MiBiotix ANTIBIOTIC THERAPY AT PILL

MIBIOTIX AT ANTIBIOTIC THERAPY CAPSULES 

PATIENT INFORMATION LEAFLET

This leaflet tells you about MiBiotix AT ANTIBIOTIC THERAPY CAPSULES.

Complementary medicine: Health Supplement.

SCHEDULING STATUS: S0

PROPRIETY NAME AND DOSAGE FORM:

MiBiotix AT ANTIBIOTIC THERAPY CAPSULES (capsules).

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

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

  • Keep this leaflet. You may need to read it again.
  • Do not share MiBiotix AT ANTIBIOTIC THERAPY 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 AT ANTIBIOTIC THERAPY CAPSULES CONTAINS: 

4 Billion CFU’s of Bacillus subtilis HU58  

2. WHAT MIBIOTIX AT ANTIBIOTIC THERAPY CAPSULES ARE USED FOR:

Your gut microflora is significantly reduced during and following antibiotic treatment. Your microflora play an important role in your immune system as they act as the first line of defense in fighting bacteria and viruses. It is therefore important to replace these bacteria which also help prevent some of the common symptoms associated with antibiotic therapy (for example diarrhoea, constipation, and intestinal cramps). Bacillus subtilis HU58 is a very robust probiotic that forms an outer protective shell, known as an endospore. This impenetrable coating protects the bacterium from harsh environments as it transits the gut, including heat, extreme pH levels, pressure, light, and lack of oxygen. The rugged nature of Bacillus subtilis HU58 makes it the perfect probiotic to survive and deliver 100% of its dose to the small intestine. Bacillus subtilis HU58 is even effective in the presence of broad-spectrum antibiotics and so it is safe to use in conjunction with other treatment protocols.

 

3. BEFORE YOU TAKE/ USE/ ARE GIVEN/ ADMINISTERED MIBIOTIX AT ANTIBIOTIC THERAPY CAPSULES:

Do NOT take/use MiBiotix AT ANTIBIOTIC THERAPY CAPSULES: 

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

Take special care with MiBiotix AT ANTIBIOTIC THERAPY CAPSULES:
MiBiotix AT ANTIBIOTIC THERAPY 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 AT ANTIBIOTIC THERAPY 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 AT ANTIBIOTIC THERAPY CAPSULES:

All inactive ingredients added on the formulation of MiBiotix AT ANTIBIOTIC THERAPY CAPSULES are known to be well tolerated.

Taking/ Giving/ Using other medicines with MiBiotix AT ANTIBIOTIC THERAPY CAPSULES:

Always tell your healthcare professional if you are taking other medicines. (This includes complementary or traditional medicine). The use of MiBiotix AT ANTIBIOTIC THERAPY 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 AT ANTIBIOTIC THERAPY CAPSULES:
The usual dose is:
Take one MiBiotix AT Capsule once daily after breakfast. Always take MiBiotix AT ANTIBIOTIC THERAPY 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 AT ANTIBIOTIC THERAPY CAPSULES:
Always take MiBiotix AT ANTIBIOTIC THERAPY 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 AT ANTIBIOTIC THERAPY 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 AT ANTIBIOTIC THERAPY CAPSULES. 

MiBiotix AT ANTIBIOTIC THERAPY CAPSULES can have side effects.

Not all side effects reported for MiBiotix AT ANTIBIOTIC THERAPY CAPSULES are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MiBiotix AT ANTIBIOTIC THERAPY 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 AT ANTIBIOTIC THERAPY CAPSULES:

Store all MiBiotix AT ANTIBIOTIC THERAPY 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 AT ANTIBIOTIC THERAPY CAPSULES if you notice any visible signs of deterioration. 

Return all unused MiBiotix AT ANTIBIOTIC THERAPY CAPSULES o your pharmacist/supplier.

Do not dispose of unused MiBiotix AT ANTIBIOTIC THERAPY CAPSULES in drains or sewage systems (e.g. toilets).

 

7. PRESENTATION OF MIBIOTIX AT ANTIBIOTIC THERAPY CAPSULES:

MiBiotix AT ANTIBIOTIC THERAPY CAPSULES is packed in 10’s, in a blister strip in an outer carton.

 

8. IDENTIFICATION OF MIBIOTIX AT ANTIBIOTIC THERAPY CAPSULES:

Containing a white powder packed in a 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

Current studies have shown that HU58 is one of the strains of Bacillus subtilis identified so far that can form spores, germinating into vegetative cells and grow in the anaerobic conditions of the human gastrointestinal tract thereby being able to create and maintain a useful microbial flora in the gut. This is particularly important for users of antibiotics because, following and during antibiotic treatment the resident population of gut microbes is significantly reduced. To replace these bacteria the consumption of harmless bacteria help to present some of the common symptoms associated with antibiotic therapy (for example diarrhea, constipation and intestinal cramps. When taken orally, spores of HU58 are extremely stable in the acidic conditions of the stomach. As such they can transit the stomach unscathed and can grow and germinate in the small intestine.

 

12. REFERENCES

Mazza P 1994. The use of Bacillus subtilis as an antidiarrheal microorganism Boll Chim Farmaceutico, 133:3-18

Hong et al 2009. Bacillus subtilis isolated from the human gastrointestinal tract. Res Microbial 160:134-143

Hong et al 2008 The safety of Bacillus subtilis and Bacillus indicus as food probiotics. Journal of Applied Microbiology 105:510-520

Cutting, S.M., 2011. Bacillus probiotics. Food Microbiol.28:214-220

 

 

MIBIOTIX AT ANTIBIOTIC THERAPY CAPSULES 

PASIËNTINLIGTINGSBLAADJIE
Hierdie voubiljet bevat inligting oor MiBiotix AT ANTIBIOTIC THERAPY CAPSULES.

