MNI Antagolin Tablets (60)

Usage instructions:
Adults: Starting dose: Take 1 tablet 3 times a day with meals. Maintenance dose: Take 1 tablet 2 times a day with meals Children: From the age of 12 years

Storage instructions:
Store at or below 25 degrees C from direct sunlight.

Warnings:
Warnings and special precautions: May cause low blood sugar levels in those taking oral diabetic medication or insulin. May increase bleeding potential when taking warfarin anticoagulant therapy and frequent blood monitoring is therefore recommended. Interactions: Concurrent use of AntaGolin™ with oral diabetic medication or insulin may cause low blood sugar levels. (See warnings and special precautions). Berberine in AntaGolin™ may act additively with the concurrent use of medications metabolised by the liver's cytochrome CYP3A4 enzyme and can therefore adversely interact with cyclosporin, warfarin, thiopental and tolbutamide. Pregnancy and lactation: Safety and efficacy in pregnancy and lactation have not been established and the administration of AntaGolin™ during pregnancy is therefore contraindicated. If pregnancy occurs during the use on AntaGolin™, further intake should be stopped. AntaGolin™ should not be used during breastfeeding. Side-effects and special precautions: Side-effects: Barberry root extract (Insul-X2™). A meta-analysis of 14 trials involving 1068 diabetic patients assessed berberine for safety at a variable range of 0.5-1.5g per day for an average period of 12 weeks. Of the more common side-effects reported were gastrointestinal or abdominal discomfort with a mixed effect on stool, with reports of both diarrhoea and constipation. Dong H (2012). This dosage is significantly higher than what is contained in AntaGolin™. Another study evaluated the side-effects of high dosages of berberine on 86 subjects with established liver disease, as caused either by chronic hepatitis B, C or alcoholic liver cirrhosis. In this study all biochemical parameters including liver function remained unaltered and no significant clinical side-effects were reported: Jiang JD (2008). Rare adverse effects include headache and skin irritation. Berberine may lower blood sugar levels and should therefore only be taken with food and not on an empty stomach. Subjects taking oral diabetic medication or insulin should be monitored or advised by a qualified healthcare professional, including a pharmacist, if symptoms of low blood sugar should arise. Use with caution if suffering from hypotension (low blood pressure), as berberine may display antihypertensive effects. Banaba leaf extract: Rare adverse effects are mild gastro-intestinal irritation, heartburn and skin rash. Banaba leaf extract may lower blood sugar levels and should therefore only be taken with food and not on an empty stomach. Subjects taking oral diabetic medication or insulin should continue routine monitoring and/or be advised by a qualified healthcare professional, including a pharmacist, if symptoms of low blood sugar should arise. Inositol: No adverse side effects at low dosage have been recorded. Rare adverse effects at high dosage of more than 12 g per day are gastro-intestinal irritation and diarrhoea. Chromium: There are no documented side-effects at this low dosage. Special precautions: Avoid in individuals with known allergy or hypersensitivity to any of the constituents. Subjects on anticoagulant therapy should keep on with regularly blood monitoring. Since AntaGolin™ may interfere with anticoagulant therapy, it is advised to ensure that blood profiles are checked within 10 days after starting AntaGolin™ to confirm safety. Subjects on diabetic medication may develop low blood sugar, especially if AntaGolin™ is taken on an empty stomach. Effects on ability to drive and operate a machine: Subjects on diabetic medication may develop low blood sugar, especially if AntaGolin™ is taken on an empty stomach. Should symptoms of low blood sugar appear, it may impair the ability to drive and operate a machine. Known symptoms of over-dosage and particulars of its treatment: May cause low blood sugar. Treatment is symptomatic and supportive. There is no specific antidote. Keep out of reach of children. Registration number: This medicine has not yet been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat cure or prevent any disease.