ROSUVASTATIN/EZETIMIBE NORMOGEN 20 mg/10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Rosuvastatin/Ezetimibe Normogen 10 mg/10 mg film-coated tablets EFG

Rosuvastatin/Ezetimibe Normogen 20 mg/10 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Rosuvastatin/Ezetimibe Normogen and what is it used for
2. What you need to know before taking Rosuvastatin/Ezetimibe Normogen
3. How to take Rosuvastatin/Ezetimibe Normogen
4. Possible side effects
5. Storage of Rosuvastatin/Ezetimibe Normogen
6. Package contents and additional information

1. What is Rosuvastatin/Ezetimibe Normogen and what is it used for

This medication contains two different active substances in one film-coated tablet. One of the active substances is rosuvastatin, which belongs to the group of statins, and the other active substance is ezetimibe.

Rosuvastatin/Ezetimibe is a medication used to reduce the levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides that circulate in the blood. Additionally, Rosuvastatin/Ezetimibe increases the levels of "good" cholesterol (HDL cholesterol). This medication works by reducing cholesterol in two ways: it reduces both the cholesterol absorbed in the digestive tract and the cholesterol produced by the body itself.

For most people, high cholesterol levels do not affect how they feel, as 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 can cause a heart attack or stroke. By reducing cholesterol levels, you can reduce your risk of having a heart attack, stroke, or other related health problems.

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

This medication is used in patients with heart disease. Rosuvastatin/Ezetimibe reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

This medication does not help you lose weight.

2. What you need to know before taking Rosuvastatin/Ezetimibe Normogen

Do not take Rosuvastatin/Ezetimibe Normogen if:

• You are allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medication (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 (medications used to treat hepatitis C virus infection).
• You are taking a medication called cyclosporine (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 should 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 another medication containing rosuvastatin.

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 Normogen if:

• 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 previous history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you have unexplained muscle pains or cramps, especially if you have general discomfort or fever. Also, inform your doctor or pharmacist if you have constant muscle weakness.
• 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 to appear (see section 4).
• 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 medications to treat infections, including HIV (AIDS virus) or hepatitis C, such as ritonavir with lopinavir and/or atazanavir. See "Taking Rosuvastatina/Ezetimiba Normogen with other medications".
• You have severe respiratory failure.
• You are taking other cholesterol-lowering medications called fibrates, see "Taking Rosuvastatina/Ezetimiba Normogen with other medications".
• You regularly consume large amounts of alcohol.
• Your thyroid gland does not function 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 medication 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 Rosuvastatin/Ezetimibe.

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 taking Rosuvastatin/Ezetimibe and seek immediate medical attentionif 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 blood 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 Rosuvastatin/Ezetimibe. It is essential that you visit your doctor for these tests.

While taking this medication, 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.

Children and adolescents

Rosuvastatin/Ezetimibe is not recommended for use in children and adolescents under 18 years of age.

Other medications and Rosuvastatin/Ezetimibe Normogen

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

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

• Cyclosporine (used after an organ transplant to prevent rejection of the transplanted organ. The effect of rosuvastatin increases with concomitant use). Do not take Rosuvastatin/Ezetimibeif you are taking cyclosporine.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and the risk of bleeding may increase if taken with Rosuvastatin/Ezetimibe), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medications called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates). The effect of rosuvastatin increases with concomitant use.
• Colestyramine (a medication also used to lower cholesterol), as it affects how ezetimibe works.
• Regorafenib (indicated for the treatment of cancer).
• Simeprevir (indicated for the treatment of chronic hepatitis C infection).
• Darolutamide (used to treat cancer).
• 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, 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 medication 2 hours after rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases with concomitant use.
• Fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you should temporarily stop taking this medication. Your doctor will indicate 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.
• Capmatinib indicated for the treatment of cancer.
• Hormone replacement therapy (increased levels of hormones in the blood).
• Fostamatinib (used to treat low platelet count).
• Febuxostat (used to treat and prevent high levels of uric acid in the blood).
• Teriflunomide (indicated for the treatment of multiple sclerosis).

