MiBiotix PRENATAL PN PILL

MIBIOTIX PN PRENATAL CAPSULES 

PATIENT INFORMATION LEAFLET

This leaflet tells you about MiBiotix PN PRENATAL CAPSULES.

Complementary medicine: Health Supplement.

SCHEDULING STATUS: S0

PROPRIETY NAME AND DOSAGE FORM:

MiBiotix PN PRENATAL CAPSULES (capsules).

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

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

  • Keep this leaflet. You may need to read it again.
  • Do not share MiBiotix PN PRENATAL 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 PN PRENATAL CAPSULES CONTAINS: 

10 Billion CFUs consisting of: 

1 Billion CFU Lactobacillus acidophilus Howaru

4 Billion CFU Lactobacillus rhamnosus Howaru,

1 Billion CFU Lactobacillus gasseri Lg-36

4 Billion CFU Bifidobacterium lactis Howaru

500 Million CFU Bifidobacterium infantis Bi-26.

 

2. WHAT MIBIOTIX PN PRENATAL CAPSULES ARE USED FOR:

Physiological changes during pregnancy may lead to altered bowel movement, and reduced immunity through increased gut permeability. All health and wellbeing starts with the gut. When taken on a regular basis MiBiotix PN PRENATAL CAPSULES will support the microflora balance in the gut. Remember to “Always start with your gut”.

 

3. BEFORE YOU TAKE/ USE/ ARE GIVEN/ ADMINISTERED MIBIOTIX PN PRENATAL CAPSULES:

Do NOT take/use MiBiotix PN PRENATAL CAPSULES: 

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

Take special care with MiBiotix PN PRENATAL CAPSULES:
MiBiotix PN PRENATAL 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 PN PRENATAL 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 PN PRENATAL CAPSULES:

All inactive ingredients added on the formulation of MiBiotix PN PRENATAL CAPSULES are known to be well tolerated.

Taking/ Giving/ Using other medicines with MiBiotix PN PRENATAL CAPSULES:

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

MiBiotix PN PRENATAL CAPSULES can have side effects.

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

Store all MiBiotix PN PRENATAL 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 PN PRENATAL CAPSULES if you notice any visible signs of deterioration. 

Return all unused MiBiotix PN PRENATAL CAPSULES to your pharmacist/supplier.

Do not dispose of unused MiBiotix PN PRENATAL CAPSULES n drains or sewage systems (e.g. toilets).

 

7. PRESENTATION OF MIBIOTIX PN PRENATAL CAPSULES:

MiBiotix PN PRENATAL CAPSULES is packed in 30’s, in a white plastic bottle with a white cap in an outer carton.

 

8. IDENTIFICATION OF MIBIOTIX PN PRENATAL 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

From the first to the third trimester, diversity of the maternal gut microbiota decreases, and the immune system becomes more inflammatory. Supplementation in pregnancy with specific probiotics has been shown to significantly reduce the risk of gestational diabetes, pre-eclampsia, gestational weight gain and decrease maternal levels of triglycerides and LDL. Probiotic interventions also seem to be most effective for infant allergies if commenced prenatally.

 

12. REFERENCES

Luoto R et al., 2010 Gestational diabetes. GDM

Brantsaeter,  AL. et al., 2010

Hoppu, U et al., 2014

Kukkonen et al., 2017 j Allergy Clin Immunol 119:192-198

Kalliomaki et al., 2001 Lancet 357:1076-1079

Kimet al., 2010 Pediatr Immunol 21:386-393

 

 

MIBIOTIX PN PRENATAL CAPSULES 

PASIËNTINLIGTINGSBLAADJIE
Hierdie voubiljet bevat inligting oor MiBiotix PN PRENATAL CAPSULES.

Komplimentêre medisyne: Gesondheidsaanvulling.

BYLAE STATUS: S0

EIENDOMSNAAM (EN DOSISVORM):

MiBiotix PN PRENATAL CAPSULES (kapsules).

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

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

  • Hou hierdie pamflet. Jy sal dit dalk weer moet lees.
    • Moenie MiBiotix PN PRENATAL 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 PN PRENATAL CAPSULES BEVAT:

10 Miljard KVEs bestaande uit: 

1 Miljard KVE Lactobacillus acidophilus Howaru

4 Miljard KVE Lactobacillus rhamnosus Howaru,

1 Miljard KVE Lactobacillus gasseri Lg-46

4 Miljard KVE Bifidobacterium lactis Howaru

500 Miljoen KVE Bifidobacterium infantis Bi-26.

 

2. WAARVOOR  MIBIOTIX PN PRENATAL CAPSULES GEBRUIK WORD:

Fisiologiese veranderings gedurende swangerskap kan tot versteurde stoelgang en verswakte immuniteit lei as gevolg van verhoogde dermkanaaldeurlaatbaarheid. Alle gesondheid en welwees begin by die dermkanaal. Gereelde gebruik van MiBiotix PN PRENATAL CAPSULES sal die mikroflorabalans in jou dermkanaal ondersteun. Onthou om “Altyd by jou dermkanaal te begin”

 

3. VOORDAT U MIBIOTIX PN PRENATAL CAPSULES NEEM:

Moenie MiBiotix PN PRENATAL 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 PN PRENATAL CAPSULES:
MiBiotix PN PRENATAL 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 PN PRENATAL 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 PN PRENATAL CAPSULES:

Al die onaktiewe bestanddele wat op die formulering van MiBiotix PN PRENATAL CAPSULES gevoeg word, word goed verdra.

Die neem van ander medisyne saam met MiBiotix PN PRENATAL CAPSULES:

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

 

4. HOE OM MIBIOTIX PN PRENATAL CAPSULES TE GEBRUIK 

Die gewone dosis is:

Neem een MiBiotix PN PRENATAL CAPSULES, daagliks na ontbyt.

Neem MiBiotix PN PRENATAL 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 PN PRENATAL CAPSULES te neem:

Neem MiBiotix PN PRENATAL 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 PN PRENATAL 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 PN PRENATAL CAPSULES geneem word nie.

MiBiotix PN PRENATAL CAPSULES kan newe-effekte hê.

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

Bewaar alle MiBiotix PN PRENATAL 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 PN PRENATAL CAPSULES gebruik as u enige sigbare tekens van agteruitgang sien nie. 

Stuur alle ongebruikte MiBiotix PN PRENATAL CAPSULES a u apteker / verskaffer terug.

Moet nie ongebruikte MiBiotix PN PRENATAL CAPSULES in riool- of rioolstelsels gooi  nie (byvoorbeeld toilette).

 

7. AANBIEDING VAN MIBIOTIX  PN PRENATAL CAPSULES:

MiBiotix PN PRENATAL CAPSULES is verpak in 30’s, in ‘n wit plastiekbottel met ‘n wit dop en in ‘n buitenste karton.

 

8. IDENTIFIKASIE VAN MIBIOTIC PN PRENATAL 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.060.1.8.19