PATIENT INFORMATION LEAFLET

SCHEDULING STATUS: S0

VITAMINME FAT BURN + APPETITE CONTROL (film-coated tablets)

Garcinia cambogia (Garcina), L-Carnitine Tartrate, Caffeine Anhydrous, Camellia sinensis (L.) Kentze (Green Tea), Alpha-Lipoic Acid, Zingiber officinale Rosc. (Ginger), Capsicum annum L. (Cayenne Pepper), Chromium Picolinate

Sugar free

Complementary Medicine: Combination Product

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

  • Keep this leaflet. You may need to read it again.
  • Do not share VITAMINME FAT BURN + APPETITE CONTROL 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 FAT BURN + APPETITE CONTROL is and what it is used for
  2. What you need to know before you use VITAMINME FAT BURN + APPETITE CONTROL
  3. How to use VITAMINME FAT BURN + APPETITE CONTROL  
  4. Possible side effects
  5. How to store VITAMINME FAT BURN + APPETITE CONTROL
  6. Contents of the pack and other information

1. What VITAMINME FAT BURN + APPETITE CONTROL is and what it is used for   

VITAMINME FAT BURN + APPETITE CONTROL is a complementary medicine that helps to support fat metabolism and oxidation, promote healthy glucose metabolism, and can be used to help with weight management. 

2. What you need to know before you use VITAMINME FAT BURN + APPETITE CONTROL

Do not use VITAMINME FAT BURN + APPETITE CONTROL:

  • If you are hypersensitive (allergic) to any of the ingredients of VITAMINME FAT BURN + APPETITE CONTROL (listed in section 6).  

Warnings and precautions 

Take special care:

  • If you have a medical condition or are currently taking any other medicine.
  • If you are scheduled for an elective surgical procedure. You should stop taking VITAMINME FAT BURN + APPETITE CONTROL at least 2 weeks before any elective surgical procedures.
  • If you want to use VITAMINME FAT BURN + APPETITE CONTROL longer than 12 weeks, as you will need to consult with a healthcare provider.
  • To consult a relevant healthcare provider prior to using VITAMINME FAT BURN + APPETITE CONTROL if any of the following applies to you:
    1. You have a liver disorder, seizure disorder, stomach ulcers, bipolar disorder, or iron deficiency.
  • To discontinue usingVITAMINME FAT BURN + APPETITE CONTROL and consult a relevant healthcare provider if you develop symptoms of liver trouble such as yellowing of the skin/eyes (jaundice), stomach pain, dark urine, sweating, nausea, unusual tiredness and/or less of appetite.

Children and adolescents 

VITAMINME FAT BURN + APPETITE CONTROL is not recommended for individuals below the age of 18 years. 

Other medicines and VITAMINME FAT BURN + APPETITE CONTROL

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

The following medicines may cause an interaction with VITAMINME FAT BURN + APPETITE CONTROL:

  • Anticoagulant/antiplatelet medicine: Green tea, alpha-lipoic acid, L-carnitine, garcinia and ginger may have antiplatelet effects and thereby increase the risk of bruising and bleeding when used with anticoagulant/antiplatelet medicine.
  • Antidiabetes medicine: Taking garcinia and chromium with antidiabetes medicine may increase the risk of hypoglycaemia.
  • Atorvastatin: Green tea can reduce the levels and clinical effects of atorvastatin.
  • Ephedrine: Concomitant use of ephedrine with green tea may increase the risk for stimulant adverse effects.
  • Nadolol: Green tea may reduce the levels and clinical effects of nadolol.
  • Thyroid hormones: L-carnitine and alpha lipoic acid may decrease the effectiveness of thyroid hormone replacement therapy.
  • Serotonergic medications: Combining garcinia with other serotonergic medications can increase the risk of developing serotonin syndrome.

VITAMINME FAT BURN + APPETITE CONTROL with food and drink

VITAMINME FAT BURN + APPETITE CONTROL 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 FAT BURN + APPETITE CONTROL.

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

Driving and using machinery 

VITAMINME FAT BURN + APPETITE CONTROL 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 FAT BURN + APPETITE CONTROL does not adversely affect their performance. 

