Rosuvastatin Krka 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Rosuvastatin Krka 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Rosuvastatina Krka contains the active substance rosuvastatin. It belongs to a group of medicines called statins.

You have been prescribed Rosuvastatina Krka because:

• You have high cholesterol levels. This means you are at risk of having a heart attack or stroke. Rosuvastatina Krka is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.

You have been advised 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 regular exercise while taking Rosuvastatina.

Or

• You have other risk factors that increase your chance of having a heart attack, stroke, or other related health problems.

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

Why is it important that you continue taking Rosuvastatina?

Rosuvastatina 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).

• Rosuvastatina 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 produce 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 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 stops the formation of fatty deposits. However, you should stop treatment if your doctor instructs you to do so, or if you become pregnant.

2. What you need to know before taking Rosuvastatin Krka

Do not take Rosuvastatin Krka

• If you are allergic to rosuvastatin or 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 Krka, 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 have repeated or unexplained muscle pain or 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 an organ transplant).

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

Also, do not take Rosuvastatin Krka 30 mg or 40 mg (the highest 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 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 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 situations mentioned above (or are unsure), please consult your doctor again.

Warnings and precautions

Talk to your doctor or pharmacist before starting rosuvastatin

• If you have kidney problems.
• If you have liver problems.
• If you have repeated or unexplained muscle pain or cramps, a personal or family history of muscle problems, or a 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 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 taken cholesterol-lowering medicines before.
• If you are taking medicines to treat HIV infection (AIDS virus), such as ritonavir with lopinavir and/or atazanavir; see “Other medicines and Rosuvastatin Krka”.
• If you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) taken orally or by injection. The combination of fusidic acid and Rosuvastatin Krka may lead to serious muscle problems (rhabdomyolysis).
• If you are over 70 years old, 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 ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking rosuvastatin or other statins.
  • If you have or have had myasthenia (a disease characterized by generalized muscle weakness that, 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 situations mentioned above (or are unsure):

• Do not take Rosuvastatin Krka 30 mg or 40 mg (the highest dose) 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 tests) before and during treatment with rosuvastatin.

If you have diabetes or are at risk of developing diabetes, your doctor will monitor you closely while you are taking this medicine. You are more likely to be at risk of developing diabetes if you have high levels of blood sugar and fats, are overweight, and have high blood pressure.

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.

Children and adolescents

• If the patient is under 6 years of age: Rosuvastatin must not be given to children under 6 years of age.
• If the patient is under 18 years of age: The 30 mg and 40 mg rosuvastatin tablets are not recommended for children and adolescents under 18 years of age.

Other medicines and Rosuvastatin Krka

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

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

• cyclosporine (used after organ transplant),
• warfarin, clopidogrel, or ticagrelor (or any other anticoagulant medicine),
• 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 under 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 may be altered by rosuvastatin or may alter the effect of rosuvastatin.

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 rosuvastatin with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

Taking Rosuvastatin Krka with food and drink

You may take rosuvastatin with or without food.

Pregnancy and breastfeeding

Do not take rosuvastatin 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 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 vehicles 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 machines.

Rosuvastatin Krka contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Rosuvastatina Krka

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.

Normal doses in adults:

If you are taking Rosuvastatina Krka for high cholesterol levels:

Starting dose:

Your treatment with Rosuvastatina Krka should be initiated 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 level.
• Your risk level of having a heart attack or stroke.
• Whether you have factors that make you more susceptible to possible side effects.

Check with your doctor or pharmacist which is the best starting dose of Rosuvastatina Krka for you.

Your doctor may decide to give you the lowest dose (5 mg) if:

• You are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• You are over 70 years old.
• You have moderate kidney problems.
• You are at risk of 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 appropriate dose of Rosuvastatina Krka for your needs. 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 Rosuvastatina Krka is 40 mg. This dose is only for patients with high cholesterol and a high risk of heart attack or stroke whose cholesterol levels have not decreased sufficiently with 20 mg.

If you are taking Rosuvastatina Krka 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.

Normal doses in children 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 usual starting dose is 5 mg daily, and your doctor may gradually increase the dose to reach the appropriate dose of Rosuvastatina Krka for you. The recommended maximum daily dose of Rosuvastatina Krka 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. Rosuvastatina Krka 40 mg tablets must not be administered to children.

How to take the tablets

Swallow each tablet whole with water.

Take Rosuvastatina Krka 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 appropriate dose of rosuvastatin for your needs.

If you take more Rosuvastatina Krka than you should

Contact your doctor or nearest hospital for advice.

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

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

If you forget to take Rosuvastatina Krka

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 Krka

Consult your doctor if you wish to stop treatment with Rosuvastatina Krka. Your cholesterol levels may rise again if you stop taking Rosuvastatina Krka.

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, which may cause difficulty swallowing.
• Intense itching of the skin (with hives).

Also stop taking rosuvastatin and contact your doctor immediately if you experience any of the following:

• Unexplained muscle pain and cramps lasting 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 resulted in a potentially life-threatening muscle injury called rhabdomyolysis.
• Lupus-like illness syndrome (including skin rash, joint disorders, and effects on blood cells).
• Muscle breakdown.
• Red, non-elevated target-shaped or circular skin lesions, 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).

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

• Headache.
• Stomach pain.
• Constipation.
• Nausea.
• Muscle pain.
• Weakness.
• Dizziness.
• Increased amount of protein in urine – this usually returns to normal on its own without the need to stop treatment with rosuvastatin tablets (frequent adverse effect only with the 40 mg daily dose 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)

• Rash, itching, and other skin reactions.
• Increased amount of protein in urine – this usually returns to normal on its own without the need to stop treatment with rosuvastatin tablets (only for rosuvastatin 5 mg, 10 mg, and 20 mg).

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 rosuvastatin 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 lasting longer than expected.
• Severe stomach pain (possible sign of inflammation of the pancreas).
• Increased liver enzymes in blood.
  • Bleeding or bruising more easily than normal due to low platelet count in the blood.
• Lupus-like illness syndrome (including skin 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.
• Enlargement of the breasts in men (gynecomastia).

Adverse effects with unknown frequency (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.
• Persistent 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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. Rosuvastatin Krka Storage

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 is the last day of the month indicated.

This medicine does not require special storage temperature conditions. Store in the original packaging to protect it from moisture.

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

6. Contents of the pack and other information

Composition of Rosuvastatin Krka

• The active substance is rosuvastatin.

Each film-coated tablet contains 5 mg of rosuvastatin (as rosuvastatin calcium).

• The other components are: lactose, microcrystalline cellulose, crospovidone (type A), magnesium stearate and colloidal anhydrous silica in the tablet core; and polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc and iron oxide red (E172) in the tablet coating.

Appearance of the product and contents of the pack

Rosuvastatin Krka 5 mg film-coated tablets are red-brown, round, slightly biconvex, film-coated tablets with bevelled edges, marked with a "5" on one side (diameter: 6 mm).

Rosuvastatin Krka is available in blister packs containing 10, 14, 15, 20, 28, 30, 56, 60, 90, 98 and 100 film-coated tablets.

Rosuvastatin Krka is also available in perforated unit dose blister packs of 10x1, 14x1, 15x1, 20x1, 28x1, 30x1, 56x1, 60x1, 90x1, 98x1 and 100x1 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer(s):

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in EEA Member States under the following names:

Date of the most recent review of this leaflet: October 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/).