BIOMEDCAN CBD MOOD CAPSULES – 300mg CBD – 60 capsules

R489.95

BIOMEDCAN CBD MOOD CAPSULES may assist you in improving your mood while decreasing anxiety, stress, depression and mood swings. It may also assist in regulating heart rhythm and lowering high blood pressure. CBD maximizes the Entourage Effect of the active ingredients in this product. Zero THC included.

Description

BIOMEDCAN CBD MOOD CAPSULES is a combination of active ingredients (herbs and minerals) and 10mg CBD isolate per daily dose of 2 capsules. CBD is one of the natural compounds of Hemp extract and maximises the Entourage Effect of the active ingredients in this product.

This CBD Mood Enhancer Product may assist you in improving your mood while decreasing anxiety, stress, depression and mood swings. It may also assist in regulating heart rhythm and lowering high blood pressure.

Take two capsules with water and food in the morning and if necessary take an extra dose as a booster in the afternoon or evening.

A dose of two capsules contains 10mg of CBD.

Do not exceed the maximum daily dose of 20mg of CBD.

This highly concentrated health / food supplement is recommended with a varied, balanced diet and a healthy lifestyle.

There is ZERO THC in this product.

This CBD for Mood product does not have a hallucinogenic effect and is non-addictive.

PRODUCED IN SOUTH AFRICA

 

Ingredients

Per Container: 60 Capsules with 300mg CBD

Active ingredients per Dose (2 Capsules)

Bacopa Monnierri 200mg

5-HTP 200mg

L-Theanine 60mg 

Passion Flower 300mg

Sceletium 40mg 

Cannabis sativa L. (CBD isolate) 10mg

ZERO THC

Take two capsules with water and food in the morning and if necessary take an extra dose as a booster in the afternoon or evening.

A dose of two capsules contains 10mg of CBD.

Do not exceed the maximum daily dose of 20mg of CBD.

This highly concentrated health / food supplement is recommended with a varied, balanced diet and a healthy lifestyle.

Please note that it is important that you seek the advice of a qualified medical professional who is well versed in the therapeutic use of CBD prior to using this product.

Consult a doctor before use during pregnancy and breastfeeding.

Keep out of reach of children.

Professional Information

Proposed professional information for MOOD CBD capsules

COMPLEMENTARY MEDICINE:
COMBINATION PRODUCT (WESTERN HERBAL MEDICINE / HEALTH SUPPLEMENT)

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

SCHEDULING STATUS

Scheduling status S0

1 NAME OF THE MEDICINE

MOOD CBD capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains:
Passiflora caerulea L. (passion flower) 150 mg
[Whole plant, 10:1 extract, providing 1,5 g dried herb equivalent]
Bacopa monnieri (L.) Wettst. 100 mg
[Whole plant, 30:1 extract standardised to 50 % bacopasides, providing 3 g dried herb
equivalent]
Griffonia simplicifolia (DC.) Baill. (5-HTP) 100 mg
[Seeds, 14:1 extract standardised to 99 % 5-hydroxytryptophan, providing 1,4 g dried herb
equivalent]
L-theanine 30 mg
Sceletium tortuosum (L.) N.E. Br. 20 mg
[Dried stems and leaves]
Cannabis sativa L. (CBD isolate) 5 mg
[hemp leaves and flowers, standardised to 99,9 % cannabidiol isolate]
Sugar free.
For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Capsules.
Clear hypromellose capsules containing a beige coloured powder.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

MOOD CBD may assist in improving your mood while decreasing anxiety, stress, depression and
mood swings.
MOOD CBD may also assist in regulating heart rhythm and lowering high blood pressure.

4.2 Posology and method of administration

Take two capsules in the morning with water and food. If necessary, take an extra two capsules
as a booster in the afternoon or evening.
Do not exceed the maximum daily dose of four capsules.

4.3 Contraindications

Hypersensitivity to any of the active ingredients or to any of the excipients listed in section 2 or
6.1.

4.4 Special warnings and precautions for use

Surgery:
MOOD CBD has central nervous system (CNS) depressant effects which might cause additive
CNS depression when combined with anaesthesia. Discontinue use at least 2 weeks prior to
surgical procedures (see section 4.5).

4.5 Interaction with other medicines and other forms of interaction

CNS depressants:
MOOD CBD can have CNS depressant effects which might be enhanced by concomitant use with
medicines and herbal supplements with sedative properties.

Antidepressants:
Combining MOOD CBD with antidepressants might increase the risk of serotonergic effects
including serotonin syndrome and cerebral vasoconstrictive disorders. Serotonergic
antidepressants include fluoxetine, paroxetine, sertraline and herbal supplements such as St.
John’s wort.

Cytochrome P450 substrates:
MOOD CBD may increase the levels of medicines that are metabolised by CYP3A4 and increase
their effects and adverse effects. Medicines that may be affected include propranolol, losartan,
diltiazem, nicardipine, verapamil, ketoconazole and itraconazole.

4.6 Fertility, pregnancy and lactation

Safety in pregnancy and lactation has not been established. MOOD CBD should not be taken
during pregnancy or lactation.

4.7 Effects on ability to drive and use machines

MOOD CBD may cause side effects such as drowsiness and can affect the ability to drive a
vehicle and use machines (see section 4.8).
Caution is advised before driving a vehicle or operating machinery until the effects of MOOD CBD
are known.

4.8 Undesirable effects

MOOD CBD is generally well tolerated.

Psychiatric disorders:
Frequent: drowsiness.

Gastrointestinal disorders:
Frequent: nausea, vomiting, diarrhoea, gastrointestinal irritation.

Skin and subcutaneous tissue disorders:
Frequent: skin rash.

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. Healthcare 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:
http://www.sahpra.org.za/Publications/Index/8

4.9 Overdose

In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8).

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Category and class:
D 33.7 Combination Product

MOOD CBD is a supplement containing CBD, various herbal components and an amino acid, L-
theanine, which may assist in improving your mood while decreasing anxiety, stress, depression

and mood swings. MOOD CBD may also assist in regulating heart rhythm and lowering high
blood pressure.

5.2 Pharmacokinetic properties

There is insufficient information available about the pharmacokinetic properties of Passiflora
caerulea L., Bacopa monnieri (L.) Wettst., Griffonia simplicifolia (DC.) Baill. and Sceletium
tortuosum (L.).
L-theanine is absorbed through the intestines, distributed to the plasma and erythrocytes,
hydrolysed to ethylamine and glutamic acid, and excreted in the urine.
Cannabidiol (CBD) from Cannabis sativa L. is poorly absorbed after oral administration. CBD and
its metabolites have a half-life of about 58 hours and are primarily excreted in the faeces, with
minimal renal elimination.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Hypromellose.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

24 months.

6.4 Special precautions for storage

Store at or below 25 °C in a dry place protected from light.
Keep the container in the outer carton.
Keep the container tightly closed.

6.5 Nature and contents of container

Amber glass container with a black polypropylene cap.
Pack size: 60 capsules.

6.6 Special precautions for disposal

No special requirements.

7. HOLDER OF CERTIFICATE OF REGISTRATION

Baltimore (Pty) Ltd
Foregate Square 1A
Heerengracht
Foreshore
Cape Town
8001

8. REGISTRATION NUMBER

Will be allocated by SAHPRA upon registration.

9. DATE OF FIRST AUTHORISATION

Will be allocated by SAHPRA upon registration.

10. DATE OF REVISION OF THE TEXT

This leaflet was last revised in July 2020.

 

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