Oestrogen Balance
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: Unscheduled
PROPRIETARY NAME (dosage form)
OESTROGEN BALANCE (60 tablets)
DISCIPLINE
Complementary medicine
Health supplement
Category D: 34.12 Multiple substance formulation
COMPOSITION
Each 1 tablet of OESTROGEN BALANCE contains the following actives:
Broccoli (Brassica Oleracea Varigate italica) extract 0.5 % (200:1) [Source: fruit] | 750 mg |
Watercress (Nasturtium Officinale) extract 2% [Source: Leaf] | 375 mg |
Cats claw (Uncaria Tomentosa) extract 2% [Source: Bark] | 125 mg |
Indole-3-carbinol | 50 mg |
3.3 Diindolylmethane (DIM) | 50 mg |
Calcium d-Glucarate | 50 mg |
Betaine Anhydrous | 25 mg |
L-Methionine | 25 mg |
Other ingredients:
Calcium phosphate,
Microcrystalline cellulose
Magnesium stearate
Flexicoat white
Contains no animal products.
Free from: Gluten, wheat, salt, sugar, dairy, soya, yeasts, preservatives, artificial flavours.
SUITABLE FOR VEGANS.
PHARMACOLOGICAL CLASSIFICATION
Complementary Medicine
INDICATION & PHARMACOLOGICAL ACTION
OESTROGEN BALANCE is carefully formulated to assist with the management of your hormone levels, assist in weight management and management of menstrual symptoms.
Ingredients | Uses for ingredient |
Broccoli (Brassica Oleracea Varigate italica) extract 0.5 % (200:1) | Broccoli is connected to hormone balance by its effect on how the body breaks down oestrogen. An important detoxification molecule, sulforaphane may help with fatty liver disease and may enhance liver detoxification pathways, which are critical to metabolizing oestrogens. Sulforaphane may also help with tissue damage known as oxidative stress, which is associated with aging and diabetes. |
Watercress (Nasturtium Officinale) extract 2% | A rich source of glucosinolates. Gluconasturtiin, the predominant glucosinolate in watercress, has been shown to have several health beneficial properties through its bioactive breakdown product phenethyl isothiocyanate. |
Cats claw (Uncaria Tomentosa) extract 2% | Cat’s claw could help with hormone balance by supporting healthy oestrogen levels. Studies have indicated that cat’s claw could inhibit oestrogen receptors, which in theory could help women struggling with oestrogen dominance |
Indole-3-carbinol | I3C has been found to modulate the expression and activity of biotransformation enzymes that are involved in the metabolism and elimination of many biologically active compounds, including steroid hormones, drugs, carcinogens, and toxins. |
3.3 Diindolylmethane (DIM) | Preclinical studies suggested that anti-oestrogenic activities of DIM might help reduce the risk of hormone-dependent cancers. |
Calcium d-Glucarate | Calcium D-glucarate works in conjunction with an enzyme in the intestine, beta-glucaronidase, and the liver’s detoxification process. In the normal functioning of the body, hormones often travel to the liver and are tagged for excretion. The neutralized hormone is excreted in bile, which travels out by way of solid waste, and must pass through the intestine. When beta-glucaronidase encounters a neutralized hormone, it breaks the bond to reactivate this hormone and the hormone is then reabsorbed through the wall of the intestine. Calcuim-d-glucarate will inhibit the latter process. |
Betaine Anhydrous | Betaine is a methyl group donor that functions in the normal metabolic cycle of methionine. It is a naturally occurring choline derivative commonly ingested through diet, with a role in regulating cellular hydration and maintaining cell function. |
L-Methionine | L-methionine is a precursor to L-cysteine. L-cysteine itself may have antioxidant activity. L-cysteine is also a precursor to the antioxidant glutathione. Recent research suggests that methionine itself has free-radical scavenging activity by virtue of its sulphur, as well as its chelating ability. It is thought that metabolism of high doses of acetaminophen in the liver lead to decreased levels of hepatic glutathione and increased oxidative stress. |
CONTRA INDICATIONS:
Avoid if allergic or sensitive to any ingredients listed. Do not use if pregnant or lactating without consulting your health care practitioner.
