Rosuvastatin Aurovitas 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rosuvastatin Aurovitas 5 mg film-coated tablets EFG

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What rosuvastatin Aurovitas is and what it is used for

Rosuvastatin belongs to a group of medicines called statins.

Your doctor has prescribed rosuvastatin because:

• You have high cholesterol levels. This means you are at risk of having a heart attack or stroke.

Rosuvastatin is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.

• Your doctor has advised you to take a statin because changes in your diet and increased physical activity have not been sufficient to correct your cholesterol levels. You must maintain a cholesterol-lowering diet and continue exercising while taking rosuvastatin.

Or

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

Heart attack, stroke, and other related health problems may be caused by a disease called atherosclerosis. Atherosclerosis is caused by the buildup of fatty deposits in your arteries.

Why it is important that you continue taking rosuvastatin

Rosuvastatin is used to correct levels of fatty substances in the blood called lipids, the best-known being cholesterol.

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

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

In most people, high cholesterol levels do not affect how you feel, as they cause no symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed vessels can become blocked, cutting off the blood supply to the heart or brain, leading to a heart attack or stroke. By lowering your cholesterol levels, you can reduce your risk of having a heart attack or stroke.

You need to keep taking rosuvastatin, even after your cholesterol levels have reached the desired level, because it prevents cholesterol levels from rising again and stops the formation of fatty deposits. However, you should stop treatment if your doctor advises you to do so, or if you become pregnant.

2. What you need to know before taking Rosuvastatin Aurovitas

Do not take Rosuvastatin Aurovitas

• If you are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatin 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 and cramps.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used for a viral liver infection called hepatitis C).
• If you are taking a medicine called cyclosporine (used, for example, after an organ transplant).

If you are in any of the above situations (or are unsure), talk to your doctor.

Also, do not take 40 mg of rosuvastatin (the highest dose):

? If you have moderate kidney problems (if in doubt, consult your doctor).

? If your thyroid gland is not functioning properly.

? If you have repeated or unexplained muscle pain and cramps, personal or family history of muscle problems, or 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 (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).

? If you are taking other medicines called fibrates to lower cholesterol.

If you are in any of the above situations (or are unsure), talk to your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Rosuvastatin Aurovitas.

• If you have kidney problems.
• If you have liver problems.
• If you have repeated or unexplained muscle pain and cramps, personal or family history of muscle problems, or history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if you also have a general feeling of illness or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness.
• If you have or have had myasthenia (a condition causing generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a condition causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking rosuvastatin or other related medicines.
• If you regularly consume large amounts of alcohol.
• If your thyroid gland is not functioning properly.
• If you are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have previously taken cholesterol-lowering medicines.
• If you are taking medicines for HIV infection (AIDS virus), such as ritonavir with lopinavir and/or atazanavir; see “Other medicines and Rosuvastatin Aurovitas”.
• If you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) by mouth or by injection. The combination of fusidic acid and rosuvastatin may lead to serious muscle problems (rhabdomyolysis); see “Other medicines and Rosuvastatin Aurovitas”.
• If you are over 70 years old, as your doctor must determine the appropriate starting dose of rosuvastatin for you.
• If you have severe respiratory insufficiency.
• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must determine the appropriate starting dose of rosuvastatin for you.

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

• Do not take the 40 mg dose of rosuvastatin (the highest dose) and consult your doctor or pharmacist before starting any dose of rosuvastatin.

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

In a small number of people, statins may affect the liver. This is detected through a simple blood test showing increased levels of liver enzymes (transaminases). For this reason, your doctor will usually perform blood tests (liver function test) before and after starting treatment with rosuvastatin.

If you have diabetes or are at risk of developing diabetes, your doctor will monitor you closely while you are taking this medicine. 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.

Children and adolescents

• If the patient is under 6 years of age: Rosuvastatin must not be given to children under 6 years of age.
• If the patient is under 18 years of age: The 40 mg tablets of rosuvastatin are not recommended for children and adolescents under 18 years of age.

Other medicines and Rosuvastatin Aurovitas

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

Tell your doctor if you are taking any of the following medicines:

• cyclosporine (used after organ transplant).
• warfarin, clopidogrel, or ticagrelor (or any other anticoagulant medicine).
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe).
• treatments for indigestion (used to neutralize stomach acid).
• erythromycin (an antibiotic).
• fusidic acid (an antibiotic – see below and 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 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, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• roxadustat (used to treat anemia in patients with chronic kidney disease).
• tafamidis (used to treat a disease called transthyretin amyloidosis).

The effects of these medicines may be altered by rosuvastatin or may change the effect of rosuvastatin.

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

Taking Rosuvastatin Aurovitas with food, drinks, and alcohol

You may take rosuvastatin with or without food.

Pregnancy, breastfeeding, and fertility

Do not take rosuvastatin if you are pregnant or breastfeeding.

