ZENON 10 MG/10 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Zenon 10 mg/10 mg film-coated tablets

Zenon 20 mg/10 mg film-coated tablets

rosuvastatin/ezetimibe

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the package leaflet

1. What is Zenon and what is it used for
2. What you need to know before you take Zenon
3. How to take Zenon
4. Possible side effects
5. Storage of Zenon

1. Package contents and further information

1. What is Zenon and what is it used for

Zenon contains two different active substances in one film-coated tablet. One of the active substances is rosuvastatin, which belongs to a group of medicines called statins, the other active substance is ezetimibe.

Zenon is a medicine used in adult patients to reduce the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally, Zenon increases the levels of "good" cholesterol (HDL cholesterol).

Zenon works by reducing cholesterol in two ways. It reduces the cholesterol absorbed in the gut and the cholesterol produced by the body itself.

Cholesterol is one of the many fatty substances that circulate in the blood. The total amount of cholesterol is mainly made up of LDL and HDL cholesterol.

It is used in patients who cannot control their cholesterol levels by diet alone. While taking this medicine, you should follow a cholesterol-lowering diet.

Zenon is used together with your cholesterol-lowering diet if you have high blood cholesterol levels due to:

• primary hypercholesterolaemia (familial heterozygous and non-familial),
• a hereditary disease (homozygous familial hypercholesterolaemia),

for which you were previously using a single statin that did not control your cholesterol level or have used a statin and ezetimibe in separate tablets.

You may also receive other treatments.

If you have heart disease, Zenon reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

Zenon does not help you lose weight.

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 build up 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 reducing cholesterol levels, you can reduce your risk of having a heart attack, stroke, or other related health problems.

You should continue taking Zenon, even if your cholesterol levels are under control, as it prevents your cholesterol levels from rising again and causing the buildup of fatty deposits.

However, you should stop taking it if your doctor tells you to or if you become pregnant.

2. What you need to know before you take Zenon

Do not take Zenon:

• If you are allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6).
• If you currently have liver problems.
• If you are pregnant or breastfeeding. If you become pregnant while taking Zenon, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Zenon using an appropriate contraceptive method.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pains or cramps (myopathy).
• If you are taking a combination of medicines containing fosbuvir/velpatasvir/voxilaprevir (used for a viral liver infection called hepatitis C).
• If you are taking a combination of medicines containing ledipasvir/sofosbuvir (used for a viral liver infection called hepatitis C).
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking Zenon or other medicines containing rosuvastatin.
• If you are taking a medicine called ciclosporin (used, for example, in patients who have had an organ transplant).

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

Also, do not take Zenon 40 mg/10 mg (the highest dose):

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland does not work properly (hypothyroidism).
• If you have repeated or unexplained muscle pains or cramps (myopathy), a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medicines.
• If you regularly drink large amounts of alcohol.
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will choose the starting dose of Zenon that best suits your needs.
• If you are taking other medicines called fibrates to lower your cholesterol (see "Other medicines and Zenon").

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zenon:

• If you have kidney problems.
• If you drink large amounts of alcohol or have ever had liver disease. Zenon may not be suitable for you.
• If you have had repeated or unexplained muscle pains or cramps, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medicines. Tell your doctor immediately if you have muscle pain or unexplained pain, especially if you feel unwell or have a fever. Also, tell your doctor or pharmacist if you have persistent muscle weakness.
• If your thyroid gland does not work properly (hypothyroidism).
• If you have severe respiratory failure.
• If you have or have had myasthenia (a disease that causes general 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).
• If you are taking medicines used to treat HIV infection, e.g., ritonavir with lopinavir and/or atazanavir, see "Other medicines and Zenon".
• If you are over 70 years old (as your doctor will choose the starting dose of Zenon that best suits your needs).
• If you are taking other medicines called fibrates to lower your cholesterol (see "Other medicines and Zenon").
• If you need to have surgery. You may need to stop taking Zenon for a while.
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will choose the starting dose of Zenon that best suits your needs.
• If you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Zenon can cause serious muscle problems (rhabdomyolysis).

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 levels of sugar and fat in your blood, are overweight, and have high blood pressure.

In a small number of people, statins can affect the liver. This is identified by a simple test that detects high levels of liver enzymes in the blood. For this reason, your doctor will regularly perform blood tests (liver function tests) during treatment with Zenon. It is important to attend the doctor's appointments for the prescribed laboratory tests.

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

Other medicines and Zenon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, tell your doctor if you are taking a medicine(s) with any of the following active substances:

• Ciclosporin (a medicine used, for example, in patients who have had an organ transplant). Do not take Zenon while taking ciclosporin.
• Medicines with active substances to prevent blood clots (anticoagulants), such as warfarin, acenocoumarol, phenprocoumon, or fluindione (their anticoagulant effect and the risk of bleeding may increase if taken with this medicine), ticagrelor, or clopidogrel.
• Colestyramine (also used to lower cholesterol), as it affects how Zenon works.
• Fibrates, such as gemfibrozil, fenofibrate (also used to lower cholesterol). Do not take Zenon 40 mg/10 mg tablets with a fibrate.
• Indigestion treatments containing aluminum and magnesium (used to neutralize stomach acid).
• Erythromycin (an antibiotic).
• An oral contraceptive (the pill).
• Hormone replacement therapy.
• 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, ledipasvir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when you can safely take Zenon again. Taking Zenon with fusidic acid can rarely cause muscle weakness, pain, or sensitivity (rhabdomyolysis). You can find more information about rhabdomyolysis in section 4.
• Belumosudil (used to treat chronic Graft-versus-Host disease).

You should tell any doctor who prescribes you a new medicine that you are taking Zenon.

