Package Leaflet: Information for the User

Rosuvastatina Normon 5 mg Film-Coated Tablets

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What isRosuvastatina Normonand what it is used for

2. What you need to know before you start takingRosuvastatina Normon

3. How to takeRosuvastatina Normon

4. Possible side effects

5. Storage ofRosuvastatina Normon

6. Contents of the pack and additional information

Rosuvastatina Normon belongs to a group of medications called statins.

They have prescribed Rosuvastatina because:

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

•They have indicated that you should take a statin because the changes made to your diet and the increase in physical exercise have not been sufficient to correct your cholesterol levels. You must maintain a diet that helps to reduce cholesterol and continue to perform physical exercise while undergoing treatment with rosuvastatina.

Or

•You present other factors that increase the risk of suffering a heart attack, cerebral infarction, or other health-related problems.

A heart attack, cerebral infarction, and other health-related problems may be caused by a disease called atherosclerosis. Atherosclerosis is caused by the formation of fatty deposits in your arteries.

Why is it important to continue taking Rosuvastatina Normon?

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

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

•Rosuvastatina reduces the amount of bad cholesterol and increases good cholesterol.

•It acts by blocking the production of bad cholesterol and improving the body's ability to eliminate it from the blood.

In most people, high cholesterol levels do not affect how they feel since they do not produce any symptoms. However, if not treated, fatty deposits can form in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed vessels can become blocked and prevent blood supply to the heart or brain, causing a heart attack or cerebral infarction. By reducing your cholesterol levels, you can reduce the risk of having a heart attack, cerebral infarction, or other health-related problems.

You needto continue taking rosuvastatina, even if you have already achieved the correct cholesterol levels, as itprevents cholesterol levels from increasing again and forming fatty deposits. However, you should interrupt treatment if your doctor instructs you to or if you become pregnant.

Do not take Rosuvastatina Normon

•If you are allergic (hypersensitive) to rosuvastatin or to any of the other ingredients of this medicine (listed in section 6).

•If you are pregnantor breastfeeding. If you become pregnant while taking rosuvastatinstop taking it immediately and inform your doctor.Women should 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 unjustified muscle pain and cramps.

•If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir medicines(used to treat a viral liver infection called hepatitis C).

•If you are taking a medicine called ciclosporin(used, for example, after an organ transplant).

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

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

•If you have moderate kidney problems(if in doubt, consult your doctor).

•If your thyroid glanddoes not function correctly.

•If you have repeated or unjustified muscle pain and 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(for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).

•If you are taking other medicines called fibratesto lower cholesterol.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rosuvastatina Normon

•If you have kidney problems.

•If you have liver problems.

•If you have repeated or unjustified muscle pain and cramps,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 unjustified muscle pain or cramps, especially if you have general discomfort or fever. Also inform your doctor or pharmacist if you have persistent muscle weakness.

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

•If you regularly consume large amounts of alcohol.

•If your thyroid glanddoes not function 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 (AIDS virus) infection,such as ritonavir with lopinavir and/or atazanavir, see “Other medicines and Rosuvastatina”.

•If you are taking or have taken in the last 7 days a medicine calledacid fusidic(a medicine to treat bacterial infections), by mouth or by injection. The combination of acid fusidic and rosuvastatin may cause severe muscle problems (rhabdomyolysis),please see“Other medicines and Rosuvastatina”.

•If you have severe respiratory failure.

•If you are of Asian origin, for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian. Your doctor should establish the appropriate starting dose of rosuvastatin for you.

•If you are over 70 years old(since your doctor should establish the appropriate starting dose of rosuvastatin for you).

• If you have or have had myasthenia(a disease that involves generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

If you find yourself in any of these situations mentioned above (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 Rosuvastatina Normon.

Severe 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 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 is detected by a simple test that detects increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will usually perform blood tests (liver function test) before and after treatment with rosuvastatina

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

Other medicines and Rosuvastatina

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

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 ezetimiba),

-medicines for indigestion (used to neutralize stomach acid),

-erythromycin (an antibiotic),

-acid fusidic (an antibiotic - please see below and in Warnings and precautions)

-oral contraceptives (the pill),

-regorafenib (used to treat cancer),

-darolutamida (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 uric acid levels in the blood),

-teriflunomida (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, 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 modified by rosuvastatin or may change the effect of rosuvastatin.

