ROSUVASTATIN/EZETIMIBE ALTER 10 mg/10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Rosuvastatin/Ezetimibe Alter 10 mg/10 mg film-coated tablets

Rosuvastatin/Ezetimibe Alter 20 mg/10 mg film-coated tablets

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Rosuvastatin/Ezetimibe Alter and what is it used for

Rosuvastatin/Ezetimibe Alter contains two different active substances in one film-coated tablet. One of the active substances is rosuvastatin, which belongs to a group of medicines called statins; the other active substance is ezetimibe.

Rosuvastatin/ezetimibe is a medication used in adult patients to reduce the levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides that circulate in the blood. Additionally, rosuvastatin/ezetimibe increases the levels of "good" cholesterol (HDL cholesterol).

Rosuvastatin/ezetimibe works by reducing cholesterol in two ways. It reduces the cholesterol absorbed in the digestive tract and the cholesterol produced by the body itself.

Cholesterol is one of the many fatty substances that circulate in the blood. The total amount of cholesterol is mainly composed of LDL and HDL cholesterol.

For most people, high cholesterol levels do not affect how they feel, as they do not produce any symptoms. However, if left untreated, fatty deposits can accumulate in the walls of blood vessels and narrow them.

Sometimes, these narrowed blood vessels can become blocked, cutting off the blood supply to the heart or brain, which can cause a heart attack or stroke. By reducing cholesterol levels, you can reduce your risk of having a heart attack, stroke, or other related health problems.

Rosuvastatin/ezetimibe is used in patients who cannot control their cholesterol levels with diet alone. While taking this medication, you should follow a cholesterol-reducing diet. Your doctor may prescribe this medication if you are already taking rosuvastatin and ezetimibe at the same dose level.

Rosuvastatin/ezetimibe is used along with your cholesterol-reducing diet if you have:

• high blood cholesterol levels (primary hypercholesterolemia)
• heart disease, this medication reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

This medication does not help you lose weight.

You should continue taking this medication, even if your cholesterol levels are under control, as it prevents your cholesterol levels from rising again and causing the accumulation of fatty deposits.

However, you should stop taking it if your doctor tells you to or if you become pregnant.

2. What you need to know before taking Rosuvastatin/Ezetimibe Alter

Do not take Rosuvastatin/Ezetimibe Alter if:

• you are allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medication (listed in section 6),
• you have liver disease,
• you have severe kidney problems,
• you have repeated and unexplained muscle pain or cramps (myopathy),
• you are taking a medication called cyclosporin (used, for example, after an organ transplant),
• you are pregnant or breastfeeding. If you become pregnant while taking this medication, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with this medication using an appropriate contraceptive method.
• you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (medications used for hepatitis C virus infection).
• you have ever developed a severe skin rash or peeling of the skin, blisters, and/or ulcers in the mouth after taking this medication or other medications containing rosuvastatin.

If you are in any of the above situations (or if you are unsure), consult your doctor.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medication if:

• you have kidney problems,
• you have liver problems,
• you have repeated and unexplained muscle pain or cramps, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you have unexplained muscle pain or cramps, especially if you have general discomfort or fever. Also, inform your doctor or pharmacist if you have constant muscle weakness,
• you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor should determine the appropriate dose for you,
• you are taking medications to treat infections, including HIV (AIDS virus) or hepatitis C, such as lopinavir/ritonavir, atazanavir, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, and/or pibrentasvir. See "Other medications and Rosuvastatin/Ezetimibe Alter",
• you have severe respiratory failure,
• you are taking other medications called fibrates to lower cholesterol, see "Other medications and Rosuvastatin/Ezetimibe Alter",
• you are going to have surgery. You may need to stop taking rosuvastatin/ezetimibe for a short period,
• you regularly drink large amounts of alcohol,
• your thyroid gland does not function properly (hypothyroidism),
• you are over 70 years old (as your doctor should choose the appropriate dose of rosuvastatin/ezetimibe for you),
• you are taking or have taken in the last 7 days a medication called fusidic acid (an antibiotic). The combination of fusidic acid and rosuvastatin/ezetimibe can cause serious muscle problems (rhabdomyolysis),
• you are taking regorafenib (a medication to treat cancer),
• 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 that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).

If you are in any of these situations (or if you are unsure): consult your doctor or pharmacist before starting to take any dose of this medication.

In a small number of people, statins can affect the liver. This is detected by a simple blood test that detects increased levels of liver enzymes in the blood. For this reason, your doctor will normally perform blood tests (liver function tests) during treatment with this medication. It is essential that you visit your doctor for these tests.

