Package Leaflet: Information for the User

Rosuvastatin calcium 5 mg film-coated tablets EFG

Rosuvastatin calcium

Read this 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to yours, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Rosuvastatina Cinfa belongs to a group of medicines called statins.

You have been prescribed rosuvastatina Cinfa because:

• You have high levels of cholesterol. This means you are at risk of having a heart attack or a stroke.
• Rosuvastatina is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol.
• Your doctor has 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 lower your cholesterol and continue exercising while on treatment with rosuvastatina.
• You have other factors that increase your risk of suffering a heart attack, stroke, or other health problems.

A heart attack, stroke, and other related health 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 rosuvastatina Cinfa

Rosuvastatina 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).

• Rosuvastatina reduces 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, preventing 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 related health problems.

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

Do not take rosuvastatin cinfa

• If you are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnantor breastfeeding. If you become pregnant while taking rosuvastatinstop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatin 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 viral liver infection called hepatitis C).
• If you are taking a medicine called ciclosporin(used, for example, after an organ transplant).
• If you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth sores after taking rosuvastatin or other related medicines.
• If you are in any of the situations mentioned above (or are unsure), please consult your doctor.

Also, do not take the higher dose (rosuvastatin cinfa 40 mg).

• If you have moderate kidney problems(if in doubt, consult your doctor).
• If your thyroid glanddoes 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 takingother medicines called fibratesto lower cholesterol.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take rosuvastatin cinfa:

• 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 regularly consume large amounts of alcohol.
• If your thyroid glanddoes not function correctly.
• If you are taking other medicines called fibratesto 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), such as ritonavir with lopinavir and/or atazanavir. See “Other medicines and rosuvastatin cinfa”.
• If you are taking or have taken in the last 7 days a medicine calledacid fusidic, (an antibiotic), orally or by injection. The combination of acid fusidic and rosuvastatin may cause severe muscle problems (rhabdomyolysis), please see “Other medicines and rosuvastatin cinfa”.
• If you are over 70 years old,sinceyour doctor must establish the starting dose of rosuvastatin appropriate 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 starting dose of rosuvastatin appropriate for you.
• If you have or have had myasthenia (a disease that is characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), since statins may sometimes worsen the disease or cause myasthenia (see section 4).

If you are 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 startingto take any dose of rosuvastatin.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) associated with rosuvastatin treatment have been reported. Stop using rosuvastatin 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 test that detects increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally perform blood tests (liver function test) before and after treatment with rosuvastatin.

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: Rosuvastatin should not be administered to children under 6 years of age.
• If the patient is under 18 years of age:Rosuvastatin tablets40 mgshould not be administered to children and adolescents under 18 years of age.

Other medicines and rosuvastatin cinfa

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:

• ciclosporina (used after an organ transplant)
• warfarina, ticagrelor or clopidogrel (or any other anticoagulant medicine, such as acenocoumarol)
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimiba)
• medicines for indigestion (used to neutralize stomach acid)
• erythromycin (an antibiotic)
• acid fusidic (an antibiotic, please see below and in Warnings and precautions)
• oral contraceptives (the pill)
• regorafenib (used to treat cancer)
• darolutamida (used to treat cancer),
• hormone replacement therapy
• 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 modified by rosuvastatin or may change the effect of rosuvastatin.

If you need to take acid fusidic orally to treat a bacterial infection, you should stop taking this medicine temporarily. Your doctor will tell you when it is safe to start taking rosuvastatin again. Taking rosuvastatin with acid fusidic may rarely cause muscle weakness, sensitivity or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Pregnancy and breastfeeding

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

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

Driving and using machines

Most patients can drive vehicles and use machines during treatment with rosuvastatin as it will not affect your 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 cinfa contains lactose.

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

Rosuvastatin cinfa contains red 40 (E-129).

This medicine may cause allergic reactions because it contains red 40 (E-129).

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Rosuvastatin cinfa contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. Incase of doubt, consult your doctor or pharmacist again.

Recommended doses in adults.

If you are taking rosuvastatin for high cholesterol levels:

Starting dose

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

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

Check with your doctor or pharmacist which is the best starting dose of rosuvastatin 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 are over 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 rosuvastatin for you. If you started with a dose of 5 mg, 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 dose of 10 mg, your doctormay decide to double the dose to 20 mg and then to 40 mg, if necessary. There will be a four-weekinterval between each dose adjustment.

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

If you are taking rosuvastatin to reduce the risk of having a heart attack, a cerebral infarction 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 dose range in children and adolescents aged 6 to 17 years is 5 mg to 20 mg once a day. The recommended starting dose is 5 mg per day and your doctor may increase your dose gradually to reach the appropriate dose of rosuvastatin for you. The maximum recommended daily dose of rosuvastatin is 10 mg 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 rosuvastatin40 mgtablets to children.

Tablet intake

Swallow each tablet whole with water.

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

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

If you take more rosuvastatin 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 rosuvastatin.

If you forget to take rosuvastatin

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

If you interrupt treatment with rosuvastatin

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

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 noteveryone 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 thefollowing 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 that may cause difficulty swallowing.
• Intense itching of the skin (with rashes).

Also, stop taking rosuvastatin and consult your doctor immediately if you experience

• unexplained muscle pain andcramps that last longer than expected. Muscle symptoms are morefrequent in children and adolescents than in adults. Like other statins, a very small number ofpeople have experienced unpleasant muscle side effects that, very rarely, have resulted in a potentially fatal muscle injury calledrhabdomyolysis.
• Symptoms similar to lupus (including rash, joint disorders, and effects on blood cells).
• Muscle rupture.
• Reddish patches on the trunk, often with blisters, peeling skin, 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 swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Common side effects (may affect up to 1 in 10 patients)

• 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 stop treatment with rosuvastatin tablets (a common 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 thismedicine.

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

• 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 stop treatment with rosuvastatin tablets (a 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 patients)

• 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 arehaving an allergic reaction, stop taking rosuvastatinand seek medical attentionimmediately.
• Muscle injury in adults – as a precaution,stop taking rosuvastatin and consult yourdoctor immediately if you experience 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.
• Symptoms similar to lupus (including rash, joint disorders, and effects on blood cells).
• Muscle rupture.

Very rare side effects (may affect up to 1 in 10,000 patients)

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)

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 Vigilance of Medicinal Products for Human Use: https://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.

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

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of rosuvastatina cinfa

• The active ingredient is rosuvastatina. The film-coated tablets containing rosuvastatina contain 5.20 mg of rosuvastatina calcium equivalent to 5 mg of rosuvastatina.
• The other components are: lactose monohydrate, microcrystalline cellulose, sodium bicarbonate, crospovidone, and magnesium stearate in the core of the tablet; and Opadry yellow 83F620008 (hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol/PEG, talc, quinoline yellow, allura red, and indigo carmine blue) on the tablet coating.

Appearance of the product and contents of the packaging

Rosuvastatina cinfa 5 mg are yellow film-coated, cylindrical, biconvex tablets marked with the code “RT1” on one side.

Rosuvastatina cinfa film-coated tablets are contained in blisters of PA-ALU-PVC / ALU. They are presented in packaging of 28 or 100 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

or

Cinfa Laboratories, S.A.

Avenida de Roncesvalles, s/n Olloki (Navarra) 31.699 Spain

Date of the last review of this leaflet:May 2023

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

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/80212/P_80212.html

QR code to:https://cima.aemps.es/cima/dochtml/p/80212/P_80212.html