Vaxar Plus 10 mg/10 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Vaxar Plus 5 mg/10 mg tablets

Vaxar Plus 10 mg/10 mg tablets

Vaxar Plus 20 mg/10 mg tablets

rosuvastatin/ezetimibe

Read the entire 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.

  1. If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

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

Leaflet contents

1. What Vaxar Plus is and what it is used for
2. What you need to know before taking Vaxar Plus
3. How to take Vaxar Plus
4. Possible side effects
5. How to store Vaxar Plus
6. Contents of the pack and other information

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

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

Rosuvastatin/ezetimibe tablets are used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, it increases levels of "good" cholesterol (HDL cholesterol).

This medicine works by reducing cholesterol in two ways: it reduces cholesterol absorbed from the digestive tract, as well as cholesterol produced by the body itself.

For most people, high cholesterol levels do not affect how they feel, as they produce no symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels and narrow them.

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

Rosuvastatin/ezetimibe tablets are used in patients who cannot control their cholesterol levels with diet alone. You must continue to follow a low-cholesterol diet while taking this medicine.

Your doctor may prescribe this medicine if you are already taking rosuvastatin and ezetimibe at the same dose.

Rosuvastatin/ezetimibe tablets are used if you have:

• High cholesterol levels in the blood (primary hypercholesterolemia).
• Heart disease; Vaxar Plus reduces the risk of myocardial infarction, stroke, surgery to improve blood flow to the heart, or hospitalization due to 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 ingredients of this medicine (listed in section 6);
• you have liver disease;
• you have severe kidney problems;
• you have repeated or unexplained muscle pain and cramps (myopathy);
• you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used for the viral liver infection called hepatitis C);
• you are taking a medicine called cyclosporine (used, for example, after organ transplant);
• you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatin/ezetimibe, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatin/ezetimibe by using an appropriate contraceptive method (see below “Pregnancy and breastfeeding”);
• you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth sores after taking rosuvastatin/ezetimibe or other related medicines.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting rosuvastatin/ezetimibe if:

• you have kidney problems;
• you have liver problems;
• you have had repeated or unexplained muscle pain and cramps, personal or family history of muscle disorders, or 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;
• you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must determine the appropriate dose of rosuvastatin/ezetimibe for you;
• you are taking medicines used to treat HIV infection (e.g., ritonavir with lopinavir and/or atazanavir) (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 previously taken other medicines for high cholesterol. See “Other medicines and Vaxar Plus”;
• you regularly consume large amounts of alcohol;
• your thyroid gland is not functioning properly (hypothyroidism);
• you are over 70 years old (as your doctor must choose the appropriate dose of rosuvastatin/ezetimibe for you);
• you are currently taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine for bacterial infection). The combination of fusidic acid and rosuvastatin/ezetimibe may cause serious muscle problems (rhabdomyolysis);
• you have or have had myasthenia (a disease causing 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);
• you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth sores after taking this medicine or other related medicines.

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. For this reason, your doctor will usually perform blood tests (liver function tests) during treatment with rosuvastatin/ezetimibe. It is important that you attend your doctor’s appointments for these tests.

While taking this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely at risk of developing diabetes if you have high levels of sugar and fats 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 with rosuvastatin treatment. Stop using this medicine and seek immediate medical attention if you notice any of the symptoms described in section 4.

Children and adolescents

The use of rosuvastatin/ezetimibe is not recommended in children and adolescents under 18 years of age.

Other medicines and Vaxar Plus

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 taking any of the following medicines:

• Cyclosporine (often used in transplant patients). Do not take rosuvastatin/ezetimibe if you are taking cyclosporine;
• Anticoagulants, such as warfarin, acenocumarol, fluindione, ticagrelor, or clopidogrel (their anticoagulant effects and risk of bleeding may increase when taken with rosuvastatin/ezetimibe);
• Other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels in blood (e.g., gemfibrozil and other fibrates). When used concomitantly, the effect of rosuvastatin increases;
• Colestiramine (a cholesterol-lowering medicine), as it affects how rosuvastatin/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 “Warnings and Precautions”;
• Treatments for indigestion containing aluminium and magnesium (used to neutralize stomach acid, as they reduce plasma levels of rosuvastatin). This effect can be minimized by taking these medicines 2 hours after rosuvastatin/ezetimibe;
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases when taken together;
• Fusidic acid. 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/ezetimibe. Taking rosuvastatin/ezetimibe with fusidic acid may rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4;
• An oral contraceptive (the pill). Levels of absorbed sex hormones are increased;
• Hormone replacement therapy;
• Fostamatinib (used to treat low platelet counts);
• Febuxostat (used to treat and prevent high levels of uric acid in blood);
• Teriflunomide (used to treat multiple sclerosis).

If you go to hospital or receive treatment for another illness, tell the medical staff that you are taking rosuvastatin/ezetimibe.

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 rosuvastatin/ezetimibe if you are pregnant, think you may be pregnant, or plan to become pregnant. If you become pregnant while taking rosuvastatin/ezetimibe, stop taking it immediately and inform your doctor. Women should use contraceptive methods during treatment with rosuvastatin/ezetimibe.

Breastfeeding

Do not take rosuvastatin/ezetimibe if you are breastfeeding, as it is unknown whether the medicine passes into breast milk.

Driving and using machines

Rosuvastatin/ezetimibe is not expected to affect your ability to drive or use machines. However, some people may experience dizziness after taking rosuvastatin/ezetimibe. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Vaxar Plus contains lactose

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

Vaxar Plus contains 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 exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You must continue to maintain a low-cholesterol diet and exercise while taking rosuvastatin/ezetimibe.

