NEOSIMVA. 40 mg. 28 tablets
NEOSIMVA. 40 mg. 28 tablets
NEOSIMVA WHAT IS AND WHAT IT IS USED
Neosimva film-coated tablets of 10, 20 , 40 and 80 mg in packs of PVC / Aluminium foil packed in a carton containing patient information leaflet . Pack of 14, 28 or 84 tablets.
Each tablet contains the 10 mg, 20 mg, 40 mg or 80 mg of active ingredient Simvastatin (Simvastatin).
Neosimva is indicated for the treatment of:
Patients at high risk of developing coronary heart disease ( CHD ) or ischemic heart disease with known
In patients with a high risk of developing coronary heart disease ( with or without hyperlipidemia ), i.e. in patients with diabetes , history of stroke or other cerebrovascular disease , peripheral vascular disease , or with proven coronary artery disease , Neosimva is indicated for :
Reduction of total mortality by reducing CHD mortality ;
Reducing the risk of major vascular events ( nonfatal myocardial infarction, coronary death , stroke or revascularization procedures) ;
Reducing the risk of major coronary events ( nonfatal myocardial infarction or coronary death ) ;
Reduce the risk of stroke ;
Reduce the need for coronary revascularisation procedures ( coronary artery bypass surgery and percutaneous coronary intervention) ;
Reducing the need for peripheral and other nekoronarni revascularization procedures ;
Reduce the risk of hospitalization for angina.
In patients with diabetes , Neosimva is indicated to reduce the risk of complications of the large peripheral vessels ( peripheral revascularization procedures , amputations of the lower limbs or legs of ulkusi ) .
In patients with hypercholesterolemia and coronary artery disease , Neosimva shown to slow the progression of coronary atherosclerosis , incl. reducing the development of new lesions and new total occlusions .
Patients with hyperlipidemia
Neosimva shown in adjunct to diet to reduce elevated total cholesterol (total - C), and LDL-C, Triglycerides (TG) and apolipoprotein B ( apo -B) , and for the increase of high density cholesterol (HDL-C) in patients with primary hypercholesterolemia , including heterozygous familial hypercholesterolemia (Fredrickson Type IIa ) or combined (mixed ) hyperlipidemia (Fredrickson type IIb), when response to diet and other appropriate nonpharmacological measures is inadequate. Neosimva ratios decreased LDL / FTOL and total cholesterol / HDL.
Neosimva is indicated for the treatment of patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia ) ;
Neosimva is indicated for treatment of patients with primary dysbetaliproteinemia (Fredrickson Type III hyperlipidemia ) ;
Neosimva is also shown in addition to diet and other nedietichni measures in patients with homozygous familial hypercholesterolemia in reducing elevated total - C , LDL-C, apo -B.
2 . BEFORE YOU TAKE NEOSIMVA
Do not take Neosimva under the following conditions :
Hypersensitivity to any component of this composition .
Active liver disease or unexplained persistent elevations of serum transaminases .
Pregnancy and lactation (see Pregnancy and lactation ) .
Special considerations for treatment Neosimva
Myopathy / rhabdomyolysis
The active ingredient Simvastatin, and other products with a similar mechanism of action, sometimes cause myopathy manifested as muscle pain or weakness associated with elevated levels of creatine kinase (CK ) more than 10 times the upper limit of normal. Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria , and in rare cases fatal outcome has occurred .
The risk of myopathy / rhabdomyolysis is increased by concomitant use of Neosimva with the following medicines :
Medicaments containing : Itraconazole, Ketoconazole, Erythromycin, Clarithromycin, Telithromycin, HTV- protease inhibitors , or Nefazodone, especially at higher doses Neosimva.
Lipid lowering drugs that can cause myopathy . when administered alone : Gemfibrozil, other fibrates , Niacin ( nicotinic acid ) in the lipid-lowering doses ( > 1 g / day ) , especially at higher doses Neosimva.
Cyclosporine: especially with large doses Neosimva.
Diltiazem: risk of myopathy is slightly increased in patients on Diltiazem, which simultaneously take Neosimva 80 mg. In these patients, the risk of myopathy is approximately 1%.
