VITA-CHROMAG

VITACHROMAG

Professional information for VITACHROMAG

 

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

VITACHROMAG

 

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

FoodMatrix® carrot, tomato and spinach extracts                     395 mg

Calcium carbonate                                                                           124,9 mg

providing calcium                                                           50 mg

Magnesium oxide                                                                             62,2 mg

providing magnesium                                                    37,5 mg

Nicotinamide (vitamin B3)                                                               6 mg

Colloidal silicon dioxide                                                                   7,17 mg

providing silicon                                                              3,35 mg

Zinc oxide                                                                                          3,3 mg

providing zinc                                                                  2,65 mg

Manganese sulphate                                                                       1,4 mg

providing manganese                                                    0,5 mg

Copper sulphate                                                                               0,63 mg

providing copper                                                             0,25 mg

Chromium polynicotinate                                                                125 µg

providing chromium                                                       25 µg

Sugar free.

For the full list of excipients, see section 6.1.

 

  1. PHARMACEUTICAL FORM

Tablets.

An off-white, round, biconvex tablet.

 

  1. CLINICAL PARTICULARS

4.1             Therapeutic indications

Support glucose metabolism and helps the body to metabolise carbohydrates and fats.

Contributes to the maintenance of normal blood glucose levels and normal muscle function.

 

4.2             Posology and method of administration

Take two tablets per day.

 

4.3             Contraindications

Hypersensitivity to any of the active ingredients or excipients (see sections 2 and 6.1).

 

4.4             Special warnings and precautions for use

Consult your healthcare provider before taking VITACHROMAG if you are taking medication or suffering from any medical condition.

 

4.5             Interaction with other medicines and other forms of interaction

Consult your healthcare provider before taking VITACHROMAG if you are taking medication or suffering from any medical condition.

 

4.6             Fertility, pregnancy and lactation

Safety and efficacy have not been established in pregnancy and lactation.

Consult your healthcare provider before taking VITACHROMAG if you are pregnant, planning to get pregnant or if you are breastfeeding.

 

4.7             Effects on ability to drive and use machines

It is not known if VITACHROMAG has an effect on the ability to drive or use machines. Caution is advised before driving a vehicle or operating machinery until the effects of VITACHROMAG are known.

 

4.8             Undesirable effects

VITACHROMAG is well tolerated.

 

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of VITACHROMAG is important. It allows continued monitoring of the benefit/risk balance of VITACHROMAG. Healthcare providers are asked to report any suspected adverse reactions to NRF HEALTH via https://www.nrfhealth.co.za

 

4.9             Overdose

In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8). Overdose treatment is symptomatic and supportive.

 

  1. PHARMACOLOGICAL PROPERTIES

Category and class: D 34.12 Multiple substance formulation.

Vitamin B3 is water-soluble and well absorbed and is excreted mainly via urine.

Calcium absorption is affected by several factors like age, race, environmental and dietary conditions. Dietary calcium absorption is inversely correlated with total dietary calcium, dietary fibre, alcohol intake and physical activity. Calcium is distributed in the bones and teeth and excreted via the urine and faeces.

Approximately 0,5 % to 2 % of chromium is absorbed and distributed to the kidney, heart, liver, brain, muscle, spleen and lungs. A small percentage of chromium that is absorbed is rapidly excreted in the urine.

Copper is absorbed from the small intestines and rapidly taken up by the liver and incorporated into caeruloplasmin. It is excreted via bile into faeces, with small amounts excreted in urine.

Magnesium requires both parathyroid hormone and vitamin D for absorption. Magnesium is absorbed throughout the gastrointestinal tract, is distributed in the skeleton and soft tissue, and excreted primary via the kidneys.

Absorbed manganese stays in the blood for a short time, but accumulates in tissues, including bone, where it can remain for many years. Manganese is cleared hepatically.

Silicon is primarily absorbed in the proximal small intestine, distributed and contained in connective tissue, and excreted via the kidneys.

Zinc is a biologically essential trace element that is absorbed in the small intestines and is distributed in the body in skeletal muscle and bone. It is mainly excreted through the faeces.

