ROSUVASTATIN/EZETIMIBE PENSA 10 mg/10 mg FILM-COATED TABLETS

2. What you need to know before you take Rosuvastatin/Ezetimibe pensa

Do not take Rosuvastatin/Ezetimibe pensa 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 (myopathy),
• you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (medicines used to treat hepatitis C virus infection).
• 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, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with rosuvastatin/ezetimibe 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/ezetimibe or other medicines containing rosuvastatin.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine 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 previous history of muscle problems during treatment with other cholesterol-lowering medicines. Tell your doctor immediately if you have unexplained muscle pain, cramp, or weakness, especially if you also feel unwell or have a high temperature. Also, tell your doctor or pharmacist if you have persistent muscle weakness,
• if you have or have had myasthenia (a disease characterized by general muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can 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 should determine the appropriate dose for you,
• if you are taking medicines to treat infections, including HIV (AIDS virus) or hepatitis C, such as ritonavir with lopinavir and/or atazanavir. See "Other medicines and Rosuvastatin/Ezetimibe pensa",
• you have severe respiratory failure,
• you are taking other cholesterol-lowering medicines called fibrates, see "Other medicines and Rosuvastatin/Ezetimibe",
• you regularly drink large amounts of alcohol,
• your thyroid gland does not work properly (hypothyroidism),
• you are over 70 years old (as your doctor should choose the right dose of rosuvastatin/ezetimibe 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 can cause serious muscle problems (rhabdomyolysis).

If you are in any of the above situations (or are unsure): consult your doctor or pharmacist before starting to take any dose of rosuvastatin/ezetimibe.

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/ezetimibe and seek medical attention immediatelyif you notice any of the symptoms described in section 4.

In a small number of people, statins can affect the liver. This can be detected by a simple blood test that checks for increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally do blood tests (liver function tests) during treatment with rosuvastatin/ezetimibe. It is important that you go to your doctor for these blood tests.

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 fats in your blood, are overweight, and have high blood pressure.

Children and adolescents

Rosuvastatin/ezetimibe is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Rosuvastatin/Ezetimibe pensa

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

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

• Ciclosporin (used after an organ transplant to prevent rejection of the transplanted organ. The effect of rosuvastatin increases with its combined use). Do not take rosuvastatin/ezetimibe if you are taking ciclosporin.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and the risk of bleeding may increase while taking rosuvastatin/ezetimibe), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates). The effect of rosuvastatin increases with its combined use.
• Colestyramine (a medicine also used to lower cholesterol), as it affects how ezetimibe works.
• Regorafenib (indicated for the treatment of cancer).
• Simeprevir (indicated for the treatment of chronic hepatitis C infection).
• 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, 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). This effect can be mitigated by taking this type of medicine 2 hours after rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases with its combined use.
• Fusidic acid. If you have 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 again. Taking rosuvastatin/ezetimibe 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). The levels of sex hormones absorbed from the pill are increased.
• Capmatinib (indicated for the treatment of cancer).
• Hormone replacement therapy (increased levels of hormones in the blood).
• Fostamatinib (used to treat low platelet count).
• Febuxostat (used to treat and prevent high levels of uric acid in the blood).
• Teriflunomide (indicated for the treatment of multiple sclerosis).

If you go to hospital or receive treatment for another condition, tell the medical staff that you are taking rosuvastatin/ezetimibe.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant while taking rosuvastatin/ezetimibe, stop taking it immediately and inform your doctor. Women must use contraceptive methods during treatment with rosuvastatin/ezetimibe.

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

Driving and using machines

Rosuvastatin/ezetimibe is unlikely to affect your ability to drive or use machines. However, some people may feel dizzy while taking rosuvastatin/ezetimibe. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatin/Ezetimibe pensa contains lactose

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

Rosuvastatin/Ezetimibe pensa contains sodium

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

3. How to take Rosuvastatin/Ezetimibe pensa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

You should continue to follow a cholesterol-lowering diet while taking rosuvastatin/ezetimibe.

The recommended daily dose for adults is one film-coated tablet of the appropriate strength.

Take Rosuvastatin/Ezetimibe once a day.

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

Rosuvastatin/Ezetimibe is not suitable for initiating 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 rosuvastatin/ezetimibe of the corresponding dose.

Regular checks of cholesterol levels

It is important that you go to your doctor regularly to have your cholesterol levels checked, to ensure that your cholesterol levels have returned to normal and remain at appropriate levels.

If you take more Rosuvastatin/Ezetimibe pensa than you should

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

In case of 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 pensa

Do not worry, just take the next scheduled dose at the right time. Do not take a double dose to make up for forgotten doses.

If you stop taking Rosuvastatin/Ezetimibe pensa

Consult your doctor if you want to stop taking rosuvastatin/ezetimibe. Your cholesterol levels may rise again if you stop taking rosuvastatin/ezetimibe.

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 this medicine and seek medical attention immediately if you notice any of the following symptoms:

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

• Allergic reactions such as swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing and swallowing.
• Unjustified muscle pains and cramps that last longer than expected. In rare cases, this can become potentially life-threatening muscle damage known as rhabdomyolysis, leading to general discomfort, fever, and kidney failure.
• Lupus-like syndrome (including rash, joint disorder, and effects on blood cells).
• Muscle rupture.

Adverse Effects of Unknown Frequency (cannot be estimated from available data):

• Red, non-elevated, target-shaped, or circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, elevated body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).
• Erythema multiforme (potentially life-threatening allergic reactions affecting the skin and mucous membranes).

Other Possible Adverse Effects:

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

• Headache;
• Constipation;
• General discomfort;
• 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.
• Abdominal pain (stomach pain);
• Diarrhea;
• Flatulence (excess gas in the intestinal tract);
• Feeling tired;
• High levels in some blood test results for liver function (transaminases).

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

• Skin rash, itching, hives;
• Increased amount of protein in urine, which usually reverses itself without the need to interrupt treatment with rosuvastatin;
• High levels in some blood test results for muscle function (CK);
• 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.

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

• Pancreatitis, which causes severe stomach pain that can extend to the back;
• Reduction of blood platelet levels.

Very Rare (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;
• Increased breast size in men (gynecomastia).

Frequency Not Known (cannot be estimated from available data):

• Breathing difficulties;
• 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;
• 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, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rosuvastatin/Ezetimibe

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

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from light and moisture.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Rosuvastatin/Ezetimibe Composition

The active ingredients are rosuvastatin (as rosuvastatin calcium) and ezetimibe. Each film-coated tablet contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe.

The other components (excipients) are:

Core of the tablet:Microcrystalline cellulose; Anhydrous colloidal silica; Magnesium stearate; Povidone; Sodium croscarmellose; Sodium lauryl sulfate; Lactose monohydrate; Hypromellose.

Coating material:

Hypromellose; Titanium dioxide; Macrogol; Yellow iron oxide (E-172); Talc.

Appearance of the Product and Package Contents

Rosuvastatin/Ezetimibe 10 mg/10 mg film-coated tablets are beige, round, biconvex, approximately 10 mm in diameter, and marked with the inscription "EL 4" on one side.

Rosuvastatin/Ezetimibe is available in cardboard boxes with blister packs (OPA/Al/PVC/Al) of 30 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Elpen Pharmaceutical Co. Inc.

Marathonos 95

190 09 Pikermi, Attiki

Greece

Or

Rontis Hellas Medical and Pharmaceutical Products S.A.

P.O Box 3012 Larissa Industrial Area,

Larissa, 41500

Greece

Date of the Last Revision of this Prospectus: August 2024

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