WARNING AND SPECIAL PRECAUTIONS
OESTROGEN BALANCE may have side effects.
If you have any of the following medical conditions, please do not take it before consulting with your healthcare practitioner: stomach ulcers, high blood pressure, atherosclerosis (hardening of arteries), high cholesterol, kidney disease, schizophrenia, autoimmune disorders, acidosis.
Should you be taking any of the following medication, do not take before consulting your healthcare practitioner before use: liver medication, lithium, blood pressure medication, certain antibiotics, blood thinners, diuretics, high blood pressure medication, alcohol.
If any of the following happens, stop using OESTROGEN BALANCE and tell your doctor or go to the casualty department at your nearest hospital:
- Swelling, hives
- Difficulty breathing
These are all serious side effects. If you have them, you may have had a serious reaction to OESTROGEN BALANCE. You may need urgent medical attention or hospitalisation.
Seek advice from a health care practitioner if you have any medical condition. Discontinue use immediately should any adverse reaction occur. Read this leaflet carefully because it contains important information for you. This product is available without a doctor’s prescription.
- Do not share medication with any other person.
- Ask your pharmacist if you need more information or advice.
- You must consult a doctor should your condition worsen or does not improve.
DO NOT USE THIS PRODUCT:
- If you are hypersensitive (allergic) to any of the ingredients listed.
- Do not accept this package if seals are broken.
- For freshness, store in the packaging supplied.
INTERACTIONS
Always tell your health care professional if you are taking any other medicine. It is possible that exposure of certain supplement ingredients may interfere with certain medications. (See Warnings & Special precautions)
DOSAGE AND DIRECTIONS FOR USE
Adults: Adults: Take 1 (one) tablet daily with a meal, twice daily or as directed by your healthcare professional, with a glass (250 ml) of liquid.
Stop taking OESTROGEN BALANCE two weeks before elective surgeries.
SIDE EFFECTS
Should your general health worsen, or if you experience any untoward effects while being exposed to this product, please consult your doctor, pharmacist, or other health care professional for advice.
KNOWN SYMPTOMS OF OVER DOSAGE AND PARTICULARS OF ITS TREATMENT
See side-effects.
Treatment:
Discontinue use and consult your doctor, pharmacist or other health care professional for advice.
IDENTIFICATION
Coated tablet
PRESENTATION
Product is presented in a bottle, with a black lid and a branded label
STORAGE INSTRUCTION
Store in a cool, dark place, below 25 °C.
Protect from direct sunlight and heat.
Store in the original bottle.
Keep the bottle tightly closed.
Replace the protective cap after each use.
Do not use after the expiry date stated on the bottle.
Do not use OESTROGEN BALANCE if you notice visible signs of deterioration.
STORE OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER
To be allocated by SAHPRA upon registration.
This medicine has not been evaluated by SAHPRA for quality, safety, or intended use. This medicine is not intended to diagnose, treat, cure or prevent any disease.
NAME AND BUSINESS ADDRESS OF APPLICANT
Manufactured for:
Whole Again Nutraceuticals (Pty) Ltd
PostNet Suite 216
Private Bag X1
Melrose Arch
2076
Phone no: 010 109 6177
Email : info@whole-again.co.za
Applicant:
Sparta Pharmaceuticals (Pty) Ltd
20 Plane Road,
Spartan,
Kempton Park,
1619
DATE OF PUBLICATION
To be allocated by the regulatory authority.
