Rosuvastatin/ezetimibe Normon 10 mg/10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rosuvastatin/Ezetimibe Normon 10 mg/10 mg film-coated tablets EFG

Rosuvastatin/Ezetimibe Normon 20 mg/10 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 or pharmacist.
• This medicine has been prescribed for you only; do 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 or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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. How to store Rosuvastatin/Ezetimibe Normon
6. Contents of the pack and other information

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

This medicine contains two different active substances in a film-coated tablet. One of the active substances is rosuvastatin, which belongs to the group of medicines known as statins; the other active substance is ezetimiba.

Rosuvastatina/Ezetimiba is a medicine used to reduce blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides. In addition, Rosuvastatina/Ezetimiba 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, leading to a heart attack or stroke. By lowering cholesterol levels, this medicine 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 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 ezetimiba at the same dose levels.

This medicine is used in patients with heart disease. Rosuvastatina/Ezetimiba reduces the risk of myocardial infarction, 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 starting to take 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 recurrent or unexplained muscle pain or cramps (myopathy).
• You are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (medicines used for the viral liver infection called hepatitis C).
• You are taking a medicine called cyclosporine (used, for example, after organ transplantation).
• You are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin/Ezetimibe, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Rosuvastatin/Ezetimibe by using an appropriate contraceptive method.
• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking Rosuvastatin/Ezetimibe or another medicine containing rosuvastatin.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Rosuvastatin/Ezetimibe Normon if:

• You have kidney problems.
• You have liver problems.
• You have recurrent or unexplained muscle pain or 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 accompanied by general malaise or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness.
• You have or have had myasthenia (a disease characterized by 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 for you.
• You are taking medicines to treat infections, including HIV (AIDS virus) or hepatitis C, such as ritonavir with lopinavir and/or atazanavir. See "Taking Rosuvastatin/Ezetimibe Normon with other medicines".
• You have severe respiratory insufficiency.
• You are taking other medicines called fibrates to lower cholesterol; see "Taking Rosuvastatin/Ezetimibe Normon with other medicines".
• You regularly consume large amounts of alcohol.
• Your thyroid gland is not functioning properly (hypothyroidism).
• You are over 70 years of age (as your doctor must choose the appropriate dose of Rosuvastatin/Ezetimibe for you).
• You are currently taking or have taken within the last 7 days a medicine called fusidic acid (an antibacterial medicine) by oral or injectable route. The combination of fusidic acid and Rosuvastatin/Ezetimibe may cause serious muscle problems (rhabdomyolysis).

If you are in any of the above situations (or are unsure), consult your doctor or pharmacist before starting any dose of Rosuvastatin/Ezetimibe.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with rosuvastatin treatment. Stop taking Rosuvastatin/Ezetimibe and seek immediate medical attention if you notice any of the symptoms described in section 4.

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 (transaminases). For this reason, your doctor will usually perform blood tests (liver function tests) during your treatment with Rosuvastatin/Ezetimibe. 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 are likely at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure.

Children and adolescents

The use of Rosuvastatin/Ezetimibe 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 transplantation to prevent organ rejection. The effect of rosuvastatin increases when taken together). Do not take Rosuvastatin/Ezetimibe if you are taking cyclosporine.
• Anticoagulants, such as warfarin, acenocoumarol, or phenindione (their anticoagulant effects and risk of bleeding may increase when taken with Rosuvastatin/Ezetimibe), 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 taken together.
• Colestipol (a medicine also used to lower cholesterol), as it affects how ezetimibe works.
• Regorafenib (used to treat cancer).
• Simeprevir (used to treat chronic hepatitis C infection).
• 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, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Indigestion treatments containing aluminium and magnesium (used to neutralize stomach acid, as they reduce plasma levels of rosuvastatin). This effect can be minimized by taking these medicines 2 hours after rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases when taken 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 Rosuvastatin/Ezetimibe. Taking Rosuvastatin/Ezetimibe 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.
• Capmatinib (used to treat cancer).
• Hormone replacement therapy (increased hormone levels in the blood).
• Fostamatinib (used to treat low platelet count).
• Febuxostat (used to treat and prevent high levels of uric acid in the blood).
• Teriflunomide (used to treat multiple sclerosis).

If you go to hospital or receive treatment for another illness, tell the medical staff that you are taking Rosuvastatin/Ezetimibe.

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. If you become pregnant while taking Rosuvastatin/Ezetimibe, stop taking it immediately and inform your doctor. Women should use contraceptive methods during treatment with Rosuvastatin/Ezetimibe.

Do not take Rosuvastatin/Ezetimibe while breastfeeding, as it is unknown whether the medicine passes into breast milk.