While taking this medication, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with rosuvastatin treatment. Stop taking this medication and seek medical attention immediately if you notice any of the symptoms described in section 4.

Children and Adolescents

The use of this medication is not suitable for children and adolescents under 18 years of age.

Other Medications and Rosuvastatin/Ezetimibe Alter

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication.

Tell your doctor if you are taking any of the following medications:

• Cyclosporin (used, for example, after an organ transplant to prevent rejection of the transplanted organ. The effect of rosuvastatin increases with concomitant use). Do not take rosuvastatin/ezetimibe if you are taking cyclosporin.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and the risk of bleeding may increase while taking this medication), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medications called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates).
• Colestyramine (a medication to lower cholesterol), as it affects how ezetimibe works.
• Regorafenib (indicated for the treatment of cancer).
• Darolutamide (indicated for the treatment of cancer).
• Any of the following medications used to treat viral infections, including HIV or hepatitis C, alone or in combination (see "Warnings and Precautions"): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. Treatments for indigestion that contain aluminum and magnesium (used to neutralize stomach acid, as they reduce the level of rosuvastatin in the blood).
• Erythromycin (an antibiotic).
• Fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you should temporarily stop taking this medication. Your doctor will tell you when you can safely take rosuvastatin/ezetimibe again. Taking this medication with fusidic acid can rarely cause muscle weakness, pain, or sensitivity (rhabdomyolysis). You can find more information about rhabdomyolysis in section 4.
• An oral contraceptive (the pill).
• Hormone replacement therapy (increasing hormone levels in the blood).

If you go to the hospital or receive treatment for another illness, tell the medical staff that you are taking this medication.

Pregnancy and Breastfeeding

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

Do not take rosuvastatin/ezetimibe if you are pregnant, think you may be pregnant, or are planning to become pregnant. If you become pregnant while taking this medication, stop taking it immediately and inform your doctor. Women should use contraceptive methods during treatment with this medication.

Do not take rosuvastatin/ezetimibe if you are breastfeeding, as it is unknown whether the medication passes into breast milk.

Driving and Using Machines

This medication is not expected to interfere with your ability to drive or use machines. However, some people may feel dizzy after taking this medication. If you feel dizzy, do not drive or use machines.

Rosuvastatin/Ezetimibe Alter contains Lactose and Sodium

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

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free"

3. How to Take Rosuvastatin/Ezetimibe Alter

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

You should continue to follow a cholesterol-reducing diet and exercise while taking this medication.

The recommended dose for adults is one tablet per day.

You can take it at any time of day, with or without food. Swallow the tablet whole with water.

Try to take the tablets every day at the same time to help you remember.

This medication is not suitable for starting treatment. The start of treatment or dose adjustments, if necessary, should only be done by taking the components separately, and once the appropriate doses are adjusted, it is possible to switch to the appropriate dose of rosuvastatin/ezetimibe.

If your doctor has prescribed rosuvastatin/ezetimibe along with another cholesterol-lowering medication that contains the active substance colestyramine or any other medication that contains a bile acid sequestrant, you should take rosuvastatin/ezetimibe at least 2 hours before or 4 hours after these medications.

Regular Cholesterol Level Checks

It is essential that you visit your doctor regularly to have your cholesterol levels checked, to ensure that your cholesterol levels have normalized and are maintained at appropriate levels.

If you take more Rosuvastatin/Ezetimibe Alter than you should

Contact your doctor or the nearest hospital emergency department, as you may need medical attention.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Rosuvastatin/Ezetimibe Alter

Do not worry, omit the missed dose and take the next scheduled dose at the usual time. Do not take a double dose to make up for missed doses.

If you stop taking Rosuvastatin/Ezetimibe Alter

Consult your doctor if you want to stop taking this medication. Your cholesterol levels may rise again if you stop taking this medication.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

It is essential that you know what these adverse effects may be.

Stop taking rosuvastatin/ezetimibe and seek immediate medical attention if you experience any of the following symptoms:

• any unexplained muscle pain, tenderness, or weakness that lasts longer than expected. This is because muscle problems, including muscle fiber destruction that damages the kidneys, can be severe and potentially lead to a life-threatening disorder (rhabdomyolysis). This is rare (may affect up to 1 in 1,000 people);
• severe allergic reactions (angioedema) whose signs include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, and intense itching of the skin (with hives). This is rare (may affect up to 1 in 1,000 people);
• if you have a lupus-like syndrome (which includes skin rash, joint disorders, and effects on blood cells). This is rare (may affect up to 1 in 1,000 people).
• if you experience muscle rupture. This is rare (may affect up to 1 in 1,000 people).
• red, non-raised, target-like, or circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome). The frequency of this is unknown (cannot be estimated from available data).
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome). The frequency of this is unknown (cannot be estimated from available data).

