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

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 or unexplained muscle pain 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 or unexplained muscle pain or cramps, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medications. 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.
• 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 are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor should determine 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 Rosuvastatin/Ezetimibe Normogen with other medications".
• You have severe respiratory failure.
• You are taking other cholesterol-lowering medications called fibrates, see "Taking Rosuvastatin/Ezetimibe 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 medical attention immediatelyif 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 measures 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 blood sugar and fat levels, 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

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

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

Driving and using machines

Rosuvastatin/Ezetimibe is not expected to interfere with 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 have been 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 remain 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 interrupt treatment with Rosuvastatin/Ezetimibe Normogen

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

If you have any other 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 assistance 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.
• Unjustified muscle pain and cramps that last longer than expected. In rare cases, this can become potentially life-threatening muscle damage known as rhabdomyolysis, leading to 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):

• Reddish, non-elevated, target-shaped or circular patches on the torso, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, elevated body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).
• Erythema multiforme (potentially life-threatening allergic reactions affecting 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 in some blood test results for liver function (transaminases).

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

• Skin rash, itching, hives.
• Increased protein in urine, which usually reverses on its own without needing to interrupt treatment with rosuvastatin.
• High levels in some blood test results for muscle function (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.
• Reduced 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 legs and arms (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 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 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: 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 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 through wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. 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).

Product Appearance and Package Contents

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

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

Rosuvastatin/Ezetimibe Normogen 20 mg/10 mg film-coated tablets EFG. Red-orange, round, biconvex film-coated tablets, anonymous on both sides, 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 the 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/)