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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rosuvastatin/Ezetimibe pensa 20 mg/10 mg film-coated tablets

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

• Keep this leaflet, as you may need to read it again.

  1. 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 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Rosuvastatina/Ezetimiba is a medicine used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, Rosuvastatina/Ezetimiba increases levels of "good" cholesterol (HDL cholesterol). This medicine works by reducing cholesterol in two ways: it reduces both the cholesterol absorbed in the digestive tract and the cholesterol produced by the body itself.

For most people, high cholesterol levels do not affect how they feel, as they cause 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.

This medicine 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 if you are already taking rosuvastatin and ezetimibe at the same dose level.

This medicine is used in patients with heart disease. Rosuvastatina/Ezetimiba reduces the risk of myocardial infarction, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Rosuvastatina/Ezetimiba does not help you lose weight.

2. What you need to know before taking Rosuvastatina/Ezetimiba pensa

Do not take Rosuvastatina/Ezetimiba 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 pain or cramps (myopathy),
• you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (medicines used to treat a viral liver infection called hepatitis C),
• you are taking a medicine called cyclosporine (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 by using an appropriate contraceptive method,
• you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking rosuvastatin/ezetimibe or another medicine containing rosuvastatin.

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

Warnings and precautions

Talk to 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 pain or cramps, a personal or family history of muscle disorders, or a previous 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 accompanied by general malaise or 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 ritonavir with lopinavir and/or atazanavir. See “Other medicines and Rosuvastatina/Ezetimiba pensa”,
• you have severe respiratory failure,
• you are taking other cholesterol-lowering medicines called fibrates; see “Other medicines and Rosuvastatina/Ezetimiba pensa”,
• you regularly consume large amounts of alcohol,
• your thyroid gland is not functioning properly (hypothyroidism),
• you are over 70 years old (as your doctor must choose the appropriate dose of rosuvastatin/ezetimibe for you),
• you are 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 may cause serious muscle problems (rhabdomyolysis).

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

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin treatment. Stop taking rosuvastatin/ezetimibe 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 (transaminases). For this reason, your doctor will usually perform blood tests (liver function tests) during treatment with rosuvastatin/ezetimibe. It is important that you attend your medical appointments for these tests.

While taking this medicine, 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 levels of sugar and fats in your blood, are overweight, and have high blood pressure.

Children and adolescents

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

Other medicines and Rosuvastatina/Ezetimiba pensa

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

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

• Cyclosporine (used after organ transplantation to prevent organ rejection. The effect of rosuvastatin increases when taken together). Do not take rosuvastatin/ezetimibe if you are taking cyclosporine.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and risk of bleeding may increase when taken with rosuvastatin/ezetimibe), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also correct blood triglyceride levels (e.g., gemfibrozil and other fibrates). The effect of rosuvastatin increases when taken together.
• Colestyramine (another medicine used to lower cholesterol), as it affects how ezetimibe works.
• Regorafenib (used to treat cancer).
• Simeprevir (used to treat 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.
• Medicines for indigestion containing aluminium and magnesium (used to neutralize stomach acid, as they reduce plasma levels of rosuvastatin). This effect can be minimized by taking these medicines 2 hours after rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases when taken together.
• Fusidic acid. If you need to take oral fusidic acid for a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart rosuvastatin/ezetimibe. Taking rosuvastatin/ezetimibe with fusidic acid may rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• An oral contraceptive (the pill). Absorbed levels of sex hormones from the pill are increased.
• Capmatinib (used to treat cancer).
• Hormone replacement therapy (increases hormone levels 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 (used to treat multiple sclerosis).

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. If you become pregnant while taking rosuvastatin/ezetimibe, stop taking it immediately and inform your doctor. Women should use contraceptive methods during treatment with rosuvastatin/ezetimibe.

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

Driving and use of machines

Rosuvastatin/ezetimibe is not expected to affect your ability to drive or use machines. However, some people may experience dizziness during treatment with rosuvastatin/ezetimibe. If you feel dizzy, consult your doctor before attempting to drive or operate machinery.

Rosuvastatina/Ezetimiba pensa contains lactose

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

Rosuvastatina/Ezetimiba pensa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; hence, it is essentially “sodium-free”.

3. How to take Rosuvastatina/Ezetimiba pensa

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

You must continue to maintain a cholesterol-lowering diet and exercise regularly while taking rosuvastatin/ezetimibe.

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

Take Rosuvastatin/Ezetimiba once daily.

You may 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 performed using the active substances separately. Once the appropriate doses have been established, switching to rosuvastatin/ezetimibe at the corresponding dose may be considered.

Regular cholesterol level checks

It is important that you visit your doctor regularly for cholesterol monitoring, to ensure that your cholesterol levels have normalized and remain within appropriate ranges.

If you take more Rosuvastatin/Ezetimiba pensa 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 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Rosuvastatin/Ezetimiba pensa

Do not worry; simply take the next scheduled dose at the usual time. Do not take a double dose to make up for missed doses.

If you stop taking Rosuvastatin/Ezetimiba pensa

Consult your doctor if you wish to discontinue treatment with rosuvastatin/ezetimibe. Your cholesterol levels may rise again if you stop taking rosuvastatin/ezetimibe.

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 this medicine and seek immediate medical attention 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 may cause difficulty breathing and swallowing.
• Unexplained muscle pain and cramps lasting longer than expected. In rare cases, this may progress to potentially life-threatening muscle damage known as rhabdomyolysis, leading to general malaise, fever, and kidney failure.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).
• Muscle rupture.

Adverse effects of unknown frequency (cannot be estimated from available data):

• Red, non-elevated spots on the trunk, target-shaped or circular rashes, 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).
• 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 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.
• Abdominal pain (stomach ache);
• Diarrhea;
• Flatulence (excess gas in the gastrointestinal tract);
• Feeling tired;
• Elevated levels in certain blood test results indicating liver function (transaminases).

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

• Skin rash, itching, hives;
• Increased amount of protein in urine, which usually returns to normal on its own without needing to stop treatment with rosuvastatin;
• Elevated levels in certain blood test results indicating muscle function (CK);
• 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.

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

• Inflammation of the pancreas, causing severe stomach pain that may spread to the back;
• Reduction in blood platelet levels.

Very rare (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 (gynecomastia).

Frequency unknown (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;
• Persistent muscle weakness;
• 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 the 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, pharmacist, or nurse, 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 Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Rosuvastatin/Ezetimibe Storage

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

This medicine does not require special storage temperature conditions.

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

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatin/Ezetimibe pensa

The active substances are rosuvastatin (as rosuvastatin calcium) and ezetimibe. Each film-coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe.

The other components (excipients) are:

Tablet core: 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.

Nature and contents of the container

Rosuvastatin/Ezetimibe pensa 20 mg/10 mg film-coated tablets are yellow, round, biconvex, approximately 10 mm in diameter, and marked with the inscription “EL 3” on one side.

Rosuvastatin/Ezetimibe pensa is available in cardboard boxes containing blisters (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 most recent revision of the summary of product characteristics: August 2024

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