Inositol Complex Patient Information Leaflet

Inositol Complex

Patient Information Leaflet
Scheduling Status: S0

Inositol Complex

Sugar free
Category D: Complementary Medicine
Health Supplement
34.12 Multiple substance formulation

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

Inositol Complex
Inositol Complex is available without a doctor’s prescription, for you to maintain your health. Nevertheless, you still need to use Inositol Complex carefully to get the best results from it.

• Keep this leaflet. You may need to read it again.
• Do not share Inositol Complex 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 Inositol Complex and what it is used for
2. What you need to know before you take Inositol Complex
3. How to take Inositol Complex
4. Possible side effects
5. How to store Inositol Complex
6. Contents of the pack and other information

 1. What is Inositol Complex 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.
• 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. 

2. What you need to know before you take Inositol Complex Do not take Inositol Complex

• 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 Inositol Complex

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

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
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.

Other medicines and Inositol Complex

• 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.
• 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.

Pregnancy, breastfeeding and fertility

The safe use of Inositol Complex while pregnant or breastfeeding has not been established.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.

Inositol Complex contains no excipients. 

3. How to take Inositol Complex

Do not share medicines prescribed for you with any other person.

Always take Inositol Complex 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 (4) x vegetable capsules daily of Inositol Complex with a meal.

If you take more Inositol Complex  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 Inositol Complex
Do not take a double dose to make up for forgotten individual doses.

4. Possible side effects

Inositol Complex 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 Inositol Complex are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Inositol Complex, 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 Inositol Complex.

5. How to store Inositol Complex

• 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 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.