Rosuvastatin Cinfamed 15 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rosuvastatina cinfamed 15 mg film-coated tablets

Rosuvastatina cinfamed 30 mg film-coated tablets

rosuvastatin

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

Contents of the leaflet

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

1. What Rosuvastatina cinfamed is and what it is used for

Rosuvastatina cinfamed belongs to a group of medicines known as statins.

You have been prescribed Rosuvastatina cinfamed because:

• You have high cholesterol levels. This means you are at risk of having a heart attack or stroke. This medicine 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 likelihood of having a heart attack, stroke, or other related health problems.

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

Why it is important that you continue taking Rosuvastatina cinfamed

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

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

• This medicine reduces the amount of "bad" cholesterol and increases "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 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, preventing blood supply to the heart or brain, leading to a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or other related health problems.

You need to continue taking rosuvastatin, even after your cholesterol levels have reached the desired level, because it prevents cholesterol levels from rising again and from causing 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 starting to take Rosuvastatin cinfamed

Do not take Rosuvastatin cinfamed

• If you are allergic to rosuvastatin or to 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 experience 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 organ transplantation).

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

Also, do not take Rosuvastatin cinfamed 30 mg film-coated tablets or a higher 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, 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 (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), please consult your doctor again.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine:

• If you have kidney problems.
• If you have liver problems.
• If you have repeated or unexplained 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 experience unexplained muscle pain or cramps, especially if you also feel generally unwell or have a fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness.
• 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 cinfamed”.
• If you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infection), taken orally or by injection. The combination of fusidic acid and rosuvastatin may cause serious muscle problems (rhabdomyolysis); please see “Other medicines and Rosuvastatin cinfamed”.
• If you are over 70 years of age, as your doctor must determine the appropriate starting dose of rosuvastatin for you.
• If you have severe respiratory failure.
• 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 have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

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

• Do not take Rosuvastatin cinfamed 30 mg film-coated tablets or a higher dose, and consult your doctor or pharmacist before starting any dose of this medicine.

Serious 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 by a simple blood test showing increased levels of liver enzymes (transaminases). For this reason, your doctor will usually perform blood tests (liver function tests) before and during treatment with rosuvastatin.

While taking this medicine, your doctor will monitor you closely 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: This medicine must not be given to children under 6 years of age.

If the patient is under 18 years of age: Rosuvastatin cinfamed 30 mg tablets or higher doses must not be given to children and adolescents under 18 years of age.

Other medicines and Rosuvastatin cinfamed

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 using any of the following medicines:

• cyclosporine (used after organ transplantation)
• warfarin, 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 ezetimibe)
• treatments 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)
• darolutamide (used to treat cancer)
• hormone replacement therapy
• fostamatinib (used to treat low platelet count)
• febuxostat (used to treat and prevent high blood levels of uric acid)
• teriflunomide (used to treat multiple sclerosis)
• leflunomide (used to treat rheumatoid arthritis)
• roxadustat (used to treat anemia in patients with chronic kidney disease)
• tafamidis (used to treat a disease called transthyretin amyloidosis)
• momelotinib (used to treat myelofibrosis in adults with anemia)
• 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 rosuvastatin, or they may change the effect of this medicine.

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 rosuvastatin. Taking this medicine with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Pregnancy and breastfeeding

Do not take this medicine 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.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Most patients can drive vehicles and operate machinery while taking this medicine, as it will not affect their ability. However, some people may experience dizziness during treatment. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatin cinfamed contains lactose

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

Rosuvastatin cinfamed contains sodium

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

3. How to take Rosuvastatina cinfamed

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

Usual doses in adults.

If you are taking this medicine 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. If 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 start treatment with the smallest dose (5 mg):

• If you are of Asian origin (e.g., 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 and cramps (myopathy).

This medicine is not suitable for initiating treatment. Your doctor will prescribe a different medicine (containing 5 mg or 10 mg of rosuvastatin).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is to ensure you are taking the rosuvastatin dose appropriate for you. The way the dose is increased will depend on your initial dose. 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 this medicine 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 factors mentioned above.

For a 20 mg dose of rosuvastatin, your doctor will prescribe a different medicine.

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 recommended starting dose is 5 mg daily, and your doctor may gradually increase the dose until reaching the rosuvastatin dose appropriate 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 condition being treated. Take your dose once daily.

Rosuvastatin 30 mg tablets must not be administered to children.