The risk of myopathy / rhabdomyolysis is dose- dependent . In this connection it should be considered:
In various clinical trials, persistent increases ( to more than 3X the ULN ) in serum transaminases in a small number of adult patients who received Simvastatin, when treatment was interrupted or stopped in these patients , the transaminase levels are predterapevtichnite to decline gradually . Preferred to perform liver function tests before initiation of treatment, and thereafter when clinically indicated. Patients in whom the dose was increased to 80 mg, should be tested prior to further increase , 3 months after the increase to 80 mg, and thereafter periodically during treatment (e.g., 6 months ) in the first year of therapy.
The preparation should be used with caution in patients who consume substantial quantities of alcohol and / or have a history of liver disease. Active liver disease or unexplained increases in transaminases are contraindications to the use of Neosimva.
Even if you do not apply any drug therapy, gradually reduce the transparency of the lens can be explained by the aging process . At present the results from a long period of clinical trials have not revealed untoward side effects of Simvastatin on human ocular lens .
The safety and efficacy of its use in children has not yet been established. Simvastatin is currently not recommended for pediatric use.
Use in the Elderly
In patients older than 65 years who are receiving other Simvastatin in controlled clinical studies , the efficacy , as measured by the rate of reduction in the levels of total and LDL-C is similar to that in the general population , and also there was no increased incidence abnormal clinical and laboratory findings .
Information on intolerance to some sugars
If your doctor has told you that you have an intolerance to some sugars , contact him before taking this medicine . Neosimva contains lactose.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with :
Cyclosporine: The risk of myopathy / rhabdomyolysis is increased by concomitant administration of cyclosporine, especially with high doses Neosimva.
Amiodarone or Verapamil: The risk of myopathy / rhabdomyolysis is increased by concomitant use of higher doses Neosimva c Amiodarone or Verapamil.
Diltiazem: Patients receiving both Diltiazem and Neosimva 80 mg have a slightly increased risk of myopathy .
Grapefruit juice contains one or more components which inhibit CYP3A4 and can increase the plasma levels of drugs that are metabolized by CYP3A4. The effect of usual consumption (one 250 ml cup a day ) is minimal and has no clinical significance. Very large amounts ( more than 1 liter per day ) , however, should be avoided .
It has been found that the Simvastatin 20-40 mg daily moderately potentiates the effect of coumarin anticoagulants. Patients makers coumarin anticoagulants , prothrombin time should be determined before the start of Simvastatin and frequently enough during early therapy to ensure that no significant alteration of prothrombin time occurs . Once a stable prothrombin time, it should be monitored in normal patients on coumarin anticoagulants . If the dose of Simvastatin is changed or it is stopped , must be dealt with in the same way . Simvastatin therapy is not associated with bleeding or with changes in prothrombin time in patients not taking anticoagulants.
In healthy volunteers, there was no clinically significant pharmacokinetic or pharmacodynamic interaction with concomitant administration of single doses of Simvastatin and Propranolol.
Coadministration of Simvastatin and Digoxin in healthy volunteers resulted in a slight increase (less than 0,3 mg / ml) of drug concentration (as measured by radioimmunoassay with experience digoxin ) in plasma , as compared to co-administration of a placebo and Digoxin .
Other concomitant therapy
In clinical trials, Simvastatin was administered concomitantly with angiotensin converting enzyme ( ACE) inhibitors , beta blockers , diuretics , nonsteroidal anti-inflammatory drugs (NSAIDs ) without evidence of clinically significant adverse interactions.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine .
Neosimva is contraindicated during pregnancy.
Safety in pregnant women has not been established . No controlled clinical trials with Simvastatin, conducted in pregnant women.
Atherosclerosis is a chronic process and the discontinuation of therapy with lipid-lowering drugs during pregnancy should have little impact on long-term risk associated with primary hypercholesterolemia . For these reasons Neosimva should not be used in pregnant women , women intending to become pregnant or those who are suspected of being pregnant . Neosimva treatment should be discontinued during pregnancy or until it is established that the woman is not pregnant.
Use during lactation
It is not known whether Simvastatin or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious side effects women receiving Neosimva, should not breastfeed .
Driving and using machines
There is no evidence to suggest that the adoption of Neosimva would affect your ability to drive or use machines.
3 . HOW TO TAKE NEOSIMVA
Always take Neosimva, exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
Neosimva dosage varies from 5 to 80 mg per day taken once daily in the evening . Where necessary , the dose adjustment is made at intervals of no less than 4 weeks , up to a maximum dose of 80 mg once daily in the evening .
