Rosuvastatin Normon 30 mg film-coated tablets

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Rosuvastatin Normon 30 mg film-coated tablets

Read the entire leaflet carefully before you start taking this medicine, as 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Rosuvastatina Normon belongs to a group of medicines called statins.

Your doctor has prescribed Rosuvastatina Normon because:

• You have high cholesterol levels. This means you are at risk of having a heart attack or stroke. Rosuvastatin is used in adults, adolescents, and children 6 years of age and older to treat high cholesterol.
• You have been advised to take a statin because changes in your diet and increased physical exercise have not been sufficient to correct your cholesterol levels. You must maintain a cholesterol-lowering diet and continue regular physical activity while taking rosuvastatin.
• You have other risk factors that increase your likelihood of experiencing a heart attack, stroke, or other related health problems.

Heart attack, stroke, 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 it is important that you continue taking Rosuvastatin Normon

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 reduces 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 form in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed vessels can become blocked, restricting blood flow to the heart or brain, leading to a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or other related health problems.

You need to keep taking Rosuvastatin Normon, 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 starting to take Rosuvastatine Normon

Do not take Rosuvastatine Normon

• If you are allergic to rosuvastatin 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 rosuvastatin, stop taking it immediately and inform your doctor. Women must 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 are taking a combination of medicines containing sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver infection called hepatitis C).

• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking rosuvastatin or other related medicines.

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

In addition, do not take rosuvastatin 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 and cramps, 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 situations listed above (or are unsure), please consult your doctor again.

Warnings and precautions

Consult your doctor or pharmacist before starting to take rosuvastatine:

-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 have previously experienced muscle problems while being treated 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 cholesterol-lowering medicines called fibrates. Read this leaflet carefully, even if you have previously taken cholesterol-lowering medicines.
• If you are taking medicines for HIV infection (AIDS virus), such as ritonavir with lopinavir and/or atazanavir; see “Other medicines and Rosuvastatina Normon”.
• If you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine for bacterial infection). The combination of fusidic acid and rosuvastatin may cause serious muscle problems (rhabdomyolysis); please see “Other medicines and Rosuvastatina Normon”.
• 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 insufficiency.

• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor should determine the appropriate starting dose of rosuvastatin for you.
• If you have or have had myasthenia gravis (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a condition causing weakness of the eye muscles), as statins may sometimes worsen the disease or trigger the onset of myasthenia (see section 4).

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin treatment. Stop taking rosuvastatin and seek immediate medical attention if you experience any of the symptoms described in section 4.

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

• Do not take Rosuvastatin 30 mg and 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 through a simple blood test that measures elevated levels of liver enzymes (transaminases). For this reason, your doctor will usually perform blood tests (liver function tests) before and during treatment with rosuvastatin.

While taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely 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: Rosuvastatin must not be administered to children under 6 years of age.

Other medicines and Rosuvastatina Normon

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

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

• cyclosporine (used after organ transplantation),
• warfarin, ticagrelor, or clopidogrel (or any other anticoagulant medicine 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 – please see below and “Warnings and precautions”),
• oral contraceptives (the pill),
• regorafenib (used to treat cancer),
• darolutamide (used to treat cancer),
• capmatinib (used to treat cancer),
• hormone replacement therapy,
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high levels of uric acid in the blood),
• teriflunomide (used to treat multiple sclerosis),
• 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, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• roxadustat (used to treat anemia in patients with chronic kidney disease),
• tafamidis (used to treat a disease called transthyretin amyloidosis).

The effects of these medicines may be altered by rosuvastatin, or they 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 more information about rhabdomyolysis in section 4.

Pregnancy and breastfeeding

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.

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 of childbearing potential should use an appropriate contraceptive method to prevent pregnancy during treatment with rosuvastatin.

Consult your doctor or pharmacist before using any 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 experience dizziness during treatment with rosuvastatin. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatina Normon contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Rosuvastatin Normon

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The tablet can be divided into equal doses.

