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Product Information A natural blend of safe, herbal and nutritional extracts that naturally elevate the levels of three energizing and mood-enhancing brain neuro-transmitters. It also enhances the brain's ability to cope with stress and has an anti-anxiety effect, by calming the central nervous system. PROPRIETARY NAME (and dosage form): Naturally High™ (capsules) COMPOSITION: Each daily dose (4 capsules) contains following as active ingredients: | 5 HTP.......................................................................................................100mg | | | L-Tyrosine................................................................................................500mg | | | L-Phenylalanine.......................................................................................800mg | | | St John’s wort extract (std to 3% hyperforin and 3% hypericin)..........500mg | | | Theanine...................................................................................................200mg | | | Vitamin B3 (Niacinamide)........................................................................30mg | | | Vitamin B6 (Pyridoxine)...........................................................................30mg | | | Vitamin B5 (Pantothenic Acid)...............................................................50mg | | | Folic Acid.................................................................................................1500µg | | | Vitamin B12 (Methylcobalamin).............................................................1000µg | | | Panax (Korean) Ginseng extract.............................................................80mg | | | Ginkgo Biloba extract..............................................................................80mg | | Contains no artificial or banned stimulants, or caffeine. Inactive ingredients: colloidal silicon dioxide, hypromellose (cellulose) vegetarian capsule shell (gelatine free), microcrystalline cellulose, magnesium stearate (vegetarian-flow agent), magnesium silicate and 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: Naturally High™ is a blend of safe herbal and nutritional extracts that naturally elevate the levels of three energizing and mood-enhancing brain neuro-transmitters called serotonin, nor-adrenaline and dopamine. Naturally High™ also enhances the brain’s ability to cope with stress and has an anti-anxiety effect, calming the central nervous system via the stimulation of anti-anxiety GABA receptors in the brain. 5-HTP is an amino acid precursor of the neurotransmitter serotonin, for improving mood and the sense of wellbeing. L-tyrosine is an amino acid precursor of the neurotransmitter, dopamine for enhanced willpower, drive, mood and self-worth. L-phenylalanine is an amino acid precursor that elevates the neurotransmitter nor-adrenaline for energy, concentration and focus. It also produces a natural anti-anxiety effect by stimulating the brain’s GABA receptors. Vitamin B3 (niacin) enhances the function of phenylalanine. Vitamin B6 (pyridoxine) enhances the function of phenylalanine and is required for the synthesis of dopamine and serotonin. Vitamin B5 (Pantothenic acid) is essential for energy release from the mitochondria. Folic acid facilitates the conversion of phenylalanine into nor-adrenaline. Vitamin B12 (methylcobalamin form) is a methyl donor which enhances mood. Theanine might work for anxiety by increasing the levels of GABA and serotonin. St. John's wort extracts improves mood, decreases anxiety and somatic symptoms and decreases insomnia related to mild to severe major depression. Panax (Korean) ginseng extract is an adaptogen that enhances mood, energy, sexual performance and stress-coping ability. Ginkgo biloba supplies oxygen to the brain for energy and is a natural mono-amine oxidase inhibitor that prevents the breakdown of serotonin, nor-adrenaline, dopamine and PEA. Unlike prescription antidepressants, Naturally High™ doesn’t artificially and dangerously prevent the breakdown of neurotransmitters, which can lead to agitation, sleep disturbances, reduced sex drive, suicidal thoughts, and aggression. Naturally High™ is safer, because it works naturally, by providing the precursors required by the body to produce these neurotransmitters. Furthermore, Naturally High™ will not cause the addictiveness and withdrawal symptoms of prescription medicines, which ultimately leads to dependence. Unlike most energisers, Naturally High™ contains no artificial stimulants that raise blood pressure, cause agitation and mood swings, heartbeat irregularities or dehydration and electrolyte loss. INDICATIONS: Naturally High™ contains herbal and nutritional extracts that elevate 3 neurotransmitters (serotonin, dopamine and nor-adrenaline), known to improve mood, willpower and prevent depression. Also in the formulation are gingko and theanine, which will help reduce nervous tension associated with depression. Naturally High™ is useful for any individual over the age of 16 who feels depressed, stressed, overwhelmed, fatigued or just wants a pick-me-up, feel-good, energising tonic. CONTRA-INDICATIONS: Contraceptive drugs: St John’s Wort can decrease norethindrone and ethinyl estradiol levels resulting in breakthrough bleeding, irregular menstrual bleeding, or unplanned pregnancy. 