Package Insert: Information for the Patient

Rosuvastatina Alter 5 mg Film-Coated Tablets

Rosuvastatina Alter 10 mg Film-Coated Tablets

Rosuvastatina Alter 20 mg Film-Coated Tablets

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Rosuvastatin belongs to a group of medications called statins.

You have been prescribed Rosuvastatin Alter because:

• You have high cholesterol levels. This means you are at risk of having a heart attack or a stroke. Rosuvastatin is used in adults, adolescents, and children 6 years of age or older to treat high cholesterol.

• Your doctor has indicated that you should take a statin because changes made to your diet and increased physical exercise have not been sufficient to correct your cholesterol levels. You should maintain a diet that helps to lower cholesterol and continue exercising while on treatment with rosuvastatin.

Or

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

A heart attack, stroke, and other health problems can 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 Rosuvastatin Alter

Rosuvastatin Alter 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).

• Rosuvastatin Alter 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 cholesterol levels 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 stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or other health problems.

You need to continue taking rosuvastatin, even if you have achieved the correct cholesterol levels, as it prevents cholesterol levels from increasing again and causing the formation of fatty deposits. However, you should stop treatment if your doctor advises you to or if you become pregnant.

Do not take Rosuvastatina Alter

• If you are allergic (hypersensitive) to the active ingredient or to any of the other components of Rosuvastatina Alter (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatina, stop taking it immediately and inform your doctor.Women should avoid becoming pregnant during treatment with Rosuvastatina Alter 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 (used to treat a liver infection called hepatitis C).
• If you are taking a medicine 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 dose (rosuvastatina 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 medicines.
• 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 medicines 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 Rosuvastatina Alter:

• 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 medicines. Inform your doctor immediately if you have unjustified muscle pain or cramps, especially if you have general discomfort or fever. Also inform your doctor or pharmacist if you have persistent muscle weakness.
• If you have ever developed a severe skin rash or skin peeling, blisters and/or mouth sores after taking rosuvastatina or other related medicines.
• If you regularly consume large amounts of alcohol.
• If your thyroid gland does not function correctly.
• If you are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medicines previously.
• If you are taking medicines to treat HIV (AIDS virus) infection, such as ritonavir with lopinavir and/or atazanavir, see “Other medicines and Rosuvastatina Alter”.
• If you have taken or are taking within the last 7 days a medicine called fusidic acid (an antibiotic), orally or by injection. The combination of fusidic acid and rosuvastatina may cause severe muscle problems (rhabdomyolysis), please see “Other medicines and Rosuvastatina Alter”.
• If you are over 70 years old, as your doctor must establish the appropriate starting dose of rosuvastatina 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 must establish the appropriate starting dose of rosuvastatina for you.

If you have or have had myasthenia (a disease that causes generalised muscle weakness, which in some cases affects the muscles used for breathing) or myasthenic eye disease (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 dose of 40 mg and consult your doctor or pharmacist before starting to take any dose of rosuvastatina.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Rosuvastatina Alter treatment. Stop using Rosuvastatina Alter 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 liver enzyme levels (transaminases). For this reason, your doctor will normally perform blood tests (liver function tests) before and after treatment with rosuvastatina.

While taking this medicine, 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:Rosuvastatina Alter should not be administered to children under 6 years of age.

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

Other medicines and Rosuvastatina Alter

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

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, such as acenocoumarol),
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimiba),
• medicines for indigestion (used to neutralise 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 medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see “Warnings and Precautions”): ritonavir, lopinavir, atazanavir,sofosbuvir, voxilaprevirombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medicines may be modified by rosuvastatina or may change the effect of rosuvastatina.

If you need to take fusidic acid orally to treat a bacterial infection, you should stop taking Rosuvastatina Alter temporarily. Your doctor will tell you when it is safe to start taking rosuvastatina again. Taking rosuvastatina 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 rosuvastatina if you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatina, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Rosuvastatina Alter using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Rosuvastatina Alter contains lactose

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

The complete list of components can be found in“Contents of the pack and additional information”.

Follow the exact administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Usual doses in adults

If you are taking rosuvastatina for high cholesterol levels:

Starting dose

Your treatment with rosuvastatina 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 having a heart attack or stroke.
• If you have factors that make you more vulnerable to potential side effects.

Check with your doctor or pharmacist to determine the best starting dose of rosuvastatina for you.

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

• If you areof Asian 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 developing muscle pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is to ensure you are taking the right dose of rosuvastatina for you. If you started with a 5 mg dose, your doctor may decide to double the dose to 10 mg, then to 20 mg, and later to 40 mg, if necessary. If you started with a 10 mg dose, your doctor may decide to double the dose to 20 mg and then to 40 mg, if necessary. There will be a four-week interval between each dose adjustment.

The maximum daily dose of rosuvastatina 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 rosuvastatina to reduce the risk of having 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 earlier.

Use in children and adolescents aged 6-17 years

The usual 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 gradually increase your dose to reach the right dose of rosuvastatina for you. The recommended maximum daily dose of rosuvastatina 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 not administer rosuvastatina 40 mg tablets to children.

Swallowing the tablets

Swallow each tablet whole with water.

Take rosuvastatina 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 to visit your doctor regularly for cholesterol level checks to ensure your cholesterol levels have normalized and remain at appropriate levels.

Your doctor may decide to increase your dose to ensure you are taking the right dose of rosuvastatina for you.

If you take more Rosuvastatina Alter 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 condition, inform the healthcare staff that you are taking rosuvastatina.

If you forget to take Rosuvastatina Alter

Do not worry, simply take the next scheduled dose at the scheduled time. Do not take a double dose to compensate for a missed dose.

If you interrupt treatment with Rosuvastatina Alter

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

If you have any other questions about using 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 rosuvastatin 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 bull's-eye 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 rosuvastatin 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 rosuvastatin 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, being overweight, 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 rosuvastatin 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 rosuvastatinand seek medical attention immediately.
• Muscle injury in adults – as a precaution,stop taking rosuvastatin 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 urticaria, 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 the 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 the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rosuvastatina Alter

• The active ingredient is rosuvastatina. The film-coated tablets of Rosuvastatina Alter contain rosuvastatina calcium equivalent to 5 mg, 10 mg or 20 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 content of the container

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

Rosuvastatina Alter 10 mg are film-coated tablets, white in color, round, with a notch on one of the faces. The notch should not be used to break the tablet.

Rosuvastatina Alter 20 mg are film-coated tablets, white in color, round, with a cross engraved on one of the faces.

Rosuvastatina Alter 5 mg tablets are presented in blisters in containers of 20, 28, 30, 60, and 90 tablets.

Rosuvastatina Alter 10 mg tablets are presented in blisters in containers of 20, 28, 30, 60, and 90 tablets.

Rosuvastatina Alter 20 mg tablets are presented in blisters in containers of 28, 30, 60, and 90 tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

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:

SpainRosuvastatina Alter 5 mg/10 mg/20 mg film-coated tablets EFG

FranceROSUVASTATINE ALTER 5 mg/10 mg/20 mg, coated tablet

ItalyRosuvastatina Alter 5 mg/10 mg/20 mg film-coated tablets

PortugalRosuvastatina Alter 5 mg/ 10 mg/ 20 mg film-coated tablets MG

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/.