 

  1. PHARMACEUTICAL PARTICULARS

6.1             List of excipients

Magnesium stearate

Talc.

 

6.2             Incompatibilities

Not applicable.

 

6.3             Shelf life

2 years.

 

6.4             Special precautions for storage

Store at or below 25 °C.

Protect from light and moisture.

 

6.5             Nature and contents of container

60 tablets are packed in a white PP securitainer with a red LDPE lid.

 

6.6             Special precautions for disposal and other handling

None.

 

  1. HOLDER OF CERTIFICATE OF REGISTRATION

Royal Square 428 Investments (Pty) Ltd

PO Box 1762

Randpark Ridge

2156

 

  1. REGISTRATION NUMBER

Will be allocated by SAHPRA upon registration.

 

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Will be allocated by SAHPRA upon registration.

 

  1. DATE OF REVISION OF THE TEXT

December 2020.

Professionele inligting vir VITACHROMAG

 

KOMPLEMENTÊRE MEDISYNE: GESONDHEIDSAANVULLING

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

 

SKEDULERINGSTATUS

S0

 

  1. NAAM VAN DIE MEDISYNE

VITACHROMAG

 

  1. KWALITATIEWE EN KWANTITATIEWE SAMESTELLING

Elke tablet bevat:

FoodMatrix® wortel-, tamatie- en spinasie-ekstrakte                  395 mg

Kalsiumkarbonaat                                                                            124,9 mg

verskaf kalsium                                                               50 mg

Magnesiumoksied                                                                            62,2 mg

verskaf magnesium                                                        37,5 mg

Nikotienamied (vitamien B3)                                                          6 mg

Kolloïdale silikondioksied                                                                7,17 mg

verskaf silikon                                                                 3,35 mg

Sinkoksied                                                                                         3,3 mg

verskaf sink                                                                     2,65 mg

Mangaansulfaat                                                                                1,4 mg

verskaf mangaan                                                            0,5 mg

Kopersulfaat                                                                                      0,63 mg

verskaf koper                                                                  0,25 mg

Chroompolinikotinaat                                                                       125 µg

verskaf chroom                                                               25 µg

Suikervry.

Vir die volledige lys onaktiewe bestanddele, sien afdeling 6.1.

 

  1. DOSEERVORM

Tablette.

’n Naaswit, ronde, bikonvekse tablet.

 

  1. KLINIESE BESONDERHEDE

4.1             Terapeutiese indikasies

Ondersteun glukosemetabolisme en help die liggaam om koolhidrate en vette te metaboliseer.

Dra by tot die instandhouding van normale bloedglukosevlakke en normale spierfunksie.

 

4.2             Posologie en metode van toediening

Neem twee tablette per dag.

 

4.3             Kontra-indikasies

Hipersensitiwiteit vir enige van die aktiewe of onaktiewe bestanddele (sien afdelings 2 en 6.1).

 

4.4             Spesiale waarskuwings en voorsorgmaatreëls vir gebruik

Konsulteer jou gesondheidsorgverskaffer voordat jy VITACHROMAG neem indien jy medikasie gebruik of aan enige mediese toestand ly.

 

4.5             Interaksies met ander medisyne en ander vorms van interaksie

Konsulteer jou gesondheidsorgverskaffer voordat jy VITACHROMAG neem indien jy medikasie gebruik of aan enige mediese toestand ly.

 

4.6             Vrugbaarheid, swangerskap en borsvoeding

Veiligheid en effektiwiteit tydens swangerskap en borsvoeding is nie vasgestel nie.

Raadpleeg jou gesondheidsorgverskaffer voordat jy VITACHROMAG neem indien jy swanger is, beplan om swanger te raak of jou baba borsvoed.

 

4.7             Uitwerking op die vermoë om te bestuur en masjiene te gebruik

Dit is onbekend of VITACHROMAG ’n uitwerking het op die vermoë om te bestuur of masjiene te gebruik. Versigtigheid word aangeraai voordat ’n voertuig bestuur of masjinerie hanteer word, totdat bekend is wat die uitwerking van VITACHROMAG is.

