PATIENT INFORMATION LEAFLET

SCHEDULING STATUS: S0

VITAMINME PREBIOTIC + PROBIOTIC (vegetable capsules)

Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus plantarum, Streptococcus thermophilus, Lactococcus lactis, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium lactis, Fructooligosaccharides (FOS), Oligofructose-enriched Inulin

Contains sugar (4,5 mg glucose, fructose and sucrose per capsule).

Complementary Medicine: Health Supplement

This unregistered medicine has not been evaluated by SAHPRA for its quality, safety or intended use.

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

VITAMINME PREBIOTIC + PROBIOTIC is available without a doctor’s prescription, for you to maintain your health. Nevertheless, you still need to use VITAMINME PREBIOTIC + PROBIOTIC carefully to get the best results from it.

  • Keep this leaflet. You may need to read it again.
  • Do not share VITAMINME PREBIOTIC + PROBIOTIC with any other person.
  • Ask your healthcare provider or pharmacist if you need more information or advice.

What is in this leaflet  

  1. What VITAMINME PREBIOTIC + PROBIOTIC is and what it is used for
  2. What you need to know before you use VITAMINME PREBIOTIC + PROBIOTIC
  3. How to use VITAMINME PREBIOTIC + PROBIOTIC
  4. Possible side effects
  5. How to store VITAMINME PREBIOTIC + PROBIOTIC
  6. Contents of the pack and other information

1. What VITAMINME PREBIOTIC + PROBIOTIC is and what it is used for

When ingested on a regular basis, VITAMINME PREBIOTIC + PROBIOTIC should improve or normalise the microbial balance in the human intestines and thereby improve the function of the digestive tract and gut.

2. What you need to know before you use VITAMINME PREBIOTIC + PROBIOTIC

A varied diet is the most effective and safe way to achieve good nutrition, health, body composition as well as mental and physical performance.

Do not use VITAMINME PREBIOTIC + PROBIOTIC:

  • If you are hypersensitive (allergic) to any of the active ingredients or to any of the other ingredients of VITAMINME PREBIOTIC + PROBIOTIC (listed in section 6).

Warnings and precautions

Take special care with VITAMINME PREBIOTIC + PROBIOTIC::

  • If you have a medical condition or if you are currently taking any other medicine.
  • You should consult your healthcare provider prior to use if:
    • You have immunodeficiency (a compromised immune system).
    • If you have a peripheral or central venous catheter.
    • If you have compromised gut integrity (such as short bowel syndrome, ulcerative colitis, or intestinal obstruction).
    • If you have valvular heart disease.

Children and adolescents 

Consult a healthcare provider prior to using VITAMINME PREBIOTIC + PROBIOTIC for individuals 18 years and younger.

Other medicines and VITAMINME PREBIOTIC + PROBIOTIC

Always tell your healthcare provider if you are taking any other medicine. This includes all complementary or traditional medicines.

The following medicines may decrease the effectiveness of VITAMINME PREBIOTIC + PROBIOTIC if taken at the same time:

  • Antibiotic medicine (used to treat bacterial infections)
  • Antifungal medicine (used to treat fungal infections)

You should take VITAMINME PREBIOTIC + PROBIOTIC two hours before or after antibiotic/antifungal medicines.

VITAMINME PREBIOTIC + PROBIOTIC with food and drink

VITAMINME PREBIOTIC + PROBIOTIC has no known interaction with food and drink (see section 3).

Pregnancy, breastfeeding and fertility 

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before using VITAMINME PREBIOTIC + PROBIOTIC.

Safety for use during pregnancy and lactation has not been established.

Driving and using machinery 

VITAMINME PREBIOTIC + PROBIOTIC is unlikely to have an effect on your ability to drive a vehicle and operate machinery.

Patients should exercise caution before driving or using machinery until they are reasonably certain that VITAMINME PREBIOTIC + PROBIOTIC does not adversely affect their performance.

Important information about some of the ingredients of VITAMINME PREBIOTIC + PROBIOTIC

  • If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking VITAMINME PREBIOTIC + PROBIOTIC.
  • VITAMINME PREBIOTIC + PROBIOTIC contains sucrose, glucose and fructose which may have an effect on the control of your blood sugar if you have diabetes mellitus.

3. How to use VITAMINME PREBIOTIC + PROBIOTIC

Do not share medicines with any other person.

