Vaxar Plus 40 mg/10 mg tablets

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Vaxar Plus 15 mg/10 mg tablets

Vaxar Plus 30 mg/10 mg tablets

Vaxar Plus 40 mg/10 mg tablets

rosuvastatin and ezetimibe

Read this 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 others, even if they have the same symptoms as you, because it may harm them.

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

Contents of this leaflet

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

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; the other active substance is ezetimibe.

Rosuvastatin/ezetimibe tablets is a medicine 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 cause 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, leading to a heart attack or stroke. By lowering cholesterol levels, your risk of having a heart attack, stroke, or other health-related problems can be reduced.

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

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

Rosuvastatin/ezetimibe is used if you have:

• High cholesterol levels in the blood (primary hypercholesterolemia)
• Heart disease; Rosuvastatin/Ezetimibe reduces the risk of myocardial infarction, stroke, surgery to increase 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 components of this medicine (listed in section 6),
• you have liver disease,
• you have severe kidney problems,
• you have repeated or unexplained muscle pain or 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 transplantation),
• 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 by using an appropriate contraceptive method.
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking Vaxar Plus or other related medicines.

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

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

• you have moderate kidney problems (if in doubt, consult your doctor),
• your thyroid gland is not functioning properly (hypothyroidism),
• you have repeated or unexplained muscle pain or cramps, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines,
• you regularly consume large amounts of alcohol,
• you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• you are taking other medicines called fibrates to lower cholesterol (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 or unexplained muscle pain or 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 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 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 medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have previously taken other medicines for high cholesterol. See “Taking Vaxar Plus with other medicines”,
• you regularly consume large amounts of alcohol,
• your thyroid gland is not functioning properly (hypothyroidism),
• you are over 70 years of age (as your doctor must choose the appropriate dose of rosuvastatin/ezetimibe for you),
• you are 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 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),
• 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 are in any of the above-mentioned situations (or are unsure): do not take Vaxar Plus 40 mg/10 mg (the highest dose) and consult your doctor or pharmacist before starting any dose of Vaxar Plus tablets.

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 Vaxar Plus. It is important that you attend your scheduled 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 may be 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 Vaxar Plus and seek immediate medical attention if you notice any of the symptoms described in section 4.

Children and adolescents

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

Other medicines and Vaxar Plus tablets

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

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

• Cyclosporine (used, for example, after organ transplantation to prevent organ rejection. The effect of rosuvastatin increases when taken together). Do not take Vaxar Plus if you are taking cyclosporine.
• Anticoagulants, such as warfarin, acenocoumarol, phenindione, ticagrelor, or clopidogrel (their anticoagulant effects and risk of bleeding may increase when taken with 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 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,
• Antacid treatments containing aluminum 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.
• 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 resume Vaxar Plus tablets. 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). Absorbed levels of sex hormones 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 blood uric acid levels),
• Teriflunomide (used to treat multiple sclerosis).

If you are admitted to hospital or receive treatment for another illness, inform 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 tablets if 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 immediately and 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 medicine passes into breast milk.

Driving and using machines

Vaxar Plus tablets are not expected to affect your ability to drive or use machines. However, some people may experience dizziness 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 informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Vaxar Plus tablets contain sodium

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

3. How to take Vaxar Plus

Follow exactly the instructions for using 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 Vaxar Plus tablets.

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

Take Vaxar Plus tablets 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.

Vaxar Plus tablets are not suitable for initiating treatment. The start of treatment or dose adjustments, if necessary, should only be done by taking the active substances separately; once the appropriate doses have been established, it is then 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 heart attack or stroke, whose cholesterol levels do not decrease sufficiently with 30 mg.

Regular cholesterol level checks

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 tablets 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, indicating the medicine and the amount ingested.

If you forget to take Vaxar Plus tablets

Do not worry. Miss the forgotten 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 tablets

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

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 will experience them.

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

Stop taking Vaxar Plus tablets and seek immediate medical attention if you experience any of the following allergic reactions:

• Allergic reactions: swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing and swallowing, intense skin itching (with raised bumps). These are uncommon possible side effects.
• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells). This is an uncommon possible side effect.
• Red, non-elevated circular or target-shaped spots on the trunk, 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 side effect is unknown.
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome 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 pain that lasts longer than expected. In rare cases, this may progress to 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 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 amount of protein in urine, which usually returns to normal on its own without discontinuing treatment with rosuvastatin/ezetimibe (only for rosuvastatin 40 mg);
• Diabetes. This is more likely if you have high blood sugar and lipid levels, 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 gastrointestinal tract);
• Feeling tired;
• Elevated levels in certain blood test results indicating 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 discontinuing treatment with rosuvastatin tablets (only for rosuvastatin 10 mg and 20 mg);
• Elevated levels in certain blood test results indicating muscle function (Creatine Kinase test);
• Cough;
• Indigestion;
• Heartburn;
• Nausea;
• Joint pain;
• Muscle spasms;
• Neck pain;
• Loss of appetite;
• Pain;
• Chest pain;
• Hot flushes;
• High blood pressure;
• Tingling sensation;
• Dry mouth;
• Inflammation of the stomach;
• Back pain;
• Muscle weakness;
• Pain in arms and legs;
• Swelling, especially of the hands and feet.

Rare adverse effects

• 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 levels in the blood.

Very rare adverse effects

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

Frequency not known

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 injury; 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 the muscles used for breathing); ocular myasthenia (a condition causing 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 or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 container after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection 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 (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, cross-linked povidone type A, povidone K-30, sodium lauryl sulfate, and magnesium stearate.

Appearance of the product and contents of the pack

Vaxar Plus 15 mg/10 mg: White to off-white, biconvex, hexagonal uncoated tablet, approximately 9 x 8 mm in size, with "E3" engraved on both sides.

Vaxar Plus 30 mg/10 mg: White to off-white, biconvex, rectangular uncoated tablet, 12 x 6 mm in size, with an "X" engraved on both sides.

Vaxar Plus 40 mg/10 mg: White to off-white, biconvex, elliptical uncoated tablet, approximately 13 x 6 mm in size, with "E6" engraved on both sides.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.
C/ de las Rosas de Aravaca, 31 - 2nd floor
28023 Madrid
Spain

Manufacturer

Adamed Pharma S.A.
Ul. Marszalka Jósefa Pilsudskiego 5
95-200 Pabianice, Lodzkie
Poland

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

Poland: Vaxar Plus

Spain: Vaxar Plus 15mg/10mg tablets
Vaxar Plus 30mg/10mg tablets
Vaxar Plus 40mg/10mg tablets

Date of the most recent review of this leaflet: March 2024

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