To initiate treatment and for doses that are not feasible/practical with rosuvastatin cinfamed 15 mg film-coated tablets, your doctor will prescribe a different medicine (containing 5 mg, 10 mg, or 20 mg of rosuvastatin).

How to take the tablets

Swallow each tablet whole with water.

Rosuvastatina cinfamed 30 mg film-coated tablets: The score line is only intended to help you divide the tablet if you have difficulty swallowing it whole.

Take this medicine 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 cholesterol level checks

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 rosuvastatin dose appropriate for you.

If you take more Rosuvastatina cinfamed than you should

Contact your doctor or the nearest hospital for advice and take your medicine with you.

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 medicine and the amount ingested.

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

If you forget to take Rosuvastatina cinfamed

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 cinfamed

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 that may cause difficulty swallowing.
• Intense itching of the skin (with hives).
• Reddish, flat spots on the trunk, often target-shaped or circular, sometimes with central blisters, skin peeling, 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 this medicine and consult your doctor immediately:

• If you experience unexplained muscle pain and 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 rupture
• If you develop lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Frequent adverse effects (may affect up to 1 in 10 people)

• Headache.
• Stomach pain.
• Constipation.
• Nausea.
• Muscle pain.
• Weakness.
• Dizziness.
• Increase in the amount of protein in urine – this usually returns to normal on its own without the need to stop treatment with this medicine (frequent adverse effect only with doses of 30 mg or higher of rosuvastatin).
• Diabetes. This is more likely if you have high levels of blood sugar and lipids, are overweight, and have high blood pressure. Your doctor will monitor you closely while you are taking this medicine.

Uncommon adverse effects (may affect up to 1 in 100 people)

• Hives, itching, and other skin reactions.
• Increase in the amount of protein in urine – this usually returns to normal on its own without the need to stop treatment with this medicine (uncommon adverse effect with doses of 20 mg or lower 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 this medicine and seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking this medicine and consult your doctor immediately if you have unexplained muscle pain or cramps that last longer than expected.
• Severe stomach pain (possible sign of pancreas inflammation).
• Increase in liver enzymes (transaminases) in blood.
• Bleeding or bruising more easily than normal due to low platelet count in the blood.
• Lupus-like syndrome (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 traces in urine.
• Nerve damage in arms and legs (with numbness or tingling).
• Joint pain.
• Memory loss.
• Breast enlargement in men (gynecomastia).

Adverse effects with frequency not known (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.
• Persistent muscle weakness.
• Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects muscles used for breathing) or 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 type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rosuvastatin cinfamed

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

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

6. Contents of the pack and other information

Composition of Rosuvastatina cinfamed

• The active substance is rosuvastatin.

Rosuvastatina cinfamed 15 mg film-coated tablets contain 15 mg of rosuvastatin (as rosuvastatin calcium).

Rosuvastatina cinfamed 30 mg film-coated tablets contain 30 mg of rosuvastatin (as rosuvastatin calcium).

• The other components are:

Tablet core: microcrystalline cellulose, monohydrate lactose, crospovidone (type B), hydroxypropyl cellulose, sodium bicarbonate, magnesium stearate;

Tablet coating: monohydrate lactose, hypromellose 6 Cp, titanium dioxide (E-171), triacetin, yellow iron oxide (E-172).

Appearance of the product and contents of the container

Rosuvastatina cinfamed 15 mg film-coated tablets: yellow, round, convex film-coated tablet, with the number “15” engraved in relief on one side and smooth on the other.

Rosuvastatina cinfamed 30 mg film-coated tablets: yellow, round, convex film-coated tablet, with the number “30” engraved on one side and a score line on the other.

This medicine is available in blister packs containing 28 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi 10. Polígono Industrial Areta 31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi 10. Polígono Industrial Areta 31620 Huarte (Navarra) – Spain

Or

Teva Pharma S.L.U

Poligono Malpica 4, Poligono Industrial Malpica

50016 Zaragoza, Spain.

Date of the most recent review of this leaflet: 08/2025

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

Rosuvastatina cinfamed 15 mg film-coated tablets

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90661/P_90661.html

QR code link: https://cima.aemps.es/cima/dochtml/p/90661/P_90661.html

Rosuvastatina cinfamed 30 mg film-coated tablets

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90662/P_90662.html

QR code link: https://cima.aemps.es/cima/dochtml/p/90662/P_90662.html