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. 5-HTP is reported to cause seizures in some individuals with Down syndrome. Individuals taking antidrepressants and anti-psychotic drugs should only use Naturally High™ under the supervision of a medical practitioner. Contains phenylalanine which should be avoided in individuals with inherited disorders of phenylalanine metabolism, such as phenylketonuria and alkaptonuria. Phenylalanine use in individuals with schizophrenia or those taking neuroleptic medicines can exacerbate tardive dyskinesia (involuntary movements, often of the face and the tongue, but also of the trunk and limbs). INTERACTIONS: Antidepressant drugs: Taking very high doses of Naturally High™, or combining Naturally High™ with prescription antidepressants, can lead to side effects of headaches, agitation, insomnia, shakiness and serotonin syndrome. Therefore concurrent use with prescription antidepressants should only be done under the close supervision of a medical practitioner. Alprazolam: St Johns wort may decrease the effect of alprazolam. Amitriptyline and nortyptyline: St John’s wort can reduce the serum concentrations of the drugs by increasing hepatic and renal clearance. Barbiturates: St John’s wort can decrease barbiturate induced sleep time. Cyclosporine: Concomitant use can decrease plasma cyclosporine levels by 30-70%. Cytochrome P450 3A4: St John’s wort induces this enzyme and can thus affect drugs that use this enzyme. Drugs affected may include some calcium channel blockers (diltiazem, nicardipine, verapamil), chemotherapeutic agents (etoposide, paclitaxel, vinblastine, vincristine, vindesine), antifungals (ketoconazole, itraconazole), glucocorticoids, alfentanil , fentanyl, losartan, fluoxetine, midazolam, omeprazole, ondansetron, propranolol, fexofenadine, and numerous others. Digoxin: Concurrent use can reduce serum levels of digoxin requiring dose adjustment. Narcotic drugs: St John’s wort can increase narcotic-induced sleep time. P-Glycoprotein substrates: St John's wort induces P-glycoprotein. P-glycoprotein is a carrier mechanism responsible for transporting drugs and other substances across cell membranes. Drugs that might be affected include some chemotherapeutic agents (etoposide, paclitaxel, vinblastine, vincristine, vindesine), antifungals (ketoconazole, itraconazole), protease inhibitors (amprenavir, indinavir, nelfinavir, saquinavir), H2 antagonists (cimetidine, ranitidine), some calcium channel blockers (diltiazem, verapamil), corticosteroids, erythromycin, cisapride, fexofenadine, cyclosporine, loperamide, quinidine, and others. Non-nucleoside reverse transcriptase inhibitors: Concomitant use can decrease serum levels of NNRTIs. St John's wort can increase the oral clearance of nevirapine (Viramune) by 35%. Paroxetine: Concomitant use with St John's wort might increase the risk of adverse effects and serotonin syndrome-like symptoms. Phenobarbital, phenytoin and phenprocoumon: St John’s wort appears to increase the metabolism of these drugs. Protease Inhibitors: Concomitant use can reduce serum concentrations of PIs. In healthy volunteers, St John's wort can reduce the serum indinavir (Crixivan) area under the curve (AUC) by 57% and the extrapolated trough by 81%. Monoamine Oxidase inhibitors (MAOIs): 5 HTP and MAOIs increase the risk of serotonergic side-effects. Reserpine: St John’s wort can antagonise the effects of reserpine. Tramadol: Concurrent use with St Johns’s wort can cause additive serotenergic affects. Tyramine: Rare cases of high blood pressure have occurred when St John’s wort is combined with tyramine containing foods, namely cheese, figs, liver and red wine. Warfarin: St John’s wort can decrease the effects of warfarin, use. PREGNANCY AND BREAST-FEEDING: Not to taken while pregnant or breast-feeding. DOSAGE AND DIRECTIONS FOR USE: Adults and children over 12 years of age: Take 2 capsules twice daily on an empty stomach or as directed by your healthcare provider. Not recommended for use in children under 12 years of age, unless supervised by a medical practitioner. The dosage for children 7-12 years of age in half the adult dose. Naturally High™ begins working after a few days. However, it can take up to 4 weeks of regular use for full effectiveness to be reached. SIDE EFFECTS AND SPECIAL PRECAUTIONS: Side effects: The following side effects have been reported: appetite suppression, insomnia, vivid dreams, anxiety, agitation, gastrointestinal discomfort, diarrhoea, constipation, nausea, heartburn, fatigue, dry mouth, photo dermatitis, dizziness, tachycardia, vertigo, euphoria, allergy, skin rash, anorexia and headache. 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 vegetarian capsule shell (size 00) containing grey/brown contents. PRESENTATION: White HDPE container with white HDPE screw cap and seal for protection. STORAGE INSTRUCTIONS: Store in a cool dry place, out of the reach of children.
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