MiBiotix PREMIUM PLUS PP PILL

MIBIOTIX PP PREMIUM PLUS CAPSULES 

PATIENT INFORMATION LEAFLET

This leaflet tells you about MiBiotix PP PREMIUM PLUS CAPSULES.

Complementary medicine: Health Supplement.

SCHEDULING STATUS: S0

PROPRIETY NAME AND DOSAGE FORM:

MiBiotix PP PREMIUM PLUS CAPSULES (capsules).

Read all of this leaflet carefully because it contains important information for you.

MiBiotix PP PREMIUM PLUS CAPSULES are available without a doctor’s prescription. Nevertheless, you still need to use MiBiotix PP PREMIUM PLUS CAPSULES carefully to get the best results from it.

  • Keep this leaflet. You may need to read it again.
  • Do not share MiBiotix PP PREMIUM PLUS CAPSULES with any other person.
  • Ask your pharmacist if you need more information or advice.
  • You must see a doctor if your symptoms worsen or do not improve.

 

1. WHAT MIBIOTIX PP PREMIUM PLUS CAPSULES CONTAINS: 

MegaSporeBioticTM: Two capsules contain a proprietary

blend of 4 Billion CFUs of: Bacillus indicus HU36, Bacillus subtilis HU58, Bacillus coagulansBacillus licheniformis, Bacillus clausii

 

2. WHAT MIBIOTIX PP PREMIUM PLUS CAPSULES ARE USED FOR:

Intestinal permeability is present in most chronic diseases and is believed to be a major driver of many inflammatory conditions. MegaSporeBiotic in MiBiotix Premium Plus is clinically shown to reduce intestinal permeability by 60%, in just 30 days without any additional interventions. MegaSporeBiotic in MiBiotix Premium Plus is a probiotic blend of 5 Bacillus spores that have been clinically shown to repair and maintain healthy gut barrier function and overall immunity. Remember to “Always start with your gut”.

 

3. BEFORE YOU TAKE/ USE/ ARE GIVEN/ ADMINISTERED MIBIOTIX PP PREMIUM PLUS CAPSULES:

Do NOT take/use MiBiotix PP PREMIUM PLUS CAPSULES: 

  • If you are known to be hypersensitive (allergic) to (active ingredient) or any of the inactive ingredients. 

Take special care with MiBiotix PP PREMIUM PLUS CAPSULES:
MiBiotix PP PREMIUM PLUS CAPSULES does not intend to prevent or cure any form of illness or disease and should not replace any medication. If you suffer from a chronic medical condition, consult your healthcare practitioner before using this product. Do not exceed the recommended dose.

Driving and using machinery:

No studies on the effect on the ability to drive or use machinery have been performed. It is unlikely that MiBiotix PP PREMIUM PLUS CAPSULES would affect your ability to drive or use machinery. However, please exercise care until you are certain that your ability to perform such activities is not affected.

Important information about some of the ingredients of MiBiotix PP PREMIUM PLUS CAPSULES:

All inactive ingredients added on the formulation of MiBiotix PP PREMIUM PLUS CAPSULES are known to be well tolerated.

Taking/ Giving/ Using other medicines with MiBiotix PP PREMIUM PLUS CAPSULES:

Always tell your healthcare professional if you are taking other medicines. (This includes complementary or traditional medicine). The use of MiBiotix PP PREMIUM PLUS CAPSULES with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional for advice.

 

4. HOW TO TAKE/ USE MIBIOTIX PP PREMIUM PLUS CAPSULES:
The usual dose is:
Take one to two MiBiotix PP PREMIUM PLUS CAPSULES once daily after breakfast. Always take MiBiotix PP PREMIUM PLUS CAPSULES exactly as per recommendation of the Package Insert or by your health care provider and if you are unsure. If the symptoms worsen or persist, please consult your healthcare practitioner.
If you forget to take /miss a dose of MiBiotix PP PREMIUM PLUS CAPSULES:
Always take MiBiotix PP PREMIUM PLUS CAPSULES as prescribed. If you miss a dose, take it as soon as you remember. If you do not remember the missed dose until the next dose is due, skip the missed dose and go back to your regular dosing schedule (see “HOW TO TAKE MiBiotix PP PREMIUM PLUS CAPSULES”). Do not take a double dose to make up for forgotten individual doses.

