ROSUVASTATIN/EZETIMIBE NORMON 5 mg/10 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Rosuvastatin/Ezetimibe Normon 5 mg/10 mg Hard Capsules

Readtheentirepackageleafletcarefullybeforeyoustarttakingthismedicinebecauseitcontains

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contentsofthepackageleaflet:

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

1. What is Rosuvastatin/Ezetimibe Normon and what is it 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 statins, the other active substance is ezetimibe.

Rosuvastatin/Ezetimibe is a medicine used to lower the levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides that circulate in the blood. Additionally, this medicine also raises the levels of "good" cholesterol (HDL cholesterol). This medicine 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, leading to a heart attack or stroke. By lowering cholesterol levels, the risk of having a heart attack, stroke, or other related health problems can be reduced.

This medicine is used in patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you should 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 level.

The capsules of this medicine are used if you have:

• high blood cholesterol levels (primary hypercholesterolemia)
• heart disease, this medicine reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain

This medicine does not help you lose weight.

2. What you need to know before you take Rosuvastatin/Ezetimibe Normon

Do not takeRosuvastatin/Ezetimibe Normonif:

• 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 repeated or unexplained muscle pains or cramps (myopathy).
• you are taking a medicine called ciclosporin (used, for example, after an organ transplant).
• you are taking a combination of medicines called sofosbuvir/velpatasvir/voxilaprevir (used for hepatitis C virus infection).
• you are pregnant or breastfeeding. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with this medicine using an appropriate contraceptive method (see below: Pregnancy and breastfeeding).
• if you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking this medicine or other related medicines.

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 medicine if:

• you have kidney problems,
• you have liver problems,
• you have repeated or 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 medicines. 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 that causes generalized muscle weakness, which 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 must establish the appropriate dose of this medicine for you,
• if you are taking medicines 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 medicines and Rosuvastatin/Ezetimibe Normon",
• you have severe respiratory failure,
• you are taking other cholesterol-lowering medicines called fibrates, see "Other medicines and Rosuvastatin/Ezetimibe Normon",
• you regularly drink large amounts of alcohol,
• your thyroid gland does not work properly (hypothyroidism),
• you are over 70 years old, (as your doctor must choose the appropriate dose of this medicine for you).
• you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic). The combination of fusidic acid and this medicine can cause serious 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 medicine.

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 normally perform blood tests (liver function test) during treatment with this medicine. It is essential that you go to the doctor to have these tests done.

While taking this medicine, 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 sugar and fat levels in your blood, are overweight, and have high blood pressure.

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

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with rosuvastatin/ezetimibe treatment. Stop using this medicine and seek medical attention immediately 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 andRosuvastatin/Ezetimibe Normon

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

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

• Ciclosporin (used, for example, after an organ transplant to prevent rejection of the transplanted organ. The effect of rosuvastatin increases with its combined use). Do not take this medicine if you are taking ciclosporin.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and the risk of bleeding may increase while taking this medicine), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates). The effect of rosuvastatin increases with its combined use.
• Colestyramine (a medicine to lower cholesterol), because it affects how ezetimibe works.
• Regorafenib (indicated for the treatment of cancer).
• Darolutamide (used to treat cancer)
• 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, simeprevir, 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 these types of medicines 2 hours after rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases with its combined use.
• Fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when you can safely take this medicine again. Taking this medicine 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.
• Hormone replacement therapy (increased levels of hormones in the blood).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

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

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines. However, some people may feel dizzy during treatment with this medicine. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatin/Ezetimibe Normon contains lactose

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

Rosuvastatin/Ezetimibe Normon contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule, i.e., it is essentially "sodium-free".

3. How to take Rosuvastatin/Ezetimibe Normon

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

You should continue to follow a cholesterol-lowering diet while taking this medicine.

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

TakeRosuvastatin/Ezetimibe Normononceaday.

You can 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 starting treatment. The initiation 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 this medicine at the corresponding dose.

