ZOSTATIN. 20 mg. 28 tablets

What ZOSTATIN and what it is used?
ZOSTATIN available as white , round, film-coated tablets. On one side of the film-coated tablets ZOSTATIN 10mg and 40 mg ZOSTATIN is scored . Each pack contains 14 or 28 tablets.
The active ingredient is simvastatin ZOSTATIN , which belongs to the group of so -called inhibitors of hydroxy- methyl -glutaryl -coenzyme A ( HMG-CoA ) reductase . Simvastatin reduces levels of LDL- cholesterol (this is called. "Bad" cholesterol, which has proven harmful effects on human health ) and fats called triglycerides , while increasing levels of HDL- cholesterol ( so-called . "good" cholesterol) .
Your doctor has prescribed ZOSTATIN, to reduce the health risks associated with ischemic heart disease (IHD ) or to reduce the amount of "bad '' cholesterol and / or triglycerides in the blood.
If you have coronary heart disease (impaired blood supply to the heart ) or have an increased risk of the occurrence of such (regardless of the level of cholesterol in your blood) , ie diabetes have had a stroke or other vascular disorders , ZOSTATIN:
- Can prolong your life by reducing the risk of heart attack ( infarction) or stroke ;
- Reduces the need for surgery (operations ) aimed at improving blood flow to the extremities or other major organs such as the brain and heart.
ZOSTATIN reduces the amount of "bad" cholesterol and / or triglycerides in the blood. An increased amount of "bad" cholesterol, can cause coronary artery disease , damages the blood vessels that supply oxygen and nutrients to the heart . Damage or hardening of the arteries is called atherosclerosis. Atherosclerosis can cause chest pain ( also called angina) and heart attack . ZOSTATIN slowing the progression of atherosclerosis and reduces the risk of the occurrence of such (including the complete occlusion of the vessels ) .
Before and during treatment with ZOSTATIN, you must follow certain diet . Diet will not only help lower your cholesterol , but its weight , which in most cases is also necessary.

2 . Before using ZOSTATIN
Do not take ZOSTATIN:
- If you are allergic (hypersensitive) to the active substance (simvastatin ) or any of the other ingredients.
- If you have active liver disease or an increase in the so-called serum transaminases ( laboratory values indicating the presence of hepatic dysfunction ) .
- If you are pregnant or breastfeeding.

Take special care with ZOSTATIN
Tell your doctor about all your diseases, especially muscle damage , diabetes, problems kidney or allergies. Tell your doctor if you drink large amounts of alcohol or if you suffer or have suffered from liver disease.
Immediately discontinue treatment and contact your doctor if you experience sudden and unexplained muscle pain or weakness, and the appearance of hypersensitivity ( allergy) .

Pay special attention to :
- If you are taking other medicines that can damage muscles ( leading to the emergence of so-called myopathy or rhabdomyolysis) , such as gemfibrozil and other fibrates (except fenofibrate ) , niacin ( nicotinic acid).
- If you are taking drugs known as inhibitors of CYP3A4 ( liver enzyme that is essential for the metabolism of many drugs ) is possible quantity of Simvastatin in your blood to rise and this may increase the risk of muscle damage . Such drugs are e.g. cyclosporine, mebefradil ( a drug used in the treatment of hypertension and angina pectoris) , antifungal agents such as itraconazole and ketoconazole, macrolide antibiotics erythromycin , clarithromycin and telithromycin , HIV- protease inhibitors ( used in the treatment of AIDS ) and the antidepressant nafadozon . Amiodarone , verapamil and diltiazem
may also inhibit the metabolism of simvastatin and increase its concentration. Therefore, if necessary, co-administered with simvastatin, then its dose should not be higher than 20 mg daily.

Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
As taking ZOSTATIN with the following medicines may increase the risk of muscle problems (see written above) , be sure to tell your doctor if you take:
- cyclosporine
- danazol
- Antifungals such as itraconazole and ketoconazole
- Macrolide antibiotics erythromycin, clarithromycin, and telithromycin
- HIV- protease inhibitor (used for the treatment of AIDS ) , as e. indinavir , nelfinavir , ritonavir and saquinavir
- Antidepressants nafadozon
- Amiodarone ( for the treatment of cardiac arrhythmias)
- Verapamil and diltiazem ( used to treat high blood pressure, and other vascular disorders)
- Niacin ( nicotinic acid ) .
You must inform your doctor if you take anticoagulants ( used to prevent blood clotting) , such as . warfarin , phenprocoumon or acenocoumarol , and if you are treated with fenofibrate ( a drug also used to lower cholesterol ) .

