FOLAVITE

FOLAVITE

Proposed professional information for FOLAVITE

 

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

FOLAVITE

 

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Folic acid                                                                                           800 µg

Cyanocobalamin (vitamin B12)                                                      25 µg

Sugar free.

For the full list of excipients, see section 6 .1.

 

  1. PHARMACEUTICAL FORM

Sublingual tablets.

A lightly speckled yellow biconvex round tablet.

 

  1. CLINICAL PARTICULARS

4.1             Therapeutic indications

Contributes to normal functioning of the nervous system and psychological function.

Helps to form red blood cells.

 

4.2             Posology and method of administration

Two tablets daily or as directed by a healthcare provider, slowly dissolved under the tongue.

 

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 FOLAVITE 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 FOLAVITE 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 FOLAVITE 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 FOLAVITE 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 FOLAVITE are known.

 

4.8             Undesirable effects

FOLAVITE is well tolerated.

 

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of FOLAVITE is important. It allows continued monitoring of the benefit/risk balance of FOLAVITE. 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 34.11 Vitamins.

Folic acid is rapidly absorbed from the gastrointestinal tract, mainly the jejunum, and enters portal circulation where it is converted to the metabolically active form 5-methyltetrahydrofolate in the plasma and liver. It is excreted mainly in the urine.

Vitamin B12 is an essential water-soluble vitamin. It is absorbed in the terminal ileum and is mainly stored in the liver. Vitamin B is excreted via urine, faeces and bile.

 

  1. PHARMACEUTICAL PARTICULARS

6.1             List of excipients

Isomalt

Magnesium stearate

Polyethylene glycol.

 

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 polypropylene securitainer with a white 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

November 2020.

Professionele inligting vir FOLAVITE

 

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

FOLAVITE

 

  1. KWALITATIEWE EN KWANTITATIEWE SAMESTELLING

Elke tablet bevat:

Foliensuur                                                                                                            800 µg

Sianokobalamien (vitamien B12)                                                   25 µg

Suikervry.

Vir die volledige lys onaktiewe bestanddele, sien afdeling 6.1.

 

  1. DOSEERVORM

Sublinguale (ondertongse) tablette.

’n Effens gespikkelde, geel, bikonvekse, ronde tablet.

 

  1. KLINIESE BESONDERHEDE

4.1             Terapeutiese indikasies

Dra by tot die normale werking van die senuweestelsel en tot psigologiese funksie.

Help met die vorming van rooibloedselle.

 

4.2             Posologie en metode van toediening

Los twee tablette daagliks stadig onder die tong op, of soveel as wat deur ’n gesondheidsorgverskaffer aangedui is.

 

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 FOLAVITE geneem word indien jy medikasie neem of aan enige mediese toestand ly.

 

4.5             Interaksies met ander medisyne en ander vorms van interaksie

Konsulteer jou gesondheidsorgverskaffer voordat FOLAVITE geneem word indien jy swanger is, beplan om swanger te raak of jou baba borsvoed.

 

4.6             Vrugbaarheid, swangerskap en borsvoeding

Die veiligheid en effektiwiteit tydens swangerskap en borsvoeding is nie vasgestel nie.

Konsulteer jou gesondheidsorgverskaffer voordat FOLAVITE geneem word 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 FOLAVITE ’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 FOLAVITE is.

 

4.8             Ongewenste effekte

FOLAVITE word goed verdra.

 

Rapportering van vermoedelike newe-effekte:

Dit is belangrik om vermoedelike newe-effekte wat waargeneem word nadat FOLAVITE goedgekeur is te rapporteer. Dit help met volgehoue monitering van die voordeel/risiko-balans van FOLAVITE. 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 34.11 Vitamiene.

Foliensuur word vinnig uit die spysverteringskanaal geabsorbeer, hoofsaaklik die jejunum, en gaan die portale sirkulasie in waar dit in die plasma en lewer na 5-metieltetrahidrofolaat omgeskakel word, wat metabolies aktief is. Dit word hoofsaaklik in die urine uitgeskei.

Vitamien B12 is ’n essensiële, water-oplosbare vitamien. Dit word in die terminale ileum geabsorbeer, en word hoofsaaklik in die lewer opgeberg. Vitamien B word via urine, feses en gal uitgeskei.

 

  1. FARMASEUTIESE BESONDERHEDE

6.1             Lys van onaktiewe bestanddele

Isomalt

Magnesiumstearaat

Poliëtileenglikol.

 

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 polipropileen-sekuriteitshouer met ’n wit 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

November 2020.

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