Rosuvastatin/ezetimibe Normon 20 mg/10 mg hard capsules

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Rosuvastatin/Ezetimibe Normon 20 mg/10 mg Hard Capsules

Read the entire leaflet carefully before you start taking 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 may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Rosuvastatina/Ezetimiba Normon is and what it is used for
2. What you need to know before starting to take 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 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 decreases both the cholesterol absorbed from 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, your 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 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 Rosuvastatin/Ezetimibe Normon

Do not take Rosuvastatin/Ezetimibe 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 to treat a 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 taking 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 feel generally unwell or have a fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness,
• you have or have had myasthenia (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 the condition or trigger the onset of myasthenia (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 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 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 (a medicine for bacterial infection). The combination of fusidic acid and this medicine may cause serious muscle problems (rhabdomyolysis).

If you are in any of the situations listed above (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 doctor’s appointments for these tests.

While taking this medicine, your doctor will monitor you closely 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 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 treatment with rosuvastatin/ezetimibe. 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 medicines.

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, taken 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 plasma levels). This effect can be minimized by taking these 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 restart 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take this medicine if you are pregnant, trying to become pregnant, or think you could 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 use of 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 use machinery.

Rosuvastatina/Ezetimiba Normon contains lactose

This medicine contains lactose. If your doctor has informed you that you have 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 each 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 colestyramine 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, in order to monitor whether your cholesterol levels have normalized and are being maintained at appropriate levels.

Rosuvastatin/Ezetimibe Normondelquedebe

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

If you forget to take Rosuvastatin/Ezetimibe Normon

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

Discontinuing 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 may 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 help if you experience any of the following adverse effects:

• Swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing and trouble swallowing.
• Intense itching of the skin (with raised bumps).
• Red, non-elevated patches, target-like or circular rashes on the trunk, often with central blisters, skin peeling, 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 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 lasting longer than expected. In rare cases, this may progress to potentially fatal muscle damage known as rhabdomyolysis, leading 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 intestinal 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 of the hands and feet.

Rare

• Inflammation of the pancreas, causing severe stomach pain that may spread 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 males (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 disorders; constant muscle weakness; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting).

Myasthenia gravis (a disease causing generalized muscle weakness which, 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 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 refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and any 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 20 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe.

Other components are:

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

• Capsule composition: gelatin, titanium dioxide (E171), iron oxide yellow (E172), iron oxide black (E172), indigo carmine (E132).

Appearance of the product and contents of the container

Hard gelatin capsules with a green cap and a white body, filled with 4 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/