Patients at high risk of developing coronary heart disease ( CHD ) or ischemic heart disease with known
In patients at high risk of CHD (with or without hyperlipidaemia ), ie patients with diabetes, history of stroke or other cerebrovascular disease , peripheral vascular disease or with known coronary artery disease , the usual starting dose of Neosimva is 40 mg once daily in the evening . Medical treatment can be started simultaneously with diet or exercise.
Patients with hyperlipidemia ( not included in the above risk category )
The patient should be placed on a standard cholesterol-lowering diet before applying Neosimva and adherence to this diet should be continued during treatment with Neosimva. The usual starting dose is 20 mg per day to be taken as a single night. For patients who need a greater reduction in LDL- cholesterol (greater than 45% ) may be initiated at a dose of 40 mg once daily in the evening . Patients with mild to moderate hypercholesterolemia can be treated with a starting dose of 10 mg Neosimva. Must be carried out adjusting the dosage if needed , as shown above .
Patients with homozygous familial hypercholesterolemia
The recommended dose for patients with homozygous familial hypercholesterolemia is 40 mg daily Neosimva day or 80 mg per day in divided doses 3 - 20 mg, 20 mg, and an evening dose of 40 mg. Neosimva must be used in addition to other cholesterol reducing treatment (e.g., LDL apheresis ) in these patients or if such treatment exists.
Neosimva is effective alone or in combination with bile acid sequestrants . Patients taking Cyclosporine, Gemfibrozil, other fibrates (except Fenofibrate) or Niacin ( nicotinic acid) in lipid-lowering doses (> 1g daily) in combination with Neosimva, the dose should not exceed 10 mg daily. In patients taking Neosimva with Amiodarone or Verapamil, the dose should not exceed 20 mg daily.
Dosage in renal failure
Since Simvastatin does not undergo significant renal excretion, is not necessary dose adjustment in patients with moderate renal insufficiency.
In patients with severe renal insufficiency (creatinine clearance <30ml/min) doses exceeding 10 mg daily should be carefully considered and assuming that needed to be applied with great care.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 . POSSIBLE SIDE EFFECTS
Like all medicines , Neosimva can cause side effects, although not everybody gets them .
If any of the side effects gets serious , or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.
Neosimva generally well tolerated , most of the known side effects are mild and transient.
Observed adverse reactions occurring with an incidence of 1% or more and considered to be possibly, probably, or definitely related to the drug were abdominal pain , constipation, and flatulence .
Other side effects were asthenia and headache. Myopathy has been reported rarely . The following additional adverse reactions were observed in daily use : nausea , diarrhea , rash , dyspepsia , pruritus , alopecia, dizziness , muscle cramps, myalgia , pancreatitis, paresthesia , peripheral neuropathy , vomiting and anemia. Rarely occur rhabdomyolysis and hepatitis / jaundice . Rarely observed pronounced hypersensitivity syndrome , which include some of the following symptoms: angioedema, lupus-like syndrome, polymyalgia rheumatica , dermatomyositis , vasculitis , thrombocytopenia , eosinophilia, ESR increase , arthritis , arthralgia , urticaria , photosensitivity , fever , flushing, dyspnea and fatigue.
For significant and persistent elevations of serum transaminases have been reported rarely . There have been reports of elevations of alkaline phosphatase and g- glutamyl transpeptidase . Variations in liver function tests have been mild and transient . Reported a rise in serum creatine kinase (CK ) released from skeletal muscle.
There is evidence of the following side effects , but not a causal relationship to therapy with Simvastatin: depression, erythema multiforme , including syndrome Stevens-Johnson, leukopenia, and purpura .
5 . STORAGE NEOSIMVA
Do not store above 25 ° C. Keep out of reach of children.
Neosimva not use after the expiry date stated on the label and carton. 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.
6 . ADDITIONAL INFORMATION
What does Neosimva
The active ingredient is Simvastatin (Simvastatiri).
The other ingredients are lactose, microcrystalline cellulose , pregelatinized starch ( starch 1500) , ascorbic acid , citric acid monohydrate, butylated hydroxy anisole , magnesium stearate, Opadry 20A54692 pink.
Neosimva looks like and contents of pack
Film-coated tablets for oral use in packs of PVC / Aluminium foil packed in a carton containing patient information leaflet . The package is 14 or 28 tablets.