Usual doses in adults

If you are taking rosuvastatin for high cholesterol levels:

Starting dose

Your treatment with rosuvastatin should begin 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 to determine the most appropriate starting dose of rosuvastatin for you.

Your doctor may decide to start treatment with the smallest 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 developing 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 your condition. If you started with a 5 mg dose, your doctor may decide to double the dose to 10 mg, then to 15 mg or 20 mg, and later to 30–40 mg, if necessary. If you started with a 10 mg dose, your doctor may increase it to 15–20 mg and then to 30–40 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 reserved only for patients with high cholesterol and a high risk of heart attack or stroke whose cholesterol levels are not sufficiently reduced with 20 mg.

If you are taking rosuvastatin to reduce your 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 previously mentioned factors.

Use in children and adolescents aged 6–17 years

The dose range for 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 your dose until reaching the rosuvastatin dose appropriate for you. The maximum recommended daily dose of rosuvastatin is 10–20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. Take your dose once daily. The 30 mg and 40 mg tablets must not be administered to children.

How to take the tablets

Swallow each tablet whole with water.

Take rosuvastatin 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 to achieve the rosuvastatin dose suitable for you.

If you take more Rosuvastatin Normon 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 91 562 04 20, indicating the medication and amount ingested.

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

If you forget to take Rosuvastatin Normon

Do not worry; simply take the next scheduled dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Rosuvastatin Normon

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

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 may 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 in swallowing.
• Intense itching of the skin (with hives).
• Reddish, flat, non-elevated skin rashes on the trunk, often circular or target-shaped, sometimes with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe 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 fatal muscle injury called rhabdomyolysis.
• If you experience muscle rupture.
• If you develop a syndrome with symptoms resembling lupus (including urticaria, joint disorders, and effects on blood cells).

Common 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 the urine – this usually returns to normal on its own without the need to stop treatment with rosuvastatin tablets (common side 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 side 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 returns to normal on its own without the need to stop treatment with rosuvastatin tablets (uncommon side effect with the 5 mg, 10 mg, and 20 mg daily doses of rosuvastatin).

Rare side 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 experience unexplained muscle pain or cramps lasting longer than expected.
• Severe stomach pain (possible sign of pancreas inflammation).
• Increased liver enzymes (transaminases) in the blood.
• Bleeding or bruising more easily than normal due to low platelet count in the blood.
• Syndrome with symptoms similar to lupus (including rash, joint disorders, and effects on blood cells).

Very rare side 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 arms and legs (with numbness or tingling), joint pain, memory loss, and enlargement of the breasts in men (gynecomastia).

Side 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 injury, and 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 weakness in the arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of side effects

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

5. Storage of Rosuvastatin Normon

Keep this medicine out of sight and reach of children. This medicine does not require any special storage conditions.

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. Instead, return unused medicines and their containers to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatina Normon

• The active substance is rosuvastatin. Rosuvastatina Normon film-coated tablets contain calcium rosuvastatin equivalent to 30 mg of rosuvastatin.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, crospovidone, magnesium stearate, sodium hydrogen carbonate, anhydrous colloidal silica, hypromellose, titanium dioxide (E171), macrogol, and talc.

Appearance of the medicinal product and contents of the pack

Rosuvastatina Normon 30 mg are white, round, biconvex film-coated tablets with a break line, approximately 11.2 mm in diameter, marked "30" on one side. The tablet can be divided into equal doses.

Rosuvastatina Normon 30 mg is supplied in aluminum/polyamide-aluminum-PVC blisters.

Pack sizes:

Rosuvastatina Normon 30 mg film-coated tablets:

28 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos

Madrid (SPAIN)

Date of the most recent revision of this leaflet: June 2024

Detailed information on this medicinal product 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 up-to-date information about this medicine by scanning the QR code included in the package leaflet and outer packaging with your mobile phone (smartphone). You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/88741/P_88741.html