Zenon 20 mg/10 mg film-coated tablets

Package leaflet: Information for the user

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 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, 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, 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.

Contents of the leaflet

1. What Zenon is and what it is used for

2. What you need to know before taking Zenon

3. How to take Zenon

4. Possible side effects

5. How to store Zenon

6. Contents of the pack and other information

1. What Zenon is and what it is used for

Zenon contains two different active substances in a 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 adults to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, Zenon increases levels of "good" cholesterol (HDL cholesterol).

Zenon works to reduce cholesterol in two ways: by reducing the cholesterol absorbed in the gastrointestinal tract and by reducing cholesterol produced by the body itself.

Cholesterol is one of many fatty substances circulating in the blood. Total cholesterol is made up mainly of LDL and HDL cholesterol.

It 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.

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

• primary hypercholesterolemia [heterozygous familial and non-familial],
• a hereditary disease [homozygous familial hypercholesterolemia],

and for which you were previously taking a single statin that did not control your cholesterol level, or you had been taking a statin and ezetimibe as 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 due to chest pain.

Zenon does not help you to lose weight.

For most people, high cholesterol levels do not affect how they feel, as they do not cause 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 blood supply to the heart or brain, leading to a heart attack or stroke. By lowering cholesterol levels, the risk of having a heart attack, stroke, or other related health problems can be reduced.

You should continue taking Zenon even if your cholesterol levels are at the desired level, as it prevents your cholesterol levels from rising again and causing fatty deposits to accumulate.

However, you must stop taking it if your doctor tells you to do so, or if you become pregnant.

2. What you need to know before taking 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 must avoid becoming pregnant during treatment with Zenon by using an appropriate contraceptive method.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pain and cramps (myopathy).
• If you are taking a combination of drugs containing sofosbuvir/velpatasvir/voxilaprevir (used for a viral liver infection called hepatitis C).
• If you are taking a combination of drugs containing ledipasvir/sofosbuvir (used for a viral liver infection called hepatitis C).
• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking Zenon or other medicines containing rosuvastatin.
• If you are taking a medicine called cyclosporine (used, for example, after an organ transplant).

If you are in any of the situations listed above (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 is not functioning properly (hypothyroidism).
• If you have repeated or unexplained muscle pain and cramps (myopathy), a personal or family history of muscle problems, or a previous history of muscle problems while taking other cholesterol-lowering medicines.
• 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 medicines called fibrates to lower cholesterol (see section “Other medicines and Zenon”).

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

Warnings and precautions

Talk to 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 pain or discomfort, a personal or family history of muscle problems, or a previous history of muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience muscle pain or unexplained aches, 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 is not functioning properly (hypothyroidism).
• If you have severe respiratory failure.
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness that, 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).
• 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 of age (as your doctor must choose the most appropriate starting dose of Zenon for your needs).
• If you are taking other medicines called fibrates to lower your cholesterol (see “Other medicines and Zenon”).
• If you are scheduled for surgery. You may need to stop taking Zenon temporarily.
• If you are of Asian-Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian origin. Your doctor must choose the most appropriate starting dose of Zenon for your needs.
• If you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection), taken orally or by injection. The combination of fusidic acid and Zenon may cause serious muscle problems (rhabdomyolysis).

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.

In a small number of people, statins may affect the liver. This is detected by a simple blood test showing elevated liver enzyme levels. For this reason, your doctor will regularly perform blood tests (liver function tests) during treatment with Zenon. It is important to attend all scheduled laboratory check-ups.

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

Other medicines and Zenon

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor if you are taking a medicine(s) containing any of the following active substances:

• Cyclosporine (a medicine often used in transplant patients). Do not take Zenon while taking cyclosporine.
• Medicines containing active ingredients used to prevent blood clots (anticoagulants), such as warfarin, acenocoumarol, phenprocoumon, or fluindione (their anticoagulant effect and risk of bleeding may increase when taken with this medicine), ticagrelor, or clopidogrel.
• Colestipol or cholestyramine (also used to lower cholesterol), as they affect how Zenon works.
• Fibrates such as gemfibrozil or fenofibrate (also used to lower cholesterol). Do not take Zenon 40 mg/10 mg tablets together with a fibrate.
• Treatments for indigestion containing aluminum and magnesium (used to neutralize stomach acid).
• Erythromycin (an antibiotic).
• An oral contraceptive (the pill).
• Hormone replacement therapy.
• Regorafenib (indicated for the treatment of cancer).
• Darolutamide (indicated for the treatment of 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 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 Zenon. Taking Zenon with fusidic acid may rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.
• Belumosudil (used to treat chronic graft-versus-host disease).

You must inform any doctor prescribing a new medicine that you are taking Zenon.

Taking Zenon with alcohol

If you regularly consume 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 might 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 medicine passes into breast milk.

Children and adolescents

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

Driving and using machines

Zenon is not expected to affect your ability to drive or operate machinery. However, some people may experience dizziness 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 informed you that you have an intolerance to certain sugars, consult him 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 instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The recommended dose is one tablet once daily.

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 individual risk situation.

Initiation of treatment or dose adjustments, if necessary, should only be performed by taking the active substances separately; once the appropriate doses have been adjusted, switching to the corresponding dose of Zenon may be possible.

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

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

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

Regular monitoring of cholesterol levels

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.

Your doctor may decide to increase your dose to ensure you are taking the amount of medicine appropriate for you.

If you take more Zenon than you should

Contact your doctor or pharmacist.

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

If you forget to take Zenon

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

If you stop taking Zenon

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

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.

Stop taking Zenon and seek immediate medical attention 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 leading to kidney damage, can be serious and may 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-elevated, target-shaped or circular spots 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome);
• lupus-like illness (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; elevated levels in certain blood test results for liver function (transaminases); headache; stomach pain; constipation; nausea; muscle pain; weakness; dizziness; increased amount of protein in urine, which usually returns to normal on its own without the need to discontinue 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):

Elevated levels in certain blood test results for muscle function (Creatine Kinase test); cough; indigestion; heartburn; joint pain; muscle spasms; neck pain; loss of appetite; hot flushes; 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 returns to normal on its own without the need to discontinue treatment with Zenon (only for rosuvastatin 10 mg and 20 mg).

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

Reduction in blood cell counts that may cause bruising/bleeding (thrombocytopenia); severe stomach pain (inflamed pancreas).

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

Jaundice (yellowing of the skin and eyes); hepatitis (inflamed liver); traces of blood in your urine; nerve damage in arms and legs (such as numbness); memory loss; gynecomastia (enlargement of breast tissue 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; persistent muscle weakness; raised red rash, sometimes with target-shaped lesions (erythema multiforme); muscle sensitivity; gallstones or inflammation of the gallbladder (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 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zenon

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

• The other components are:

• Core: lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, povidone, colloidal anhydrous 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).

Nature of the product and contents of the pack

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/10 mg 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 contained in a folding carton box.

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

Only certain pack 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-

Brueningstrasse 50

65926 Frankfurt am Main, Germany

This medicinal product 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 most recent review 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/).