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40 1 Ovabalance Powder Professional Information

40:1 Ova Balance Powder

Professional Information
SCHEDULING STATUS: S0

1. NAME OF THE MEDICINE:

40:1 Ova Balance Powder

2. QUALITATIVE & QUANTITATIVE COMPOSITION

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

Active Ingredients:

Serving size
(1 x scoop = 2,4 g)

Myo-Inositol

2000 mg

D-chiro Inositol

50 mg


Inactive Ingredients:
None

Sugar free

3. PHARMACEUTICAL FORM

White powder

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: One (1) x scoop twice a day of 40:1 Ova Balance Powder to be taken daily with a meal or as recommended by your health care provider.

Do not exceed daily dose without consulting a relevant health caremprovider.

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- 30g 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 phospholipids. 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.