SCHEDULING STATUS

S0

PROPRIETARY NAME AND DOSAGE FORM

Mood Capsules

COMPOSITION

Ingredient

Amount per 1 Capsule

Withania somnifera (Ashwaghanda)

[Root]

180 mg

Passiflora incarnata (Passionflower)

[Herb top]

160 mg

Rhodiola rosea (Rhodiola)

[Root]

150 mg

Magnesium AAC

            Providing Magnesium Elemental

130 mg

26 mg

Pantothenic Acid (Vitamin B5)

2 mg

 

Excipients: veggie capsule.

Sugar Free

 

CATEGORY AND CLASS

Category D: Complementary Medicine

Class 33.7 Combination Product

PHARMACOLOGICAL ACTION

Pharmacological Action

The Pharmacological action is achieved by the combination of ingredients to help increase energy and resistance to stress.

 

Pharmacokinetic Properties

The active ingredients in this formulation are well known. Pharmacokinetic studies have not been conducted on Mood formulation.

 

INDICATIONS

  • Used in Herbal Medicine as an adaptogen to help increase energy and resistance to stress.
  • Traditionally used in Herbal Medicine to help relieve restlessness and/or nervousness.
  • A factor in the maintenance of good health.

WARNINGS AND SPECIAL PRECAUTIONS

  • Consult a health care practitioner if sleeplessness persists for more than 4 weeks.
  • Consult a healthcare practitioner prior to use if you are pregnant or breastfeeding.
  • Avoid taking with alcohol or products that cause drowsiness.
  • 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.

INTERACTIONS

None known.

Consult a health care practitioner prior to use if you are on any chronic or prescription medicine.

HUMAN REPRODUCTION

Consult a health care practitioner prior to use if you are pregnant, intending on becoming pregnant or breast feeding.

DOSAGE AND DIRECTIONS FOR USE

Adults 18 years and older:

Take one capsule once daily with meals or as directed by a healthcare practitioner.

SIDE EFFECTS

Adverse reactions are listed below by system organ class and by frequency. Frequencies are defined as: Very common (≥1/10), common (≥ 1/100, < 1/10), uncommon (≥1/1,000, < 1/100), rare (≥1/10,000, < 1/1,000), very rare (< 1/10,000), according to the MedDRA frequency convention and system organ classification.

Immune system disorders

Frequency unknown

Hypersensitivity reaction (such as rash)

Drowsiness

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care 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: https://www.sahpra.org.za/Publications/Index/8.

CONTRAINDICATIONS

Hypersensitivity/allergy to any of the ingredients, in which case, discontinue use.

Pregnancy and breastfeeding.

Do not use this product if you have bipolar disorder or bipolar spectrum disorder.

KNOWN SYMPTOMS OF OVER-DOSAGE AND PARTICULARS OF ITS TREATMENT

See section Warnings and Special Precautions and Side Effects.

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

Treatment should be symptomatic and supportive.

IDENTIFICATION

Clear, size 00 veggie capsule filled with a light brown powder.

PRESENTATION

Clear, glass jar with aluminium screw lid.

STORAGE INSTRUCTIONS

Store in a dark, dry place at or below 25˚C.

REGISTRATION NUMBER

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

DATE OF PUBLICATION

February 2022

AFRIKAANS

SKEDULERINGSTATUS

S0

BENAMING EN DOSISVORM

Mood Kapsules

SAMESTELLING:

Bestanddele

Hoeveelheid per 1 Kapsule

Withania somnifera (Ashwaghanda)

[Wortel]

180 mg

Passiflora incarnata (Passieblom)

[Kruie top]

160 mg

Rhodiola rosea (Rhodiola)

[Wortel]

150 mg

Magnesium AAC

            Verskaf Elementêre Magnesium

130 mg

26 mg

Pantoteensuur (Vitamine B5)

2 mg

 

Hulpstowwe: groentekapsule.

