Package Insert: Information for the Patient

Vaxar 5 mg Film-Coated Tablets

Vaxar 10 mg Film-Coated Tablets

Vaxar 20 mg Film-Coated Tablets

Vaxar 40 mg Film-Coated Tablets

rosuvastatina calcium

Read this package insert carefully before starting to take this medication, as it contains important information for you.

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

Contents of the package and additional information

This medication contains the active ingredient rosuvastatin and belongs to a group of medications called statins.

You have been prescribed Vaxar because:

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

A heart attack, stroke, and other 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 Vaxar

Rosuvastatin 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).

High cholesterol levels in most people 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 other health problems.

You need to continue taking rosuvastatin, even if you have achieved the correct cholesterol levels, as it prevents 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 Vaxar

• If you are allergic to rosuvastatinor to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnantor breastfeeding. If you become pregnant while taking rosuvastatinstop 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 unjustified muscle pain and cramps.
• 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 find yourself in any of the above situations (or are unsure), please consult your doctor.

Also, do not take Vaxar 40 mg (the highest dose):

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take rosuvastatin:

• 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 medicines. Inform your doctor immediately if you have unjustified 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 have or have had myasthenia (a disease that is characterized by 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 may sometimes worsen the disease or cause myasthenia (see section 4).
• If you have ever developed a severe skin rash or skin peeling, blisters and/or mouth sores after taking rosuvastatin or other related medicines.
• If you regularly consume large amounts of alcohol.
• If your thyroid glanddoes not function correctly.
• If you are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medicines previously.
• If you are taking medicines to treat HIV (AIDS virus) infection,or hepatitis C infection, such as ritonavir with lopinavir and/or atazanavir or simeprevir, see “Other medicines and Vaxar”.
• If you are taking or have taken in the last 7 days a medicine called fusidic acid(a medicine to treat bacterial infections), by mouth or by injection. The combination of fusidic acid and rosuvastatin may cause severe muscle problems (rhabdomyolysis).
• If you are over 70 years old(as your doctor must establish the starting dose of rosuvastatin suitable 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 starting dose of rosuvastatin suitable 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 rosuvastatin.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) associated with rosuvastatin treatment have been reported. Stop using rosuvastatin 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 detects increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally perform blood tests (liver function test) before and after treatment with rosuvastatina

While taking this medicine, 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

Other medicines and Vaxar

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

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

• ciclosporina (used after an organ transplant),
• anticoagulants, p. ej. warfarina, acenocumarol or fluindiona (its anticoagulant effect and the risk of bleeding may increase if taken with this medicine), ticagrelor or clopidogrel,fibrates (such as gemfibrozilo, fenofibrato) or any other medicine used to lower cholesterol (such as ezetimiba),
• medicines 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 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 modified by rosuvastatin or may change the effect of rosuvastatin.

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

Vaxar with food

You can take this medicine with or without food.

Pregnancy and breastfeeding

Do not take rosuvastatinif you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatinstop 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 vehicles and use machines during treatment with rosuvastatin as it will not affect your 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.

Vaxar contains lactose

If your doctor has told you that you have intolerance to certain sugars, consult with him before taking this medicine.

Vaxar 5 mg contains quinoline yellow

May cause allergic reactions.

Vaxar 10 mg contains red iron oxide

May cause allergic reactions.

Vaxar 40 mg contains Sunset Yellow S and Ponceau 4R

This medicine may cause allergic reactions because it contains “Sunset Yellow S (E110)”. May cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicine may cause allergic reactions because it contains “Ponceau 4R (E124)”. May cause asthma, especially in patients allergic to acetylsalicylic acid.

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 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 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 possible 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 lower 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 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 17 years is 5 mg to 20 mg once a day. The usual starting dose for treatment is 5 mg per day and your doctor may increase your dose gradually to reach the right dose of rosuvastatin for you. The recommended maximum 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 a day.Do not administer rosuvastatin 40 mg tablets to children.

Swallowing the tablets

Swallow each tablet whole with water.

Take this medication 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 checks

It is essential that you attend your doctor regularly for cholesterol 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, phone 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 rosuvastatin.

If you forget to take rosuvastatin

Do not worry, simply take the next scheduled dose at the planned 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 doubts 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 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 may cause difficulty swallowing.
• Intense skin itching (with rashes).
• Reddish patches on the trunk, in the shape of a bull's-eye or circles, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and flu-like symptoms (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 cramps that 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 effects, which, very rarely, have resulted in a potentially fatal muscle injury called rhabdomyolysis.
• If you experience muscle rupture.
• If you have lupus or a similar disease(including skin rash, joint disorders, and effects on blood cells).

Frequent side 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 urine – this usually returns to normal on its own without the need to stop treatment with rosuvastatin tablets (frequent side effect only with a daily dose of 40 mg of rosuvastatin).
• Diabetes. This is more likely if you have high blood sugar and lipid levels, being overweight, and high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Rare side effects (may affect up to 1 in 100 people)

Very rare side effects (may affect up to 1 in 1,000 people)

Very rare side effects (may affect up to 1 in 10,000 people)

• Ictericia (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
• enlargement of the breasts in men (gynecomastia).

Side effects of unknown frequency (frequency cannot be estimated from available data):

• Diarrhea (loose stools),
• cough,
• shortness of breath,

• 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, 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.

This medication does not require special storage conditions.

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

Do not use this medication if you notice any visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Vaxar Composition

The active ingredient is rosuvastatina.

Each film-coated tablet contains 5 mg of rosuvastatina (as rosuvastatina calcium).

Each film-coated tablet contains 10 mg of rosuvastatina (as rosuvastatina calcium).

Each film-coated tablet contains 20 mg of rosuvastatina (as rosuvastatina calcium).

Each film-coated tablet contains 40 mg of rosuvastatina (as rosuvastatina calcium).

The other excipients are: Microcrystalline cellulose type 102 (E460),lactose, crospovidone type A, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), quinoline yellow (E104) (only for 5 mg tablets), allura red (E129) (only for 10 mg tablets), carmine acid (E120) (only for 20 mg tablets), yellow orange S (E110) (only for 40 mg tablets), ponceau 4R (E124) (only for 40 mg tablets).

Appearance of the product and contents of the package

Vaxar 5 mg are film-coated tablets. The tablets are round, biconvex, yellow, with the inscription "5" on one side.

Vaxar 10 mg are film-coated tablets. The tablets are round, biconvex, pale pink, with the inscription "10" on one side.

Vaxar 20 mg are film-coated tablets. The tablets are round, biconvex, dark pink, with the inscription "20" on one side.

Vaxar 40 mg are film-coated tablets. The tablets are round, biconvex, red, with the inscription "40" on one side.

Vaxar 5 mg tablets are presented in blisters in packages of 28, 56, and 98 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

C/ de las Rosas de Aravaca, 31 - 2nd floor

28023 Aravaca - Madrid

Spain

Responsible for manufacturing

Adamed Pharma, S.A.

ul. Marszalka Jozefa Pilsudskiego 5

95-200 - Pabianice

Poland

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

Last review date of this leaflet: November 2024

More detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.