Rosuvastatin Kern Pharma 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Rosuvastatin Kern Pharma 5 mg film-coated tablets EFG

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.

Leaflet contents:

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

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

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

Your doctor has prescribed this medicine 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.

You have been prescribed 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 factors that increase your risk of 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 is it important that you continue taking Rosuvastatina Kern Pharma?

Rosuvastatin 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).

• Rosuvastatin lowers the amount of "bad" cholesterol and increases "good" cholesterol.
• It works by blocking the production of "bad" cholesterol and improves the body's ability to remove it from the blood.

In most people, high cholesterol levels do not affect how they 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, cutting off 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 heart attack, stroke, or related health problems.

You need to continue taking this medicine, even after your cholesterol levels have returned to normal, because it prevents cholesterol levels from rising again and stops 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 taking Rosuvastatina Kern Pharma

Do not take Rosuvastatina Kern Pharma

• If you are allergic (hypersensitive) to the active substance 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 this medicine, 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 medicine called cyclosporine (used, for example, after organ transplantation).
• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking Rosuvastatina 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 (Rosuvastatina 40 mg)

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland is not functioning properly.
• If you experience repeated or unexplained muscle pain and cramps, have a personal or family history of muscle disorders, 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 rosuvastatin.

• 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 have kidney problems.
• If you have liver problems.
• If you experience repeated or unexplained muscle pain and cramps, have a personal or family history of muscle disorders, 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 accompanied by malaise or 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 to treat HIV infection (AIDS virus), such as ritonavir with lopinavir and/or atazanavir; see "Use of Rosuvastatina Kern Pharma with other medicines".
• If you are taking or have taken within the last 7 days a medicine containing fusidic acid, (used to treat bacterial infection) taken orally or by injection. The combination of fusidic acid and Rosuvastatina Kern Pharma may cause serious muscle problems (rhabdomyolysis).

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Rosuvastatina Kern Pharma. Stop using Rosuvastatina Kern Pharma and seek immediate medical attention 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: The 40 mg rosuvastatin tablets are not recommended for children and adolescents under 18 years of age.
• 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 insufficiency.
• 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 are in any of the above situations (or are unsure):

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

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 test) before and after starting 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 are likely to 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 medicines

Tell your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Inform your doctor if you are taking any of the following medicines: cyclosporine (used after organ transplantation), anticoagulants (e.g., warfarin, acenocoumarol, or phenindione – their anticoagulant effect and risk of bleeding may increase when taken with this medicine), ticagrelor or clopidogrel, fibrates (such as gemfibrozil, fenofibrate), or any other medicine used to lower cholesterol (such as ezetimibe), medicines for indigestion (used to neutralize stomach acid), erythromycin (an antibiotic), oral contraceptives (the pill), hormone replacement therapy, regorafenib (used to treat cancer), or 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 change the effect of this medicine.

If you need to take oral fusidic acid to treat a bacterial infection, you must stop taking this medicine. Your doctor will advise you when you can restart treatment with Rosuvastatina Kern Pharma. Using Rosuvastatina Kern Pharma with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

Pregnancy and breastfeeding

Do not take rosuvastatin if you are pregnant or breastfeeding. If you become pregnant while taking this medicine, 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 are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Most patients can drive and operate machinery while being treated with 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 machinery.

Rosuvastatina Kern Pharma contains lactose

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

3. How to take Rosuvastatina Kern Pharma

Follow exactly the administration instructions given by your doctor. 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 start 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 level of having a heart attack or stroke.
• Whether you have factors that make you more susceptible to possible adverse 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 lowest 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).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you receive the rosuvastatin dose appropriate for you. If you started with a 5 mg dose, 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 10 mg dose, 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 heart attack or stroke whose cholesterol levels do not decrease sufficiently with 20 mg.

If you are taking rosuvastatin to reduce the risk of heart attack, 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 above.

Use in children and adolescents aged 6–17 years

The recommended usual starting dose is 5 mg. Your doctor may increase your dose to reach the rosuvastatin dose appropriate for treating your condition. The recommended maximum 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. Administration of 40 mg rosuvastatin tablets is not recommended in children.

How to take the tablets

Swallow each tablet whole with water.

Take this medicine once a day. 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 monitoring

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 receive the rosuvastatin dose appropriate 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating 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 Kern Pharma

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 Kern Pharma

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

If you have any further questions about 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 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, which may cause difficulty swallowing.
• Intense itching of the skin (with hives).
• Lupus-like illness syndrome (including rash, joint disorders, and effects on blood cells).
• Muscle rupture.
• Red, flat spots on the trunk, target-shaped or circular, often with central blisters, skin peeling, and 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 rosuvastatin and consult your doctor immediately if you experience unexplained muscle pain and cramps that 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 experienced unpleasant muscle effects, which very rarely have resulted in a potentially life-threatening muscle injury called rhabdomyolysis.

Common 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 discontinue treatment with rosuvastatin tablets (common adverse effect only with the 40 mg daily dose of rosuvastatin).
• Diabetes. This is more likely if you have high levels of sugar and lipids in your blood, 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 discontinue treatment with rosuvastatin tablets (uncommon adverse effect with the 5 mg, 10 mg, and 20 mg daily doses 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, and 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 rosuvastatin 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.

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 urine.
• Nerve damage in arms and legs (with numbness or tingling).
• Joint pain.
• Memory loss.
• Enlargement of the breasts in men (gynecomastia).

Adverse effects with unknown frequency (cannot be estimated from 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.
• Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).
• 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 adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rosuvastatin Kern Pharma

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatin Kern Pharma

• The active substance 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 pack

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

Each standard pack contains 28 film-coated tablets, packed in aluminum/aluminum blisters.

Each clinical pack contains 100 film-coated tablets, packed in aluminum/aluminum blisters.

Only some pack 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 most recent revision of this summary: May 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/