Package Leaflet: Information for the User

Rosuvastatin/Ezetimibe Cinfa 10 mg/10 mg Film-Coated Tablets

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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. Do not give it to others even if they have similar symptoms to yours, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

This medicine contains two different active principles in one tablet. One of the active principles is rosuvastatina, which belongs to the group of medicines called statins, the other active principle is ezetimiba.

Rosuvastatina/ezetimiba is a medicine used in adult patients to reduce high levels of cholesterol, the "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. In addition, this medicine increases the concentrations of the "good" cholesterol (HDL cholesterol). This medicine acts by reducing cholesterol in two ways: reducing the cholesterol absorbed in the digestive tract as well as the cholesterol produced by the body itself.

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. Sometimes, these narrowed blood vessels can become blocked, cutting off the 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.

This medicine is used in patients who cannot control their cholesterol levels solely with diet. While taking this medicine, you must follow a cholesterol-reducing diet.

Your doctor may prescribe this medicine if you are already taking rosuvastatina and ezetimiba at the same dose level.

Rosuvastatina/ezetimiba is used if you have:

- high cholesterol levels in the blood (primary hypercholesterolemia)

- heart disease, rosuvastatina/ezetimiba reduces the risk of myocardial infarction, stroke, coronary artery bypass surgery, or hospitalization for chest pain.

This medicine does not help you lose weight.

Do not take rosuvastatina/ezetimiba cinfa if

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take rosuvastatina/ezetimiba cinfa if:

• you have kidney problems,
• you have liver problems,
• you have repeated or unexplained muscle pain and cramps, a personal or family history of muscle problems or a previous history of muscle problems during treatment with other cholesterol-lowering medicines. 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 persistent muscle weakness,
• you are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian). Your doctor should establish the appropriate dose for you,
• you are taking medicines to treat infections, including HIV (AIDS virus) or hepatitis C, such as ritonavir with lopinavir and/or atazanavir. See “Other medicines and rosuvastatina/ezetimiba cinfa”,
• you have severe respiratory failure,
• you are taking other medicines called fibrates to lower cholesterol, see “Other medicines and rosuvastatina/ezetimiba cinfa”,
• you are going to have an operation. You may need to stop taking rosuvastatina/ezetimiba for a short time
• you regularly consume large amounts of alcohol,
• your thyroid gland does not function correctly (hypothyroidism),
• you are over 70 years old, (since your doctor should choose the appropriate dose of rosuvastatina/ezetimiba for you).
• you are taking or have taken within the last 7 days a medicine called fusidic acid (an antibacterial medicine) by mouth or injection. The combination of fusidic acid and rosuvastatina/ezetimiba can cause severe muscle problems (rhabdomyolysis).
• you are taking regorafenib (a cancer medicine)
• if you have or have had myasthenia (a disease that causes generalised muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (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 mentioned above (or are unsure): consult your doctor or pharmacist before starting to take any dose of this medicine.

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

In a small number of people, statins can 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 medicine. It is essential that you go to the doctor for the tests.

While taking this medicine, 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.

Children and adolescents

This medicine is not suitable for children and adolescents under 18 years of age.

Other medicines and rosuvastatina/ezetimiba cinfa

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

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

• Ciclosporina (used for example after an organ transplant to prevent organ rejection. The effect of rosuvastatina is increased with its use together).Do not takethis medicine 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 medicine together), ticagrelor or clopidogrel.
• Other medicines to lower cholesterol called fibrates, which also correct triglyceride levels in the blood (e.g. gemfibrozil and other fibrates).
• Colestiramina (a medicine to lower cholesterol), because it affects how ezetimiba works.
• Regorafenib (used to treat cancer).
• Darolutamida (used to treat cancer).
• Any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Antacids containing aluminium and magnesium (used to neutralise stomach acid, as they reduce the level of rosuvastatina in plasma).
• Erythromycin (an antibiotic).
• Fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking this medicine. Your doctor will tell you when you can safely take rosuvastatina/ezetimiba again. Taking this medicine with fusidic acid can cause muscle weakness, pain or tenderness (rhabdomyolysis) in rare cases. See more information about rhabdomyolysis in section 4.
• Oral contraceptive (the pill).
• Hormone replacement therapy (increasing hormone levels in the blood).

