health-matrix-flora-leaflet

Health Matrix Flora

 

www.healthmatrix.co.za

 

NAPPI code: 723354-001

 

 

 

 

PROPOSED PATIENT INFORMATION LEAFLET FOR HEALTH MATRIX FLORA

 

Health supplement

This medicine has not been evaluated by the South African Health Products Regulatory Authority (SAHPRA). This medicine is not intended to diagnose, treat, cure, or prevent any disease.

 

SCHEDULING STATUS

Schedule 0

 

PROPRIETARY NAME AND DOSAGE FORM

HEALTH MATRIX FLORA capsules

 

Please read all of this leaflet carefully because it contains important information for you. HEALTH MATRIX FLORA is available without a doctor’s prescription, for you to treat a mild illness.  Nevertheless, you still need to use HEALTH MATRIX FLORA carefully to get the best results from it.

  • Keep this leaflet. You may need to read it again.
  • Do not share HEALTH MATRIX FLORA with any other person.
  • Ask your pharmacist if you need more information or advice.

 

  1. WHAT HEALTH MATRIX FLORA CONTAINS

The active substances are Bacillus coagulans (sporebiotic), Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus salivarius, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium breve and Streptococcus thermophilus.

Other ingredients are microcrystalline cellulose and inulin and the vegetable-based capsules are made from hypromellose.

Does not contain any artificial flavouring, tartrazine, gluten, dairy, yeast, sugar or salt.

 

  1. WHAT HEALTH MATRIX FLORA IS USED FOR

When ingested on a regular basis, HEALTH MATRIX FLORA should improve or normalise the microbial balance in your intestine and thereby improve the functioning of your digestive tract/gut.

 

  1. BEFORE YOU TAKE HEALTH MATRIX FLORA

Do not take HEALTH MATRIX FLORA:

If you are hypersensitive (allergic) to Bacillus coagulans, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus salivarius, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium breve and Streptococcus thermophilus, or any of the other ingredients of HEALTH MATRIX FLORA (see WHAT HEALTH MATRIX FLORA CONTAINS).

 

Take special care with HEALTH MATRIX FLORA:

  • If your immune system is compromised.
  • If you have small bowel syndrome (a condition where part of your intestines have been removed).
  • If you are having cholesterol tests done.

 

Taking HEALTH MATRIX FLORA with food or drink:

HEALTH MATRIX FLORA should be taken before meals.

 

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, please consult your doctor, pharmacist or healthcare professional before taking HEALTH MATRIX FLORA.

Driving and using machinery:

Do not drive a vehicle, operate machinery, or do anything else that requires your attention until you know how HEALTH MATRIX FLORA affects you.

 

Taking other medicines with HEALTH MATRIX FLORA: 

Always tell your healthcare professional if you are taking any other medicine (this includes complementary or traditional medicines).

The following medicines may cause an interaction when used in combination with HEALTH MATRIX FLORA:

  • Certain antibiotics (used to treat bacterial infections).

 

  1. HOW TO TAKE HEALTH MATRIX FLORA

You should check with your doctor or pharmacist if you are unsure.

The usual dose is 1 capsule taken daily before meals, or as directed by your healthcare professional. If you have the impression that the effect of HEALTH MATRIX FLORA is too strong or too weak, talk to your doctor or pharmacist.

 

If you take more HEALTH MATRIX FLORA than you should:

In the event of over dosage, consult your doctor or pharmacist.  If neither is available, contact the nearest hospital or poison control centre. Take this leaflet and the rest of the remaining capsules with you so the doctor will know what you have taken.

 

If you forget to take HEALTH MATRIX FLORA:

If you have missed your dose by only a few hours, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take HEALTH MATRIX FLORA at the next regularly scheduled time. Remember to take HEALTH MATRIX FLORA before meals.

Do not take a double dose to make up for forgotten individual doses.

 

  1. POSSIBLE SIDE EFFECTS

HEALTH MATRIX FLORA can have side effects. 

Not all side effects reported for HEALTH MATRIX FLORA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking HEALTH MATRIX FLORA, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking HEALTH MATRIX FLORA and tell your doctor immediately or go to the casualty department at your nearest hospital:

  • Swelling of your hands, feet, ankles, face, mouth or throat, which may cause difficulty in swallowing or breathing.
  • Rash or itching.

These are all very serious side effects.  If you have them, you may have had a serious allergic reaction to HEALTH MATRIX FLORA.  You may need urgent medical attention or hospitalisation.

