Rosuvastatin/ezetimibe Stadagen 20 mg/10 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rosuvastatin/Ezetimibe Stadagen 5 mg/10 mg film-coated tablets
Rosuvastatin/Ezetimibe Stadagen 10 mg/10 mg film-coated tablets
Rosuvastatin/Ezetimibe Stadagen 20 mg/10 mg film-coated tablets

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

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Rosuvastatin/Ezetimibe Stadagen is and what it is used for
2. What you need to know before taking Rosuvastatin/Ezetimibe Stadagen
3. How to take Rosuvastatin/Ezetimibe Stadagen
4. Possible side effects
5. How to store Rosuvastatin/Ezetimibe Stadagen
6. Contents of the pack and other information

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

Rosuvastatina/Ezetimiba Stadagen contains two different active substances in one tablet. One of the active substances is rosuvastatin, which belongs to a group of medicines called statins; the other active substance is ezetimibe.

Rosuvastatina/Ezetimiba Stadagen is a medicine used in adult patients to reduce elevated levels of cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, Rosuvastatina/Ezetimiba Stadagen increases levels of "good" cholesterol (HDL cholesterol). This medicine works to reduce cholesterol in two ways: by reducing cholesterol absorption in the gastrointestinal tract and by reducing cholesterol produced by the body itself.

For most people, elevated cholesterol levels do not affect how they feel, as they produce 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.

Rosuvastatina/Ezetimiba Stadagen is used in patients who cannot control their cholesterol levels through diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet. Your doctor may prescribe Rosuvastatina/Ezetimiba Stadagen if you are already taking rosuvastatin and ezetimibe at the same dose levels.

Rosuvastatina/Ezetimiba Stadagen is used if you have:

• elevated blood cholesterol levels (primary hypercholesterolemia)
• heart disease; Rosuvastatina/Ezetimiba Stadagen reduces the risk of myocardial infarction, stroke, surgery to increase blood flow to the heart, or hospitalization due to chest pain.

Rosuvastatina/Ezetimiba Stadagen does not help you lose weight.

2. What you need to know before taking Rosuvastatin/Ezetimibe Stadagen

Do not take Rosuvastatin/Ezetimibe Stadagen 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 and cramps (myopathy).
• you are taking a medicine called cyclosporine (used, for example, after organ transplant).
• you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin/Ezetimibe Stadagen, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with this medicine by using an appropriate contraceptive method.
• you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking rosuvastatin or other related medicines.
• you are taking the combination sofosbuvir/velpatasvir/voxilaprevir (medicines used to treat a viral liver infection called hepatitis C).

In addition, do not take Rosuvastatin/Ezetimibe Stadagen 40mg/10mg (the highest dose):

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland is not working properly (hypothyroidism).
• If you have recurrent or unexplained muscle pain and cramps, personal or family history of muscle problems, or have experienced muscle problems during treatment with 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 “Taking Rosuvastatin/Ezetimibe Stadagen with other medicines”).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Rosuvastatin/Ezetimibe Stadagen if:

• you have any medical conditions, including allergies.
• you have kidney problems.
• you have liver problems.
• you have recurrent or unexplained muscle pain and cramps, a personal or family history of muscle problems, or a 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 for you.
• you are taking medicines to treat infections, including HIV (human immunodeficiency virus) or hepatitis C, such as lopinavir, ritonavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, sofosbuvir, voxilaprevir, velpatasvir, grazoprevir, elbasvir, glecaprevir, and/or pibrentasvir. See “Other medicines and Rosuvastatin/Ezetimibe Stadagen”.
• you have severe respiratory insufficiency.
• you are taking other medicines called fibrates to lower cholesterol; see “Taking Rosuvastatin/Ezetimibe Stadagen with other medicines”.
• you are scheduled for surgery. You may need to stop taking Rosuvastatin/Ezetimibe Stadagen for a short period.
• 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 Stadagen for you).
• you are currently 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 Rosuvastatin/Ezetimibe Stadagen may cause serious muscle problems (rhabdomyolysis).

If you are in any of the above situations (or if you are unsure), consult your doctor or pharmacist before starting any dose of this medicine.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin treatment. Stop using rosuvastatin 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 through a simple blood test showing increased levels of liver enzymes. For this reason, your doctor will usually perform blood tests (liver function tests) during treatment with this medicine. It is important that you attend your 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.

Children and adolescents

This medicine is not suitable for children and adolescents under 18 years of age.

