ROSUVASTATIN VIVANTA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Rosuvastatin Vivanta 10 mg film-coated tablets EFG

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 symptoms 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 package leaflet. See section 4.

Contents of the package leaflet:

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

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

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

You have been prescribed Rosuvastatin because:

• You have high levels of cholesterol. 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 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 Rosuvastatin.

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 buildup of fatty deposits in your arteries.

Why it is important to keep taking Rosuvastatin

Rosuvastatin 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 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, as they do not cause 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 your risk of having a heart attack, stroke, or related health problems.

You need to keep taking rosuvastatin, even if you have already achieved the correct cholesterol levels, as 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 Rosuvastatin Vivanta

Do not take Rosuvastatin

• If you are allergic (hypersensitive) to rosuvastatin 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 rosuvastatin, stop 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 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.

In addition, do not take Rosuvastatin 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 previous 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 taking Rosuvastatin

• 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 previous 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 rosuvastatin 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, or pibrentasvir (see Other medicines and Rosuvastatin).
• If you are taking a medicine called fusidic acid (an antibiotic) by mouth or by injection. The combination of fusidic acid and rosuvastatin can rarely cause muscle weakness, tenderness, or pain (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 rosuvastatin 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 for you.

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

• Do not take the highest dose of 40 mg and consult your doctor or pharmacist before taking any dose of rosuvastatin.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in patients taking rosuvastatin. Stop taking Rosuvastatin Vivanta 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 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.

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 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 given to children under 6 years of age.
• If the patient is under 18 years of age: The 40 mg tablets of rosuvastatin should not be given to children and adolescents under 18 years of age.

Other medicines and Rosuvastatin

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 Warnings and precautions and section 4),
• 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, 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 altered by rosuvastatin or may alter the effect of rosuvastatin.

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 again. Taking Rosuvastatin 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 rosuvastatinif you are pregnant or breast-feeding. If you become pregnant while taking rosuvastatin, stop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatin 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, as it will not affect their ability. However, some people may feel dizzy while taking rosuvastatin. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatin 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 further information.

3. How to take Rosuvastatin 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 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 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 rosuvastatin is for you.

Your doctor may decide to start treatment with the lowest 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 pain or weakness (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that 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 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 enough 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 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 the dose to the dose of rosuvastatin that is right 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 daily. Do notgive the 40 mg tablets of rosuvastatin to children.

Taking the tablets

Swallow each tablet whole with water.

Take rosuvastatin 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 see your doctor regularly for cholesterol checks to ensure that your cholesterol levels have returned to normal and remain at the right 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 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 Rosuvastatin.

If you forget to take Rosuvastatin

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

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 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 rosuvastatin 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.
• Severe skin itching (with hives).
• Reddish patches on the torso, not raised, 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 rosuvastatin 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 fatal muscle injury called rhabdomyolysis.

• If you experience muscle rupture.
• If you present with a syndrome that has similar symptoms to lupus(including hives, joint disorders, and effects on blood cells).

Frequent 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 rosuvastatin tablets (frequent adverse effect only with the daily dose of 40 mg of rosuvastatin).
• Diabetes. This is more likely if you have high sugar and lipid levels in the 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 rosuvastatin tablets (only for rosuvastatin 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, severe skin itching (with hives). If you think you are having an allergic reaction, stop taking rosuvastatinand seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking rosuvastatin 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 similar symptoms 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), 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 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 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 the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of 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 rosuvastatin. The film-coated tablets of Rosuvastatina Vivanta contain rosuvastatin calcium equivalent to 10 mg of rosuvastatin.

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

Film-coated tablet,biconvex, round,white or off-white in color,7 mm in diameter and 4 mm in thickness (approximately), engraved with "R10" on one side and smooth on the other side.

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

Package sizes:

Al/Al blister packs: 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 10 mg film-coated tablets

Germany Rosuvastatin Vivanta 10 mg film-coated tablets

Spain Rosuvastatina Vivanta 10 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/