AXOCAR 10 mg/20 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Axocar, 10 mg+10 mg, tablets
3. Axocar, 10 mg+20 mg, tablets
4. Axocar, 10 mg+40 mg, tablets
5. Axocar, 10 mg+80 mg, tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
6. What is Axocar and what is it used for
7. Important information before taking Axocar
   1. Do not take Axocar if:
   2. Warnings and precautions
   3. Children and adolescents
   4. Axocar and other medicines
   5. Axocar with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
8. How to take Axocar
   1. Taking a higher dose of Axocar than recommended
   2. Missing a dose of Axocar
   3. Stopping treatment with Axocar
9. Possible side effects
   1. Immediately consult a doctor if the patient experiences unexplained muscle pain, tenderness, or weakness. In rare cases, muscle problems can be serious, including muscle breakdown leading to kidney damage; in very rare cases, death has occurred.
   2. Reporting side effects
10. How to store Axocar
11. Contents of the packaging and other information
    1. What Axocar contains
    2. What Axocar looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer

Leaflet accompanying the packaging: patient information

Axocar, 10 mg+10 mg, tablets

Axocar, 10 mg+20 mg, tablets

Axocar, 10 mg+40 mg, tablets

Axocar, 10 mg+80 mg, tablets

Ezetimibe + Simvastatin

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1.What is Axocar and what is it used for
• 2.Important information before taking Axocar
• 3.How to take Axocar
• 4.Possible side effects
• 5.How to store Axocar
• 6.Contents of the packaging and other information

1. What is Axocar and what is it used for

Axocar contains the active substances ezetimibe and simvastatin. Axocar is a medicine used to
reduce the level of total cholesterol, "bad" cholesterol (LDL cholesterol) and fatty substances called
triglycerides in the blood. Additionally, Axocar increases the level of "good" cholesterol (HDL cholesterol).
Axocar works through 2 mechanisms that reduce cholesterol levels. The active substance ezetimibe reduces
the absorption of cholesterol in the digestive tract. The active substance simvastatin, belonging to a class
of medicines called "statins", inhibits the production of cholesterol in the body.
Cholesterol is one of several fatty substances present in the blood. Total cholesterol consists mainly of
LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can accumulate on the walls of arteries, forming
plaques that can eventually cause narrowing of the arteries, limiting or blocking blood flow to vital organs,
such as the heart and brain. Blocking blood flow can lead to a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent the accumulation of bad cholesterol
in the arteries and protects against heart disease.
Triglycerides are another type of fat present in the blood that can contribute to the increased risk of developing
heart disease.
Axocar is used in patients for whom diet alone is not sufficient to control cholesterol levels. During treatment
with this medicine, a cholesterol-lowering diet should be followed.
Axocar is used as a supplementary measure to a cholesterol-lowering diet in cases of:

• high blood cholesterol (primary hypercholesterolemia [heterozygous familial or non-familial]) or high blood fat levels (mixed hyperlipidemia):
• when adequate improvement has not been achieved with statin therapy alone,
• when statin and ezetimibe have been taken in separate tablets.
• hereditary disorder (homozygous familial hypercholesterolemia) that causes high blood cholesterol levels. Other treatment methods may also be used.
• heart disease. Axocar reduces the risk of heart attack, stroke, the need for surgical procedures to increase blood flow to the heart, or hospitalization due to chest pain.

Axocar does not affect weight loss.

2. Important information before taking Axocar

Do not take Axocar if:

• the patient is allergic to ezetimibe, simvastatin, or any of the other ingredients of this medicine (listed in section 6).
• there are current liver problems.
• the patient is pregnant, breastfeeding, or planning to become pregnant.
• the patient is taking certain medicines that interact with Axocar (see section 2).
• the patient is taking or has taken in the last 7 days a medicine called fusidic acid (used to treat bacterial infections) orally or by injection. Taking fusidic acid with Axocar can lead to serious muscle problems (rhabdomyolysis). Do not take Axocar in a dose greater than 10 mg + 40 mg if the patient is taking lomitapide (used to treat a rare genetic cholesterol disorder).

In case of doubt about taking any of the above-mentioned medicines, consult a doctor.

Warnings and precautions

Before starting treatment with Axocar, inform your doctor:

• about all medical conditions, including allergies.
• about consuming large amounts of alcohol or having a history of liver disease. Taking Axocar may not be suitable.
• about upcoming surgical procedures. It may be necessary to stop taking Axocar for a short time.
• if the patient is of Asian origin, as a different dose may be suitable for the patient.
• about severe lung disease.

