SCHEDULING STATUS

S0

 

PROPRIETARY NAME AND DOSAGE FORM

Nourish Capsules

COMPOSITION

Ingredient

Amount per 1 Capsule

Ascophylium nodosum (Brown Algae)

[Whole plant: extract standardized as brown algae 40% extract providing 177,59 mg of dried herb equivalent]

443,99 mg

Arctium lappa (Burdock root)

[Root: extract standardized as Burdock root 400 % extract providing 280 mg of dried herb equivalent]

70 mg

Zinc Gluconate

              Providing Zinc (Elemental)

47,82 mg

11,00 mg

Alpha-tocopheryl acetate (Vitamin E)

Providning Vitamin E (Elemental)

30 mg

15 mg

D-Biotin (Vitamin H)

0,01 mg

 

Excipients:

  • Veggie capsule.
  •  
  • Sugar Free

 

CATEGORY AND CLASS

Category D: Complementary Medicine

Health supplement

Class 34.12 multiple substance formulation

PHARMACOLOGICAL ACTION

Pharmacological Action

Pharmacodynamic effect due to the combination of active ingredients for promoting improved Immune system, hair and skin health.

Pharmacokinetic Properties

Brown Algae

No Pharmacokinetic data available

Burdock Root

No Pharmacokinetic data available.

Zinc Gluconate

Zinc is absorbed from the gastrointestinal tract and distributed throughout the body. The highest concentrations occur in hair, eyes, male reproductive organs and bone. Lower levels are present in liver, kidney and muscle. In blood 80% is found in erythrocytes. Plasma zinc levels range from 70 to 110μg/dL and about 50% of this is loosely bound to albumin. About 7% is amino-acid bound and the rest is tightly bound to alpha 2-macroglobulins and other proteins

Vitamin E

Vitamin E is absorbed from the gastrointestinal tract. Most of the vitamin appears in the lymph and is then widely distributed to all tissues. Most of the dose is slowly excreted in the bile and the remainder is eliminated in the urine as glucuronides of tocopheronic acid or other metabolites.

Biotin

Biotin is a co-enzyme for carboxylation during the metabolism of proteins and carbohydrates.

 

INDICATIONS

  • Support hair growth.
  • Maintain skin health.
  • Maintain skin structure.
  • Support skin regeneration.
  • Support wound healing.
  • Antioxidant / Reduce free radicals formed in the body.
  • May reduce skin inflammation.
  • May improve skin barrier function.
  • Source of fungal polysaccharides with immunomodulating properties.
  • Helps the body to metabolise carbohydrates, fats and proteins.
  • Helps in connective tissue formation.
  • Helps to maintain immune function.

WARNINGS AND SPECIAL PRECAUTIONS

  • Vitamin E has been reported to increase bleeding tendency in vitamin-K deficient patients or those taking anticoagulant treatments, it is therefore recommended to monitor the prothrombin time and international normalised ratio (INR) to detect any changes in haemostasis.
  • Vitamin E has been reported to increase the risk of thrombosis in patients predisposed to this condition, including patients taking oestrogens.
  • This finding has not been confirmed but should be borne in mind when selecting patients for treatment, in particular women taking oral contraceptives containing oestrogens.
  • Accumulation of zinc may occur in cases of renal failure.
  • Consult a health care practioner if symptoms persist or worsen.
  • Consult a health care practitioner prior to use if you are breasfeeding.

INTERACTIONS

  • Vitamin E may increase the risk of haemorrhage in patients taking anticoagulants
  • Vitamin E may increase the risk of thrombosis in patients taking oestrogens
  • Colestyramine may reduce the absorption of Vitamin E.

Copper:

Zinc may inhibit the absorption of copper (see section 4.3).

Tetracycline Antibacterials:

Zinc may reduce the absorption of concurrently administered tetracyclines, also the absorption of zinc may be reduced by tetracyclines; when both are being given an interval of at least three hours should be allowed.

Quinolone Antibacterials:

Zinc may reduce the absorption of quinolones; ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin.

Calcium Salts:

The absorption of zinc may be reduced by calcium salts.

Iron:

The absorption of zinc may be reduced by oral iron, also the absorption of oral iron may be reduced by zinc.

Penicillamine:

The absorption of zinc may be reduced by penicillamine, also the absorption of penicillamine may be reduced by zinc.

Trientine:

The absorption of zinc may be reduced by trientine, also the absorption of trientine may be reduced by zinc.

HUMAN REPRODUCTION

Consult a health care practitioner prior to use if you are pregnant, intending on becoming pregnant or breast feeding. Zinc crosses the placenta and is present in breast milk.

DOSAGE AND DIRECTIONS FOR USE

Adults 18 years and older:

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

Do not exceed daily dose without consulting a relevant health care provider.

