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Product Information Nicotinic Acid is a specific form of Vitamin B3. Nicotinic Acid supplements are manufactured by oxidizing Nicotine this is not a cause for alarm as Nicotinic Acid is not associated with any of the toxic effects attributable to Nicotine. PROPRIETARY NAME (and dosage form): Flush-Free Niacin (capsules) COMPOSITION: Each capsule contains the following as active ingredients: Inositol hexanicotinate............................................500 mg Inactive ingredients: Hypromellose (cellulose) vegetarian capsule shell (gelatin free), microcrystalline cellulose, magnesium stearate (vegetarian - flow agent), magnesium silicate, silicon dioxide and colloidal silicon dioxide. Contains no colourants, preservatives, lactose, gluten, yeast, starch or artificial fillers. Contains plant extracts and natural fillers, with no colourants added - therefore the colour of the capsule contents may vary slightly from batch to batch. PHARMACOLOGICAL ACTION: Inositol hexanicotinate, an ester of inositol and 6 molecules of niacin, is the preferred source of niacin in terms of reduced adverse effects and slow release effect. Niacin is metabolized to form niacinamide adenine dinucleotide (NAD), niacinamide adenine dinucleotide phosphate (NADP), and nicotinuric acid, all coenzymes necessary for the following cell functions: glycolysis, tissue respiration, lipid, amino acid and purine metabolism. Niacin reduces serum cholesterol and triglycerides by inhibiting the synthesis of VLDLs, which are the precursors of LDLs and increases HDL. Niacin has also been demonstrated to suppress the hepatic synthesis of cholesterol. Niacin causes direct periferal vasodilation thus increasing peripheral blood flow. Pharmacokinetics: 60-70% of inositol hexanicotinate is absorbed from the GI tract after ingestion. Once in the blood stream, it is hydrolyzed to free niacin (nicotinic acid) and inositol. Hydrolysis occurs slowly, with peak serum levels not occurring until at least 10 hours after ingestion. Niacin is then metabolised in the liver with 60-76% being excreted by the kidneys. INDICATIONS: Flush-Free Niacin aids by helping in the following: • Reduction of cholesterol • Improving blood circulation, especially to the peripheral parts of the body, such as the hands and feet • Niacin reduces cravings for alcohol and reduces the formation of acetaldehyde, a toxic alcohol metabolite Other indications include Niacin deficiency (pellagra), Alzheimer’s disease, arthrosclerosis, assists with cataract prevention. WARNINGS: Do not exceed recommended dosages unless on the advice of a healthcare provider. Do not use this product if you are allergic to any of the ingredients. If you are on any medication or suffering from any medical condition, it is advisable to seek medical advice before starting any new medicine, supplement or remedy. INTERACTIONS: HMG CoA Reductase Inhibitors (Statins) lipid-lowering drugs: increased risk of rhabdomyolysis and myopathy (combined therapy should include careful monitoring). Alcohol: May exacerbate flushing and pruritis. Allopurinol: Large doses of niacin may reduce urinary excretion of uric acid requiring allopurinol doses to be increase to maintain control of gout in patients taking niacin. Niacin taken in high doses can impair glucose tolerance in a dose-dependent manner. Diabetics should thus only use niacin under the supervision of a health care provider as they may need adjustment of their hypoglycaemic medication. PREGNANCY AND BREASTFEEDING: Safety in pregnancy and breastfeeding has not been established, do not use. DOSAGE AND DIRECTIONS FOR USE: Adults and children over 12 years of age: Take 1 capsule once or twice daily, with meals. Doses as high as 6 capsules daily (3000mg) can be used, but only under the supervision of a health care provider. SIDE EFFECTS AND SPECIAL PRECAUTIONS: Side effects: Although generally flush-free, sensitive individuals or those taking high doses may still experience mild skin flushing, pruritis, warm sensation, headache, gastrointestinal upset, nausea, bloating, flatulence, hunger pains, vomiting, heartburn, diarrhoea, increased sebaceous gland activity, low blood pressure, dizziness, rapid heart rate, irregular heartbeat and blurred vision, however these effects often diminish after 1-2 weeks of continued use. Other side effects include occasional decrease in glucose tolerance, increased uric acid levels and hypertension. Flush-Free Niacin can aggravate gout or peptic ulcer disease. Very high doses [greater than 3000mg (6 capsules) daily] might cause jaundice and elevated serum transaminases. Such high doses should be discontinued if liver function tests rise to three times the upper limit of normal. Niacin can increase the chance of cardiac arrhythmias in individuals with coronary artery disease and should be used with caution. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Treatment should be symptomatic and supportive. In the case of accidental overdose of the product, contact the nearest hospital or poison control centre. IDENTIFICATION: Clear vegetable capsule shell containing white contents. PRESENTATION: White HDPE container with white HDPE screw cap and seal for protection. STORAGE INSTRUCTIONS: Store in a cool dry place, keep out of the reach of children.
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