 

4.8             Ongewenste effekte

VITACHROMAG word goed verdra.

 

Rapportering van vermoedelike newe-effekte:

Dit is belangrik om vermoedelike newe-effekte wat waargeneem word nadat VITACHROMAG goedgekeur is te rapporteer. Dit help met volgehoue monitering van die voordeel/risiko-balans van VITACHROMAG. Gesondheidsorgverskaffers moet asseblief enige vermoedelike newe-effekte rapporteer aan NRF HEALTH via https://www.nrfhealth.co.za

 

4.9             Oordosering

Met oordosering kan newe-effekte gepresipiteer word en/of ernstiger wees (sien afdeling 4.8). Na oordosering moet simptomatiese en ondersteunende behandeling toegepas word.

 

  1. FARMAKOLOGIESE EIENSKAPPE

Kategorie en klas: D 34.12 Formule met verskeie bestanddele.

Vitamien B3 is wateroplosbaar en word goed geabsorbeer. Dit word hoofsaaklik via die urine uitgeskei.

Kalsiumabsorpsie word deur verskeie faktore beïnvloed, soos ouderdom, ras, omgewingstoestande en eetgewoontes. Absorpsie van kalsium uit die dieet is omgekeerd eweredig aan die hoeveelheid kalsium in die dieet, dieetvesel, alkoholinname en fisieke aktiwiteit. Kalsium word na die bene en tande versprei, en via die urine en feses uitgeskei.

Ongeveer 0,5 % tot 2 % van die chroom word geabsorbeer en na die niere, hart, lewer, brein, spiere, milt en longe versprei. ’n Klein persentasie van die chroom wat geabsorbeer word, word vinnig via die urine uitgeskei.

Koper word uit die dunderm geabsorbeer en vinnig in die lewer opgeneem, waar dit in seruloplasmien (ferroksidase) geïnkorporeer word. Dit word via gal in die feses uitgeskei, met klein hoeveelhede in die urine.

Magnesium benodig sowel paratiroïedhormoon as vitamien D vir absorpsie. Magnesium word uit die hele lengte van die spysverteringskanaal geabsorbeer, word na die skelet en sagteweefsel versprei, en hoofsaaklik via die niere uitgeskei.

Geabsorbeerde mangaan bly vir ’n kort rukkie in die bloed, maar akkumuleer in weefsel, insluitende been, waar dit vir baie jare kan bly. Mangaan word deur die lewer opgeruim.

Silikon word hoofsaaklik uit die proksimale dunderm geabsorbeer, versprei en geberg in bindweefsel, en via die niere uitgeskei.

Sink is ’n biologies essensiële spoorelement wat uit die dunderm geabsorbeer word en na die skeletspiere en -bene versprei word. Dit word hoofsaaklik in die feses uitgeskei.

 

  1. FARMASEUTIESE BESONDERHEDE

6.1             Lys van onaktiewe bestanddele

Magnesiumstearaat

Talk.

 

6.2             Onverenigbaarhede

Nie van toepassing nie.

 

6.3             Rakleeftyd

2 jaar.

 

6.4             Spesiale voorsorgmaatreëls vir berging

Bêre by of onder 25 °C.

Beskerm teen lig en vog.

 

6.5             Aard en inhoud van die houer

60 tablette word in ’n wit PP-sekuriteitshouer met ’n rooi LDPE-deksel verpak.

 

6.6             Spesiale voorsorgmaatreëls vir wegdoening en ander hantering

Geen.

 

  1. HOUER VAN DIE REGISTRASIESERTIFIKAAT

Royal Square 428 Investments (Edms.) Bpk.

Posbus 1762

Randparkrif

2156

 

  1. REGISTRASIENOMMER

Sal met registrasie deur SAHPRA toegeken word.

 

  1. DATUM VAN EERSTE MAGTIGING/HERNUWING VAN MAGTIGING

Sal met registrasie deur SAHPRA toegeken word.

 

  1. DATUM VAN HERSIENING VAN DIE TEKS

Desember 2020.

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