Prospect: Information for the user

Rosuvastatina Kern Pharma 5 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Rosuvastatina Kern Pharma and for what it is used

2.What you need to know before starting to take Rosuvastatina Kern Pharma

3.How to take Rosuvastatina Kern Pharma

4.Possible adverse effects

5Storage of Rosuvastatina Kern Pharma

6.Contents of the package and additional information

Rosuvastatina Kern Pharma belongs to a group of medications called statins.

They have prescribed this medication because:

• You have high cholesterol levels. This means you are at risk of suffering a heart attack or a cerebral infarction.

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

They have 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 reduce cholesterol and continue exercising while on treatment with rosuvastatina.

Or:

• You present other factors that increase the risk of suffering a heart attack, cerebral infarction, or other health-related problems.

A heart attack, cerebral infarction, and other health-related problems may be caused by a disease called atherosclerosis. Atherosclerosis is caused by the formation of fatty deposits in your arteries.

Why is it important to continue taking Rosuvastatina Kern Pharma?

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 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.

At times, these narrowed vessels can become blocked and prevent blood supply to the heart or brain, causing a heart attack or cerebral infarction. By reducing your cholesterol levels, you can reduce the risk of suffering a heart attack, cerebral infarction, or other health-related problems.

You needto continue taking this medication,even if you have already achieved the correct cholesterol levels, as itprevents cholesterol levels from increasing again and forming fatty deposits.However, you should interrupt treatment if your doctor instructs you to do so or if you become pregnant.

Do not take Rosuvastatina Kern Pharma

• if you areallergicto the active ingredient or any of the other components of this medication (listed in section 6).
• if you are pregnantor breastfeeding. If you become pregnant while taking this medicationstop taking it immediately and inform your doctor. Women should 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 unjustified muscle pain and cramps.
• if you are taking a medication called ciclosporin(used, for example, after an organ transplant).
• if you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking Rosuvastatina Kern Pharma or other related medications.

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

Also, do not take the highest dose (Rosuvastatina 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 medications.
• 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 medications called fibratesto lower cholesterol.

If you are 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.

• if you have or have had myasthenia(a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).
• 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 medications. 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 medications called fibratesto lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medications previously.
• if you are taking medications to treat HIV (human immunodeficiency virus) infection, such as ritonavir with lopinavir and/or atazanavir, see “Use of Rosuvastatina Kern Pharma with other medications”.
• ifyou are taking or have taken within the last 7 days a medication containing fusidic acid(used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and Rosuvastatina Kern Pharma may cause severe muscle problems (rhabdomyolysis).

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

Children and adolescents

• if the patient is under 6 years of age:Rosuvastatina 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.
• if you are over 70 years old, as your doctor should 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 should establish the appropriate starting dose of rosuvastatina for you.

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

• Do not take the 40 mg dose and consult your doctor or pharmacist before starting to take any dose of rosuvastatina.

In a small number of people, statins can affect the liver. This is detected by a simple test that detects elevated liver enzymes (transaminases) in the blood. For this reason, your doctor will usually perform blood tests (liver function test) before and after treatment with rosuvastatina.

While taking this medication, 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.

Use of Rosuvastatina Kern Pharma with other medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

Inform your doctor if you are using any of the following medications: ciclosporin (used after an organ transplant), anticoagulants (e.g. warfarin, acenocoumarol, or fluindione - your anticoagulant effect and risk of bleeding may increase if taken with this medication -, ticagrelor or clopidogrel, fibrates (such as gemfibrozil, fenofibrate) or any other medication used to lower cholesterol (such as ezetimiba), treatments for indigestion (used to neutralize stomach acid), erythromycin (an antibiotic), oral contraceptives (the pill), hormone replacement therapy, regorafenib (used to treat cancer), any of the following medications used to treat viral infections, including HIV or hepatitis C, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir . The effects of these medications may be modified by rosuvastatina or may change the effect of this medication.

If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop taking this medication. Your doctor will tell you when you can restart treatment with Rosuvastatina Kern Pharma. The use of Rosuvastatina Kern Pharma with fusidic acid may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Pregnancy and breastfeeding

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

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

Driving and operating machinery

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

Rosuvastatina Kern Pharma contains lactose

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

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

Usual doses in adults

If you are taking this medication for high cholesterol levels:

Starting dose

Your treatment with rosuvastatin should start witha dose of 5 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 possible 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 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 rosuvastatin 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 rosuvastatin 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 recommended starting dose is 5 mg. Your doctor may increase your dose to reach the right dose of rosuvastatin to treat your condition. The maximum recommended daily dose is 10 mg for children aged 6-9 years and 20 mg for children aged 10-17 years. Take the dose indicated by your doctor once a day.Do notadminister Rosuvastatin Kern Pharma40 mgtablets to children.

Tablet intake

Swallow each tablet whole with water.

Take this medication 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 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 rosuvastatin for you.

If you take more Rosuvastatina Kern Pharma 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 rosuvastatin.

If you forget to take Rosuvastatina Kern Pharma

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 Rosuvastatina Kern Pharma

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

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can 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 within 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).
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).
• Muscle rupture.
• Reddish-brown patches on the trunk, often with blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (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 and prolonged muscle pain and cramps.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, which, very rarely, have resulted in a potentially fatal muscle injury calledrabdomyolysis.

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 stop 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, obesity, 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 stop 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, 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 this medicineand seek medical attention immediately.
• Muscle injury in adults – as a precaution,stop taking rosuvastatin and consult your doctor immediately if you experience unexplained and prolonged muscle pain and cramps.
• Intense stomach pain (possible sign of pancreatitis).
• Increased liver enzymes (transaminases) in the blood.

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

• Ictericia (yellowing of the skin and eyes).
• Hepatitis (inflamed liver).
• Traces of blood in the urine.
• Nerve damage in the legs and arms (with numbness or tingling).
• Joint pain.
• Memory loss.
• Enlargement of the breasts in men (gynecomastia).

Side effects of unknown frequency(cannot be estimated from available data)that may include

• Diarrhea (loose stools).
• Cough.
• Shortness of breath.
• Swelling.
• Sleep disturbances, including insomnia and nightmares.
• Sexual difficulties.
• Depression.
• Respiratory problems, including persistent cough and/or shortness of breath or fever.
• Tendon injuries.
• Constant muscle weakness.
• Myasthenia gravis (a disease that causes generalized muscle weakness, which, 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 not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: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.

No special storage conditions are required.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines.By doing so, you will help protect the environment.

Composition of Rosuvastatina Kern Pharma

-The active ingredient is rosuvastatin. Each tablet contains 5.20 mg of rosuvastatin calcium, equivalent to 5 mg of rosuvastatin.

-The other components are anhydrous lactose, microcrystalline cellulose, crospovidone, sodium citrate (E-331), and magnesium stearate in the core. The coating components are monohydrate lactose, hypromellose, triacetin, titanium dioxide (E-171), and yellow iron oxide (E-172).

Appearance of the product and contents of the packaging

Rosuvastatina Kern Pharma are film-coated tablets, round, yellow, and with a diameter of 6 mm.

Each standard package contains 28 film-coated tablets, conditioned in aluminum/aluminum blisters.

Each clinical package contains 100 film-coated tablets, conditioned in aluminum/aluminum blisters.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: May 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/