Vaxar 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Vaxar 5 mg film-coated tablets EFG

Vaxar 10 mg film-coated tablets EFG

Vaxar 20 mg film-coated tablets EFG

Vaxar 40 mg film-coated tablets EFG

rosuvastatin calcium

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Vaxar is and what it is used for
2. What you need to know before taking Vaxar
3. How to take Vaxar
4. Possible side effects
5. How to store Vaxar

Contents of the pack and other information

1. What Vaxar is and what it is used for

This medicine contains the active substance rosuvastatin and belongs to a group of medicines known as statins.

Your doctor has prescribed Vaxar 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 and older to treat high cholesterol.

• You have been advised to take a statin because changes in your diet and increased physical activity have not been sufficient to correct your cholesterol levels. You must maintain a cholesterol-lowering diet and continue exercising while being treated with rosuvastatin.

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

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

Why it is important that you continue taking Vaxar

Rosuvastatin is used to correct 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 reduces the amount of "bad" cholesterol and increases "good" cholesterol.
• It works by blocking the production of "bad" cholesterol and improves the body's ability to remove it from the blood.

In most people, high cholesterol levels do not affect how you feel, as they produce no symptoms. However, if left untreated, fatty deposits can build up 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, 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 keep taking rosuvastatin, even after your cholesterol levels have reached the desired level, because it prevents cholesterol levels from rising again and causing the formation of fatty deposits. However, you should stop treatment if your doctor instructs you to do so, or if you become pregnant.

2. What you need to know before taking Vaxar

Do not take Vaxar

• If you are allergic to rosuvastatin or any of the other ingredients of this medicine (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 by using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pain and cramps.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used for the viral liver infection called hepatitis C).
• If you are taking a medicine called cyclosporine (used, for example, after organ transplantation).

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

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

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland is not functioning properly.
• If you have repeated or unexplained muscle pain and cramps, a personal or family history of muscle disorders, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines.
• If you regularly consume large amounts of alcohol.
• If you are of Asian origin (e.g., 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 situations mentioned above (or are unsure), please consult your doctor again.

Warnings and precautions

Talk to your doctor or pharmacist before starting rosuvastatin:

• If you have kidney problems.
• If you have liver problems.
• If you have repeated or unexplained muscle pain and cramps, a personal or family history of muscle disorders, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if accompanied by general malaise or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness.
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking rosuvastatin or related medicines.
• If you regularly consume large amounts of alcohol.
• If your thyroid gland is not functioning properly.
• If you are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medicines before.
• If you are taking medicines for HIV infection (AIDS virus) 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 within the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections), either orally or by injection. The combination of fusidic acid and rosuvastatin may cause serious muscle problems (rhabdomyolysis).
• If you are over 70 years old (as your doctor must determine the appropriate starting dose of rosuvastatin for you).
• If you have severe respiratory insufficiency.
• If you are of Asian origin, e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor must determine the appropriate starting dose of rosuvastatin for you.

If you are in any of the situations mentioned above (or are unsure):

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

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 immediate medical attention if you notice any of the symptoms described in section 4.

In a small number of people, statins may affect the liver. This is detected by a simple blood test showing increased levels of liver enzymes (transaminases). For this reason, your doctor will usually perform blood tests (liver function tests) before and during treatment with rosuvastatin.

While taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely 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 must not be given to children under 6 years of age.
• If the patient is under 18 years of age: Rosuvastatin 40 mg tablets must not be given to children and adolescents under 18 years of age.

Other medicines and Vaxar

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

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

• cyclosporine (used after organ transplantation),
• anticoagulants, e.g., warfarin, acenocoumarol, or phenindione (their anticoagulant effect and risk of bleeding may increase when taken with this medicine), ticagrelor or clopidogrel, fibrates (such as gemfibrozil, fenofibrate), or any other medicine used to lower cholesterol (such as ezetimibe),
• treatments 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),
• 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 change the effect of rosuvastatin.

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart rosuvastatin. Taking rosuvastatin with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Vaxar with food

You may take this medicine with or without food.

Pregnancy and breastfeeding

Do not take rosuvastatin 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 by using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Most patients can drive and operate machinery while being treated with rosuvastatin, as it will not affect their ability. However, some people may experience dizziness 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 informed you that you have an 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 Allura red

May cause allergic reactions.

