Patient Information Leaflet: Product Information

Rosuvastatina Vivanta 20 mg Film-Coated Tablets

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isRosuvastatina Vivantaand what it is used for

2. What you need to know before takingRosuvastatina Vivanta

3. How to takeRosuvastatina Vivanta

4. Possible side effects

5. Storage ofRosuvastatina Vivanta

6. Contents of the pack and additional information

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

You have been prescribed Rosuvastatina because:

•You have high cholesterol levels. 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.

•Your doctor has indicated that you should take a statin because changes made to your diet and increased physical exercise have not been sufficient to correct your cholesterol levels. You must maintain a diet that helps to lower cholesterol and continue exercising while on treatment with Rosuvastatina.

Or

•You have other factors that increase your risk of suffering a heart attack, stroke, or other health problems.

A heart attack, stroke, and other related health problems may be caused by a disease called atherosclerosis. Atherosclerosis is caused by the formation of fatty deposits in your arteries.

Why it is important to continue taking Rosuvastatina

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

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

•Rosuvastatina reduces the amount of "bad" cholesterol and increases "good" cholesterol.

•It acts 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 since 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 vessels can become blocked, preventing blood supply to the heart or brain, causing a heart attack or stroke. By reducing your cholesterol levels, you can reduce your risk of having a heart attack, stroke, or related health problems.

You needto continue taking rosuvastatina, even if you have achieved the correct cholesterol levels, as itprevents cholesterol levels from increasing again and forming fatty deposits. However, you should stop treatment if your doctor advises you to or if you become pregnant.

Do not take Rosuvastatina

• If you are allergic (hypersensitive) to rosuvastatina or to any of the other components of this medication (listed in section 6).
• If you are pregnantor breastfeeding. If you become pregnant while taking rosuvastatinastop taking it immediately and inform your doctor.Women should 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 unjustified muscle pain and cramps.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir medications(used to treat a liver virus infection called hepatitis C).
• If you are taking a medication called ciclosporina(used, for example, after an organ transplant).

If you find yourself in any of the situations mentioned above (or are unsure), please return to see your doctor.

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

•If you have moderate kidney problems(if in doubt, consult your doctor).

•If your thyroid glanddoes not function correctly.

•If you have repeated or unjustified muscle pain and cramps, a personal or family history of muscle problems or a previous history of muscle problems during treatment with other cholesterol-lowering medications.

•If you regularly consume large amounts of alcohol.

•If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).

•If you are taking other medications called fibratesto lower cholesterol.

If you find yourself in any of the situations mentioned above (or are unsure),please return to see your doctor.

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 unjustified muscle pain and cramps,a personal or family history of muscle problems or a previous history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you have unjustified muscle pain or cramps, especially if you experience general discomfort or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness.

•Ifyou have ever developed a severe skin rash or skin peeling, blisters and/or mouth sores after taking rosuvastatina or other related medications.

•If you have or have had myasthenia (a disease that involves generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).

•If you regularly consume large amounts of alcohol.

•If your thyroid glanddoes not function correctly.

•If you are taking other medications called fibratesto lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medications previously.

•If you are taking medications to treat HIV (AIDS virus) or hepatitis C infection,such as ritonavir with lopinavir and/or atazanavir or simeprevir, seeOther medications and Rosuvastatina

•If you are taking or have taken within the last 7 days a medication called fusidic acid(a medication to treat bacterial infections), orally or by injection. The combination of fusidic acid and rosuvastatina can cause severe muscle problems (rhabdomyolysis).

•If you are over 70 years old(as your doctor must establish the appropriate starting dose of rosuvastatina for you).

•If you have severe respiratory failure,

•If you are of Asian origin, for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian. Your doctor must establish the appropriate starting dose of rosuvastatina for you.

If you find yourself in any of these situations mentioned above (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 rosuvastatina.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatina treatment. Stop using Rosuvastatina 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 test that measures elevated liver enzymes (transaminases) in the blood. For this reason, your doctor will usually perform blood tests (liver function test) before and after treatment with rosuvastatina

While taking this medication, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You may 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: Rosuvastatina should not be administered to children under 6 years of age.

•If the patient is under 18 years of age:Rosuvastatina 40 mg tablets should not be administered to children and adolescents under 18 years of age.

Other medications and Rosuvastatina

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

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

• ciclosporina (used after an organ transplant),
• warfarina, ticagrelor or clopidogrel (or any other anticoagulant, such as acenocoumarol),
• fibrates (such as gemfibrozilo, fenofibrato) or any other medication used to lower cholesterol (such as ezetimiba),
• medications for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic), fusidic acid (an antibiotic - please see below and in Warnings and precautions),
• oral contraceptives (the pill),
• regorafenib (used to treat cancer),
• darolutamida (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 uric acid levels in the blood),
• teriflunomida (used to treat multiple sclerosis),
• 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,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 medications may be modified by rosuvastatina or may change the effect of rosuvastatina.

If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking this medication. Your doctor will indicate when it is safe to start taking Rosuvastatina again. Taking Rosuvastatina with fusidic acid can rarely cause muscle weakness, sensitivity or pain (rhabdomyolysis). See more information about rhabdomyolysis in section4.

Pregnancy and breastfeeding

Do not take rosuvastatinaif you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatinastop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatina using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Rosuvastatina Vivanta contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

The complete list of components can be found inContainer contents and additional information.

