NOOLIT: RPM PROPOSED PACKAGE INSERT/RPM PROPOSED PATIENT INFORMATION LEAFLET

*%Nutrient Reference Values for individuals 4 years and older.
CONTAINS CAFFEINE. ADULTS ONLY.
Contains sweetener: 65 mg Sucralose

PHARMACOLOGICAL CLASSIFICATION
Complementary Medicines
Category D
D. 33.7 Combination Product, Complimentary Medicine: 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.

Vitamin B12 is generally water soluble. Water soluble vitamins are liable to degrade in solution especially if exposed to light.
Caffeine promotes alertness, wakefulness, temporarily assists to relieve fatigue and temporarily assists to increase mental activity.
Hericium erinaceus is a mushroom that grows on trunks of hardwood tress.
It is taken orally for a decline in memory to improve overall mental function and memory.
Proteins are constituents of living cells essential for growth and repair of tissues.
Taurine is an amino acid that plays a role in the support of the immune system and is also an antioxidant.
L-Citrulline is a source of a non-essential amino acid.

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: RPM is indicated for the following:

• aids with cognitive function and impaired concentration
• temporarily promotes alertness and wakefulness
• temporarily assists to relieve fatigue
• temporarily assists to increase mental activity
• helps to decrease cognitive fatigue due to physically stressful situations
• energy metabolism / the transformation of food into energy
• may improve physical performance and exercise capacity
• may help to delay muscle fatigue during physical activity.

CONTRA-INDICATIONS
Patients who have shown hypersensitivity to this product or any of its components, in which case, discontinue use.
Pregnant women or women of childbearing potential.

WARNINGS AND SPECIAL PRECAUTIONS
DO NOT EXCEED THE MAXIMUM RECOMMENDED INTAKE (4 SCOOPS PER DAY). CONTAINS CAFFEINE. ADULTS ONLY.
Contains 150 mg caffeine per scoop. A cup of instant coffee contains approximately 80 mg of caffeine. The use of caffeine may result in sleep deprivation.
Limit the use of caffeine-containing products (including tea and coffee) when taking this product.
Consult a registered healthcare professional if you are taking any other medicine or have been diagnosed with a chronic condition.
Consult a relevant health care provider prior to use if you are following a low protein diet or if you are pregnant or breastfeeding.
Sufficient protein is provided in normal well-balanced daily meals. Do not exceed daily dosage level without consulting a relevant health care provider.
If you have liver or kidney disease, consult a relevant health care provider prior to use.
May cause a flushing, tingling and/or prickling sensation of the skin, in which case, reduce the dose.

WARNINGS AND SPECIAL PRECAUTIONS
DO NOT EXCEED THE MAXIMUM RECOMMENDED INTAKE (4 SCOOPS PER DAY). CONTAINS CAFFEINE. ADULTS ONLY.
Contains 150 mg caffeine per scoop. A cup of instant coffee contains approximately 80 mg of caffeine. The use of caffeine may result in sleep deprivation.
Limit the use of caffeine-containing products (including tea and coffee) when taking this product.
Consult a registered healthcare professional if you are taking any other medicine or have been diagnosed with a chronic condition.
Consult a relevant health care provider prior to use if you are following a low protein diet or if you are pregnant or breastfeeding.
Sufficient protein is provided in normal well-balanced daily meals. Do not exceed daily dosage level without consulting a relevant health care provider.
If you have liver or kidney disease, consult a relevant health care provider prior to use.
May cause a flushing, tingling and/or prickling sensation of the skin, in which case, reduce the dose.

Effects on ability to drive and use machines: No data available

INTERACTIONS
No interaction studies have been performed.

PREGNANCY AND LACTATION
Total caffeine intake of more than 200 mg per day is not recommended during pregnancy or breastfeeding.
Do not use during pregnancy and lactation.

DOSAGE AND DIRECTIONS FOR USE
Dissolve 2 scoops in a glass of water, and take them once to twice daily to aid cognitive function and impaired concentration.
DO NOT EXCEED THE MAXIMUM RECOMMENDED INTAKE (4 SCOOPS PER DAY).

SIDE-EFFECTS
NOOLIT: RPM may have the following side effects:

• nausea (probably due to a secondary
• dopaminergic activation) may require
• dosage reduction
• gastritis
• gastrointestinal disease
• drowsiness
• insomnia
• nervousness
• convulsion
• hyperkinesia
• sleep deprivation.

KNOWN SYMPTOMS OF OVERDOSE AND PARTICULARS OF ITS TREATMENT
At doses of more than 600 mg per day, caffeine may cause anxiety, tachycardia (rapid heart rate), palpitations, insomnia, restlessness, nervousness, tremor and headache.

IDENTIFICATION
Red powder.

PRESENTATION
NOOLIT: RPM powder is packaged in a PET tub with a 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
November 2021

CATEGORY D
D. 33.7 Combination Product, Complimentary Medicine: 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.