 

5. POSSIBLE SIDE EFFECTS:

There has not been a case of any side effects reported when taking MiBiotix PP PREMIUM PLUS CAPSULES. 

MiBiotix PP PREMIUM PLUS CAPSULES can have side effects.

Not all side effects reported for MiBiotix PP PREMIUM PLUS CAPSULES are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MiBiotix PP PREMIUM PLUS CAPSULES, please consult your healthcare provider for advice. Please report/ inform your doctor or pharmacist if you notice any side effects not mentioned in this leaflet. 

 

6. STORAGE AND DISPOSING OF MIBIOTIX PP PREMIUM PLUS CAPSULES:

Store all MiBiotix PP PREMIUM PLUS CAPSULES out of reach of children.

Store in a cool, dry place below or at 25 0 C.

Keep the container in the original packaging and in an outer carton.

Protect from light.

Do not store in a bathroom.

Do not use after expiry date stated on the label/carton and on the bottle.

Do not use MiBiotix PP PREMIUM PLUS CAPSULES if you notice any visible signs of deterioration. 

Return all unused MiBiotix PP PREMIUM PLUS CAPSULES to your pharmacist/supplier.

Do not dispose of unused MiBiotix PP PREMIUM PLUS CAPSULES n drains or sewage systems (e.g. toilets).

 

7. PRESENTATION OF MIBIOTIX PP PREMIUM PLUS CAPSULES:

MiBiotix PP PREMIUM PLUS CAPSULES is packed in a white plastic bottle with a white cap in an outer carton.

 

8. IDENTIFICATION OF MIBIOTIX PP PREMIUM PLUS CAPSULES:

Containing a white powder packed in DR vegetarian capsule.

 

9. REGISTRATION NUMBER:

Will be allocated by Council upon registration. This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

 

 

10. NAME AND ADDRESS OF REGISTRATION HOLDER:

Kenza Health (Pty) Ltd Suite 177, Private Bag X7, Northriding 2162
For professional information go to www.mibiotix.co.za


11. SCIENTIFIC SUPPORT

MegaSporeBiotic in MiBiotix Premium Plus is a probiotic blend of 5 Bacillus spores that have been clinically shown to maintain healthy gut barrier function and overall immunity. The bi-phasic life cycle of the Bacillus spores allows them to remain dormant in harsh environments until they reach more favourable environments like the human gastrointestinal tract. Once inside the large intestine, these dormant spores can change into their active, vegetative forms and begin colonizing in the gut. This unique probiotic blend aims to recondition the gut instead of reseeding with probiotic strains that generally struggle to survive digestion or colonize the gut.

 

12. REFERENCES

Vreeland RH, Rosenzweig WD, Powers DW. Isolation of a 250 million-year-old halotolerant bacterium from a primary salt crystal. Nature. 2000;407:897-900. 

Rhee KJ, Sethupathi P, Driks A, et al. Role of commensal bacteria in development of gut-associated lymphoid tissue and preimmune antibody repertoire. J Immunol. 2004;172(2):1118-24. 

De Punder K, Pruimboom L. Stress induces endotoxemia and low-grade inflammation by increasing barrier permeability. Front Immunol. 2015;15(6):223.

Nagpal R, Kumar M, Yadav AK, et al. Gut microbiota in health and disease: an overview focused on metabolic inflammation. Benef Microbes. 2016;7(2):181-94. 

Gong Y, Li H, Li Y. Effects of Bacillus subtilis on epithelial tight junctions of mice with inflammatory bowel disease. J Interferon Cytokine Res. 2016;36(2). 

 

 

MIBIOTIX PP PREMIUM PLUS CAPSULES 

PASIËNTINLIGTINGSBLAADJIE
Hierdie voubiljet bevat inligting oor MiBiotix PP PREMIUM PLUS CAPSULES.

Komplimentêre medisyne: Gesondheidsaanvulling.

