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