What is in this leaflet
What NOOLIT: RPM is and what it is used for
What you need to know before you take NOOLIT: RPM
How to take NOOLIT: RPM
Possible side effects
How to store NOOLIT: RPM
Contents of the pack and other information

WHAT NOOLIT: RPM IS AND WHAT IT IS USED FOR
NOOLIT: RPM is used for the following:
aids with cognitive function and impaired concentration
temporarily promotes alertness and wakefulness
temporarily assists to relieve fatigue
temporarily assists to increase mental activity
helps to decrease cognitive fatigue due to physically stressful situations
energy metabolism / the transformation of food into energy
may improve physical performance and exercise capacity
may help to delay muscle fatigue during physical activity.

What you need to know before you take NOOLIT: RPM
Contains 150 mg caffeine per scoop. A cup of instant coffee contains approximately 80 mg of caffeine. Use of caffeine may result in sleep deprivation.
Not suitable for children under the age of 18 years.
Some medical conditions may interact with the product.
Use of caffeine may result in sleep deprivation.
Consumption with other caffeine-containing products or foods (e.g. medications, coffee, tea, colas, cocoa, guarana, maté) is not recommended.
Discontinue use two weeks prior to surgery.
If you are of childbearing age, pregnant or breastfeeding and have concerns that your daily intake of caffeine from all sources may exceed 200 mg per day, please consult a relevant health care provider prior to use.
Tell your doctor or pharmacist if you are taking any other medications.

Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you have allergies to medicines, foods, or other substances

Do not take NOOLIT: RPM
If you are hypersensitive (allergic) to NOOLIT: RPM (see section “WHAT NOOLIT: RPM CONTAINS”) in which case, discontinue use.
If you are under the age of 18 years old.
If you are pregnant, breastfeeding or planning on falling pregnant.
Contact your doctor or pharmacist right away if this applies to you.

Taking other medicines with NOOLIT: RPM
The effect of other medication and NOOLIT: RPM is not known.
Consult a registered healthcare professional if you:
are taking any other medicine (such as lithium) including chronic, complementary or traditional medicines
have high blood pressure, glaucoma, and/or detrusor instability(overactive bladder syndrome).
Consumption with other medicines (e.g. bitter orange extract, synephrine, octopamine, ephedra, ephedrine) which increase blood pressure is not recommended.
Ask your doctor or pharmacist if this product may interact with other medicines that you take.
Check with your doctor or pharmacist before you start, stop, or change the dose of any medicine.
Consult a doctor or pharmacist before using the product, if on any prescribed medication.

Taking NOOLIT: RPM with food and drink
NOOLIT: RPM can be taken after consumption of food.
Limit the use of caffeine-containing products (including tea and coffee) when taking this product.

Pregnancy and Lactation
Total caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.
Do not use during pregnancy and lactation.

Driving and using machines
NOOLIT: RPM does not cause drowsiness; however, as with any new medicine you should take care while driving or using machinery until you know how it affects you.

HOW TO TAKE NOOLIT: RPM
Do not share medicines prescribed for you with any other person.
In the event of over dosage, consult your doctor or pharmacist.
If neither is available, contact the nearest hospital or poison control center.

How much to take
Dissolve 1 scoop in a glass of water, and take once to twice daily to aid cognitive function and impaired concentration.
DO NOT EXCEED THE MAXIMUM RECOMMENDED INTAKE (2 SCOOPS PER DAY).
Use as only as directed by your doctor or pharmacist.

If you take more NOOLIT: RPM than you should
If you take more than the prescribed dose of NOOLIT: RPM, contact your Doctor or Pharmacist, or nearest hospital emergency department or poison control center immediately. Do this even if there are no signs of discomfort.

If you forget to take NOOLIT: RPM
If you forget to take a dose, take it as soon as you remember, and then continue as before.
Do not take a double dose to make up for forgotten individual doses.

Possible Side Effects
NOOLIT: RPM can cause side effects.
Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor or pharmacist for advice.
All medicines may cause side effects, but many people have no, or minor, side effects
Do not exceed recommended dosage unless otherwise prescribed by your doctor or pharmacist.
NOOLIT: RPM may have the following side effects:
nausea
inflammation of the stomach
problems with your gut
drowsiness
sleeplessness; trouble sleeping; unable to sleep
nervousness
convulsion
increase in body movements
sleep deprivation.
Seek medical attention right away if any of these severe side effects occur: (You may need urgent medical attention or hospitalization.) Tell your doctor immediately if you experience any of the following side-effects, or go to the hospital straight away.

HOW TO STORE NOOLIT: RPM
STORE ALL MEDICINE OUT OF REACH OF CHILDREN.
Store in a cool, dry place below 25 °C.
Protect from light.
Do not store in a bathroom.
Do not use after the expiry date stated on the label.
Check with your pharmacist about how to dispose safely of unused medicine.
Do not dispose of unused medicine in drains or sewerage systems (e.g toilets)
Return all unused medicine to your pharmacist.

What NOOLIT: RPM looks like and contents of the pack
NOOLIT: RPM is a red powder that is packaged in a PET tub with a lid.

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 PATIENT INFORMATION LEAFLET
November 2021

CATEGORY D
D. 33.7 Combination Product, Complimentary Medicine: 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.