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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

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

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

• Keep this 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Rosuvastatin/Ezetimibe Kern Pharma is and what it is used for
2. What you need to know before taking Rosuvastatin/Ezetimibe Kern Pharma
3. How to take Rosuvastatin/Ezetimibe Kern Pharma
4. Possible adverse effects
5. How to store Rosuvastatin/Ezetimibe Kern Pharma
6. Contents of the pack and other information

1. What Rosuvastatina/Ezetimiba Kern Pharma is and what it is used for

This medicine contains two different active substances in one capsule. One of the active substances is rosuvastatin, which belongs to the group of medicines called statins; the other active substance is ezetimibe.

This medicine is used to lower blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides. In addition, Rosuvastatina/Ezetimiba increases levels of "good" cholesterol (HDL cholesterol). This medicine works in two ways: by reducing cholesterol absorption in the digestive tract and by reducing cholesterol produced by the body itself.

For most people, high cholesterol levels do not affect how they feel, as they produce no symptoms. However, if left untreated, fatty deposits can build up 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, leading to a heart attack or stroke. By lowering cholesterol levels, your risk of having a heart attack, stroke, or other related health problems can be reduced.

What Rosuvastatina/Ezetimiba Kern Pharma is used for

This medicine is used in patients who cannot control their cholesterol levels through diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet. Your doctor may prescribe this medicine if you are already taking rosuvastatin and ezetimibe at the same dose levels.

This medicine is used if you have:

• high cholesterol levels in the blood (primary hypercholesterolemia)
• heart disease; this medicine reduces the risk of myocardial infarction and stroke, and is used in surgery to improve blood flow to the heart or to prevent hospitalization due to chest pain.

Rosuvastatina/Ezetimiba does not help you lose weight.

2. What you need to know before taking 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 medicine (listed in section 6),
• you have liver disease,
• you have severe kidney problems,
• you have recurrent or unexplained muscle pain and cramps (myopathy),
• you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (medicines used to treat a viral liver infection called hepatitis C),
• you are taking a medicine called cyclosporine (used, for example, after organ transplantation),
• you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin/Ezetimibe, stop taking it immediately and inform your doctor. Women must use an appropriate contraceptive method during treatment with Rosuvastatin/Ezetimibe to avoid becoming pregnant.
• you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores 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

Talk to your doctor or pharmacist before starting to take Rosuvastatin/Ezetimibe if:

• you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• you have kidney problems,
• you have liver problems,
• you have recurrent or unexplained muscle pain and cramps, a personal or family history of muscle disorders, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if accompanied by malaise or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness,
• you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will determine the appropriate dose for you,
• you are taking medicines to treat infections, including HIV (human immunodeficiency 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 insufficiency,
• you are taking other medicines called fibrates to lower cholesterol; see "Other medicines and Rosuvastatin/Ezetimibe Kern Pharma",
• you regularly consume large amounts of alcohol,
• you have an underactive thyroid gland (hypothyroidism),
• you are over 70 years old (as your doctor must select the appropriate dose of Rosuvastatin/Ezetimibe for you),
• you are taking or have taken within the last 7 days a medicine called fusidic acid (an antibacterial medicine) by oral or injectable route. The combination of fusidic acid and Rosuvastatin/Ezetimibe may cause serious muscle problems (rhabdomyolysis).

If you are in any of the above situations (or are unsure), consult your doctor or pharmacist before starting any dose of this medicine.

In a small number of people, statins may affect the liver. This is detected through a simple blood test showing increased levels of liver enzymes (transaminases). For this reason, your doctor will usually perform blood tests (liver function tests) during your treatment with this medicine. It is important that you attend your scheduled appointments 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 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.

Take special care 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 medicine and seek immediate medical attention if you notice any of the symptoms described in section 4.

Children and adolescents

This medicine is not recommended for use 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 need to take any other medicines.

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

• Cyclosporine (used after organ transplantation to prevent organ rejection. The effect of rosuvastatin increases when taken together). Do not take Rosuvastatin/Ezetimibe if you are taking cyclosporine.

• Anticoagulants, such as warfarin, acenocoumarol, or phenindione (their anticoagulant effects and risk of bleeding may increase when taken with this medicine), ticagrelor, or clopidogrel.

• Other cholesterol-lowering medicines called fibrates, which also correct blood triglyceride levels (e.g., gemfibrozil and other fibrates). The effect of rosuvastatin increases when taken together.

