BERBERINE COMPLEX PATIENT INFORMATION LEAFLET AND PROFESSIONAL INFORMATION

BERBERINE COMPLEX PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S0

BERBERINE COMPLEX (VEGETABLE CAPSULES)

Sugar free

Category D: Complementary Medicine
            Discipline: 33.3 Discipline specific, Ayurvedic Product.

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

The other ingredients are: 
Berberine Complex contains Sweet Potato starch powder and Microcrystalline Cellulose. 

Sugar free.

What Berberine Complex looks like and contents of the pack
Berberine Complex is contained in a 250 ml Clear Polyethylene Terephthalate (PET) container with a 43 mm white cap, induction seal with silica and foam insert providing 120 x size 00 white vegetable capsules. 

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

This leaflet was last revised in
20 February 2025

Registration number
To be allocated 

Access to the corresponding Professional Information
The Professional Information can be found below

BERBERINE COMPLEX PROFESSIONAL INFORMATION
SCHEDULING STATUS:
S0

1. NAME OF THE MEDICINE:
Berberine Complex

Strength 
Multicomponent

Pharmaceutical form
Vegetable capsules

2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each serving size (2 - 4 x vegetable capsules) of Berberine Complex
contains:

Inactive Ingredients:
For full list of excipients, see section 6.1.

Sugar free.

3. PHARMACEUTICAL FORM
White vegetable capsules.

4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Traditionally used in Western Herbal Medicine to support natural body
detoxification processes. 
Helps in maintenance of healthy blood lipids.
Helps support healthy cholesterol.
Helps maintain healthy blood sugar.
Traditionally used in Western herbal medicine to maintain/support healthy
digestion.
Traditionally used in Western herbal medicine to decrease/reduce/relieve
symptoms of indigestion/dyspepsia.
Traditionally used in Western herbal medicine to maintain/support healthy
liver function.

4.2. Posology and method of administration
Up to four (4) x vegetable capsules of Berberine Complex to be taken daily
with a meal.

Start with two (2) capsules before a meal for the first week of use. After a week, take two (2) capsules before a meal twice daily. Up to four (4) capsules of Berberine Complex can be taken daily. For optimal results, we recommend taking two (2) capsules before lunch and dinner. Research suggests taking Berberine half an hour before food for optimum efficacy. 

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 substances and to plants of the
Asteraceae (Compositae) family or to any of the excipients or
residues from the manufacturing process in which case, discontinue use.

Do not use if pregnant or breastfeeding.

Do not use while taking antibiotics.

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 leucopenia, a kidney disorder, hypotension or blood pressure
problems, hypoglycemia or diabetes use anti-depressants or blood thinners.

4.5. Interaction with other medicines and other forms of interaction
None known.

4.6. Fertility, pregnancy and lactation
Berberine 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 
Frequency not known:
Allergic reactions (dermatitis, urticaria, skin rash, pruritus, anaphylaxis,
asthma) may occur. 

Gastrointestinal disorder 
Frequency not known:
Mild gastrointestinal symptoms such as dry mouth, nausea, vomiting, 
upset stomach, abdominal pain, gastric irritation and diarrhoea may occur. 

Nervous system disorder
Frequency not known:
Headache

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine
is important. It allows continued monitoring of the benefit/risk balance of the
medicine. Health care providers are requested to report any suspected
adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X
SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA
website. 

4.9. Overdose
In overdose, side effects can be precipitated and/or be of increased
severity.

Treatment is symptomatic and supportive. 
See section “4.8. Undesirable effects.” 

5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
D33.3 Complementary Medicine:
Discipline specific, Ayurvedic Product.

The combination of active ingredients in Berberine Complex is formulated
to possibly assist in alleviating symptoms associated with polycystic ovary
syndrome (PCOS).

5.2. Pharmacokinetic properties
Berberine (Hydrochloride)
Oral treatment with 100 mg/kg berberine has an absolute bioavailability of
0.68% as measured in rat plasma samples, with a mean maximum plasma
concentration (Cmax) of 9.48 ng/ml and an area under the curve (AUC)0
36 h of 46.
Some studies have also reported the absorption of berberine in humans. In
one study, the mean Cmax at 8 h post-administration was reported to be
approximately 0.4 ng/ml for 400 mg berberine administered orally (n = 20).
Another study reported that the Cmax of berberine in 10
healthy individuals given 500 mg berberine orally was extremely low, at
0.07 nM. It is thought that the lower in vivo bioavailability of berberine is
closely related to extensive intestinal first pass elimination, in which the drug
is filtered out of the circulation by the liver resulting in a low level of systemic
circulation. 
After orally administrated with 100 mg/kg berberine to rats, approximately
half of berberine ran intact through the gastrointestinal tract and another half
was disposed of by the small intestine, resulting in an extremely low extent
of absolute oral bioavailability (0.36%). Additionally, a caco-2 cell monolayer
model was used to confirm that berberine is the substrate for the drug
transporter P glycoprotein, which may contribute to the lower
absorption of berberine in small intestinal epithelial cells by passive
diffusion.

Milk Thistle
Significant pharmacokinetic variability among the many commercially
available milk thistle extracts has been documented, and the bioavailability
of most oral formulations is generally regarded as poor and highly variable.
Major reasons cited for the low bioavailability of silymarin constituents
include extensive presystemic conjugative metabolism, poor permeability
across intestinal epithelial cells, and low aqueous solubility.

Plasma samples were obtained from 13 healthy volunteers participating in a
dose-escalation study after receiving single oral doses of 175, 350, and 525
mg of standardized milk thistle extract, respectively, on three separate
occasions. Silymarin determinations were made via LC-MS/MS assay as
described above. Additionally, determinations of steady-state
concentrations of flavonolignans after 28 days of exposure to 175 mg three
times daily were assessed. Pharmacokinetic parameters of individual
silymarin flavonolignans were estimated by a noncompartmental analysis
using WinNonlin 5.3 (Pharsight, Mountain View, CA). The maximum plasma
concentration (Cmax) and time to maximum plasma concentration (Tmax)
were obtained directly from the plasma concentration-time data. The
terminal elimination rate constant (λz) was estimated by linear least-squares
regression of the terminal portion of the plasma concentration-time curve,
and the corresponding elimination half-live (t1/2) was then calculated using
the formula t1/2 = 0.693/λz. The area under the plasma concentration-time
curve from time 0 to infinity (AUC0→∞) for single-dose assessments and
AUC 0→8h for steady-state evaluations were calculated according to the
linear trapezoidal rule. The apparent clearance (CL/F) was calculated using
the formula dose/AUC0→∞. The apparent volume distribution (V/F) was
estimated by dividing CL/F by λz.

5.3. Preclinical safety data
No data available. 

6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Berberine Complex:
Sweet Potato starch powder and Microcrystalline Cellulose. 

6.2. Incompatibilities 
Not applicable.

6.3. Shelf life
24 months.

6.4. Special precautions for storage
Store in the original container, at or below 25 ˚C.

6.5. Nature and contents of the container
Berberine Complex
250 ml Clear Polyethylene Terephthalate (PET) container with a 43 mm
white cap, induction seal with silica and foam insert providing 120 x size 00
white 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.