Prospecto:Information for the Patient

Vaxar Plus 15mg/10mg Tablets

Vaxar Plus 30mg/10mg Tablets

Vaxar Plus 40mg/10mg Tablets

rosuvastatina and ezetimiba

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• 1. If you have any doubts, consult yourdoctor or pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this prospectus. See section 4.

1.What is Vaxar Plus and what is it used for

2.What you need to knowbeforestarting totake Vaxar Plus

3.How to take Vaxar Plus

4.Possible adverse effects

5Storage of Vaxar Plus

6.Contents of the package and additional information

Rosuvastatina/ezetimiba contains two different active principles in one tablet. One of the active principles is rosuvastatina, which belongs to the group of medications called statins, the other active principle is ezetimiba.

Vaxar Plus tablets are a medication used to reduce total cholesterol levels, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally, it increases the concentrations of "good" cholesterol (HDL cholesterol). This medication acts by reducing cholesterol in two ways: reducing the cholesterol absorbed in the digestive tract, as well as the cholesterol produced by the body itself.

For 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 accumulate in the walls of blood vessels and narrow them.

At times, these narrowed blood vessels can become blocked, cutting off blood supply to the heart or brain, which would cause a heart attack or stroke. By reducing cholesterol levels, the risk of having a heart attack, stroke, or other related health problems can be reduced.

Rosuvastatina/ezetimiba is used in patients who cannot control their cholesterol levels solely with diet. While taking this medication, a cholesterol-reducing diet should be followed.

Your doctor may prescribe Vaxar Plus if you are already taking rosuvastatina and ezetimiba at the same dosage level.

Rosuvastatina/ezetimiba is used if you have:

• High cholesterol levels in the blood (primary hypercholesterolemia)
• Cardiac disease, Rosuvastatina/Ezetimiba reduces the risk of myocardial infarction, stroke, coronary artery bypass surgery, or hospitalization for chest pain

This medication does not help with weight loss.

Do not take Vaxar Plus if:

• You are allergic to rosuvastatin, ezetimibe, or any of the other components of this medication (listed in section 6),
• You have liver disease,
• You have severe kidney problems,
• You have repeated or unjustified muscle pain and cramps (myopathy),
• You are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver infection called hepatitis C);
• You are taking a medication called ciclosporina (used, for example, after an organ transplant),
• You are pregnant or breastfeeding. If you become pregnant while taking Vaxar Plus, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Vaxar Plus using an appropriate contraceptive method.
• You have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking Vaxar Plus or other related medications.

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

Additionally, do not take Vaxar Plus 40 mg/10 mg (the highest dose) if:

• You have moderate kidney problems (if in doubt, consult your doctor).
• You have hypothyroidism (thyroid gland not functioning correctly).
• 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.
• You regularly consume large amounts of alcohol.
• You are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• You are taking other medications called fibrates to lower cholesterol (see section “Other medications and Vaxar Plus”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vaxar Plus if:

• You have kidney problems,
• You have liver problems,
• 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 have general discomfort or fever. Also, inform your doctor or pharmacist if you have constant muscle weakness,
• You are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor should establish the appropriate dose of Vaxar Plus for you,
• You are taking medications to treat infections, including HIV (AIDS virus) or hepatitis C, such as lopinavir/ritonavir and/or atazanavir or simeprevir. See “Other medications and Vaxar Plus”,
• You have severe respiratory failure,
• You are taking other medications called fibrates to lower cholesterol. Read this prospectus carefully, even if you have taken other cholesterol-lowering medications before. See “Taking Vaxar Plus with other medications”,
• You regularly consume large amounts of alcohol,
• You have hypothyroidism (thyroid gland not functioning correctly),
• You are over 70 years old, (since your doctor should choose the appropriate dose of rosuvastatin/ezetimibe for you).
• You are taking or have taken in the last 7 days a medication called fusidic acid (a medication for bacterial infection) by oral or injectable route. The combination of fusidic acid and rosuvastatin/ezetimibe can cause severe muscle problems (rhabdomyolysis).
• You have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).
• You have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking rosuvastatin or other related medications

If you find yourself in any of these situations mentioned above (or are unsure): do not take Vaxar Plus 40 mg/10 mg (the highest dose) and consult your doctor or pharmacist before starting to take any dose of Vaxar Plus tablets.

In a reduced number of people, statins can affect the liver. This is detected by a simple test that detects increased levels of liver enzymes in the blood. For this reason, your doctor will usually perform blood tests (liver function test) during treatment with Vaxar Plus. It is essential that you go to the doctor for the tests.

