PROSTAVITE

PROSTAVITE

Professional information for PROSTAVITE

 

COMPLEMENTARY MEDICINE: HEALTH SUPPLEMENT / WESTERN HERBAL MEDICINE

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

 

SCHEDULING STATUS

S0

 

  1. NAME OF THE MEDICINE

PROSTAVITE

 

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

FoodMatrix® carrot, tomato and spinach extracts     500 mg

Serenoa repens (saw palmetto extract)                     160 mg

Glycine                                                                             125 mg

L-Alanine                                                                         75 mg

L-Glutamic acid                                                              75 mg

L-Glutamine                                                                    75 mg

Zinc gluconate                                                                34,14 mg

providing zinc                                                4,9 mg

Zinc oxide                                                                        12,45 mg

providing zinc                                                10 mg

Selenium (as amino acid chelate)                               50 µg

Cholecalciferol (vitamin D3)                                         6,25 µg

Sugar free.

For the full list of excipients, see section 6.1.

 

  1. PHARMACEUTICAL FORM

Tablets.

A light brown, biconvex, oval tablet with a break-line.

 

  1. CLINICAL PARTICULARS

4.1             Therapeutic indications

  • May help to relieve urologic symptoms associated with moderate benign prostatic hyperplasia.
  • May relieve frequent day- and night-time urination.

 

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 PROSTAVITE 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 PROSTAVITE 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 PROSTAVITE 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 PROSTAVITE 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 PROSTAVITE are known.

 

4.8             Undesirable effects

PROSTAVITE is well tolerated.

 

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of PROSTAVITE is important. It allows continued monitoring of the benefit/risk balance of PROSTAVITE. 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 33.7 Combination product.

Vitamin D is a fat-soluble vitamin. It is well absorbed and requires hydroxylation in the body to form the active metabolite, calcitriol. Excretion occurs mainly through the bile and faeces, with small amounts appearing in urine.

After absorption from the gastrointestinal tract, selenium is incorporated into the enzyme glutathione peroxidase. It is excreted mainly in the urine.

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.

Glycine is an amino acid. It is rapidly absorbed in the blood with maximal levels about 40 minutes after ingestion. Glycine appears to passively diffuse across the blood-brain barrier and is eliminated within hours after ingestion.

L-alpha-alanine is a nonessential amino acid used in protein synthesis and gluconeogenesis. It is obtained from dietary proteins, by conversion from other amino acids, and by metabolism of glucose via pyruvate.

L-Glutamine is a free amino acid which is absorbed in the jejunum. It is produced primarily in the skeletal muscle and then released into the circulation. Glutamine is primarily oxidised and a small portion is used for gluconeogenesis.

After intake, saw palmetto reaches peak plasma levels at about 1,5 hours, and has a half-life of about 19 hours.

 

  1. PHARMACEUTICAL PARTICULARS

6.1             List of excipients

Gum Arabic powder

Isomalt

Magnesium stearate

Microcrystalline cellulose

Polyethylene glycol

Silicon dioxide

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 PROSTAVITE

 

KOMPLEMENTÊRE MEDISYNE: GESONDHEIDSAANVULLING / WESTERSE KRUIEMEDISYNE

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

 

SKEDULERINGSTATUS

S0

 

  1. NAAM VAN DIE MEDISYNE

PROSTAVITE

 

  1. KWALITATIEWE EN KWANTITATIEWE SAMESTELLING

Elke tablet bevat:

FoodMatrix® wortel-, tamatie- en spinasie-ekstrakte                  500 mg

Serenoa repens (saagblaarpalmetto-ekstrak)                             160 mg

Glisien                                                                                                125 mg

L-Alanien                                                                                           75 mg

L-Glutamiensuur                                                                               75 mg

L-Glutamien                                                                                      75 mg

Sinkglukonaat                                                                                   34,14 mg

verskaf sink                                                                     4,9 mg

Sinkoksied                                                                                         12,45 mg

verskaf sink                                                                     10 mg

Seleen (as aminosuurchelaat)                                                       50 µg

Cholekalsiferol (vitamien D3)                                                         6,25 µg

Suikervry.

Vir die volledige lys onaktiewe bestanddele, sien afdeling 6.1.

 

  1. DOSEERVORM

Tablette.

’n Ligbruin, bikonvekse, ovaal tablet met ’n breeklyn.

 

  1. KLINIESE BESONDERHEDE

4.1             Terapeutiese indikasies

  • Mag help om urologiese simptome wat gepaardgaan met matige benigne prostaathiperplasie (goedaardige prostaatvergroting) te verlig.
  • Mag gereelde urinering bedags en snags verlig.

 

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 PROSTAVITE 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 PROSTAVITE 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 PROSTAVITE 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 PROSTAVITE ’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 PROSTAVITE is.

 

4.8             Ongewenste effekte

PROSTAVITE word goed verdra.

 

Rapportering van vermoedelike newe-effekte:

Dit is belangrik om vermoedelike newe-effekte wat waargeneem word nadat PROSTAVITE goedgekeur is te rapporteer. Dit help met volgehoue monitering van die voordeel/risiko-balans van PROSTAVITE. 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 33.7 Kombinasieproduk.

Vitamien D is ’n vetoplosbare vitamien. Dit word goed geabsorbeer en word dan in die liggaam gehidroksileer om die aktiewe metaboliet kalsitriol te vorm. Dit word hoofsaaklik in gal en feses uitgeskei, met klein hoeveelhede in die urine.

Seleen word in die ensiem glutatioonperoksidase geïnkorporeer nadat dit uit die spysverteringskanaal geabsorbeer is. Dit word hoofsaaklik in die urine 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.

Glisien is ’n aminosuur. Dit word vinnig in die bloed geabsorbeer, en maksimum vlakke word ongeveer 40 minute na inname bereik. Dit lyk asof glisien passief oor die bloedbreinskans beweeg en dit word binne ure na inname uitgeskei.

L-alfa-alanien is ’n nie-essensiële aminosuur wat tydens proteïensintese en glukoneogenese benut word. Dit word verkry uit proteïen in die dieet, deur omskakeling van ander aminosure, en deur metabolisme van glukose via piruvaat.

L-Glutamien is ’n vry aminosuur wat in die jejunum geabsorbeer word. Dit word hoofsaaklik in skeletspiere gevorm en dan in die sirkulasie vrygestel. Glutamien word hoofsaaklik geoksideer en ’n klein hoeveelheid word vir glukoneogenese gebruik.

Piek plasmavlakke van saagblaarpalmetto word ongeveer 1,5 uur na inname bereik, en het ’n halfleeftyd van ongeveer 19 uur.

 

  1. FARMASEUTIESE BESONDERHEDE

6.1             Lys van onaktiewe bestanddele

Akasiagompoeier

Isomalt

Magnesiumstearaat

Mikrokristallyne sellulose

Poliëtileenglikol

Silikondioksied

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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