; hearing loss,
• vomiting,
• belching,
• hair loss,
• high temperature,
• presence of white blood cells in urine tests,
• blurred vision; visual disturbances,
• gynecomastia (enlargement of breast tissue 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 sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• persistent muscle pain, tenderness, or weakness, especially if accompanied by malaise or high temperature, which may not resolve after stopping ezetimibe/atorvastatin treatment (frequency unknown).

Reporting of adverse effects

If you experience any 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 Kern Pharma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister 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. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimiba/Atorvastatina Kern Pharma

The active substances are ezetimibe and atorvastatin:

• Each tablet of Ezetimiba/Atorvastatina Kern Pharma 10 mg/10 mg contains 10 mg of ezetimibe and 10 mg of atorvastatin (as atorvastatin calcium trihydrate).
• Each tablet of Ezetimiba/Atorvastatina Kern Pharma 10 mg/20 mg contains 10 mg of ezetimibe and 20 mg of atorvastatin (as atorvastatin calcium trihydrate).
• Each tablet of Ezetimiba/Atorvastatina Kern Pharma 10 mg/40 mg contains 10 mg of ezetimibe and 40 mg of atorvastatin (as atorvastatin calcium trihydrate).
• Each tablet of Ezetimiba/Atorvastatina Kern Pharma 10 mg/80 mg contains 10 mg of ezetimibe and 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other components (excipients) are:

Tablet core:

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

Tablet coating:

Ezetimiba/Atorvastatina Kern Pharma 10 mg/10 mg, 10 mg/20 mg and 10 mg/40 mg:

Opadry White (hypromellose, polyethylene glycol, titanium dioxide (E-171), and monohydrate lactose).

Ezetimiba/Atorvastatina Kern Pharma 10 mg/80 mg:

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

Appearance of the product and contents of the pack

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

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

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

Ezetimiba/Atorvastatina Kern Pharma 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.

Pre-cut blister packs of OPA/Al/PVC/Al containing 30 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

ELPEN Pharmaceutical Co. Inc.

Marathonos Avenue 95,

Pikermi, Attiki, 190 09,

Greece

or

ELPEN Pharmaceutical Co. Inc.

Zapani, Block 1048,

Keratea, 190 01,

Greece

Date of the most recent review of this leaflet: September 2025

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