 

Tell your doctor as soon as possible if you notice any of the following:

  • Stomach upset, bloating, gas/wind (flatulence).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

 

  1. STORING AND DISPOSING OF HEALTH MATRIX FLORA
  • Store at or below 25 °
  • Protect from light and moisture.
  • Do not remove from outer container until required for use.
  • STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
  • Do not use after the expiry date printed on the label or container.
  • Return all unused medicine to your pharmacist.
  • Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).

 

  1. PRESENTATION OF HEALTH MATRIX FLORA

White HDPE plastic container with polypropylene cap, containing 60 capsules.

 

  1. IDENTIFICATION OF HEALTH MATRIX FLORA

White, hard, vegetable-based capsules.

 

  1. REGISTRATION NUMBER

To be allocated by SAHPRA.

 

  1. NAME AND ADDRESS OF THE REGISTRATION HOLDER

The Highly Ethical Supplement Company

18 Rivonia Road, Boundary Place Office Park, Illovo, Johannesburg

orders@healthmatrix.co.za

 

  1. DATE OF PUBLICATION

To be allocated by SAHPRA.

 

 

PASIËNTINLIGTINGSBLAD VIR HEALTH MATRIX FLORA

 

Gesondheidsaanvulling

Hierdie medisyne is nie deur die South African Health Products Regulatory Authority (SAHPRA) geëvalueer nie. Hierdie medisyne is nie bedoel om enige siekte te diagnoseer, behandel, genees of te voorkom nie.

 

SKEDULERINGSTATUS

Skedule 0

 

EIENDOMSNAAM EN DOSEERVORM

Health Matrix Flora kapsules

 

Lees hierdie hele inligtingsblad noukeurig want dit bevat inligting wat belangrik is vir u.

Health Matrix Flora is beskikbaar sonder ‘n dokter se voorskrif.  U moet Health Matrix Flora nietemin steeds versigtig neem om die beste resultate te verkry.

  • Hou hierdie inligtingsblad. Dit mag nodig wees dat u dit weer lees.
  • Moenie Health Matrix Flora met enige ander persoon deel nie.
  • Vra u apteker indien u verdere inligting of advies nodig het.

 

  1. WAT Health Matrix Flora BEVAT

Die aktiewe bestandele in een kapsule is Bacillus coagulans (spoorbiotika), Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus salivarius, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium breve en Streptococcus thermophilus.

Die ander bestandele is mikrokristallyn sellulose en inulien en die plant-gebasseerde kapsules is vervaardig met hypromellose. Bevat geen kunsmatige geurmiddels, tartrasien, gluten, suiwel, gis, suiker of sout nie.

 

  1. WAARVOOR Health Matrix Flora GEBRUIK WORD

Health Matrix Flora is ‘n unieke vermenging van probiotiese bakterieë wat indien gereeld ingeneem word die normale mikrobiale balans in die dermkanaal kan verbeter. Dit kan verbeterde dermkanaal funksionering tot gevolg hê.

 

  1. VOORDAT U Health Matrix Flora NEEM

Moenie Health Matrix Flora neem:

Indien u hipersensitief (allergies) is vir Bacillus coagulans, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus salivarius, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium breve en Streptococcus thermophilus of enige van die ander bestanddele van Health Matrix Flora (kyk WAT Health Matrix Flora BEVAT).

 

Neem spesiale sorg met Health Matrix Flora:

  • Indien u ‘n onderdrukte immuun sisteem het,
  • Indien u kort derm sindroom het (‘n kondisie waar ‘n deel van die derm verwyder is),
  • Indien u ‘n cholesterol toets moet ondergaan (probiotika kan totale cholesterol verlaag)

 

Die neem van Health Matrix Flora met kos en drinkgoed:

Health Matrix Flora moet voor maaltye geneem word.

 

Swangerskap en borsvoeding:

Veiligheid gedurende swangerskap en borsvoeding is nie bewys nie so raadpleeg asseblief u dokter, apteker of ander gesondheidsorgdeskundige voordat u Health Matrix Flora neem.

 

Bestuur en die gebruik van masjinerie:

Moenie ‘n voertuig bestuur of masjinerie hanteer totdat u weet hoe Health Matrix Flora u affekteer nie.

 

Die neem van ander medisynes saam met Health Matrix Flora:

Sê altyd vir u gesondheidsorgdeskundige indien u enige ander medisyne neem. (Dit sluit aanvullende of tradisionele medisynes in.)

Die volgende medisynes kan potensieel ‘n interaksie hê met Health Matrix Flora:

  • Sekere antibiotika (word gebruik om bakteriële infeksies te behandel)

 

  1. HOE OM Health Matrix Flora TE NEEM

Kontroleer met u dokter of apteker indien u onseker is.