BYLAE STATUS: S0

EIENDOMSNAAM (EN DOSISVORM):

MiBiotix PP PREMIUM PLUS CAPSULES (kapsules).

Lees die hele blaadjie sorgvuldig deur, want dit bevat belangrike inligting vir u.

MiBiotix PP PREMIUM PLUS CAPSULES is beskikbaar sonder die voorskrif van ‘n dokter. U moet egter steeds MiBiotix PP PREMIUM PLUS CAPSULES versigtig gebruik om die beste resultate daarmee te verkry.

  • Hou hierdie pamflet. Jy sal dit dalk weer moet lees.
    • Moenie MiBiotix PP PREMIUM PLUS CAPSULES met enige ander persoon deel nie.
    • Vra jou apteker as jy meer inligting of advies benodig.
    • U moet ’n dokter raadpleeg indien u simptome vererger of nie verbeter nie.

 

1. WAT MIBIOTIX PP PREMIUM PLUS CAPSULES BEVAT:

MegaSporeBiotic: Twee kapsules bevat ‘n samestelling van 4 Miljard KVEs: Bacillus indicus HU36, Bacillus subtilis HU58, Bacillus coagulansBacillus licheniformis, Bacillus clausii

 

 

2. WAARVOOR  MIBIOTIX PP PREMIUM PLUS CAPSULES GEBRUIK WORD:

Dermkanaaldeurlaatbaarheid is in die meeste chroniese siektes aanwesig, en word beskou as ’n belangrike oorsaak van baie inflammatoriese toestande. Kliniese aanduidings

toon dat MegaSporeBioticTM in MiBiotix Premium Plus dermkanaaldeurlaatbaarheid binne 30 dae met 60% verminder, sonder enige bykomende ingrypings. MegaSporeBioticTM in MiBiotix Premium Plus is ’n probiotiese kombinasie van vyf Bacillus-spore wat kliniese studies bewys is om dermwandfunksie te herstel en algemene immuniteit te handhaaf. Onthou om “Altyd by jou dermkanaal te begin”.

 

3. VOORDAT U MIBIOTIX PP PREMIUM PLUS CAPSULES NEEM:

Moenie MiBiotix PP PREMIUM PLUS CAPSULES gebruik as:

  • jy bewus is daarvan dat jy hipersensitief (allergies) is vir (aktiewe bestanddeel) of enige van die bestanddele. 

Neem Spesiale sorg met MiBiotix PP PREMIUM PLUS CAPSULES:
MiBiotix PP PREMIUM PLUS CAPSULES beoog nie om enige ongesteldheid of siektetoestand te genees nie en moet nie enige medikasie vervang nie. Mense wat aan ’n chroniese mediese toestand ly moet hulle gesondheidspraktisyn raadpleeg voor hulle hierdie produk gebruik. Moenie die voorgeskrewe dosis oorskry nie.

Bestuur en die gebruik van masjinerie:

Geen navorsingstudies is uitgevoer oor die effek op die vermoë om te bestuur of masjinerie te hanteer nie. Dit is onwaarskynlik dat MiBiotix PP PREMIUM PLUS CAPSULES die vermoë om te bestuur of masjinerie te gebruik sal beïnvloed. Wees egter versigtig tot u seker is u vermoë om hierdie aktiwiteite uit te voer word nie beïnvloed nie.

Belangrike inligting oor sommige van die bestanddele van MiBiotix PP PREMIUM PLUS CAPSULES:

Al die onaktiewe bestanddele wat op die formulering van MiBiotix PP PREMIUM PLUS CAPSULES gevoeg word, word goed verdra.

Die neem van ander medisyne saam met MiBiotix PP PREMIUM PLUS CAPSULES:

Lig altyd u gesondheidpraktisyn in wanneer u medisyne neem. (Dit sluit in komplementêre of tradisionele medisyne). Die gebruik van MiBiotix PP PREMIUM PLUS CAPSULES saam met hierdie medisyne mag ongewenste wisselwerkings veroorsaak. Raadpleeg asseblief u dokter, apteker of ander professionele gesondheidsorgwerker vir advies.

