ROSUVASTATIN/EZETIMIBE KERN PHARMA 10 mg/10 mg HARD CAPSULES

2. What you need to know before you take Rosuvastatin/Ezetimibe Kern Pharma

Do not take Rosuvastatin/Ezetimibe Kern Pharma if:

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

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 Rosuvastatin/Ezetimibe 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 cause myasthenia (see section 4).
• you have kidney problems,
• you have liver problems,
• you have repeated and unexplained muscle pains or cramps, a personal or family history of muscle problems, or a 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 constant muscle weakness,
• you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor should establish the appropriate dose for you,
• if you are taking medicines to treat infections, including HIV (AIDS virus) or hepatitis C, such as ritonavir with lopinavir and/or atazanavir or simeprevir. See "Other medicines and Rosuvastatin/Ezetimibe Kern Pharma"
• you have severe respiratory failure,
• you are taking other cholesterol-lowering medicines called fibrates, see "Other medicines and Rosuvastatin/Ezetimibe Kern Pharma",
• 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 appropriate dose of Rosuvastatin/Ezetimibe for you).
• you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic). The combination of fusidic acid and Rosuvastatin/Ezetimibe can cause serious muscle problems (rhabdomyolysis).

If you are in any of these situations (or are unsure), consult your doctor or pharmacist before starting to take any dose of this medicinal product.

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 (transaminases) in the blood. For this reason, your doctor will normally perform blood tests (liver function tests) during treatment with this medicinal product. It is essential that you go to the doctor to have these tests done.

While taking this medicinal product, 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.

Be careful with Rosuvastatin/Ezetimibe Kern Pharma

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

Children and adolescents

The use of this medicinal product is not recommended in children and adolescents under 18 years of age.

Other medicines and Rosuvastatin/Ezetimibe Kern Pharma

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

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

• Ciclosporin (used after an organ transplant to prevent rejection of the transplanted organ. The effect of rosuvastatin increases with its combined use). Do not take Rosuvastatin/Ezetimibe 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 medicinal product), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates). The effect of rosuvastatin increases with its combined use.
• Colestyramine (a medicine to lower cholesterol), as it affects how ezetimibe works.
• Regorafenib (indicated for the treatment of cancer).
• Darolutamide (used to treat cancer).
• Simeprevir (indicated for the treatment of chronic hepatitis C infection).
• 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, 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). This effect can be mitigated by taking this type of medicine 2 hours after rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases with its combined use.

• Fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you should temporarily stop taking this medicinal product. Your doctor will tell you when you can safely take Rosuvastatin/Ezetimibe again. Taking Rosuvastatin/Ezetimibe 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). The levels of sex hormones absorbed from the pill are increased.
• Hormone replacement therapy (increased levels of hormones in the blood).

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

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 medicinal product. If you become pregnant while taking Rosuvastatin/Ezetimibe, stop taking it immediately and inform your doctor. Women must use contraceptive methods during treatment with Rosuvastatin/Ezetimibe.

Do not take this medicinal product if you are breastfeeding, as it is not known whether the medicinal product passes into breast milk.

Driving and using machines

Rosuvastatin/Ezetimibe is not expected to affect your ability to drive or use machines. However, some people may feel dizzy during treatment with Rosuvastatin/Ezetimibe. If you feel dizzy, consult your doctor before attempting to drive or use machines.

This medicinal product contains lactose and sodium

This medicinal product contains lactose. Patients with hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.

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

3. How to take Rosuvastatin/Ezetimibe Kern Pharma

Follow exactly the administration instructions of this medicinal product given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

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

Take this medicinal product 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 each day.

This medicinal product is not suitable for initiating 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 this medicinal product of the corresponding dose.

Regular cholesterol level checks

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

If you take more Rosuvastatin/Ezetimibe Kern Pharma 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 medicinal product and the amount ingested.

If you forget to take Rosuvastatin/Ezetimibe Kern Pharma

Do not worry, simply take the next scheduled dose at the planned time. Do not take a double dose to make up for forgotten doses.

If you stop taking Rosuvastatin/Ezetimibe Kern Pharma

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

If you have any further questions on the use of this medicinal product, 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 can be.

Stop taking this medicine and seek immediate medical attention if you experience any of the following symptoms:

• 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 swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Stop taking this medicine and seek immediate medical attention if you experience any of the following adverse effects:

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

• Allergic reactions such as swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing and swallowing.
• Unexplained muscle pain and cramps that last longer than expected. In rare cases, this can lead to potentially life-threatening muscle damage known as rhabdomyolysis, which can cause general discomfort, fever, and kidney failure.
• Lupus-like syndrome (including rash, joint disorder, and effects on blood cells).

• Muscle rupture.

Other adverse 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, 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 of certain liver function test results (transaminases);

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

• Skin rash, itching, hives;
• Increased protein in the urine, which usually reverses on its own without the need to interrupt treatment with rosuvastatin;
• High levels of certain muscle function test results (CK);
• 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.

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

• Pancreatitis, which causes severe stomach pain that can radiate to the back;
• Decreased platelet count.

Very rare (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):

• Breathing difficulties;
• 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;
• 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: 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 Kern Pharma

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date shown on the carton and blister pack after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Rosuvastatin/Ezetimibe Kern Pharma

The active ingredients are rosuvastatin (as rosuvastatin calcium) and ezetimibe. The capsules contain rosuvastatin calcium equivalent to 10 mg or 20 mg of rosuvastatin. Each capsule contains 10 mg of ezetimibe.

The other ingredients are:

Capsule content

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

Capsule coating

Rosuvastatin/Ezetimibe Kern Pharma 10 mg/10 mg hard capsules

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

Rosuvastatin/Ezetimibe Kern Pharma 20 mg/10 mg hard capsules

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

Body: Titanium dioxide (E171), gelatin.

Product Appearance and Package Contents

Rosuvastatin/Ezetimibe Kern Pharma 10 mg/10 mg hard capsules: Hard gelatin capsule, with yellow cap and body, filled with two rosuvastatin film-coated tablets, round and pink, and two ezetimibe tablets, round and white.

Rosuvastatin/Ezetimibe Kern Pharma 20 mg/10 mg hard capsules: Hard gelatin capsule, with green cap and white body, filled with four rosuvastatin film-coated tablets, round and pink, and two ezetimibe tablets, round and white.

Packaging: 30 hard capsules in a Poliamide/Aluminum/PVC (OPA) blister pack - Aluminum inside a cardboard box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande, 2, Abrunheira,

2710 – 089 Sintra, Portugal

Date of the Last Revision of this Leaflet: May 2023

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