MOOD PROPOSED PATIENT INFORMATION LEAFLETS0

SCHEDULING STATUS: S0

*%Nutrient Reference Values for individuals 4 years and older.
Contains sweetener: 1 mg Sucralose
Preservatives: Sodium benzoate (0,027 %) and Potassium sorbate (0,013 %)

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

• Keep this leaflet. You may need to read it again.
• Do not share NOOLIT: MOOD 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: MOOD is and what it is used for
• What you need to know before you take NOOLIT: MOOD
• How to take NOOLIT: MOOD
• Possible side effects
• How to store NOOLIT: MOOD
• Contents of the pack and other information

WHAT NOOLIT: MOOD IS AND WHAT IT IS USED FOR
NOOLIT: MOOD helps to support relaxation (reducing stress) and also helps to temporarily promote relaxation (reducing anxiety), supports maintenance of healthy sleep and is also a factor in the maintenance of good health

What you need to know before you take NOOLIT: MOOD
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: MOOD

• If you are hypersensitive (allergic) to NOOLIT: MOOD (see section “WHAT NOOLIT: MOOD 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: MOOD
The effect of other medication and NOOLIT: MOOD 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: MOOD with food and drink
NOOLIT: MOOD can be taken after 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: MOOD 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: MOOD
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
Take 1 sachet (10 ml) once a day to aid with the reduction of stress and anxiety by promoting relaxation. Can be used twice daily when required.
DO NOT EXCEED THE MAXIMUM RECOMMENDED INTAKE OF 20 ML PER DAY
(2 SACHETS PER DAY).
Use as only as directed by your doctor or pharmacist.

If you take more NOOLIT: MOOD than you should
If you take more than the prescribed dose of NOOLIT: MOOD, 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: MOOD
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: MOOD 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: MOOD may have the following side effects:

• lower blood pressure
• nausea
• vomiting
• diarrhoea
• stomach pain
• loss of appetite
• headache
• tingling
• sleepiness.

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: MOOD
STORE ALL MEDICINE OUT OF REACH OF CHILDREN.
Store at or below 25 °C.
Protect from light.
Do not store in a bathroom.
Do not use it 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: MOOD looks like and contents of the pack
NOOLIT: MOOD is a raspberry red liquid that is packaged in single, foil sachets.

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.