Neem een kapsule een maal daagliks voor maaltye as ‘n aanvulling, of soos wat deur u gesondheidsorgdeskundige aangedui is.

Indien u die indruk kry dat die uitwerking van Health Matrix Flora te sterk of te swak is, sê dit vir u dokter of apteker.

 

Indien u meer Health Matrix Flora neem as wat u behoort:

In die geval van ‘n oordosis, raadpleeg u dokter of apteker. Indien nie een van hulle beskikbaar is nie, kontak die naaste hospitaal of gifsentrum.

Neem hierdie inligtingsblad en die houer met die oorblywende Health Matrix Flora saam met u, sodat die dokter kan sien wat u geneem het.

 

Indien u vergeet om Health Matrix Flora te neem:

Indien dit net ‘n paar uur later is, neem die dosis wat u oorgeslaan het saam met ‘n maaltyd sodra u onthou.  Indien dit byna tyd is vir die volgende dosis, slaan die dosis wat u vergeet het oor en neem Health Matrix Flora soos gewoonlik op die volgende geskeduleerde tyd met ‘n maaltyd. Moenie ‘n dubbele dosis neem om te vergoed vir die vergete dosis nie.

 

  1. MOONTLIKE NEWE-EFFEKTE

Health Matrix Flora kan newe-effekte hê.

Nie al die newe-effekte wat aangemeld is vir Health Matrix Flora word in hierdie inligtingsblad ingesluit nie.  Indien u algemene gesondheid verswak of u enige ongunstige effekte ervaar terwyl Health Matrix Flora geneem word, konsulteer asseblief u dokter, apteker of ander gesondheidsorgdeskundige.

Indien enige van die volgende gebeur, hou op om Health Matrix Flora te neem en sê onmiddellik vir u dokter of gaan na die ongevalle-afdeling by u naaste hospitaal:

  • Swelling van u hande, voete, enkels, gesig, lippe, mond of keel, wat dit moeilik kan maak om te sluk of asem te haal.
  • Uitslag of gejeuk.

Hierdie is almal baie ernstige newe-effekte. Indien u dit het, mag u ‘n ernstige allergiese reaksie op Health Matrix Flora gehad het.  U mag dringende mediese aandag of hospitalisasie benodig.

Sê vir u dokter indien u enige van die volgende opmerk:

  • Opgeblase of ongemaklike buik, meer winde of flatus.

Indien u enige newe-effekte opmerk wat nie in hierdie inligtingsblad genoem word nie, lig asseblief u dokter of apteker in.

 

  1. BERGING EN WEGDOENING VAN Health Matrix Flora
  • Bêre by of onder 25 °C.
  • Beskerm teen lig en vog.
  • BERG ALLE MEDISYNE BUITE BEREIK VAN KINDERS.
  • Moet nie gebruik ná die vervaldatum wat op die etiket of houer gedruk is nie.
  • Neem alle ongebruikte medisyne terug na u apteker.
  • Moet nie ongebruikte medisyne in dreine en rioolstelsels (bv. toilette) weggooi nie.

 

  1. AANBIEDING VAN Health Matrix Flora

Wit HDPE-plastiekhouer met polipropileenprop, wat 60 kapsules bevat.

 

  1. IDENTIFIKASIE VAN Health Matrix Flora

Wit, harde, plant-gebasseerde kapsules.

 

  1. REGISTRASIENOMMER

Sal deur SAHPRA toegeken word met registrasie.

 

  1. NAAM EN ADRES VAN DIE REGISTRASIEHOUER

The Highly Ethical Supplement Company

18 Rivonia Road, Boundary Place Office Park, Illovo, Johannesburg

orders@healthmatrix.co.za

 

  1. DATUM VAN PUBLIKASIE

Sal deur SAHPRA toegeken word met registrasie.

 

 

 

 

PACKAGE INSERT FOR HEALTH MATRIX FLORA

Health supplement

This medicine has not been evaluated by the South African Health Products Regulatory Authority (SAHPRA). This medicine is not intended to diagnose, treat, cure, or prevent any disease.

 

SCHEDULING STATUS

S0

 

PROPRIETARY NAME AND DOSAGE FORM

HEALTH MATRIX FLORA capsules

 

COMPOSITION

Active ingredients:

Each capsule contains ≥ 400 million CFU (colony forming units) of each of the following probiotic bacteria strains:

Bacillus coagulans (sporebiotic), Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus salivarius, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium breve and Streptococcus thermophilus.

Inactive ingredients:

Microcrystalline cellulose, inulin, hypromellose.

