Professional Information

PROFESSIONAL INFORMATION
SCHEDULING STATUS
S0
1. NAME OF THE MEDICINE
Category D 33.6: human complementary medicine, western herbal medicine. This medicine
has not been evaluated by the SAHPRA. This medicine is not intended to diagnose, treat,
cure, or prevent any disease.
Brand New Me Sutherlandia OPC (Capsules)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Category D 33.6: human complementary medicine, western herbal medicine. This medicine
has not been evaluated by the SAHPRA. This medicine is not intended to diagnose, treat,
cure, or prevent any disease.
Each capsule contains:
Active Ingredients: 250 mg Sutherlandia frutescens and 100 mg Nerium oleander extract.
Inactive ingredients: cellulose, silica, magnesium stearate and vegetable gelatine. Sugar
free.
3. PHARMACEUTICAL FORM
Category D 33.6: human complementary medicine, western herbal medicine. This medicine
has not been evaluated by the SAHPRA. This medicine is not intended to diagnose, treat,
cure or prevent any disease.

Brand New Me Sutherlandia OPC is hard gelatine capsule encapsulating green herbal
powder.
4. CLINICAL PARTICULARS
Category D 33.6: human complementary medicine, western herbal medicine. This medicine
has not been evaluated by the SAHPRA. This medicine is not intended to diagnose, treat,
cure or prevent any disease.
4.1. Therapeutic Indications
For general health enhancement and maintenance.
4.2. Posology and method of administration
Posology
Adults: Take one capsule orally twice a day with a glass of water, with or without meals.
Not for use in breastfeeding or pregnancy or children.
Dosing must be increased slowly when starting treatment with Sutherlandia OPC from one
capsule per day for one month then one capsule twice per day if no side effects are
experienced. Sutherlandia OPC must not be used for longer than 12 months consecutively.
In the event of adverse reactions, dosing must cease immediately. Untreated overdose and
toxicity may be fatal.
Method of administration
Capsules must be swallowed whole with a glass of water.
4.3. Contraindications
This medicine is contraindicated in kidney and liver impairment, cardiovascular conditions
such as dysrrhythmias and in patients taking anticoagulants. Avoid if allergic or sensitive to any of the listed ingredients. Do not use if pregnant or breastfeeding. Do not exceed
recommended dosage(s).
4.4. Special warnings and precautions for use
Discontinue use immediately should any adverse reaction occur due to hypersensitivity to
any of the ingredients of Sutherlandia OPC. Side effects can be a sign of toxicity which if
left untreated may be fatal.
4.5. Interaction with other medicines and other forms of interaction
Since data on Sutherlandia OPC is limited, there may be interactions with other medicines
and in special populations. Caution is to be exercised when taking Sutherlandia OPC with
other medicines. Sutherlandia OPC is not indicated in populations with special consideration
such as renal or hepatic impairment and cardiovascular conditions such as dysrhythmias or
patients taking anticoagulants (e.g., warfarin).
4.6. Fertility, pregnancy and lactation
Safety in pregnancy and lactation has not yet been established.
4.7. Effects on ability to drive and use machines
Brand New Me Sutherlandia OPC may cause drowsiness or fatigue. Caution is to be
exercised when driving or operating heavy machinery.
4.8. Undesirable effects
Brand New Me Sutherlandia OPC may cause unwanted weight loss. Excessive use may
lead to toxicity and adverse events. Stop use immediately and consult your doctor if you
experience any side effects such as weight loss, irregular heartbeat, abdominal pain,
drowsiness, headache, vomiting or diarrhoea. Untreated overdose and toxicity may be fatal.
4.9. Overdose

In overdose, side effects can be precipitated and/or be of increased severity. Overdose is
treated by stopping further administration immediately and contacting the nearest hospital or
poison centre if undesirable effects persist. Untreated overdose and toxicity may be fatal.
5. PHARMACOLOGICAL PROPERTIES
Category D 33.6: human complementary medicine, western herbal medicine. This medicine
has not been evaluated by the SAHPRA. This medicine is not intended to diagnose, treat,
cure or prevent any disease.
5.1. Pharmacodynamic properties
33.6 Western Herbal Medicine. Nerium oleander contains cardiac glycosides that exerts an
effect on cardiac muscle. Their action is derived from inhibition of the plasmalemma (cell
membrane) Na+/K+-ATPase. It may induce cell death in human cancer cells.
The mechanism of action of Sutherlandia frutescence is unknown. It contains phenolic
compounds that may contribute to an antioxidant effect resulting in enhancement and
maintenance of general health and wellbeing.
5.2. Pharmacokinetic properties
There is insufficient pharmacokinetic data available on the active ingredients via the route of
administration described.
5.3. Preclinical safety data
There is pre-clinical data of relevance available to the prescriber on the active ingredients via
the route of administration described.
6. PHARMACEUTICAL PARTICULARS
Category D 33.6: human complementary medicine, western herbal medicine. This medicine
has not been evaluated by the SAHPRA. This medicine is not intended to diagnose, treat,
cure, or prevent any disease.
6.1. List of excipients
Inactive ingredients: cellulose, silica, magnesium stearate and vegetable gelatine.
6.2. Incompatibilities
6.3. Shelf life
2 years
6.4. Special precautions for storage
Store below 25 °C in a cool, dry place. KEEP OUT OF REACH OF CHILDREN.
6.5. Nature and contents of container
Brand New Me Sutherlandia OPC is a hard gelatine capsule containing green herbal powder
in a white HDPE container. Each container contains 60 capsules with a Patient Information
Leaflet.
6.6. Special precautions for disposal
Return Sutherlandia OPC to your local pharmacy for safe disposal.
7. HOLDER OF CERTIFICATE OF REGISTRATION
Category D 33.6: human complementary medicine, western herbal medicine. This medicine
has not been evaluated by the SAHPRA. This medicine is not intended to diagnose, treat,
cure or prevent any disease.
Well Like Me Products (Pty) Ltd
312 Thornibrae, 8 York Rd, Cape Town, 8001.
Distributed by: Brand New Me (Pty) Ltd