Package Insert: 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 this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Rosuvastatina/Ezetimiba Altercontains two different active principles in a film-coated tablet. One of the active principles is rosuvastatina, which belongs to a group of medications called statins; the other active principle is ezetimiba.

Rosuvastatina/ezetimibais a medication used in adult patients to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides that circulate in the blood. Additionally, rosuvastatina/ezetimiba increases concentrations of "good" cholesterol (HDL cholesterol).

Rosuvastatina/ezetimibaacts by reducing cholesterol in two ways. It reduces the cholesterol absorbed in the digestive tract as well as 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 composed mainly of LDL and HDL cholesterol.

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

At times, these narrowed blood vessels can become blocked, cutting off blood supply to the heart or brain, which would cause a heart attack or stroke. By reducing cholesterol levels, the risk of having a heart attack, stroke, or other related health problems can be reduced.

Rosuvastatina/ezetimibais used in patients who cannot control their cholesterol levels solely with diet. While taking this medication, you must follow a cholesterol-reducing diet. Your doctor may prescribe this medication if you are already taking rosuvastatina and ezetimiba at the same dosage level.

Rosuvastatina/ezetimibais used in conjunction with your cholesterol-reducing diet if you have:

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

This medicationdoes not help reduce weight.

You must continue taking this medication, even if your cholesterol levels are within the normal range, 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 instructs you to do so or if you are pregnant.

Do not take Rosuvastatina/Ezetimiba Alter if:

• You are allergic to rosuvastatina, ezetimiba, or any of the other components of this medication (listed in section 6),
• You have liver disease,
• You have severe kidney problems,
• You have repeated or unjustified muscle pain and cramps (myopathy),
• You are taking a medication called ciclosporina (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 to treat a viral liver infection called hepatitis C),
• You have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking this medication or other medications containing rosuvastatina.

If you find yourself in any of the above situations (or 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 or unjustified muscle pain and cramps, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other medications to lower cholesterol levels. Inform your doctor immediately if you have unjustified 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 (for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must establish the appropriate dose for you,
• You are taking medications to treat infections, including HIV (HIV 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 Rosuvastatina/Ezetimiba Alter”,
• You have severe respiratory insufficiency,
• You are taking other medications called fibrates to lower cholesterol, see “Other medications and Rosuvastatina/Ezetimiba Alter”,
• You are about to have surgery. You may need to stop taking rosuvastatina/ezetimiba for a short period,
• You regularly consume large amounts of alcohol,
• Your thyroid gland does not function correctly (hypothyroidism),
• You are over 70 years old (since your doctor must choose the appropriate dose of rosuvastatina/ezetimiba for you),
• You are taking or have taken within the last 7 days a medication called fusidic acid (an antibiotic) by mouth or injection. The combination of fusidic acid and rosuvastatina/ezetimiba may cause severe muscle problems (rhabdomyolysis),
• You are taking regorafenib (a medication to treat cancer),
• You have or have had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

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

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

While taking this medication, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You may be at risk of developing diabetes if you have high blood sugar and fat levels, 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 rosuvastatina treatment. Stop using 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 Rosuvastatina/Ezetimiba Alter

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

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

• Ciclosporina (used, for example, after an organ transplant to prevent organ rejection. The effect of rosuvastatina is increased with its use together). Do not take rosuvastatina/ezetimiba if you are taking ciclosporina.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and the risk of bleeding may increase while taking this medication together), ticagrelor, or clopidogrel.
• Other medications to lower cholesterol called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates).
• Colestiramina (a medication to lower cholesterol), as it affects how ezetimiba works.
• Regorafenib (used to treat cancer).
• Darolutamida (used to treat 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 containing aluminum and magnesium (used to neutralize stomach acid, as they reduce the level of rosuvastatina in plasma).
• Eritromicina (an antibiotic).
• Fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medication. Your doctor will indicate when you can safely take rosuvastatina/ezetimiba again. Taking this medication with fusidic acid may occasionally cause muscle weakness, pain, or sensitivity (rhabdomyolysis). You can find more information about rhabdomyolysis in section 4.
• Oral contraceptive (the pill).
• Hormone replacement therapy (increasing hormone levels in the blood).