Other Adverse Effects

Frequent Adverse Effects (may affect up to 1 in 10 people)

• headache;
• constipation;
• general malaise;
• muscle pain;
• weakness;
• dizziness;
• diabetes. This is more likely if you have high blood sugar and lipid levels, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine;
• stomach pain;
• diarrhea;
• flatulence (excess gas in the intestinal tract);
• feeling tired;
• high levels in some blood test results of liver function (transaminases).

Infrequent Adverse Effects (may affect up to 1 in 100 people)

• skin rash, itching, hives;
• high levels in some blood test results of muscle function (Creatine Kinase test);
• cough;
• indigestion;
• heartburn;
• joint pain;
• muscle spasms;
• neck pain;
• decreased appetite;
• pain;
• chest pain;
• hot flashes;
• high blood pressure;
• tingling sensation;
• dry mouth;
• stomach inflammation;
• back pain;
• muscle weakness;
• pain in the arms and legs;
• swelling, especially of the hands and feet.
• an increase in the amount of protein in the urine, which usually normalizes without the need to interrupt treatment with rosuvastatin/ezetimibe (only with rosuvastatin 10 mg and 20 mg).

Rare Adverse Effects (may affect up to 1 in 1,000 people)

• pancreatitis, which causes severe stomach pain that can extend to the back
• decrease in the number of platelets in the blood, which can cause bruising or bleeding (thrombocytopenia).

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

• jaundice (yellowing of the skin and eyes);
• liver inflammation (hepatitis);
• traces of blood in the urine;
• nerve damage in the legs and arms (such as numbness);
• memory loss;
• breast enlargement in men (gynecomastia).

Unknown Frequency (cannot be estimated from available data)

• difficulty breathing;
• edema (swelling);
• sleep disturbances, including insomnia and nightmares;
• sexual dysfunction;
• depression;
• respiratory problems, including persistent cough and/or difficulty breathing or fever;
• tendon injuries;
• constant muscle weakness;
• hives and target-like lesions (erythema multiforme);
• gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting);
• severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing);
• ocular myasthenia (a disease that causes 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.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rosuvastatin/Ezetimibe Alter

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

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from light and moisture.

Do not use this medicine after the expiration date that appears on the box or blister pack after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Rosuvastatin/Ezetimibe Alter

• The active ingredients are rosuvastatin (as rosuvastatin calcium) and ezetimibe.

Rosuvastatin/Ezetimibe Alter 10 mg/10 mg: Each film-coated tablet contains rosuvastatin calcium, equivalent to 10 mg of rosuvastatin, and 10 mg of ezetimibe.

Rosuvastatin/Ezetimibe Alter 20 mg/10 mg: Each film-coated tablet contains rosuvastatin calcium, equivalent to 20 mg of rosuvastatin, and 10 mg of ezetimibe.

• The other ingredients are:

Tablet core

Lactose monohydrate, croscarmellose sodium, povidone, sodium lauryl sulfate, microcrystalline cellulose, hypromellose, anhydrous colloidal silica, magnesium stearate.

Tablet coating

Rosuvastatin/Ezetimibe Alter 10 mg/10 mg: Hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol, talc.

Rosuvastatin/Ezetimibe Alter 20 mg/10 mg: Hypromellose, titanium dioxide (E171), talc, macrogol, yellow iron oxide (E172).

Product Appearance and Package Contents

Rosuvastatin/Ezetimibe Alter 10 mg/10 mg: Film-coated tablets, round, biconvex, beige in color, with a diameter of approximately 10 mm and the inscription "EL 4" on one side.

Rosuvastatin/Ezetimibe Alter 20 mg/10 mg: Film-coated tablets, round, biconvex, yellow in color, with a diameter of approximately 10 mm and the inscription "EL 3" on one side.

OPA/Al/PVC//Al blisters packaged in cardboard boxes.

Packages of 30 film-coated tablets.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Elpen Pharmaceutical Co. Inc.

Marathonos Ave. 95

19009 Pikermi Attiki

Greece

or

Elpen Pharmaceutical Co. Inc.

Zapani, Block 1048

190 01 Keratea

Greece

Date of the Last Revision of this Prospectus:May 2023.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/.