Taking ZOSTATIN with food and drink
Grapefruit juice contains some substances that inhibit enzymes involved in the metabolism of simvastatin (CYP3A4). Therefore , the regular consumption of large amounts of grapefruit juice (> 1 liter per day ) may result in increasing the amount of simvastatin in the blood, and should be avoided .
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine .
ZOSTATIN is contraindicated during pregnancy and lactation . ZOSTATIN can be administered to women of childbearing age only if it is determined that the probability of pregnancy is minimal. If you become pregnant during treatment with ZOSTATIN, you should immediately stop taking the drug and contact your doctor.

Driving and using machines
No data on the effect of simvastatin on ability to drive and use machines.

Important information about some of the ingredients of ZOSTATIN
Due to the excipient butylated risk of occurrence of irritation of eyes, skin and mucous membranes.

3 . How to use ZOSTATIN?
Always ZOSTATIN exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist. Do not forget to take your medicine .
You must follow a standard cholesterol - lowering diet before initiation of therapy with simvastatin , and to stick to this diet during treatment with the drug .
The dosage of simvastatin varied from 5 to 80 mg a day, once in the evening. When dosage adjustments are necessary , it should be done at intervals of not less than four weeks , the maximum daily dose is 80 mg a day, once in the evening.

In patients with a high risk of developing coronary heart disease ( with or without elevated cholesterol ) , i.e., in patients with diabetes , stroke or other cerebrovascular or vascular injury with proven coronary artery disease , the usual initial dose is 40 mg, once daily , evening
If you ZOSTATIN is used to reduce "bad " cholesterol and triglycerides , the usual starting dose is 20 mg taken as a single daily dose in the evening. For patients that require a significant reduction in cholesterol (above 45%) can be initiated at a dose of 40 mg, once a day in the evening . In patients with mild to moderate elevations of cholesterol can be started at a dose of 5 mg simvastatin.
In some cases , your doctor may increase the dose to a maximum of 80 mg daily, usually divided into three doses : 20 mg in the morning , 20 mg at noon and 40 mg at night .
Your doctor may prescribe a lower dose , especially if you are taking certain medicines or if you have severe kidney disease (see written above) .
If you take more dose ZOSTATIN always strictly follow the instructions of your doctor.
If you take more than you should , contact your doctor or call the emergency center (visit the nearest facility for medical emergencies) .
If you forget to take ZOSTATIN
Take the medicine as soon as you remember. If it is almost time for your next dose , skip the missed dose and take the next right , at the usual time, and then proceed with the usual regimen. Do not take a double dose to make up for a forgotten tablet (s) .
If you stop taking ZOSTATIN
Your doctor will determine the duration of treatment with ZOSTATIN. Not discontinued therapy prematurely because your cholesterol levels may rise again .
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 . Possible side effects
Like all medicines , ZOSTATIN can cause side effects, although not everybody gets them .
In most cases, side effects are mild and transient.
Below are presented the observed side effects , depending on their frequency (very common ( ^ / 10) , common ( > 1/100 to <1 /10) , uncommon (si / 1000 to <1/ 100) rare ( 21/10 , 000 to < 1/1 , 000), very rare (<1 /10, 000 ) and not known ( data can not be estimated ) .
very common: constipation
Common: abdominal pain, flatulence ( excessive gas and bloating ) , indigestion, diarrhea , nausea, vomiting
rare: inflammation of the pancreas , inflammation of the liver , anemia , headache , muscle pain , numbness and aching muscles , dizziness, peripheral nerve damage , hair loss , fatigue, various allergic reactions (rash , itching, redness, swelling of the face including shortness of breath ) .
Rarely observed changes in some liver function , and myopathy ( muscle damage ) , so your doctor will conduct certain tests ( blood tests) .
Immediately discontinue treatment and contact your doctor if you experience sudden and unexplained muscle pain or weakness, and the appearance of hypersensitivity ( allergy) .
If any of the side effects gets serious, or you notice other effects not listed in this leaflet , please tell your doctor.

5.Sahranenie of ZOSTATIN
Store in original containers at temperatures below 30 ° C. Do not use after the expiry date printed on the package. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required .
These measures will help to protect the environment.
Keep out of reach of children!

6 . Additional information
What does ZOSTATIN?
- The active ingredient is simvastatin. Each tablet contains 10, 20 or 40 mg simvastatin (Simvastatin).
- Excipients: butylhydroxyanisole ( E320 ) , ascorbic acid , limonene acid , microcrystalline cellulose , pregelatinized corn starch , lactose (anhydrous ) , crospovidone, magnesium stearate , hypromellose , titanium dioxide ( E171 ) , of nitroglycerin .