SIDE EFFECTS

The frequencies of adverse reactions are ranked according to the following:

  • frequent > 1/100
  • less frequent < 1/100

Immune system disorders

Less frequent:

Anaphylactic shock has been reported with Burdock root

Gastrointestinal disorder

Less frequent:

  • Zinc salts may cause abdominal pain, dyspepsia, nausea, vomiting, diarrhoea, gastric irritation and gastritis. There have also been cases of irritability, headache and lethargy observed.
  • Zinc may interfere with the absorption of copper, leading to reduced copper levels, and potentially copper deficiency. The risk of copper deficiency may be greater with long-term treatment (e.g. if zinc deficiency is no longer present) and/or with higher doses of zinc

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 the active substance or to any of the excipients or residues from the manufacturing process in which case, discontinue use.
  • Do not use this product if you are pregnant.
  • Consult a registered healthcare provider prior to use if you are taking any other medicine or have been diagnosed with a chronic condition.
  • See “Special warnings and precautions for 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.

Overdose may lead to abdominal pain, dyspepsia, nausea, vomiting, diarrhoea, gastric irritation and gastritis, anaphylactic shock, irritability, headache and lethargy.

IDENTIFICATION

Clear, size 00 veggie capsule filled with a light brown/green 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

Nourish Kapsules

SAMESTELLING:

Bestanddeel

Hoeveelheid per 1 Kapsule

Withania somnifera (Ashwaghanda)

[Wortel]

180 mg

Passiflora incarnata (Passionflower)

[Kruietop]

160 mg

Rhodiola rosea (Rhodiola)

[Wortel]

150 mg

Magnesium AAC

            Verskaf Elementale Magnesium

130 mg

26 mg

Pantoteesuur (Vitamine B5)

2 mg

 

Hulpstowwe:

  • Groentekapsule.
  • Talk.
  • Suikervry

KATEGORIE EN KLAS

Kategorie D: Aanvullende medisyne

Gesondheidsaanvulling

Klas 34.12 meervoudige substansieformulering

FARMAKOLOGIESE AKSIE

Farmakologiese aksie

Farmakodinamiese effek as gevolg van die kombinasie van aktiewe bestanddele vir die bevordering van verbeterde Immuunstelsel, hare en velgesondheid.

Farmakokinetiese eienskappe

Bruin alge

Geen farmakokinetiese data beskikbaar nie

Klitwortel

Geen farmakokinetiese data beskikbaar nie.

Sink

Sink word uit die spysverteringskanaal opgeneem en deur die hele liggaam versprei. Die hoogste konsentrasies kom voor in hare, oë, manlike voortplantingsorgane en been. Laer vlakke is in lewer, nier en spier aanwesig. In bloed word 80 % in eritrosiete aangetref. Plasma-sinkvlakke wissel van 70 tot 110μg / dL en ongeveer 50 % hiervan is losweg aan albumien gebind. Ongeveer 7 % is aan aminosuur gebind en die res is styf gebind aan alfa 2 -makroglobuliene en ander proteïene

Vitamine E

Vitamine E word uit die spysverteringskanaal opgeneem. Die meeste vitamine verskyn in die limf en word dan wyd versprei na alle weefsels. Die meeste van die dosis word stadig in die gal uitgeskei en die res word in die urine uitgeskakel as glukuroniede van tokoferonsuur of ander metaboliete.

Biotien

Biotien is ‘n ko-ensiem vir karboksilase tydens die metabolisme van proteïene en koolhidrate.

AANWYSINGS

  • Ondersteun haargroei.
  • Handhaaf velgesondheid.
  • Handhaaf velstruktuur.
  • Ondersteun velvernuwing.
  • Ondersteun wondgenesing.
  • Antioksidant / Verminder vrye radikale wat in die liggaam gevorm word.
  • Mag velontsteking verminder.
  • Mag die velversperringfunksie verbeter.
  • Bron van swampolisakkaried met immunomodulerende eienskappe.
  • Help die liggaam om koolhidrate, vette en proteïene te metaboliseer.
  • Help in bindweefselvorming.
  • Help om immuunfunksie te handhaaf.

WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS

  • Daar is berig dat vitamine E die neiging tot bloeding by pasiënte met vitamien-K-tekort of diegene wat antikoagulantbehandelings neem, verhoog. Dit word dus aanbeveel om die protrombientyd en die internasionale genormaliseerde verhouding (INR) te monitor om enige veranderinge in hemostase op te spoor.
  • Daar is berig dat vitamien E die risiko van trombose verhoog by pasiënte wat tot hierdie toestand geneig is, insluitend pasiënte wat estrogeen neem.
  • Hierdie bevinding is nie bevestig nie, maar moet in gedagte gehou word by die keuse van pasiënte vir behandeling, veral vroue wat orale voorbehoedmiddels neem wat estrogeen bevat.
  • Opeenhoping van sink kan voorkom in gevalle van nierversaking.
  • Raadpleeg ‘n gesondheidsorg-praktisyn as simptome voortduur of vererger.
  • Raadpleeg ‘n gesondheidsorgpraktisyn voordat u dit gebruik indien u borsvoed.

