Package Insert: Information for the Patient

Rosuvastatina/Ezetimiba Kern Pharma 10 mg/10 mg Hard Capsules

Rosuvastatina/Ezetimiba Kern Pharma 20 mg/10 mg Hard Capsules

Read this package insert carefully before starting to take this medicine, as it contains important information for you

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine 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.

This medication contains two different active principles in one capsule. One of the active principles is rosuvastatina, which belongs to the group of statins, the other active principle is ezetimiba.

This medication is used to reduce the concentrations of total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. In addition, Rosuvastatina/Ezetimiba increases the concentrations of "good" cholesterol (HDL cholesterol). This medication 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 blood supply to the heart or brain, which would cause a heart attack or cerebral embolism. By reducing cholesterol levels, the risk of having a heart attack, cerebral embolism, or other related health problems can be reduced.

What is Rosuvastatina/Ezetimiba Kern Pharma used for

Thismedicationis used in patients who cannot control their cholesterol levels solely with a 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 dose level.

This medication is used if you have:

• high blood cholesterol levels (primary hypercholesterolemia)
• heart disease, this medication reduces the risk of myocardial infarction and cerebrovascular accident, and is used in surgery to increase blood flow to the heart or hospitalization for chest pain.

Rosuvastatina/Ezetimiba does not help you lose weight.

Do not take Rosuvastatina/Ezetimiba Kern Pharma 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 combination of sofosbuvir/velpatasvir/voxilaprevir (medications used to treat a viral liver infection called hepatitis C).
• 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 Rosuvastatina/Ezetimiba, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Rosuvastatina/Ezetimiba using an appropriate contraceptive method.
• You have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking Rosuvastatina/Ezetimiba or other related medications.

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 Rosuvastatina/Ezetimiba if:

• You have or have had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).
• 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. Inform your doctor immediately if you have unjustified muscle pain or cramps, especially if you experience general discomfort or fever. Also, inform your doctor or pharmacist if you experience 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 ritonavir with lopinavir and/or atazanavir or simeprevir. See “Other medications and Rosuvastatina/Ezetimiba Kern Pharma”
• You have severe respiratory failure,
• You are taking other medications called fibrates to lower cholesterol, see “Other medications and Rosuvastatina/Ezetimiba Kern Pharma”,
• You regularly consume large amounts of alcohol,
• Your thyroid gland does not function correctly (hypothyroidism),
• You are over 70 years old, (as 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 antibacterial medication) orally or injectable. The combination of fusidic acid and Rosuvastatina/Ezetimiba may cause severe muscle problems (rhabdomyolysis).

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 can affect the liver. This is detected by a simple test that detects increased levels of liver enzymes (transaminases) 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 to perform 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 levels of sugar and fats in your blood, are overweight, and have high blood pressure.

Be especially careful with Rosuvastatina/Ezetimiba Kern Pharma

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

Children and adolescents

This medication is not recommended for use in children and adolescents under 18 years of age.

Other medications and Rosuvastatina/Ezetimiba Kern Pharma

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 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). The effect of rosuvastatina is increased with its use together.
• Colestiramina (a medication to lower cholesterol), because it affects how ezetimiba works.
• Regorafenib (used to treat cancer).
• Darulotamida (used to treat cancer.
• Simeprevir (used to treat chronic hepatitis C).
• 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, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Medications for indigestion containing aluminum and magnesium (used to neutralize stomach acid, as they reduce the level of rosuvastatina in plasma). This effect can be mitigated by taking this type of medication 2 hours after rosuvastatina.
• Eritromicina (an antibiotic). The effect of rosuvastatina is reduced with its use together.

• Fusidic acid.If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily interrupt taking this medication. Your doctor will indicate when you can safely take Rosuvastatina/Ezetimiba again. Taking Rosuvastatina/Ezetimiba with fusidic acid may cause rare muscle weakness, pain, or sensitivity (rhabdomyolysis). You can find more information about rhabdomyolysis in section 4.
• Oral contraceptive (the pill).The levels of sex hormonesthat are absorbed fromthe pillare increased.
• Hormone replacement therapy (increased levels of hormones in the blood).

If you visit a hospital or receive treatment for another condition, inform the medical staff that you are taking Rosuvastatina/Ezetimiba.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication. If you become pregnant while taking Rosuvastatina/Ezetimiba, stop taking it immediately and inform your doctor. Women should use contraceptive methods during treatment with Rosuvastatina/Ezetimiba.

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

Driving and operating machinery

Rosuvastatina/Ezetimiba is not believed to interfere with your ability to drive or operate machinery. However, some people may experience dizziness during treatment with Rosuvastatina/Ezetimiba. If you feel dizzy, consult your doctor before attempting to drive or operate machinery.

