ROSUVASTATIN/EZETIMIBE STADAGEN 20 mg/10 mg FILM-COATED TABLETS

2. What you need to know before you take 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 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,
• you are taking a medicine called ciclosporin (used, for example, after an 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 should avoid becoming pregnant during treatment with this medicine using an appropriate contraceptive method.
• you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking rosuvastatin or other related medicines.
• you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (medicines used for the viral infection of the liver called hepatitis C).

Also, do not take Rosuvastatin/Ezetimibe Stadagen 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 correctly (hypothyroidism).
• If you have 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.
• If you regularly drink 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 not sure), consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rosuvastatin/Ezetimibe Stadagen if:

• you have kidney problems,
• you have liver problems,
• you have 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. Inform your doctor immediately if you have unexplained muscle pain or cramp, especially if you feel unwell or have a fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness,
• you are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor should determine the appropriate dose for you,
• if you are taking medicines to treat infections, including HIV (AIDS 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 failure,
• you are taking other medicines called fibrates to lower cholesterol, see "Taking Rosuvastatin/Ezetimibe Stadagen with other medicines",
• you are going to have an operation. You may need to stop taking Rosuvastatin/Ezetimibe Stadagen for a short time
• you regularly drink large amounts of alcohol,
• your thyroid gland does not work correctly (hypothyroidism),
• you are over 70 years old, (since your doctor should choose the appropriate dose of Rosuvastatin/Ezetimibe Stadagen for you).
• you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic). The combination of fusidic acid and Rosuvastatin/Ezetimibe Stadagen can cause serious muscle problems (rhabdomyolysis).
• you are taking regorafenib (a medicine to treat cancer)
• if you have or have had myasthenia (a disease that causes 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), since statins can sometimes worsen the disease or cause myasthenia (see section 4).

If you are in any of these situations mentioned above (or if you are not sure): consult your doctor or pharmacist before starting to take any dose of this medicine.

In a small 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 normally perform blood tests (liver function test) during treatment with this medicine. It is important that you go to the doctor to have these tests done.

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.

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

Children and adolescents

The use of 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 take any other medicines.

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

• Ciclosporin (used, for example, after an organ transplant to prevent rejection of the transplanted organ. The effect of rosuvastatin increases with its combined use). Do not takeRosuvastatin/Ezetimibe Stadagen if you are taking ciclosporin.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and the risk of bleeding may increase while taking this medicine), ticagrelor, or clopidogrel.
• Other medicines to lower cholesterol called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates).
• Colestyramine (a medicine to lower cholesterol), because it affects how ezetimibe works.
• Regorafenib (indicated for the treatment of 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, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Treatments for indigestion that contain aluminum and magnesium (used to neutralize stomach acid, as they reduce the level of rosuvastatin in the blood).
• Erythromycin (an antibiotic).
• Fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking this medicine. Your doctor will tell you when you can safely take Rosuvastatin/Ezetimibe Stadagen again. Taking this medicine with fusidic acid can rarely cause muscle weakness, pain, or sensitivity (rhabdomyolysis). You can find more information about rhabdomyolysis in section 4.
• An oral contraceptive (the pill).
• Hormone replacement therapy (increasing hormone levels in the blood).

If you go to the 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 are planning to become pregnant. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor. Women should use contraceptive methods during treatment with this medicine.

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

Driving and using machines

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

Rosuvastatin/Ezetimibe Stadagen contains lactose and sodium

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

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

3. How to take Rosuvastatin/Ezetimibe Stadagen

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

You should continue to follow a cholesterol-lowering diet and exercise while taking Rosuvastatin/Ezetimibe 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 medicine is not suitable for starting treatment. The start of treatment 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 Rosuvastatin/Ezetimibe Stadagen.

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

Regular checks of cholesterol levels

It is important that you go to your doctor regularly to have your cholesterol levels checked, in order to check that your cholesterol levels have returned to normal and are being maintained at appropriate levels.

If you take more Rosuvastatin/Ezetimibe Stadagen than you should

Contact your doctor or the nearest hospital emergency department immediately, as you may need medical attention.

In the event of an 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 Rosuvastatin/Ezetimibe Stadagen

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

If you stop taking Rosuvastatin/Ezetimibe Stadagen

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

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.

It is essential that you know what these adverse effects can be.

Stop taking Rosuvastatina/Ezetimiba 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 muscle fiber destruction that damages the kidneys, can be severe and potentially lead to a life-threatening disorder (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 hives). Rare (may affect up to 1 in 1000 people);
• red, non-raised spots on the torso, target-shaped or circular, 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). The frequency is unknown (cannot be estimated from available data).
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome). The frequency is unknown (cannot be estimated from available data).
• lupus-like syndrome (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 Adverse Effects

Common 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 blood sugar and lipid levels, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine;
• stomach pain;
• diarrhea;
• flatulence (excess gas in the intestinal tract);
• feeling tired;
• high levels in some blood test results of liver function (transaminases).
• an increase in the amount of protein in the urine that usually normalizes without the need to interrupt treatment with Rosuvastatina/Ezetimiba Stadagen (only with rosuvastatina 40 mg).

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• skin rash, itching, hives;
• high levels in some blood test results of muscle function (Creatine Kinase test);
• cough;
• indigestion;
• heartburn;
• joint pain;
• muscle spasms;
• neck pain;
• decreased appetite;
• pain;
• chest pain;
• hot flashes;
• high blood pressure;
• tingling sensation;
• dry mouth;
• stomach inflammation;
• 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 that usually normalizes without the need to interrupt treatment with Rosuvastatina/Ezetimiba Stadagen (only with rosuvastatina 10 mg and 20 mg).

Rare Adverse 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 bruising or bleeding (thrombocytopenia).

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

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

Frequency Not Known (cannot be estimated from available data)

• difficulty breathing;
• edema (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;
• hives and target-shaped lesions (erythema multiforme).
• muscle sensitivity.
• gallstones or gallbladder inflammation (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 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 Rosuvastatina/Ezetimiba Stadagen

This medicine does not require any special storage temperature. Keep it 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 expiration date shown on the carton or blister pack after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Rosuvastatina/Ezetimiba Stadagen

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

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

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

Rosuvastatina/Ezetimiba 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 ingredients are:

Tablet core

Lactose monohydrate, sodium croscarmellose, 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 Package Contents

Rosuvastatina/Ezetimiba Stadagen 5 mg/10 mg film-coated tablets Film-coated, biconvex, round tablets, light yellow in color, with a diameter of approximately 10 mm and with the inscription "EL 5" on one side.

Rosuvastatina/Ezetimiba Stadagen 10 mg/10 mg film-coated tablets Film-coated, biconvex, round tablets, beige in color, with a diameter of approximately 10 mm and with the inscription "EL 4" on one side.

Rosuvastatina/Ezetimiba Stadagen 20 mg/10 mg film-coated tablets Film-coated, biconvex, round tablets, yellow in color, with a diameter of approximately 10 mm and with the inscription "EL 3" on one side.

OPA/Al/PVC//Al blisters packaged in cardboard boxes.

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

Not all 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 medicine 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 film-coated tablets

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

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 film-coated tablets

Date of the Last Revision of this Leaflet:October 2023

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