40:1 OVA BALANCE POWDER PATIENT INFORMATION LEAFLET AND PROFESSIONAL INFORMATION

Patient Information Leaflet

Scheduling Status
S0

40:1 Ova Balance Powder

Sugar free
Category D: Complementary Medicine
Health Supplement
34.13 Other

This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

Read all of this leaflet carefully because it contains important information for you

40:1 Ova Balance Powder
40:1 Ova Balance Powder is available without a doctor’s prescription, for you to maintain your health. Nevertheless, you still need to use 40:1 Ova Balance Powder carefully to get the best results from it.

• Keep this leaflet. You may need to read it again.
• Do not share 40:1 Ova Balance Powder with any other person.
• Ask your health care provider or pharmacist if you need more information or advice.

What is in this leaflet
1. What is 40:1 Ova Balance Powder and what it is used for.
2. What you need to know before you take 40:1 Ova Balance Powder.
3. How to take 40:1 Ova Balance Powder.
4. Possible side effects.
5. How to store 40:1 Ova Balance Powder.
6. Contents of the pack and other information

1. What is 40:1 Ova Balance Powder and what it is used for

• May reduce hormonal, metabolic and oxidative abnormalities associated with polycystic ovary syndrome (PCOS).
• Improved Insulin sensitivity.
• Improves ovulatory function, menstrual cycle & ovulation rate.
• May reduce serum androgen concentrations.
• May promote decreased Body Mass Index (BMI) and fat mass.
• May decrease total cholesterol concentration.
• May relieve symptoms associated with mild to moderate depression.
• May relieve symptoms of panic attacks
• Clinical studies support that 40:1 Myo Inositol / D-chiro Inositol ratio as the best ratio for PCOS treatment aimed at restoring ovulation in patients with PCOS.

2. What you need to know before you take 40:1 Ova Balance Powder

Do not take 40:1 Ova Balance Powder

• If you are pregnant or breastfeeding.
• If you are Hypersensitive / Allergic to the active substance or to any of the excipients or residues from the manufacturing process in which case, discontinue use.
• Consult a registered healthcare provider prior to use if you are taking any other medicine or have been diagnosed with a chronic condition.

Warnings and precautions
Special care should be taken with 40:1 Ova Balance Powder

• If you are pregnant or breastfeeding.
• If you have high blood pressure.
• If you are taking anti-depressants or blood thinners.
• Inositol has been shown to reduce blood sugar and haemoglobin A1c levels. If you have diabetes and use inositol you blood sugar levels may be reduced. 

A varied diet is the most effective and safe way to achieve good nutrition, health, body composition as well as mental and physical performance.

Children
Not suitable for Children under the age of 18 years.

Other medicines and 40:1 Ova Balance Powder
Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines). 

Consult your health care provider if you are taking anti-depressants. 
Consult your health care provider if you are taking blood thinners.

Pregnancy, breastfeeding and fertility
Do not use if you are pregnant or breast feeding.

40:1 Ova Balance Powder contains no excipients. 

3. How to take 40:1 Ova Balance Powder

Do not share medicines prescribed for you with any other person.
Always take 40:1 Ova Balance Powder exactly as described in this leaflet or as your doctor, or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

It is recommended that adults take one (1) x scoop once or twice daily of 40:1 Ova Balance Powder with a meal. May be mixed into any hot or cold uncarbonated and unsweetened liquid. 

If you take more 40:1 Ova Balance Powder than you should

Overdose may lead to dizziness, fatigue and headaches at doses of 12 g of Inositol per day. Doses of 12 – 30 g per day of Inositol may also lead to nausea, flatulence, loose stool and diarrhoea.

In the event of over dosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take 40:1 Ova Balance Powder

Do not take a double dose to make up for forgotten individual doses.

4. Possible side effects
40:1 Ova Balance Powder can have side effects.
Less Frequent side effects: (Occurs in less than 1 in 100 users)

Immune system disorder:

• May lead to dizziness, fatigue and headaches at doses of 12 g per day of Inositol.
• Allergic reactions such as skin redness, rash, itching, hives, difficulty breathing and anaphylactic reactions (including shock).  

Gastrointestinal: 

• Nausea, flatulence, loose stools and diarrhea may occur at doses of 12 – 30 g per day of Inositol. 

Not all side effects reported for 40:1 Ova Balance Powder are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking 40:1 Ova Balance Powder, please consult your health care provider for advice.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects 

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of 40:1 Ova Balance Powder. 

5. How to store 40:1 Ova Balance Powder,

Store all medicines out of reach of children.
Store in the airtight container, protected from light at or below 25 ˚C. 
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

6. Contents of the pack and other information

What 40:1 Ova Balance Powder contains
The active substances are:

The other ingredients are:

40:1 Ova Balance Powder has no excipients. 

What 40:1 Ova Balance Powder looks like and contents of the pack
40:1 Ova Balance Powder 250 ml white aqueous jar with a White Cap and heat induction seal with white powder

Holder of Certificate of Registration
Meloono (Pty) Ltd
info@meloono.co.za

This leaflet was last revised in
12 April 2022

Registration number
This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

Access to the corresponding Professional Information
Refer to below

Professional Information

SCHEDULING STATUS:

S0

1. NAME OF THE MEDICINE:

40:1 Ova Balance Powder 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each serving size (1 x Scoop) of 40:1 Ova Balance Powder contains:

Inactive Ingredients:

None.