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

Usual doses in adults

If you are taking rosuvastatin for high cholesterol levels:

Starting dose

Your rosuvastatin treatment should start witha dose of 5 mg or 10 mg, even if you have taken a higher dose of another statin previously. 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 factor that makes you more vulnerable to potential side effects.

Check with your doctor or pharmacist which is the best starting dose of rosuvastatin for you.

Your doctor may decide to start treatment with the lowest dose (5 mg):

•If you are ofAsian 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 have a risk of developing muscle pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is 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 a four-week interval between each dose adjustment.

The maximum daily dose of rosuvastatin is 40 mg. This dose is only for patients with high cholesterol levels 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, a 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 earlier.

Use in children and adolescents aged 6-17 years

The dose range in children and adolescents aged 6 to 17years is 5mg to 20mg once a day. The usual starting dose for treatment is 5mg per day and your doctor may increase your dose gradually to reach the right dose of rosuvastatin for you. The maximum recommended daily dose of rosuvastatin is 10mg or 20mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take your dose once a day.Do notadminister rosuvastatin40 mgtablets to children.

Tablet intake

Swallow each tablet whole with water.

Take rosuvastatin once a day.You can take it at any time of the day with or without food.

Try to take the tablets at the same time every day. This will help you remember to take them.

Regular cholesterol level checks

It is essential that you attend your doctor regularly for cholesterol level checks, in order to check that your cholesterol levels have normalized and are maintained at appropriate 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 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 medication and the amount ingested.

If you enter a hospital or receive treatment for another illness, inform the healthcare staff that you are taking Rosuvastatina.

If you forget to take Rosuvastatin

Do not worry, simply take the next scheduled dose at the scheduled time. Do not take a double dose to compensate for a missed dose.

If you interrupt treatment with Rosuvastatin

Consult your doctor if you want to stop taking rosuvastatin. Your cholesterol levels may increase again if you stop taking rosuvastatin.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

It is important that you know which side effects may occur. They are usually mild and disappear within a short period of time.

Stop taking rosuvastatin and seek medical attention immediatelyif 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 may cause difficulty swallowing.
• Intense itching of the skin (with rashes).
• Reddish patches on the trunk, often with blisters, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and symptoms similar to the flu (Stevens-Johnson syndrome).
• Generalized 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 unexplained muscle pain and crampsthat last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. Like other statins, a very small number of people have experienced unpleasant muscle side effects, which, very rarely, have resulted in a potentially fatal muscle injury calledrabdomyolysis.

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

Frequent side effects(may affectbetween 1 in 10 and 1 in 100 patients):

•Headache, stomach pain, constipation, nausea, muscle pain, weakness, dizziness.

•Increased protein levels in urine – this usually returns to normal on its own without the need to stop treatment with rosuvastatin tablets (frequent side effect only with the daily dose of 40 mg of rosuvastatin).

•Diabetes. This is more likely if you have high blood sugar and lipid levels, obesity, and high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Less frequent side effects (may affectbetween 1 in 100 and 1 in 1,000 patients):

•Urticaria, itching, and other skin reactions.

•Increased protein levels in urine – this usually returns to normal on its own without the need to stop treatment with rosuvastatin tablets (only for rosuvastatin 5 mg, 10 mg, and 20 mg).

Rare side 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 rashes). If you think you are having an allergic reaction, stop taking rosuvastatinand seek medical attention immediately.
• Muscle injury in adults – as a precaution,stop taking rosuvastatin and consult your doctor immediately if you experience unexplained muscle pain and crampsthat last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes (transaminases) in blood.
• Bleeding or bruising more easily than normal due to low platelet count in the blood.
• Syndrome with symptoms similar to lupus (including urticaria, joint disorders, and effects on blood cells).

Very rare side effects (may affectless than 1 in 10,000 patients):

• Jaundice (yellowing of the skin and eyes), hepatitis (inflamed liver), blood in urine, nerve damage in the legs and arms (with numbness or tingling), joint pain, memory loss, and breast enlargement in men (gynecomastia).

Side 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.
• Myasthenia gravis (a disease that causes generalized muscle weakness, which, in some cases, affects the muscles used for breathing).
• Myasthenia ocular (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 eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://wwwnotificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging, bottle, and blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rosuvastatina Vivanta

The active ingredient of Rosuvastatina Vivanta is rosuvastatin. The film-coated tablets of Rosuvastatina Vivanta contain rosuvastatin calcium equivalent to 20 mg of rosuvastatin.

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

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

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

Appearance of the product and contents of the package

Film-coated, biconvex, round, white or off-white, 9 mm in diameter and 5 mm in thickness (approximately), engraved with "R20" on one side and smooth on the other side.

Rosuvastatina Vivanta is presented in carton packs with Al/Al blisters or in HDPE bottles with child-resistant closures and induction-sealed, including a silica gel desiccant bag of 1 g.

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 responsible manufacturer

Marketing authorization holder:

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9

Czech Republic

Responsible manufacturer:

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA3000

Malta

For more information about this medication, please contact the local representative of the marketing authorization holder:

Local Representative:

Mabo-Farma S.A.

Calle Rejas 2, planta 1

28821 Coslada, Madrid

Spain

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

NetherlandsRosuvastatine Vivanta 20 mg filmomhulde tabletten

GermanyRosuvastatin Vivanta 20 mg Filmtabletten

SpainRosuvastatina Vivanta 20 mg comprimidos recubiertos con película EFG

Last review date of this leaflet: June 2024

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/