Package Leaflet: Information for the Patient

Rosuvastatina/Ezetimiba Normon 10 mg/10 mg Film-Coated Tablets

Rosuvastatina/Ezetimiba Normon 20 mg/10 mg Film-Coated Tablets

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

• Keep this package 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2. What you need to know before you start taking Rosuvastatina/Ezetimiba Normon

3. How to take Rosuvastatina/Ezetimiba Normon

4. Possible side effects

5. Storage of Rosuvastatina/Ezetimiba Normon

6. Contents of the pack and additional information

This medicine contains two different active principles in a film-coated tablet. One of the active principles is rosuvastatina, which belongs to the group of statins, the other active principle is ezetimiba.

Rosuvastatina/Ezetimibais a medicine used to reduce the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. In addition, Rosuvastatina/Ezetimiba increases the levels of "good" cholesterol (HDL cholesterol). This medicine 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.

This medicine is used in patients who cannot control their cholesterol levels solely with diet. While taking this medicine, you must follow a cholesterol-reducing diet. Your doctor may prescribe this medicine if you are already taking rosuvastatina and ezetimiba at the same dose level.

This medicine is used in patients with heart disease. Rosuvastatina/Ezetimiba reduces the risk of myocardial infarction, cerebral accident, heart surgery to increase blood flow to the heart, or hospitalization for chest pain.

This medicine does not help you lose weight.

Do not take Rosuvastatina/Ezetimiba Normon 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 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 another medication containing rosuvastatina.

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 Normon if:

• 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 levels. 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 have or have had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

• 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 (the virus that causes AIDS) or hepatitis C, such as ritonavir with lopinavir and/or atazanavir. See “Taking Rosuvastatina/Ezetimiba Normon with other medications”.
• You have severe respiratory failure.
• You are taking other medications called fibrates to lower cholesterol, see “Taking Rosuvastatina/Ezetimiba Normon with other medications”.
• 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 in the last 7 days a medication called fusidic acid (an antibiotic) by mouth or injection. 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 Rosuvastatina/Ezetimiba.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with rosuvastatina treatment.Stop taking Rosuvastatina/Ezetimiba and seek medical attention immediatelyif you observe any of the symptoms described in section 4.

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 usually perform blood tests (liver function test) during treatment with Rosuvastatina/Ezetimiba. It is essential that you visit your doctor for 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 blood sugar and fat levels, are overweight, and have high blood pressure.

Children and adolescents

It is not recommended to useRosuvastatina/Ezetimibain children and adolescents under 18 years of age.

Other medications and Rosuvastatina/Ezetimiba Normon

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 increases with its use together).Do not takeRosuvastatina/Ezetimibaif you are taking ciclosporina.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and the risk of bleeding may increase if taken together with Rosuvastatina/Ezetimiba), 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 increases with its use together.
• Colestiramina (a medication also used to lower cholesterol), because it affects the way ezetimiba works.
• Regorafenib (used to treat cancer).
• Simeprevir (used to treat chronic hepatitis C infection).
• Darolutamida (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.
• 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 decreases with its use together.
• Fusidic acid.If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop 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 hormonesabsorbed fromthe pillare increased.
• Capmatinib used to treat 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).
• Teriflunomida (used to treat multiple sclerosis).

If you visit a hospital or receive treatment for another disease, 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 Rosuvastatina/Ezetimiba 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 withRosuvastatina/Ezetimiba. If you feel dizzy, consult your doctor before attempting to drive or operate machinery.

Rosuvastatina/Ezetimiba Normon 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.

Rosuvastatina/Ezetimiba Normon contains sodium

This medication contains less than 1mmol of sodium (23mg) per coated tablet, that is, it is essentially “sodium-free.”

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

You should continue to maintain a low-cholesterol diet and exercise while taking Rosuvastatina/Ezetimiba.

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

Take Rosuvastatina/Ezetimiba once a day.

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

Rosuvastatina/Ezetimiba is not suitable for starting treatment. The initiation 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 Rosuvastatina/Ezetimiba at 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 Rosuvastatina/Ezetimiba Normon 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 at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Rosuvastatina/Ezetimiba Normon

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

If you interrupt treatment with Rosuvastatina/Ezetimiba Normon

Consult your doctor if you want to discontinue treatment with Rosuvastatina/Ezetimiba. Your cholesterol levels may increase again if you stop taking Rosuvastatina/Ezetimiba.

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 Rosuvastatina/Ezetimiba and seek medical assistance 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 can become a potentially fatal 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.

Side effects of unknown frequency (cannot be estimated from available data):

• Flat, red spots, in the shape of a target or circles on the trunk, often with central blisters, skin peeling, 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, elevated body temperature, and increased lymph nodes (DRESS or drug hypersensitivity syndrome).
• Erythema multiforme (potentially fatal allergic reactions affecting the skin and mucous membranes).

Other possible 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.
• Abdominal pain (stomach pain).
• Diarhea.
• 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 rosuvastatina.
• 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.
• Tickling 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 extend 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).
• Hepatitis (inflammation of the liver).
• Blood in the urine.
• Nerve damage in the legs and arms (such as numbness).
• Memory loss.
• Enlargement of the breasts in men (gynecomastia).

Unknown frequency (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 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 or pharmacist, even if it is a possible side effect that does not appear 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.

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

This medication does not require any special storage temperature.

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

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition ofRosuvastatina/Ezetimiba Normon

-The active principles are rosuvastatina (as rosuvastatina calcium) and ezetimiba. The film-coated tablets contain rosuvastatina calcium equivalent to 10 mg or 20 mg of rosuvastatina. Each film-coated tablet contains 10 mg of ezetimiba.

-The other components are:

Ezetimiba Coating:

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

Rosuvastatina Coating:

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

Coating:

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

Appearance of the product and content of the container

Rosuvastatina/EzetimibaNormon 10 mg/10 mg film-coated tablets EFG.

Film-coated tablets of red color, round, biconvex, anonymous on both faces, and with a diameter of 8.8 mm.

Rosuvastatina/Ezetimiba Normon 20 mg/10 mg film-coated tablets EFG. Film-coated tablets of reddish-orange color, round, biconvex, anonymous on both faces, and with a diameter of 8.8 mm.

Container of 30 film-coated tablets in Aluminio/Aluminio-Poliamida-PVC blister.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6,

28760 Tres Cantos (Madrid)-Spain

Last review date of this leaflet:May 2024

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)