ARROX 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Arrox 5 mg film-coated tablets EFG

Arrox 10 mg film-coated tablets EFG

Arrox 15 mg film-coated tablets

Arrox 20 mg film-coated tablets EFG

Arrox 30 mg film-coated tablets

Arrox 40 mg film-coated tablets EFG

rosuvastatin

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Arrox and what is it used for
2. What you need to know before taking Arrox
3. How to take Arrox
4. Possible side effects
5. Storage of Arrox
6. Package contents and additional information

1. What is Arrox and what is it used for

Arrox belongs to a group of medications called statins.

You have been prescribed Arrox because:

• You have high cholesterol levels. This means you are at risk of having a heart attack or stroke. Arrox is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol.
• You have been told to take a statin because changes in your diet and increased physical exercise have not been enough to correct your cholesterol levels. You should maintain a diet that helps lower cholesterol and continue to exercise while being treated with Arrox.

Or

• You have other factors that increase your risk of having a heart attack, stroke, or other related health problems.

A heart attack, stroke, and other related health problems can be caused by a disease called atherosclerosis. Atherosclerosis is caused by the formation of deposits of fatty substances in your arteries.

Why it is important to keep taking Arrox

Arrox is used to correct the levels of fatty substances in the blood called lipids, the most well-known being cholesterol.

There are different types of cholesterol in the blood, "bad" cholesterol (C-LDL) and "good" cholesterol (C-HDL).

• Arrox decreases the amount of "bad" cholesterol and increases "good" cholesterol.
• It works by blocking the production of "bad" cholesterol and improving the body's ability to remove it from the blood.

In most people, high cholesterol levels do not affect how they feel, as they do not produce any symptoms. However, if left untreated, fatty deposits can form in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed blood vessels can become blocked, preventing blood from reaching the heart or brain, causing a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or related health problems.

You need to keep taking Arrox, even if you have already achieved the correct cholesterol levels, as it prevents cholesterol levels from rising againand causing the formation of fatty deposits. However, you should stop treatment if your doctor tells you to or if you become pregnant.

2. What you need to know before taking Arrox

Do not take Arrox

• If you are allergic (hypersensitive) to the active ingredient or any of the other ingredients of Arrox(listed in section 6).
• If you are pregnantor breastfeeding. If you become pregnant while taking Arrox, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Arrox using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated and unexplained muscle pain or cramps.
• If you are taking a combination of medications called sofosbuvir/velpatasvir/voxilaprevir(used to treat a viral liver infection called hepatitis C).
• If you are taking a medication called cyclosporine(used, for example, after an organ transplant).

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

Additionally, do not take the highest doses (Arrox 30 mg or 40 mg)

• If you have moderate kidney problems(if you are unsure, consult your doctor).
• If your thyroid glandis not working properly.
• If you have repeated and unexplained muscle pain or cramps, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medications.
• If you regularly drink large amounts of alcohol.
• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medications called fibratesto lower cholesterol.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Arrox:

• If you have kidney problems.
• If you have liver problems.
• If you have repeated and unexplained muscle pain or cramps, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you have unexplained muscle pain or cramps, especially if you have general discomfort or fever. Also, inform your doctor or pharmacist if you have constant muscle weakness.
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking Arrox or other related medications.
• If you regularly drink large amounts of alcohol.
• If your thyroid glandis not working properly.
• If you are taking other medications called fibratesto lower cholesterol. Read this package leaflet carefully, even if you have taken cholesterol-lowering medications before.
• If you are taking medications to treat HIV infection(such as ritonavir with lopinavir and/or atazanavir), see "Other medications and Arrox".
• If you are taking or have taken in the last 7 days a medication called fusidic acid(an antibiotic) orally or by injection. The combination of fusidic acid and Arrox can rarely cause serious muscle problems (rhabdomyolysis), please see "Other medications and Arrox".
• If you are over 70 years old, as your doctor will need to determine the appropriate starting dose of Arrox for you.
• If you have severe respiratory failure.
• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will need to determine the appropriate starting dose of Arrox for you.
• If you have or have had myasthenia (a disease that causes generalized muscle weakness, which can affect 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 to appear (see section 4).

If you are in any of the above situations (or are unsure):

• Do not take the highest doses of 30 mg and 40 mg, and consult your doctor or pharmacist before starting to take any dose of Arrox.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Arrox. Stop using Arrox and seek medical attention immediately if you notice any of the symptoms described in section 4.

