Product Information for the User

Rosuvastatina/Ezetimiba Stadagen 5 mg/10 mg Film-Coated Tablets

Rosuvastatina/Ezetimiba Stadagen 10 mg/10 mg Film-Coated Tablets

Rosuvastatina/Ezetimiba Stadagen 20 mg/10 mg Film-Coated Tablets

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

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

2. What you need to know before starting to take Rosuvastatina/Ezetimiba Stadagen

3. How to take Rosuvastatina/Ezetimiba Stadagen

4. Possible adverse effects

5. Storage of Rosuvastatina/Ezetimiba Stadagen

6. Contents of the package and additional information

Rosuvastatina/Ezetimiba Stadagen contains two different active principles in one tablet. One of the active principles is rosuvastatina, which belongs to the group of medications called statins, the other active principle is ezetimiba.

Rosuvastatina/Ezetimiba Stadagen is a medication used in adult patients to reduce elevated levels of cholesterol, the "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally, Rosuvastatina/Ezetimiba Stadagen increases the concentrations of the "good" cholesterol (HDL cholesterol). This medication acts by reducing cholesterol in two ways: reducing the cholesterol absorbed in the digestive tract as well as the cholesterol produced by the body itself.

For most people, elevated 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, the 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 solely with diet. While taking this medication, you must follow a cholesterol-reducing diet. Your doctor may prescribe Rosuvastatina/Ezetimiba Stadagen if you are already taking rosuvastatina and ezetimiba at the same dose level.

Rosuvastatina/Ezetimiba Stadagen is used if you have:

• elevated cholesterol levels in the blood (primary hypercholesterolemia)
• heart disease, Rosuvastatina/Ezetimiba Stadagen reduces the risk of myocardial infarction, stroke, coronary artery bypass surgery, or hospitalization for chest pain.

Rosuvastatina/Ezetimiba Stadagen does not help you lose weight.

Do not take Rosuvastatina/Ezetimiba Stadagen if

• you are allergic to rosuvastatina, ezetimiba, or any of the other ingredients of this medication (listed in section 6),
• you have liver disease,
• you have severe kidney problems,
• you have repeated or unjustified muscle pain and cramps (myopathy),
• you are taking a medication called ciclosporina (used, for example, after an organ transplant),
• you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina/Ezetimiba Stadagen, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with this medication using an appropriate contraceptive method.
• you have ever developed a severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking rosuvastatina or other related medications.
• you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (medications used to treat a viral liver infection called hepatitis C).

Also, do not takeRosuvastatina/Ezetimiba Stadagen40mg/10mg (the highest dose):

• if you have moderate kidney problems (consult your doctor if unsure).
• if your thyroid gland does not function correctly (hypothyroidism).
• if you have repeated or unjustified muscle pain and cramps, a personal or family history of muscle problems, or have experienced muscle problems during treatment with other cholesterol-lowering medications.
• 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 cholesterol (see “Taking Rosuvastatina/Ezetimiba Stadagen with other medications”).

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 Rosuvastatina/Ezetimiba Stadagen if:

• you have kidney problems,
• you have liver problems,
• you have repeated or unjustified muscle pain and cramps, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you experience unjustified muscle pain or cramps, especially if accompanied by general discomfort or fever. Also, inform your doctor or pharmacist if you experience persistent muscle weakness.
• you are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor should establish the appropriate dose for you,
• if you are taking medications to treat infections, including HIV (HIV virus) or hepatitis C, such as lopinavir/ritonavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, sofosbuvir, voxilaprevir, velpatasvir, grazoprevir, elbasvir, glecaprevir, and/or pibrentasvir. See “Other medications and Rosuvastatina/Ezetimiba Stadagen”,
• you have severe respiratory failure,
• you are taking other medications called fibrates to lower cholesterol, see “Taking Rosuvastatina/Ezetimiba Stadagen with other medications”,
• you are about to undergo surgery. You may need to stop taking Rosuvastatina/Ezetimiba Stadagen for a short period
• you regularly consume large amounts of alcohol,
• your thyroid gland does not function correctly (hypothyroidism),
• you are over 70 years old, (since your doctor should choose the appropriate dose of Rosuvastatina/Ezetimiba Stadagen for you).
• you are taking or have taken within the last 7 days a medication called fusidic acid (an antibiotic) orally or injectable. The combination of fusidic acid and Rosuvastatina/Ezetimiba Stadagen may cause severe muscle problems (rhabdomyolysis).
• you are taking regorafenib (a medication for cancer)
• 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 that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

If you find yourself in any of these situations mentioned above (or are unsure): consult your doctor or pharmacist before starting to take any dose of this medication.