• Colestipol (a cholesterol-lowering medicine), as it affects how ezetimibe works.

• Regorafenib (used to treat cancer).

• Darolutamide (used to treat cancer).

• Simeprevir (used to treat 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.

• Indigestion treatments containing aluminium and magnesium (used to neutralize stomach acid, as they reduce plasma levels of rosuvastatin). This effect can be minimized by taking these medicines 2 hours after rosuvastatin.

• Erythromycin (an antibiotic). The effect of rosuvastatin decreases when taken together.

• Fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart Rosuvastatin/Ezetimibe. Taking Rosuvastatin/Ezetimibe with fusidic acid may rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

• An oral contraceptive (the pill). Levels of absorbed sex hormones from the pill are increased.

• Hormone replacement therapy (increased hormone levels in the blood).

If you are admitted to hospital or receiving treatment for another condition, inform the medical staff that you are taking Rosuvastatin/Ezetimibe.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. 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 medicine if you are breastfeeding, as it is unknown whether the medicine passes into breast milk.

Driving and using machines

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

This medicine contains lactose and sodium

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

This medicine 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 instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You must continue to maintain a low-cholesterol diet and exercise while taking this medicine.

The recommended daily dose for adults is one capsule of the respective strength.

Take this medicine once daily.

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

This medicine is not suitable for initiating treatment. The start of treatment or dose adjustments, if necessary, should only be performed by taking the active substances separately. Once the appropriate doses have been established, it is then possible to switch to this medicine at the corresponding dose.

Regular cholesterol level monitoring

It is important 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 Rosuvastatin/Ezetimibe Kern Pharma than you should

Contact your doctor or the nearest hospital emergency department, as you may require medical assistance.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Rosuvastatin/Ezetimibe Kern Pharma

Do not worry; simply 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 Kern Pharma

Consult your doctor if you wish to discontinue treatment with this medicine. Your cholesterol levels may rise again if you stop taking this medicine.

If you have any further questions about 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 everyone will experience them.

It is important that you are aware of what these adverse effects may be.

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

• Red, flat spots on the trunk, target-shaped or circular, often with central blisters, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome 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 may cause difficulty breathing and swallowing.
• Unexplained muscle pain and cramps lasting longer than expected. In rare cases, this may progress to potentially life-threatening muscle damage known as rhabdomyolysis, leading to general malaise, fever, and kidney failure.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).
• Muscle rupture.

Other adverse effects:

Common (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 levels of blood sugar and lipids, overweight, and high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Stomach pain;
• Diarrhea;
• Flatulence (excess gas in the gastrointestinal tract);
• Feeling tired;
• Elevated levels in certain blood test results for liver function (transaminases);

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

• Skin rash, itching, hives;
• Increased amount of protein in urine, which usually returns to normal on its own without the need to discontinue rosuvastatin treatment;
• Elevated levels in certain blood test results for muscle function (CK);
• Cough;
• Indigestion;
• Heartburn;
• Joint pain;
• Muscle spasms;
• Neck pain;
• Decreased appetite;
• Pain;
• Chest pain;
• Hot flushes;
• High blood pressure;
• Tingling sensation;
• Dry mouth;
• Inflammation of the stomach;
• Back pain;
• Muscle weakness;
• Pain in arms and legs;
• Swelling, especially of the hands and feet.

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

• Inflammation of the pancreas, causing severe stomach pain that may spread to the back;
• Reduction in blood platelet levels.

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

• Jaundice (yellowing of the skin and eyes);
• Inflammation of the liver (hepatitis);
• Traces of blood in urine;
• Nerve damage in arms and legs (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 injury;
• Persistent muscle weakness;
• Gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting).
• Myasthenia gravis (a condition causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a condition causing 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 drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide 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 any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Rosuvastatin/Ezetimibe Kern Pharma

The active substances 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 components are:

Capsule contents

Lactose monohydrate, hypromellose, sodium croscarmellose (E468), sodium lauryl sulfate (E514), microcrystalline cellulose (E460), stearic fumarate and sodium, lactose (anhydrous), 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.

Appearance of the product and contents of the container

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

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

Packaging: 30 hard capsules in a Poliamide/Aluminum/PVC (OPA)-Aluminum blister pack, contained in 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 most recent review of this leaflet: May 2023

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