Ginkgo Biloba

VITAL GINKGO BILOBA
Version: 2
February 2016

PATIENT INFORMATION LEAFLET
Combination product – Western Herbals.

This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease.

SCHEDULING STATUS
Not scheduled.

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
Vital Ginkgo biloba soft gelatine capsules.

Read this leaflet carefully because it contains important information.

Vital Ginkgo biloba is available without a doctor’s prescription. However, you still need to use Vital Ginkgo biloba carefully to get the best results.

• • Keep this leaflet. You may need to read it again.

• • Ask your pharmacist if you need more information or advice.

• • You must see a doctor if your symptoms worsen or do not improve.

WHAT VITAL GINKGO BILOBA CONTAINS
Each Vital Ginkgo biloba soft gelatine capsule contains:

**Added as herbal extract.

The other ingredients are Antifoam M, gelatine, glycerine, hardened unsaturated oil, iron oxide black, iron oxide red, iron oxide yellow, purified water and sunflower seed oil/ canola oil.

Vital Ginkgo biloba contains no lactose or sugar.

WHAT VITAL GINKGO BILOBA IS USED FOR
Vital Ginkgo biloba may be beneficial to support poor memory and concentration as well as healthy blood circulation.

BEFORE YOU TAKE VITAL GINKGO BILOBA
Do not take Vital Ginkgo biloba:

• • If you are hypersensitive (allergic) to the active ingredient or any other ingredients (see “WHAT VITAL GINKGO BILOBA CONTAINS”).

Take special care with Vital Ginkgo biloba:

• • If you are undergoing anticoagulant therapy (blood thinning medicines), or if you are suffering from a bleeding disorder (see “Taking other medicines with Vital Ginkgo biloba”).

• • If you have any known clotting disorders. Vital Ginkgo biloba should be discontinued two weeks prior to some surgical or dental procedures.

Taking Vital Ginkgo Biloba with food or drink:

• • Take Vital Ginkgo biloba with water after food.

Pregnancy and breastfeeding:
Safety in pregnancy and breastfeeding has not been established.

If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking Vital Ginkgo biloba.

Driving and using machinery:
Vital Ginkgo biloba should not affect your ability to drive or operate machinery.

Important information about some of the ingredients of Vital Ginkgo biloba:
The capsule is made from Halaal gelatine of bovine (animal) origin.

Taking other medicines with Vital Ginkgo biloba:
Always tell your healthcare professional if you are taking any other medicines (This includes complementary and traditional medicines).

Vital Ginkgo biloba may interfere with anti-coagulant medicines (blood thinning medicines). If unsure, speak to your healthcare practitioner.

HOW TO TAKE VITAL GINKGO BILOBA
Always take Vital Ginkgo biloba exactly as indicated or as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

The usual dose is 1 capsule daily. Take with water after food.

If you take more Vital Ginkgo biloba than you should:
See “POSSIBLE SIDE EFFECTS”.

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

Treatment should be symptomatic and supportive.

If you forget to take a dose of Vital Ginkgo biloba:
Take your missed dose when you remember. Do not take a double dose to make up for forgotten individual doses.

POSSIBLE SIDE EFFECTS
Vital Ginkgo biloba can have side effects.

Not all side effects reported for Vital Ginkgo biloba are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

Minor symptoms include headache, nausea, and gastrointestinal discomfort. Restlessness, diarrhoea, dizziness, and dermatitis (inflammation of the skin) have also been infrequently reported.

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

STORING AND DISPOSING OF VITAL GINKGO BILOBA
Store all medicines out of reach of children.
Store at or below 25 °C in a dry place. Protect from light.
Do not use after the expiry date stated on the label.
Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

PRESENTATION OF VITAL GINKGO BILOBA
An appropriately-labelled plastic container with flip-off lid, containing 30 Vital Ginkgo biloba soft gelatine capsules.

IDENTIFICATION OF VITAL GINKGO BILOBA
An oval, dark-olive green, soft gelatine capsule.

NAME AND ADDRESS OF APPLICANT
Vital Health Foods (Pty) Ltd
Lavender Lane
Kuils River
7580.

DATE OF PUBLICATION
August 2011.
© Vital Health Foods (Pty) Ltd 2016.

VITAL GINKGO BILOBA
Weergawe: 2
Februarie 2016

PASIËNTINLIGTINGSPAMFLET
Kombinasieproduk – Westerse kruiemiddels.