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

Pregnancy and breastfeeding

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

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 medicine, stop taking it immediately and inform your doctor. Women should use an appropriate contraceptive method during treatment with this medicine.

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

Driving and using machines

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

Rosuvastatina/ezetimiba cinfa contains lactose

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

Rosuvastatina/ezetimiba cinfa contains sodium

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

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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 each 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 done by taking the active principles separately, and once the appropriate doses have been adjusted, it is possible to switch to the appropriate dose of rosuvastatina/ezetimiba cinfa.

If your doctor has prescribed rosuvastatina/ezetimiba along with another cholesterol-lowering medication that contains the active ingredient colestiramine or any other medication that contains a bile acid sequestrant, you should take rosuvastatina/ezetimiba cinfa at least 2 hours before or 4 hours after taking 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 cinfa than you should

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

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

If you forget to take rosuvastatina/ezetimiba cinfa

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 the missed dose.

If you interrupt treatment with rosuvastatina/ezetimiba cinfa

Consult your doctor if you want to stop taking 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 essential that you know which side effects may occur.

Stop taking this medicine and seek medical help immediately 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 may lead to a potentially life-threatening condition (rhabdomyolysis). 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). Rare (may affect up to 1 in 1,000 people);
• flat, red patches on the trunk, often with blisters, peeling skin, 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);
• generalized rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome);
• if you experience muscle rupture;
• if you experience a syndrome with symptoms similar to lupus (including urticaria, joint disorders, and effects on blood cells).

Other side effects

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

• headache;
• constipation;
• general discomfort;
• muscle pain;
• weakness;
• dizziness;
• diabetes. This is more likely if you have high blood sugar and lipid levels, obesity, 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 of certain liver function test results (transaminases) in the blood;
• an increase in the amount of protein in the urine, which usually normalizes without the need to interrupt treatment with rosuvastatin/ezetimiba (only with rosuvastatin 40 mg).

Rare side effects (may affect up to 1 in 100 people)

• skin rash, itching, urticaria;
• high levels of certain muscle function test results (creatine kinase test);
• cough;
• indigestion;
• heartburn;
• joint pain;
• muscle spasms;
• neck pain;
• loss of appetite;
• pain;
• chest pain;
• angina;
• high blood pressure;
• tingling sensation;
• dry mouth;
• inflammation of the stomach;
• 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/ezetimiba (only with rosuvastatin 10 mg and 20 mg).

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

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

Unknown frequency (cannot be estimated from available data)

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, 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 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.

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

This medication does not require any special storage temperature.

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

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

Rosuvastatina/Ezetimiba Cinfa Composition

• The active principles are rosuvastatina (as rosuvastatina calcium) and ezetimiba.
• Each film-coated tablet contains rosuvastatina calcium equivalent to 10 mg of rosuvastatina and 10 mg of ezetimiba.

• The other components are:

Core

Lactose monohydrate, Croscarmelosa sodium, Povidone, Laurilsulfate of sodium, Microcrystalline cellulose, Hypromellose, Anhydrous colloidal silica, and Magnesium stearate.

Coating

Opadry beige 02F270003 containing: Hypromellose, Titanium dioxide (E-171), Yellow iron oxide (E-172), Macrogol, and Talc.

Product Appearance and Packaging Content

Rosuvastatina/Ezetimiba Cinfa 10 mg/10 mg are film-coated, biconvex, round, beige-colored tablets, approximately 10 mm in diameter, with the inscription "EL 4" on one face.

Rosuvastatina/Ezetimiba Cinfa is available in OPA/Al/PVC//Al blister packs of 30 film-coated tablets.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Cinfa Laboratories, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible Manufacturer

Cinfa Laboratories, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

or

ELPEN Pharmaceutical Co Inc

Marathonos Ave. 95, Pikermi Attiki,

19009, Greece

or

ELPEN Pharmaceutical Co Inc

Inc Zapani, Block 1048, Keratea, 190 01, Greece

Last Review Date of this Leaflet:May 2023

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/88170/P_88170.html

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