 

4. HOE OM MIBIOTIX PP PREMIUM PLUS CAPSULES TE GEBRUIK 

Die gewone dosis is:

Neem een tot twee MiBiotix PP PREMIUM PLUS CAPSULES, daagliks na ontbyt.

Neem MiBiotix PP PREMIUM PLUS CAPSULES altyd volgens aanbevelings van die pakketinvoer of deur u gesondheidsorgverskaffer en indien u onseker is. As die simptome vererger of voortduur, raadpleeg ’n gesondheidsorgpraktisyn.

As jy vergeet om ‘n dosis MiBiotix PP PREMIUM PLUS CAPSULES te neem:

Neem MiBiotix PP PREMIUM PLUS CAPSULES altyd soos voorgeskryf. Indien u ’n dosis vergeet het, neem dit sou gou as wat u onthou. Indien u egter nie van die vergete dosis onthou voordat dit tyd is vir die volgende dosis is nie, slaan die vergete dosis oor en keer terug na u gewone doseringskedule (sien “HOE OM MiBiotix PP PREMIUM PLUS CAPSULES TE GEBRUIK”). Moenie ’n dubbele dosis neem om te vergoed vir die oorgeslane individuele dosis nie.

 

5. MOONTLIKE NEWE EFFEKTE

Daar was nie gevalle van enige newe-effekte gerapporteer wanneer MiBiotix PP PREMIUM PLUS CAPSULES geneem word nie.

MiBiotix PP PREMIUM PLUS CAPSULES kan newe-effekte hê.

Nie alle newe-effekte wat vir MiBiotix PP PREMIUM PLUS CAPSULES gemeld is, is in hierdie inligtingstuk vervat nie. Indien u algemene gesondheid agteruitgaan of u ongewenste wisselwerkings ervaar terwyl MiBiotix PP PREMIUM PLUS CAPSULES gebruik, raadpleeg asseblief u gesondheidsorgvoorsiener vir advies. Lig asseblief u dokter of apteker in indien u enige newe-effekte opmerk wat nie in hierdie inligtingstuk genoem word nie.

 

6. BERGING EN WEGDOEN VAN MIBIOTIX PP PREMIUM PLUS CAPSULES:

Bewaar alle MiBiotix PP PREMIUM PLUS CAPSULES buite bereik van kinders.

Berg in ‘n koel, droë plek onder of by 25 ° C.

Hou die houer in die oorspronklike verpakking en in ‘n buitenste karton.

Beskerm teen lig.

Moenie in ‘n badkamer stoor nie.

Moet nie gebruik word na die vervaldatum wat op die etiket / karton en op die bottel aangedui word nie.

Moenie MiBiotix PP PREMIUM PLUS CAPSULES gebruik as u enige sigbare tekens van agteruitgang sien nie. 

Stuur alle ongebruikte MiBiotix PP PREMIUM PLUS CAPSULES na u apteker / verskaffer terug.

Moet nie ongebruikte MiBiotix PP PREMIUM PLUS CAPSULES in riool- of rioolstelsels gooi nie (byvoorbeeld toilette).

 

7. AANBIEDING VAN MiBiotix PP PREMIUM PLUS CAPSULES:

MiBiotix PP PREMIUM PLUS CAPSULES is verpak  in ‘n wit plastiekbottel met ‘n wit dop en in ‘n buitenste karton.

 

8. IDENTIFIKASIE VAN MiBiotix PP PREMIUM PLUS CAPSULES:

Wit poeier verpak in n DR vegetariese kapsule.

 

9. REGISTRASIENOMMER:

Sal deur die Raad toegeken word by registrasie.

Hierdie ongeregistreerde medisyne is nie deur die SAHPRA geevalueer ten opsigte van kwaliteit, veiligheid of beoogde gebruik nie.

 

10. NAAM EN ADRES VAN DIE HOUER VAN DIE REGISTRASIE:

Kenza Health (Edms) Bpk Suite 177, Private BagX7, Northriding 2162

Vir proffessionele inligting gaan na www.mibiotix.co.za

 

11. DATUM VAN PUBLIKASIE:

August 2019; PI.062.1.8.19