ATOZET 10/10MG 30'S

What Ezetimibe, Atorvastatin is and what it is used for:

• This medicine contains the active substances ezetimibe and Atorvastatin.
• This medicine is used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood.
• In addition, EZETIMIBE, ATORVASTATIN raises levels of “good” cholesterol (HDL cholesterol).
• EZETIMIBE, ATORVASTATIN works to reduce your cholesterol in two ways.
• The active ingredient ezetimibe reduces the cholesterol absorbed in your digestive tract.
• The active ingredient Atorvastatin belonging to the class of “statins” inhibits the production of the cholesterol your body makes by itself.
• Cholesterol is one of several fatty substances found in the bloodstream.
• Your total cholesterol is made up mainly of LDL and HDL cholesterol.
• LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of your arteries forming plaque.
• Eventually this plaque build-up can lead to a narrowing of the arteries.
• This narrowing can slow or block blood flow to vital organs such as the heart and brain.
• This blocking of blood flow can result in a heart attack or stroke.
• HDL cholesterol is often called “good” cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease.
• Triglycerides are another form of fat in your blood that may increase your risk for heart disease.
• EZETIMIBE, ATORVASTATIN is used for patients who cannot control their cholesterol levels by diet alone.
• You should stay on a cholesterol-lowering diet while taking this medicine.

EZETIMIBE, ATORVASTATIN is used in addition to your cholesterol-lowering diet if you have:

• A raised cholesterol level in your blood (primary hypercholesterolaemia [heterozygous familial and non-familial]) or elevated fat levels in your blood (mixed hyperlipidaemia):
• That is not well controlled with a statin alone,
• For which you have used a statin and ezetimibe as separate tablets.
• A hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood.
• You may also receive other treatments.
• Heart disease, EZETIMIBE, ATORVASTATIN reduces the risk of heart attack, stroke, surgery to increase heart blood flow, or hospitalisation for chest pain.

EZETIMIBE, ATORVASTATIN does not help you lose weight.

What you need to know before you use Ezetimibe, Atorvastatin:

Do not use Ezetimibe, Atorvastatin:

Tell your doctor if:

• You are allergic (hypersensitive) to ezetimibe, Atorvastatin, or any of the other ingredients of this medicine
• You currently have liver problems,
• You are pregnant or breastfeeding,

Warnings and precautions:

You should let your doctor know:

• About all your medical conditions including allergies,
• If you drink large amounts of alcohol or have ever had liver disease.

• If you are due to have an operation.
• If you are Asian, because a different dose may be applicable to you.

Other medicines and Ezetimibe, Atorvastatin:

Tell the doctor or pharmacist if you you are taking any of the following:

• If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine.
• Your doctor will tell you when it is safe to restart EZETIMIBE, ATORVASTATIN.
• Taking this medicine with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis).
• Ciclosporin (often used in organ transplant patients),
• Danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
• Medicines with an active ingredient like itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
• Fibrates with active ingredients like 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 AIDS),
• Hepatitis C antiviral agents such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection),
• Nefazodone (used to treat depression),
• Medicines with the active ingredient cobicistat,
• Amiodarone (used to treat an irregular heartbeat),
• Verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions),
• Lomitapide (used to treat a serious and rare genetic cholesterol condition),
• Daptomycin (a drug used to treat complicated skin and skin structure infections and bacteraemia).
• It is possible that side effects affecting the muscles may be higher when this medicine is taken during treatment with Atorvastatin.
• Large amounts (1 gram or more each day) of niacin or nicotinic acid (also used to lower cholesterol),
• Colchicine (used to treat gout).
• As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without prescription.
• In particular, tell your doctor if you are taking any of the following:
• Medicines with an active ingredient to prevent blood clots, such as warfarin, fluindione, phenprocoumon or acenocoumarol (anticoagulants),
• Cholestyramine (also used to lower cholesterol), because it affects the way EZETIMIBE, ATORVASTATIN works,
• Fenofibrate (also used to lower cholesterol),
• Rifampicin (used to treat tuberculosis),
• Ticagrelor (antiplatelet medicine).

How to use Ezetimibe, Atorvastatin:

• Your doctor will determine the appropriate tablet strength for you, depending on your current treatment and your personal risk status.
• The tablets are not scored and should not be divided.
• Always take this medicine exactly as your doctor or pharmacist has told you.
• Check with your doctor or pharmacist if you are not sure.
• Before starting EZETIMIBE, ATORVASTATIN, you should be on a diet to lower your cholesterol.
• You should keep on this cholesterol-lowering diet while taking EZETIMIBE, ATORVASTATIN.
• Adults: The dose is1 tabletEZETIMIBE, ATORVASTATIN by mouth once a day.
• Use in adolescents(10 to 17 years of age): The dose is1 tabletEZETIMIBE, ATORVASTATIN by mouth once a day (a maximum dose of 10 mg/40 mg once daily must not be exceeded).
• The EZETIMIBE, ATORVASTATIN 10 mg/80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses.
• Take EZETIMIBE, ATORVASTATIN in the evening.
• You can take it with or without food.
• If your doctor has prescribed EZETIMIBE, ATORVASTATIN along with another medicine for lowering cholesterol containing the active ingredient cholestyramine or any other bile acid sequestrant, you should take EZETIMIBE, ATORVASTATIN at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Possible side effects:

• Stop using the product and seek immediate medical attention if
• Difficulty breathing or swallowing, swelling of face, lips, throat or tongue, skin rash
• Unexplained muscle pain, tenderness, or weakness.

How to store Ezetimibe, Atorvastatin:

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton or container after [EXP].
• Do not store Ezetimibe, Atorvastatin Tablets above 30°C.