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 sugar and fat levels in your blood, are overweight, and have high blood pressure.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported associated with rosuvastatin treatment. Stop using Vaxar Plus and seek medical attention immediately if you notice any of the symptoms described in section 4.

Children and adolescents

Vaxar Plus is not recommended for use in children and adolescents under 18 years of age.

Other medications and Vaxar Plus tablets

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 taking any of the following medications:

• Ciclosporina (used, for example, after an organ transplant to prevent organ rejection. The effect of rosuvastatin increases with its use together).Do not take Vaxar Plus if you are taking ciclosporina.
• Anticoagulants, such as warfarin, acenocoumarol, fluindione, ticagrelor, or clopidogrel (their anticoagulant effects and the risk of bleeding may increase while taking Vaxar Plus together).
• Other medications to lower cholesterol called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates). During concomitant use, the effect of rosuvastatin increases.Do not take Vaxar Plus 40 mg/10 mg tablets with concomitant use of a fibrate.
• Colestiramina (a medication to lower cholesterol), because it affects how ezetimibe works.
• Darolutamida, regorafenib, capmatinib (used to treat cancer);
• 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, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.See section Warnings and Precautions
• Medications for indigestion containing aluminum and magnesium (used to neutralize stomach acid, as they reduce the level of rosuvastatin in plasma). This effect can be mitigated by taking this type of medication 2 hours after rosuvastatin.
• Eritromicina (an antibiotic). The effect of rosuvastatin decreases with its use together.
• Fusidic acid. 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 you can safely take Vaxar Plus tablets again. Taking rosuvastatin/ezetimibe with fusidic acid can cause rare muscle weakness, pain, or sensitivity (rhabdomyolysis). You can consult more information about rhabdomyolysis in section 4.
• Oral contraceptive (the pill). The levels of sex hormones absorbed from the pill are increased.
• Hormone replacement therapy (increased hormone levels in the blood).
• Fostamatinib (used to treat low platelet counts),
• Febuxostat (used to treat and prevent high uric acid levels in the blood),
• Teriflunomida (used to treat multiple sclerosis).

If you go to a hospital or receive treatment for another disease, inform the medical staff that you are taking Vaxar Plus tablets.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not take Vaxar Plus tabletsif you are pregnant, think you might be pregnant, or intend to become pregnant. If you become pregnant while taking Vaxar Plus tablets,stop taking it immediatelyand inform your doctor. Women should use contraceptive methods during treatment with Vaxar Plus.

Breastfeeding

Do not take Vaxar Plus tablets,if you are breastfeeding, as it is unknown whether the medication passes into breast milk.

Driving and operating machinery

Vaxar Plus tablets are not expected to interfere with your ability to drive or operate machinery. However, some people may feel dizzy after taking Vaxar Plus tablets. If you feel dizzy, consult your doctor before attempting to drive or operate machinery.

Vaxar Plus tablets contain lactose monohydrate

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Vaxar Plus tablets contain sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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

You should continue to maintain a low-cholesterol diet and exercise while taking Vaxar Plus tablets.

The recommended daily dose for adults is one tablet of the indicated dose.

Take Vaxar Plus tablets once a day.

You can take it at any time of the day, with or without food. Swallow each tablet whole with water.

Take your medication at the same time every day.

Vaxar Plus tabletsare not suitable for starting treatment. The start of treatment or dose adjustments, if necessary, should only be made by taking the active ingredients separately, and once the appropriate doses have been adjusted, it is possible to switch to the appropriate dose ofVaxar Plus tablets.

The maximum daily dose of rosuvastatin is 40 mg. This dose is only for patients with high cholesterol levels and a high risk of suffering a heart attack or stroke, whose cholesterol levels do not decrease enough with 30 mg.

Regular cholesterol level checks

It is essential that you attend your doctor regularly for cholesterol checks, in order to verify that your cholesterol levels have normalized and are maintained at appropriate levels.

If you take more Vaxar Plus tablets than you should

Contact your doctor or the nearest hospital's emergency service as you may need medical assistance.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Vaxar Plus tablets

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

If you interrupt treatment with Vaxar Plus tablets

Consult your doctor if you want to discontinue treatment withVaxar Plus tablets. Your cholesterol levels may increase again if you stop takingVaxar Plus tablets.

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.

Stop taking Vaxar Plus tablets and seek medical assistance immediatelyif you experience any of the following allergic reactions:

• Allergic reactions: swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing and swallowing, intense skin itching (with raised bumps). These are possible side effects that are infrequently reported.
• Lupus-like disease syndrome (including skin rash, joint disorders, and effects on blood cells). This is a possible side effect that is infrequently reported.
• Flat, red spots on the trunk, often with blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome). The frequency of this possible side effect is unknown.
• Generalized rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome). The frequency of this possible side effect is unknown.