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 (transaminases) in the blood. For this reason, your doctor will normally perform blood tests (liver function tests) before and after treatment with Arrox.

While taking this medication, 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 blood sugar levels, are overweight, and have high blood pressure.

Children and adolescents

• If the patient is under 6 years of age: Arrox should not be administered to children under 6 years of age.
• If the patient is under 18 years of age: Arrox 40 mg tablets should not be administered to children and adolescents under 18 years of age.

Other medications and Arrox

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

Inform your doctor if you are using any of the following medications:

• cyclosporine (used after an organ transplant),
• warfarin, or clopidogrel or ticagrelor (or any other anticoagulant medication, such as acenocoumarol),
• fibrates (such as gemfibrozil, fenofibrate) or any other medication used to lower cholesterol (such as ezetimibe),
• treatments for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic - please see below and in "Warnings and precautions"),
• oral contraceptives (the pill),
• regorafenib (used to treat cancer),

• darolutamide (used to treat cancer),
• capmatinib (used to treat cancer),

• hormone replacement therapy,
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high uric acid levels in the blood),
• teriflunomide (used to treat multiple sclerosis),
• any of the following medications 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.

The effects of these medications may be altered by Arrox or may change the effect of Arrox

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medication. Your doctor will tell you when it is safe to restart Arrox. Taking Arrox with fusidic acid can rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding

Do not take Arroxif you are pregnant or breastfeeding. If you become pregnant while taking Arrox, stop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant during treatment with Arrox using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

Most patients can drive vehicles and use machines during treatment with Arrox, as it will not affect their ability. However, some people may feel dizzy during treatment with Arrox. If you feel dizzy, consult your doctor before attempting to drive or use machines.

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

The complete list of ingredients is found in "Package contents and additional information".

3. How to take Arrox

Follow the instructions for administration of this medication indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Usual doses in adults

If you are taking Arrox for high cholesterol levels:

Starting dose

Your treatment with Arrox should start with a dose of 5 mg or 10 mg, even if you have taken a higher dose of another statin before.

The choice of starting dose will depend on:

• Your cholesterol levels.
• The degree of risk you have of having a heart attack or stroke.
• If you have factors that make you more vulnerable to possible side effects.

Check with your doctor or pharmacist what the best starting dose of Arrox is for you.

Your doctor may decide to start treatment with the smallest dose (5 mg):

• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are over 70 years old.
• If you have moderate kidney problems.
• If you are at risk of having muscle pain or cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you are taking the appropriate dose of Arrox for you. If you started with a dose of 5 mg, your doctor may decide to double the dose to 10 mg, then 15 mg or 20 mg, and later to 30-40 mg, if necessary. If you started with a dose of 10 mg, your doctor may decide to double the dose to 15-20 mg and then to 30-40 mg, if necessary. There will be an interval of four weeks between each dose adjustment.

The maximum daily dose of Arrox is 40 mg. This dose is only for patients with high cholesterol levels and a high risk of having a heart attack or stroke, whose cholesterol levels do not decrease enough with 20 mg.

If you are taking Arrox to reduce the risk of having a heart attack, stroke, or related health problems:

The recommended dose is 20 mg per day. However, your doctor may decide to use a lower dose if you have any of the above-mentioned factors.

Use in children and adolescents aged 6-17 years

The dose range in children and adolescents aged 6 to 17 years is 5 mg to 20 mg once daily. The usual starting dose is 5 mg per day, and your doctor may gradually increase the dose until you reach the appropriate dose of Arrox for you. The maximum recommended daily dose of Arrox is 10 or 20 mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take your dose once daily. Do notadminister Arrox 30 mg and 40 mgtablets to children.

Tablet intake

Swallow each tablet whole with water.

Take Arrox once daily. You can take it at any time of day, with or without food.

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

Regular cholesterol level checks

It is important to visit your doctor regularly for cholesterol checks to ensure that your cholesterol levels have normalized and are being maintained at appropriate levels.

Your doctor may decide to increase your dose so that you are taking the appropriate dose of Arrox for you.

If you take more Arrox than you should

Contact your doctor or the nearest hospital for advice.

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 medication and the amount ingested.

If you are admitted to the hospital or receive treatment for another condition, inform the healthcare staff that you are taking Arrox.

If you forget to take Arrox

Do not worry, simply take the next scheduled dose at the planned time. Do not take a double dose to make up for a forgotten dose.

