ATOZET 10 mg./20 mg. 30 tablets

What is ATOZET and what it is used for
ATOZET is a medicine to lower elevated cholesterol levels. ATOZET contains ezetimibe and atorvastatin.
ATOZET is used in adults to lower total cholesterol levels, "bad" cholesterol (LDL cholesterol), and fatty substances in the blood called triglycerides. In addition, ATOZET increases the levels of "good" cholesterol (HDL cholesterol).
ATOZET lowers your cholesterol in two ways. It lowers cholesterol, which is absorbed in the digestive tract, as your body lowers cholesterol by itself.
Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is mainly made of LDL and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol, as it can accumulate on the walls of your arteries, forming plaques. Finally, this plaque build-up may cause narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and the brain. This blockage of blood flow can cause a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol as it prevents bad cholesterol from accumulating in the arteries and preventing heart disease.
Triglycerides are another form of fat in your blood that can increase the risk of heart disease.
ATOZET is used in patients who can not control their cholesterol levels by diet alone. You should stay on a cholesterol-lowering diet while taking this medicine.

ATOZET is used as an additional supplement to your cholesterol-lowering diet if you have:
Increased cholesterol in your blood (primary hypercholesterolaemia [heterozygous family or non-family] or increased levels of fat in your blood (mixed type hyperlipidemia);
When there is no good control with a statin alone;
For which you have used statin and ezetimib as separate tablets;
Hereditary illness (homozygous familial hypercholesterolemia), which increases the level of cholesterol in your blood. You can also get another treatment.
ATOZET does not help to lower body weight.

2. What you need to know before you take ATOZET
Do not take ATOZET
If you are allergic to ezetimibe, atorvastatin or any of the other ingredients of this medicine (listed in section 6);
If you have or have had a disease that affects the liver;
If you have any unexplained bias in blood tests for hepatic function;
If you are a woman of childbearing age and you are not using a reliable method of contraception;
If you are pregnant, plan to become pregnant or breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking ATOPE if:
You have had a previous stroke with hemorrhage in the brain or have small "pockets" with fluid in the brain from previous strokes;
Have kidney problems;
Have decreased thyroid function (hypothyroidism);
Have recurrent or unexplained muscle pain, personal or family history of muscle problems;
You have had previous muscle problems during treatment with other lipid-lowering medicines (eg other statins or fibrates);
Regularly drink a large amount of alcohol;
You have had liver disease;
You are over 70 years of age;
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.
Contact your doctor immediately if you have any complaints of unexplained muscle pain, weakness or tiredness while taking ATOZET. This is necessary because, in rare cases, muscle problems may be serious, including muscle breakdown and subsequent kidney damage. It is known that atorvastatin causes muscle problems, and cases of muscle problems have also been reported with the use of ezetimibe.
Also tell your doctor or pharmacist if you have a muscle weakness that is constant. It may be necessary to perform further studies and take additional medicines to diagnose and treat this condition.
Ask your doctor or pharmacist before taking ATOZET if you have severe respiratory failure.
If any of these conditions apply to you (or you are not sure), talk to your doctor or pharmacist before taking ATOZET as your doctor will need to carry out blood tests before and probably during treatment with  ATOZET to Predict the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, Rhabdomyolysis is increased when some medicines are taken at the same time (see section "Other medicines and ATOZET
While you are being treated with this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are probably at risk of developing diabetes if you have high blood sugar and fat levels if you are overweight and have high blood pressure.
Tell your doctor about all of your illnesses, including allergies.
Concomitant use of ATOZET and fibrates (cholesterol lowering drugs) should be avoided as the combined use of  ATOZET and fibrates has not been studied.

Children
ATOZET  is not recommended in children and adolescents.

Other Drugs and ATOZET
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

There are some medicines that can alter the effect of  ATOZET or their effect can be changed by ATOZET (see section 3). This type of interaction could make one or both of these drugs less effective. Another possibility is to increase the risk or severity of side effects, including the severe muscle wasting condition known as "rhabdomyolysis" described in section 4:
Ciclosporin (often used in organ transplant patients);
Erythromycin, clarithromycin, telithromycin, fusidic acid, rifampicin (medicines for bacterial infections);
Ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines for fungal infections);
Gemfibrozil, other fibrates, nicotinic acid, derivatives, colestipol, cholestyramine (medicines for regulating lipid levels);
Some calcium channel blockers used for chest pain or high blood pressure, e.g. Amlodipine, diltiazem;
Digoxin, verapamil, amiodarone (medicines to regulate heart rhythm);
Medicines used to treat HIV, e.g. Ritonavir, lopinavir, atazanavir, indinavir, darunavir, a combination of tipranavir / ritonavir and others (AIDS medicines);
Some medicines used to treat hepatitis C, e.g. Telaprevir.
Other medicines known to interact with ATOZET
Oral contraceptives (medicines to prevent pregnancy);
Stiripentol (an anticonvulsant medicine for the treatment of epilepsy);
Cimetidine (a medicine used for stomach acids and peptic ulcers);
Fenazone (painkiller);
Antacids (digestive products containing aluminum or magnesium);
Warfarin, phenprocoumon, acenocoumarol or fluindion (medicines to prevent blood clots);
Boceprevir (a medicine used to fight hepatitis C infection);
Colchicine (used to treat gout);
St. John's Wort (a medicine to treat depression).
ATOZET with food and alcohol
See section 3 for instructions on how to take ATOZET. Please note the following:

Grapefruit juice
Do not take more than one or two small glasses of grapefruit juice a day because large amounts of grapefruit juice can alter the effects of ATOZET

Alcohol
Avoid drinking too much alcohol while taking this medicine. Refer to Section 2 "Warnings and Precautions" for details.

