NEOSIMVA . 40 mg. 28 tablets

NEOSIMVA . 40 mg. 28 tablets
€ 19.00
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Neosimva is indicated for the treatment of:
Patients at high risk of developing coronary heart disease (CHD) or CHD proven
Patients at high risk of CHD (with or without hyperlipidaemia), ie in patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or with known coronary artery disease



NEOSIMVA . 40 mg. 28 tablets
 

NEOSIMVA WHAT IS AND WHAT IT IS USED

Neosimva tablets of 10, 20, 40 and 80 mg in packs of PVC / aluminum foil, packed in carton containing patient information leaflet. Pack of 14, 28 or 84 tablets.
Each film-coated tablet contains 10 mg, 20 mg, 40 mg or 80 mg of the active ingredient Simvastatin (Simvastatin).
 
Neosimva is indicated for the treatment of:
Patients at high risk of developing coronary heart disease (CHD) or CHD proven
Patients at high risk of CHD (with or without hyperlipidaemia), ie in patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or with known coronary artery disease, Neosimva is indicated for:
 Reduction of total mortality by reducing CHD mortality;
 Reducing the risk of major cardiovascular events (nonfatal myocardial infarction, coronary death, stroke, or revascularization procedures);
 Reducing the risk of major coronary events (nonfatal myocardial infarction or coronary death);
 Reducing the risk of stroke;
 Reduce the need for coronary revascularization procedures (coronary artery bypass surgery and percutaneous coronary intervention);
 Reducing the need for peripheral revascularization nekoronarni and other procedures;
 Reduce the risk of hospitalization for angina.
 
In patients with diabetes, Neosimva been shown to reduce the risk of developing complications from the large peripheral vessels (peripheral revascularization procedures, amputations of the lower limbs or feet ulkusi).
In patients with coronary artery disease and hypercholesterolemia, Neosimva been shown to slow the progression of coronary atherosclerosis, incl. reduce the development of new lesions and new total occlusions.
 
Patients with hyperlipidemia
Neosimva is shown in addition to diet to reduce elevated total cholesterol (total-C) and LDL-C, triglycerides (TG) and apolipoprotein B (apo-B), and increase 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 non-pharmacological means is insufficient. 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 the treatment of patients with primary disbetalipoproteinemiya (Fredrickson type III hyperlipidemia);
 Neosimva is also indicated in addition to diet and other measures nedietichni for the treatment of patients with homozygous familial hypercholesterolemia to reduce elevated total-C, LDL-C, apo-B.
 

 BEFORE YOU TAKE NEOSIMVA

 
Do not take Neosimva under the following conditions:
 Hypersensitivity to any component of this preparation.
 Active liver disease or unexplained persistent elevations of serum transaminases.
 Pregnancy and breast-feeding (see Pregnancy).
 
Special considerations for treatment Neosimva
Myopathy / Rhabdomyolysis
The active ingredient Simvastatin, and other products with a similar mechanism of action, sometimes cause myopathy, which is manifested as muscle pain or weakness associated with increasing 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 due to myoglobinuria, and in rare cases fatalities occurred.
The risk of myopathy / rhabdomyolysis is increased by concomitant administration of Neosimva following medications:
 Medicinal products containing: Itraconazole, Ketoconazole, Erythromycin, Clarithromycin, Telithromycin, HTV-protease inhibitors, or Nefazodone, especially at higher doses Neosimva.
 Lipid-lowering drugs that can cause myopathy. when given alone: Gemfibrozil, other fibrates, Niacin (nicotinic acid) in lipid lowering doses (> 1 g / day), especially at higher doses Neosimva.
 Cyclosporine: especially with large doses Neosimva.
 Diltiazem: The risk of myopathy is increased slightly in patients Diltiazem, who simultaneously accept Neosimva 80 mg. In these patients, the risk of myopathy was approximately 1%.
 
The risk of myopathy / rhabdomyolysis is dose-dependent. It must be considered:
 
Hepatic effects
In various clinical trials, persistent increases (to more than 3 times 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 fell gradually to have predterapevtichnite. It is recommended that 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 before further increase after three months increased to 80 mg, and periodically thereafter during treatment (eg, 6 months) in the first year of treatment.
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 diseases or unexplained transaminase increases are contraindications to the use of Neosimva.
 
Ophthalmic manifestations
Even without the application of any drug therapy, gradually reduce the transparency of the lens can be explained by the aging process. Present the results of a long period of clinical trials have shown no adverse side effects of Simvastatin on human eye lenses.
 
Pediatric use
Safety and efficiency of use in children has not been established. Simvastatin is currently not recommended for pediatric use.
 
