ROSUVASTATIN NORMON 30 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Rosuvastatina Normon 30 mg Film-Coated Tablets

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

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

Rosuvastatina Normon belongs to a group of medicines called statins.

You have been prescribed Rosuvastatina Normon because:

• You have high levels of cholesterol. This means you are at risk of having a heart attack or a stroke. Rosuvastatina is used in adults, adolescents, and children aged 6 years or older 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 lower your cholesterol and continue to exercise while you are on rosuvastatina treatment.
• You have other factors that increase your risk of having a heart attack, stroke, or other related health problems.

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

WhyitisimportanttokeeptakingRosuvastatinaNormon

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

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

• Rosuvastatina decreases 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 levels of cholesterol do not affect how they feel, as they do 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, leading to a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or related health problems.

You need to keep takingRosuvastatina Normon, even if you have already achieved the correct cholesterol levels, as it prevents your cholesterol levels from rising againand causing the buildup of fatty deposits. However, you should stop treatment if your doctor tells you to or if you become pregnant.

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

Do not take Rosuvastatina Normon

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

if you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatina, stop taking it immediatelyand inform your doctor. Women must avoid becoming pregnant during treatment with rosuvastatina using an appropriate contraceptive method.

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

Also, do not take rosuvastatina 30 mg or 40 mg (the highest dose)

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland does not work correctly.
• If you have repeated or unexplained muscle pains or cramps, a personal or family history of muscle problems, or a 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 cholesterol.

If you are 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:

-ifyouhavekidneyproblems

• If you have liver problems.
• If you have repeated or unexplained muscle pains 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 have unexplained muscle pain or cramp, especially if you feel unwell or have a fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness.
• If you regularly drink large amounts of alcohol.
• If your thyroid glanddoes not work correctly.
• If you are taking other medicines called fibratesto lower cholesterol.
• If you are taking medicines to treat HIV infection(such as ritonavir with lopinavir and/or atazanavir), see “Other medicines and Rosuvastatina Normon”.
• If you are taking or have taken in the last 7 days a medicine called fusidic acid(an antibiotic), see “Other medicines and Rosuvastatina Normon”. The combination of fusidic acid and rosuvastatina can rarely cause muscle problems (rhabdomyolysis), see more information on rhabdomyolysis in section 4.
• If you are over 70 years old, as your doctor will need to choose the right starting dose of rosuvastatina for you.

-ifyouhavesevererespiratoryfailure

• 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 rosuvastatina 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 the disease worse or trigger the onset of myasthenia (see section 4).

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

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

• Do not take Rosuvastatina 30 mg and 40 mg (the highest dose) and consult your doctor or pharmacist before starting to take any dose of rosuvastatina.

In a small number of people, statins can affect the liver. This is 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 treatment with rosuvastatina.

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, and have high blood pressure.

Children and adolescents

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

Other medicines and Rosuvastatina Normon

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

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

• ciclosporin (used after organ transplantation),
• 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 "Warnings and precautions" and below),
• 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 can be altered by rosuvastatina or can change the effect of rosuvastatina.

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 rosuvastatina again. Taking rosuvastatina with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not takerosuvastatinaif you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatina, stop taking it immediatelyand inform your doctor. Women must avoid becoming pregnant during treatment with rosuvastatina using an appropriate contraceptive method.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Most patients can drive and use machines while taking rosuvastatinaas it will not affect their ability. However, some people may feel dizzy during treatment with rosuvastatina. 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 told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Rosuvastatina Normon

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

The tablet can be divided into equal doses.

Usual dose in adults

If you are takingrosuvastatinafor high cholesterol:

Starting dose

Your treatment with rosuvastatina 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.
• If you have factors that make you more vulnerable to possible side effects.

Check with your doctor or pharmacist what the best starting dose of rosuvastatina is for you.

Your doctor may decide to start treatment with the smallest 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 pains or cramps (myopathy).

Increasing the dose and maximum daily dose

Your doctor may decide to increase your dose. This is so that you are taking the right dose of rosuvastatina for you. If you started with a dose of 5 mg, your doctor may decide to double the dose to 10 mg, then 15 mg or 20 mg, and later to 30-40 mg if necessary. If you started with a dose of 10 mg, your doctor may decide to increase the dose 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 rosuvastatina 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 rosuvastatina 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 to the dose of rosuvastatina that is right for you. The maximum recommended daily dose of rosuvastatina is 10-20 mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take your dose once daily. Do notgive the 30 mg and 40 mg tablets to children.

Taking the tablets

Swallow each tablet whole with water.

Takerosuvastatinaonce daily. You can 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 checks of your cholesterol levels

It is important that you see your doctor regularly for cholesterol checks to ensure that your cholesterol levels have returned to normal and are being kept at the right levels.

Your doctor may decide to increase your dose so that you are taking the right dose of rosuvastatina for you.

If you take more Rosuvastatina Normon than you should

Contact your doctor or the 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 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 rosuvastatina.

If you forget to take Rosuvastatina Normon

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

If you stop taking Rosuvastatina Normon

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

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 takingrosuvastatinaand 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 spots on the torso, 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 crampsthat 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 takingrosuvastatinaand seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop takingrosuvastatinaand consult your doctor immediately if you have unjustified muscle pain or crampsthat 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 platelet count in the blood.
• Syndrome that has symptoms similar to lupus (including 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 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 (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 the arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or breathing.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rosuvastatina Normon

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

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

Medicines should not be disposed of through wastewater or household waste. 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

Composition of Rosuvastatina Normon

• The active ingredient is rosuvastatina. The film-coated tablets of Rosuvastatina Normon contain rosuvastatina calcium equivalent to 30 mg of rosuvastatina.
• 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 Product and Package Contents

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

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

Package 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 Last Revision of this Leaflet:June 2024

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/.

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet 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/88741/P_88741.html