INTERAKSIES

  • Vitamine E kan die risiko van bloeding verhoog by pasiënte wat antikoagulante neem
  • Vitamine E kan die risiko van trombose verhoog by pasiënte wat estrogeen neem
  • Kolesteramien kan die opname van Vitamin E verminder.

Koper:

Sink kan die opname van koper belemmer (sien afdeling 4.3).

Tetrasiklien antibakteriese middels:

Sink kan die opname van gelyktydig toegediende tetrasikliene verminder, en die opname van Sinnk kan ook deur tetrasikliene verminder word; wanneer albei ‘n interval van ten minste drie uur kry, moet dit toegelaat word.

Kinoloon Antibakteriese middels:

Sink kan die opname van kinolone verminder; siprofloksasien, levofloksasien, moksifloksasien, norfloksasien en vanloksasien.

Kalsiumsoute:

Die opname van sink kan deur kalsiumsoute verminder word.

Yster:

Die opname van sink kan deur orale yster verminder word, en die opname van orale yster kan met sink verminder word.

Penisillamien:

Die opname van sink kan deur penisillamien verminder word, en die opname van penisillamien kan met sink verminder word.

Trientien:

Die opname van sink kan deur trientien verminder word, en die opname van trientien kan met sink verminder word.

MENSLIKE VOORTPLANTING

Raadpleeg ‘n geneesheer vir gesondheidsorg voordat u swanger is, van plan is om swanger te raak of borsvoed. Sink kruis die plasenta en is in borsmelk aanwesig.

DOSERING EN AANWYSINGS VIR GEBRUIK

  • Volwassenes van 18 jaar en ouer:
  • Neem een kapsule een keer per dag met maaltye of soos aangedui deur ‘n gesondheidsorgpraktisyn.
  • Moenie die daaglikse dosis oorskry sonder om ‘n relevante gesondheidsorgverskaffer te raadpleeg nie.

NEWE-EFFEKTE

Die frekwensies van newe-reaksies word volgens die volgende ranglys gerangskik:

  • gereeld > 1 / 100
  • minder gereeld < 1 / 100

Immuunstelselafwykings

Minder gereeld:

Anafilaktiese skok is met Klitwortel aangemeld

Maagdermversteuring

Minder gereeld:

  • Sinksoute kan buikpyn, dispepsie, naarheid, braking, diarree, maagirritasie en gastritis veroorsaak. Daar is ook gevalle van prikkelbaarheid, hoofpyn en lusteloosheid waargeneem.
  • Sink kan inmeng met die opname van koper, wat lei tot verminderde kopervlakke en potensiële kopertekort. Die risiko van kopertekort kan groter wees met langdurige behandeling (bv. as sinktekort nie meer aanwesig is nie) en / of met hoër dosisse sink.

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 Nadelilge medisynereaksie-verslagdoeningsvorm”, wat aanlyn gevind word onder SAHPRA se publikasies: https: //www.sahpra.org.za / Publikasies / Indeks / 8.

KONTRA-INDIKASIES

  • Hipersensitiwiteit / allergie vir die aktiewe stof of vir enige van die hulpstowwe of residue uit die vervaardigingsproses, in welke geval, staak die gebruik.
  • Moenie hierdie produk gebruik as u swanger is nie.
  • Raadpleeg ‘n geregistreerde gesondheidsorgverskaffer voordat u enige ander medisyne neem of indien u met ‘n chroniese toestand gediagnoseer is.
  • Kyk na “Spesiale waarskuwings en voorsorgmaatreëls vir gebruik”.

BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN DIE BEHANDELING DAARVAN

Kyk afdeling Waarskuwings en spesiale voorsorgmaatreëls en newe-effekte.

Met oordosis kan newe-effekte neerslag vind en / of van groter erns wees.

Oordosis kan lei tot buikpyn, dispepsie, naarheid, braking, diarree, maagirritasie en gastritis, anafilaktiese skok, prikkelbaarheid, hoofpyn en lusteloosheid.

 

IDENTIFIKASIE:

Helder, grootte 00 groentekapsel gevul met ‘n ligbruin / groen poeier.

AANWYSING

Helder, glaskruik met aluminium-skroefdeksel.

BERGINGSINSTRUKSIES

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

Junie 2022