Rosuvastatin/ezetimibe Normon 10 mg/10 mg hard capsules

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Rosuvastatin/Ezetimibe Normon 10 mg/10 mg Hard Capsules

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Rosuvastatin/Ezetimibe Normon is and what it is used for
2. What you need to know before taking Rosuvastatin/Ezetimibe Normon
3. How to take Rosuvastatin/Ezetimibe Normon
4. Possible side effects
5. Storage of Rosuvastatin/Ezetimibe Normon
6. Contents of the pack and other information

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

This medicine contains two different active substances in one capsule. One of the active substances is rosuvastatin, which belongs to a group of medicines called statins; the other active substance is ezetimibe.

Rosuvastatin/Ezetimibe is a medicine used to lower total cholesterol levels, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides circulating in the blood. In addition, this medicine also increases levels of "good" cholesterol (HDL cholesterol). This medicine works by reducing cholesterol in two ways: it reduces both the cholesterol absorbed through 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 cause no symptoms. However, if left untreated, fatty deposits can build up 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 could lead to a heart attack or stroke. By lowering cholesterol levels, you can reduce your risk of having a heart attack, stroke, or other related health problems.

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

This medicine's capsules are used if you have:

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

This medicine does not help you lose weight.

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

Do not take Rosuvastatina/Ezetimiba Normon if:

• 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 pain and cramps (myopathy).
• you are taking a medicine called cyclosporine (used, for example, after an organ transplant).
• you are taking a combination of medicines containing sofosbuvir / velpatasvir / voxilaprevir (used for the viral liver infection called hepatitis C).
• 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 by using an appropriate contraceptive method (see below: Pregnancy and breastfeeding).
• you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking this medicine or other related medicines.

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting this medicine if:

• you have kidney problems,
• you have liver problems,
• you have repeated or unexplained muscle pain and cramps, a personal or family history of muscle disorders, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if you also have a general feeling of being unwell or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness,
• you have or have had myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen these conditions or trigger the onset of myasthenia gravis (see section 4),
• you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must determine the appropriate dose of this medicine for you,
• 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 Rosuvastatina/Ezetimiba Normon”,
• you have severe respiratory failure,
• you are taking other medicines called fibrates to lower cholesterol; see “Other medicines and Rosuvastatina/Ezetimiba Normon”,
• you regularly consume large amounts of alcohol,
• your thyroid gland is not functioning properly (hypothyroidism),
• you are over 70 years old (as your doctor must choose the appropriate dose for you),
• you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (an antibacterial infection treatment). The combination of fusidic acid and this medicine may cause serious muscle problems (rhabdomyolysis).

If you are in any of the above-mentioned situations (or are unsure), consult your doctor or pharmacist before taking any dose of this medicine.

In a small number of people, statins may affect the liver. This is detected by a simple blood test showing increased levels of liver enzymes. For this reason, your doctor will usually perform blood tests (liver function tests) during your treatment with this medicine. It is important that you attend your scheduled appointments for these tests.

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

If you are admitted to hospital or receive treatment for another condition, inform the medical staff that you are taking this medicine in capsule form.

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 immediate medical attention if you notice any of the symptoms described in section 4.

Children and adolescents

The use of this medicine is not recommended in children and adolescents under 18 years of age.

Other medicines and Rosuvastatin/Ezetimibe Normon

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

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

• Cyclosporine (used after organ transplant to prevent rejection of the transplanted organ. The effect of rosuvastatin increases when used together). Do not take this medicine if you are taking cyclosporine.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and risk of bleeding may increase when taken together with this medicine), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also correct blood triglyceride levels (e.g., gemfibrozil and other fibrates). The effect of rosuvastatin increases when used together.
• Colestyramine (a cholesterol-lowering medicine), because it affects how ezetimibe works.
• Regorafenib (used to treat 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 containing aluminium and magnesium (used to neutralize stomach acid, as they reduce rosuvastatin levels in plasma). This effect can be minimized by taking these types of medicines 2 hours after rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases when used together.
• Fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to resume taking this medicine. Taking this medicine together with fusidic acid may rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.
• An oral contraceptive (the pill). Levels of absorbed sex hormones are increased.
• Hormone replacement therapy (increased hormone levels in the blood).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take this medicine if you are pregnant, are trying to become pregnant, or think you might be pregnant. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor. Women should 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 operating machinery

This medicine is not expected to impair your ability to drive or operate machinery. However, some people may experience dizziness during treatment with this medicine. If you feel dizzy, consult your doctor before attempting to drive or operate machinery.