In a reduced number of people, statins can affect the liver. This is detected by a simple test that detects increased levels of liver enzymes in the blood. For this reason, your doctor will usually perform blood tests (liver function test) during treatment with this medication. It is essential that you visit your doctor for the tests.

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.

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

Children and adolescents

The use of this medication is not suitable for children and adolescents under 18 years of age.

Other medications and Rosuvastatina/Ezetimiba Stadagen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• Ciclosporina (used, for example, after an organ transplant to prevent organ rejection. The effect of rosuvastatina is increased with its use together). Do not take Rosuvastatina/Ezetimiba Stadagen if you are taking ciclosporina.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and the risk of bleeding may increase while taking this medication together), ticagrelor, or clopidogrel.
• Other medications to lower cholesterol called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates).
• Colestiramina (a medication to lower cholesterol), as it affects how ezetimiba works.
• Regorafenib (used to treat cancer).
• Darolutamida (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, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Medications for indigestion containing aluminum and magnesium (used to neutralize stomach acid, as they reduce the level of rosuvastatina in plasma).
• Eritromicina (an antibiotic).
• Fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking this medication. Your doctor will indicate when you can safely take Rosuvastatina/Ezetimiba Stadagen again. Taking this medication with fusidic acid may occasionally cause muscle weakness, pain, or sensitivity (rhabdomyolysis). You can find more information about rhabdomyolysis in section 4.
• Oral contraceptive (the pill).
• Hormone replacement therapy (increasing hormone levels in the blood).

If you visit a hospital or receive treatment for another condition, inform the medical staff that you are taking Rosuvastatina/Ezetimiba Stadagen.

Pregnancy and breastfeeding

Do not take Rosuvastatina/Ezetimiba Stadagen if you are pregnant, think you may be pregnant, or intend to become pregnant. If you become pregnant while taking this medication, stop taking it immediately and inform your doctor. Women should use contraceptive methods during treatment with this medication.

Do not take Rosuvastatina/Ezetimiba Stadagen if you are breastfeeding, as it is unknown whether the medication passes into breast milk.

Driving and operating machinery

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

Rosuvastatina/Ezetimiba Stadagen contains lactose and sodium

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You should continue to maintain a low-cholesterol diet and exercise while taking Rosuvastatina/Ezetimiba Stadagen.

The recommended dose for adults is one tablet per day.

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

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

This medication is not suitable for starting treatment. The initiation of treatment or dose adjustments, if necessary, should only be done by taking the active ingredients separately, and once the appropriate doses are adjusted, it is possible to switch to the appropriate dose of Rosuvastatina/Ezetimiba Stadagen.

If your doctor has prescribed Rosuvastatina/Ezetimiba Stadagen along with another cholesterol-lowering medication that contains the active ingredient colestiramine or any other medication that contains a bile acid sequestrant, you should take Rosuvastatina/Ezetimiba Stadagen at least 2 hours before or 4 hours after these medications.

Regular Cholesterol Level Checks

It is essential 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 Rosuvastatina/Ezetimiba Stadagen Than You Should

Contact your doctor or the nearest hospital's emergency service as you may need medical assistance.

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

If You Forget to Take Rosuvastatina/Ezetimiba Stadagen

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

If You Interrupt Treatment with Rosuvastatina/Ezetimiba Stadagen

Consult your doctor if you want to stop taking this medication. Your cholesterol levels may increase again if you stop taking this medication.

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

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

It is important that you know which side effects may occur.

Stop taking Rosuvastatina/Ezetimiba Stadagen and seek medical help immediately if you experience any of the following symptoms:

• any muscle pain, tenderness or weakness that lasts longer than expected. This is due to muscle problems, including muscle fibre destruction that can damage the kidneys, which can be severe and potentially life-threatening (rhabdomyolysis).Rare (may affect up to 1 in 1000 people);
• severe allergic reactions (angioedema) whose signs include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, and intense itching of the skin (with urticaria).Rare (may affect up to 1 in 1000 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). The frequency is unknown (cannot be estimated from available data).
• generalised rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome). The frequency is unknown (cannot be estimated from available data).
• condition similar to lupus (including rash, joint disorder, and effects on blood cells). The frequency is rare (may affect up to 1 in 1000 people).
• muscle rupture. The frequency is rare (may affect up to 1 in 1000 people).

