ROSUVASTATIN NORMON 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rosuvastatin Normon 10 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Rosuvastatin Normon belongs to a group of medicines called statins.

You have been prescribed Rosuvastatin because:

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

• You have been told to take a statin because changes to your diet and increasing exercise have not been enough to correct your cholesterol levels. You should maintain a diet that helps to lower your cholesterol and continue to exercise while you are taking rosuvastatin.

Or

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

A heart attack, stroke, and other related health problems can be caused by a disease called atherosclerosis. Atherosclerosis is caused by the build-up of fatty deposits in your arteries.

Why is it important to keep taking Rosuvastatin Normon?

Rosuvastatin is used to correct the levels of fatty substances in the blood called lipids, the most well-known of which is cholesterol.

There are different types of cholesterol in the blood, the “bad” cholesterol (LDL-C) and the “good” cholesterol (HDL-C).

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

In most people, high cholesterol does not affect how they feel because it does not produce any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed blood vessels can become blocked, cutting off the blood supply to the heart or brain, causing a heart attack or stroke. By lowering your cholesterol levels, you can reduce your risk of having a heart attack, stroke, or related health problems.

You need to keep taking rosuvastatin, even if you have already achieved the correct cholesterol levels, because it prevents cholesterol levels from rising again and causing the build-up of fatty deposits. However, you should stop taking it if your doctor tells you to or if you become pregnant.

2. What you need to know before you take Rosuvastatin Normon

Do not take Rosuvastatin Normon

• If you are allergic (hypersensitive) to rosuvastatin or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breast-feeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant while taking rosuvastatin and use 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 combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C, a viral liver infection).
• If you are taking a medicine called ciclosporin (used, for example, after an organ transplant).

If you are in any of these situations (or if you are not sure), please go back to your doctor.

Also, do not take the highest dose (40 mg):

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland does not work properly.
• 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 fibrates to lower your cholesterol.

If you are in any of these situations (or if you are not sure), please go back to your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rosuvastatin Normon

• 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. Tell your doctor immediately if you have unexplained muscle pain or weakness, especially if you also feel unwell or have a high temperature. Also, tell your doctor or pharmacist if you have persistent muscle weakness.
• If you have ever developed an allergic reaction to a medicine, which caused a severe skin rash, blisters, or sores in the mouth.
• If you regularly drink large amounts of alcohol.
• If your thyroid gland does not work properly.
• If you are taking other medicines called fibrates to lower your 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 “Other medicines and Rosuvastatin Normon”.
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) by mouth or by injection. The combination of fusidic acid and rosuvastatin can cause muscle problems (rhabdomyolysis), see section 4.
• If you have severe respiratory problems.
• If you are of Asian origin, for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor will need to choose the right starting dose of rosuvastatin for you.
• If you are over 70 years old (as your doctor will need to choose the right starting dose of rosuvastatin for you).
• 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 make this condition worse or trigger the onset of myasthenia (see section 4).

If you are in any of these situations (or if you are not sure):

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

Severe 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 medical attention immediately if you notice any of the symptoms described in section 4.

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

While you are on 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 levels of sugar in your blood, are overweight, or have high blood pressure.

Children and adolescents

• If the patient is under 6 years of age: Rosuvastatin should not be given to children under 6 years of age.

Other medicines and Rosuvastatin Normon

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

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

• ciclosporin (used after an organ transplant),
• warfarin, ticagrelor, or clopidogrel (or any other anticoagulant, such as acenocoumarol),
• fibrates (such as gemfibrozil, fenofibrate), or any other medicine used to lower cholesterol (such as ezetimibe),
• indigestion treatments (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic - see also section “Warnings and precautions” and section 4),
• 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 section “Warnings and precautions”): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, 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 can be altered by rosuvastatin or they can alter the effect of rosuvastatin.

