ARROX PLUS 10 mg/10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Arrox Plus 10 mg/10 mg film-coated tablets

Arrox Plus 20 mg/10 mg film-coated tablets

Arrox Plus 40 mg/10 mg film-coated tablets

rosuvastatin/ezetimibe

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 their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Arrox Plus and what is it used for

Arrox Plus contains two different active substances in one 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.

Arrox Plus is a medicine used in adult patients to reduce the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. In addition, rosuvastatin/ezetimibe raises the levels of "good" cholesterol (HDL cholesterol).

Rosuvastatin/ezetimibe works by reducing cholesterol in two ways. It reduces the cholesterol absorbed in the gut and the cholesterol produced by the body itself.

Cholesterol is one of the many fatty substances that circulate in the blood. The total amount of cholesterol is mainly made up of LDL and HDL cholesterol.

For most people, high cholesterol levels do not affect how they feel because they do not produce 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 the blood supply to the heart or brain, which can cause a heart attack or stroke. By reducing cholesterol levels, you can reduce your risk of having a heart attack, stroke, or other health problems related to high cholesterol.

Rosuvastatin/ezetimibe is used in patients who cannot control their cholesterol levels by diet alone. While taking this medicine, you should 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 along 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 increase blood flow to the heart, or hospitalization for chest pain.

This medicine does not help you lose weight.

You should continue taking this medicine, even if your cholesterol levels are normal, as it prevents your cholesterol levels from rising again and causing the buildup of fatty deposits.

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

2. What you need to know before you take Arrox Plus

Do not take Arrox Plus 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 medicine called ciclosporin (used, for example, after an organ transplant)
• you are pregnant or breast-feeding. 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 using an appropriate contraceptive method.
• you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (medicines used for the viral infection of the liver called hepatitis C).
• you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking this medicine or other medicines containing rosuvastatin.

Also, do not take Arrox Plus 40 mg/10 mg (the highest dose):

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland does not work correctly (hypothyroidism).
• If you have repeated or unexplained muscle pains or cramps, a personal or family history of muscle problems, or have had muscle problems during treatment with other cholesterol-lowering medicines.
• If you regularly drink large amounts of alcohol.
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other cholesterol-lowering medicines called fibrates (see "Other medicines and Arrox Plus").

If you are in any of the above situations (or if you are not sure), 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 have had muscle problems during treatment with other cholesterol-lowering medicines. Tell your doctor immediately if you have unexplained muscle pain, cramps, or weakness, especially if you also feel unwell or have a fever. Also, tell your doctor or pharmacist if you have persistent muscle weakness.
• you are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will determine the appropriate dose for you
• you are taking medicines to treat infections, including HIV (AIDS virus) or hepatitis C, such as lopinavir/ritonavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, and/or pibrentasvir. See "Other medicines and Arrox Plus"
• you have severe respiratory failure
• you are taking other cholesterol-lowering medicines called fibrates, see "Other medicines and Arrox Plus"
• you are going to have an operation. You may need to stop taking rosuvastatin/ezetimibe for a short time
• you regularly drink large amounts of alcohol
• your thyroid gland does not work correctly (hypothyroidism)
• you are over 70 years old (as your doctor will choose the appropriate 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)
• you are taking regorafenib (a medicine to treat cancer)
• you have or have had myasthenia (a disease that causes general muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).

If you are in any of these situations (or if you are not sure), consult your doctor or pharmacist before starting to take any dose of this medicine.

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

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

Children and adolescents

The use of this medicine is not suitable for children and adolescents under 18 years of age.

Other medicines and Arrox Plus

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, for example, after an organ transplant to prevent rejection of the transplanted organ. The effect of rosuvastatin increases with concomitant 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 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).
• Colestyramine (a medicine to lower cholesterol), as it affects how ezetimibe works.
• Regorafenib (indicated for the treatment of cancer).
• Darolutamide (indicated for the treatment of 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, simeprevir, 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).
• Erythromycin (an antibiotic).
• Fusidic acid. If you have to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when you can safely take rosuvastatin/ezetimibe again. Taking this medicine 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).
• Hormone replacement therapy (increasing hormone levels in the blood).

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Arrox Plus if you are pregnant, think you may be pregnant, or are planning to have a baby. 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 Arrox Plus if you are breast-feeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

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

Arrox Plus contains lactose and sodium

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

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 and exercise while taking this medicine.

