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

Patient Information Leaflet

Introduction

Patient Information Leaflet

rosuvastatin/ezetimibe cinfa 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.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 cinfa is and what it is used for
2. What you need to know before taking rosuvastatin/ezetimibe cinfa
3. How to take rosuvastatin/ezetimibe cinfa
4. Possible side effects
5. How to store rosuvastatin/ezetimibe cinfa
6. Contents of the pack and other information

1. What rosuvastatin/ezetimibe cinfa is and what it is used for

This medicine 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.

Rosuvastatin/ezetimibe 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, this medicine increases levels of "good" cholesterol (HDL cholesterol). This medicine works by reducing cholesterol in two ways: it reduces the cholesterol absorbed in the digestive tract as well as the cholesterol produced by the body itself.

For most people, high cholesterol levels do not affect how they feel, as they do not cause any 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 cause a heart attack or stroke. By lowering cholesterol levels, you can reduce your risk of having a heart attack, stroke, or other related health problems.

This medicine is used in patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.

Your doctor may prescribe this medicine if you are already taking rosuvastatin and ezetimibe at the same dose level.

Rosuvastatin/ezetimibe is used if you have:

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

This medicine does not help you lose weight.

2. What you need to know before taking rosuvastatin/ezetimibe cinfa

Do not take rosuvastatin/ezetimibe cinfa 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 unexplained, repeated muscle pain or cramps (myopathy),
• you are taking a medicine called cyclosporine (used, for example, after organ transplantation),
• you are taking a combination of medicines containing sofosbuvir/velpatasvir/voxilaprevir (used for a viral liver infection called hepatitis C),
• you are pregnant or breastfeeding. If you become pregnant while taking this medicine, 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 this medicine or other related medicines.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take rosuvastatin/ezetimibe cinfa if:

• you have kidney problems,
• you have liver problems,
• you have unexplained, repeated 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 you also have malaise or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness,
• 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 (AIDS virus) or hepatitis C, such as ritonavir with lopinavir and/or atazanavir. See "Other medicines and rosuvastatin/ezetimibe cinfa",
• you have severe respiratory failure,
• you are taking other medicines called fibrates to lower cholesterol; see "Other medicines and rosuvastatin/ezetimibe cinfa",
• you are scheduled for surgery. You may need to stop taking rosuvastatin/ezetimibe for a short period,
• you regularly consume large amounts of alcohol,
• you have an underactive thyroid gland (hypothyroidism),
• you are over 70 years of age (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 (used for bacterial infection). The combination of fusidic acid and rosuvastatin/ezetimibe may cause serious muscle problems (rhabdomyolysis),
• you are taking regorafenib (a medicine used to treat cancer),
• you have or have had myasthenia (a disease causing generalized muscle weakness that, 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).

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 this medicine 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 by a simple blood test showing increased liver enzyme levels. 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 doctor’s 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 are likely 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 cinfa

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, for example, after organ transplantation to prevent organ rejection. The effect of rosuvastatin increases when taken together). Do not take this medicine if you are taking cyclosporine.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (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 the blood (e.g., gemfibrozil and other fibrates).
• Cholestyramine (a medicine to lower cholesterol), as it affects how ezetimibe works.
• Regorafenib (used to treat 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, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Indigestion treatments containing aluminium and magnesium (used to neutralize stomach acid, as they reduce rosuvastatin plasma levels).
• 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 restart rosuvastatin/ezetimibe. Taking this medicine 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).
• Hormone replacement therapy (increased hormone levels in the blood).

If you go to hospital or receive treatment for another illness, tell the medical staff that you are taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

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

Rosuvastatin/ezetimibe cinfa contains lactose

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

Rosuvastatin/ezetimibe cinfa contains sodium

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

3. How to take rosuvastatin/ezetimibe cinfa

Follow exactly the administration instructions for 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 while taking this medicine.

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. The initiation 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 the suitable strength of rosuvastatin/ezetimibe cinfa is possible.

If your doctor has prescribed rosuvastatin/ezetimibe 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 cinfa at least 2 hours before or 4 hours after taking those medicines.

Regular cholesterol level checks

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 cinfa 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 cinfa

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 forgotten doses.

If you stop taking rosuvastatin/ezetimibe cinfa

Consult your doctor if you wish to stop 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 may 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 experience any of the following symptoms:

• any unexplained muscle pain, tenderness or weakness lasting longer than expected. This is because muscle problems, including destruction of muscle fibres that can damage the kidneys, can be serious and may lead to a potentially life-threatening condition (rhabdomyolysis). Rare (may affect up to 1 in 1,000 people);
• severe allergic reactions (angioedema) with signs including swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, and intense skin itching (with urticaria). Rare (may affect up to 1 in 1,000 people);
• flat, red, target-shaped or circular spots on the trunk, 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);
• if you experience muscle rupture;
• if you develop a syndrome with symptoms similar to lupus (including urticaria, joint disorders, and effects on blood cells).

Other adverse effects

Common adverse effects (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 levels of sugar and lipids in your blood, 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 intestinal tract);
• feeling tired;
• elevated levels in certain blood tests of liver function (transaminases);
• increased amount of protein in the urine, which usually returns to normal without the need to discontinue treatment with rosuvastatin/ezetimibe (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;
• stomach inflammation;
• back pain;
• muscle weakness;
• pain in arms and legs;
• swelling, especially of the hands and feet;
• increased amount of protein in the urine, which usually returns to normal without the need to discontinue treatment with rosuvastatin/ezetimibe (only with rosuvastatin 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;
• reduced number of platelets in the blood, which may cause bruising or bleeding (thrombocytopenia);
• pseudolupus syndrome (including skin rash, joint disorders, and effects on blood cells);
• muscle rupture.

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 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 weakness in your arms or legs that worsens 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 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 Medicines: 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 cinfa

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of rosuvastatin/ezetimibe cinfa

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

• Each film-coated tablet contains rosuvastatin calcium equivalent to 20 mg of rosuvastatin and 10 mg of ezetimibe.

• Other components are:

Core

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

Coating

Vivacoat PC-2P-308 containing: hypromellose, titanium dioxide (E-171), talc, macrogol, and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Rosuvastatin/ezetimibe cinfa 20 mg/10 mg are film-coated tablets, biconvex, round, yellow in colour, with an approximate diameter of 10 mm, and marked "EL 3" on one side.

Rosuvastatin/ezetimibe cinfa is available in OPA/Al/PVC//Al blister packs containing 30 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

or

ELPEN Pharmaceutical Co Inc

Marathonos Ave. 95, Pikermi Attiki,

19009, Greece

or

ELPEN Pharmaceutical Co Inc

Zapani Street, Block 1048, Keratea, 190 01, Greece

Date of the most recent revision of this leaflet: May 2023

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/88171/P_88171.html

QR code to: https://cima.aemps.es/cima/dochtml/p/88171/P_88171.html