Pregnancy and breastfeeding
Do not take ATOZET  if you are pregnant, planning a pregnancy or think you may be pregnant. Do not take ATOZET if you are able to get pregnant unless you use a reliable method of contraception. If you become pregnant while taking ATOZET, stop taking it immediately and tell your doctor.
Do not take ATOZET if you are breast-feeding.
The safety of ATOZET during pregnancy and lactation has not yet been demonstrated.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Do not expect ATOZET to affect your ability to drive or use machines. However, it should be borne in mind that some people may feel dizzy after receiving ATOZET

ATOZET contains lactose
ATOZET tablets contain sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take ATOZET
Always take this medicine exactly as your doctor has told you. Your doctor will determine the appropriate tablet for you, depending on your current treatment and your risk. If you are not sure, ask your doctor or pharmacist.
Before starting treatment with ATOZET, you should have a cholesterol lowering diet;
You have to stay on this cholesterol-lowering diet while you are taking ATOZET
How much to take
The recommended dose is one ATOZET tablet orally once a day.

When to take
ATOZET is taken at any time of the day. You can take it with or without food.
If you have been prescribed ATOZET with your cholestyramine or other bile acid sequestrant (cholesterol lowering medicines), you should take ATOZET at least 2 hours before or 4 hours after taking bile acid sequestrant.

If you take more than the necessary dose of ATOZET
Please contact your doctor or pharmacist.

If you forget to take ATOZET
Do not take an extra dose, simply take the usual amount of ATOZET at the usual time the next day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, ATOZET  can cause side effects, although not everyone gets them.

If you have any of the following serious side effects, stop taking your tablets and tell your doctor immediately or go to the nearest hospital emergency room:
Severe allergic reaction that causes swelling of the face, tongue and throat, which may cause difficulty in breathing;
Severe illness with severe flaking and swelling of the skin, blistering of the skin, mouth, eyes, genitals and fever; Skin rash in the form of pink-red spots, especially on the palms of the hands or feet, which can lead to blistering;
Muscle weakness, soreness or pain, and especially if you are not feeling well or feverish, it can be caused by unusual muscle breakdown that can be life-threatening and lead to kidney problems.
You should consult your doctor as soon as possible if you have problems with unexpected or abnormal bleeding or bruising, as this may be a hepatic complaint.

The following common side effects have been observed (may affect up to 1 in 10 people):
Diarrhea;
Muscle pain.
The following uncommon side effects (may affect up to 1 in 100 people) have been observed:
Influenza;
Depression, sleeping problems, sleep disturbances;
Dizziness, headache, numbness;
Slow heartbeat;
Hot waves;
Breathlessness;
Abdominal pain, abdominal swelling, constipation, indigestion, gas, frequent bowel movements, stomach inflammation, nausea, stomach discomfort, upset stomach;
Acne, urticaria;
Joint pain, back pain, leg cramps, muscle fatigue, cramps or weakness, pain in the hands and feet;
Abnormal weakness, feeling tired or unwell, swelling;
Increased laboratory blood tests for liver or muscle function (CK);
Weight gain.
In addition, the following side effects were seen in people taking ATOPEST or ezetimibe or atorvastatin tablets:
Allergic reactions including swelling of the face, lips, tongue and / or throat which may cause difficulty in breathing or swallowing (which requires immediate treatment);
Embossed red rash, sometimes with lesions;
Liver problems;
Coughing;
Stomach acids;
Decreased appetite, loss of appetite;
high blood pressure;
Skin rash and pruritus, allergic reactions including rash and urticaria;
Tendon problems;
Gall stones or gallbladder inflammation (which may cause abdominal pain, nausea, vomiting);
Inflammation of the pancreas often with severe abdominal pain;
Decreasing the number of blood cells, which may cause bruising / bleeding (thrombocytopenia);
Inflammation of the nasal passages; Bleeding from the nose;
Neck pain; Pain; Chest pain; throatache;
Increase and lower blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels);
You have nightmares;
Numbness or tingling of the fingers and toes;
Decreased sensitivity to pain or touch;
Change in taste, dry mouth;
Loss of memory;
Tinnitus and / or headache; Hearing loss;
Vomiting;
Burping;
Hair loss;
Fever;
A positive white urine blood test;
Blurred vision, visual disturbances;
Gynecomastia (breast enlargement in men and women).
Additional possible side effects have been reported with some statins:
Sexual difficulties;
Depression;
Breathing problems, including persistent cough and / or shortness of breath or fever;
Diabetes. This is more likely if you have high levels of sugars and fat in your blood if you are overweight and have high blood pressure. Your doctor will monitor you while taking this medicine;
Muscle pain, tenderness or weakness that is persistent and may not resolve after stopping ATOZET (frequency not known).
How to Store ATOZET
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton or blister after "EXP" and "EXP".
Store in the original package in order to protect from oxygen.
Do not dispose of medicines in the sewers or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What ATOSET contains
The active ingredients are: ezetimibe and atorvastatin. Each film-coated tablet contains 10 mg of ezetimibe and 20 mg of atorvastatin (as atorvastatin calcium trihydrate).
The other ingredients are: calcium carbonate, colloidal anhydrous silica, croscarmellose sodium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone, sodium lauryl sulfate.
The film coating contains: hypromellose, macrogol 8000, titanium dioxide (E171), talc.

What ATOZET looks like and contents of the pack
White to off-white, oblong, biconvex, film-coated tablets.
ATOZET 10 mg / 20 mg tablets: debossed with "333" on one side.

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