Other medicines and Rosuvastatin/Ezetimibe Stadagen

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor if you are taking any of the following medicines:

• Cyclosporine (used, for example, after organ transplant to prevent organ rejection). The effect of rosuvastatin increases when taken together. Do not take Rosuvastatin/Ezetimibe Stadagen if you are taking cyclosporine.
• Anticoagulants, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants) (their anticoagulant effects and risk of bleeding may increase when taken with this medicine), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels in blood (e.g., gemfibrozil and other fibrates).
• Colestiramine (a cholesterol-lowering medicine), as it affects how ezetimibe works.
• Regorafenib (used to treat cancer).
• Darolutamide (used to treat cancer).
• Capmatinib (used to treat cancer).
• Fostamatinib (used to treat low platelet count).
• Febuxostat (used to treat and prevent high levels of uric acid in blood).
• Teriflunomide (used to treat multiple sclerosis).
• Leflunomide (used to treat rheumatoid arthritis).
• 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, simeprevir, 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).
• Erythromycin (an antibiotic).
• 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 Stadagen. Taking this medicine 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).
• Hormone replacement therapy (increasing hormone levels in blood).
• Roxadustat (used to treat anaemia in patients with chronic kidney disease).
• Tafamidis (used to treat a disease called transthyretin amyloidosis).
• Momelotinib (used to treat myelofibrosis in adults with anaemia).

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

Pregnancy and breastfeeding

Do not take Rosuvastatin/Ezetimibe Stadagen if you are pregnant, think you may be pregnant, or plan to become pregnant. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor. Women must use contraceptive methods during treatment with this medicine.

Do not take Rosuvastatin/Ezetimibe Stadagen if you are breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine is not expected to affect your ability to drive or operate machinery. However, some people may experience dizziness after taking this medicine. If you feel dizzy, do not drive or use machinery.

Rosuvastatin/Ezetimibe Stadagen contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

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

3. How to take Rosuvastatin/Ezetimibe Stadagen

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

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

The recommended dose for adults is one tablet daily.

You may take it at any time of day, with or without food. Swallow each tablet whole with water.

Try to take the tablets at the same time every day to help you remember.

This medicine is not suitable for initiating treatment. Treatment initiation or dose adjustments, if necessary, should only be done using the active substances separately. Once the appropriate doses have been established, switching to the corresponding dose of Rosuvastatin/Ezetimibe Stadagen is possible.

If your doctor has prescribed Rosuvastatin/Ezetimibe Stadagen together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant, you must take Rosuvastatin/Ezetimibe Stadagen at least 2 hours before or 4 hours after taking those medicines.

Regular cholesterol level monitoring

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

If you take more Rosuvastatin/Ezetimibe Stadagen than you should

Contact your doctor or the nearest hospital emergency department, 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 Stadagen

Do not worry. Skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Rosuvastatin/Ezetimibe Stadagen

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 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 Stadagen and seek immediate medical attention if you experience any of the following symptoms:

• any unexplained muscle pain, tenderness, or weakness that lasts longer than expected. This is because muscle problems, including breakdown of muscle fibres that can damage the kidneys, may be serious and could lead to a potentially life-threatening condition (rhabdomyolysis). Rare (may affect up to 1 in 1,000 people).
• severe allergic reactions (angioedema), signs of which include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, and intense skin itching (with hives). Rare (may affect up to 1 in 1,000 people).
• non-elevated reddish spots on the trunk, often target-shaped or circular, sometimes 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). Frequency is not known (cannot be estimated from available data).
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). Frequency is not known (cannot be estimated from available data).
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells). Frequency is rare (may affect up to 1 in 1,000 people).
• muscle rupture. Frequency is rare (may affect up to 1 in 1,000 people).

Other adverse effects

Frequent adverse effects (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 levels of blood sugar and lipids, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• stomach pain
• diarrhoea
• flatulence (excess gas in the gastrointestinal tract)
• feeling tired
• elevated levels in certain blood tests of liver function (transaminases)
• increased levels of protein in the urine, which usually return to normal without the need to discontinue treatment with Rosuvastatin/Ezetimibe Stadagen (only with rosuvastatin 40 mg).

Uncommon adverse effects (may affect up to 1 in 100 people)

• skin rash, itching, urticaria
• elevated levels in certain blood tests of muscle function (Creatine Kinase test)
• 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
• increased levels of protein in the urine, which usually return to normal without the need to discontinue treatment with Rosuvastatin/Ezetimibe Stadagen (only with rosuvastatin 5 mg, 10 mg, and 20 mg).