Always use VITAMINME PREBIOTIC + PROBIOTIC exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults 18 years and older:

Take 1 capsule daily after food, or as recommended by a healthcare provider.

You should take VITAMINME PREBIOTIC + PROBIOTIC two hours before or after antibiotic or antifungal medicines.

Do not exceed the recommended dose.

If you take more VITAMINME PREBIOTIC + PROBIOTIC than you should

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

If you forget to take VITAMINME PREBIOTIC + PROBIOTIC

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

4. Possible side effects  

VITAMINME PREBIOTIC + PROBIOTIC can have side effects.

Not all side effects reported for VITAMINME PREBIOTIC + PROBIOTIC are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VITAMINME PREBIOTIC + PROBIOTIC, please consult your healthcare provider for advice.

If any of the following happens, stop using VITAMINME PREBIOTIC + PROBIOTIC and tell your doctor immediately, or go to the casualty department at your nearest hospital:

  • swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing;
  • rash or itching;
  • fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to VITAMINME PREBIOTIC + PROBIOTIC. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

  • Mild gastrointestinal adverse effects such as diarrhoea, indigestion, abdominal pain or cramps, nausea, vomiting, bloating, belching, and/or flatulence.
  • Skin rash, itching and redness.

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

Reporting of side effects 

If you get side effects, inform your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of VITAMINME PREBIOTIC + PROBIOTIC.

5. How to store VITAMINME PREBIOTIC + PROBIOTIC.

  • Store at or below 25 °C in a dry place away from moisture and direct sunlight.
  • Store all medicines out of reach of children.
  • Store in the original container until required for use.
  • Do not use after the expiry date stated on the packaging.
  • Return all unused medicine to your pharmacist.
  • Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

6. Contents of the pack and other information

What VITAMINME PREBIOTIC + PROBIOTIC contains

Each vegetable capsule contains:

PROBIOTICS 

9-strain probiotic powder 

Providing 6,50 billion CFU

Of which:

Lactobacillus spp and Coccus spp

Lactobacillus acidophilus 

Lactobacillus casei 

Lactobacillus rhamnosus 

Lactobacillus plantarum 

Streptococcus thermophilus 

Lactococcus lactis

Bifidobacterium spp

Bifidobacterium bifidum 

Bifidobacterium longum 

Bifidobacterium lactis

PREBIOTICS 

Fructooligosaccharides (FOS)

Oligofructose-enriched inulin

 

650,00 mg

 

 

 

2,93 billion CFU

 

 

 

 

 

 

3,48 billion CFU

 

 

 

 

65,00 mg

45,00 mg
   

CFU = Colony Forming Unit

The other ingredients are silicon dioxide, magnesium stearate, maize starch, and hypromellose.

Contains sugar (4,5 mg glucose, fructose and sucrose per capsule).

What VITAMINME PREBIOTIC + PROBIOTIC looks like and contents of the pack

Size 00, white vegetable capsules containing an off-white powder. The capsules are packed in a clear, amber glass jar with a pressure seal and a white, ribbed screwcap lid, packed into an outer carton.
Pack size: 30 vegetable capsules.

Holder of Certificate of Registration

VitaminMe (Pty) Ltd
32 Fricker Road
Illovo
Johannesburg
South Africa
2196

This leaflet was last revised in

Will be allocated by SAHPRA upon registration.

Registration number 

Will be allocated by SAHPRA upon registration.

Registration number

Will be allocated by SAHPRA upon registration.

PASIËNTINLIGTINGSBLAD

SKEDULERINGSTATUS: S0

VITAMINME PREBIOTIC + PROBIOTIC (groentekapsules)

Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus plantarum, Streptococcus thermophilus, Lactococcus lactis, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium lactis, Frukto-oligosakkariede (FOS), Oligofruktose-verrykte inulien.

Bevat suiker (4,5 mg glukose, fruktose en sukrose per kapsule).

Komplementêre Medisyne: Gesondheidsaanvulling

Hierdie ongeregistreerde medisyne is nie deur SAHPRA vir gehalte, veiligheid of beoogde gebruik geëvalueer nie.

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

VITAMINME PREBIOTIC + PROBIOTIC is beskikbaar sonder ‘n dokter se voorskrif, om jou gesondheid te handhaaf. Nietemin moet VITAMINME PREBIOTIC + PROBIOTIC versigtig gebruik word ten einde die beste resultate te verkry.