Also, stop taking Vaxar plus and consult your doctor immediately if you experience unusual muscle pain that lasts longer than expected. In rare cases, this may develop into a potentially fatal muscle injury known as rhabdomyolysis, which causes general discomfort, fever, and kidney damage.

The following terms are used to describe how often side effects have been reported:

Very common side effects (may affect more than 1 in 10 people)

Common side effects (may affect up to 1 in 10 people)

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

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, including isolated cases)

Common side effects

• Headache;
• Constipation;
• General discomfort;
• Muscle pain;
• Weakness;
• Dizziness;
• Increased protein levels in urine, which usually returns to normal on its own without the need to discontinue treatment with rosuvastatin/ezetimibe (only for rosuvastatin 40 mg).
• Diabetes. This is more likely if you have high blood sugar and lipid levels, being overweight, and high blood pressure. Your doctor will monitor you while taking this medicine;
• Stomach pain;
• Diarrhea;
• Flatulence (excess gas in the intestinal tract);
• Feeling tired;
• High levels in some blood test results for liver function (transaminases).

Uncommon side effects

• Skin rash, itching, urticaria;
• Increased protein levels in urine – this usually returns to normal on its own without the need to discontinue treatment with rosuvastatin tablets(only for rosuvastatin 10 mg and 20 mg).
• High levels in some blood test results for muscle function (Creatine Kinase test);
• Cough;
• Indigestion;
• Heartburn;
• Nausea
• Joint pain;
• Muscle spasms;
• Neck pain;
• Loss of appetite;
• Pain;
• Chest pain;
• Hot flashes;
• High blood pressure;
• Tickling sensation;
• Dry mouth;
• Stomach inflammation;
• Back pain;
• Muscle weakness;
• Pain in the arms and legs;
• Swelling, especially in the hands and feet.

Rare side effects

• Pancreatitis, which causes severe stomach pain that may spread to the back;
• Bleeding or bruising more easily than normal due to low platelet levels in the blood

Very rare side effects

Jaundice (yellowing of the skin and eyes); liver inflammation (hepatitis); blood in the urine; nerve damage in the legs and arms (numbness); memory loss; breast enlargement in men (gynecomastia).

Unknown frequency

Difficulty breathing; edema (swelling); sleep disturbances, including insomnia and nightmares; sexual dysfunction; depression; respiratory problems, including persistent cough and/or difficulty breathing or fever; tendon injuries; persistent muscle weakness; red, raised rash, sometimes with target-shaped lesions (erythema multiforme); muscle sensitivity; gallstones or inflammation of the gallbladder (which may cause stomach pain, nausea, vomiting);

Miyasthenia 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 the 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:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store in the original packaging to protect it from light. This medication does not require special storage conditions.

Keep this medication out of sight and reach of children.

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 dispose of medications through drains or trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofVaxar Plus

The active principles are rosuvastatina (as rosuvastatina calcium) and ezetimiba. The tablets contain rosuvastatina calcium equivalent to 15 mg, 30 mg or 40 mg of rosuvastatina. Each tablet contains 10 mg of ezetimiba.

The other components are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, crospovidone type A, povidone K-30, sodium laurilsulfate and magnesium stearate.

Appearance of the product and contents of the packaging

Vaxar Plus 15 mg/10 mg: Uncoated hexagonal biconvex tablet of white to off-white color, with approximate dimensions of 9 x 8 mm and with "E3" engraved on both faces.

Vaxar Plus 30 mg/10 mg: Uncoated biconvex tablet of white to off-white color, rectangular shape, with dimensions of 12 x 6 mm and with an "X" engraved on both faces.

Vaxar Plus 40 mg/10 mg: Uncoated biconvex elliptical tablet of white to off-white color, with approximate dimensions of 13 x 6 mm and with "E6" engraved on both faces.

This medication is available in packaging of 28, 30, 56, 60 and 90 tablets

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Adamed Laboratorios, S.L.U.

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

28023 Madrid

Spain

Responsible for manufacturing

Adamed Pharma S.A.

Ul. Marszalka Jósefa Pilsudskiego 5

95-200 Pabianice, Lodzkie

Poland

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

Poland:Vaxar Plus

Spain:Vaxar Plus 15mg/10mg tablets

Vaxar Plus 30mg/10mg tablets

Vaxar Plus 40mg/10mg tablets

Last review date of this prospectus: March 2024

Detailed information about this medication is available on the website of the {Spanish Agency of Medicines and Medical Devices (AEMPS)} (http://www.aemps.gob.es/)