The doctor should perform a blood test before starting treatment with Axocar and during treatment if the patient has any liver problems. The purpose of the test is to assess liver function.
The doctor may also perform blood tests to assess liver function after starting treatment with Axocar.
During therapy, the doctor will closely monitor the patient's health if they have diabetes or are at risk of developing diabetes. The risk of developing diabetes is higher in people who have high blood sugar and fat levels, are overweight, and have high blood pressure.
Avoid taking Axocar and fibrates (certain cholesterol-lowering medicines) at the same time, as there is no data on the simultaneous use of Axocar and fibrates.

Children and adolescents

Axocar is not recommended for children under 10 years of age.

Axocar and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines they plan to take, including those containing the following active substances. Taking Axocar with any of the following medicines may increase the risk of muscle problems (some of which are listed in the "Do not take Axocar" section):

• if oral fusidic acid is necessary to treat a bacterial infection, it may be necessary to temporarily stop taking Axocar. The doctor will inform when it is safe to restart Axocar. Taking Axocar with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). Additional information on rhabdomyolysis can be found in section 4.

Additional information on rhabdomyolysis can be found in section 4.

• cyclosporine (often used in patients who have undergone organ transplantation).
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the lining of the uterus grows outside the uterus).
• medicines containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections).
• fibrates containing active substances such as gemfibrozil and bezafibrate (used to lower cholesterol levels).
• erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections).
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV/AIDS).
• antiviral medicines used to treat hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir.
• nefazodone (used to treat depression).
• medicines containing the active substance cobicistat.
• amiodarone (used to treat heart rhythm disorders).
• verapamil, diltiazem, or amlodipine (used to treat high blood pressure, angina pectoris, or other heart conditions).
• lomitapide (used to treat a rare genetic cholesterol disorder).
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia). It is possible that muscle-related side effects may be greater when taking this medicine with simvastatin (e.g., Axocar). The doctor may decide to stop taking Axocar for a while.
• high doses (1 g or more per day) of niacin or nicotinic acid (also used to lower cholesterol levels).
• colchicine (used to treat gout).

Tell your doctor or pharmacist about all medicines the patient has taken recently, including those available without a prescription. In particular, tell your doctor if the patient is taking any of the following:

• medicines containing active substances that prevent blood clotting, such as warfarin, acenocoumarol, or phenindione (anticoagulant medicines).
• colestyramine (also used to lower cholesterol levels), as it affects the action of Axocar.
• fenofibrate (also used to lower cholesterol levels).
• rifampicin (used to treat tuberculosis).
• tikagrelor (used to prevent heart attack or stroke).

Inform any doctor who prescribes a new medicine about taking Axocar.

Axocar with food and drink

Grapefruit juice contains one or more components that increase the metabolism of certain medicines, including Axocar. Grapefruit juice should be avoided, as it may increase the risk of muscle problems.

Pregnancy and breastfeeding

Do not take Axocar if pregnant, planning to become pregnant, or suspecting pregnancy. If the patient becomes pregnant while taking Axocar, they should stop taking the medicine and consult a doctor immediately. Do not take Axocar during breastfeeding, as it is not known whether the medicine passes into breast milk.
Consult a doctor or pharmacist before taking any medicine.

Driving and using machines

It is not expected that Axocar will affect driving or using machines. However, consider that some people may experience dizziness after taking Axocar.
Axocar contains lactose and sodium.
Axocar tablets contain a sugar called lactose. If the patient has been diagnosed with intolerance to some sugars, they should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is "sodium-free".

3. How to take Axocar

The doctor will determine the dose of Axocar suitable for the patient based on their current treatment and individual risk.
Take this medicine always as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

• Before starting treatment with Axocar, follow a cholesterol-lowering diet.
• During treatment with Axocar, follow a cholesterol-lowering diet.

Adults: the recommended dose is 1 tablet, taken orally, once a day.
Use in adolescents (10 to 17 years old): the recommended dose is 1 tablet, taken orally, once a day (do not exceed the maximum dose of 10 mg + 40 mg per day).
The dose of Axocar, 10 mg + 80 mg, is recommended only for adult patients with very high cholesterol levels and a high risk of heart disease, who have not achieved target cholesterol levels with lower doses of the medicine.
If optimal dosing cannot be achieved with Axocar, the doctor may prescribe other tablets containing ezetimibe with simvastatin.
The tablets do not have a dividing line and should not be divided.
Axocar should be taken in the evening. It can be taken with or without food.
If the doctor has prescribed Axocar and another cholesterol-lowering medicine containing the active substance colestyramine or another bile acid sequestrant, take Axocar at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking a higher dose of Axocar than recommended

Consult a doctor or pharmacist.

Missing a dose of Axocar

Do not take a double dose to make up for a missed dose; take the usual dose of Axocar the next day at the usual time

Stopping treatment with Axocar

Consult a doctor or pharmacist, as cholesterol levels may rise again.
If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Axocar can cause side effects, although not everybody gets them (see section 2).
The following side effects have been reported commonly(may affect up to 1 in 10 people):

• muscle pain,
• increased liver enzyme levels and/or muscle enzyme levels (creatine kinase, CK) in the blood.