Hierdie medisyne is nie deur die Medisynebeheerraad geëvalueer nie. Die doel van hierdie medisyne is nie om enige siekte te diagnoseer, behandel, genees of te voorkom nie.

SKEDULERINGSTATUS
Nie geskeduleerd nie.

EIENDOMSNAAM, STERKTE EN FARMASEUTIESE VORM
Vital Ginkgo biloba– sagte gelatienkapsules.

Lees hierdie pamflet sorgvuldig, aangesien dit belangrike inligting bevat.

Vital Ginkgo biloba is sonder ’n doktersvoorskrif beskikbaar. Jy moet nogtans Vital Ginkgo biloba versigtig gebruik om die beste resultate te verkry.

• • Hou hierdie pamflet. Dit mag nodig wees om dit weer te lees.

• • Vra jou apteker indien jy meer inligting of advies benodig.

• • Raadpleeg ’n dokter indien jou simptome vererger of nie verbeter nie.

WAT VITAL GINKGO BILOBA BEVAT
Elke Vital Ginkgo biloba– sagte gelatienkapsule bevat:

**Bygevoeg as kruie esktrak.

Die ander bestanddele is Antifoam M, geel ysteroksied, gelatien, gesuiwerde water, gliserien, rooi ysteroksied, sonneblomsaadolie/ kanola-olie en swart ysteroksied.

Vital Ginkgo biloba bevat geen laktose of suiker.

WAARVOOR VITAL GINKGO BILOBA GEBRUIK WORD
Vital Ginkgo biloba kan voordelig wees in die ondersteuning van geheue en konsentrasie, asook gesonde bloedsomloop.

VOORDAT JY VITAL GINKGO BILOBA NEEM
Moenie Vital Ginkgo biloba neem:

• • indien jy hipersensitief (allergies) vir enige van die bestanddele is nie (sien “WAT VITAL GINKGO BILOBA BEVAT”).

Neem spesiale voorsorg met Vital Ginkgo biloba:

• • indien jy teenstollingsterapie (met bloedverdunningsmiddels) ondergaan, of ’n bloedingstoornis het (sien “Neem van ander medisyne saam met Vital Ginkgo biloba”).

• • indien jy ’n bekende stollingstoornis het. Vital Ginkgo Biloba moet twee weke voor sommige chirurgiese of tandheelkundige prosedures gestaak word.

Neem van Vital Ginkgo biloba met voedsel of drank:
Neem Vital Ginkgo biloba met water ná voedsel.

Swangerskap en borsvoeding:
Veiligheid tydens swangerskap en borsvoeding is nie vasgestel nie.

Indien jy swanger is of jou baba borsvoed, raadpleeg asseblief jou dokter, apteker of ander professionele gesondheidswerker vir advies voordat jy Vital Ginkgo biloba gebruik.

Bestuur en die gebruik van masjinerie:
Vital Ginkgo biloba behoort nie jou vermoë om te bestuur of masjinerie te bedryf, te beïnvloed nie.

Belangrike inligting oor sommige van die bestanddele van Vital Ginkgo biloba:
Die kapsule is van Halaal gelatien van bees- (dier-) oorsprong gemaak.

Neem van ander medisyne saam met Vital Ginkgo biloba:
Stel altyd jou professionele gesondheidswerker in kennis indien jy enige ander medikasie gebruik (Dit sluit komplementêre en tradisionele medisyne in).

Vital Ginkgo biloba kan met teenstollingsmiddels (bloedverdunningsmiddels) inmeng. Daar is geen bekende interaksies met ander medisyne nie. Indien jy onseker is, raadpleeg jou gesondheidsorgpraktisyn.

HOE OM VITAL GINKGO BILOBA TE NEEM
Neem Vital Ginkgo biloba altyd presies soos aangedui, of soos jou dokter aan jou voorgeskryf het. Raadpleeg jou dokter of apteker indien jy onseker is.

Die normale dosis is 1 kapsule daagliks. Neem met water ná voedsel.

Indien jy meer Vital Ginkgo biloba as nodig neem:
Sien “MOONTLIKE NEWE-EFFEKTE “.

In die geval van ’n oordosis raadpleeg jou dokter of apteker. Indien geeneen beskikbaar is nie, kontak die naaste hospitaal of gifbeheersentrum.
Behandeling moet simptomaties en ondersteunend wees.

Indien jy vergeet om ’n dosis Vital Ginkgo biloba te neem:
Neem jou oorgeslane dosis wanneer jy onthou. Moenie ’n dubbele dosis neem om vir die oorgeslane dosis op te maak nie.