If your doctor has prescribed rosuvastatin/ezetimibe along with another cholesterol-lowering medicine that contains the active ingredient colestyramine or any other medicine that contains a bile acid sequestrant, you should take this medicine at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Regularchecksofcholesterollevels

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

IfyoutakemoreRosuvastatin/Ezetimibe Normonthanyoushould

Contact your doctor or the nearest hospital emergency department, as you may need medical attention.

IfyouforgettotakeRosuvastatin/Ezetimibe Normon

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.

IfyoustoptakingRosuvastatin/Ezetimibe Normon

Consult your doctor if you want to stop taking this medicine. Your cholesterol levels may increase again if you stop taking this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

It is essential that you know what these side effects can be.

StoptakingRosuvastatin/Ezetimibe Normonandseekmedicalattentionimmediatelyifyouexperienceanyofthefollowingsideeffects

• Swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing and swallowing.
• Severe itching of the skin (with raised lumps).
• Red patches, not raised, target-like or circular patches on the trunk, often with central blisters, peeling of the skin, 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 skin rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

AlsostoptakingRosuvastatin/Ezetimibe Normonandcontactyourdoctorimmediatelyifyouhave:

• any unusual muscle pain or pain that lasts longer than expected. In rare cases, this can become a potentially life-threatening muscle damage known as rhabdomyolysis, which leads to discomfort, fever, and kidney failure.
• Lupus-like syndrome (which includes 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 people)
• Common (may affect up to 1 in 10 people)
• Uncommon (may affect up to 1 in 100 people)
• Rare (may affect up to 1 in 1,000 people)
• Very rare (may affect up to 1 in 10,000 people, including isolated reports).

Common

• Headache;

• Constipation;
• General discomfort;
• Muscle pain;
• Weakness;
• Dizziness;
• Diabetes. This is more likely if you have high sugar and fat levels in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Stomach pain;
• Diarrhea;
• Flatulence (excess gas in the intestinal tract);
• Feeling tired;
• High levels in some blood test results of liver function (transaminases).

Uncommon

• Skin rash, itching, hives;
• Increased amount of protein in the urine, which usually returns to normal on its own without the need to stop treatment with rosuvastatin;
• High levels in some blood test results of muscle function (CK);
• Cough;
• Indigestion;
• Heartburn;
• Joint pain;
• Muscle spasms;
• Neck pain;
• Decreased appetite;
• Pain;
• Chest pain;
• Hot flashes;
• High blood pressure;
• Feeling of tingling;
• Dry mouth;
• Stomach inflammation;
• Back pain;
• Muscle weakness;
• Pain in the arms and legs;
• Swelling, especially of the hands and feet.

Rare

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

Very Rare

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; enlargement of the breasts 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; constant muscle weakness; gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting).

Severe myasthenia (a disease that causes generalized muscle weakness that, 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 of Adverse Reactions

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

5. Storage of Rosuvastatina/Ezetimiba Normon

This medicinal product does not require any special storage conditions.

Keep this medicinal product out of the sight and reach of children.

Do not use this medicinal product after the expiry date stated on the carton and blister after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicinal products in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicinal products. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Rosuvastatina/Ezetimiba Normon

The active substances are rosuvastatin (as rosuvastatin calcium) and ezetimibe.

Each hard capsule contains 5 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe.

The other ingredients are:

• Capsule content: lactose monohydrate, hypromellose, sodium croscarmellose, sodium lauryl sulfate, cellulose, microcrystalline, sodium stearyl fumarate, lactose (anhydrous), crospovidone, talc (E553b), silica, colloidal anhydrous, titanium dioxide (E171), triacetin (E1518), red iron oxide (E172).

• Capsule composition: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).

Appearance of the Product and Package Contents

Hard gelatin capsules with orange body and cap, filled with 1 pink film-coated tablet and 2 white tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation HolderLaboratorios Normon, S.A.

Ronda de Valdecarrizo 6,

28760 Tres Cantos - Madrid

(Spain)

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2,

2710-089 Abrunheira, Sintra

Portugal

Date of Last Revision of this Leaflet: March 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products http://www.aemps.es/