Patient Information Leaflet

Zenon 10 mg/10 mg Film-Coated Tablets

Zenon 20 mg/10 mg Film-Coated Tablets

rosuvastatina/ezetimiba

Read this 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, ask your doctor or pharmacist.
• 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, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

Zenon contains two different active principles in a film-coated tablet. One of the active principles is rosuvastatina, which belongs to the group of medications called statins, the other active principle is ezetimiba.

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

Zenon acts by reducing cholesterol in two ways. It reduces the cholesterol absorbed in the digestive tract as well as 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 composed of LDL and HDL cholesterol.

It is used in patients who cannot control their cholesterol levels solely with a diet. While taking this medication, you must follow a cholesterol-reducing diet.

Zenon is used in combination with your cholesterol-reducing diet if you have high cholesterol levels in the blood due to:

• primary hypercholesterolemia [familial heterozygous and non-familial],
• an inherited disease [familial hypercholesterolemia homozygous],

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

You may also receive other treatments.

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

Zenondoes not help reduce weight.

For most people, high cholesterol levels do not affect how they feel since 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 blood supply to the heart or brain, which would cause 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 must continue taking Zenon, even if your cholesterol levels are in the correct range, as it prevents your cholesterol levels from rising again and causing the accumulation of fatty deposits.

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

Do not take Zenon:

• If you are allergic to rosuvastatin, ezetimibe, or any of the other components of this medication (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 unjustified muscle pain and cramps (myopathy).
• If you are taking a combination of fosbuvir/velpatasvir/voxilaprevir (used for a viral liver infection called hepatitis C).
• If you are taking a combination of ledipasvir/sofosbuvir (used for a viral liver infection called hepatitis C).
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking Zenon or other medications containing rosuvastatin.
• If you are taking a medication called ciclosporin (used, for example, after an organ transplant).

If you find yourself 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 (in case of doubt, consult your doctor).
• If your thyroid gland does not function properly (hypothyroidism).
• If you have repeated or unjustified muscle pain and cramps (myopathy), a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other medications to lower cholesterol levels.
• If you regularly consume large amounts of alcohol.
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medications called fibrates to lower your cholesterol (see section “Other medications and Zenon”).

If you find yourself 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 consume large amounts of alcohol or have ever had liver disease. Zenon may not be suitable for you.
• If you have had repeated or inexplicable muscle pain or discomfort, personal or family history of muscle problems, or previous history of muscle problems when taking other medications to lower cholesterol. Inform your doctor immediately if you have muscle pain or unexplained pain, especially if you feel unwell or have a fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness.
• If your thyroid gland does not function properly (hypothyroidism).
• If you have severe respiratory insufficiency.
• 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 myasthenia gravis (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).
• If you are taking medications used to combat HIV infection, for example, ritonavir with lopinavir and/or atazanavir, consult “Other medications and Zenon”.
• If you are over 70 years old (as your doctor must choose the starting dose of Zenon that best suits your needs).
• If you are taking other medications called fibrates to lower your cholesterol (see section “Other medications and Zenon”).
• If you need to undergo 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 must choose the starting dose of Zenon that best suits your needs.
• If you are taking or have taken in the last 7 days a medication containing fusidic acid (used for bacterial infection treatment), orally or by injection. The combination of fusidic acid and Zenon can cause severe muscle problems (rhabdomyolysis).

While taking this medication, 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 blood sugar and fat levels, are overweight, and have high blood pressure.

In a reduced number of people, statins can affect the liver. This is identified by a simple test that detects elevated levels of liver enzymes in the blood. For this reason, your doctor will perform regular blood tests (liver function test) during treatment with Zenon. It is essential to attend the doctor for the prescribed laboratory controls.

