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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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

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

Ezetimibe/Atorvastatin Olpha 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 must 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.

Contents of the leaflet

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

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

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

Ezetimibe/atorvastatin is used in adults to lower total cholesterol levels, "bad" cholesterol (LDL cholesterol), and blood levels of certain fatty substances called triglycerides. In addition, ezetimibe/atorvastatin increases levels of "good" cholesterol (HDL cholesterol).

Ezetimibe/atorvastatin works by reducing cholesterol in two ways: by decreasing the cholesterol absorbed from 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 consists 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 lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Such disruption 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 against heart disease.

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

Ezetimibe/atorvastatin 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.

Ezetimibe/atorvastatin 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 treatment with a statin and ezetimibe has previously been administered as separate tablets.
• a hereditary disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You may also receive other treatments.
• heart disease; in such cases, ezetimibe/atorvastatin reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Ezetimibe/atorvastatin does not help you lose weight.

2. What you need to know before taking Ezetimibe/Atorvastatin Olpha

• 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 a liver disease,
• if you have ever 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 to take ezetimibe/atorvastatin

• if you have previously had a stroke with intracranial bleeding, or have small accumulations of fluid in the brain due to prior 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) by mouth or 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 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).

Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness, or muscle weakness while taking ezetimibe/atorvastatin. This is because, 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 have persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Consult your doctor or pharmacist before starting to take ezetimibe/atorvastatin:

• if you suffer from 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 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 simultaneously (see section 2 “Other medicines and Ezetimibe/Atorvastatin Olpha”).

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.

Inform your doctor of 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 and fibrates has not been studied.

Children

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

Other medicines and Ezetimibe/Atorvastatin Olpha

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

Some medicines may alter the effect of ezetimibe/atorvastatin or their effects may be affected by ezetimibe/atorvastatin (see section 3). This type of interaction could reduce the effectiveness of one or both medicines. It could also 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**, 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, ledipasvir/sofosbuvir,
• letermovir, a medicine that helps prevent cytomegalovirus infection,
• 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. The use of ezetimibe/atorvastatin 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 (products for treating 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 Olpha 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 are planning to become pregnant, consult your doctor 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 operate machinery. However, it should be noted that some people may experience dizziness after taking ezetimibe/atorvastatin.

Ezetimibe/Atorvastatin Olpha contains lactose

Ezetimibe/Atorvastatin tablets contain a sugar called lactose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Ezetimibe/Atorvastatin Olpha contains sodium

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

3. How to take Ezetimiba/Atorvastatina Olpha

Follow exactly the instructions for use of this medicine as given by your doctor. Your doctor will determine the appropriate tablet dose for you, depending on your current treatment and your personal risk situation. If in doubt, consult your doctor or pharmacist again.

• Before starting to take 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 once daily by oral administration.

Method of administration

Take Ezetimiba/Atorvastatina Olpha 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 Olpha than you should

Consult your doctor or pharmacist.

If you forget to take Ezetimiba/Atorvastatina Olpha

Do not take a double dose to make up for missed doses. On the following 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 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, 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, pain, or rupture, or a change in urine color to red-brown, especially if accompanied by a general 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 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 reported as common (may affect up to 1 in 10 people):

• diarrhea,
• muscle pain.

The following adverse effects have been reported as uncommon (may affect up to 1 in 100 people):

• flu,
• depression; trouble sleeping; sleep disorders,
• dizziness; headache; tingling sensation,
• slow heart rate,
• hot flushes,
• shortness of breath,
• abdominal pain; bloating; constipation; indigestion; flatulence; frequent bowel movements; stomach inflammation; nausea; stomach discomfort; gastrointestinal discomfort,
• acne; hives,
• joint pain; back pain; leg cramps; muscle fatigue, spasms, or weakness; pain in arms and legs,
• unusual weakness; feeling tired or unwell; swelling, especially in the ankles (edema),
• increased liver or muscle function tests (CK) in laboratory blood tests,
• weight gain.

Additionally, the following adverse effects have been reported in people taking ezetimibe/atovastatin tablets, ezetimibe alone, or atorvastatin 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 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 the fingers of the 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 the breast in men),
• myasthenia gravis (a disease causing generalized muscle weakness that, in some cases, affects the 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.

Possible adverse effects reported with some statins

• sexual dysfunction,
• depression,
• respiratory problems, including persistent cough and/or shortness of breath 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, especially if accompanied by a feeling of malaise or high temperature that does not resolve after stopping ezetimibe/atorvastatin (frequency not known).

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 Olpha

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

Do not use this medicine after the expiry date stated on the carton or container after “EXP”. The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimiba/Atorvastatina Olpha

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 are: calcium carbonate; anhydrous colloidal silica; sodium croscarmellose; hydroxypropylcellulose; lactose monohydrate; povidone; magnesium stearate; microcrystalline cellulose; polysorbate 80; sodium lauryl sulfate (E487).

The tablet coating contains: hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol, talc.

Appearance of the product and contents of the pack

Film-coated tablets, biconvex, capsule-shaped, white to off-white in colour.

Ezetimiba/Atorvastatina Olpha 10 mg/10 mg film-coated tablets EFG: with "1T" engraved on one side.

Ezetimiba/Atorvastatina Olpha 10 mg/20 mg film-coated tablets EFG: with "2T" engraved on one side.

Ezetimiba/Atorvastatina Olpha 10 mg/40 mg film-coated tablets EFG: with "4T" engraved on one side.

Ezetimiba/Atorvastatina Olpha 10 mg/80 mg film-coated tablets EFG: with "8T" engraved on one side.

Pack sizes:

Blister packs of 10, 30, 90 and 100 film-coated tablets in aluminium/aluminium blisters.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Olpha AS,

Rupnicu iela 5,

Olaine, Olaines novads, LV-2114,

Latvia

Manufacturer

Delorbis Pharmaceuticals LTD,

17 Athinon street,

Ergates Industrial Area,

2643 Ergates Lefkosia,

Cyprus

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000,

Malta

This medicinal product is authorised in the European Economic Area member states under the following names:

Date of the last revision of this leaflet: November 2025

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