Ezetimibe/atorvastatin Olpha 10 mg/80 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See Section 4.

Leaflet Contents

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 certain fatty substances called triglycerides circulating in the blood. In addition, ezetimibe/atorvastatin increases levels of "good" cholesterol (HDL cholesterol).

Ezetimibe/atorvastatin works by reducing cholesterol in two ways: it reduces cholesterol absorbed through the gastrointestinal tract, as well as cholesterol produced by the body itself.

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 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 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.

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 a statin and ezetimibe have previously 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; ezetimibe/atorvastatin reduces the risk of heart attack, stroke, surgery to increase 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 blood test results for 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

Talk to your doctor or pharmacist before taking ezetimibe/atorvastatin

• if you have previously had a stroke with intracranial hemorrhage, 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 had 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 taking 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, consult with 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 failure.

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 to assess your risk of developing muscle-related side effects. It is known that the risk of muscle-related adverse effects, e.g., rhabdomyolysis, increases when certain medicines are taken at the same time (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 about all your medical conditions, including allergies.

The combined use of ezetimibe/atorvastatin and fibrates (certain cholesterol-lowering medicines) should be avoided, as the combination of ezetimibe/atorvastatin with 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 may have their effects altered by ezetimibe/atorvastatin (see section 3). 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:

• 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 and 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 combinations 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 more information about rhabdomyolysis, see section 4.

• Other medicines known to interact with ezetimibe/atorvastatin:
  • oral contraceptives (medicines to prevent pregnancy),
  • stiripentol (an anticonvulsant used to treat epilepsy),
  • cimetidine (a medicine used for stomach acidity and peptic ulcers),
  • phenazone (an analgesic),
  • antacids (products 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 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, breastfeeding, think you may be pregnant, or plan 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 if you are 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, 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 administration instructions for this medicine given by your doctor. Your doctor will determine the appropriate tablet dose 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 ezetimiba/atorvastatina, you should already be following a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking ezetimiba/atorvastatina.

What amount should you 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 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 experiences 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 change in urine color to red-brown, and particularly 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 rash, joint disorders, and effects on blood cells)

Consult your doctor as soon as possible if you experience unexpected or unusual bleeding or bruising, as this may indicate liver disease.

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

• diarrhea,
• muscle pain.

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

• flu,
• depression; trouble sleeping; 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 cramps; muscle fatigue, spasms or weakness; pain in arms and legs,
• unusual weakness; feeling tired or unwell; swelling, especially in the ankles (edema),
• increased levels in certain liver or muscle function tests (CK) in laboratory blood tests,
• weight gain.

Additionally, the following adverse effects have been reported in people taking ezetimibe/atorvastatin tablets, or ezetimibe 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 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 and toes,
• reduced 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 (breast enlargement in men),
• myasthenia gravis (a condition causing generalized muscle weakness, which in some cases affects muscles used for breathing),
• ocular myasthenia (a condition causing weakness of the eye muscles).

Consult your doctor if you develop arm or leg weakness that worsens with 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 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 particularly if occurring together with malaise or high temperature that does not resolve after stopping ezetimibe/atorvastatin treatment (frequency not known).

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 Ezetimiba/Atorvastatina 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 does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. 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, biconvex, capsule-shaped tablets, 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:

Aluminium/aluminium blister packs containing 10, 30, 90 or 100 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization 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 authorized in the European Economic Area member states under the following names:

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

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