ROSUVASTATIN VIVANTA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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

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

Rosuvastatina Vivanta contains the active substance rosuvastatin, which belongs to a group of medicines called statins.

You have been prescribed Rosuvastatina because:

• You have high levels of cholesterol. This means you are at risk of having a heart attack or stroke. Rosuvastatina 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 lower cholesterol and continue to exercise while taking Rosuvastatina.

Or

• 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.

Why it is important to keep taking Rosuvastatina

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 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 levels do not affect how they feel because 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, 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 rosuvastatina, even if you have already achieved the correct cholesterol levels, because it prevents cholesterol levels from rising again and 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 Vivanta

Do not take Rosuvastatina

• If you are allergic (hypersensitive) to rosuvastatina 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 rosuvastatina, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with Rosuvastatina 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 weakness.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir(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 are in any of the above situations (or are unsure), please consult your doctor again.

Also, do not take Rosuvastatina 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 pain or weakness, 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

• 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 history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you have unexplained muscle pain or weakness, especially if you feel unwell or have a fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness.
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking rosuvastatina or other related medicines.
• 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 myasthenic syndrome (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• If you regularly drink large amounts of alcohol.
• If your thyroid gland does not work correctly.
• If you are taking other medicines called fibrates to lower cholesterol.
• If you are taking medicines to treat HIV infection or hepatitis C, such as ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• If you are taking a medicine called roxadustat (used to treat anemia in patients with chronic kidney disease).
• If you are taking a medicine called tafamidis (used to treat a disease called transthyretin amyloidosis).

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

Children and adolescents

• If the patient is under 6 years of age: Rosuvastatina 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 rosuvastatina should not be given to children and adolescents under 18 years of age.

Other medicines and Rosuvastatina

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 medicine, 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"),
• 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 also section "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medicines may be altered by rosuvastatina or may alter the effect of rosuvastatina.

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. 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 breast-feeding

Do not take rosuvastatinaif you are pregnant or breast-feeding. 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.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Most patients can drive and use machines while taking rosuvastatina as 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 Vivanta 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.

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

3. How to take Rosuvastatina Vivanta

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

Usual dose in adults

If you are taking rosuvastatina for 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 any 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 you on 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 having muscle pain or weakness (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is so you are taking the dose of rosuvastatina 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 4-week interval 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 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 rosuvastatina to children.

Taking the tablets

Swallow each tablet whole with water.

Take rosuvastatina once daily. You can take it at any time of 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 regularly visit your doctor to have your cholesterol levels checked, 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 dose of rosuvastatina that is right for you.

If you take more Rosuvastatina 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

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

If you stop taking Rosuvastatina

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 taking rosuvastatina and seek immediate medical attentionif you experience any of the following symptoms:

• 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).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Also, stop taking rosuvastatina and consult your doctor immediately

• 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 affectbetween 1 in 10 and 1 in 100 patients):

• 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 affectbetween 1 in 100 and 1 in 1,000 patients):

• 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 affectbetween 1 in 1,000 and 1 in 10,000 patients):

• 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 rosuvastatinaand 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 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 usual due to a low platelet count in the blood.
• Syndrome that has symptoms similar to lupus (including hives, joint disorders, and effects on blood cells).

Very Rare Adverse Effects (may affectless than 1 in 10,000 patients):

• 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 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 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 Medicines Monitoring System for Human Use: https://wwwnotificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Rosuvastatina Vivanta

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, bottle, and blister pack after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

.

Medicines should not be thrown away through drains 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

Composition of Rosuvastatina Vivanta

The active ingredient of Rosuvastatina Vivanta is rosuvastatina. The film-coated tablets of Rosuvastatina Vivanta contain rosuvastatina calcium equivalent to 5 mg of rosuvastatina.

The other components are: microcrystalline cellulose (E460), crospovidone (Type B),

pregelatinized corn starch, meglumine, mannitol (E421), magnesium stearate (E572).

The tablets are coated with OPADRY II 32K580000 White which contains: HPMC 2910/hypromellose, lactose, titanium dioxide (E171), triacetin.

Appearance of the Product and Package Contents

Coated tablet, biconvex, round,white or off-white in color, 7 mm in diameter and 4 mm in thickness (approximately), engraved with "R5" on one side and smooth on the other side.

Rosuvastatina Vivanta is presented in cardboard boxes with Al/Al blisters or in HDPE bottles with child-resistant closure and induction seal, including a 1g silica gel desiccant bag.

Package sizes:

Al/Al blisters: 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98, and 100 tablets

HDPE bottles: 90 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9

Czech Republic

Manufacturer:

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA3000

Malta

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Local Representative:

Mabo-Farma S.A.

Calle Vía de los Poblados 3, Edificio 6

28033 Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Netherlands Rosuvastatine Vivanta 5 mg film-coated tablets

Germany Rosuvastatin Vivanta 5 mg film-coated tablets

Spain Rosuvastatina Vivanta 5 mg film-coated tablets EFG

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/