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 plan to become pregnant, consult your doctor or pharmacist before using this medication. If you become pregnant while taking Rosuvastatin/Ezetimibe, stop taking it immediately and inform your doctor. Women should use contraceptive methods during treatment with Rosuvastatin/Ezetimibe.

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

Driving and using machines

Rosuvastatin/Ezetimibe is not believed 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.

Rosuvastatin/Ezetimibe Normogen contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Rosuvastatin/Ezetimibe Normogen contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which is essentially "sodium-free.

3. How to take Rosuvastatin/Ezetimibe Normogen

Follow the instructions for administration of this medication indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

You should continue to follow a cholesterol-reducing diet and exercise while taking Rosuvastatin/Ezetimibe.

The recommended daily dose for adults is one film-coated tablet of the corresponding concentration.

Take Rosuvastatin/Ezetimibe once a day.

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

Rosuvastatin/Ezetimibe 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 are adjusted, it is possible to switch to Rosuvastatin/Ezetimibe of the corresponding dose.

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 are maintained at appropriate levels.

If you take more Rosuvastatin/Ezetimibe Normogen than you should

Contact your doctor or the nearest hospital emergency department, 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, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Rosuvastatin/Ezetimibe Normogen

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 Normogen

Consult your doctor if you want to stop taking Rosuvastatin/Ezetimibe. Your cholesterol levels may increase again if you stop taking Rosuvastatin/Ezetimibe.

If you have any further questions about the use of this medication, 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 Rosuvastatin/Ezetimibe and seek medical attention immediately 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 pains 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.

Adverse Effects of Unknown Frequency (cannot be estimated from available data):

• Red, target-like, or circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, elevated body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• Erythema multiforme (potentially life-threatening allergic reactions that affect the skin and mucous membranes).

Other Possible 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.
• Abdominal pain (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 spread to the back.
• Decreased blood platelet levels.

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 arms and legs (such as numbness).
• Memory loss.
• Increased breast size in men (gynecomastia).

Unknown Frequency (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, which can affect the muscles used for breathing in some cases).
• 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 breathing difficulties.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: 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 Normogen

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

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

This medicine does not require any special storage temperature.

Do not use this medicine after the expiration date shown on the box and blister pack after CAD. 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 any unused medicines in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofRosuvastatin/Ezetimibe Normogen

• The active ingredients are rosuvastatin (as rosuvastatin calcium) and ezetimibe. The film-coated tablets contain rosuvastatin calcium equivalent to 10 mg or 20 mg of rosuvastatin. Each film-coated tablet contains 10 mg of ezetimibe.
• The other ingredients are:

Ezetimibe Layer:

Povidone, sodium lauryl sulfate, sodium croscarmellose, microcrystalline cellulose, hypromellose, mannitol (E421), and magnesium stearate.

Rosuvastatin Layer:

Microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, red iron oxide (E-172), colloidal anhydrous silica, and magnesium stearate.

Coating:

Hypromellose, propylene glycol, talc, red iron oxide (E-172), and yellow iron oxide (E-172) (only for 20 mg/10 mg dose).

Appearance and Package Contents

Rosuvastatin/Ezetimibe Normogen 10 mg/10 mg film-coated tablets EFG.

Red, round, biconvex, anonymous film-coated tablets with a diameter of 8.8 mm.

Rosuvastatin/Ezetimibe Normogen 20 mg/10 mg film-coated tablets EFG. Red-orange, round, biconvex, anonymous film-coated tablets with a diameter of 8.8 mm.

Package of 30 film-coated tablets in aluminum/aluminum-polyamide-PVC blisters.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6,

28760 Tres Cantos (Madrid), Spain

Date of Last Revision of this Leaflet: May 2024

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/)