Patient Information Leaflet

Rosuvastatina/Ezetimiba Normon 20 mg/10 mg Hard Capsules

Readallthepatient information leaflet carefullybeforeyoustarttakingthismedicine,becauseitcontainsimportantinformationforyou

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Patient Information Leaflet

1. What Rosuvastatina/Ezetimiba Normon is and what it is 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 one capsule. One of the active principles is rosuvastatina, which belongs to the group of statins, the other active principle is ezetimiba.

Rosuvastatina/Ezetimiba is a medicine used to reduce total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. In addition, this medicine also raises 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 cholesterol levels 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.

The capsules of this medicine are used if you have:

- high blood cholesterol (primary hypercholesterolemia)

- heart disease, this medicine reduces the risk of heart attack, stroke, coronary artery bypass surgery, or hospitalization for chest pain

This medicine does not help you lose weight.

Do not takeRosuvastatina/Ezetimiba Normonif:

• You are allergic to rosuvastatina, ezetimiba, 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 unjustified muscle pain and cramps (myopathy).
• You are taking a medication called ciclosporina (used, for example, after an organ transplant).
• You are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver infection called hepatitis C).
• You are pregnant or breastfeeding. If you become pregnant while taking this medication, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with this medication using an appropriate contraceptive method (see below: Pregnancy and breastfeeding).
• You have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking this medication or other related medications.

If you are in any of the above situations (or are unsure), consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication 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 have general discomfort or fever. Also, inform your doctor or pharmacist if you have 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 eye muscle weakness), 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 should establish the appropriate dose of this medication for you.
• You are taking medications to treat infections, including HIV or hepatitis C, such as lopinavir, ritonavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, and/or pibrentasvir (see "Other medications and Rosuvastatina/Ezetimiba Normon").
• You have severe respiratory failure.
• You are taking other medications called fibrates to lower cholesterol (see "Other medications and Rosuvastatina/Ezetimiba Normon").
• You regularly consume large amounts of alcohol.
• Your thyroid gland does not function correctly (hypothyroidism).
• You are over 70 years old (as your doctor should choose the appropriate dose of this medication for you).
• You are taking or have taken within the last 7 days a medication called fusidic acid (an antibiotic) orally or by injection. The combination of fusidic acid and this medication may cause severe muscle problems (rhabdomyolysis).

If you are in any of these situations mentioned above (or are unsure): consult your doctor or pharmacist before starting to take any dose of this medication.

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 in the blood. For this reason, your doctor will usually perform blood tests (liver function test) during treatment with this medication. 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.

If you enter the hospital or receive treatment for another condition, inform the medical staff that you are taking capsules of this medication.

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

Children and adolescents

This medication is not recommended for use in children and adolescents under 18 years of age.

Other medications andRosuvastatina/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 is increased with its use together).Do not take this medication if you are taking ciclosporina.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and the risk of bleeding may increase while taking this medication together), 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 is increased with its use together.
• Colestiramina (a medication to lower cholesterol), as it affects how ezetimiba works.
• Regorafenib (used to treat cancer).
• 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, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, and/or 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 is decreased 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 resume taking this medication. Taking this medication 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 hormones absorbed from the pill are increased.
• Hormone replacement therapy (increased levels of hormones in the blood).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not take this medication if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking this medication, stop taking it immediately and inform your doctor. Women should use contraceptive methods during treatment with this medication.

Breastfeeding

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

Driving and operating machinery

This medication is not believed to interfere with your ability to drive or operate machinery. However, some people may feel dizzy during treatment with this medication. 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 indicated that you have a lactose intolerance, consult with them before taking this medication.

Rosuvastatina/Ezetimiba Normon contains sodium

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

Follow exactly the administration instructions of 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 this medication.

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

TakeRosuvastatina/Ezetimiba Normononceaday.

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 every day.

This medication is not suitable for starting treatment. The initiation of treatment or dose adjustments, if necessary, should only be done by taking the active ingredients separately, and once the appropriate doses have been adjusted, it is possible to switch to this medication at the corresponding dose.