If you need to take fusidic acid by mouth to treat a bacterial infection, you must stop taking this medicine temporarily. Your doctor will tell you when it is safe to start taking rosuvastatin again. Taking rosuvastatin with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Pregnancy and breast-feeding

Do not take rosuvastatinif you are pregnant or breast-feeding. If you become pregnant while taking rosuvastatin, stop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant while taking rosuvastatin and use an appropriate contraceptive method.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Most patients can drive and use machines while taking rosuvastatin as it is unlikely to affect their ability to do so. However, some people may feel dizzy while taking rosuvastatin. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatin Normon contains lactose.

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

Rosuvastatin Normon contains sodium.

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

3. How to take Rosuvastatin Normon

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, consult your doctor or pharmacist.

Usual dose in adults

If you are taking rosuvastatin 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.
• Whether you have any factors that make you more sensitive to the 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 you on the lowest 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 muscle pain or weakness (myopathy).

Increasing the dose and maximum daily dose

Your doctor may decide to increase your dose 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 a gap of at least 4 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 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 once daily and your doctor may gradually increase your dose as needed, up to a maximum dose of 10 mg or 20 mg once daily for children aged 6 to 17 years, depending on the underlying disease being treated. Take one dose once daily.

How to take the tablets

Swallow each tablet whole with water.

Take rosuvastatin once a day.You can take it at any time of the day, with or without food.

Try to take your 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 go back to your doctor regularly for cholesterol checks, to make sure that your cholesterol levels have normalized and are being kept under control.

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

If you take more rosuvastatin 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, telephone 91 562 04 20, stating the name of 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 Normon.

If you forget to take Rosuvastatin Normon

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

If you stop taking Rosuvastatin Normon

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

If you have any further questions on 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 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 rosuvastatina 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).
• Red patches on the trunk, not elevated, in a target or circular shape, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions can 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 rosuvastatina and consult your doctor immediately:

• If you experience unjustified 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 suffered unpleasant muscle effects that, very rarely, have resulted in a potentially fatal muscle injury called rhabdomyolysis.
• If you experience muscle rupture.
• If you present with a syndrome that has symptoms similar to lupus (including hives, joint disorders, and effects on blood cells).

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 rosuvastatina tablets (common adverse effect only with the daily dose of 40 mg of rosuvastatina).
• 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 rosuvastatina tablets (uncommon adverse effect with daily doses of 5 mg, 10 mg, and 20 mg of rosuvastatina).

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 rosuvastatina and seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking rosuvastatina and consult your doctor immediately if you have unjustified muscle pain or cramps that last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes (transaminases) in the blood.
• Bleeding or bruising more easily than normal due to a low level of platelets in the blood.
• Syndrome that has symptoms similar to lupus (including hives, 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), traces of blood in the urine, nerve damage in the legs and arms (with numbness or tingling), joint pain, memory loss, and breast enlargement in men (gynecomastia).

Adverse Effects of Unknown Frequency (frequency cannot be estimated from available data) that 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, and constant muscle weakness.
  • Severe myasthenia (a disease that causes generalized muscle weakness that, 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://wwwnotificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rosuvastatina Normon

No special storage conditions are required.

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

Do not use this medicine after the expiration date that appears on the packaging/blister/label after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

The active ingredient of Rosuvastatina Normon is rosuvastatina. The film-coated tablets of Rosuvastatina Normon 10 mg contain rosuvastatina calcium equivalent to 10 mg of rosuvastatina. The other components of the tablet core are: lactose monohydrate, microcrystalline cellulose, crospovidone, sodium bicarbonate, anhydrous colloidal silica, and magnesium stearate. The film coating contains: hypromellose, titanium dioxide (E171), macrogol 6000, talc, and red iron oxide (E172).

Product Appearance and Package Contents

Rosuvastatina Normon is presented in packages with blisters of 28 tablets.

Rosuvastatina Normon 10 mg film-coated tablets are pink, round, biconvex, and marked with 10.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

C/ Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Date of the Last Revision of this Prospectus:June 2024

Detailed and updated information about this medicine 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 updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/81935/P_81935.html