SCHEDULING STATUS:

S0

PROPRIETARY NAME (AND DOSAGE FORM):

ThermoMX Capsules

COMPOSITION:

Each dose (2 capsules) provides:	%NRV
Thermo Lipotropic Accelerator	270 mg
Caffeine	220 mg	*
Curcuma longa
(Turmeric root extract standardized to 95% Curcuminoids)	40 mg	*
Pterostilbene	10 mg	*
Chromium picolinate (providing elemental Chromium)	24 mcg	69%
Cognitive Hyper Focus	600mg	*
L-Tyrosine	250 mg
L-Alpha Glycerophosphorylcholine
(providing 50% Alpha GPC)	200 mg	*
Vitis vinifera
(Grape seed extract standardized to 95%
Oligomeric proanthocyanadins)	50 mg	*
L-Theanine	100 mg	*
Sinetrol XPUR	450 mg
Citrus paradisi (Grapefruit extract)	270 mg	*
Paullinia cupana (Guarana seed extract)	90 mg	*
Sweet orange (Citrus sinensis extract)	67.5 mg	*
Blood orange (Citrus sinensis concentrate)	22.5 mg	*

Thiamin HCl (Vitamin B1)	.5 mg	42%
Riboflavin (Vitamin B2)	4 mg	308%
Niacin (Vitamin B3)	5 mg	31%
Pyridoxine HCl (Vitamin B6)	.5 mg	29%
Cyanocobalamin (Vitamin B12 )	3 mcg	125%
D-Biotin	90 mcg	300%

Nutrient Reference Values (NRVs) for individuals 4 years and older

*%NRV not established

PHARMACOLOGICAL CLASSIFICATION:

Category D Complementary Medicines. 32.3 – Slimming preparation

PHARMACOLOGICAL ACTION:

Caffeine acts on the central nervous system as a stimulant and has a stimulatory effect on general metabolic function.

Pterostilbene is a polyphenol, a type of molecule that occurs in plants, particularly small berries and nuts. Blueberries are a particularly rich source of pterostilbene. Polyphenols may serve as powerful antioxidants, which prevent damage to cells.

Sinetrol is thought to facilitate lipolysis trough the inhibition of phosphodiesterase PDE-4, the enzyme that catalyzes the hydrolysis of cyclic adenosine monophosphate (cAMP). Consequently, higher cAMP levels lead to an increased rate of triglyceride (TG) breakdown.

Tyrosine is a nonessential amino acid that might improve performance under extreme physical stress.

Theanine is the major amino acid found in green tea. It is traditionally used for relaxation and reducing anxiety.

INDICATION:

ThermoMX is indicated when a deficiency of the active ingredients exists.

CONTRA-INDICATIONS:

If you suffer from anxiety or depression consult with your healthcare practitioner before using this product.

Diabetics should use this product under the supervision of their healthcare practitioner and blood glucose levels should be monitored closely. If you suffer from high blood pressure use this product under the supervision of your healthcare practitioner. Discontinue use 2 weeks prior to any planned surgical procedure.

INTERACTION:

ANTIDEPRESSANT DRUGS

Theoretically, combining with other antidepressant or other serotonergic drugs might increase the risk of serotonergic side effects, including serotonin syndrome.

MONOAMINE OXIDASE INHIBITORS (MAOIs)

Concomitant use might result in increased blood pressure. Avoid taking together with MAOIs

ANTICOAGULANT/ANTIPLATELET DRUGS

There is preliminary evidence of platelet aggregation inhibition. Theoretically, taking along with anticoagulant or antiplatelet drugs might increase the risk of bruising and bleeding.

ANTIDIABETES DRUGS

Theoretically, concomitant use might cause additive hypoglycemic effects. Dosing adjustments for insulin or oral hypoglycemic agents may be necessary.

THYROID HORMONE

There is a concern that this might have additive effects with thyroid hormone medications. Dosing adjustments may be necessary.

ANTIHYPERTENSIVE DRUGS

Concomitant use may potentiate the activity of antihypertensive medications.

PREGNANCY AND LACTATION:

Pregnant and breastfeeding women should avoid using this product.

DOSAGE AND DIRECTIONS FOR USE:

Take 1-2 capsules in the morning. Start with one capsule and increase the dosage to 2 capsules or as required. Do not take at the same time as any prescription medication – wait at least 2 hours. Do not take within 5 hours of bed time. Maintain an adequate state of hydration. Do not exceed the recommended dosage. For best results, combine with a balanced, kilojoule-controlled diet and moderate exercise.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

Discontinue the use of this product where there is sensitivity towards any of the ingredients.

KNOWN SYMPTOMS OF OVERDOSE AND TREATMENT:

Use only as directed.

IDENTIFICATION:

White size 00 veggie-capsules with light brown powder.

PRESENTATION:

White HDPE bottle with label containing 40 capsules.

STORAGE INSTRUCTIONS:

Store at or below 25º C. Protect from light and moisture. Keep out of reach of children.

REGISTRATION NUMBER/APPLICATION NUMBER:

This medicine has not been evaluated by the South African Health Products Regulatory Authority. This medicine is not intended to diagnose, treat, cure or prevent any disease

NAME AND BUSINESS ADDRESS OF APPLICANT:

New Age Africa

Postnet Suite 152

Private Bag X1

Glenvista

Gauteng

2053

0800 172 963

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

April 2021

DISCIPLINE OF THE MEDICINE

Discipline-Specific Traditional – Combination Product

REFERENCES

Human Psychopharmacology Clinical and Experimental 2004; 58: 390-401

JAMA 2004; 291: 1231-9

Journal of Nutrition 2002; 132: 55-8.

Journal of Pharmacology and Experimental Therapeutics 2001; 299: 96-104

Leung AY, Foster S; Encyclopedia of Common Natural Ingredients Used in Food, Drugs and Cosmetics; 2^nd edition; New York; John Wiley & Sons; 1996