Does not contain any artificial flavouring, tartrazine, gluten, dairy, yeast, sugar or salt.

 

PHARMACOLOGICAL CLASSIFICATION

D 30.4 Pre- and probiotics

 

PHARMACOLOGICAL ACTION

Bifidobacteria are anaerobic, rod shaped, Gram-positive bacteria that normally colonise the human colon.  Lactobacillus refers to a group of lactic acid producing Gram-positive rods that are obligate and facultative anaerobes. Bifidobacteria and lactobacilli are considered “friendly” bacteria and taken for the purpose of re-colonising areas where they normally would occur.

Probiotics may also assist with the removal of heavy metal contaminants from the human intestine.

Bacillus coagulans belongs to group of beneficial bacteria called sporebiotics. These bacteria are more resistant to heat and thus survive longer at room temperature. They also have the ability to withstand damage from antibiotics and will survive if the probiotic is taken simultaneously with an antibiotic. Sporebiotics like Bacillus coagulans also have the unique feature that they support the growth of several lactobacilli and bifidobacterial probiotic species.

 

INDICATIONS

When ingested on a regular basis, HEALTH MATRIX FLORA should improve or normalise the microbial balance in the human intestine and thereby improve the functioning of the digestive tract/gut.

 

CONTRAINDICATIONS

Hypersensitivity to Bacillus coagulans, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus salivarius, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium breve and Streptococcus thermophilus or any of the other ingredients of HEALTH MATRIX FLORA (see COMPOSITION).

 

WARNINGS AND SPECIAL PRECAUTIONS

HEALTH MATRIX FLORA should be used with caution in patients with immunodeficiency since it may cause pathogenic colonisation.

HEALTH MATRIX FLORA should be used with caution in patients with short bowel syndrome since impaired gut integrity in these patients may predispose them to pathogenic infection from Lactobacillus.

HEALTH MATRIX FLORA may reduce total cholesterol and thus interact with cholesterol laboratory tests.

 

Effects on ability to drive and use machines:

Caution is advised before driving a vehicle or operating machinery until the effects of HEALTH MATRIX FLORA are known.

 

INTERACTIONS

Concomitant use of certain antibiotics with HEALTH MATRIX FLORA may decrease its effectiveness.  HEALTH MATRIX FLORA and antibiotics should be separated by at least 2 hours.

 

PREGNANCY AND LACTATION

Safety in pregnancy and lactation has not been established. 

 

DOSAGE AND DIRECTIONS FOR USE

HEALTH MATRIX FLORA is a health supplement. 

Adults

1 capsule taken once daily before meals, or as directed by a healthcare professional.

 

SIDE EFFECTS

Gastrointestinal disorders

Less frequent:               Gastrointestinal upset, bloating, flatulence.

 

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

See SIDE EFFECTS.

In the event of over dosage, treatment should be symptomatic and supportive.

 

IDENTIFICATION

White, hard, vegetable-based capsules.

 

PRESENTATION

White HDPE plastic container with polypropylene cap, containing 60 capsules.

 

STORAGE INSTRUCTIONS

Store at or below 25 °C.

Protect from light and moisture.

KEEP OUT OF REACH OF CHILDREN.

 

REGISTRATION NUMBERS

To be allocated by SAHPRA.

 

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION

The Highly Ethical Supplement Company

18 Rivonia Road, Boundary Place Office Park, Illovo, Johannesburg

orders@healthmatrix.co.za

 

DATE OF PUBLICATION OF PACKAGE INSERT

To be allocated by SAHPRA.

 

 

 

VOUBILJET VIR HEALTH MATRIX FLORA

Gesondheidsaanvulling

Hierdie medisyne is nie deur die South African Health Products Regulatory Authority (SAHPRA) geëvalueer nie. Hierdie medisyne is nie bedoel om enige siekte te diagnoseer, behandel, genees of te voorkom nie.

 

SKEDULERINGSTATUS

S0

 

EIENDOMSNAAM EN DOSEERVORM

Health Matrix Flora kapsules

 

SAMESTELLING

Aktiewe bestanddele:

Elke kapsule bevat ≥ 400 miljoen KVE (kolonie vormende eenhede) van elk van die volgende bakteriële stamme:

Bacillus coagulans (spoorbiotika), Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus salivarius, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium breve en Streptococcus thermophilus.

Onaktiewe bestanddele:

Mikrokristallyn sellulose, inulien en hypromellose.

Bevat geen kunsmatige geurmiddels, tartrasien, gluten, suiwel, gis, suiker of sout nie.

