VAXAR PLUS 40 MG/10 MG TABLETS

Introduction

Leaflet: information for the patient

Vaxar Plus 15mg/10mg tablets

Vaxar Plus 30mg/10mg tablets

Vaxar Plus 40mg/10mg tablets

rosuvastatin and ezetimibe

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• 1. If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

5 Preservation of Vaxar Plus

1. Contents of the package and additional information

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

Vaxar Plus contains two different active substances in one tablet. One of the active substances is rosuvastatin, which belongs to a group of medicines called statins, and the other active substance is ezetimibe.

Rosuvastatin/ezetimibe tablets are a medicine used to reduce total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides that circulate in the blood. Additionally, it raises the levels of "good" cholesterol (HDL cholesterol). This medicine works by reducing cholesterol in two ways: it reduces 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, as they do not produce any symptoms. However, if left untreated, fatty deposits can accumulate in the walls of blood vessels and narrow them.

Sometimes, these narrowed blood vessels can become blocked, cutting off the blood supply to the heart or brain, which can cause a heart attack or stroke. By reducing cholesterol levels, you can reduce your risk of having a heart attack, stroke, or other related health problems.

Rosuvastatin/ezetimibe is used in patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you should follow a cholesterol-reducing diet.

Your doctor may prescribe Vaxar Plus if you are already taking rosuvastatin and ezetimibe at the same dose level.

Rosuvastatin/ezetimibe is used if you have:

• High blood cholesterol levels (primary hypercholesterolemia)
• Heart disease, Rosuvastatin/Ezetimibe reduces the risk of heart attack, stroke, cardiac surgery to increase blood flow, or hospitalization for chest pain

This medicine does not help you lose weight.

2. What you need to know before taking Vaxar Plus

Do not take Vaxar Plus if:

• you are allergic to rosuvastatin, ezetimibe, or any of the other components of this medicine (listed in section 6),
• you have liver disease,
• you have severe kidney problems,
• you have repeated and unjustified muscle pain or cramps (myopathy),
• you are taking a combination of medicines called sofosbuvir/velpatasvir/voxilaprevir (used for the viral infection of the liver called hepatitis C);
• you are taking a medicine called ciclosporin (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.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking Vaxar Plus or other related medicines.

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

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

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland does not function correctly (hypothyroidism).
• You have repeated and unjustified muscle pain or cramps, a personal or family history of muscle problems, or a 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 cholesterol-lowering medicines called fibrates (see section "Other medicines 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 and unjustified muscle pain or cramps, a personal or family history of muscle problems, or a 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,
• you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor should establish the appropriate dose of Vaxar Plus for you,
• you are taking medicines to treat infections, including HIV (AIDS virus) or hepatitis C, such as lopinavir/ritonavir and/or atazanavir or simeprevir. See "Other medicines and Vaxar Plus",
• you have severe respiratory failure,
• you are taking other cholesterol-lowering medicines called fibrates. Read this leaflet carefully, even if you have taken other cholesterol medicines before. See "Taking Vaxar Plus with other medicines",
• you regularly consume large amounts of alcohol,
• your thyroid gland does not function correctly (hypothyroidism),
• you are over 70 years old (as your doctor should choose the appropriate dose of rosuvastatin/ezetimibe for you).
• you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic). The combination of fusidic acid and rosuvastatin/ezetimibe can rarely cause muscle problems (rhabdomyolysis).
• you have or have had myasthenia (a disease that causes generalized muscle weakness, which 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 sores in the mouth after taking rosuvastatin or other related medicines.

If you are 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 small 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 normally perform blood tests (liver function tests) during treatment with Vaxar Plus. It is essential that you visit your doctor for these tests.

While 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 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 in association 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 medicines and Vaxar Plus tablets

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

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

• Ciclosporin (used, for example, after an organ transplant to prevent organ rejection. The effect of rosuvastatin increases with concomitant use). Do not take Vaxar Plus if you are taking ciclosporin.
• Anticoagulants, such as warfarin, acenocoumarol, fluindione, ticagrelor, or clopidogrel (their anticoagulant effects and the risk of bleeding may increase while taking Vaxar Plus).
• Other cholesterol-lowering medicines 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.
• Colestyramine (a medicine to lower cholesterol), as it affects how ezetimibe works.
• Darolutamide, regorafenib, capmatinib (used to treat cancer);
• 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, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. See section Warnings and Precautions
• Treatments for indigestion that contain aluminum and magnesium (used to neutralize stomach acid, as they reduce the level of rosuvastatin in the blood). This effect can be mitigated by taking these types of medicines 2 hours after rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases with concomitant use.
• Fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you should temporarily stop taking this medicine. Your doctor will tell you when you can safely take Vaxar Plus tablets again. Taking rosuvastatin/ezetimibe with fusidic acid can rarely cause muscle weakness, pain, or sensitivity (rhabdomyolysis). You can find more information about rhabdomyolysis in section 4.
• An 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),
• Teriflunomide (used to treat multiple sclerosis).