Suikervry

KATEGORIE EN KLAS

Kategorie D: Aanvullende medisyne

Klas 33.7 Kombinasieproduk

FARMAKOLOGIESE AKSIE

Farmakologiese aksie

Die farmakologiese werking word bewerkstellig deur die kombinasie van bestanddele om energie en weerstand teen spanning te verhoog.

Farmakokinetiese eienskappe

Die aktiewe bestanddele in hierdie formulering is bekend. Farmakokinetiese studies is nie uitgevoer op Mood-formulering nie.

AANWYSINGS

– Word gebruik in Kruie Geneeskunde as ‘n adaptogeen om energie en weerstand teen spanning te verhoog.

 – Tradisioneel gebruik in Kruie Geneeskunde om rusteloosheid en / of senuweeagtigheid te verlig.

– ‘n Faktor in die handhawing van goeie gesondheid.

WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS

– Raadpleeg ‘n geneesheer as slapeloosheid langer as vier weke aanhou.

– Raadpleeg ‘n geneesheer voordat u swanger is of borsvoed.

– Vermy alkohol of produkte wat slaperigheid veroorsaak.

– Oor die algemeen moet gesondheidsaanvullings nie bedoel wees vir verskaffing aan kinders onder die ouderdom van sewe (7) maande nie, tensy dit medies geregverdig is om aanvulling te kry.

INTERAKSIES

Geen bekend nie.

Raadpleeg ‘n geneesheer voor gebruik as u chroniese of voorskrifmedisyne het.

MENSLIKE REPRODUKSIE-VERSLAE

Raadpleeg ‘n geneesheer voor gebruik as u swanger is, beoog om swanger te raak of borsvoed.

DOSERING EN GEBRUIKSAANWYSING

Volwassenes van 18 jaar en ouer:

Neem een kapsule een keer per dag met maaltye of soos aangedui deur ‘n gesondheidsorgpraktisyn.

NEWE-EFFEKTE

Die newe-reaksies word hieronder gelys volgens die orgaanklas en volgens frekwensie. Frekwensies word gedefinieer as: Baie gereeld (≥1 / 10), algemeen (≥ 1/100, <1/10), ongewoon (≥1 / 1, 000, <1/100), skaars (≥1 / 10,000, <1/1, 000), baie skaars (<1/10,00000)  volgens die MedDRA frekwensie konvensie en stelselorgaanklassifikasie.

Immuunstelsel-afwykings

Frekwensie onbekend

Hipersensitiwiteitsreaksie (soos uitslag)

Slaperigheid

Verslagdoening oor vermoedelike newe-reaksies

Dit is belangrik om vermoedelike newe-reaksies na die magtiging van die medisyne aan te meld. Dit laat voortgesette monitering van die voordeel / risiko-balans van die medisyne toe. Verskaffers van gesondheidsorgword gevra om enige vermoedelike nadelige reaksies by SAHPRA aan te meld via die “6.04 Nadelige Medisyne Reaksie-verslagdoeningsvorm”, wat aanlyn gevind word onder SAHPRA se publikasies: https: //www.sahpra.org.za / Publikasies / Indeks / 8.

KONTRAINDIKASIES

Oorgevoeligheid / allergie vir enige van die bestanddele, in welke geval die gebruik gestaak word.

Swangerskap en borsvoeding.

Moenie hierdie produk gebruik as u bipolêre versteuring of bipolêre spektrumversteuring het nie.

BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN BEHANDELING

Sien afdeling Waarskuwings en spesiale voorsorgmaatreëls en newe-effekte.

 By oordosis kan newe-effekte versnel word en / of vererger word.

Behandeling moet simptomaties en ondersteunend wees.

IDENTIFIKASIE

Helder, grootte 00 groente-kapsule gevul met ‘n ligbruin poeier.

AANWYSING

Helder, glaskruik met aluminiumskroefdeksel.

BERGING-INSTRUKSIES

Berg in ‘n donker, droë plek by of onder 25˚C

REGISTRASIENOMMER

Hierdie ongeregistreerde medisyne is nie deur die SAHPRA geëvalueer vir die kwaliteit, veiligheid of beoogde gebruik nie.

DATUM VAN PUBLIKASIE

Februarie 2022