Driving and using machines

Rosuvastatin/Ezetimibe is not expected to affect your ability to drive or use machines. However, some people may experience dizziness during treatment with Rosuvastatin/Ezetimibe. 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 diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

Rosuvastatin/Ezetimibe Normon contains sodium

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

3. How to take Rosuvastatin/Ezetimibe Normon

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

You must continue to follow a cholesterol-lowering diet and exercise regularly while taking Rosuvastatin/Ezetimibe Normon.

The recommended daily dose for adults is one film-coated tablet of the prescribed strength.

Take Rosuvastatin/Ezetimibe Normon once daily.

You may take it at any time of day, with or without food. Swallow each tablet whole with water. Try to take the film-coated tablet at the same time each day.

Rosuvastatin/Ezetimibe Normon is not suitable for initiating treatment. The start of treatment or dose adjustments, if necessary, should only be performed by taking the active substances separately. Once the appropriate doses have been established, switching to Rosuvastatin/Ezetimibe Normon at the corresponding dose may be considered.

Regular cholesterol level monitoring

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

If you take more Rosuvastatin/Ezetimibe Normon than you should

Contact your doctor or the nearest hospital emergency department immediately, as you may require medical assistance.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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 a missed dose.

If you stop taking Rosuvastatin/Ezetimibe Normon

Consult your doctor if you wish to discontinue treatment with Rosuvastatin/Ezetimibe Normon. 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 and seek immediate medical attention if you experience any of the following adverse effects:

Rare adverse 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 or swallowing.
• Unexplained muscle pain and cramps lasting longer than expected. In rare cases, this may lead to potentially life-threatening muscle damage known as rhabdomyolysis, resulting in general malaise, fever, and kidney failure.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).
• Muscle rupture.

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

• Reddish, non-elevated, target-shaped or circular skin lesions on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious 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).
• Erythema multiforme (potentially life-threatening allergic reactions affecting the skin and mucous membranes).

Other possible adverse effects:

Common (may affect up to 1 in 10 people):

• 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.
• Abdominal pain (stomach ache).
• Diarrhea.
• Flatulence (excess gas in the gastrointestinal tract).
• Feeling tired.
• Elevated levels in certain blood test results indicating liver function (transaminases).

Uncommon (may affect up to 1 in 100 people):

• Skin rash, itching, hives.

• Increased levels of protein in urine, which usually returns to normal on its own without the need to stop treatment with rosuvastatin.

• 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.

• Stomach inflammation.

• Back pain.

• Muscle weakness.

• Pain in arms and legs.

• Swelling, especially in the hands and feet.

Rare (may affect up to 1 in 1,000 people):

• Inflammation of the pancreas, causing severe stomach pain that may spread to the back.
• Reduced levels of blood platelets.

Very rare (may affect up to 1 in 10,000 people):

• Jaundice (yellowing of the skin and eyes).
• Liver inflammation (hepatitis).
• Blood traces in urine.
• Nerve damage in arms and legs (such as numbness).
• Memory loss.
• Enlargement of breasts in men (gynecomastia).

Frequency not known (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 injuries.

• Persistent muscle weakness.

• Gallstones or gallbladder inflammation (which may cause abdominal pain, nausea, vomiting).

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

• Ocular myasthenia (a condition 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 effects

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

5. Storage of Rosuvastatin/Ezetimibe Normon

Keep this medicine out of sight and reach of children.

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

This medicine does not require any special storage temperature.

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 unused medicines at the SIGRE collection point at your pharmacy. 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 Rosuvastatina/Ezetimiba Normon

• The active substances are rosuvastatin (as rosuvastatin calcium) and ezetimibe. The film-coated tablets contain rosuvastatin calcium equivalent to 10 mg or 20 mg of rosuvastatin. Each film-coated tablet contains 10 mg of ezetimibe.
• The other components are:

Ezetimibe layer:

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

Rosuvastatin layer:

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

Coating:

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

Appearance of the product and contents of the pack

Rosuvastatina/Ezetimiba Normon 10 mg/10 mg film-coated tablets EFG.

Red, round, biconvex, film-coated tablets, unmarked on both sides, with a diameter of 8.8 mm.

Rosuvastatina/Ezetimiba Normon 20 mg/10 mg film-coated tablets EFG. Orange-red, round, biconvex, film-coated tablets, unmarked on both sides, with a diameter of 8.8 mm.

Pack containing 30 film-coated tablets in an aluminum/aluminum-polyamide-PVC blister.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6,

28760 Tres Cantos (Madrid), Spain

Date of the most recent revision of this leaflet: May 2024

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