ARROX 15 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 this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 experience 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 and what is it used for
2. What you need to know before you take Arrox
3. How to take Arrox
4. Possible side effects
5. Storage of Arrox
6. Contents of the pack and further information

1. What is Arrox and what is it used for

Arrox belongs to a group of medicines called statins.

You have been prescribed Arrox because:

• You have high levels of cholesterol. 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 to your diet and increased exercise have not been enough to correct your cholesterol levels. You should maintain a diet that helps to lower your cholesterol and continue to exercise while you are on treatment 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 buildup of fatty deposits 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 of which is cholesterol.

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

• Arrox lowers the amount of "bad" cholesterol and increases the "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 cause any symptoms. However, if left untreated, fatty deposits can build up 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 your 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 your cholesterol levels from rising againand causing the buildup 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 you take Arrox

Do not take Arrox

• If you are allergic (hypersensitive) to the active substance 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 by using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pain or weakness.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir(used to treat a viral liver infection called hepatitis C).
• If you are taking a medicine called ciclosporin(used, for example, after an organ transplant).

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

Also, do not take the higher doses (Arrox 30 mg or 40 mg)

• If you have moderate kidney problems(if in doubt, consult your doctor).
• If your thyroid gland is not working correctly.
• If you have repeated or unexplained muscle pain or weakness, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines.
• 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 medicines 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 treatment with Arrox:

• If you have kidney problems.
• If you have liver problems.
• If you have repeated or unexplained muscle pain or weakness, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you have unexplained muscle pain or weakness, especially if you feel unwell or have a fever. Also, inform your doctor or pharmacist if you experience persistent 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 medicines.
• If you regularly drink large amounts of alcohol.
• If your thyroid gland is not working correctly.
• If you are taking other medicines called fibratesto lower cholesterol.
• If you are taking medicines to treat HIV infection(such as ritonavir with lopinavir and/or atazanavir), see "Other medicines and Arrox".
• If you are taking or have taken in the last 7 days a medicine called fusidic acid(an antibiotic), consult your doctor, see "Other medicines and Arrox".
• If you are over 70 years old, as your doctor will need to choose the right 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 choose the right starting dose of Arrox for you.
• If you have or have had myasthenia (a condition that causes muscle weakness) or ocular myasthenia (a condition that causes weakness of the eye muscles), as statins can sometimes make the condition worse or trigger the onset of myasthenia (see section 4).

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

• Do not take the higher doses of 30 mg and 40 mg and consult your doctor or pharmacist before starting treatment with any dose of Arrox.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in patients taking Arrox. Stop taking 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 can be 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 carry out blood tests (liver function tests) before and after starting treatment with Arrox.

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

Other medicines and Arrox

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

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

• ciclosporin (used after an organ transplant),
• warfarin, or clopidogrel or ticagrelor (or any other anticoagulant medicine, such as acenocoumarol),
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe),
• indigestion treatments (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic - see also "Warnings and precautions" and below),
• 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 levels of uric acid in the blood),
• teriflunomide (used to treat multiple sclerosis),
• 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.

The effects of these medicines may be altered by Arrox or may alter the effect of Arrox

If you need to take oral fusidic acid to treat a bacterial infection, you must stop taking Arrox temporarily. Your doctor will tell you when it is safe to start taking Arrox again. Taking Arrox with fusidic acid can rarely cause muscle weakness, tenderness, 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 by using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

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

The complete list of ingredients is found in "Contents of the pack and further information".

3. How to take Arrox

Follow the instructions for administration of this medicine exactly as told by your doctor. If in doubt, consult your doctor or pharmacist again.

Usual dose in adults

If you are taking Arrox for high cholesterol:

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 level 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 muscle pain or weakness (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is so that you are taking the right 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 later 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 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 once daily. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.

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 once daily, and your doctor may gradually increase the dose until the dose of Arrox that is right for you is reached. The maximum recommended daily dose of Arrox is 10 or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. Take your dose once daily. Do notgive the 30 mg and 40 mg tablets of Arrox to children.

Taking the tablets

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 checks of your cholesterol levels

It is important that you visit your doctor regularly to have your cholesterol levels checked, to ensure that your cholesterol levels have returned to normal and are being maintained at the right levels.

Your doctor may decide to increase your dose so that you are taking the right 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, telephone 91 562 04 20, stating the medicine and the amount taken.

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

If you forget to take Arrox

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

If you stop taking Arrox

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

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 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 spots on the torso, not raised, 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, very rarely, have resulted in a potentially fatal 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 usual 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 increased breast size 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 the sight and reach of children.

This medicine does not require special storage conditions.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at 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.

Not all 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/.