Komplimentêre medisyne: Gesondheidsaanvulling.

BYLAE STATUS: S0

EIENDOMSNAAM (EN DOSISVORM):

MiBiotix AT ANTIBIOTIC THERAPY CAPSULES (kapsules).

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

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

  • Hou hierdie pamflet. Jy sal dit dalk weer moet lees.
    • Moenie MiBiotix AT ANTIBIOTIC THERAPY 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 AT ANTIBIOTIC THERAPY CAPSULES BEVAT:

4 Miljard KVE’s van: Bacillus subtilis; HU58

 

2. WAARVOOR  MIBIOTIX AT ANTIBIOTIC THERAPY CAPSULES GEBRUIK WORD:

Jou dermkanaalmikroflora verminder aansienlik tydens en ná antibiotiese behandeling. Jou mikroflora speel ’n belangrike rol in jou immuunstelsel, aangesien dit as die eerste verdedigingslinie in die bekamping van bakterieë en virusse dien. Dit is dus belangrik om hierdie bakterieë te vervang om te help met die voorkoming van algemene simptome wat met antibiotiese behandeling gepaard gaan (bv. diarree, hardlywigheid en dermkrampe).

Bacillus subtilis HU58TM is ’n uiters robuuste probiotikum wat ’n beskermende laag aan die buitekant vorm, bekend as ’n endospoor. Hierdie ondeurdringbare laag beskerm die bakterie van ongenaakbare omstandighede wanneer dit deur die dermkanaal gaan, insluitende hitte, uiterste pH-vlakke, druk, lig en ’n gebrek aan suurstof.

Die geharde aard van Bacillus subtilis HU58TM maak dit die perfekte probiotikum om te oorleef en 100% van sy dosis aan die dunderm te lewer. Bacillus subtilis HU58TM is selfs doeltreffend in die aanwesigheid van breëspektrum-antibiotika, dus is dit veilig om saam met ander behandelingsprotokolle te gebruik.

 

3. VOORDAT U MIBIOTIX AT ANTIBIOTIC THERAPY CAPSULES NEEM:

Moenie MiBiotix AT ANTIBIOTIC THERAPY 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 AT ANTIBIOTIC THERAPY CAPSULES:
MiBiotix AT ANTIBIOTIC THERAPY 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 AT ANTIBIOTIC THERAPY 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 AT ANTIBIOTIC THERAPY CAPSULES:

Al die onaktiewe bestanddele wat op die formulering van MiBiotix AT ANTIBIOTIC THERAPY CAPSULES gevoeg word, word goed verdra.

Die neem van ander medisyne saam met MiBiotix AT ANTIBIOTIC THERAPY CAPSULES:

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

 

4. HOE OM MIBIOTIX AT ANTIBIOTIC THERAPY CAPSULES TE GEBRUIK 

Die gewone dosis is:

Neem een MiBiotix AT ANTIBIOTIC THERAPY Capsule, daagliks na ontbyt.

Neem MiBiotix AT ANTIBIOTIC THERAPY 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 u meer MiBiotix AT ANTIBIOTIC THERAPY CAPSULES gebruik as wat u behoort:

Moenie meer as aanbevole dosis gebruik nie. (Sien pakketinvoegsel)

In die geval van ’n oordosis, raadpleeg u dokter of apteker. As geeneen van hulle beskikbaar is nie, contak onmiddellik die naaste hospitaal of gifbeheersentrum.

As jy vergeet om ‘n dosis MiBiotix AT ANTIBIOTIC THERAPY CAPSULES te neem:

Neem MiBiotix AT ANTIBIOTIC THERAPY 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 AT ANTIBIOTIC THERAPY 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 AT ANTIBIOTIC THERAPY CAPSULES geneem word nie.

MiBiotix AT ANTIBIOTIC THERAPY CAPSULES kan newe-effekte hê.

Nie alle newe-effekte wat vir MiBiotix AT ANTIBIOTIC THERAPY CAPSULES gemeld is, is in hierdie inligtingstuk vervat nie. Indien u algemene gesondheid agteruitgaan of u ongewenste wisselwerkings ervaar terwyl MiBiotix AT ANTIBIOTIC THERAPY 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 AT ANTIBIOTIC THERAPY CAPSULES:

Bewaar alle MiBiotix AT ANTIBIOTIC THERAPY 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 AT ANTIBIOTIC THERAPY CAPSULES gebruik as u enige sigbare tekens van agteruitgang sien nie. 

Stuur alle ongebruikte MiBiotix AT ANTIBIOTIC THERAPY CAPSULES na u apteker / verskaffer terug.

Moet nie ongebruikte MiBiotix AT ANTIBIOTIC THERAPY CAPSULES in riool- of rioolstelsels gooi  nie (byvoorbeeld toilette).

 

7. AANBIEDING VAN MIBIOTIX AT ANTIBIOTIC THERAPY CAPSULES:

MiBiotix AT ANTIBIOTIC THERAPY CAPSULES is verpak in 10’s, in ‘n wit plastiekbottel met ‘n wit dop en in ‘n buitenste karton.

 

8. IDENTIFIKASIE VAN MIBIOTIX AT ANTIBIOTIC THERAPY 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

 

DATE OF PUBLICATION:

August 2019; PI.048.1.8.19