Rosuvastatina/Ezetimiba Normon contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Rosuvastatina/Ezetimiba Normon contains sodium

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

3. How to take Rosuvastatin/Ezetimibe Normon

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You must continue to maintain a cholesterol-lowering diet and exercise while taking this medicine.

The recommended daily dose for adults is one capsule of the respective strength.

Take Rosuvastatin/Ezetimibe Normon once daily.

You may 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 every day.

This medicine is not suitable for initiating treatment. Treatment initiation or dose adjustments, if necessary, should only be done by taking the active substances separately. Once the appropriate doses have been established, switching to this medicine at the corresponding dose is possible.

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

Regular Cholesterol Level Checks

It is important to visit your doctor regularly for cholesterol checks, to ensure that your cholesterol levels have normalized and are maintained at appropriate levels.

CytomaRosuvastatin/Ezetimibe Normondelquedebe

Contact your doctor or the nearest hospital emergency service as you may require medical attention.

If you forget to take Rosuvastatin/Ezetimibe Normon

Do not worry; simply take the next scheduled dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop treatment with Rosuvastatin/Ezetimibe Normon

Consult your doctor if you wish to discontinue treatment with this medicine. Your cholesterol levels may rise again if you stop taking this medicine.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

It is important that you are aware of what these adverse effects may be.

Stop taking Rosuvastatin/Ezetimibe Normon and seek immediate medical attention if you experience any of the following adverse effects:

• Swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing.
• Intense itching of the skin (with raised bumps).
• Red, non-elevated, target-like or circular rashes on the trunk, often with central blisters, peeling skin, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also stop taking Rosuvastatin/Ezetimibe Normon and contact your doctor immediately if you have:

• Any unusual muscle pain or pain that lasts longer than expected. In rare cases, this may progress to potentially life-threatening muscle damage known as rhabdomyolysis, which can lead to malaise, fever, and kidney failure.
• Lupus-like illness syndrome (including skin rash, joint disorders, and effects on blood cells).
• Muscle rupture.

The following terms are used to describe how frequently 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 malaise;
• 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.
• Stomach pain;
• Diarrhea;
• Flatulence (excess gas in the gastrointestinal tract);
• Feeling tired;
• Elevated levels in certain blood test results for liver function (transaminases).

Uncommon

• Skin rash, itching, urticaria;
• Increase in the amount of protein in urine, which usually returns to normal on its own without the need to discontinue rosuvastatin treatment;
• Elevated levels in certain blood test results indicating muscle function (CK);
• Cough;
• Indigestion;
• Heartburn;
• Joint pain;
• Muscle spasms;
• Neck pain;
• Decreased appetite;
• Pain;
• Chest pain;
• Hot flushes;
• High blood pressure;
• Tingling sensation;
• Dry mouth;
• Inflammation of the stomach;
• Back pain;
• Muscle weakness;
• Pain in arms and legs;
• Swelling, especially in hands and feet.

Rare

• Inflammation of the pancreas, causing severe stomach pain that may extend to the back; reduction in blood platelet levels.

Very rare

Jaundice (yellowing of the skin and eyes); inflammation of the liver (hepatitis); traces of blood in the urine; nerve damage in the arms and legs (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; 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, vomiting).

Myasthenia gravis (a disease causing generalized muscle weakness that, in some cases, affects the muscles used for breathing).

Ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse reactions

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

5. Storage of Rosuvastatin/Ezetimibe Normon

This medicine does not require any special storage conditions.

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

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

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatin/Ezetimibe Normon

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

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

The other components are:

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

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

Appearance of the product and contents of the container

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder

Laboratorios Normon, S.A.

Ronda de Valdecarrizo 6,

28760 Tres Cantos - Madrid

(Spain)

Manufacturing Responsible Party

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2,

2710-089 Abrunheira, Sintra

Portugal

Date of the most recent review of this leaflet: March 2023

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