  • Hou hierdie inligtingsblad. Dit kan nodig wees dat jy dit weer lees.
  • Moenie VITAMINME PREBIOTIC + PROBIOTIC met enige ander persoon deel nie.
  • Vra jou gesondheidsorgverskaffer of apteker indien jy meer inligting of advies nodig het.

Wat is in hierdie inligtingsblad

  1. Wat is VITAMINME PREBIOTIC + PROBIOTIC en warvoor word dit gebruik
  2. Wat jy moet weet voordat jy VITAMINME PREBIOTIC + PROBIOTIC gebruik
  3. Hoe om VITAMINME PREBIOTIC + PROBIOTIC te gebruik
  4. Moontlike newe-effekte
  5. Hoe om VITAMINME PREBIOTIC + PROBIOTIC te bêre
  6. Inhoud van die pak en ander inligting

1. Wat is VITAMINME PREBIOTIC + PROBIOTIC en waarvoor word dit gebruik

Wanneer dit op ‘n gereelde basis ingeneem word, behoort VITAMINME PREBIOTIC + PROBIOTIC die mikrobiese balans in die menslike ingewande te verbeter of te normaliseer en sodoende die funksie van die spysverteringskanaal en derm te verbeter.

2. Wat jy moet weet voordat jy VITAMINME PREBIOTIC + PROBIOTIC gebruik

‘n Gevarieerde dieet is die doeltreffendste en veiligste manier om goeie voeding, gesondheid, liggaamsamestelling, sowel as geestelike en fisiese prestasie te behaal.

Moenie VITAMINME PREBIOTIC + PROBIOTIC neem nie:

  • Indien jy hipersensitief (allergies) is vir enige van die aktiewe bestanddele of vir enige van die ander bestanddele van VITAMINME PREBIOTIC + PROBIOTIC (gelys in afdeling 6).

Waarskuwings en voorsorgmaatreëls

Neem spesiale sorg:

  • Indien jy ‘n mediese toestand het of as jy tans enige ander medisyne gebruik.
  • Jy moet jou gesondheidsorgverskaffer raadpleeg voor gebruik indien:
    • Jy het immuniteitsgebrek (jou immuunstelsel gekompromitteer is).
    • Jy ‘n perifere of sentrale veneuse kateter het.
    • Jou ingewande se integriteit gekompromitteer is (soos kortderm-sindroom, ulseratiewe kolitis of intestinale obstruksie).
    • Jy hartklepsiekte het.

Kinders en adolessente

Raadpleeg ‘n gesondheidsorgverskaffer voordat VITAMINME PREBIOTIC + PROBIOTIC gebruik word by individue 18 jaar en jonger.

Ander medisyne en VITAMINME PREBIOTIC + PROBIOTIC

Lig altyd jou gesondheidsorgverskaffer in indien jy enige ander medisyne neem. Dit sluit aanvullende of tradisionele medisyne in.

Die volgende medisyne mag die effektiwiteit van VITAMINME PREBIOTIC + PROBIOTIC verminder indien dit terselfdertyd geneem word:

  • Antibiotiese medisyne (gebruik om bakteriële infeksies te behandel).
  • Antiswammedisyne (gebruik om swaminfeksies te behandel).

Jy moet VITAMINME PREBIOTIC + PRBIOTIC twee ure voor of na antibiotika/antiswammedisyne neem.

VITAMINME PREBIOTIC + PROBIOTIC met kos en drinkgoed

VITAMINME PREBIOTIC + PROBIOTIC het geen bekende interaksie met kos of drinkgoed nie (sien afdeling 3).

Swangerskap, borsvoeding en vrugbaarheid

Indien jy swanger is of jou baba borsvoed, vermoed dat jy swanger mag wees of beplan om swanger te raak, raadpleeg asseblief jou dokter, apteker of ander gesondheidsorgverskaffer voordat jy VITAMINME PREBIOTIC + PROBIOTIC neem.

Veiligheid vir gebruik tydens swangerskap en laktasie is nie vasgestel nie.

Bestuur en die gebruik van masjinerie

Dit is onwaarskynlik dat VITAMINME PREBIOTIC + PROBIOTIC jou vermoë om ‘n voertuig te bestuur en masjinerie te gebruik sal affekteer.

Pasiënte moet versigtig wees voordat hulle bestuur of masjinerie gebruik, totdat hulle redelik seker is dat VITAMINME PREBIOTIC + PROBIOTIC nie hul werkverrigting nadelig beïnvloed nie.

Belangrike inligting oor sommige van die bestanddele van VITAMINME PREBIOTIC + PROBIOTIC

  • Indien jy deur jou dokter gesê is dat jy ’n onverdraagsaamheid teenoor sommige suikers het, kontak jou dokter voordat jy VITAMINME PREBIOTIC + PROBIOTIC neem.
  • VITAMINME PREBIOTIC + PROBIOTIC bevat sukrose, glukose en fruktose wat ’n uitwerking op die beheer van jou bloedsuiker kan hê as jy diabetes mellitus het.

3. Hoe om VITAMINME PREBIOTIC + PROBIOTIC te gebruik

Moenie medisyne met enige ander persoon deel nie.

Gebruik VITAMINME PREBIOTIC + PROBIOTIC altyd presies soos wat in hierdie inligtingsblad aangedui word, of soos wat jou dokter of apteker vir jou aangewys het. Vra gerus jou dokter of apteker indien jy onseker is.

Volwassenes 18 jaar en ouer

Neem 1 kapsule daagliks na ete, of soos aanbeveel deur jou gesondheidsorgverskaffer.

Jy moet VITAMINME PREBIOTIC + PROBIOTIC twee ure voor of na antibiotika of antiswammedisyne neem.

Moenie die aanbevole dosis oorskry nie.

 Wat om te doen indien jy meer VITAMINME PREBIOTIC + PROBIOTIC geneem het as wat jy moet

In die geval van ‘n oordosis, raadpleeg jou dokter of apteker. Indien nie een van hulle beskikbaar is nie, kontak die naaste hospitaal of gifsentrum. Neem hierdie inligtingsblad en die res van die kapsules saam sodat die dokter weet wat jy geneem het.

Indien jy vergeet het om VITAMINME PREBIOTIC + PROBIOTIC te neem

Moenie ‘n dubbele dosis neem om op te maak vir die individuele dosisse wat oorgeslaan is nie.

4. Moontlike newe-effekte

VITAMINME PREBIOTIC + PROBIOTIC kan newe-effekte hê.

Nie alle newe-effekte wat vir VITAMINME PREBIOTIC + PROBIOTIC gerapporteer is, word in hierdie inligtingsblad ingesluit nie. Indien jou algemene gesondheid verswak of indien jy enige ongunstige effekte onderwind terwyl VITAMINME PREBIOTIC + PROBIOTIC geneem word, raadpleeg asseblief jour gesondheidsverskaffer.

Indien jy enige van die volgende ervaar, hou op om VITAMINME PREBIOTIC + PROBIOTIC te neem en sê dadelik vir jou dokter of gaan na die ongevalle-afdeling by jouse naase hospitaal:

  • swelling van jou hande, voete, enkels, gesig, lippe en mond of keel, wat probleme kan veroorsaak met sluk en asemhaling;
  • uitslag of gejeuk;
  • floute.

Hierdie is baie ernstige newe-effekte. Indien jy dit het, mag jy ’n ernstige allergiese reaksie op VITAMINME PREBIOTIC + PROBIOTIC gehad het. Jy mag dringende mediese bystand of hospitalisasie benodig.

Sê vir jou dokter indien jy enige van die volgende opmerk:

  • Ligte gastroïntestinale nadelige effekte soos diarree, indigestie, abdominale pyn of krampe, naarheid, braking, opgeblasenheid, winde opbreek, en/of winderigheid.
  • Veluitslag, jeuk en rooiheid.

Indien jy enige newe-effekte opmerk wat nie in hierdie inligtingsblad genome word nie, lig asseblief jou dokter of apteker in.

Rapportering van newe-effekte

Indien jy newe-effekte ondervind, bespreek dit met jou dokter of apteker. Jy kan ook newe-effekte aan SAHPRA rapporteer via die “6.04 Adverse Drug Reactions Reporting Form”, wat aanlyn by SAHPRA se publikasies beskikbaar is: http://www.sahpra.org.za/Publications/Index/8. Deur newe-effekte te rapporteer kan jy help om meer inligting rakende die veiligheid van VITAMINME PREBIOTIC + PROBIOTIC te verskaf.

