ROSUVASTATIN/EZETIMIBE CINFA 5 mg/10 mg FILM-COATED TABLETS

2. What you need to know before you take rosuvastatin/ezetimibe cinfa

Do not take rosuvastatin/ezetimibe cinfa if

• you are allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6),
• you have liver disease,
• you have severe kidney problems,
• you have repeated or unexplained muscle pains or cramps (myopathy),
• you are taking a medicine called ciclosporin (used, for example, after an organ transplant),
• you are taking a combination of medicines called sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver infection called hepatitis C).
• you are pregnant or breastfeeding. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor. Women must use a suitable contraceptive method during treatment with this medicine.
• if you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking this medicine or other related medicines.

If you are in any of these situations (or if you are not sure), consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take rosuvastatin/ezetimibe cinfa if:

• you have kidney problems,
• you have liver problems,
• you have repeated or unexplained muscle pains or cramps, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines. Tell your doctor immediately if you have unexplained muscle pain or cramp, especially if you feel unwell or have a fever. Also, tell your doctor or pharmacist if you have persistent 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 medicines to treat infections, including HIV (AIDS) or hepatitis C, such as ritonavir with lopinavir and/or atazanavir. See "Other medicines and rosuvastatin/ezetimibe cinfa",
• you have severe respiratory failure,
• you are taking other cholesterol-lowering medicines called fibrates, see "Other medicines and rosuvastatin/ezetimibe cinfa",
• you are going to have an operation. You may need to stop taking rosuvastatina/ezetimiba for a short time
• you regularly drink large amounts of alcohol,
• your thyroid gland does not work properly (hypothyroidism),
• you are over 70 years old, (as your doctor should choose the right dose of rosuvastatin/ezetimibe for you).
• you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic), by mouth or by injection. The combination of fusidic acid and rosuvastatin/ezetimibe can cause serious muscle problems (rhabdomyolysis).
• you are taking regorafenib (a medicine to treat cancer)
• if 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 trigger the onset of myasthenia (see section 4).

If you are in any of these situations mentioned above (or if you are not sure): 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 in association with rosuvastatin 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 can be detected by a simple blood test that checks for increased levels of liver enzymes in the blood. For this reason, your doctor will normally do blood tests (liver function tests) during treatment with this medicine. It is important that you go to the doctor for these tests.

While taking this medicine, 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 fats in the blood, are overweight, and have high blood pressure.

Children and adolescents

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

Other medicines and rosuvastatin/ezetimibe cinfa

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

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

• Ciclosporin (used, for example, after an organ transplant to prevent rejection of the transplanted organ. The effect of rosuvastatin increases with its combined use). Do not take this medicine if you are taking ciclosporin.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and the risk of bleeding may increase while taking this medicine), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates).
• Colestyramine (a medicine to lower cholesterol), as it affects how ezetimibe works.
• Regorafenib (indicated for the treatment of cancer).
• Darolutamide (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.
• 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 fusidic acid by mouth to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when you can safely start taking rosuvastatin/ezetimibe again. Taking this medicine 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 medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take rosuvastatin/ezetimibe if you are pregnant, think you may be pregnant, or are planning to have a baby. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor. Women must use a suitable contraceptive method during treatment with this medicine.

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

Driving and using machines

This medicine is unlikely to affect 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.

Rosuvastatin/ezetimibe cinfa contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Rosuvastatin/ezetimibe cinfa contains sodium

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

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3. How to take rosuvastatin/ezetimibe cinfa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

You should continue to follow a cholesterol-lowering diet while taking this medicine.

The recommended dose for adults is one tablet per day.

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

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

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

If your doctor has prescribed rosuvastatin/ezetimibe with another cholesterol-lowering medicine that contains colestyramine or any other bile acid sequestrant, you should take rosuvastatin/ezetimibe cinfa at least 2 hours before or 4 hours after these medicines.

Regular checks of cholesterol levels

It is important that you go to your doctor regularly to have your cholesterol levels checked, to ensure that your cholesterol levels have returned to normal and remain at appropriate levels.

If you take more rosuvastatin/ezetimibe cinfa than you should

Contact your doctor or the nearest hospital emergency department immediately, 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take rosuvastatin/ezetimibe 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 missed doses.

If you stop taking rosuvastatin/ezetimibe cinfa

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

If you have any further questions on 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 all people suffer from them.

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

Stop taking this medicine 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). Rare (may affect up to 1 in 1000 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). Rare (may affect up to 1 in 1000 people);
• red, non-raised spots on the torso, target-shaped or circular, 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);
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).
• if you experience muscle rupture
• if you present with a syndrome that has symptoms similar to lupus (including hives, joint disorders, and effects on blood cells).

Other Adverse Effects

Common 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).
• 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 40 mg).

Uncommon 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 spread to the back
• decrease in the number of platelets in the blood, which can cause bruising or bleeding (thrombocytopenia).
• pseudolupus syndrome (including skin rash, joint disorders, and effects on blood cells).
• muscle rupture.

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;
• enlargement of the breasts in men (gynecomastia).

Frequency Not Known (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-shaped lesions (erythema multiforme).
• muscle sensitivity.
• 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 your 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 Cinfa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine 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 drain or into the trash. 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 Cinfa

• The active ingredients are rosuvastatin (as rosuvastatin calcium) and ezetimibe.
• Each film-coated tablet contains rosuvastatin calcium equivalent to 5 mg of rosuvastatin and 10 mg of ezetimibe.

• The other ingredients are:

Core

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

Coating

Opadry yellow 02F220026 which contains: Hypromellose, Macrogol, Titanium dioxide (E-171), Yellow iron oxide (E-172), Talc, Red iron oxide (E-172).

Appearance of the Product and Package Contents

Rosuvastatin/Ezetimibe Cinfa 5 mg/10 mg are film-coated tablets, biconvex, round, light yellow in color, with a diameter of approximately 10 mm and with the inscription "EL 5" on one face.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial 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

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) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/88173/P_88173.html

QR code to: https://cima.aemps.es/cima/dochtml/p/88173/P_88173.html