SIMVASTATIN. 20 mg. 28 tablets

The active substance is simvastatin. Each tablet contains 20 mg simvastatin ( International Nonproprietary Name ) .
The other ingredients are lactose monohydrate, microcrystalline cellulose , pregelatinized starch, butilhidrooksianizol (E 320 ) , ascorbic acid , citric acid , colloidal silica , talc , magnesium stearate , hypromellose, iron oxide red ( E 172 ) , yellow iron oxide (E 171 ) , triethyl nitrate , titanium dioxide (E 171 ) , povidone .
 
What is Simvastatin and what it is used?
Simvastatin is a medicine that lowers cholesterol and fatty substances - blood triglycerides .
Available in packs of 28 count tablets.
Each tablet contains :
10 mg simvastatin
20 mg simvastatin
40 mg simvastatin
 

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This product is used to decrease the amount of cholesterol and triglycerides in the blood, when the response from the diet is not sufficient. Cholesterol may cause coronary heart disease through a blockage of the blood vessels that carry oxygen and nutrients to the heart. These blockages or hardening of the arteries is called atherosclerosis Atherosclerosis can cause chest pain (called angina ) and heart attack .
If you have heart disease , your doctor prescribed simvastatin ozone to prolong your life , reduce the risk of heart attack or cerebrovascular accident / complications and reduce the risk of surgery to increase blood flow to the heart.
Furthermore Simvastatin Ozone slows progression of atherosclerosis and reduces the development of new atherosclerotic changes.
 
When you should not use simvastatin Ozone ?
• With hypersensitivity to any component
• If you have a confirmed diagnosis of active liver disease
• During pregnancy and lactation
Special considerations for treatment with simvastatin Ozone
Take special care with Simvastatin Ozone in the cases :
• If you consume large amounts of alcohol;
• If you have a history of liver disease ;
• When running a combination therapy of simvastatin with Ozone other drugs ( fibrtati and niacin / nicotinic acid ) , which can cause myopathy, in self -administration . In this case you should carefully evaluate the benefit / risk , and patients monitored for symptoms of muscle pain , tenderness or weakness, in the initial months of therapy and during the period of increasing doses of both drugs ;
• To be used with caution in patients with renal disease, uncontrolled hypothyroidism, personal or family history of hereditary muscular disorders , as well as in cases of muscle damage following administration of other statins and fibrates ;
• During treatment with amidaron , verapamil , diltiazem .
Tell your doctor about current and past medical problems and if you have any allergies.
Ozone simvastatin is not recommended for children.
 
What you should consider during pregnancy and lactation ?
pregnancy
Pregnant women or women planning to become pregnant should not take Simvastatin ozone.
If you become pregnant while taking Simvastatin Ozone should stop treatment immediately and tell your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
breastfeeding
If you are breastfeeding your baby should not take Simvastatin ozone.
Ask your doctor or pharmacist for advice before taking any medicine.
What you need to know when driving or operating machinery ?
According to currently available information , Ozone Simvastatin should not affect the ability to drive and use machines.
Must keep in mind that can rarely be seen Dizziness when driving or operating machinery.
 
Alert!
Simvastatin Ozone contain butilhidrooksianizol and therefore can irritate the eyes, skin and mucous membranes .
 
What side effects can cause Simvastatin Ozone ?
Like all medicines , Simvastatin Ozone can have side effects .
Generally Simvastatin Ozone was well tolerated . In most cases, side effects were mild and of short duration .
The most common side effects are digestive disorders ( constipation , abdominal pain , flatulence, dyspepsia , diarrhea, nausea , vomiting, pancreatitis) , headache , dizziness , loss of balance , rash , itching , hair loss , asthenia. Rarely encountered myopathy ( muscle pain, muscle weakness) , liver problems, and hypersensitivity ( allergic reactions that may have different symptoms, including joint pain , fever or breathing difficulties ) .
Due to the fact that in very rare occasions, muscle problems are severe , consult your doctor if you have pain , faint or weak muscles . Other side effects may occur in rare cases , some may be severe , in which case tell your doctor immediately .
Upon the occurrence of any side effects , ask your doctor !
 
What other drugs affect the effect of simvastatin Ozone ?
Consult your doctor or pharmacist if you are taking or have recently taken any other medicines , including medicines obtained without a prescription.
It is especially important that your doctor knows if you are taking cyclosporine , anticoagulants (drugs that prevent blood clotting such as warfarin , phenprocoumon , acenocoumarol ), antifungals (such as itraconazole , ketoconazole ), fibrates (such benzafibrate , fenofibrate , gemfibrozil ), antibiotics ( such as erythromycin , clarithromycin ); HIV protease inhibitors ( such as indinavir , nelfinavir , ritonavir ), antidepressants ( nefazodone ), or high doses ( > 1 g / day ) nicotinic acid or niacin .
The risk of myopathy is entrained by concomitant use of higher doses of simvastatin ozone amidaron , verapamil and diltiazem .
Must be prevented to the adoption of significant amounts of grapefruit juice during treatment with simvastatin Ozone .
Other studies have shown that inhibition of HMG-CoA reductase may result in damage to the fetus due to the reduced level of mevalonic acid in the developing embryo.
 
6 . PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Core : Lactose monohydrate, Macrocrystalline cellulose, Pregelatinised starch 1500 , Butilated hydroxyanisole, Ascorbic acid, Citric acid, Colloidal anhydrous silica, Talc, Magnesium stearate, Ethanol 96 ° *, Purified water *
Film coating : Hydroxypropylmethylcellulose (Pharmacoat 606 ), Hydroxypropylmethylcellulose (Methocel E15 LV Premium), Red iron oxide, Yellow iron oxide, Triethyl citrate, Titanium dioxide, Povidone K- 30 , Purified water ** are removed during production
 
6.2 . Incompatibilities
Not applicable .
 
6.3. Expiration date
3 (three) years
 
6.4 . Special precautions for storage
At temperatures below 30 ° C. Store in the original package .
 
6.5 Nature and contents of container
Simvastatin Ozone for 10 mg, 20 mg and 40 mg - blister PVC / PVDC / AI at 28 pcs . film-coated tablets
 
6.6. Recommendations for use
To obtain a dose of 5 mg of the 10 mg tablet is broken along the score line .