The following side effects have been reported uncommonly(may affect up to 1 in 100 people):

• increased liver enzyme levels in the blood; increased uric acid levels in the blood; prolonged blood clotting time; presence of protein in the urine; weight loss,
• dizziness; headache; tingling sensation,
• abdominal pain; nausea; bloating; nausea; vomiting; abdominal distension; diarrhea; dry mouth; heartburn,
• rash; itching; hives,
• joint pain; muscle pain, tenderness, weakness, or cramps; neck pain; pain in the arms and legs; back pain,
• unusual tiredness or weakness; feeling of fatigue; chest pain; swelling, especially of the hands and feet,
• sleep disorders; sleep problems.

The following side effects have been reported rarely(may affect up to 1 in 1,000 people):

• blurred vision and vision disturbances (which may affect up to 1 in 1,000 people).
• allergic reactions, including: allergic reactions, including swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing and require immediate treatment (angioedema), joint pain or inflammation, blood vessel inflammation, unusual bruising, skin rash, and swelling; hives; sensitivity to sunlight; fever; flushing; shortness of breath; malaise.
• memory loss; confusion.

The following side effects have been reported very rarely(may affect up to 1 in 10,000 people):

• severe allergic reaction causing difficulty breathing or dizziness (anaphylaxis).
• breast enlargement in men (gynecomastia).
• skin rash that may occur on the skin or mouth ulcers (drug-induced lupus-like eruption).
• muscle rupture.

The following side effects have been reported with an unknown frequency(frequency cannot be estimated from the available data) in patients taking both ezetimibe and simvastatin combination and ezetimibe or simvastatin:

• decreased red blood cell count (anemia); decreased platelet count, which can lead to bruising/bleeding (thrombocytopenia).
• numbness or weakness in the hands and feet.
• lung inflammation causing breathing problems, including persistent cough and/or shortness of breath or fever.
• constipation.
• pancreatitis, often with severe abdominal pain.
• gastritis.
• liver inflammation with symptoms such as yellowing of the skin and eyes; itching, dark urine, or pale stools, fatigue or weakness, loss of appetite; liver failure; gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting).

Additional possible side effects reported in patients taking some statins:

• sleep disturbances, including nightmares.
• sexual dysfunction.
• diabetes. The risk of developing diabetes is higher if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure. The doctor will monitor the patient's condition during treatment with this medicine.

Immediately consult a doctor if the patient experiences unexplained muscle pain, tenderness, or weakness. In rare cases, muscle problems can be serious, including muscle breakdown leading to kidney damage; in very rare cases, death has occurred.

death has occurred.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Axocar

Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and packaging after "EXP".
The expiry date refers to the last day of the month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Axocar contains

The active substances of Axocar are ezetimibe and simvastatin.
Each tablet contains 10 mg of ezetimibe and 10 mg of simvastatin.
Each tablet contains 10 mg of ezetimibe and 20 mg of simvastatin.
Each tablet contains 10 mg of ezetimibe and 40 mg of simvastatin.
Each tablet contains 10 mg of ezetimibe and 80 mg of simvastatin.
Other ingredients are:
Core:lactose monohydrate, hypromellose, sodium croscarmellose, microcrystalline cellulose, ascorbic acid, citric acid, butylhydroxyanisole (BHA), propyl gallate, magnesium stearate.
Color mixture:lactose monohydrate, yellow iron oxide (E 172), red iron oxide (E 172), and black iron oxide (E 172).

What Axocar looks like and contents of the pack

Axocar, 10 mg+10 mg, are light brown, speckled, round tablets with a diameter of 6 mm, convex on both sides with the marking "511" on one side.
Axocar, 10 mg+20 mg, are light brown, speckled, round tablets with a diameter of 8 mm, convex on both sides with the marking "512" on one side.
Axocar, 10 mg+40 mg, are light brown, speckled, round tablets with a diameter of 10 mm, convex on both sides with the marking "513" on one side.
Axocar, 10 mg+80 mg, are light brown, speckled, capsule-shaped tablets with dimensions of 17.5x7.55 mm, convex on both sides with the marking "515" on one side.
Pack sizes
Blisters.
Axocar, 10 mg+10 mg: 10, 30, 50, 100, and 300 tablets.
Axocar, 10 mg+20 mg, 10 mg+40 mg, 10 mg+80 mg: 30, 50, 100, and 300 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Street, 2600 Dupnitsa, Bulgaria
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Denmark: Ezimvalla
Germany: Ezetimib Simvastatin
Italy: Ezetimibe e Simvastatina Zentiva
Portugal: Sinvastatina + Ezetimiba Zentiva
Slovakia: Cornusan
Poland : Axocar
Date of last revision of the leaflet:September 2021