Inositol Complex Professional Information

Professional Information
SCHEDULING STATUS: S0

1. NAME OF THE MEDICINE:

Inositol Complex

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
Four (4) x vegetable capsules of Inositol Complex to be taken daily with a meal.

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

Paediatric population
In general, health supplements should not be intended for supply to any children under the age of seven (7) months old unless where supplementation is medically warranted

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

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- 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: 34.12 Multiple substance formulation

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. 

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 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.

Folic Acid
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 Methyl cobalamin
Methyl cobalamin 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 43 mm WHITE cap 120 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
063 616 0309 

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.