Use in Elderly
In patients older than 65 years who received Simvastatin in several controlled clinical trials, the efficacy, as measured by the degree of reduction in the levels of total and LDL-cholesterol was 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 taking concomitant Neosimva and Diltiazem 80 mg have a slightly increased risk of myopathy.
 
Other interactions
Grapefruit juice contains one or more components that inhibit CYP3A4 and can increase the plasma concentrations of drugs metabolized by CYP3A4. The effect of regular consumption (one 250 ml cup a day) is minimal and clinically irrelevant. Very large quantities (over 1 liter daily), however, should be avoided.
 
Coumarin derivatives
It was found that Simvastatin 20-40 mg daily moderately potentiated 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 during normal for patients on coumarin anticoagulants. If the dose of Simvastatin change or stop it must proceed in the same way. Simvastatin therapy has not been associated with bleeding or with changes in prothrombin time in patients not taking anticoagulants.
 
Propranolol
In healthy volunteers, there was no clinically significant pharmacokinetic or pharmacodynamic interaction with concomitant single-dose Simvastatin and Propranolol.
 
Digoxin
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 radio experience with digoxin) in plasma compared to concomitant administration of placebo and Digoxin .
 
Other concomitant therapy
In clinical studies Simvastatin was administered concomitantly with angiotensin converting enzyme (ACE) betablokeri, 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.
 
Pregnancy
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 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 who intend to become pregnant or those who are supposed to be 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 operating machinery
There is no evidence to suggest that taking Neosimva would affect your ability to drive or use machines.
 

 HOW TO TAKE NEOSIMVA

 
Always Neosimva, just as you have been told your doctor. If you're not sure, ask your doctor or pharmacist.
Neosimva dosage ranges from 5 to 80 mg per day taken once daily in the evening. Where necessary, dose adjustments are made at intervals of not less than 4 weeks to a maximum dose of 80 mg once daily in the evening.
 
Patients at high risk of developing coronary heart disease (CHD) or CHD proven
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 is 40 mg Neosimva once daily in the evening. Medical treatment can be started simultaneously with diet or exercise.
 
Patients with hyperlipidemia (not included in the top risk category)
The patient should be placed on a standard cholesterol-lowering diet before applying Neosimva and adhering to this diet should be continued during treatment with Neosimva. The usual starting dose is 20 mg to be taken once at night. Patients who require a large reduction in LDL-C (more than 45%) may be started at a dose of 40 mg once daily in the evening. Patients with mild to moderate hypercholesterolemia can be treated with an initial dose of 10 mg Neosimva. You have to make dose adjustments if necessary, as shown above.
 
Patients with homozygous familial hypercholesterolemia
The recommended dosage for patients with homozygous familial hypercholesterolemia is Neosimva 40 mg daily in the evening or 80 mg daily in 3 divided doses - 20 mg, 20 mg, and an evening dose of 40 mg. Neosimva should be used in addition to other cholesterol-lowering treatments (eg LDL apheresis) in these patients or if such treatments do not exist.
 
Concomitant therapy
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, it is necessary to adjust the dose 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 it takes to be implemented with great care.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
 

 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, the majority of the known side effects are mild and transient.
Observed adverse events occurring with an incidence of 1% or more and considered as possibly, probably, or definitely related to the drug were abdominal pain, constipation and flatulence.
Other side effects were asthenia and headache. The occurrence of myopathy has been reported rarely. The following additional adverse reactions were observed in daily use: nausea, diarrhea, rash, dyspepsia, alopecia, dizziness, muscle cramps, myalgia, pancreatitis, paresthesia, peripheral neuropathy, vomiting and anemia. Rarely occur rhabdomyolysis and hepatitis / jaundice. Rarely been observed pronounced hypersensitivity syndrome, which includes 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.
 
Laboratory abnormalities
A significant and persistent elevations of serum transaminases have been reported rarely. Has also been reported to increase in alkaline phosphatase and g-glutamyl transpeptidase. Deviations in liver function tests have been mild and transient. Reported an increase in serum creatine kinase (CK) released from skeletal muscle.
There are reports of these side effects, but established a causal relationship to therapy with Simvastatin: depression, erythema multiforme, including Syndrome Stevens-Johnson, leukopenia, and purpura.
 

 STORAGE NEOSIMVA

 
Do not store above 25 ° C. Keep out of reach of children.
Neosimva Do 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.
 

 ADDITIONAL INFORMATION

 
What Neosimva
Simvastatin is the active ingredient (Simvastatiri).
The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinized starch (starch 1500), ascorbic acid, citric acid monohydrate, butylated hydroxyl anizol, magnesium stearate, Opadry 20A54692 pink.
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