3. How to use VITAMINME FAT BURN + APPETITE CONTROL

Do not share medicines with any other person. 

Always use VITAMINME FAT BURN + APPETITE CONTROL 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 – 2 tablets daily after food, or as recommended by a healthcare provider.

Swallow the tablet whole and do not chew or crush.

Do not exceed the recommended dose. 

If you take more VITAMINME FAT BURN + APPETITE CONTROL 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 FAT BURN + APPETITE CONTROL

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

4. Possible side effects  

VITAMINME FAT BURN + APPETITE CONTROL can have side effects. 

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

If any of the following happens, stop using VITAMINME FAT BURN + APPETITE CONTROL 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 FAT BURN + APPETITE CONTROL. You may need urgent medical attention or hospitalisation. 

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

  • nausea or vomiting; abdominal pain and bloating; constipation; indigestion; reflux; loss of appetite; increased thirst; flatulence; diarrhoea; muscle pain; headache; anxiety; dizziness; insomnia; fatigue; agitation; tremors; restlessness; confusion; change in urine odour; mania (extreme changes in mood); signs of low blood sugar (fast heartbeat, shaking, sweating, confusion, dizziness, hunger); high blood pressure; skin rash, irritation or itching; liver problems (characterised by stomach pain, nausea and yellow discolouration of your skin and eyes).

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 FAT BURN + APPETITE CONTROL.  

5. How to store VITAMINME FAT BURN + APPETITE CONTROL.

  • 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 thelabel.
  • 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 FAT BURN + APPETITE CONTROL contains 

Each tablet contains:

Garcinia cambogia (Garcinia) [fruit, extract standardised to 60 % hydroxycitric acid (HCA)]

L-Carnitine Tartrate Providing 136,00 mg L-Carnitine

Caffeine Anhydrous

Camellia sinensis (L.) Kentze (Green Tea) [leaves, extract standardised to 95 % epigallocatechin gallates (EGCG)]

Alpha-Lipoic Acid

Zingiber officinale Rosc. (Ginger) [root, 4:1 extract providing 200,00 mg dried herb equivalent]

Capsicum annum L. (Cayenne Pepper)

Chromium Picolinate Providing 66,00 µg elemental Chromium

200,00 mg

200,00 mg

100,00 mg

100,00 mg

50,00 mg

50,00 mg

15,00 mg

540,00 µg

The other ingredients are microcrystalline cellulose, magnesium stearate, silicon dioxide, maize starch, yellow-orange film-coating.

Sugar free

What VITAMINME FAT BURN + APPETITE CONTROL looks like and contents of the pack

Oval, yellow-orange film-coated tablets. The tablets are packed in a clear, amber glass jar with a pressure seal and a white, ribbed screw cap lid.
Pack size: 30 tablets.

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.

 

PASIËNTINLIGTINGSBLAD

SKEDULERINGSTATUS: S0

VITAMINME FAT BURN + APPETITE CONTROL (filmbedekte tablette)

Garcinia cambogia (Garcina), L-Karnitientartraat, Watervrye Kafeïen, Camellia sinensis (L.) Kentze (Groentee), Alfa-Lipoïensuur, Zingiber officinale Rosc. (Gemmer), Capsicum annum L. (Brandrissie), Chroompikolinaat

Suikervry

Komplementêre Medisyne: Kombinasieproduk

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

  • Hou hierdie inligtingsblad. Dit kan nodig wees dat jy dit weer lees.
  • Moenie VITAMINME FAT BURN + APPETITE CONTROL 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 FAT BURN + APPETITE CONTROL en warvoor word dit gebruik
  2. Wat jy moet weet voordat jy VITAMINME FAT BURN + APPETITE CONTROL gebruik
  3. Hoe om VITAMINME FAT BURN + APPETITE CONTROL te gebruik
  4. Moontlike newe-effekte
  5. Hoe om VITAMINME FAT BURN + APPETITE CONTROL te bêre
  6. Inhoud van die pak en ander inligting

1. Wat is VITAMINME FAT BURN + APPETITE CONTROL en waarvoor word dit gebruik

VITAMINME FAT BURN + APPETITE CONTROL is ‘n komplementêre medisyne wat help om vetmetabolisme en oksidasie te ondersteun, gesonde glukosemetabolisme te bevorder, en kan gebruik word om te help met hantering van gewigsverlies.  

