Omacor capsules. 28 pc

Description

Contraindications
Hypersensitivity to the active substance, auxiliary substances, as well as soy. Age 18 years (effectiveness and safety have been established). Pregnancy and breast-feeding. Omacor should not be used in patients with exogenous hypertriglyceridemia (type I giperhilomikronemii).
Carefully. Age older than 70 years, liver function abnormalities, concomitant use with oral anticoagulants, fibrates; hemorrhagic diathesis, severe trauma, surgery (risk of increased bleeding time). Previous use in secondary endogenous hypertriglyceridemia limited (especially uncontrolled diabetes).
Dosage
1000 mg
Indications
Hypertriglyceridemia: endogenous hypertriglyceridemia type IV classification Frederickson (monotherapy) as a supplement to the lipid-lowering diet during its insufficient efficiency; Endogenous hypertriglyceridemia IIb or III type classification Frederickson in combination with inhibitors of HMG-CoA reductase inhibitors (statins), when the concentration of triglycerides insufficiently controlled statins. Secondary prophylaxis following myocardial infarction (in combination therapy) in conjunction with statins, antiplatelet agents, beta-blockers, angiotensin-converting enzyme (ACE).
Interaction with other drugs
In an application with oral anticoagulants and other drugs that affect hemostasis, the risk of increased bleeding time. The combined use of warfarin does not lead to any hemorrhagic complications. However, the combined use of Omacor and warfarin or termination of the course of treatment with Omacor is necessary to monitor the prothrombin time or INR (international normalized ratio).
* Complete information on the drug is presented in the medical instructions.
Overdose
Symptoms: may cause side effects. Treatment: symptomatic therapy.
pharmachologic effect
Pharmacological properties:
Polyunsaturated fatty acids are a class of omega-3 – eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) – are indispensable (essential) fatty acids. GISSI-Prevenzione – a multicenter, randomized, open-label clinical study in patients with recent myocardial infarction (less than 3 months), taking Omacor, and not taking the drug Omacor. Results obtained after 3.5 years of observation in patients receiving Omacor 1 g per day showed a significant reduction in the combined endpoint of criteria, including component all-cause mortality, nonfatal myocardial infarction, and stroke (relative risk reduction of 15%, p = 0 , 0226) in patients taking Omacor alone compared to control group. It has been shown to reduce the predetermined criteria secondary endpoint, including death due to cardiovascular disease, non-fatal myocardial infarction and stroke (relative risk reduction of 20%, p = 0.0082) in patients taking only Omacor compared with the control group. The study GISSI-Heart Failure Omacor studied the effect on reducing mortality and hospitalization for cardiovascular disease in patients with chronic heart failure (II-IV functional class NYHA classification) treated with standard medical therapy. The results showed a reduction criteria of both endpoints, including death from all causes (relative risk reduction 9%, p = 0.041), and death from any cause and hospitalization due to cardiovascular events (relative risk reduction of 8%, p = 0.009) . Secondary analyzes of the primary hospitalization for ventricular arrhythmias showed a relative risk reduction of 28% (p = 0.013) in the group receiving the drug Omacor, compared with the placebo group. According to the results shown subanalysis was the relative increase in left ventricular ejection fraction of 8.1%, 11.1% and 11.5% after 1, 2 and 3, respectively in the group receiving the drug Omacor, compared with 6.3%, 8 , 2% and 9.9% in the placebo group (p = 0.005).
* Complete information on the drug is presented in the medical instructions.
Pregnancy and breast-feeding
Omacor assign pregnant women with caution, only after careful evaluation of the risk-benefit ratio when benefit to the mother outweighs the potential risk to the fetus.
Conditions of supply of pharmacies
On prescription.
side effects
Gastrointestinal disorders (including bloating, abdominal pain, constipation, diarrhea, dyspepsia, flatulence, belching, gastroesophageal reflux disease, nausea or vomiting). A list of all side effects presented in the medical instructions.
special instructions
Due to the moderate increase in bleeding time (when receiving the high dose – 4 capsules) requires monitoring of patients having disorders of the blood coagulation system and receiving anticoagulant therapy or drugs affecting the system hemostasis (acetyl salicylic acid as antiplatelet agents, non-steroidal anti-inflammatory drugs) and, where appropriate – the corresponding dose correction or anticoagulant agents affecting hemostasis. Requires monitoring of AST and ALT in patients with signs of liver dysfunction (especially when taking high dose – 4 capsules).
Effects on ability to drive vehicles and other classes of potentially hazardous activities that require high concentration and psychomotor speed reactions *.
Omacor could be slightly affected (risk of dizziness) on the ability to drive vehicles and other classes of potentially hazardous activities that require high concentration and psychomotor speed reactions, so be careful.
* Complete information on the drug is presented in the medical instructions.
Storage conditions
In a dry place at a temperature not higher than 25 ° C. Do not freeze. Keep out of the reach of children!.
Dosing and Administration
Inside, during a meal in order to avoid the development of undesirable effects on the gastrointestinal tract. Hypertriglyceridemia. The initial dose of 2 capsules a day. In the absence of therapeutic effect may increase the dose to the maximum daily dose – 4 capsules. The duration of treatment and repeated courses – on doctor’s advice. Secondary prevention of myocardial infarction. It is recommended to take 1 capsule per day. The duration of treatment and repeated courses – on doctor’s advice.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist