ROSUVASTATIN KERN PHARMA 20 mg FILM-COATED TABLETS

2. What you need to know before you take Rosuvastatin Kern Pharma

Do not take Rosuvastatin Kern Pharma

• If you are allergic(hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnantor breast-feeding. If you become pregnant while taking this medicine, stop taking it immediatelyand inform your doctor. Women must 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 unexplained muscle pain or weakness.
• 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, blisters, and/or sores in the mouth after taking Rosuvastatin Kern Pharma 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 (Rosuvastatin 40 mg)

• If you have moderate kidney problems(if you are unsure, consult your doctor).
• If your thyroid glandis not working correctly.
• If you have repeated or unexplained muscle pain or weakness, 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 treatment with rosuvastatin.

• 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 disease or cause myasthenia to appear (see section 4).
• If you have kidney problems.
• If you have liver problems.
• If you have repeated or unexplained muscle pain or weakness, 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 or weakness, especially if you also have a general feeling of being unwell or 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. Read this leaflet carefully, even if you have taken cholesterol-lowering medicines before.
• If you are taking medicines to treat HIV infection(such as ritonavir with lopinavir and/or atazanavir), see "Using Rosuvastatin Kern Pharma with other medicines".
• If you are taking or have taken in the last 7 days a medicine that contains fusidic acid(used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and Rosuvastatin Kern Pharma can cause serious muscle problems (rhabdomyolysis).

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in patients taking Rosuvastatin Kern Pharma. Stop using Rosuvastatin 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:Rosuvastatin should not be given to children under 6 years of age.
• If the patient is under 18 years of age:It is not recommended to give Rosuvastatin 40 mg tablets to children and adolescents under 18 years of age.
• If you are over 70 years old, as your doctor will need to determine the appropriate starting dose of rosuvastatin 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 will need to determine the appropriate starting dose of rosuvastatin for you.

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 rosuvastatin.

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

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.

Using Rosuvastatin Kern Pharma with other medicines

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medicines.

Inform your doctor if you are using any of the following medicines: ciclosporin (used after an organ transplant), anticoagulants (e.g., warfarin, acenocoumarol, or fluindione - their anticoagulant effect and the risk of bleeding may increase if taken with this medicine), ticagrelor or clopidogrel, fibrates (such as gemfibrozil or fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe), 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 medicines 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 medicines may be altered by rosuvastatin or may alter the effect of this medicine.

If you need to take fusidic acid by mouth to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with Rosuvastatin Kern Pharma. Using Rosuvastatin Kern Pharma with fusidic acid can cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Pregnancy and breast-feeding

Do not take rosuvastatinif you are pregnant or breast-feeding. If you become pregnant while taking this medicine, stop taking it immediatelyand inform your doctor. Women must avoid becoming pregnant during treatment with rosuvastatin using an appropriate contraceptive method.

If you are pregnant or breast-feeding, or 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 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 Kern Pharma contains lactose

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

3. How to take Rosuvastatin Kern Pharma

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Usual dose in adults

If you are taking this medicine for high cholesterol:

Starting dose

Your treatment with rosuvastatin 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 rosuvastatin 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 having muscle pain or weakness (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is so that you are taking the dose of rosuvastatin that is right 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 rosuvastatin 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 rosuvastatin 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 recommended starting dose is 5 mg. Your doctor may increase your dose to achieve the dose of rosuvastatin that is right for treating your condition. The maximum recommended daily dose is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. Take the dose prescribed by your doctor once daily. Do notgive Rosuvastatin 40 mgtablets to children.

Taking the tablets

Swallow each tablet whole with water.

Take this medicine once daily. 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 your cholesterol levels

It is important that you regularly visit your doctor to have your cholesterol levels checked, to ensure that your cholesterol levels have returned to normal and remain at appropriate levels.

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

If you take more Rosuvastatin Kern Pharma 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 rosuvastatin.

If you forget to take Rosuvastatin Kern Pharma

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

If you stop taking Rosuvastatin Kern Pharma

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

If you have any further questions on the use of this product, 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, which can cause difficulty swallowing.
• Intense itching of the skin (with hives).
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells)
• Muscle rupture
• Red, non-raised spots on the trunk, 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).

Also, stop taking rosuvastatin and consult your doctor immediately if you experience unjustified muscle pain and 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, which have very rarely resulted in a potentially fatal muscle injury called rhabdomyolysis.

Common Adverse 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 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 blood sugar and lipid levels, 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 people)

• Hives, 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 people)

• Severe allergic reaction – symptoms include swelling of the face, 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 medicineand seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking rosuvastatin and consult your doctor 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.

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

• Jaundice (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).

Adverse Effects of Unknown Frequency(cannot be estimated from the available data)which may include

• 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.
• Constant muscle weakness.
• Severe myasthenia (a disease that causes generalized muscle weakness, which 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rosuvastatin Kern Pharma

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

No special storage conditions are required.

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.

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

6. Package Contents and Additional Information

Composition of Rosuvastatin Kern Pharma

• The active ingredient is rosuvastatin. Each tablet contains 20.80 mg of rosuvastatin calcium, equivalent to 20 mg of rosuvastatin.
• The other ingredients are anhydrous lactose, microcrystalline cellulose, crospovidone, sodium citrate (E-331), and magnesium stearate in the core. The coating ingredients are lactose monohydrate, hypromellose, triacetin, titanium dioxide (E-171), and red iron oxide (E-172).

Appearance of the Product and Package Contents

Rosuvastatin Kern Pharma are film-coated tablets, round, pink, scored on one side, and 9 mm in diameter.

The score line is to facilitate breaking and swallowing but not to divide into equal doses.

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

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

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the Last Revision of this Leaflet: May 2023

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