2. Wat jy moet weet voordat jy VITAMINME FAT BURN + APPETITE CONTROL gebruik

Moenie VITAMINME FAT BURN + APPETITE CONTROL neem nie:

  • Indien jy hipersensitief (allergies) is vir enige van die bestanddele van VITAMINME FAT BURN + APPETITE CONTROL (gelys in afdeling 6).

Waarskuwings en voorsorgmaatreëls

Neem spesiale sorg:

  • Indien jy ‘n mediese toestand het of as jy tans enige ander medisyne gebruik.
  • Indien jy geskeduleer is vir ‘n elektiewe chirurgiese procedure. Jy moet ten minste 2 weke voor enige elektiewe chrirurgiese prosedures ophou om VITAMINME FAT BURN + APPETITE CONTROL te neem.
  • Indien jy VITAMINME FAT BURN + APPETITE CONTROL vir langer as 12 weke wil gebruik, aangesien jy met ‘n gesondheidsorgverskaffer sal moet raadpleeg.
  • Om ‘n relevante gesondheidsverskaffer te raadpleeg voordat VITAMINME FAT BURN + APPETITE CONTROL gebruik word indien enige van die volgende op jou van toepassing is: Jy het ‘n lewerversteuring, beslagleggingsversteuring, maagsere, bipolêre versteuring of ystertekort.
  • Om op te hou met die gebruik van VITAMINME FAT BURN + APPETITE CONTROL en raadpleeg ‘n relevante gesondheidsorgverskaffer indien jy simptome van lewerprobleme ontwikkel soos vergeling van die vel/oë (geelsug), maagpyn, donker urine, sweet, naarheid, ongewone moegheid en / of minder eetlus.

Kinders en adolessente

VITAMINME FAT BURN + APPETITE CONTROL word nie aanbeveel vir individue onder die ouderdom van 18 jaar nie.

Ander medisyne en VITAMINME FAT BURN + APPETITE CONTROL 

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

Die volgende medisynes kan interaksie met VITAMINME FAT BURN + APPETITE CONTROL hê:

  • Antikoagulant/antiplaatjie-medisyne: Groentee, alfa-lipoïensuur, L-karnitien, garcinia en gemmer kan anti-plaatjie-effekte hê en daardeur die risiko van kneusing en bloeding verhoog wanneer dit saam met antikoagulant/antiplaatjie-medisyne gebruik word.
  • Antidiabetiese medisyne: Die neem van garcinia en chroom saam met antidiabetiese medisyne kan die risiko van hipoglukemie verhoog.
  • Atorvastatien: Groentee kan die vlakke en kliniese effekte van atorvastatien verminder.
  • Efedrien: Gelyktydige gebruik van efedrien met groentee kan die risiko vir stimulant nadelige effekte verhoog.
  • Nadolol: Groentee kan die vlakke en kliniese effekte van nadolol verminder.
  • Skildklierhormone: L-karnitien en alfa-lipoïensuur kan die effektiwiteit van skildklierhormoonvervangingsterapie verminder.
  • Serotonergiese medikasie: Die kombinasie van garcinia met ander seotonergiese medikasie kan die risiko verhoog om serotoniensindroom te ontwikkel.

VITAMINME FAT BURN + APPETITE CONTROL met kos en drinkgoed

VITAMINME FAT BURN + APPETITE CONTROL het geen bekende interaksies 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 FAT BURN + APPETITE CONTROL neem.

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

Bestuur en die gebruik van masjinerie

Dit is onwaarskynlik dat VITAMINME FAT BURN + APPETITE CONTROL 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 FAT BURN + APPETITE CONTROL nie hul werkverrigting nadelig beïnvloed nie.

3. Hoe om VITAMINME FAT BURN + APPETITE CONTROL te gebruik

Moenie medisyne met enige ander persoon deel nie. 

Gebruik VITAMINME FAT BURN + APPETITE CONTROL 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 – 2 tablette daagliks na ete, of soos aanbeveel deur jou gesondheidsorgverskaffer.

Sluk die tablet heel in en moet dit nie kou of opbreek nie. 

Moenie die aanbevole dosis oorskry nie.

Wat om te doen indien jy meer VITAMINME FAT BURN + APPETITE CONTROL 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 FAT BURN + APPETITE CONTROL te neem

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

4. Moontlike newe-effekte

VITAMINME FAT BURN + APPETITE CONTROL kan newe-effekte hê. 

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

Indien jy enige van die volgende ervaar, hou op om VITAMINME FAT BURN + APPETITE CONTROL 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 FAT BURN + APPETITE CONTROL gehad het. Jy mag dringende mediese bystand of hospitalisasie benodig.

Sê so gou as moontlik vir jou dokter indien jy enige van die volgende opmerk: 

  • naarheid of braking; buikpyn of opgeblasenheid; hardlywigheid; indigestie; refluks; verloor van eetlus; verhoogde dors; winderigheid; diarree; spierpyn; hoofpyn; angs; duiseligheid; slapeloosheid; moegheid;agitasie;bewing; rusteloosheid; verwarring; verandering in urine reuk; manie (oormatige veranderinge in bui); tekens van lae bloedsuiker (vinnige hartklop, bewing, sweet, verwarring, duiseligheid, honger); hoë bloeddruk; veluitslag; irritasie of jeuk; lewerprobleme (gekenmerk deur maagpyn, naarheid en geel verkleuring van u vel en oë). 

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 FAT BURN + APPETITE CONTROL te verskaf.

5. Hoe omVITAMINME FAT BURN + APPETITE CONTROL 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 dieetiketnie.
  • 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 FAT BURN + APPETITE CONTROL bevat

Elke tablet bevat:

Garcinia cambogia (Garcinia) [vrug, ekstrak tot 60 % hidroksisitroensuur (HCA) gestandaardiseer]

L-Karnitientartraat Verskaf 136,00 mg L-Karnitien Watervrye Kafeïen

Camellia sinensis (L.) Kentze (Groentee) [blare, ekstrak tot 95 % epigallokatesjiengallaat (EGCG) gestandaardiseer]

Alfa-Lipoïensuur

Zingiber officinale Rosc. (Gemmer) [wortel, 4:1 ekstrak wat 200,00 mg gedroogde kruie ekwivalent lewer]

Capsicum annum L. (Brandrissie)

Chroompikolinaat Verskaf 66,00 µg elementale Chroom

200,00 mg

200,00 mg

100,00 mg

100,00 mg

50,00 mg

50,00 mg

15,00 mg

540,00 µg

Die ander bestanddele is mikrokristallyne sellulose, magnesiumstearaat, silikondioksied, mieliestysel, geel-oranje film-bedekking.

Suikervry

Hoe VITAMINME FAT BURN + APPETITE CONTROL lyk en inhoud van die verpakking

Ovaal, geel-oranje filmbedekte tablette.  Die tablette word verpak in ‘n deursigtige, bruinkleurige glasfles met ‘n drukseël en ‘n wit, geribde skroefdop deksel.

Verpakkingsgrootte: 30 tablette. 

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: COMBINATION PRODUCT

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 FAT BURN + APPETITE CONTROL (film-coated tablets)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Garcinia cambogia (Garcinia) [fruit, extract standardised to 60 % hydroxycitric acid (HCA)]

L-Carnitine Tartrate Providing 136,00 mg L-Carnitine

Caffeine Anhydrous

Camellia sinensis (L.) Kentze (Green Tea) [leaves, extract standardised to 95 % epigallocatechin gallates (EGCG)]

Alpha-Lipoic Acid

Zingiber officinale Rosc. (Ginger) [root, 4:1 extract providing 200,00 mg dried herb equivalent]

Capsicum annum L. (Cayenne Pepper)

Chromium Picolinate Providing 66,00 µg elemental Chromium

200,00 mg

200,00 mg

100,00 mg

100,00 mg

50,00 mg

50,00 mg

15,00 mg

540,00 µg

Sugar free.

For full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablets.  
19 mm, oval yellow-orange film-coated tablets.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

VITAMINME FAT BURN + APPETITE CONTROL is a complementary medicine that helps to support fat metabolism and oxidation, promote healthy glucose metabolism, and can be used to help with weight management. 

4.2 Posology and method of administration

Posology

Adults 18 years and older: Take 1 – 2 tablets daily after food, or as recommended by a healthcare provider.

Swallow the tablets whole and do not chew or crush.

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

  • Patients should be advised to discontinue VITAMINME FAT BURN + APPETITE CONTROL at least 2 weeks before elective surgical procedures due to potential interference with blood glucose and bleeding control.
  • Patients must consult their relevant healthcare provider for use of VITAMINME FAT BURN + APPETITE CONTROL longer than 12 weeks.
  • Patients should be advised to consult a relevant healthcare provider before using VITAMINME FAT BURN + APPETITE CONTROL if they have a liver disorder, seizure disorder, stomach ulcers, bipolar disorder, or iron deficiency.
  • Patients should be advised to discontinue using VITAMINME FAT BURN + APPETITE CONTROL and consult a relevant healthcare provider if they develop symptoms of liver trouble such as yellowing of the skin/eyes (jaundice), stomach pain, dark urine, sweating, nausea, unusual tiredness and/or loss of appetite.

4.5 Interaction with other medicines and other forms of interaction

  • Anticoagulant/antiplatelet medicine: Green tea, alpha-lipoic acid, L-carnitine, garcinia and ginger may have antiplatelet effects and thereby increase the risk of bruising and bleeding when used with anticoagulant/antiplatelet medicine.
  • Antidiabetes medicine: Taking garcinia and chromium with antidiabetes medicine may increase the risk of hypoglycaemia.
  • Atorvastatin: Green tea can reduce the levels and clinical effects of atorvastatin.
  • Ephedrine: Concomitant use of ephedrine with green tea may increase the risk for stimulant adverse effects.
  • Nadolol: Green tea may reduce the levels and clinical effects of nadolol.
  • Thyroid hormones: L-carnitine and alpha lipoic acid may decrease the effectiveness of thyroid hormone replacement therapy.
  • Serotonergic medications: Combining garcinia with other serotonergic medications can increase the risk of developing serotonin syndrome.

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 FAT BURN + APPETITE CONTROL is not likely to cause drowsiness. Patients should take caution before performing activities requiring their attention, until they are reasonably certain that VITAMINME FAT BURN + APPETITE CONTROL does not adversely affect their performance.

4.8 Undesirable effects 

VITAMINME FAT BURN + APPETITE CONTROL is generally well tolerated. 

Cardiac disorders

Frequency unknown: hypertension. 

Gastrointestinal disorders

Frequency unknown: nausea, vomiting, abdominal pain and bloating, constipation, dyspepsia, reflux, morning anorexia, increased thirst, flatulence, diarrhoea. 

Hepatobiliary disorders

Frequency unknown: hepatotoxicity. 

Metabolism and nutrition disorders

Frequency unknown: insulin autoimmune syndrome (IAS). 

Musculoskeletal disorders

Frequency unknown: muscle pain. 

Nervous system disorders

Frequency unknown: central nervous system stimulation, headache, anxiety, dizziness, insomnia, fatigue, agitation, tremors, restlessness, confusion. 

Renal and urinary disorders

Frequency unknown: change in urine odour. 

Psychiatric disorders

Frequency unknown: mania. 

Skin and subcutaneous tissue disorders

Frequency unknown: skin rash, skin irritation, itching,

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 33.7 Combination Product.  

VITAMINME FAT BURN + APPETITE CONTROL is a complementary medicine that helps to support fat metabolism and oxidation, promote healthy glucose metabolism, and can be used to help with weight management. 

5.2 Pharmacokinetic properties

Pharmacokinetic studies have not been conducted on VITAMINME FAT BURN + APPETITE CONTROL. 

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Core:

Microcrystalline cellulose
Magnesium stearate
Silicon dioxide
Maize starch

Yellow-orange film-coating:

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 screw cap lid. 
Pack size: 30 tablets. 

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.