Other side effects

Frequent side effects (may affect up to 1 in 10 people)

• headache;
• constipation;
• general feeling of being unwell;
• muscle pain;
• weakness;
• dizziness;
• diabetes. This is more likely if you have high blood sugar and lipid levels, being overweight, and high blood pressure.Your doctor will monitor you while taking this medicine;
• stomach pain;
• diarrhea;
• flatulence (excess gas in the intestinal tract);
• feeling tired;
• high levels of certain liver function test results (transaminases) in the blood.
• an increase in the amount of protein in the urine, which usually normalizes without the need to interrupt treatment with Rosuvastatina/Ezetimiba Stadagen (only with rosuvastatin 40 mg).

Rare side effects (may affect up to 1 in 100 people)

• skin rash, itching, urticaria;
• high levels of certain muscle function test results (Creatine Kinase) in the blood;
• cough;
• indigestion;
• heartburn;
• joint pain;
• muscle spasms;
• neck pain;
• loss of appetite;
• pain;
• chest pain;
• angina;
• high blood pressure;
• tingling sensation;
• dry mouth;
• inflammation of the stomach;
• back pain;
• muscle weakness;
• pain in the arms and legs;
• swelling, especially of the hands and feet.
• an increase in the amount of protein in the urine, which usually normalizes without the need to interrupt treatment with Rosuvastatina/Ezetimiba Stadagen (only with rosuvastatin 10 mg and 20 mg).

Rare side effects (may affect up to 1 in 1000 people)

• pancreatitis, which causes severe stomach pain that can spread to the back
• decrease in the number of platelets in the blood, which can cause bruises or bleeding (thrombocytopenia).

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

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

Frequency unknown (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 damage;
• constant muscle weakness;
• urticaria and target lesions (erythema multiforme).
• muscle sensitivity.
• gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, and vomiting).
• myasthenia gravis (a disease that causes generalised muscle weakness, which 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 the 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 is a possible side effect that does not 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.

This medication does not require any special temperature for conservation. Store in the original packaging to protect it from light and humidity.

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

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

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Rosuvastatina/Ezetimiba Stadagen

• The active principles are rosuvastatina (as rosuvastatina calcium) and ezetimiba.

Rosuvastatina/Ezetimiba Stadagen 5 mg/10 mg: Each film-coated tablet contains rosuvastatina calcium, equivalent to 5 mg of rosuvastatina, and 10 mg of ezetimiba.

Rosuvastatina/Ezetimiba Stadagen 10 mg/10 mg: Each film-coated tablet contains rosuvastatina calcium, equivalent to 10 mg of rosuvastatina, and 10 mg of ezetimiba.

Rosuvastatina/Ezetimiba Stadagen 20 mg/10 mg: Each film-coated tablet contains rosuvastatina calcium, equivalent to 20 mg of rosuvastatina, and 10 mg of ezetimiba.

• The other components are:

Tablet core

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

Tablet coating

Rosuvastatina/Ezetimiba Stadagen 5 mg/10 mg - Opadry yellow 02F220026 consisting of:

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

Rosuvastatina/Ezetimiba Stadagen 10 mg/10 mg - Opadry beige 02F270003 consisting of:

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

Rosuvastatina/Ezetimiba Stadagen 20 mg/10 mg - VIVACOAT PC-2P-308 consisting of:

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

Appearance of the product and contents of the package

Rosuvastatina/Ezetimiba Stadagen 5 mg/10 mg film-coated tablets Biconvex, round, yellowish, approximately 10 mm in diameter, with the inscription "EL 5" on one face.

Rosuvastatina/Ezetimiba Stadagen 10 mg/10 mg film-coated tablets Biconvex, round, beige, approximately 10 mm in diameter, with the inscription "EL 4" on one face.

Rosuvastatina/Ezetimiba Stadagen 20 mg/10 mg film-coated tablets Biconvex, round, yellow, approximately 10 mm in diameter, with the inscription "EL 3" on one face.

OPA/Al/PVC//Al blisters conditioned in carton boxes.

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

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

ELPEN Pharmaceutical Co. Inc.

95 Marathonos Ave.,

19009, Pikermi Attica,

Greece

or

ELPEN Pharmaceutical Co. Inc.

Zapani, Block 1048, Keratea,

190 01

Greece

Thismedicineis authorized in the member states of the European Economic Area with the following nonmembers:

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 film-coated tablets

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

Date of the last review of thisleaflet:October 2023

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