If your doctor has prescribed rosuvastatina/ezetimiba along with another medication to reduce cholesterol that contains the active ingredient colestiramine or any other medication that contains a bile acid sequestrant, you should take this medication at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Regularchecksofcholesterollevels

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

IfyoutakemoreRosuvastatina/Ezetimiba Normonthanyoushould

Contact your doctor or the nearest hospital's emergency service as you may need medical assistance.

IfyouforgettotakeRosuvastatina/Ezetimiba Normon

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

IfyouinterruptthetreatmentwithRosuvastatina/Ezetimiba Normon

Consult your doctor if you want to discontinue treatment with this medication. Your cholesterol levels may increase again if you stop taking this medication.

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 essential that you know which side effects may occur.

Stop takingRosuvastatina/Ezetimiba Normonand seek medical assistanceimmediately if you experience any of the following side effects:

Also, stop taking Rosuvastatina/Ezetimiba Normon andcontact your doctor immediately if you have:

- any unusual muscle pain or pain that lasts longer than expected. In rare cases, this may become a potentially fatal muscle damage known as rhabdomyolysis, which leads to discomfort, fever, and kidney failure.

- Lupus-like disease syndrome (including skin rash, joint disorders, and effects on blood cells).

- Muscle rupture

The following terms are used to describe the frequency with which side effects have been reported:

- Very common (may affect more than 1 in 10 patients)

- Common (may affect up to 1 in 10 patients)

- Uncommon (may affect up to 1 in 100 patients)

- Rare (may affect up to 1 in 1,000 patients)

- Very rare (may affect up to 1 in 10,000 patients, including isolated reports).

Common

• Headache;

• Constipation;
• General feeling of being unwell;
• 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.
• Stomach pain;
• Diarrhea;
• Flatulence (excess gas in the intestinal tract);
• Feeling tired;
• High levels in some blood test results for liver function (transaminases).

Uncommon

• Skin rash, itching, urticaria;
• Increased protein levels in urine, which usually returns to normal on its own without the need to discontinue treatment with rosuvastatin;
• 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 flushes;
• High blood pressure;
• Tingling sensation;
• Dry mouth;
• Stomach inflammation;
• Back pain;
• Muscle weakness;
• Pain in the arms and legs;
• Swelling, especially in the hands and feet.

Rare

• Pancreatitis, which causes severe stomach pain that may extend to the back; reduction of blood platelet levels.

Very rare

Jaundice (yellowing of the skin and eyes); liver inflammation (hepatitis); blood in the urine; nerve damage in the legs and arms (such as numbness); memory loss; breast enlargement in men (gynecomastia).

Frequency not known

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 injuries; persistent 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 of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

This medication does not require special conditions for conservation.

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

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

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Rosuvastatina/Ezetimiba Normon

The active principles are rosuvastatina (as rosuvastatina calcium) and ezetimiba.

Each hard capsule contains 20 mg of rosuvastatina (as rosuvastatina calcium) and 10 mg of ezetimiba.

The other components are:

- Contents of the capsule : lactose monohydrate, hypromellose, croscarmellose sodium, sodium lauryl sulfate, cellulose, microcrystalline, sodium stearoylfumarate, lactose (anhydrous), crospovidone, talc (E553b), silica, colloidal anhydrous, titanium dioxide (E171), triacetin (E1518), iron oxide red (E172).

- Composition of the capsule : gelatin, titanium dioxide (E171), iron oxide yellow (E172), iron oxide black (E172), indigotin (E132).

Appearance of the product and contents of the packaging

Hard gelatin capsules with a green cap and white body, filled with 4 pink-coated tablets and 2 white tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Normon Laboratories, S.A

Ronda de Valdecarrizo 6,

28760 Tres Cantos- Madrid

(Spain)

Responsible for manufacturing

Atlantic Pharma – Pharmaceutical Productions, S.A.

Rua da Tapada Grande, n.º 2,

2710-089 Abrunheira, Sintra

Portugal

Last review date of this leaflet: March 2023

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