If you need to take acid fusidic orally for the treatment of a bacterial infection, you should stop taking this medicine temporarily. Your doctor will indicate when it is safe to start taking rosuvastatina again. Taking rosuvastatina with acid fusidic may rarely cause muscle weakness, sensitivity or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding

Do not take rosuvastatinaif you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatinstop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatina using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

Most patients can drive vehicles and use machines during treatment 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.

Rosuvastatina Normon contains lactose.

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Rosuvastatina Normon contains sodium.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Usual doses in adults

If you are taking rosuvastatin for high cholesterol levels:

Starting dose

Your treatment with rosuvastatin should start witha dose of 5 mg or 10 mg, even if you have taken a higher dose of another statin previously. The choice of starting dose will depend on:

•Your cholesterol levels.

•The degree of risk you have of having a heart attack or stroke.

•If you have any factor that makes you more vulnerable to potential side effects.

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

Your doctor may decide to start treatment with the lower 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 have a risk of developing 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 right dose of rosuvastatin 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 later to 40 mg, if necessary. There will be a four-week interval between each dose adjustment.

The maximum daily dose of rosuvastatin is 40 mg. This dose is only for patients with high cholesterol levels 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, a 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 earlier.

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 a day. The usual starting dose for treatment is 5 mg per day and your doctor may increase your dose gradually to reach the right dose of rosuvastatin for you. The maximum recommended daily dose of rosuvastatin is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take your dose once a day.

Swallowing 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 the tablets at the same time every day. This will help you remember to take them.

Regular cholesterol checks

It is essential that you attend your doctor regularly for cholesterol checks, to ensure that your cholesterol levels have normalized and remain at appropriate levels.

Your doctor may decide to increase your dose so that you are taking the right dose of rosuvastatin 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, phone 91 562 04 20, indicating the medication and the amount ingested.

If you enter a hospital or receive treatment for another illness, inform the healthcare staff that you are taking rosuvastatin.

If you forget to take Rosuvastatina Normon

Do not worry, simply take the next scheduled dose at the planned time. Do not take a double dose to compensate for a missed dose.

If you interrupt treatment with Rosuvastatina Normon

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

It is important that you know which side effects may occur. They are usually mild and disappear within a short period of time.

Stop taking rosuvastatin and seek medical attention immediatelyif 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 rashes).

•Reddish patches on the trunk, often with blisters, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may 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 rosuvastatin and consult your doctor immediately:

•If you experience unexplained muscle pain and crampsthat last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. Like other statins, a very small number of people have experienced unpleasant muscle side effects, which, very rarely, have resulted in a potentially fatal muscle injury calledrabdomiolysis.

•If you experience muscle rupture.

•If you experience a syndrome with symptoms similar to lupus(including urticaria, joint disorders, and effects on blood cells).

Frequent 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 urine – this usually returns to normal on its own without the need to stop treatment with rosuvastatin tablets (frequent side 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, obesity, and high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Rare side effects (may affect up to 1 in 100 people)

•Urticaria, itching, and other skin reactions.

•An increase in the amount of protein in urine – this usually returns to normal on its own without the need to stop treatment with rosuvastatin tablets (rare side effect with daily doses of 5 mg, 10 mg, and 20 mg of rosuvastatin).

Very rare side effects (may affect up to 1 in 10,000 people)

•Severe allergic reaction – symptoms include swelling of the face, lips, tongue, and/or throat, difficulty breathing, intense itching of the skin (with rashes). If you think you are having an allergic reaction, stop taking rosuvastatinand seek medical attention immediately.

•Muscle injury in adults – as a precaution,stop taking rosuvastatin and consult your doctor immediately if you experience unexplained muscle pain and crampsthat last longer than expected.

•Intense stomach pain (possible sign of pancreatitis).

•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 (includingurticaria, 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), 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).

Side 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.

• Myasthenia gravis (a disease that causes generalized muscle weakness, which, in some cases, affects the muscles used for breathing).
• Myasthenia ocular (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 eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://wwwnotificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

No special storage conditions are required.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

The active ingredient of Rosuvastatina Normon is rosuvastatina. The film-coated tablets of Rosuvastatina Normon contain rosuvastatina calcium equivalent to 5 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 yellow iron oxide (E172).

Appearance of the product and content of the container

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

Rosuvastatina Normon 5 mg film-coated tablets are yellow, round, biconvex tablets with marking 5.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

C/ Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Last review date of this leaflet:June 2024

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/81934/P_81934.html