Package Insert: Information for the Patient

Arrox 5 mg Film-Coated Tablets

Arrox 10 mg Film-Coated Tablets

Arrox 15 mg Film-Coated Tablets

Arrox 20 mg Film-Coated Tablets

Arrox 30 mg Film-Coated Tablets

Arrox 40 mg Film-Coated Tablets

rosuvastatina

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Arrox belongs to a group of medications called statins.

They have prescribed Arrox because:

• You have high levels of cholesterol. This means you have a risk of suffering a heart attack or a cerebral infarction. Arrox is used in adults, adolescents, and children 6 years of age or older to treat high cholesterol.
• They have indicated that you should take a statin because the changes made to your diet and the increase in physical exercise have not been sufficient to correct your cholesterol levels. You must maintain a diet that helps to reduce cholesterol and continue to perform physical exercise while undergoing treatment with Arrox.

Or

• You present other factors that increase the risk of suffering a heart attack, cerebral infarction, or other health-related problems.

A heart attack, cerebral infarction, and other health-related problems may be caused by a disease called atherosclerosis. Atherosclerosis is caused by the formation of fatty deposits in your arteries.

Why it is important to continue taking Arrox

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

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

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

In most people, high levels of cholesterol do not affect how they feel since 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 vessels can become blocked and prevent blood supply to the heart or brain, causing a heart attack or cerebral infarction. By reducing your cholesterol levels, you can reduce the risk of suffering a heart attack, cerebral infarction, or other health-related problems.

You needto continue taking Arrox, even if you have already achieved the correct cholesterol levels,since it prevents cholesterol levels from increasing againand forming fatty deposits. However, you should interrupt treatment if your doctor indicates so or if you become pregnant.

Do not take Arrox

• If you are allergic (hypersensitive) to the active ingredient or to any of the other components of Arrox (listed in section 6).
• If you are pregnant or 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 or unjustified muscle pain and cramps.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir medications (used to treat a liver infection called hepatitis C).
• If you are taking a medication called ciclosporin (used, for example, after an organ transplant).

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

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 does not function correctly.
• If you have repeated or unjustified muscle pain and cramps, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medications.
• If you regularly consume 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 fibrates to lower cholesterol.

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

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 or unjustified muscle pain and cramps, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you experience unjustified muscle pain or cramps, especially if you have general discomfort or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking Arrox or other related medications.
• If you regularly consume large amounts of alcohol.
• If your thyroid gland does not function correctly.
• If you are taking other medications called fibrates to lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medications previously.
• If you are taking medications to treat HIV (AIDS virus) infections, such as ritonavir with lopinavir and/or atazanavir, see“Other medications and Arrox”.
• If you are taking or have taken within the last 7 days a medication called fusidic acid (an antibacterial medication) orally or by injection. The combination of fusidic acid and Arrox may cause severe muscle problems (rhabdomyolysis), please see“Other medications and Arrox”.
• If you are over 70 years old, as your doctor must establish the appropriate starting dose of Arrox for you.
• If you have severe respiratory insufficiency.
• If you are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must establish the appropriate starting dose of Arrox for you.
• If you have or have had myasthenia (a disease that causes generalized 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 may sometimes worsen the disease or cause myasthenia (see section 4).

If you find yourself in any of these situations mentioned above (or are unsure):

• Do not take the higher 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 treatment. 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 measures elevated liver enzymes (transaminases). For this reason, your doctor will usually 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 may 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:The 40 mg Arrox tablets should not be administered to children and adolescents under 18 years of age.

Other medications and Arrox

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• ciclosporina (used after an organ transplant),
• warfarina,or clopidogrel orticagrelor(or any other anticoagulant medication, such as acenocoumarol),
• fibrates (such as gemfibrozil, fenofibrate) or any other medication used to lower cholesterol (such as ezetimiba),
• medications 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),

• darolutamida (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),
• teriflunomida (used to treat multiple sclerosis),
• any of the following medications used to treat viral infections, including HIV or hepatitis C infections, 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 modified by Arrox or may change the effect of Arrox

If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking this medication. Your doctor will indicate when it is safe to start taking Arrox again. Taking Arrox with fusidic acid may rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information about 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 immediately and 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 operating machinery

Most patients can drive vehicles and use machines during Arrox treatment as it will not affect their ability. However, some people may experience dizziness during Arrox treatment. 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 components can be found in“Container contents and additional information”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, 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 witha dose of5 mg or 10 mg, even if you have taken a higher dose of another statin previously.

The choice of starting dose will depend on:

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

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

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

• If you are ofAsian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).
• If you areover 70 years old.
• If you have moderate kidney problems.
• If you have a risk of suffering muscle pain and cramps (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 then to 30-40 mg, if necessary. There will be a four-week interval 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 suffering 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 suffering a heart attack, a 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 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 a day. The usual starting dose is 5 mg per day and your doctor may increase your dose gradually to reach the right dose of Arrox for you. The recommended maximum 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 a day.Do notadminister Arrox tablets30 mg and 40 mgto children.

Swallowing the tablets

Swallow each tablet whole with water.

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

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

Regular cholesterol level checks

It is essential that you attend your doctor regularly for cholesterol checks, to ensure that your cholesterol levels have normalized and are maintained at appropriate 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 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 enter a hospital or receive treatment for another illness, 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 compensate for a missed dose.

If you interrupt 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

It is important that you know which side effects may occur. They are usually mild and disappear in a short period of time.

Stop taking Arrox and seek medical attention immediatelyif 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 may cause difficulty swallowing.
• Intense itching of the skin (with rashes).
• Reddish patches on the trunk, not elevated, in the shape of a target or circles, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and symptoms similar to the flu (Stevens-Johnson syndrome).
• Generalized 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 unexplained muscle pain and crampsthat last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. Like other statins, a very small number of people have experienced unpleasant muscle effects that, very rarely, have resulted in a potentially fatal muscle injury calledrabdomiólisis.
• If you experience muscle rupture.
• If you experience a syndrome with symptoms similar to lupus(including urticaria, joint disorders, and effects on blood cells).

Frequent side 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 urine – this usually returns to normal on its own without the need to interrupt treatment with Arrox tablets (frequent side effect only with a daily dose of 40 mg of rosuvastatin).
• Diabetes. This is more likely if you have high blood sugar and lipid levels, obesity, and high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Rare side effects (may affect up to 1 in 100 people)

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

Very rare side 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 rashes). If you think you are having an allergic reaction, stop taking Arroxand seek medical attention immediately.
• Muscle injury in adults – as a precaution,stop taking Arrox and consult your doctor immediately if you have unexplained muscle pain or cramps that 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 low platelet count in the blood.
• Syndrome with symptoms similar to lupus (including rash, joint disorders, and effects on blood cells).

Very rare side 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).

Side 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,
• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing),
• Myasthenia 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, eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Arrox

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

Appearance of the product and contents of the package

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

Arrox 10 mg are film-coated tablets, white in color, round, biconvex, and notched on one face. The notch should not be used to break the tablet.

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

Arrox 20 mg are film-coated tablets, white in color, round, biconvex, and engraved with a cross on one face.

Arrox 30 mg are film-coated tablets, white in color, round, biconvex, and notched on one face.

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

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

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

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

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

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

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

SpainArrox 5 mg/10 mg/20 mg/40 mg film-coated tablets EFG

Arrox 15 mg/30 mg film-coated tablets

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

Rosuvastatina Bisten 15 mg/30 mg film-coated tablets

Last review date of this leaflet:September 2023

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