Sugar free.

3. PHARMACEUTICAL FORM

Clear vegetable capsules.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

• May reduce hormonal, metabolic and oxidative abnormalities associated with polycystic ovary syndrome (PCOS).
• Improved Insulin sensitivity.
• Improves ovulatory function, menstrual cycle & ovulation rate.
• May reduce serum androgen concentrations.
• May promote decreased Body Mass Index (BMI) and fat mass.
• May decrease total cholesterol concentration.
• May relieve symptoms associated with mild to moderate depression.
• May relieve symptoms of panic attacks.
• Clinical studies support that 40:1 Myo Inositol / D-chiro Inositol ratio as the best ratio for PCOS treatment aimed at restoring ovulation in patients with PCOS 

4.2 Posology and method of administration

Adults: It is recommended that adults take one (1) x scoop once or twice daily of 40:1 Ova Balance Powder with a meal. May be mixed into any hot or cold uncarbonated and unsweetened liquid. 

Do not exceed daily dose without consulting a relevant health care provider.

Paediatric population
Recommended for adults 18 years and older 

4.3 Contraindications

Contraindicated for use in pregnancy and breastfeeding.
Hypersensitivity/allergy to the active substance or to any of the excipients or residues from the manufacturing process in which case, discontinue use.

Consult a registered healthcare provider prior to use if you are taking any other medicine or have been diagnosed with a chronic condition. 

See “4.4 SPECIAL WARNINGS AND PRECAUSTIONS FOR USE”.

4.4 Special warnings and precautions for use

• Consult a health care provider prior to use if you are pregnant or breastfeeding.
• Consult a health care provider prior to use if you have high blood pressure.
• Consult a health care provider prior to use if you are taking anti-depressants or blood thinners.
• Inositol has been shown to reduce blood sugar and haemoglobin A1c levels.
• If you have diabetes and use inositol you blood sugar levels may be reduced.

See “4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTION.”

4.5 Interaction with other medicines and other forms of interaction

Consult a health care provider prior to use if you are taking anti-depressants or blood thinners.

See “4.4 SPECIAL WARNINGS AND PRECAUSTIONS FOR USE”. 

4.6 Fertility, pregnancy and lactation

Do not use if you are pregnant or breast feeding 

4.7 Effects on ability to drive and use machines

Effects on ability to drive and use machines has not been established. 

4.8 Undesirable effects

The frequencies of adverse reactions are ranked according to the following:

frequent > 1/100 

less frequent < 1/100 

Immune system disorder 
Less frequent:
Dizziness, fatigue and headaches may occur at doses of 12 g of Inositol per day. 

Gastrointestinal disorder 
Less frequent:
Nausea, flatulence, loose stools and diarrhoea may occur at doses of 12- 30 g of Inositol per day. 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8

4.9 Overdose

In overdose, side effects can be precipitated and/or be of increased severity. Overdose may lead to dizziness, fatigue and headaches at doses of 12 g of Inositol per day. 

Overdose may also lead to nausea, flatulence, loose stools and diarrhoea may occur at doses of 12- 30 g of Inositol per day. 

Treatment is symptomatic and supportive. 
See section “4.8. Undesirable effects.” 

5. PHARMACOLOGICAL PROPERTIES
Category D: Complementary Medicine
Discipline: Health Supplement
Classification: 34.13 Other

5.2 Pharmacodynamic properties

Pharmacodynamic effect due to the combination of active ingredients for promoting hormonal, metabolic and oxidative abnormalities associated with polycystic ovary syndrome. Promoting normal psychological functions through relieving symptoms of depression and anxiety. Contributes to reduction of fatigue and contributes to a normal energy yielding metabolism which leads to a lower Body Mass Index (BMI) and fat mass. 

5.2 Pharmacokinetic properties

Inositol

Inositol is a naturally occurring isomer of glucose.  It is a key intermediate of a second messenger system used by numerous serotonergic, cholinergic and noradrenergic receptors, making compounds containing inositol important in signal transduction.  In addition, inositol is a primary component of cellular membrane phospholipidis. Inositol is generally considered to be a member of the B vitamin family and is present mainly as the fibre component, phytic acid Myoinositol (MI) and D-chiro-inositol (DCI) are involved in a number of biochemical pathways within oocytes having a role in oocyte maturation, fertilization, implantation, and post implantation development. Both inositol’s have a role in insulin signalling and hormonal synthesis in the Ovaries.

5.3 Preclinical safety data

No data available. 

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
40:1 Ova Balance Powder:
No Inactive ingredients are used in this product. 

6.2 Incompatibilities 
Not applicable.

6.3 Shelf life
24 months.

6.4 Special precautions for storage
Store in cool, dry place at or below 25 ˚C.

6.5 Nature and contents of the container Inositol Complex
250 ml white aqueous jar with a White Cap and heat induction seal with white powder

6.6 Special precautions for disposal 
No special requirements.

7. HOLDER OF CERTIFICATE OF REGISTRATION: 
Meloono (Pty) Ltd
info@meloono.co.za

8. REGISTRATION NUMBER:
This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Not applicable.

10. DATE OF REVISION OF TEXT
Not applicable.