ROSUVASTATIN CINFA 40 mg FILM-COATED TABLETS

2. What you need to know before you take rosuvastatina cinfa

Do not take rosuvastatina cinfa

• If you are allergic to rosuvastatina or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnantor breastfeeding. If you become pregnant while taking rosuvastatina, stop taking it immediatelyand inform your doctor. Women must avoid becoming pregnant during treatment with rosuvastatina using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pains or 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 skin peeling, blisters, and/or sores in the mouth after taking rosuvastatina or other related medicines.
• If you are in any of the above situations (or are unsure), please consult your doctor again.

Also, do not take the highest dose (rosuvastatina cinfa 40 mg).

• If you have moderate kidney problems(if in doubt, consult your doctor).
• If your thyroid glandis not working correctly.
• If you have repeated or unexplained muscle pains or 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 drink 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 fibratesto lower cholesterol.

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

Warnings and precautions

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

• If you have kidney problems.
• If you have liver problems.
• If you have repeated or unexplained muscle pains or 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 unexplained muscle pain, tenderness, or weakness, especially if you also have a fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness.
• If you regularly drink large amounts of alcohol.
• If your thyroid glandis not working correctly.
• If you are taking other medicines called fibratesto lower cholesterol.
• If you are taking medicines to treat HIV infection(such as ritonavir with lopinavir and/or atazanavir). See "Other medicines and rosuvastatina cinfa".
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infection), by mouth or by injection. The combination of fusidic acid and rosuvastatina can cause serious muscle problems (rhabdomyolysis), see more information on rhabdomyolysis in section 4.
• If you are over 70 years old, as your doctor will need to choose the right starting dose of rosuvastatina for you.
• If you have severe respiratory problems.
• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will need to choose the right starting dose of rosuvastatina for you.
• If you have or have had myasthenia (a disease that causes general 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 can sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

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

• Do not take the highest 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 treatment. Stop using rosuvastatina 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 checks for increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally do blood tests (liver function tests) before and after starting treatment with rosuvastatina.

While you are taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely to 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 should not be given to children under 6 years of age.
• If the patient is under 18 years of age: The 40 mg tablets of rosuvastatina should not be given to children and adolescents under 18 years of age.

Other medicines and rosuvastatina cinfa

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

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

• ciclosporin (used after an organ transplant)
• warfarin, ticagrelor, or clopidogrel (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, see above and in Warnings and precautions)
• oral contraceptives (the pill)
• regorafenib (used to treat cancer)
• darolutamide (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 can be altered by rosuvastatina or can change the effect of rosuvastatina.

If you need to take fusidic acid by mouth to treat a bacterial infection, you must stop taking this medicine temporarily. Your doctor will tell you when it is safe to start taking rosuvastatina again.Taking rosuvastatina with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

rosuvastatina cinfa contains lactose.

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

rosuvastatina cinfa contains sodium.

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

3. How to take rosuvastatina cinfa

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are in doubt, consult your doctor or pharmacist again.

Recommended doses in adults.

If you are taking rosuvastatina for high cholesterol:

Starting dose

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

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

Check with your doctor or pharmacist what the best starting dose of rosuvastatina is for you.

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

• If you are of Asian 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 are at risk of muscle pains or cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you are taking the right dose of rosuvastatina 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 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 rosuvastatina is 40 mg. This dose is only for patients with high cholesterol 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, stroke, or related health problems:

The recommended dose is 20 mg once daily. 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 daily. The recommended starting dose is 5 mg once daily, and your doctor may gradually increase the dose to the dose of rosuvastatina that is right for you. The maximum recommended daily dose of rosuvastatina is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take your dose once daily. Do notgive the 40 mg tablets of rosuvastatina to children.

Taking the tablets

Swallow each tablet whole with water.

The tablet can be divided into equal doses.

Take rosuvastatina once a day. You can 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 checks of cholesterol levels

It is important that you visit your doctor regularly to have your cholesterol levels checked, to ensure that your cholesterol levels have returned to normal and are being maintained at the right levels.

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

If you take more rosuvastatina than you should

Contact your doctor or the nearest hospital for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

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

If you forget to take rosuvastatina

Do not worry, just take the next scheduled dose at the right time. Do not take a double dose to make up for forgotten doses.

If you stop taking rosuvastatina

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

If you have any further questions on 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 all people suffer from them.

It is essential that you know what these adverse effects can be. They are usually mild and disappear in a short period.

Stop taking rosuvastatin and seek immediate medical attentionif 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 can cause difficulty swallowing.
• Intense itching of the skin (with hives).

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

• unjustified muscle pain andmuscle crampsthat last longer than expected. Muscle symptoms are more frequent in children and adolescents than in adults. As with other statins, a very small number of people have suffered unpleasant muscle effects that, very rarely, have resulted in a potentially life-threatening muscle injury called rhabdomyolysis.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).
• Muscle rupture.
• Red, non-raised spots on the torso, target-shaped or circular, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Common Adverse 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 the urine – this usually reverses on its own without the need to interrupt treatment with rosuvastatin tablets (common adverse effect only with the daily dose of 40 mg of rosuvastatin).
• Diabetes. This is more likely if you have high sugar and lipid levels in the blood, are overweight, and have high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Uncommon Adverse Effects (may affect up to 1 in 100 patients)

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

Rare Adverse 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 hives). If you think you arehaving an allergic reaction, stop taking rosuvastatinand seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking rosuvastatin and consult yourdoctor immediately if you have unjustified muscle pain or crampsthat last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes (transaminases) in the blood.
• Bleeding or bruising more easily than usual due to a low platelet count in the blood.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).
• Muscle rupture.

Very Rare Adverse Effects (may affect up to 1 in 10,000 patients)

Jaundice (yellowing of the skin and eyes), hepatitis (inflamed liver), blood traces in the urine, nerve damage in the legs and arms (with numbness or tingling), joint pain, memory loss, and breast enlargement in men (gynecomastia).

Adverse 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.

Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).

Ocular myasthenia (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 or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting Adverse Effects

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

5. Storage of Rosuvastatin Cinfa

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

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Rosuvastatin Cinfa

• The active ingredient is rosuvastatin. The film-coated rosuvastatin tablets contain 41.60 mg of rosuvastatin calcium, equivalent to 40 mg of rosuvastatin.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium bicarbonate, crospovidone, and magnesium stearate in the tablet core; and Opadry pink 85F240135 (hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol/PEG, talc, iron oxide red (E-172)) in the tablet coating.

Appearance and Packaging of the Product

Rosuvastatin Cinfa 40 mg are film-coated tablets, pink, oblong, biconvex, scored on one side, and marked with the code "RT4" on the other.

Rosuvastatin Cinfa film-coated tablets are packaged in PA-ALU-PVC/ALU blisters. They are available in packs of 28 or 100 tablets.

Only certain 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

Laboratorios Cinfa, S.A.

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

Date of the Last Revision of this Leaflet:May 2023

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80215/P_80215.html

QR code to: https://cima.aemps.es/cima/dochtml/p/80215/P_80215.html