INOSITOL COMPLEX PATIENT INFORMATION LEAFLET AND PROFESSIONAL INFORMATION

Scheduling Status:
S0

INOSITOL COMPLEX (VEGETABLE CAPSULES)

Sugar free

Category D: Complementary Medicine
Classification: Health Supplement 
Discipline: 34.12 Multiple substance formulation

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

The other ingredients are: 
Inositol Complex does not contain any other ingredients.

Sugar free.

What Inositol Complex looks like and contents of the pack
Inositol Complex contains 120 x size 00 clear vegetable capsules in a 250 ml Polyethylene Terephthalate (PET) clear container with a 43 mm white cap.

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

This leaflet was last revised in
08 November 2024

Registration number
To be allocated 

Access to the corresponding Professional Information
Refer to the Professional Information below

What Inositol Complex contains
The active substances are:

The other ingredients are:
Inositol Complex has no excipients.

What Inositol Complex looks like and contents of the pack
Inositol Complex 250 ml Polyethylene Terephthalate (PET) CLEAR container, 43 mm WHITE Child resistant cap (CRC) cap with 120 x size 00 clear vegetable capsules.

Holder of Certificate of Registration
Meloono (PTY) Ltd
info@meloono.co.za
063 616 0309

This leaflet was last revised in
9 November 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 QR Code on the Label to access the Professional Information.

INOSITOL COMPLEX PROFESSIONAL INFORMATION

SCHEDULING STATUS:

SO

1. NAME OF THE MEDICINE:
Inositol Complex

Strength 
Multicomponent

Pharmaceutical form
Vegetable capsules

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each serving size (4 x vegetable capsules) of Inositol Complex 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.
• Assists with reduction of tiredness and fatigue.
• May promote normal psychological function.
• Contributes to the normal function of the nervous system.
• Contributes to normal energy – yielding metabolism.
• Helps to reduce the risk of neural tube defects when taken daily prior to           
  becoming pregnant.

4.2 Posology and method of administration
It is recommended to take two (2) x vegetable capsules of Inositol Complex twice daily a few minutes before your morning and evening meal. May be taken in one dosage of four (4) capsules.

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

Paediatric population
Not recommended for use in children

4.3 Contraindications
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. 
Folic acid may lower the serum concentration of phenytoin and obscure
pernicious anaemia.

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.
Folic acid may lower the serum concentration of phenytoin and there is a
possibility that such an effect could also occur with barbiturates and
antiepileptics.

See “4.4 SPECIAL WARNINGS AND PRECAUSTIONS FOR USE”. 

4.6 Fertility, pregnancy and lactation
Inositol Complex has not been tested for safe use during 
Pregnancy and Lactation. 

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 
Frequency not known

Immune system disorder 
Less frequent:
Dizziness, fatigue and headaches may occur at doses of 12 g of Inositol per
day. 
Allergic reactions such as erythema, rash, itching, urticaria, difficulty in
breathing and anaphylactic reactions (including shock).
 
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
5.1 Pharmacodynamic properties
D34.12 Health Supplement, Multiple substance formulation.
The combination of active ingredients in Inositol Complex is formulated to
help alleviate symptoms associated with polycystic ovary syndrome (PCOS).
 
      
5.2 Pharmacokinetic properties
Inositol
The adsorption of myo-Ins or inositol-phosphate derivatives (including
InsP6) from the diet occurs in the gut. At high concentrations, cellula
adsorption occurs by a diffusion process, while the active uptake is primarily
carried out by a system of transporters. The Na+-coupled transport is
exerted by two higher-affinity transporters, namely Sodium/myo-Inositol
Transporter-1 (SMIT1) and Sodium/myo-Inositol Transporter-2 (SMIT2),
while the H+-coupled transport is exerted by the lower affinity H+/myo
Inositol transporter (HMIT). These transporters exhibit a different distribution
in the human body. HMIT is primarily expressed in brain and less in kidneys,
adipocytes, and oocytes. SMIT1 and SMIT2 transporters belong to
the SLC5 human gene sub-family of the Na+-dependent glucose
cotransporters, and their codifying genes exhibit similar expression
patterns. SLC5A3, encoding SMIT1, is expressed in kidney, brain, placenta,
pancreas, heart, skeletal muscle, and lung. SLC5A11, encoding SMIT2,
exhibits high expression in the small intestine, kidney, heart, skeletal muscle,
liver, and placenta, and it is weakly expressed in brain.

Magnesium Glycinate
Magnesium is primarily stored in bone, muscle, and soft tissue, and less 
than 1% is present in the extracellular fluid. Roughly 30% of ingested
 magnesium through food or drinking water is absorbed by the intestine,
although the extent of absorption depends on the body magnesium 
status (increased in case of Mg2+ deficiency). Magnesium homeostasis 
is further regulated through the secretion and reabsorption in the 
kidneys, where about 95% of the filtered magnesium is reabsorbed. 
Transfer of magnesium from serum to urine begins immediately 
when magnesium pools are saturated.

