Axocar

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 you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 two mechanisms that reduce cholesterol levels. The active substance ezetimibe reduces the absorption of cholesterol in the digestive tract. The active substance simvastatin, which belongs 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. Ultimately, these plaques can cause narrowing of the arteries, resulting in restricted or blocked blood flow to vital organs, such as the heart and brain. Restricted blood flow can lead to 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, which can contribute to an 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-reducing diet should be followed.
Axocar is used as a supplementary treatment to a cholesterol-reducing diet in cases of:

• high blood cholesterol (primary hypercholesterolemia [heterozygous familial or non-familial]) or high blood fat (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 reduction.

2. Important information before taking Axocar

Do not take Axocar if:

• you are allergic to ezetimibe, simvastatin, or any of the other ingredients of this medicine (listed in section 6).
• you currently have liver problems.
• you are pregnant or breastfeeding.
• you are taking any of the following medicines:
• itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections),
• erythromycin, clarithromycin, or telithromycin (used to treat infections),
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infection),
• boceprevir or telaprevir (used to treat hepatitis C),
• nefazodone (used to treat depression),
• cobicistat,
• gemfibrozil (used to lower cholesterol),
• cyclosporine (often used in patients who have had an organ transplant),
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the lining of the uterus grows outside the uterus).
• you are currently taking or have taken within the last 7 days a medicine called fusidic acid (an antibiotic) orally or by injection. Taking fusidic acid with Axocar may lead to serious muscle problems (rhabdomyolysis). Do not take Axocar at a dose greater than 10 mg + 40 mg if you are taking lomitapide (used to treat a rare genetic cholesterol disorder).

In case of doubt about whether you are taking any of the above-mentioned medicines, consult your doctor.

Warnings and precautions

Before starting treatment, inform your doctor:

• about all your conditions, including allergies.
• about consuming large amounts of alcohol or having a history of liver disease. Taking Axocar may not be suitable.
• about an upcoming surgical procedure. It may be necessary to stop taking Axocar tablets for a short time.
• if you are of Asian origin, as a different dose may be suitable for you.
• about severe lung disease.

Your doctor should perform a blood test before starting Axocar and during treatment if you have any liver problems. The test will assess liver function.
Your doctor may also perform blood tests to assess liver function after starting Axocar.
During therapy, your doctor will closely monitor your health if you have diabetes or are at risk of developing diabetes. The risk of developing diabetes exists 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 no studies have been conducted 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 you are currently taking or have recently taken, as well as any medicines you plan to take, including those containing any of 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 will be necessary to temporarily stop taking Axocar. Your doctor will inform you 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.

tkliwości or bólu mięśni (rabdomioliza). Dodatkowe informacje dotyczące rabdomiolizy
znajdują się w punkcie 4.

• cyclosporine (often used in patients who have had an organ transplant).
• 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).
• erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections).
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infection).
• 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, or other heart conditions).
• lomitapide (used to treat a rare genetic cholesterol disorder).
• daptomycin (an antibiotic used to treat complicated skin and soft tissue infections and bacteremia). It is possible that muscle-related side effects may be greater when this medicine is taken with simvastatin (e.g., Axocar). Your doctor may decide to stop Axocar for a while.
• high doses (1 g or more per day) of niacin or nicotinic acid (also used to lower cholesterol).
• colchicine (used to treat gout).

Similarly, tell your doctor or pharmacist about all medicines you have taken recently, including those available without a prescription. In particular, tell your doctor if you are taking any of the following:

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

Also, inform any doctor who prescribes a new medicine that you are taking Axocar.

Axocar with food and drink

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

Pregnancy and breastfeeding

Do not take Axocar if you are pregnant, plan to become pregnant, or suspect you may be pregnant. If you become pregnant while taking Axocar, stop taking the medicine and consult your doctor immediately. Do not take Axocar while breastfeeding, as it is not known whether the medicine passes into breast milk.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

You should not expect Axocar to affect your ability to drive or use 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 you have been diagnosed with intolerance to some sugars, consult your 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

Your doctor will determine the dose of Axocar suitable for you, depending on your current treatment and individual risk.
Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

• Before starting Axocar, you should be on a cholesterol-reducing diet.
• While taking Axocar, you should follow a cholesterol-reducing diet.

Adults: the recommended dose is 1 tablet, taken orally, once a day.
Use in adolescents (10-17 years): 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.
If optimal dosing cannot be achieved with Axocar, your 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 your doctor has prescribed Axocar and another cholesterol-lowering medicine containing the active substance cholestyramine 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 your 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 Axocar treatment

Consult your doctor or pharmacist, as your cholesterol levels may rise again.
If you have any further questions about taking this medicine, consult your 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 values of liver function parameters (aminotransferase activity) and (or) muscle (creatine kinase activity, CK) in the blood.

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

• increased liver function parameters in the blood; elevated 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 fatigue or weakness; feeling tired; 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 1000 people):

• blurred vision and vision disturbances (which may occur in up to 1 in 1000 people).
• allergic reactions, including: allergic reactions, including face, lip, tongue, and (or) throat swelling, 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, skin sensitivity to sunlight, fever, redness, difficulty breathing, and malaise; a condition similar to lupus (including rash, joint disorders, and effects on white blood cells).
• memory loss, memory impairment, disorientation.

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

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

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

• reduced red blood cell count (anemia); reduced platelet count, which can lead to bruising/bleeding (thrombocytopenia).
• numbness or weakness in the hands and feet.
• inflammation of the lungs, 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).

hair loss; red, raised rash, sometimes with changes in the shape of a target (erythema multiforme).

• muscle pain, tenderness, weakness, or cramps; muscle damage; tendon disorders, sometimes complicated by tendon rupture.
• decreased appetite.
• hot flashes; high blood pressure.
• pain.
• erectile dysfunction.
• depression.
• changes in the results of some laboratory tests that assess liver function.
• persistent muscle weakness.

Additional possible side effects reported in patients taking some statins:

• sleep disturbances, including nightmares.
• sexual dysfunction.
• diabetes. The risk of developing diabetes is greater if you have high blood sugar and fat levels, are overweight, and have high blood pressure. Your doctor will monitor your condition during treatment with this medicine.

If you experience unexplained muscle pain, tenderness, or weakness, consult your doctor immediately. In rare cases, muscle problems can be serious, including muscle breakdown leading to kidney damage; in very rare cases, death has occurred.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Axocar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister 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 no longer required. 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.
The other ingredients are:
Tablet 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