If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatin by using an appropriate contraceptive method.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Rosuvastatin Aurovitas contains lactose, Allura Red AC, and Orange Yellow S

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

This medicine may cause allergic reactions because it contains Allura Red AC (E129) and Orange Yellow S (E110).

It may cause allergic-type reactions.

The complete list of ingredients is in Contents of the pack and other information.

3. How to take Rosuvastatina Aurovitas

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

Normal doses in adults:

If you are taking rosuvastatin for high cholesterol levels:

Starting dose:

Your treatment with rosuvastatin should begin with a dose of 5 mg or 10 mg, even if you have previously taken a higher dose of another statin. The choice of starting dose will depend on:

• Your cholesterol levels.
• Your risk of having a heart attack or stroke.
• Whether you have factors that make you more susceptible to possible side effects.

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

Your doctor may decide to give you the lowest dose (5 mg) if:

• You are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• You are over 70 years old.
• You have moderate kidney problems.
• You are at risk of 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 appropriate dose of rosuvastatin for your condition. 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 an interval of four weeks between each dose adjustment.

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

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

The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the previously mentioned risk factors.

Use in children and adolescents aged 6–17 years

The dose range for children and adolescents aged 6 to 17 years is 5 mg to 20 mg once daily. The usual recommended starting dose is 5 mg daily, and your doctor may gradually increase the dose until reaching the appropriate rosuvastatin dose for treating your condition. The maximum recommended daily dose of rosuvastatin is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. Take the dose prescribed by your doctor once daily. The 40 mg tablets must not be given to children.

How to take the tablets

Swallow each tablet whole with water.

Take rosuvastatin once daily. You may 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 monitoring of cholesterol levels

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

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

If you take more Rosuvastatina Aurovitas than you should

Contact your doctor or nearest hospital for advice.

If you are admitted to hospital or receiving treatment for another condition, inform healthcare staff that you are taking rosuvastatin.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Rosuvastatina Aurovitas

Do not worry—simply take the next scheduled dose at the usual time.

Do not take a double dose to make up for missed doses.

If you stop taking Rosuvastatina Aurovitas

Consult your doctor if you wish to stop treatment with rosuvastatin. Your cholesterol levels may rise again if you stop taking rosuvastatin.

If you have any further questions about 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 everyone will experience them.

It is important that you are aware of what these adverse effects may be. They are usually mild and disappear within a short period of time.

Stop taking rosuvastatin and seek immediate medical attention if 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.
• Severe skin itching (with hives).
• Red, flat spots on the trunk, often in a target or circular shape, sometimes with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also stop taking rosuvastatin and consult your doctor immediately:

• If you experience unexplained muscle pain or cramps that 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 experienced unpleasant muscle effects, which very rarely have led to a potentially fatal muscle injury called rhabdomyolysis.
• If you experience muscle breakdown.
• If you develop a syndrome with symptoms resembling 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.
• Increased levels of protein in urine – this usually returns to normal on its own without the need to discontinue treatment with rosuvastatin tablets (common adverse effect only with the 40 mg daily dose of rosuvastatin).
• Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Uncommon adverse effects: may affect up to 1 in 100 people

• Rash, itching, and other skin reactions.
• Increased levels of protein in urine – this usually returns to normal on its own without the need to discontinue treatment with rosuvastatin tablets (uncommon adverse effect with the 5 mg, 10 mg, and 20 mg daily doses 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, and severe skin itching (with hives). If you think you are having an allergic reaction, stop taking rosuvastatin and seek immediate medical attention.
• 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 inflammation of the pancreas).
• 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 resembling lupus (including rash, joint disturbances, 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 (inflammation of the liver).
• Blood traces in urine.
• Nerve damage in the arms and legs (with numbness or tingling).
• Joint pain.
• Memory loss.
• Enlargement of the breasts in men (gynecomastia).

Adverse effects with unknown frequency: frequency cannot be estimated from the available data

• 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.
• Persistent muscle weakness.
• Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).

Ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rosuvastatin Aurovitas

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 from light.

Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This way you can help protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatin Aurovitas

• The active substance is rosuvastatin. Each film-coated tablet contains 5 mg of rosuvastatin (as rosuvastatin calcium).
• The other components are:

Tablet core: lactose monohydrate, calcium hydrogen phosphate, microcrystalline cellulose, crospovidone (type B), magnesium stearate.

Coating: hypromellose (15 cP) (E464), lactose monohydrate, titanium dioxide (E171), sunset yellow FCF (E110), allura red AC (E129), indigo carmine (E132), triacetin.

Appearance of the product and contents of the pack

Film-coated pink, oval, biconvex tablets, marked with "J" on one side and "53" on the other.

Rosuvastatin Aurovitas tablets are available in blister packs made of Polyamide/Al/PVC/Al.

Pack sizes: 20, 28 and 60 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

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

Spain:	Rosuvastatin Aurovitas 5 mg film-coated tablets EFG
Italy:	Rosuvastatin Aurobindo
Poland:	Aporoza
Portugal:	Rosuvastatin Aurovitas

Date of the last review of this leaflet: October 2024

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