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

• inflammation of the pancreas, causing severe stomach pain that may spread to the back
• decreased number of platelets in the blood, which may cause bruising or bleeding (thrombocytopenia).

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

• jaundice (yellowing of the skin and eyes)
• inflammation of the liver (hepatitis)
• traces of blood in the urine
• nerve damage in arms and legs (such as numbness)
• memory loss
• enlargement of the breasts in men (gynaecomastia).

Frequency not known (cannot be estimated from available data)

• difficulty breathing
• oedema (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
• urticaria and target-shaped skin lesions (erythema multiforme)
• muscle sensitivity
• 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 muscles used for breathing)
• ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in your 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, consult 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 Rosuvastatin/Ezetimibe Stadagen

This medicine does not require any special storage temperature. Keep in the original packaging to protect it from light and moisture.

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

Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatin/Ezetimibe Stadagen

• The active substances are rosuvastatin (as rosuvastatin calcium) and ezetimibe.

Rosuvastatin/Ezetimibe Stadagen 5 mg/10 mg: Each film-coated tablet contains rosuvastatin calcium, equivalent to 5 mg of rosuvastatin, and 10 mg of ezetimibe.

Rosuvastatin/Ezetimibe Stadagen 10 mg/10 mg: Each film-coated tablet contains rosuvastatin calcium, equivalent to 10 mg of rosuvastatin, and 10 mg of ezetimibe.

Rosuvastatin/Ezetimibe Stadagen 20 mg/10 mg: Each film-coated tablet contains rosuvastatin calcium, equivalent to 20 mg of rosuvastatin, and 10 mg of ezetimibe.

• The other components are:

Tablet core

Lactose monohydrate, sodium croscarmellose, povidone, sodium lauryl sulfate, microcrystalline cellulose 102, hypromellose 2910, colloidal anhydrous silica, magnesium stearate

Tablet coating

Rosuvastatin/Ezetimibe Stadagen 5 mg/10 mg - Opadry Yellow 02F220026 composed of:

Hypromellose 2910 (E464), titanium dioxide (E171), yellow iron oxide (E172), talc (E553b), red iron oxide (E172), macrogol 4000 (E1521)

Rosuvastatin/Ezetimibe Stadagen 10 mg/10 mg - Opadry Beige 02F270003 composed of:

Hypromellose 2910 (E464), titanium dioxide (E171), yellow iron oxide (E172), macrogol 4000 (E1521), talc (E553b)

Rosuvastatin/Ezetimibe Stadagen 20 mg/10 mg - VIVACOAT PC-2P-308 composed of:

Hypromellose 6 (E464), titanium dioxide (E171), talc (E553b), macrogol 4000 (E1521), yellow iron oxide (E172)

Appearance of the product and contents of the pack

Rosuvastatin/Ezetimibe Stadagen 5 mg/10 mg film-coated tablets: Film-coated, biconvex, round, light yellow tablets, approximately 10 mm in diameter, with the imprint "EL 5" on one side.

Rosuvastatin/Ezetimibe Stadagen 10 mg/10 mg film-coated tablets: Film-coated, biconvex, round, beige tablets, approximately 10 mm in diameter, with the imprint "EL 4" on one side.

Rosuvastatin/Ezetimibe Stadagen 20 mg/10 mg film-coated tablets: Film-coated, biconvex, round, yellow tablets, approximately 10 mm in diameter, with the imprint "EL 3" on one side.

Blister packs made of OPA/Al/PVC//Al, packed in cardboard boxes.

Pack sizes of 14, 15, 28, 30, 56, 60, 84, 90 and 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

ELPEN Pharmaceutical Co. Inc.

95 Marathonos Ave.,

19009, Pikermi Attica,

Greece

or

ELPEN Pharmaceutical Co. Inc.

Zapani, Block 1048, Keratea,

190 01

Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Rosuvastatin/Ezetimibe Elpen

Cyprus: Lipopen 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, 40 mg/10 mg film-coated tablets

Germany: Rosuvastatin/Ezetimib-Elpen 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, 40 mg/10 mg Filmtabletten

Greece: Lipopen 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, 40 mg/10 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

Spain: Rosuvastatina/Ezetimiba Stadagen 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg comprimidos recubiertos con película

Austria: Ezerosu 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, 40 mg/10 mg Filmtabletten

Date of latest revision of the leaflet: January 2026

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