Zinc Citrate 
Zinc is absorbed in the small intestine by a carrier-mediated 
mechanism.
Zinc is released from food as free ions during its digestion. These 
freed ions may then combine with endogenously secreted ligands 
before their transport into the enterocytes in the duodenum and 
jejunum. Selected transport proteins may facilitate the passage 
of zinc across the cell membrane into the hepatic circulation. 
With high intake, zinc may also be absorbed through a passive 
paracellular route.
The portal system carries absorbed zinc directly into the hepatic 
circulation, and then it is released into systemic circulation for 
delivery to various tissues.
Zinc absorption is concentration dependent and increases with 
increasing dietary zinc up to a maximum rate. In addition, zinc 
status may influence zinc absorption. Zinc-deprived humans absorb 
this element with increased efficiency, whereas humans on a
 high-zinc diet shows a reduced efficiency of absorption.

Vitamin K2 Menaquinone 7
The absorption (time-to-peak) of MK-7 from tablets was slower than from
capsules, 6 h as compared to 2 h-4 h, respectively. Probably, the oily matrix
of the capsules released the lipophilic MK-7 more rapidly than the powder
matrix of the tablets. We further found a dose response relationship for MK
7 at 24 h after the single-dose intakes (at group level). As compared to
baseline, circulating MK-7 levels were still elevated at 24 h after intake,
confirming the relatively long half-life of MK-7. The different MK-7 carrier
materials showed similar 24 h-absorption profiles, indicating that the carrier
was not influencing MK-7 absorption. Next to high intra-subject variability,
high inter-subject variability was seen in the different studies. This was found
for both, peak height and for total absorption (measured as 24 h-AUC). While
some subjects showed a linear dose-response relation, other subjects had
similar 24 h-AUCs after intake of MK-7 at different dosages.

Vitamin D3 Cholecalciferol
Vitamin D substances are well absorbed from the gastro-intestinal tract.
The presence of bile is essential for adequate intestinal absorption;
absorption may be decreased in patients with decreased fat absorption.
Vitamin D can be stored in adipose and muscle tissue for long periods 
Of time. Cholecalciferol has a slow onset and a long duration of action. 
Cholecalciferol is hydroxylated in the liver by the enzyme vitamin D 
25-hydroxycholecalciferol. This compound undergoes further 
Hydroxylation in the kidney by the enzyme vitamin D 1-hydroxylase to
form the active metabolite 1,25-dihydroxycholecalciferol. Further
metabolism also occurs in the kidneys, including the formation of the
1,24,25-trihydroxy derivatives.
Cholecalciferol and its metabolites are excreted mainly in the bile and faeces
Certain vitamin D substances may be distributed into breast milk.

Folate
Folic acid, also known as folate or Vitamin B9, is a member of the 
B vitamin family and an essential cofactor for enzymes involved in DNA 
and RNA synthesis.
Absorbed rapidly from the GI tract, mainly from the proximal part of the 
small intestine. Normal serum folate levels range from 0.005 to 
0.015 mcg/ml. Usually, serum levels less than 0.005 mcg/ml indicate 
folate deficiency; those less than 0.002 mcg/ml usually result 
in megaloblastic anaemia.
The active tetrahydro folic acid and its derivatives are distributed into all 
body tissues; the liver contains about half of the total body folate 
stores. Folate is actively concentrated in the Cerebrospinal fluid. 
Folic acid is distributed into breast milk.
Metabolized in the liver to N-methyltetrahydrofolic acid, the main form 
of folate storage and transport.
A single 0.1-mg to 0.2-mg dose usually results in only a trace amount of 
drug in urine. After administering large doses, excessive folate is 
excreted unchanged in urine. Small amounts of folic acid have 
been recovered in faeces. About 0.05 mg/day of normal body folate stores
is lost by a combination of urinary and faecal excretion and oxidative 
cleavage of the molecule.

Vitamin B12 Methylcobalamin 
Methylcobalamin is absorbed from the gastro-intestinal tract and is
extensively bound to specific plasma proteins. A study with labelled 
Vitamin B showed it was quickly taken up by the intestinal mucosa 
and held there for 2 - 3 hours. Peak concentrations in the blood and 
tissues did not occur until 8 - 12 hours after dosage with maximum
concentrations in the liver within 24hours. Cobalamins are stored in 
the liver, excreted in the bile and undergo enterohepatic recycling. 
Part of a dose is excreted in the urine, most of it in the first eight 
hours.

5.3 Preclinical safety data
No data available. 

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Inositol Complex:
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 Polyethylene Terephthalate (PET) clear container with a 43 mm
cap, 120 x size 00 clear vegetable capsules. 

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.