Rovalenze 10 mg/10 mg hard capsules

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Rovalenze 5 mg/10 mg hard capsules

Rovalenze 10 mg/10 mg hard capsules

Rovalenze 20 mg/10 mg hard capsules

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, ask your doctor, pharmacist, or nurse.
• 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 reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Rovalenze is and what it is used for

This medicine contains two different active substances in one capsule. 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 lower total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides circulating in the blood. In addition, this medicine also increases levels of "good" cholesterol (HDL cholesterol). This medicine works by reducing cholesterol in two ways: it reduces both the cholesterol absorbed from 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 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 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 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.

This medicine's capsules are used if you have:

• high cholesterol levels in the blood (primary hypercholesterolemia)
• heart disease; this medicine reduces the risk of myocardial infarction and stroke, and is used in 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 starting to take Rovalenze

Do not take Rovalenze 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, recurrent muscle pain or cramps (myopathy).
• you are taking a medicine called cyclosporine (used, for example, after organ transplantation).
• you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used for the viral liver infection known as hepatitis C).
• 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 (see below: Pregnancy and breastfeeding).
• you have ever developed a severe skin rash, peeling skin, blisters, and/or mouth sores after taking this medicine or other related medicines.

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take this medicine if:

• you have kidney problems,
• you have liver problems,
• you have unexplained, recurrent 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 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 will need to determine the appropriate dose of this medicine for you,
• you are taking medicines to treat infections, including HIV (AIDS virus) or hepatitis C, such as ritonavir with lopinavir and/or atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, and/or pibrentasvir. See “Other medicines and Rovalenze”,
• you have severe respiratory insufficiency,
• you are taking other medicines called fibrates to lower cholesterol. See “Other medicines and Rovalenze”,
• you are scheduled for surgery. You may need to temporarily stop taking rosuvastatin/ezetimiba,
• you regularly consume large amounts of alcohol,
• you have an underactive thyroid gland (hypothyroidism),
• you are over 70 years old (as your doctor must choose the appropriate dose for you),
• you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (an antibacterial infection treatment). The combination of fusidic acid and this medicine 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, 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).

If you are in any of the above situations (or are unsure), consult your doctor or pharmacist before taking 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 (transaminases). For this reason, your doctor will usually perform blood tests (liver function tests) during your treatment with this medicine. It is important that you attend these appointments.

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, or 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 treatment with rosuvastatin/ezetimiba. 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 recommended for use in children and adolescents under 18 years of age.

Other medicines and Rovalenze

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 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, acenocumarol, 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 blood triglyceride levels (e.g., gemfibrozil and other fibrates). The effect of rosuvastatin increases when taken together.

• Colestiramine (a cholesterol-lowering medicine), as it affects how ezetimiba 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.

• Antacids containing aluminium and magnesium (used to neutralize stomach acid), as they reduce rosuvastatin plasma levels. 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 resume. 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.

• Oral contraceptives (the pill). Levels of absorbed sex hormones from the pill may be increased.

• Hormone replacement therapy (increased hormone levels in the blood).

If you are admitted to hospital or receiving treatment for another condition, inform the medical staff that you are taking this medicine.

Pregnancy and breastfeeding

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

Do not take this medicine if you are pregnant, trying to become pregnant, or think you might be pregnant. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor. Women should use effective contraception during treatment with this medicine.

Do not take this medicine 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 experience dizziness during treatment with this medicine. If you feel dizzy, do not drive or operate machinery.

Rovalenze contains lactose and sodium

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

This medicine contains less than 23 mg of sodium (1 mmol) per capsule, i.e., essentially "sodium-free".

3. How to take Rovalenze

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

You must continue to maintain a low-cholesterol diet and exercise while taking this medicine.

The recommended daily dose for adults is one capsule of the relevant strength.

Take Rovalenze once a day.

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

This medicine is not suitable for initiating treatment. Initiation of treatment or dose adjustments, if necessary, should only be performed by taking the active substances separately; once the appropriate doses have been established, switching to this medicine at the corresponding dose may then be 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 this medicine at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Regular monitoring of cholesterol levels

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 Rovalenze than you should

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

In the case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Rovalenze

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 Rovalenze

Consult your doctor if you wish to discontinue 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 can cause adverse effects, although not everyone experiences them.

It is important that you are aware of what these adverse effects may be.

Stop taking Rovalenze and seek immediate medical attention if you experience any of the following adverse effects:

• any unexplained muscle pain, tenderness, or weakness that lasts longer than expected. This is because muscle problems, including the breakdown of muscle fibres that can damage the kidneys, may be serious and could lead to a potentially life-threatening condition (rhabdomyolysis). This is rare (may affect up to 1 in 1,000 people);
• severe allergic reactions (angioedema), signs of which include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, and intense itching of the skin (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, red, non-elevated spots on the trunk, target-shaped or circular, 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). 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 (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 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;
• Diarrhea;
• Flatulence (excess gas in the intestinal tract);
• Feeling tired;
• Elevated levels in certain blood tests of 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 the need to stop treatment with rosuvastatin;
• 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;
• 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 (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;
• gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting);
• myasthenia gravis (a condition causing generalized muscle weakness that, 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 the 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 type of 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. Storage of Rovalenze

This medicinal product does not require any special storage conditions.

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

Do not use this medicinal product 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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at 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 Rovalenze

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

Rovalenze 5 mg/10 mg: Each hard capsule contains 5 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe.

Rovalenze 10 mg/10 mg: Each hard capsule contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe.

Rovalenze 20 mg/10 mg: Each hard capsule contains 20 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe.

The other components are:

• Capsule contents: monohydrate lactose, hypromellose, sodium croscarmellose, sodium lauryl sulfate, microcrystalline cellulose, stearoyl fumarate and sodium, lactose, crospovidone, talc, anhydrous colloidal silica,

• Coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, red iron oxide (E172).

• Capsule composition:

Rovalenze 5 mg/10 mg: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).

Rovalenze 10 mg/10 mg: gelatin, titanium dioxide (E171), yellow iron oxide (E172).

Rovalenze 20 mg/10 mg: gelatin, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), indigotine (E132).

Nature of the product and contents of the pack

Rovalenze 5 mg/10 mg: Hard gelatin capsules with orange body and cap, filled with 1 pink film-coated tablet and 2 white tablets.

Rovalenze 10 mg/10 mg: Hard gelatin capsules with yellow body and cap, filled with 2 pink film-coated tablets and 2 white tablets.

Rovalenze 20 mg/10 mg: Hard gelatin capsules with green cap and white body, filled with 4 pink film-coated tablets and 2 white tablets.

Rovalenze 5 mg/10 mg: available in OPA/PVC/Al blister packs containing 30 hard capsules.

Rovalenze 10 mg/10 mg: available in OPA/PVC/Al blister packs containing 30 hard capsules.

Rovalenze 20 mg/10 mg: available in OPA/PVC/Al blister packs containing 30 hard capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A. Rua da Tapada Grande, n.º 2,

2710-089 Abrunheira, Sintra

Portugal

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

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