This medication contains lactose and sodium

This medication contains lactose. Patients with hereditary intolerance to galactose, total lactase deficiency, or problems with glucose or galactose absorption should not take this medication.

This medication contains less than 1 mmol of sodium (23 mg) per hard capsule, i.e., it is essentially “sodium-free”.

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

You should continue to maintain a low-cholesterol diet and exercise while taking this medication.

The recommended daily dose for adults is one capsule of the concentration in question.

Take this medication once a day.

You can take it at any time of the day with or without food. Swallow each capsule whole with water. Try to take the capsules at the same time every day.

This medication is not suitable for initiating treatment. The start of treatment or dose adjustments, if necessary, should only be made by taking the active ingredients separately, and once the appropriate doses have been adjusted, it is possible to switch to this medication at the corresponding dose.

Regular cholesterol level checks

It is essential that you visit your doctor regularly for cholesterol checks, in order to verify that your cholesterol levels have normalized and are maintained at appropriate levels.

If you take more Rosuvastatina/Ezetimiba Kern Pharma 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 Kern Pharma

Do not worry, simply take the next scheduled dose at the planned time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Rosuvastatina/Ezetimiba Kern Pharma

Consult your doctor if you want to interrupt 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 this medicine and seek medical help immediately if you experience any of the following symptoms:

• Flat red spots on the trunk, often with blisters, peeling skin, mouth ulcers, throat, nose, genital, and eye ulcers. 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).

Stop taking this medicine and seek medical help immediately if you experience any of the following side effects:

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

• Allergic reactions such as swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing and swallowing.
• Unjustified muscle pain and cramps that last longer than expected. In rare cases, this may become a potentially fatal muscle damage known as rhabdomyolysis, leading to general discomfort, fever, and kidney failure.
• Syndrome similar to lupus (including rash, joint disorder, and effects on blood cells).

• Muscle rupture.

Other side effects:

Frequent (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, 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);

Occasional (may affect up to 1 in 100 people):

• Skin rash, itching, urticaria;
• Increased protein levels in urine, which usually returns to normal on its own without the need to stop treatment with rosuvastatin;
• High levels in some blood test results for muscle function (CK);
• Cough;
• Indigestion;
• Heartburn;
• Joint pain;
• Muscle spasms;
• Neck pain;
• Loss of 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 in the hands and feet.

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

• Pancreatitis, which causes severe stomach pain that may spread to the back;
• Reduced platelet levels in the blood.

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

• Ictericia (yellowing of the skin and eyes);
• Liver inflammation (hepatitis);
• Blood in the urine;
• Nerve damage in the legs and arms (such as numbness);
• Memory loss;
• Enlargement of the breasts in men (gynecomastia).

Frequency unknown (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;
• Gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, and vomiting).
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia ocular (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, eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: 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 special conditions for conservation.

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

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

Rosuvastatina/Ezetimiba Kern Pharma Composition

The active principles are rosuvastatina (as rosuvastatina calcium) and ezetimiba. The capsules contain rosuvastatina calcium equivalent to 10 mg or 20 mg of rosuvastatina. Each capsule contains 10 mg of ezetimiba.

The other components are:

Capule Content

Lactose monohydrate, hypromellose, sodium croscarmellose (E468), sodium laurilsulfate (E514), microcrystalline cellulose (E460), stearic acid fumarate and sodium, lactose (anhydrous), crospovidone, talc, anhydrous colloidal silica (E551), titanium dioxide (E171), triacetin, and iron oxide red (E172).

Capule Coating

Rosuvastatina/Ezetimiba Kern Pharma 10 mg/10 mg hard capsules

Crown and body: Yellow iron oxide (E172), titanium dioxide (E171), gelatin.

Rosuvastatina/Ezetimiba Kern Pharma 20 mg/10 mg hard capsules

Crown: Titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), carmine lake (E132), gelatin.

Body: Titanium dioxide (E171), gelatin.

Product Appearance and Packaging Content

Rosuvastatina/Ezetimiba Kern Pharma 10 mg/10 mg hard capsules: Hard gelatin capsule, with yellow-colored crown and body, filled with two rosuvastatina film-coated tablets, round and pink, and two ezetimiba round and white tablets.

Rosuvastatina/Ezetimiba Kern Pharma 20 mg/10 mg hard capsules: Hard gelatin capsule, with green-colored crown and white-colored body, filled with four rosuvastatina film-coated tablets, round and pink, and two ezetimiba round and white tablets.

Packaging of 30 hard capsules in a Poliamida/Aluminio/PVC (OPA) - Aluminio blister inside a cardboard box.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

Responsible Manufacturer

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande, 2, Abrunheira,

2710 – 089 Sintra, Portugal

Last Review Date of this Prospectus: May 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.es/.