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

Other medications and Zenon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. In particular, inform your doctor if you are taking a medication(s) with any of the following active principles:

• Ciclosporin (a medication often used in transplant patients).Do not take Zenon while taking ciclosporin.
• Medications with active principles to prevent blood clots (anticoagulants), such as warfarin, acenocoumarol, phenprocoumon, or fluindione (their anticoagulant effect and risk of bleeding may increase if taken with this medication), ticagrelor, or clopidogrel.
• Colestiramine (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 fibrates.
• Antacids containing aluminum and magnesium (used to neutralize stomach acid).
• Erythromycin (an antibiotic).
• Oral contraceptive (the pill).
• Hormone replacement therapy.
• Regorafenib (used to treat cancer).
• Darolutamide (used to treat cancer).
• Any of the following medications 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 medication. Your doctor will indicate when you can safely take Zenon again. Taking Zenon with fusidic acid can occasionally cause muscle weakness, pain, or sensitivity (rhabdomyolysis). You can find more information about rhabdomyolysis in section 4.
• Belumosudil (used to treat chronic Transplant Rejection Disease).

You must inform the doctors who will prescribe a new medication that you are taking Zenon.

Taking Zenon with alcohol

If you regularly consume large amounts of alcohol, do not take Zenon 40mg/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 unknown whether the medication passes into breast milk.

Children and adolescents

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

Driving and operating machinery

Zenon is not expected to interfere with your ability to drive or operate machinery. However, some people may feel dizzy after taking Zenon. If you feel dizzy, do not drive or operate machinery.

Zenon contains lactose (a type of sugar) and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• Before starting to take Zenon, you must be on a diet to reduce cholesterol.
• You must continue with this cholesterol-reducing 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 your personal risk situation.

The initiation of treatment or dose adjustments, if necessary, should only be made by taking the active ingredients separately, and once the appropriate doses are 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 suffering a heart attack or stroke, whose cholesterol levels do not decrease enough with 20 mg.

Try to take your tablet at the same time every 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 together with another cholesterol-lowering medication that contains the active ingredient colestiramine or another medication that contains a bile acid sequestrant, you must take Zenon at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Regular cholesterol level checks

It is essential that you attend your doctor regularly for cholesterol checks, in order to verify that your cholesterol levels have normalized and are maintained at appropriate levels.

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

If you takemore Zenon than you should

Get in touch with your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Zenon

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Zenon

Consult your doctor or pharmacist because your cholesterol levels may increase again.

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

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

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

• any unexplained muscle pain, tenderness or weakness that lasts longer than expected. This is because muscle problems, including muscle degradation that leads to kidney damage, can be serious and potentially life-threatening (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);
• flat, red patches on the trunk, often with blisters, peeling skin, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
• generalized rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome);
• illness similar to lupus (including rash, joint problems, and blood cell effects;
• muscle rupture.

Other side effects

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

Diarrhea; flatulence; feeling tired; high levels of some liver function blood test results (transaminases); headache; stomach pain; constipation; nausea; muscle pain; weakness; dizziness;increased protein levels in urine, which usually returns to normal on its own without the need to stop taking Zenon (only for rosuvastatin 40 mg); diabetes - this is more likely if you have high blood sugar and lipid levels, overweight, and high blood pressure. Your doctor will monitor you while taking this medicine.

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

High levels of some muscle function blood test results (creatine kinase test); cough; indigestion; heartburn; joint pain; muscle spasms; neck pain; loss of appetite; hot flashes; high blood pressure; numbness; dry mouth; stomach inflammation; tingling; rash; urticaria, and other skin reactions; back pain; muscle weakness; arm and leg pain; swelling, especially in hands and feet;increased protein levels in urine, which usually returns to normal on its own without the need to stop taking Zenon (only for rosuvastatin 10 mg and 20 mg).

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

Reduction in blood cell count that can cause bruising / bleeding (thrombocytopenia);intense stomach pain (pancreatitis).

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

Jaundice (yellow skin and eyes); hepatitis (inflamed liver); blood in urine; nerve damage in legs and arms (numbness); memory loss; gynecomastia (breast enlargement in men).

Frequency not known(cannot be estimated from available data):

Difficulty breathing; 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).

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

Myasthenia gravis (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, eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting side effects

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

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

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

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Zenon

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

• 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 contents of the package

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

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

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

Packaging sizes available: 10, 15, 30, 60, 90, 100 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Responsible 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-

Brueningstrasse 50

65926 Frankfurt am Main, Germany

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

Last review date of this leaflet:September 2024

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