If you stop treatment with Arrox

Consult your doctor if you want to stop treatment with Arrox. Your cholesterol levels may increase again if you stop taking Arrox.

If you have any other questions about the use of this medication, 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 can be. They are usually mild and disappear in a short period.

Stop taking Arrox and seek immediate medical attentionif you experience any of the following allergic reactions:

• Difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat.
• Swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing.
• Intense itching of the skin (with hives).
• Red patches on the torso, not elevated, in a target or circular shape, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Also, stop taking Arrox and consult your doctor immediately:

• If you experience muscle pain and crampsthat last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have suffered unpleasant muscle effects that have very rarely resulted in a potentially life-threatening muscle injury called rhabdomyolysis.
• If you experience muscle rupture.
• If you present with a syndrome that has symptoms similar to lupus(including hives, joint disorders, and effects on blood cells).

Common Adverse Effects (may affect up to 1 in 10 people)

• Headache, stomach pain, constipation, nausea, muscle pain, weakness, dizziness.
• An increase in the amount of protein in the urine – this usually reverses on its own without the need to interrupt treatment with Arrox tablets (common adverse effect only with the daily dose of 40 mg of rosuvastatin).
• Diabetes. This is more likely if you have high blood sugar and lipid levels, are overweight, and have high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

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

• Hives, itching, and other skin reactions.
• An increase in the amount of protein in the urine – this usually reverses on its own without the need to interrupt treatment with Arrox tablets (uncommon adverse effect with daily doses of 5 mg, 10 mg, and 20 mg of rosuvastatin).

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

• Severe allergic reaction – symptoms include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, intense itching of the skin (with hives). If you think you are having an allergic reaction, stop taking Arroxand seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking Arrox and consult your doctor immediately if you have unjustified muscle pain or crampsthat last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes (transaminases) in the blood.
• Bleeding or bruising more easily than normal due to a low platelet count in the blood.
• Syndrome that has symptoms similar to lupus (including rash, joint disorders, and effects on blood cells).

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

• Jaundice (yellowing of the skin and eyes), hepatitis (inflamed liver), blood in the urine, nerve damage in the legs and arms (with numbness or tingling), joint pain, memory loss, and breast enlargement in men (gynecomastia).

Adverse Effects of Unknown Frequency (cannot be estimated from available data) that may include

• Diarrhea (loose stools), cough, shortness of breath, edema (swelling), sleep disturbances, including insomnia and nightmares, sexual difficulties, depression, respiratory problems, including persistent cough and/or shortness of breath or fever, tendon injuries, and constant muscle weakness,
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing),
• Myasthenic ocular (a disease that causes 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 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 Arrox

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Arrox

• The active ingredient of Arrox is rosuvastatin. The film-coated Arrox tablets contain rosuvastatin calcium equivalent to 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, or 40 mg of rosuvastatin.
• The other components are: lactose monohydrate, microcrystalline cellulose, heavy magnesium oxide, crospovidone, calcium stearate, hypromellose, glycerol triacetate, titanium dioxide (E171).

Appearance of the Product and Package Contents

Arrox 5 mg are film-coated tablets, white, round, biconvex, and without a score.

Arrox 10 mg are film-coated tablets, white, round, biconvex, scored on one side. The score should not be used to split the tablet.

Arrox 15 mg are film-coated tablets, white, round, biconvex, and without a score.

Arrox 20 mg are film-coated tablets, white, round, biconvex, engraved with a cross on one side.

Arrox 30 mg are film-coated tablets, white, round, biconvex, scored on one side.

Arrox 40 mg are film-coated tablets, white, oval, smooth.

Arrox 5 mg is available in blisters in packages of 20, 28, 30, and 60 tablets.

Arrox 10 mg is available in blisters in packages of 20, 28, 30, and 60 tablets.

Arrox 15 mg is available in blisters in packages of 28, 30, and 60 tablets.

Arrox 20 mg is available in blisters in packages of 28, 30, and 60 tablets.

Arrox 30 mg is available in blisters in packages of 28, 30, and 60 tablets.

Arrox 40 mg is available in blisters in packages of 28, 30, and 60 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain Arrox 5 mg/10 mg/20 mg/40 mg film-coated tablets EFG

Arrox 15 mg/30 mg film-coated tablets

Portugal Rosuvastatina Bisten 5 mg/10 mg/20 mg/40 mg film-coated tablets MG

Rosuvastatina Bisten 15 mg/30 mg film-coated tablets

Date of the last revision of this prospectus:September 2023

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