Rosuvastatin/ezetimibe Alter 10 mg/10 mg film-coated tablets EFG

Package Leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rosuvastatin/Ezetimibe Alter 10 mg/10 mg film-coated tablets

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

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if they have the same symptoms as you.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Rosuvastatin/Ezetimibe Alter is and what it is used for

Rosuvastatin/Ezetimibe Alter contains two different active substances in a film-coated 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 total cholesterol levels, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides circulating in the blood. In addition, rosuvastatin/ezetimibe increases levels of "good" cholesterol (HDL cholesterol).

Rosuvastatin/ezetimibe works to reduce cholesterol in two ways. It reduces cholesterol absorbed from the digestive tract as well as cholesterol produced by the body itself.

Cholesterol is one of many fatty substances circulating in the blood. Total cholesterol is made up mainly of LDL and HDL cholesterol.

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

Rosuvastatin/ezetimibe 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 levels.

Rosuvastatin/ezetimibe is used together with your cholesterol-lowering diet if you have:

• high blood cholesterol levels (primary hypercholesterolemia)
• heart disease; this medicine reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

This medicine does not help you lose weight.

You should continue taking this medicine even if your cholesterol levels are at the desired level, as it helps prevent cholesterol levels from rising again and causing fatty deposits to accumulate.

However, you should stop taking it if your doctor tells you to do so, or if you become pregnant.

2. What you need to know before taking Rosuvastatin/Ezetimibe Alter

Do not take Rosuvastatin/Ezetimibe Alter 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 and cramps (myopathy),
• 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 this medicine, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with this medicine by using an appropriate contraceptive method.
• you are taking a combination of sofosbuvir / velpatasvir / voxilaprevir (medicines used for the viral liver infection called hepatitis C).
• you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth sores after taking this medicine or other medicines containing rosuvastatin.

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 this medicine if:

• you have kidney problems,
• you have liver problems,
• you have repeated or unexplained muscle pain and 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 feel generally unwell or have a 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 (human immunodeficiency virus) or hepatitis C, such as lopinavir/ritonavir, atazanavir, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir and/or pibrentasvir. See "Other medicines and Rosuvastatin/Ezetimibe Alter",
• you have severe respiratory failure,
• you are taking other medicines called fibrates to lower cholesterol; see "Other medicines and Rosuvastatin/Ezetimibe Alter",
• you are due to have surgery. You may need to stop taking rosuvastatin/ezetimibe for a short time,
• 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),
• you are taking regorafenib (a medicine to treat cancer),
• 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 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-mentioned situations (or are unsure): consult your doctor or pharmacist before starting to take any dose of this medicine.

In a small number of people, statins may affect the liver. This is detected by a simple blood test showing increased levels of liver enzymes. 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 monitor you closely 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.

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 using this medicine and seek immediate medical attention if you notice any of the symptoms described in section 4.

Children and adolescents

This medicine is not suitable for children and adolescents under 18 years of age.

Other medicines and Rosuvastatin/Ezetimibe Alter

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

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

• Cyclosporine (used, for example, after an organ transplant 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 phenindione (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).
• Colestipol (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, simeprevir, 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).
• 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 (increasing hormone levels in the blood).

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

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.

Do not take rosuvastatin/ezetimibe if you are pregnant, think you might be pregnant, or plan 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 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 operate machinery. However, some people may feel dizzy after taking this medicine. If you feel dizzy, do not drive or use machinery.

Rosuvastatin/Ezetimibe Alter contains lactose and sodium

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

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

3. How to take Rosuvastatin/Ezetimibe Alter

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 the tablet whole with water.

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

This medicine is not suitable for initiating treatment. Treatment initiation or dose adjustments, if necessary, should only be done using the individual components separately. Once the appropriate doses have been established, switching to the appropriate dose of rosuvastatin/ezetimibe 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 at least 2 hours before or 4 hours after taking these medicines.

Regular cholesterol level monitoring

It is important 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 Rosuvastatin/Ezetimibe Alter than you should

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

In the event 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 Alter

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 Alter

Consult your doctor if you wish to stop treatment with this medicine. Your cholesterol levels may rise again if you stop taking it.

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 rosuvastatin/ezetimibe 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 destruction of muscle fibers that can damage the kidneys, can be serious and may lead to a potentially life-threatening condition (rhabdomyolysis). This is 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 hives). This is rare (may affect up to 1 in 1,000 people);
• if you develop a lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells). This is rare (may affect up to 1 in 1,000 people);
• if you experience a muscle tear. This is rare (may affect up to 1 in 1,000 people);
• flat, reddish spots on the trunk, often target-shaped or circular, sometimes with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome). The frequency of this is unknown (cannot be estimated from available data);
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). The frequency of this is unknown (cannot be estimated from available data).

Other adverse effects

Frequent 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 levels of blood sugar and lipids, 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 gastrointestinal tract);
• feeling tired;
• elevated levels in certain blood tests of liver function (transaminases).

Uncommon adverse effects (may affect up to 1 in 100 people)

• skin rash, itching, hives;
• 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;
• decreased number of platelets in the blood, which may 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);
• inflammation of the liver (hepatitis);
• traces of blood in the urine;
• nerve damage in the 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;
• persistent muscle weakness;
• hives and target-shaped skin lesions (erythema multiforme);
• 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, 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 Alter

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 from light and moisture.

Do not use this medicine after the expiry date stated on the carton or blister pack 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 medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatin/Ezetimibe Alter

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

Rosuvastatin/Ezetimibe Alter 10 mg/10 mg: Each film-coated tablet contains rosuvastatin calcium, equivalent to 10 mg of rosuvastatin, and 10 mg of ezetimibe.

Rosuvastatin/Ezetimibe Alter 20 mg/10 mg: Each film-coated tablet contains rosuvastatin calcium, equivalent to 20 mg of rosuvastatin, and 10 mg of ezetimibe.

• Other components are:

Tablet core

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

Tablet coating

Rosuvastatin/Ezetimibe Alter 10 mg/10 mg: Hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol, talc.

Rosuvastatin/Ezetimibe Alter 20 mg/10 mg: Hypromellose, titanium dioxide (E171), talc, macrogol, yellow iron oxide (E172).

Appearance of the product and contents of the pack

Rosuvastatin/Ezetimibe Alter 10 mg/10 mg: Film-coated tablets, round, biconvex, beige-colored, with an approximate diameter of 10 mm and the imprint "EL 4" on one side.

Rosuvastatin/Ezetimibe Alter 20 mg/10 mg: Film-coated tablets, round, biconvex, yellow-colored, with an approximate diameter of 10 mm and the imprint "EL 3" on one side.

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

Packs of 30 film-coated tablets.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Elpen Pharmaceutical Co. Inc.

Marathonos Ave. 95

19009 Pikermi Attiki

Greece

or

Elpen Pharmaceutical Co. Inc.

Zapani, Block 1048

190 01 Keratea

Greece

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

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