Your doctor will determine the appropriate dose for you, based on your current treatment and your individual risk status.

The recommended dose is one tablet of this medicine once daily.

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

Take your medicine at the same time each day.

This medicine is not suitable for initiating treatment. Treatment initiation or dose adjustment, if necessary, should only be done by administering the active substances separately; once the appropriate doses have been established, switching to the appropriate dose of rosuvastatin/ezetimibe is then possible.

Regular cholesterol monitoring

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

If you take more Vaxar Plus than you should

Contact your doctor or the nearest hospital emergency department, as you may require medical assistance.

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

If you forget to take Vaxar Plus

Do not worry. Skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Vaxar Plus

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

4. Possible adverse effects

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

It is important that you are aware of what these adverse effects may be.

Stop taking rosuvastatin/ezetimibe and seek immediate medical attention if you experience any of the following adverse effects:

• Allergic reactions: swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing and swallowing, severe itching of the skin (with raised lumps). These are possible uncommon adverse effects;
• Lupus-like disease syndrome (including skin rash, joint disorders, and effects on blood cells). This is a possible uncommon adverse effect;
• Muscle breakdown. This is an uncommon adverse effect;
• Flat red spots on the trunk, bull's-eye or circular in shape, 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). The frequency of this possible adverse effect is unknown;
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). The frequency of this possible adverse effect is unknown.

Contact your doctor immediately if you have unusual muscle pain that lasts longer than expected. In rare cases, this may develop into a potentially life-threatening muscle injury known as rhabdomyolysis, which causes general malaise, fever, and kidney problems.

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

• Very common (may affect more than 1 in 10 people).
• Common (may affect up to 1 in 10 people).
• Uncommon (may affect up to 1 in 100 people).
• Rare (may affect up to 1 in 1,000 people).
• Very rare (may affect up to 1 in 10,000 people, including isolated cases).

Common adverse effects

• Headache;
• Constipation;
• General malaise;
• Muscle pain;
• Tenderness;
• Weakness;
• Dizziness;
• 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 while you are taking this medicine;
• Stomach pain;
• Diarrhea;
• Flatulence (excess gas in the intestinal tract);
• Feeling tired;
• Elevated levels in certain blood tests of liver function (transaminases).

Uncommon adverse effects

• Skin rash, itching, hives;
• Increased amount of protein in urine – this usually returns to normal on its own without needing to stop taking rosuvastatin;
• Elevated levels in certain blood tests of muscle function (Creatine Kinase test);
• Cough;
• Indigestion;
• Heartburn;
• Nausea;
• Joint pain;
• Muscle spasms;
• Neck pain;
• Decreased appetite;
• Pain;
• Chest pain;
• Hot flushes;
• High blood pressure;
• Tingling sensation;
• Dry mouth;
• Stomach inflammation;
• Back pain;
• Muscle weakness;
• Pain in arms and legs;
• Swelling, especially in hands and feet.

Rare adverse effects

• Pancreatitis (inflammation of the pancreas), causing severe stomach pain that may spread to the back;
• Bleeding or bruising more easily than normal due to low platelet count in the blood.

Very rare adverse effects

• Jaundice (yellowing of the skin and eyes);
• Hepatitis (liver inflammation);
• Blood traces in urine;
• Nerve damage in arms and legs (such as numbness);
• Memory loss;
• Enlargement of breasts in men (gynaecomastia).

Frequency not known

Difficulty breathing; oedema (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; raised red rash, sometimes with target-like lesions (erythema multiforme); muscle tenderness; gallstones or inflammation of the gallbladder (which may cause stomach pain, nausea, vomiting).

Myasthenia gravis (a condition causing generalized muscle weakness which, in some cases, affects muscles used for breathing); ocular myasthenia (a condition causing weakness of the eye muscles). Consult your doctor if you experience worsening arm or leg weakness after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects

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

5. Storage of Vaxar Plus

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

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

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, 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 Plus

• The active substances are rosuvastatin and ezetimibe. Each tablet contains 5 mg, 10 mg, or 20 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe.
• The other components are:

Lactose monohydrate, microcrystalline cellulose, crospovidone type A, sodium croscarmellose, povidone K-30, sodium lauryl sulfate, and magnesium stearate.

Appearance of the product and contents of the pack

Vaxar Plus 5 mg/10 mg: Round, white to off-white, flat, uncoated tablet with a score line, marked with "E" on both sides, 7.6 mm in diameter.

Vaxar Plus 10 mg/10 mg: Round, white to off-white, biconvex, uncoated tablet, marked with "E1" on both sides, 8 mm in diameter.

Vaxar Plus 20 mg/10 mg: Square, white to off-white, biconvex, uncoated tablet, marked with "E2" on both sides, 8.35 mm in diameter.

This medicine is available in packs of 28, 30, 56, 60, 84, and 90 tablets in PA/AL/PVC/Al blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

Calle de las Rosas de Aravaca, 31 - 2nd floor

28023 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

Ul. Marszalka Jósefa Pilsudskiego 5

95-200 Pabianice

Poland

This medicine is authorized in the European Economic Area member states under the following names:

Poland: Vaxar Plus

Spain: Vaxar Plus 5 mg/10 mg tablets

Vaxar Plus 10 mg/10 mg tablets

Vaxar Plus 20 mg/10 mg tablets

Date of the most recent review of this leaflet: August 2025

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