The recommended dose for adults is one tablet a day.

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

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

This medicine is not suitable for starting treatment. The start of treatment or dose adjustments, if necessary, should only be done by taking the components separately, and once the appropriate doses have been adjusted, it is possible to switch to the appropriate dose of rosuvastatin/ezetimibe.

If your doctor has prescribed rosuvastatin/ezetimibe with another cholesterol-lowering medicine that contains the active substance colestyramine or any other medicine that contains a bile acid sequestrant, you should take rosuvastatin/ezetimibe at least 2 hours before or 4 hours after these medicines.

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 are being maintained at appropriate levels.

If you take more Arrox Plus than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Arrox Plus

Do not worry, skip the missed dose and take the next scheduled dose at the planned time. Do not take a double dose to make up for missed doses.

If you stop taking Arrox Plus

Consult your doctor if you want to stop taking this medicine. Your cholesterol levels may rise again if you stop taking this medicine.

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 may be.

Stop taking Arrox Plus 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 muscle fiber destruction that damages the kidneys, can be severe and potentially lead to a life-threatening disorder (rhabdomyolysis). This is rare (may affect up to 1 in 1,000 people);
• severe allergic reactions (angioedema) whose signs 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 have a lupus-like syndrome (which includes skin rash, joint disorders, and effects on blood cells). This is rare (may affect up to 1 in 1,000 people).
• if you experience muscle rupture. This is rare (may affect up to 1 in 1,000 people).
• red, non-raised spots on the trunk, target-shaped or circular, often with central blisters, skin peeling, 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 or drug hypersensitivity syndrome). The frequency of this is unknown (cannot be estimated from available data).

Other Adverse Effects

Common 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 blood sugar and lipid levels, 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;
• high levels in some blood test results for liver function (transaminases).
• an increase in the amount of protein in the urine, which usually normalizes without needing to interrupt treatment with rosuvastatin/ezetimibe (only with rosuvastatin 40 mg).

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• skin rash, itching, hives;
• high levels in some blood test results for muscle function (Creatine Kinase test);
• 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.
• an increase in the amount of protein in the urine, which usually normalizes without needing to interrupt treatment with rosuvastatin/ezetimibe (only with rosuvastatin 10 mg and 20 mg).

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

• pancreatitis, which causes severe stomach pain that can spread to the back
• decrease in the number of platelets in the blood, which can 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);
• liver inflammation (hepatitis);
• traces of blood in the urine;
• nerve damage in the legs and arms (such as numbness);
• memory loss;
• breast enlargement in men (gynecomastia).

Frequency Not Known (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;
• constant muscle weakness;
• hives and target-shaped lesions (erythema multiforme);
• 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 the 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 or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Arroxibe

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 shown on the carton or blister pack after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Arrox Plus

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

Arrox Plus 10 mg/10 mg: Each film-coated tablet contains rosuvastatin calcium, equivalent to 10 mg of rosuvastatin, and 10 mg of ezetimibe.

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

Arrox Plus 40 mg/10 mg: Each film-coated tablet contains rosuvastatin calcium, equivalent to 40 mg of rosuvastatin, and 10 mg of ezetimibe.

• The other ingredients are:

Tablet core

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

Tablet coating

Arrox Plus 10 mg/10 mg: Hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol, talc.

Arrox Plus 20 mg/10 mg: Hypromellose, titanium dioxide (E171), talc, macrogol, yellow iron oxide (E172).

Arrox Plus 40 mg/10 mg: Lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol.

Product Appearance and Package Contents

Arrox Plus 10 mg/10 mg: Film-coated tablets, round, biconvex, beige in color, with a diameter of approximately 10 mm and the inscription "EL 4" on one side.

Arrox Plus 20 mg/10 mg: Film-coated tablets, round, biconvex, yellow in color, with a diameter of approximately 10 mm and the inscription "EL 3" on one side.

Arrox Plus 40 mg/10 mg: Film-coated tablets, round, biconvex, white in color, with a diameter of approximately 10 mm and the inscription "EL 2" on one side.

Blister packs of OPA/Al/PVC//Al packaged in cardboard boxes.

Packages 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 Last Revision of this Prospectus:May 2023

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