MYOFOLATETM powder
2 000 mg Myo-Inositol & 200 μg L-5-methyltetrahydrofolate Sugar Free
COMPLEMENTARY MEDICINE
D.22.2 Others (Health Supplement)
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.
MyofolateTM is available without a doctor's prescription, for you to maintain your health. Nevertheless, you still need to use MyofolateTM carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Do not share MyofolateTM with any other person.
• Ask your healthcare provider or pharmacist if you need more information or advice.
What is in this leaflet
What MyofolateTM is and what it is used for
What you need to know before you take MyofolateTM
How to take MyofolateTM
Possible side effects
How to store MyofolateTM
Content of the pack and other information
1. What MyofolateTM is and what it is used for
MyofolateTM is intended to supplement your diet to overcome possible nutritional deficiencies of inositol and folate.
2. What you need to know before you take MyofolateTM
Do not use MyofolateTM if you are hypersensitive or allergic to any of the ingredients.
Warnings and precautions
Do not use MyofolateTM if you are hypersensitive (allergic) to myo-inositol or L-5-methyltatrahydrofolate, or any of the other ingredients of MyofolateTM (listed in section 6).
Other medicines and MyofolateTM
Always tell your healthcare provider if you are using any other medicines. This includes all complementary and traditional medicines. No known interactions with other medicines.
Children
Do not give MyofolateTM to children under the age of 10 years old.
Pregnancy, breastfeeding and fertility
Myo-inositol has been used in amounts up to 4 000 mg daily during pregnancy with no adverse effects reported. The safety during breastfeeding has not been established. MyofolateTM may assist in overcoming possible nutritional deficiencies that may impact fertility. 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.
Driving and using machines
No known effects on mental / physical abilities to perform or execute tasks that require mental alertness, judgement and / or sound coordination and vision eg. driving, flying, sailing etc.
3. How to take MyofolateTM
Always take MyofolateTM exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. Do not share medicines prescribed for you with any other person.
Dissolve one (1) sachet in a glass of water. Then drink the contents of the whole glass. Take one (1) sachet once or twice daily.
If you take more MyofolateTM than you should
In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.
If you forget to take MyofolateTM
Do not take a double dose to make up for forgotten individual doses.
4. Possible side effects
MyofolateTM can have side effects. Not all side effects reported for MyofolateTM are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MyofolateTM, please consult your healthcare provider for advice.
MyofolateTM is usually well tolerated but gastrointestinal disturbances such as abdominal / stomach cramps, diarrhoea, flatulence or wind may occur in some individuals.
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 Reactions & Quality Problem Reporting Form", found online under SAHPRA's publications: https://sahpra.org.za/wp-content/uploads/2020/01/6.04_ARF1_v5.1_27Jan2020.pdf.
By reporting side effects, you can help provide more information on the safety of MyofolateTM.
5. How to store MyofolateTM
Store all medicines out of reach of children.
Store at or below 25 ̊C in a dry place. Do not store in a bathroom.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems (eg. toilets).
6. Content of the pack and other information What MyofolateTM contains
The active substances are 2 000 mg (miligram) Myo-Inositol and 200 μg (microgram) L-5-methyltetrahydrofolate per sachet.
What MyofolateTM looks like and contents of the pack
Dry white powder packed in individual sachets. Each box contains 30 sachets.
Holder of Certificate of Registration:
Delfran (Pty) Ltd.
70 Jacaranda Str, Unit 7, Diamond Park, Hennopspark, Centurion, 0157, South Africa. +27 12 654 3029
This leaflet was last revised on: May 2021 Registration number: To be allocated
MYOF PIL V1 2021