Taking Zenon with alcohol

If you regularly drink large amounts of alcohol, do not take Zenon 40 mg/10 mg tablets (the highest dose).

Pregnancy and breastfeeding

Do not take Zenon if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking Zenon, stop taking it immediately and inform your doctor.

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

Children and adolescents

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

Driving and using machines

Zenon is not expected to affect your ability to drive or use machines. However, some people may feel dizzy after taking Zenon. If you feel dizzy, do not drive or use machines.

Zenon contains lactose (a type of sugar) and sodium

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Zenon

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• Before starting to take Zenon, you should be on a cholesterol-lowering diet.
• You should continue with this cholesterol-lowering diet while taking Zenon.

The recommended dose is one tablet once a day.

Zenon is not suitable for initiating treatment.

If your cholesterol level is not controlled, your doctor will determine the appropriate tablet dose for you, depending on your current treatment and personal risk situation.

Treatment initiation 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 the appropriate dose of Zenon.

The maximum daily dose of rosuvastatin is 40 mg. This dose is only for patients with high cholesterol levels and a high risk of having a heart attack or stroke, whose cholesterol levels do not decrease sufficiently with 20 mg.

Try to take your tablet at the same time each day, it will help you remember. You can take it with or without food. Swallow each tablet whole with water.

If your doctor has prescribed Zenon with another cholesterol-lowering medicine containing the active substance colestyramine or another medicine containing a bile acid sequestrant, you should take Zenon at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Regular checks of your cholesterol levels

It is important that you regularly visit your doctor to have your cholesterol levels checked, to ensure that your cholesterol levels have returned to normal and are being maintained at appropriate levels.

Your doctor may decide to increase your dose so that you are taking the right amount of medicine for you.

If you take more Zenon than you should

Contact your doctor or pharmacist.

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

If you forget to take Zenon

Do not take a double dose to make up for forgotten doses.

If you stop taking Zenon

Consult your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any further questions on 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 all people suffer from them.

Stop taking Zenon and seek medical attention immediately if you experience any of the following adverse effects:

• any unexplained muscle pain, tenderness, or weakness that lasts longer than expected. This is because muscle problems, including muscle breakdown resulting in kidney damage, can be serious and can become a potentially life-threatening condition (rhabdomyolysis). This is rare (may affect up to 1 in 1,000 people);
• severe allergic reaction (angioedema) - signs include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, and severe skin itching (with raised bumps). This is rare (may affect up to 1 in 1,000 people);
• red, non-raised, target-shaped, or circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome);
• lupus-like disease (including rash, joint disorders, and effects on blood cells;
• muscle rupture.

Other Adverse Effects

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

Diarrhea; flatulence; feeling tired; high levels in some blood test results of liver function (transaminases); headache; stomach pain; constipation; nausea; muscle pain; weakness; dizziness; increased amount of protein in urine, which usually reverses on its own without the need to interrupt treatment with Zenon (only for rosuvastatin 40 mg); 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.

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

High levels in some blood test results of muscle function (Creatine Kinase test); cough; indigestion; stomach burning; joint pain; muscle spasms; neck pain; decreased appetite; hot flashes; high blood pressure; tingling sensation; dry mouth; stomach inflammation; tingling; rash; hives and other skin reactions; back pain; muscle weakness; pain in arms and legs; swelling, especially of the hands and feet; increased amount of protein in urine, which usually reverses on its own without the need to interrupt treatment with Zenon (only for rosuvastatin 10 mg and 20 mg).

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

Decrease in blood cell count that can cause bruising/bleeding (thrombocytopenia); severe stomach pain (inflamed pancreas).

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

Jaundice (yellow color of the skin and eyes); hepatitis (inflamed liver); traces of blood in your urine; nerve damage in the arms and legs (such as numbness); memory loss; gynecomastia (enlargement of breast tissue in men).

Frequency Not Known(cannot be estimated from the available data):

Breathing difficulties; 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; red, raised rash, sometimes with target-shaped lesions (erythema multiforme); muscle sensitivity; gallstones or inflammation of the gallbladder (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 Effects

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

5. Storage of Zenon

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

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

Store below 30 °C. Store in the original package to protect it from light and moisture.

Medicines should not be disposed of through wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Zenon

• The active ingredients are rosuvastatin and ezetimibe. Each tablet contains 10 mg or 20 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe.
• The other ingredients are:

• Core: lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, povidone, anhydrous colloidal silica, sodium croscarmellose, magnesium stearate.
• Coating: hypromellose (E464), macrogol, titanium dioxide (E171), talc (E553).

Zenon 20 mg/10 mg also contains yellow iron oxide (E172).

Appearance of the Product and Package Contents

Zenon 10 mg/10 mg are film-coated tablets (tablets), white to off-white, round, biconvex, with a diameter of approximately 9.1 mm.

Zenon 20 mg/10mg are film-coated tablets (tablets), yellow to light yellow, round, biconvex, with a diameter of approximately 9.9 mm.

The film-coated tablets are packaged in blisters and in a folding carton box.

Available packages: 10, 15, 30, 60, 90, 100 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer

Zentiva k.s

U kabelovny 130

102 37-Prague (Czech Republic)

or

Sanofi Winthrop Industrie

30-36 avenue Gustave Eiffel

37100 Tours, France

or

Sanofi-Aventis Deutschland GmbH,

Industriepark Hoechst-

Brueningstrase 50

65926 Frankfurt am Main, Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:Rosuvastatin/Ezetimib Sanofi in the Czech Republic, SUVREZA in France, Zenon in Germany and Spain.

Date of the Last Revision of this Leaflet:September 2024

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