SCHEDULING STATUS:

S0

PROPRIETARY NAME (AND DOSAGE FORM):

ImmunoMX Capsule

COMPOSITION:

Each dose (2 capsules) provides: %NRV

L-Ascorbic acid (Vitamin C) 500 mg 500%

Cholecalciferol (Vitamin D3) 25 mcg 167%

Zinc oxide (providing elemental Zinc) 10 mg 91%

Selenium glycinate (providing elemental Selenium) 50 mcg 91%

Echinacea purpurea

(Echinacea flower powder extract 4:1) 100 mg *

Olea europea

(Olive leaf powder extract 4:1) 100 mg *

Vitis vinifera

(Grape seed extract standardized to

95% proanthocyanadins) 50 mg *

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

*%NRV not established

PHARMACOLOGICAL CLASSIFICATION:

Category D Complementary Medicines: Discipline-Specific Traditional 33.7 – Combination Product

PHARMACOLOGICAL ACTION:

Vitamin C is a water soluble vitamin found in fresh fruits and vegetables. Vitamin C has a role in several physiological functions. Vitamin C is also involved in a variety of metabolic processes including oxidation-reduction reactions and cellular respiration, carbohydrate metabolism, synthesis of lipids and proteins, catabolism of cholesterol to bile acids, conversion of folic acid to folinic acid, and iron metabolism. Vitamin C is probably best known for its effects as an antioxidant and its role in maintaining proper immune function.

Vitamin D is a fat soluble vitamin found in eggs and fatty fish. Vitamin D is synthesised in the skin together with exposure to sunlight. Vitamin D seems to be important for promoting respiratory health and improving lung function.

Zinc is the second most abundant trace element in the body. It is thought that zinc ions have anti-viral activity and plays an important role in maintaining a healthy immune system.

Selenium works as a powerful antioxidant by activating glutathione peroxidase. Selenium seems to improve general immunologic function.

Alpha lipoic acid is a powerful antioxidant and is important for the regeneration of Vitamin C in the body.

Echinacea has been traditionally used for upper respiratory tract infections due to its antiviral activity as well as immuno-stimulatory properties.

The primary olive leaf constituents are secoiridoids (oleuropein and its derivatives), hydroxytyrosol, polyphenols (verbascoside, apigenin-7-glucoside, and luteolin-7-glucoside), triterpenes including oleanolic acid, and flavonoids (rutin and diosmin). The primary constituent, oleuropein, first isolated in 1908, is believed to be responsible for many of the therapeutic properties of olive leaf extracts. Although oleuropein is present in the olive fruit and oil, content in the leaf is significantly higher than in other parts of the tree.

Grape seed extract is rich in proanthocyanidins which seem to have powerful antioxidant properties.

INDICATION:

ImmunoMX is indicated as a general supplement where a deficiency of any of the ingredients exists.

CONTRA-INDICATIONS:

If you suffer from a chronic medical condition, only use large doses of vitamin C under the supervision of your healthcare practitioner. If you have a history of kidney stones, avoid using large doses of vitamin C. Individuals suffering from auto-immune disorders should avoid using this product.

INTERACTION:

If you are using chronic prescription medication, use large doses of vitamin C under the supervision of your healthcare practitioner.

PREGNANCY AND LACTATION:

Pregnant and breastfeeding women should avoid using doses exceeding 1800mg per day.

DOSAGE AND DIRECTIONS FOR USE:

Take 2 capsules daily at breakfast, or as advised by your healthcare practitioner.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

Discontinue the use of this product where there is sensitivity towards any of the ingredients. If symptoms do not improve within 5 days of use, consult with your healthcare practitioner.

KNOWN SYMPTOMS OF OVERDOSE AND TREATMENT:

Large doses of Vitamin C will cause diarrhea.

IDENTIFICATION:

White size 00 veggie-capsule with light brown powder

PRESENTATION:

White HDPE labelled container containing 60 capsules

STORAGE INSTRUCTIONS:

Store 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

REFERENCES

Archives of Internal Medicine 2000; 160:931-6

Chest 2005; Vol 128:3792-8

Gunning K. Echinacea in the treatment and prevention of upper respiratory tract infections. West J Med 1999;171:198-200.

Journal of Nutrition 2000; 130:2626-9

Leibovitz B, Siegel BV. Ascorbic acid and the immune response. Adv Exp Med Biol 1981;135:1-25.

Medical Hypotheses; 1985; 17:157-75

Phytomedicine 2003; 10:66-86

Science M, Johnstone J, Roth DE, et al. Zinc for the treatment of the common cold: a systematic review and meta-analysis of randomized controlled trials. CMAJ 2012;184:E551-61.

Walter WM Jr, Fleming HP, Etchells JL. Preparation of antimicrobial compounds by hydrolysis of oleuropein from green olives. Appl Microbiol 1973;26:773-776.