 

FARMAKOLOGIESE KLASSIFIKASIE

D 30.4 Pre-en-probiotika

 

FARMAKOLOGIESE WERKING

Farmakodinamiese eienskappe:

Bifidobakterieë is anaerobiese, staafvormige, Gram positiewe bakterieë wat normaalweg die menslike kolon koloniseer. Lactobacillus verwys na ‘n groep laktaatsuur produserende, Gram positiewe, staafvormige bakterieë wat obligaat en fakultatiewe anaerobies is. Bifidobakterieë en lactobacilli word beskou as ‘vriendelike’ bakterieë en word ingeneem met die doel om areas van die dermkanaal waar hulle normaalweg voorkom te koloniseer. Probiotika kan ook potensieël bydra tot die verwydering van swaar metale uit die menslike dermakanaal.

Bacillus coagulans behoort aan 'n groep voordelige bakterieë genaamd spoorbiotika. Hierdie bakterieë is meer bestand teen hitte en oorleef dus langer by kamertemperatuur. Hulle het ook die vermoë om skade van antibiotika te weerstaan en sal oorleef as die probiotika gelyktydig met 'n antibiotikum geneem word. Spoorbiotika soos Bacillus coagulans het ook die unieke eienskap dat hulle die groei van verskeie lactobacilli- en bifidobakteriese probiotiese spesies ondersteun.

 

 

INDIKASIES

Health Matrix Flora is ‘n unieke vermenging van probiotiese bakterieë wat indien gereeld ingeneem word die normale mikrobiale balans in die dermkanaal kan verbeter. Dit kan verbeterde dermkanaal funksionering tot gevolg hê.

 

KONTRA-INDIKASIES

Indien u hipersensitief (allergies) is vir Bacillus coagulans, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus salivarius, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium breve en Streptococcus thermophilus of enige van die ander bestanddele van Health Matrix Flora (kyk WAT Health Matrix Flora BEVAT).

 

WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS

Health Matrix Flora moet met sorg in pasiente wat immuun gebreke het aangewend word aangesien dit potensieel patogeniese kolonisasie kan veroorsaak.

Health Matrix Flora moet met sorg in pasiente met kort derm sindroom gebruik word aangesien hierdie pasiente ingeperkte dermkanaal integriteit het en hulle moontlik patogeniese infeksie van Lactobacillus kan ontwikkel.

Health Matrix Flora kan totale cholesterol vlakke verlaag en moet dus in oorleg met u gesondheidsorgdeskundige gebruik word voor die neem van bloed toetse.

 

Uitwerking op die vermoë om te bestuur en masjiene te gebruik:

Versigtigheid word aanbeveel voordat ‘n voertuig bestuur of masjinerie hanteer word, totdat dit bekend is wat die uitwerking van Health Matrix Flora is.

 

INTERAKSIES

Gesamentlike gebruik van Health Matrix Flora met sekere antibiotika kan tot verminderde effektiwiteit lei. Die inname van Health Matrix Flora en antibiotika moet met ten minste 2 ure geskei word.

 

SWANGERSKAP EN BORSVOEDING

Veiligheid tydens swangerskap of borsvoeding is nie bepaal nie.

 

DOSIS EN GEBRUIKSAANWYSINGS

Volwassenes:

Neem een kapsule een maal per dag voor maaltye as ‘n aanvulling, of soos wat deur u gesondheidsorgdeskundige aangedui is.

 

NEWE-EFFEKTE

Gastro-intestinale versteurings:

Minder dikwels:             Abdominale opsetting, winderigheid.

 

BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VIR DIE BEHANDELING DAARVAN

Kyk NEWE-EFFEKTE.

In die geval van oordosering moet behandeling simptomaties en ondersteunend wees.

 

IDENTIFIKASIE

Wit, harde, plant-gebasseerde kapsules.

 

AANBIEDING

Wit HDPE-plastiekhouer met polipropileenprop, wat 60 kapsules bevat.

 

BEWARINGSINSTRUKSIES

Bêre by of onder 25 °C.

Beskerm teen lig en vog.

HOU BUITE BEREIK VAN KINDERS.

 

REGISTRASIENOMMER

Sal deur SAHPRA toegeken word met registrasie.

 

NAAM EN BESIGHEIDSADRES VAN DIE HOUER VAN DIE REGISTRASIESERTIFIKAAT

The Highly Ethical Supplement Company

18 Rivonia Road, Boundary Place Office Park, Illovo, Johannesburg

orders@healthmatrix.co.za

 

DATUM VAN PUBLIKASIE VAN DIE VOUBILJET

Sal deur SAHPRA toegeken word met registrasie.

 

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