5. Hoe om VITAMINME PREBIOTIC + PROBIOTIC te bêre

  • Bêre by of onder 25 °C in ‘n droë plek weg van vog en direkte sonlig.
  • Bêre alle medisyne buite bereik van kinders.
  • Bêre in die oorspronklike houer tot benodig word vir gebruik.
  • Moenie gebruik na die vervaldatum op die verpakking nie.
  • Neem alle ongebruikte medisyne na u apteker terug.
  • Moenie ongebruikte medisyne in afvoerpype of rioolsisteme (bv. toilette) weggooi nie.

6. Inhoud van die verpakking en ander inligting

Wat VITAMINME PREBIOTIC + PROBIOTIC bevat

Elke groentekapsule bevat:

PROBIOTIKA

9-stam probiotiese poeier

Verskaf 6,50 miljard KVE

Waarvan:

Lactobacillus spp en Coccus spp

Lactobacillus acidophilus 

Lactobacillus casei 

Lactobacillus rhamnosus

Lactobacillus plantarum 

Streptococcus thermophilus 

Lactococcus lactis

Bifidobacterium spp

Bifidobacterium bifidum 

Bifidobacterium longum 

Bifidobacterium lactis

PREBIOTIKUM

Frukto-oligosakkariede (FOS)

Oligofruktose-verrykte inulien

 

650,00 mg

 

 

 

2,93 miljard KVE

 

 

 

 

 

 

3,48 miljard KVE

 

 

 

 

65,00 mg

45,00 mg
   

KVE = Kolonievormende Eenhede

Die ander bestanddele is silikondioksied, magnesiumstearaat, mieliestysel, en hipromellose.

Bevat suiker (4,5 mg glukose, fruktose en sukrose per kapsule).

Hoe VITAMINME PREBIOTIC + PROBIOTIC lyk en inhoud van die verpakking

Grootte 00, wit groentekapsules wat ‘n af-wit poeier bevat. Die kapsules word verpak in ‘n deursigtige, bruinkleurige glasfles met ‘n drukseël en ‘n wit, geribde skroefdop deksel, verpak in ‘n buitenste karton.

Verpakkingsgrootte: 30 groentekapsules.

Houer van Registrasiesertifikaat

VitaminMe (Edms.) Bpk.
Frickerpad 32
Illovo
Johannesburg
Suid-Afrika
2196

Hierdie inligtingsblad is laas hersien in

Sal met registrasie deur SAHPRA toegeken word.

Registrasienommer

Sal met registrasie deur SAHPRA toegeken word.

PROFESSIONAL INFORMATION

COMPLEMENTARY MEDICINE: HEALTH SUPPLEMENT

This unregistered medicine has not been evaluated by SAHPRA for its quality, safety or intended use.

SCHEDULING STATUS
S0

1. NAME OF THE MEDICINE

VITAMINME PREBIOTIC + PROBIOTIC (vegetable capsules)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each vegetable capsule contains:

PROBIOTICS 

9-strain probiotic powder 

Providing 6,50 billion CFU

Of which:

Lactobacillus spp and Coccus spp

Lactobacillus acidophilus 

Lactobacillus casei 

Lactobacillus rhamnosus 

Lactobacillus plantarum 

Streptococcus thermophilus 

Lactococcus lactis

Bifidobacterium spp

Bifidobacterium bifidum 

Bifidobacterium longum 

Bifidobacterium lactis

PREBIOTICS 

Fructooligosaccharides (FOS)

Oligofructose-enriched inulin

 

650,00 mg

 

 

 

2,93 billion CFU

 

 

 

 

 

 

3,48 billion CFU

 

 

 

 

65,00 mg

45,00 mg

CFU = Colony Forming Unit

Contains sugar (4,5 mg glucose, fructose and sucrose per capsule).

For full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Capsules.
Size 00, white vegetable capsules containing an off-white powder.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

When ingested on a regular basis, VITAMINME PREBIOTIC + PROBIOTIC should improve or normalise the microbial balance in the human intestines and thereby improve the function of the digestive tract and gut.

4.2 Posology and method of administration

Posology

Adults 18 years and older:

Take 1 capsule daily after food, or as recommended by a healthcare provider.

