BRAIN STACK

COMPOSITION

Each sachet pack contains:

* % Nutrient Reference Values for individuals 4 years and older
Sugar free.

PHARMACOLOGICAL CLASSIFICATION
Complementary Medicines
Category D
D. 33.7 Combination Product, Complementary Medicines: Discipline-specific medicine
This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use. Intended to only complement the health or supplement the diet

PHARMACOLOGICAL ACTION
L-alpha-glycerylphosphorylcholine, also called choline alfoscerate, is a phospholipid metabolite. After oral administration, choline alfoscerate is cleaved within gut mucosal cells, by the action of glycerylphosphoryl-choline diesterase (L-3-glyceryl-phosphorylcholine glycerophosphohydrolase), into glycerylphosphate and free choline, which enters the portal circulation and can reach brain tissues, where it is incorporated into the phospholipid fraction of the neuronal plasma membrane and into microsomes. In the brain, the concentration of choline alfoscerate increases slowly and attains maximum levels 8 hours after administration, thereafter remaining constant over 30 hours. Pantothenic acid, vitamins B1, B2, B6, and B12 are generally water soluble. Water soluble vitamins are liable to degrade in solution especially if exposed to light.

Pharmacodynamics
Mechanism of Action: Choline alfoscerate is involved in brain phospholipid metabolism, being cleaved by the enzyme glycerylphosphorylcholine diesterase into a molecule of choline and another of glycerol-1-phosphate. Choline can be used for synthesizing acetylcholine whereas glycerol-1-phosphate, after phosphorylation, can enter the phospholipid pool. Activation of these pathways could provide both free choline and phospholipids for synthesizing acetylcholine and reconstituting nerve cell membrane components. On the other hand, both choline kinase and phosphocholine acyltransferase are able to covert choline into phospholipids. Choline alfoscerate is therefore a source of choline of the same form that a cell would obtain scavenging its own membranes and probably the form of choline that neurons use for synthesizing acetylcholine when larger amounts of choline are required, or when it is poorly available.

Pharmacokinetics
Absorption and distribution: After oral administration, absorption is 88 %. Readily crosses the
blood-brain barrier and accumulates mainly in the brain (the concentration reaches 45 % of
the level in blood plasma), lung and liver.

Metabolism and excretion: In the body of choline alfoscerate enzymatically biotransformed to choline and glycerophosphate (providing the pharmacological effects of the drug). 85% is excreted in the lungs as carbon dioxide, the remaining part (15 %) is excreted in the urine and feces.

INDICATIONS
NOOLIT: BRAIN STACK aids with cognitive function and impaired concentration.
Helps to decrease cognitive fatigue due to physically stressful situations (e.g. extended wakefulness, exposure to cold, excessive noise).
Contributes to normal growth and development. Contributes to tissue formation. Contributes to normal red blood cell formation.
A factor in the maintenance of good health.
Helps to metabolise carbohydrates, fats and proteins.
Multi-vitamin supplement.

CONTRA-INDICATIONS
Patients who have shown hypersensitivity to this product or any of its components.
Pregnant women or women of childbearing potential.

WARNINGS AND SPECIAL PRECAUTIONS
Consult a relevant health care provider prior to use if you are:

• following a low protein diet
• pregnant or breastfeeding.

Vitamin deficiency may result from an inadequate diet, perhaps due to increased requirements such as during pregnancy, or may be induced by disease or drugs.
Excessive intake of most water-soluble vitamins, such as those contained in NOOLIT: BRAIN STACK, have little effect due to their rapid excretion in urine, but excessive intakes of fat-soluble vitamins accumulate in the body and are potentially dangerous.
DO NOT EXCEED THE MAXIMUM RECOMMENDED DOSAGE (2 SACHETS) PER DAY.
Effects on ability to drive and use machines: No data available.

INTERACTIONS
No interaction studies have been performed.

PREGNANCY AND LACTATION
The safety of this product in human pregnancy has not been established.
Do not use during pregnancy and lactation.

DOSAGE AND DIRECTIONS FOR USE
Adults: Take 1 sachet pack daily to assist with the improvement of cognitive function and impaired concentration. Can be used twice daily when an added boost is required to assist with mental clarity and concentration.
DO NOT EXCEED THE MAXIMUM RECOMMENDED DOSAGE (2 SACHET PACKS) PER DAY.

SIDE-EFFECTS
Any nausea (probably due to a secondary dopaminergic activation) may require dosage reduction.
Digestive system: gastritis, gastrointestinal disease.
Central Nervous System: drowsiness, insomnia, nervousness, convulsion, hyperkinesia.

KNOWN SYMPTOMS OF OVERDOSE AND PARTICULARS OF ITS TREATMENT
No data available.

KNOWN SYMPTOMS OF OVERDOSE AND PARTICULARS OF ITS TREATMENT
No data available.

IDENTIFICATION
Each sachet pack contains a:

• white capsule
• orange capsule
• X tablet
• transparent softgel capsule

PRESENTATION
NOOLIT: BRAIN STACK capsules are packaged in a white pet bottle with heat seal
and a white safety screw top lid.

STORAGE INSTRUCTIONS
Store in a cool, dry place below 25 °C.
KEEP OUT OF REACH OF CHILDREN.
PROTECT FROM LIGHT.

REGISTRATION NUMBER
To be allocated

NAME AND BUSINESS ADDRESS OF THE APPLICANT
XS PHARMA (Pty) Ltd
The Innovation Hub
1 Mark Shuttleworth St
Lynwood
Pretoria
0087

DATE OF PUBLICATION OF THE PACKAGE INSERT
October 2021

CATEGORY D
D. 33.7 Combination Product, Complementary Medicines: Discipline-specific medicine
This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use. Intended to only complement the health or supplement the diet.