SCHEDULING STATUS

S0

PPROPIETARY NAME AND DOSAGE VORM

Planted Capsules

COMPOSITION:

Ingredient

Amount per 1 Capsule

Linum usitatissimum (Linseed)

[seed]

749,88 mg

Cyanocobalamin (Vitamin B12)

100 µg

Cholecalciferol (Vitamin D3)

25 µg

Excipients: veggie capsules

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 promote general well-being.

 

Pharmacokinetic Properties

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

 

INDICATIONS

Source of Omega-3 fatty acids for the maintenance of good health

A factor in the maintenance of good health.

WARNINGS AND SPECIAL PRECAUTIONS

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.

Please consult your health care practitioner prior to use if you are taking any medication.

HUMAN REPRODUCTION

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

DOSAGE AND DIRECTIONS FOR USE

Take one capsule once daily or as directed by a health care 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)

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 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.

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 capsule filled with 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 DOSERINGVORM

Planted kapsules

SAMESTELLING

Bestanddeel

Hoeveelheid per 1 Kapsule

Linum usitatissimum (Lynsaad)

[saad]

749,88 mg

Sianokobalamien (Vitamine B12)

100 µg

Cholekalsiferol (Vitamine D3)

25 µg

Hulpstowwe: groente-kapsules

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 algemene welstand te bevorder.

Farmakokinetiese eienskappe

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

AANWYSINGS

Bron van Omega-3-vetsure vir die handhawing van goeie gesondheid

‘n Faktor in die handhawing van goeie gesondheid.

WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS

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 u gesondheidsorgpraktisyn voordat u dit gebruik as u medikasie neem.

MENSLIKE REPRODUKSIE

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

DOSERING EN AANWYSINGS VIR GEBRUIK

Neem een kapsule een keer per dag of soos aangedui deur ‘n geneesheer.

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)

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 gesondheidsorg word 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.

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 kapsule gevul met bruin poeier.

AANWYSING

Helder, glaskruik met aluminiumskroefdeksel.

BERGINGINSTRUKSIES

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

REGISTRASIENOMMER

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

DATUM VAN PUBLIKASIE

Februarie 2022