ROSUVASTATIN FARMAPROJECTS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rosuvastatin Farmaprojects10 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.
• 1. 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 experience 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 and other information

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

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

Rosuvastatin Farmaprojects belongs to a group of medicines called statins.

You have been prescribed Rosuvastatin Farmaprojects because:

• You have high levels of cholesterol. This means that you are at risk of having a heart attack or stroke. Rosuvastatin Farmaprojects 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 physical exercise have not been enough to correct your cholesterol levels. You should maintain a diet that helps to lower cholesterol and continue to exercise while being treated with Rosuvastatin Farmaprojects.

• 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 formation of deposits of fatty substances in your arteries.

Why it is important to keep taking Rosuvastatin Farmaprojects

Rosuvastatin Farmaprojects 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 Farmaprojects 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 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, preventing blood from reaching the heart or brain, causing 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 taking Rosuvastatin Farmaprojects, even if you have already achieved the correct cholesterol levels, as it prevents cholesterol levels from rising again and causing the formation 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 taking Rosuvastatin Farmaprojects

Do not take Rosuvastatin Farmaprojects

• If you are allergic (hypersensitive) to the active substance or any of the other ingredients of Rosuvastatin Farmaprojects (listed in section 6).
• If you are pregnantor breastfeeding. If you become pregnant while taking Rosuvastatin Farmaprojects, stop taking it immediately and inform your doctor.Women should avoid becoming pregnant during treatment with Rosuvastatin Farmaprojects using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pains or cramps.
• If you are taking a medicine called ciclosporin(used, for example, after an organ transplant).
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking rosuvastatin or other related medicines.

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

Additionally, do not take the highest dose (Rosuvastatin Farmaprojects 40 mg)

• If you have moderate kidney problems(if you are unsure, consult your doctor).
• If your thyroid glandis not working 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 fibratesto 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 Rosuvastatin Farmaprojects

• 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 worsen the disease or cause myasthenia (see section 4).
• If you have kidney problems.
• 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 also have a general feeling of being 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 glandis not working 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 infection (AIDS virus),such as ritonavir with lopinavir and/or atazanavir, see Other medicines and Rosuvastatina Farmaprojects.
• If you are taking or have taken in the last 7 days a medicine called fusidic acid,(an antibiotic), by mouth or by injection. The combination of fusidic acid and Rosuvastatin Farmaprojects can cause serious muscle problems (rhabdomyolysis), see Other medicines and Rosuvastatina Farmaprojects.
• If you are over 70 years old,as your doctor will need to choose the right starting dose of Rosuvastatin Farmaprojects for you.
• 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 Farmaprojects for you.
• Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin. Stop using rosuvastatin 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 the 40 mg dose and consult your doctor or pharmacist before starting to take any dose of Rosuvastatin Farmaprojects.

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 Rosuvastatin Farmaprojects.

While you are taking 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:Rosuvastatin Farmaprojects should not be given to children under 6 years of age.
• If the patient is under 18 years of age:The 40 mg tablets of Rosuvastatin Farmaprojects should not be given to children and adolescents under 18 years of age.

Other medicines and Rosuvastatin Farmaprojects

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),
• anticoagulants, e.g., warfarin, acenocoumarol, or fluindione (their anticoagulant effect and the risk of bleeding may increase if taken with this medicine), ticagrelor, or clopidogrel.
• 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 - see also under Warnings and precautions and section 4),
• oral contraceptives (the pill),
• hormone replacement therapy,
• regorafenib (used to treat cancer),
• 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, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medicines may be altered by Rosuvastatin Farmaprojects or may change the effect of Rosuvastatin Farmaprojects.

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

Pregnancy and breastfeeding

Do not take Rosuvastatin Farmaprojectsif you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Farmaprojects, stop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant during treatment with Rosuvastatin Farmaprojects using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Most patients can drive and use machines while taking Rosuvastatin Farmaprojects, as it will not affect their ability. However, some people may feel dizzy during treatment with Rosuvastatin Farmaprojects. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatin Farmaprojects contains lactose.

If your doctor has told you that you have an intolerance to some sugars (lactose or milk sugar), consult your doctor before taking Rosuvastatin Farmaprojects.

The complete list of ingredients is found in Contents of the pack and further information.

3. How to take Rosuvastatin Farmaprojects

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

Usual dose in adults

If you are taking Rosuvastatin Farmaprojects for high cholesterol:

Starting dose

Your treatment with Rosuvastatin Farmaprojects 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 Rosuvastatin Farmaprojects 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 so that you are taking the right dose of Rosuvastatin Farmaprojects 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 an interval of four weeks between each dose adjustment.

The maximum daily dose of Rosuvastatin Farmaprojects is 40 mg. This dose is only for patients with very 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 Farmaprojects 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 Rosuvastatin Farmaprojects that is right for you. The maximum recommended daily dose of Rosuvastatin Farmaprojects is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take your dose once daily. Do notgive the 40 mg tablets of Rosuvastatin Farmaprojects to children.

Taking the tablets

Swallow each tablet whole with water.

Take Rosuvastatin Farmaprojects once 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 cholesterol levels

It is important that you visit your doctor regularly to have your cholesterol levels checked, to ensure that your cholesterol levels have returned to normal and are being maintained at the right levels.

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

If you take more Rosuvastatin Farmaprojects 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, indicating 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 Farmaprojects.

If you forget to take Rosuvastatin Farmaprojects

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 Rosuvastatin Farmaprojects

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

If you have any other 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 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 Farmaprojects 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).

Stop using Rosuvastatina Farmaprojects and seek immediate medical attention if you notice any of the following symptoms:

• Red, non-elevated patches on the trunk, target-shaped or circular, 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).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Also, stop taking Rosuvastatina Farmaprojects 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, which have very rarely resulted in a potentially life-threatening muscle injury called rhabdomyolysis.

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

Rare Adverse Effects (may affect up to 1 in 1,000 people)

• Lupus-like syndrome (including rash, joint disorder, and effects on blood cells). If you experience these symptoms, stop taking Rosuvastatina Farmaprojects and consult your doctor immediately.
• 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 Farmaprojectsand seek immediate medical attention.
• Muscle injury in adults, muscle rupture – as a precaution, stop taking Rosuvastatina Farmaprojects and 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.

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, which 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 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://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rosuvastatina Farmaprojects

• No special storage conditions are required. Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiration date stated on the packaging/blister/label 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 unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Rosuvastatina Farmaprojects

The active ingredient of Rosuvastatina Farmaprojects is rosuvastatin. The film-coated tablets of Rosuvastatina Farmaprojects contain rosuvastatin calcium equivalent to 10 mg of rosuvastatin. The other ingredients of the tablets are lactose monohydrate, microcrystalline cellulose, sodium citrate, crospovidone type B, anhydrous colloidal silica, and magnesium stearate (core) and Opadry II 33G28523 white: hypromellose 2910 (6 cP), lactose monohydrate, macrogol 3350, triacetin, titanium dioxide (E-171) (coating).

Appearance of the Product and Package Contents

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

Rosuvastatina Farmaprojects 10 mg film-coated tablets are round, biconvex, white tablets with the engraving “10” on one side.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Farmaprojects S.A.U.

Carrer Provenca 392, 6th floor

08025 Barcelona

Manufacturer:

Pharmaceutical Works POLPHARMA SA

ul. Pelplinska 19, 83-200 Starogard Gdanski

Poland

Date of the Last Revision of this Prospectus: June 2023

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