NOOLIT: LION’S MANE PROPOSED PATIENT / PROPOSED PACKAGE INSERT INFORMATION LEAFLET

SCHEDULING STATUS: S0

Each capsule contains:

Sugar free.
Read all of this leaflet carefully because it contains important information for you
NOOLIT: LION’S MANE is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use NOOLIT: LION’S MANE carefully to get the best results from it.

• Keep this leaflet. You may need to read it again.
• Do not share NOOLIT: LION’S MANE with any other person.
  Ask your healthcare provider or pharmacist if you need more information or advice.
• You must see a doctor if your symptoms worsen or do not improve after 10 days.

What is in this leaflet

• What NOOLIT: LION’S MANE is and what it is used for
• What you need to know before you take NOOLIT: LION’S MANE
• How to take NOOLIT: LION’S MANE

Possible side effects
How to store NOOLIT: LION’S MANE
Contents of the pack and other information

WHAT NOOLIT: LION’S MANE IS AND WHAT IT IS USED FOR
NOOLIT: LION’S MANE aids with cognitive function and impaired concentration.

What you need to know before you take NOOLIT: LION’S MANE
Some medical conditions may interact with the product.
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: LION’S MANE

• If you are hypersensitive (allergic) to
• Hericium erinaceus (see section “WHAT NOOLIT: LION’S MANE CONTAINS”)
• If you are under the age of 18 years old.
• Contact your doctor or pharmacist right away if this applies to you.

Taking other medicines with NOOLIT: LION’S MANE
The effect of other medication and NOOLIT: LION’S MANE is not known.
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.
Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines).

Taking NOOLIT: LION’S MANE with food and drink
NOOLIT: LION’S MANE can be taken after the consumption of food.

Pregnancy and Lactation
The safety of this product in human pregnancy has not been established.
Do not use during pregnancy and lactation.
Driving and using machines
NOOLIT: LION’S MANE 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: LION’S MANE
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
Adults: Take 1 capsule once a day before meals to aid with cognitive function and impaired concentration. Can be used more than once daily.
DO NOT EXCEED THE MAXIMUM RECOMMENDED INTAKE OF 2 CAPSULES PER DAY.
Use as only as directed by your doctor or pharmacist.

If you take more NOOLIT: LION’S MANE than you should
If you take more than the prescribed dose of NOOLIT: LION’S MANE, 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: LION’S MANE
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: LION’S MANE 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: LION’S MANE may cause stomach discomfort.
Seek medical attention right away if experience this or any other severe side effect: (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: LION’S MANE
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: LION’S MANE looks like and contents of the pack
NOOLIT: LION’S MANE capsules are white and green and are 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. 33.4 Traditional Chinese Medicine, Complementary Medicines: Discipline-specific
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.