Vaxar 40 mg contains Sunset Yellow FCF and Ponceau 4R

This medicine may cause allergic reactions because it contains "Sunset Yellow FCF (E110)". It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

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

3. How to take Vaxar

Follow exactly the instructions for using this medicine as given 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 begin with a dose of 5 mg or 10 mg, even if you have previously taken a higher dose of another statin. The choice of starting dose will depend on:

• Your cholesterol levels.
• Your risk level of having a heart attack or stroke.
• Whether you have any factors that make you more susceptible to possible side effects.

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

Your doctor may decide to start treatment with the lowest 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 muscle pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is to ensure you are taking the appropriate dose of rosuvastatin for your condition. If you started with a 5 mg dose, 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 10 mg dose, 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 heart attack or stroke whose cholesterol levels do not decrease sufficiently with 20 mg.

If you are taking rosuvastatin to reduce the risk of heart attack, stroke, or related health problems:

The recommended dose is 20 mg 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 for children and adolescents aged 6 to 17 years is 5 mg to 20 mg once daily. The usual starting dose is 5 mg daily, and your doctor may gradually increase the dose until reaching the appropriate rosuvastatin dose 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 condition being treated. Take your dose once daily. Rosuvastatin 40 mg tablets must not be administered to children.

How to take the tablets

Swallow each tablet whole with water.

Take this medicine once daily. You may 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 monitoring

It is important to visit your doctor regularly for cholesterol checks to ensure your cholesterol levels have normalized and remain at appropriate levels.

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

If you take more Vaxar than you should

Contact your doctor or nearest hospital for advice.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to take Vaxar

Do not worry; simply take the next scheduled dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Vaxar

Consult your doctor if you wish to stop treatment with rosuvastatin. Your cholesterol levels may rise again if you stop taking rosuvastatin.

If you have any further 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 everyone experiences them.

It is important that you are aware of what these adverse effects may be. They are usually mild and disappear within a short period of time.

Stop taking rosuvastatin and seek immediate medical attention if 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 itching of the skin (with hives).
• Reddish, flat, non-elevated spots on the trunk, circular or target-shaped, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome 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 frequent in children and adolescents than in adults. As with 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 develop lupus or a lupus-like illness (including skin rash, joint disorders, and effects on blood cells).

Frequent adverse effects (may affect up to 1 in 10 people)

• Headache,
• stomach pain,
• constipation,
• nausea,
• muscle pain,
• weakness,
• dizziness.
• 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 adverse effect only with the daily 40 mg dose of rosuvastatin).
• Diabetes. This is more likely if you have high levels of blood sugar and lipids, are overweight, and have high blood pressure. Your doctor will monitor you closely while you are taking this medicine.

Uncommon adverse effects (may affect up to 1 in 100 people)

• Hives, itching, and other skin reactions.
• 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 (only for rosuvastatin 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 rosuvastatin and seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking rosuvastatin and consult your doctor immediately if you have unexplained muscle pain or cramps that last longer than expected.
• Severe stomach pain (possible sign of pancreas inflammation).
• Increase in liver enzymes (transaminases) in blood.
• Bleeding or bruising more easily than normal due to low platelet count in the blood.
• Lupus or lupus-like illness (including skin 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),
• traces of blood in the urine,
• nerve damage in arms and legs (with numbness or tingling),
• joint pain,
• memory loss,
• enlargement of the breasts in men (gynecomastia).

Adverse effects with 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 injury, and persistent muscle weakness.
• myasthenia gravis (a condition causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).
• ocular myasthenia (a condition causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://wwwnotificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vaxar

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vaxar

The active substance is rosuvastatin.

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

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

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

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

The other excipients are: microcrystalline cellulose type 102 (E460), lactose, crospovidone type A, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171), glyceryl triacetate (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), orange yellow S (E110) (only for 40 mg tablets), ponceau 4R (E124) (only for 40 mg tablets).

Appearance of the product and contents of the pack

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

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

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

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

Vaxar 5 mg tablets are available in blister packs in pack sizes of 28, 56 and 98 tablets.

Only certain pack 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

Manufacturer

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 under the following names:

Member State	Name of the medicinal product
Germany	Zahron
Italy	Rosuvastatina Adamed
Spain	Vaxar 5 mg film-coated tablets EFG Vaxar 10 mg film-coated tablets EFG Vaxar 20 mg film-coated tablets EFG Vaxar 40 mg film-coated tablets EFG

Date of the last revision of this leaflet: November 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.