The administration of antibiotic and/or antifungal medicines and VITAMINME PREBIOTIC + PROBIOTIC should be separated by at least 2 hours.

Do not exceed the recommended dose.

Method of administration

For oral use. To be taken after food.

4.3 Contraindications

  • Hypersensitivity to any of the active ingredients or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

  • Probiotics may cause pathogenic colonisation in patients with immunodeficiency. Patients with a compromised immune system should consult with a healthcare provider prior to use.
  • Rare cases of bacteremia and fungemia have been reported in patients with peripheral or central venous catheters who were taking probiotics. Patients with peripheral or central venous catheters should only take VITAMINME PREBIOTIC + PROBIOTIC under the guidance of a healthcare provider.
  • Probiotics may cause pathogenic colonisation in patients with compromised gut integrity, such as short bowel syndrome, ulcerative colitis, or intestinal obstruction. Patients with compromised gut integrity should consult with a healthcare provider prior to use.
  • Probiotics may cause pathogenic colonisation in patients with valvular heart disease and use of VITAMINME PREBIOTIC + PROBIOTIC should be avoided prior to dental surgery or other procedures.
  • Contains fructose. Patients with the rare hereditary conditions of galactose intolerance e.g. galactosaemia, Lapp lactase deficiency, glucose-galactose malabsorption or fructose intolerance should not take VITAMINME PREBIOTIC + PROBIOTIC.
  • Contains sucrose. Patients with rare hereditary conditions such as fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take VITAMINME PREBIOTIC + PROBIOTIC.
  • Contains sucrose, glucose and fructose which may have an effect on the glycaemic control of patients with diabetes mellitus.

4.5 Interaction with other medicines and other forms of interaction

Concomitant use of certain antibiotic and antifungal medicines with VITAMINME PREBIOTIC + PROBIOTIC may decrease its effectiveness. The administration of antibiotic and/or antifungal medicines and VITAMINME PREBIOTIC + PROBIOTIC should be separated by at least 2 hours.

4.6 Fertility, pregnancy and lactation

Safety in fertility, pregnancy and lactation has not been established.

4.7 Effects on ability to drive and use machines

VITAMINME PREBIOTIC + PROBIOTIC is unlikely to affect the ability to drive and/or use machines. Patients should exercise caution before driving or operating machinery until they are reasonably certain that VITAMINME PREBIOTIC + PROBIOTIC does not adversely affect their performance.

4.8 Undesirable effects

VITAMINME PREBIOTIC + PROBIOTIC is generally well tolerated.

Gastrointestinal disorders

Less frequent: mild gastrointestinal adverse effects such as diarrhoea, indigestion, abdominal pain or cramps, nausea, vomiting, bloating, belching and flatulence.

Less frequent: rash, itching and redness, dermatitis.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare 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.

4.9 Overdose

In the event of an overdose, undesirable effects as listed in 4.8 can be precipitated or be of increased severity.

Treatment of overdose is symptomatic and supportive.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Class and category: Category D 34.9 Probiotics.

Probiotics are non-pathogenic, living microbes that are thought to provide a therapeutic benefit to the host.

Probiotics usually exert their effects in the gastrointestinal tract, where they may influence the intestinal microbiota. Probiotics can transiently colonize the human gut mucosa in highly individualized patterns, depending on the baseline microbiota, probiotic strain, and gastrointestinal tract region.

5.2 Pharmacokinetic properties

Pharmacokinetic studies have not been conducted on VITAMINME PREBIOTIC + PROBIOTIC.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Contents:

Silicon dioxide
Magnesium stearate
Maize starch

Capsule shell:

Hypromellose

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

24 months.

6.4 Special precautions for storage

Store at or below 25 °C.
Store in a dry place away from direct sunlight and moisture.
Store in the original packaging until required for use.

6.5 Nature and contents of container

Clear, amber glass jar with a pressure seal and a white, ribbed screwcap lid packed in an outer carton.
Pack size: 30 vegetable capsules.

6.6 Special precautions for disposal

No special requirements.

7. HOLDER OF CERTIFICATE OF REGISTRATION

VitaminMe (Pty) Ltd
32 Fricker Road
Illovo
Johannesburg
South Africa
2196

8. REGISTRATION NUMBER

Will be allocated by SAHPRA upon registration.

9. DATE OF FIRST AUTHORISATION

Will be allocated by SAHPRA upon registration.