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take Vaxar Plus tabletsif you are pregnant, think you may be pregnant, or plan 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 tabletsif you are breastfeeding, as it is unknown whether the medicine passes into breast milk.

Driving and using machines

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

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 medicine.

Vaxar Plus tablets contain sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially, "sodium-free".

3. How to take Vaxar Plus

Follow the instructions for taking this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You should continue to follow a cholesterol-reducing 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 day, with or without food. Swallow each tablet whole with water.

Take your medicine at the same time every day.

Vaxar Plus tabletsare not suitable for initiating treatment. The start of treatment or dose adjustments, if necessary, should only be done by taking the active substances separately, and once the appropriate doses are adjusted, it is possible to switch to the appropriate dose of Vaxar 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 having a heart attack or stroke, whose cholesterol levels do not decrease sufficiently with 30 mg.

Regular cholesterol level checks

It is essential that you visit your doctor regularly to have your cholesterol levels checked, to ensure 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 emergency department, as you may need medical assistance.

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 medicine 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 planned time. Do not take a double dose to make up for missed doses.

If you interrupt treatment with Vaxar Plus tablets

Consult your doctor if you want to interrupt treatment with Vaxar Plus tablets. Your cholesterol levels may increase again if you stop taking Vaxar Plus tablets.

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.

Stop taking Vaxar Plus tablets and seek immediate medical attentionif 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 itching of the skin (with raised bumps). These are possible uncommon side effects.
• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells). This is a possible uncommon side effect.
• Red, non-raised spots on the torso, target-shaped or circular, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome). The frequency of this possible side effect is unknown.
• Widespread rash, high body temperature, and enlarged 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 have unusual muscle pains that last longer than expected. In rare cases, this can become a potentially life-threatening muscle injury known as rhabdomyolysis, which causes general discomfort, fever, and kidney problems.

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

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

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

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

Rare adverse effects (may affect up to 1 in 1,000 people)

Very rare adverse effects (may affect up to 1 in 10,000 people, including isolated cases)

Common Adverse Effects

• Headache;
• Constipation;
• General malaise;
• Muscle pain;
• Weakness;
• Dizziness;
• Increased protein in urine, which usually reverses on its own without needing to interrupt treatment with rosuvastatin/ezetimibe (only for rosuvastatin 40 mg).
• Diabetes. This is more likely if you have high sugar and lipid levels in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are 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 Adverse Effects

• Skin rash, itching, hives;
• An increase in the amount of protein in urine – this usually reverses on its own without needing to interrupt 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;
• Decreased appetite;
• Pain;
• Chest pain;
• Hot flashes;
• High blood pressure;
• Tingling sensation;
• Dry mouth;
• Stomach inflammation;
• Back pain;
• Muscle weakness;
• Pain in the arms and legs;
• Swelling, especially of the hands and feet.

Rare Adverse Effects

• Pancreatitis, which causes intense stomach pain that can extend to the back;
• Bleeding or bruising more easily than normal due to a low platelet count in the blood

Very Rare Adverse Effects

Jaundice (yellowing of the skin and eyes); liver inflammation (hepatitis); blood in the urine; nerve damage in the legs and arms (such as 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; constant muscle weakness; red, raised rash, sometimes with target-shaped lesions (erythema multiforme); muscle sensitivity; gallstones or gallbladder inflammation (which can cause stomach pain, nausea, vomiting),

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

5. Storage of Vaxar Plus

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

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 after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in 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 ofVaxar Plus

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

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

Appearance of the Product and Package Contents

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

Vaxar Plus 30 mg/10 mg: Rectangular, biconvex, uncoated tablet, white to off-white in color, with dimensions of 12 x 6 mm and an "X" engraved on both sides.

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

This medicine is available in packages of 28, 30, 56, 60, and 90 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 - 2ª planta

28023 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

Ul. Marszalka Jósefa Pilsudskiego 5

95-200 Pabianice, Lodzkie

Poland

This medicine 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

Date of the last revision of this prospectus: March 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/)