ROSUVASTATIN VEGAL 5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet: Information for the Patient

Rosuvastatin Vegal 5 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What is Rosuvastatin Vegal and what is it used for
2. What you need to know before taking Rosuvastatin Vegal
3. How to take Rosuvastatin Vegal
4. Possible side effects
5. Storage of Rosuvastatin Vegal
6. Package contents and additional information

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

Rosuvastatin Vegal contains the active ingredient rosuvastatin, which belongs to a group of medications called statins.

You have been prescribed Rosuvastatin Vegal 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 aged 6 years or older to treat high cholesterol.

• You have been advised to take a statin because changes to your diet and increased physical exercise have not been sufficient to correct your cholesterol levels. You should maintain a diet that helps lower cholesterol and continue to exercise while taking Rosuvastatin Vegal.

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 formation of fatty deposits in your arteries.

Why it is essential to continue taking Rosuvastatin Vegal

Rosuvastatin Vegal 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, "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Rosuvastatin Vegal 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 cholesterol levels do not affect how they feel, as they do not produce any symptoms. However, if left untreated, fatty deposits can form 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, 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 continue taking rosuvastatin, even if your cholesterol levels have returned to normal, as it prevents your cholesterol levels from rising again and causing the formation of fatty deposits. However, you should stop treatment if your doctor advises you to or if you become pregnant.

2. What you need to know before taking Rosuvastatin Vegal

Do not take Rosuvastatin Vegal

• If you are allergic (hypersensitive) to rosuvastatin or any of the other ingredients of this medication (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 should avoid becoming pregnant during treatment with Rosuvastatin Vegal using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pain or cramps.
• If you are taking a medication called ciclosporin (used, for example, after an organ transplant).
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or ulcers in the mouth after taking rosuvastatin or other statins

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

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

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland is not functioning correctly.
• If you have repeated or unexplained muscle pain or cramps, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medications.
• If you regularly drink large amounts of alcohol.
• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medications 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 Rosuvastatin Vegal

• If you have kidney problems.
• If you have liver problems.
• If you have repeated or unexplained muscle pain or cramps, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you have unexplained muscle pain or cramps, especially if you have general discomfort or fever. Also, inform your doctor or pharmacist if you have constant muscle weakness.
• If you regularly drink large amounts of alcohol.
• If your thyroid gland is not functioning correctly.
• If you are taking other medications called fibrates to lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medications before.
• If you are taking medications to treat HIV (AIDS) or hepatitis C infection, such as ritonavir with lopinavir and/or atazanavir or simeprevir, see Other medications and Rosuvastatin Vegal
• If you are taking or have taken in the last 7 days a medication called fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection. The combination of fusidic acid and rosuvastatin can cause serious muscle problems (rhabdomyolysis).
• If you are over 70 years old (as your doctor will determine the appropriate starting dose of rosuvastatin for you).
• If you have severe respiratory failure,
• If you are of Asian origin, e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor will determine the appropriate starting dose of rosuvastatin for you.

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.

If you are in any of the above situations (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 rosuvastatin.

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 perform blood tests (liver function tests) before and after treatment with rosuvastatin.

While taking this medication, 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 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.
• If the patient is under 18 years of age: Rosuvastatin 40 mg tablets should not be administered to children and adolescents under 18 years of age.

Other medications and Rosuvastatin Vegal

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

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

• 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 medication), ticagrelor, or clopidogrel.

• Warfarin or clopidogrel (or any other anticoagulant medication, such as acenocoumarol)
• Fibrates (such as gemfibrozil, fenofibrate) or any other medication used to lower cholesterol (such as ezetimibe)
• Medications for indigestion (used to neutralize stomach acid)
• Erythromycin (an antibiotic)
• Fusidic acid (an antibiotic - see also Warnings and precautions and section 4)
• Oral contraceptives (the pill)
• Hormone replacement therapy
• Regorafenib (used to treat cancer)
• Any of the following medications 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 medications may be altered by rosuvastatin or may change the effect of rosuvastatin.

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medication. Your doctor will tell you when it is safe to restart Rosuvastatin Vegal. Taking Rosuvastatin Vegal with fusidic acid can rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medication.

Driving and using 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.

Rosuvastatin Vegal contains lactose

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

3. How to take Rosuvastatin Vegal

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

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 degree of risk you have of having a heart attack or stroke.
• If you have any factors that make you more vulnerable to 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 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 having muscle pain or cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you are taking the appropriate 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 then to 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 only for patients with high cholesterol and a high risk of having a heart attack or stroke, whose cholesterol levels do not decrease sufficiently 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 per day. 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 per day, and your doctor may gradually increase the dose until the appropriate dose of rosuvastatin for you is reached. The maximum recommended daily dose of rosuvastatin is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. Take your dose once a day. Do notadminister rosuvastatin 40 mgtablets to children.

Taking the tablets

Swallow each tablet whole with water.

Take rosuvastatin once a day.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 cholesterol level checks

It is essential to visit your doctor regularly for cholesterol checks to ensure that your cholesterol levels have returned to normal and remain at appropriate levels.

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

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

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

If you forget to take Rosuvastatin Vegal

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

If you stop taking Rosuvastatin Vegal

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 about the use of this medication, 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).

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 experience a lupus-like syndrome(including rash, joint disorders, and effects on blood cells).
• If you experience red, non-raised spots 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 rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• If you experience a generalized rash, high body temperature, and enlarged lymph nodes(DRESS or drug hypersensitivity syndrome).

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 sugar and lipid levels in your blood, 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 (only for rosuvastatina 5 mg, 10 mg, and 20 mg).

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.
  • Lupus-like syndrome (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 (frequency cannot be estimated from available data):

• 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.

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 Vegal

This medicine does not require special storage conditions.

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

Do not use this medicine after the expiration date shown on the box and blister packs after EXP. The expiration date is the last day of the month indicated.

Medicines should not be thrown away 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

Rosuvastatina Vegal Composition

The active ingredient is rosuvastatina. The rosuvastatina film-coated tablets contain rosuvastatina calcium equivalent to 40 mg of rosuvastatina. The other ingredients are: tablet core: lactose monohydrate, microcrystalline cellulose (E460), sodium bicarbonate powder (E500), crospovidone (E1202), magnesium stearate (E572), tablet coating: hypromellose (E464), lactose monohydrate, triacetin (E1518), titanium dioxide (E171), red iron oxide (E172).

Product Appearance and Package Contents

Rosuvastatina tablets are presented in blister packs containing 10, 28, 30, 56, and 84 tablets (some pack sizes may not be marketed).

Rosuvastatina Vegal 40 mg are film-coated tablets, pink, oval, 11.50 mm x 6.90 mm, biconvex, with the mark 'R40' on one side.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Vegal Farmacéutica, S.L.

Vía de las Dos Castillas 9C, portal 2, 2ºC

28224 Pozuelo de Alarcón – Madrid

Spain

Manufacturer responsible for batch release

Misom Labs Limited

Malta Life Sciences Park, LS2.01.06. Industrial Estate,

San Gwann, SGN 3000, Malta

Date of the last revision of this prospectus: August 2021

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/)