MOONTLIKE NEWE-EFFEKTE
Vital Ginkgo biloba kan newe-effekte hê.
Nie alle newe-effekte wat vir Vital Ginkgo biloba aangemeld is, is in hierdie pamflet ingesluit nie. Indien jou algemene gesondheid agteruitgaan of jy enige ongewenste uitwerkings met die gebruik van die medisyne ondervind, raadpleeg asseblief jou dokter, apteker of gesondheidsorgpraktisyn.

Geringe simptome, insluitende hoofpyn, naarheid en gastroïntestinale ongemak. Rusteloosheid, diarree, duiseligheid en dermatitis (inflammasie van die vel) is ook ongereeld gerapporteer.

Indien jy enige newe-effekte opmerk wat nie in hierdie pamflet ingesluit is nie, stel asseblief jou dokter of apteker in kennis.

BERGING EN WEGDOENING VAN VITAL GINKGO BILOBA
Berg alle medisyne buite bereik van kinders.
Berg teen of benede 25 °C op ’n droë plek. Beskerm teen lig.
Moenie ná die vervaldatum wat op die etiket aangedui word, gebruik nie.
Neem alle ongebruikte medisyne terug na jou apteker. Moenie ongebruikte medisyne in afvoerpype of rioolstelsels (bv. toilette) weggooi nie.

AANBIEDING VAN VITAL GINKGO BILOBA
ʼn Toepaslik geëtiketteerde plastiekhouer met ’n wipdeksel wat 30 Vital Ginkgo biloba– sagte gelatienkapsules bevat.

IDENTIFIKASIE VAN VITAL GINKGO BILOBA
’n Ovaal, donker-olyfgroen, sagte gelatienkapsule.

NAAM EN ADRES VAN APPLIKANT
Vital Health Foods (Pty) Ltd
Lavenderlaan
Kuilsrivier
7580.

DATUM VAN PUBLIKASIE
Augustus 2011.
© Vital Health Foods (Edms) Bpk. 2016.

VITAL GINKGO BILOBA
Version: 2
February 2016

PACKAGE INSERT
SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME AND DOSAGE FORM:
Vital Ginkgo biloba softgel capsules.

COMPOSITION:
Each Vital Ginkgo biloba softgel capsule contains:

**Added as herbal extract.

The inactive ingredients are Antifoam M, gelatine, glycerine, hardened unsaturated oil, iron oxide black, iron oxide red, iron oxide yellow, purified water and sunflower seed oil/ canola oil.

Vital Ginkgo biloba contains no lactose or sugar.

The fill oil for each capsule is encapsulated in Halaal gelatine of bovine origin.

PHARMACOLOGICAL CLASSIFICATION:
D.32.2. Other.
Discipline: Western herbals.

PHARMACOLOGICAL ACTION:
Supplementation with vitamins and herbal substances (see “COMPOSITION”). Ginkgo biloba extract is at therapeutic level. The exact mechanism of action for Ginkgo biloba has not been established.

INDICATIONS:
Vital Ginkgo biloba may be beneficial to support poor memory and concentration as well as healthy blood circulation.

CONTRAINDICATIONS:
Do not take if hypersensitive (allergic) to any of the ingredients (see “COMPOSITION”).

WARNINGS AND SPECIAL PRECAUTIONS:
Use with caution in patients taking anti-coagulants or anti-inflammatories, or patients with known clotting disorders and discontinue two weeks prior to some surgical or dental procedures (see “INTERACTIONS”). Not suitable for children. Nutritional supplements should not replace a balanced diet.

Keep out of reach of children.

INTERACTIONS:
Anticoagulants (see “WARNINGS AND SPECIAL PRECAUTIONS”).

PREGNANCY AND LACTATION:
Safety in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE:
Take 1 capsule daily. Take with water after food.

SIDE EFFECTS:
Post-market surveillance of >10,000 subjects using Ginkgo biloba found a 1,69 % incidence of minor symptoms, including headache, nausea, and gastrointestinal discomfort. Restlessness, diarrhoea, dizziness, and dermatitis have also been infrequently reported during trials. Ginkgo biloba may reduce platelet aggregation. Side effects are dose-related and reduced when taken with food.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “SIDE EFFECTS”. Treatment: Discontinue use.

IDENTIFICATION:
An oval, dark-olive green, soft gelatine capsule.

PRESENTATION:
An appropriately-labelled plastic container with flip-off lid, containing 30 Vital Ginkgo biloba soft gelatine capsules.

