Degreasian® 1000 mg, 28 capsules
Available at Pharmaegy Pharmacy. Use as directed by your doctor.
Trade Name: Degreasian® 1000 mg 28 soft gelatin capsules Composition: Each soft gelatin capsule contains: Omega-3 acid ethyl esters 90 1000 mg composed of: Eicosapentaenoic acid (EPA) Ethyl ester 460 mg Docosahexaenoic acid (DHA) Ethyl ester 380 mg Alpha tocopherol acetate (Vitamin E) 4 mg Inactive ingredients: Gelatin, Sorbitol special, Glycerol, Sodium Ethyl hydroxybenzoate, Sodium propyl hydroxybenzoate, purified water. Properties: Ethyl esters are produced by reacting crude fish oil in a free fatty acid form with ethanol (and industrial alcohol) to form a synthetic substrate. Under a vacuum, the mix is then heat distilled and the resulting condensate is a concentrated Omega-3 ethyl ester solution. Omega-3-acid ethyl esters are used together with a proper diet to lower very high triglyceride (fat-like substance) levels in the blood. This medicine may help prevent medical problems caused by clogged blood vessels such as heart attacks and strokes. Indications: -Hypertriglyceridemia Endogenous hypertriglyceridemia as a supplement to diet when dietary measures alone are insufficient to produce an adequate response: – type IV in monotherapy, – typellb/l in combination with statins, when control of triglycerides is insufficient. Dosage and administration: -Hypertriglyceridemia: Initial treatment two capsules daily or as prescribed by your physician. If adequate response is not obtained, the dose may be increased to four capsules daily. -The capsules may be taken with food to avoid gastrointestinal disturbances. Side effects: -Immune system disorders: Rare: hypersensitivity -Metabolism and nutrition disorders: Uncommon: hyperglycaemia, gout -Nervous system disorders: Uncommon: dizziness, dysgeusia, headache -Vascular disorders: Uncommon: hypotension -Respiratory thoracic and mediastinal disorders: Uncommon: epistaxis -Gastrointestinal disorders: Common: gastrointestinal disorders (including abdominal distension, abdominal pain, constipation, diarrhea, dyspepsia, flatulence, eructation, gastro-oesophageal reflux disease, nausea or vomiting) Uncommon: gastrointestinal hemorrhage -Hepatobiliary disorders: Rare: liver disorders (including transaminases increased, alanine aminotransferase increased and aspartate aminotransferase increased) -Skin and subcutaneous tissue disorders: Uncommon: rash Rare: urticaria Pharmacotherapeutic group: Omega-3-triglycerides, including other esters and acids Contraindications: -Hypersensitivity to the active substance, to soya or to any of the excipients Warnings and precautions: Because of the moderate increase in bleeding time (with the high dosage, ie. 4 capsules), patients receiving anticoagulant therapy must be monitored and the dosage of anticoagulants adjusted if necessary. Use of this medication does not eliminate the need for the surveillance usually required for patients of this type. Make allowance for the increased bleeding time in patients at high risk of hemorrhage (because of severe trauma, surgery, etc). •In the absence of efficacy and safety data, use of this medication in children is not recommended. During treatment with Omega 3-acid-ethyl esters 90, there is a fall in thromboxane A2 production. No significant effect has been observed on the other coagulation factors. Some studies with Omega-3-acids demonstrated a prolongation of bleeding time, but the bleeding time reported in these studies has not exceeded normal limits and did not produce clinically significant bleeding episodes. Clinical data regarding the use of Omega 3-acid-ethyl esters 90 in elderly patients over 70 years of age are limited. Degreasian capsules should be used with caution in patients with known sensitivity or allergy to fish. Drug interactions: Some products that may interact with this drug include: drugs which can increase triglycerides (such as beta blockers, estrogens, certain “water pills”/diuretics such as thiazides), other vitamins/supplements (such as fish/flaxseed/cod liver oils). Omega-3-acid ethyl esters 90 have been given in conjunction with warfarin without haemorrhagic complications. However, the prothrombin time must be checked when Omega-3-acid ethyl esters 90 are combined with warfarin or when treatment with Omega-3-acid ethyl esters 90 are stopped. Pregnancy and lactation: Omega-3-acid ethyl esters 90 should not be used during pregnancy unless clearly necessary. No data on the excretion of Omega-3-acid ethyl esters 90 in animal and human milk is available. Omega-3-acid ethyl esters 90 should not be used during lactation. Effects on ability to drive and use machines: Omega-3-acid ethyl esters 90 is expected to have no or negligible influence on the ability to drive and use machines. Storage: Store at a temperature not exceeding 25°C, in a dry place. Package: Carton box contains 4 blisters each of 7 capsules, and an insert leaflet.