If you visit a hospital or receive treatment for another disease, inform the medical staff that you are taking this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Do not take rosuvastatina/ezetimiba if you are pregnant, think you may be pregnant, or intend to become pregnant. If you become pregnant while taking this medication, stop taking it immediately and inform your doctor. Women should use an appropriate contraceptive method during treatment with this medication.

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

Driving and operating machinery

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

Rosuvastatina/Ezetimiba Alter contains lactose and sodium

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

You should continue to maintain a low-cholesterol 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 the 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 initiation of treatment or dose adjustments, if necessary, should only be made by taking the components separately, and once the appropriate doses have been adjusted, it is possible to switch to the appropriate dose of rosuvastatina/ezetimiba.

If your doctor has prescribed rosuvastatina/ezetimiba along with another medication to reduce cholesterol that contains the active ingredient colestiramine or any other medication that contains a bile acid sequestrant, you should take rosuvastatina/ezetimiba at least 2 hours before or 4 hours after these medications.

Regular Cholesterol Level Checks

It is essential that you visit your doctor regularly for cholesterol checks to ensure that your cholesterol levels have normalized and remain at appropriate levels.

If You Take More Rosuvastatina/Ezetimiba Alter Than You Should

Contact your doctor or the nearest hospital's emergency service as you may need medical assistance.

In the case of overdose or accidental ingestion, consult

immediately with your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Rosuvastatina/Ezetimiba 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 compensate for the missed dose.

If You Interrupt Treatment with Rosuvastatina/Ezetimiba Alter

Consult your doctor if you want to discontinue treatment with this medication. Your cholesterol levels may increase again if you stop taking this medication.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

It is important that you know which side effects may occur.

Stop taking rosuvastatina/ezetimiba and seek medical assistance immediately if you experience any of the following symptoms:

• any muscle pain, tenderness or weakness that lasts longer than expected. This is due to muscle problems, including muscle fibre destruction that can damage the kidneys, which can be severe and potentially life-threatening (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 urticaria). 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 a muscle rupture. This is rare (may affect up to 1 in 1,000 people);
• flat red patches on the trunk, often with blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).This is unknown (cannot be estimated from available data);
• generalised rash, high body temperature and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).This is unknown (cannot be estimated from available data).

Other side effects

Frequent side effects (may affect up to 1 in 10 people)

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

Rare side effects (may affect up to 1 in 1,000 people)

• pancreatitis, which causes intense stomach pain that may spread to the back
• decreased platelet count in the blood, which may cause bruising or bleeding (thrombocytopenia).

Very rare side effects (may affect up to 1 in 10,000 people)

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

Unknown frequency (cannot be estimated from available data)

• difficulty breathing;
• swelling;
• sleep disturbances, including insomnia and nightmares;
• sexual dysfunction;
• depression;
• respiratory problems including persistent cough and/or difficulty breathing or fever;
• tendon damage;
• constant muscle weakness;
• urticaria and target lesions (erythema multiforme);

• gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting);

• myasthenia gravis (a disease that causes generalised 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 eyelid drooping, difficulty swallowing or difficulty breathing.

Reporting side effects

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

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

This medication does not require any special temperature for conservation.

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

Do not use this medication after the expiration date that appears on the case or in the blister after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofRosuvastatina/Ezetimiba Alter

• The active principles are rosuvastatina (as rosuvastatina calcium) and ezetimiba.

Rosuvastatina/Ezetimiba Alter 10 mg/10 mg: Each film-coated tablet contains rosuvastatina calcium, equivalent to 10 mg of rosuvastatina, and 10 mg of ezetimiba.

Rosuvastatina/Ezetimiba Alter 20 mg/10 mg: Each film-coated tablet contains rosuvastatina calcium, equivalent to 20 mg of rosuvastatina, and 10 mg of ezetimiba.

• The other components are:

Tablet core

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

Tablet coating

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

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

Appearance of the product and contents of the package

Rosuvastatina/Ezetimiba 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 face.

Rosuvastatina/Ezetimiba 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 face.

OPA/Al/PVC//Al blister packs conditioned in cardboard boxes.

Packages of 30 film-coated tablets.

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

Elpen Pharmaceutical Co. Inc.

Marathonos Ave. 95

19009 Pikermi Attiki

Greece

or

Elpen Pharmaceutical Co. Inc.

Zapani, Block 1048

190 01 Keratea

Greece

Last review date of this leaflet:May 2023.

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/.