STORAGE INSTRUCTIONS:
Store at or below 25 ºC in a dry place.
Protect from light.

KEEP OUT OF REACH OF CHILDREN.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Vital Health Foods (Pty) Ltd
Lavender Lane
Kuils River
7580.

DATE OF PUBLICATION OF PACKAGE INSERT:
August 2011.

Disclaimer: This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease.
© Vital Health Foods (Pty) Ltd 2016

VITAL GINKGO BILOBA
Weergawe: 2
Februarie 2016

VOUBILJET
SKEDULERINGSTATUS:
Nie geskeduleerd nie.

EIENDOMSNAAM EN DOSEERVORM:
Vital Ginkgo biloba– sagte jelkapsules.

SAMESTELLING:
Elke Vital Ginkgo biloba– sagte jelkapsule bevat:

** Bygevoeg as kruie-ekstrak

Die onaktiewe bestanddele is Antifoam M, geel ysteroksied, gelatien, gesuiwerde water, gliserien, rooi ysteroksied, sonneblomsaadolie/ kanola-olie, swart ysteroksied en verharde onversadigde olie.

Vital Ginkgo biloba bevat geen laktose of suiker.

Die olie-inhoud vir elke kapsule is in Halaal-gelatien van bees-oorsprong omhul.

FARMAKOLOGIESE KLASSIFIKASIE:
D.32.2. Ander.
Dissipline: Westerse kruiemiddels.

FARMAKOLOGIESE WERKING:
Aanvulling met vitamiene en kruiemiddels (sien “SAMESTELLING”). Ginkgo biloba-ekstrak is op terapeutiese vlak. Die presiese meganisme van aksie vir Ginkgo biloba is nie vasgestel nie.

INDIKASIES:
Vital Ginkgo biloba kan voordelig wees in die ondersteuning van geheue en konsentrasie, asook gesonde bloedsomloop.

KONTRA-INDIKASIES:
Moenie gebruik indien jy hipersensitief (allergies) vir enige van die bestanddele is nie (sien “SAMESTELLING”).

WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS:
Gebruik versigtig indien jy teenstollingsmiddels of anti-inflammatoriese middels gebruik of indien jy ʼn bekende stollingstoornis het, en staak gebruik twee weke voor sommige chirurgiese of tandheelkundige prosedures (sien “INTERAKSIES”). Nie geskik vir kinders nie. Voedingsaanvullings vervang nie ’n gebalanseerde dieet nie. Hou buite bereik van kinders.

INTERAKSIES:
Teenstollingsmiddels (sien “WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS”).

SWANGERSKAP EN BORSVOEDING:
Veiligheid tydens swangerskap en borsvoeding is nie vasgestel nie.

DOSIS EN GEBRUIKSAANWYSINGS:
Neem 1 kapsule daagliks. Neem met water ná voedsel.

NEWE-EFFEKTE:
Markwaarneming van >10 000 persone wat Ginkgo biloba gebruik het, het ’n voorkomssyfer van 1,69 % vir geringe simptome, insluitende hoofpyn, naarheid en gastroïntestinale ongemak, gevind. Rusteloosheid, diarree, duiseligheid en dermatitis is ook ongereeld tydens proewe gerapporteer. Ginkgo biloba kan plaatjie-aggregasie verminder. Newe-effekte is dosisverwant en verminder met die inname van voedsel.

BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VIR DIE BEHANDELING DAARVAN:
Sien “NEWE-EFFEKTE”. Behandeling: Staak gebruik.

IDENTIFIKASIE:
’n Ovaal, donker-olyfgroen sagte gelatienkapsule.

AANBIEDING:
’n Toepaslik geëtiketteerde plastiekhouer met ’n wipdeksel wat 30 Vital Ginkgo biloba– sagte gelatienkapsules bevat.

BERGINGSINSTRUKSIES:
Berg teen of benede 25 °C in ’n droë plek.
Beskerm teen lig.

HOU BUITE BEREIK VAN KINDERS.

NAAM EN BESIGHEIDSADRES VAN DIE APPLIKANT:
Vital Health Foods (Pty) Ltd
Lavenderlaan
Kuilsrivier
7580.

DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET:
Augustus 2011.

Vrywaring: Hierdie medisyne is nie deur die Medisynebeheerraad geëvalueer nie. Die doel van hierdie medisyne is nie om enige siekte te diagnoseer, behandel, genees of te voorkom nie.
© Vital Health Foods (Edms) Bpk. 2016