PASIËNTINLIGTINGSBLAADJIE
SKEDULERINGSTATUS: Ongeskeduleer
OESTROGEN BALANCE (60 tablette)
DISSIPLINE
Komplementêre medisyne
Gesondheidsaanvulling
Kategorie D: 34.12 Meervoudige stofformulering
SAMESTELLING
Elke 1 tablet OESTROGEN BALANCE bevat die volgende aktiewe middels:
Broccoli (Brassica Oleracea Varigate italica) uittreksel 0,5 % (200: 1) [Bron: vrugte ] | 750 mg |
Waterkers (Nasturtium Officinale) onttrek 2% [Bron: blaar] | 375 mg |
Katte klou (Uncaria Tomentosa) uittreksel 2% [Bron: Bluf] | 125 mg |
Indool-3-karbinol | 50 mg |
3.3 Diindolylmetaan (DIM) | 50 mg |
Kalsium d-glukaraat | 50 mg |
Betaine Watervrye | 25 mg |
L-Methionine | 25 mg |
Ander bestanddele:
Kalsiumfosfaat,
Mikrokristallyne sellulose
Magnesium stearaat
Flexicoat wit
Bevat geen diereprodukte nie.
Vry van: Gluten, koring, sout, suiker, suiwel, soja, giste, preserveermiddels, kunsmatige geure.
GESKIK VIR VEGANE.
FARMAKOLOGIESE KLASSIFIKASIE
Komplementêre medisyne
AANDUIDING EN FARMAKOLOGIESE WERKING
OESTROGEN BALANCE is noukeurig geformuleer om te help met die bestuur van jou hormoonvlakke, help met gewigsbestuur en bestuur van menstruele simptome.
Bestanddele | Gebruike vir bestanddeel |
Broccoli (Brassica Oleracea Varigate italica) uittreksel 0,5 % (200:1) | Broccoli is verbind met hormoonbalans deur die effek daarvan op hoe die liggaam estrogeen afbreek. ‘n Belangrike ontgiftingsmolekule, sulforafaan, kan help met vetterige lewersiekte en kan lewerontgiftingsweë verbeter, wat van kritieke belang is vir die metabolisering van estrogeen. Sulforaphane kan ook help met weefselskade bekend as oksidatiewe stres, wat verband hou met veroudering en diabetes. |
Waterkers (Nasturtium Officinale) onttrek 2% | ‘n Ryk bron van glukosinolate. Glukonasturtiin, die oorheersende glukosinolaat in waterkers, het getoon dat dit verskeie gesondheidsvoordeel-eienskappe het deur middel van sy bioaktiewe afbreekproduk fenethyl isothiocyanate. |
Katte klou (Uncaria Tomentosa) uittreksel 2% | Cat se klou kan help met hormoonbalans deur gesonde estrogeenvlakke te ondersteun. Studies het aangedui dat kat se klou estrogeenreseptore kan inhibeer, wat in teorie vroue kan help wat sukkel met estrogeen dominansie |
Indool-3-karbinol | Daar is gevind dat I3C die uitdrukking en aktiwiteit van biotransformasie-ensieme moduleer wat betrokke is by die metabolisme en eliminasie van baie biologies aktiewe verbindings, insluitend steroïedhormone, middels, karsinogene en gifstowwe. |
3.3 Diindolylmetaan (DIM) | Prekliniese studies het voorgestel dat anti-estrogeen aktiwiteite van DIM kan help om die risiko van hormoonafhanklike kankers te verminder. |
Kalsium d-glukaraat | Kalsium D-glukarate werk saam met ‘n ensiem in die dunderm, beta-glukaronidase en die lewer se ontgiftingsproses. In die normale funksionering van die liggaam beweeg hormone dikwels na die lewer en word gemerk vir uitskeiding. Die geneutraliseerde hormoon word uitgeskei in gal, wat deur middel van vaste afval uitbeweeg en deur die dunderm moet beweeg. Wanneer beta-glukaronidase ‘n geneutraliseerde hormoon teëkom, breek dit die binding om hierdie hormoon te heraktiveer en die hormoon word dan deur die dermwand herabsorbeer. Kalsium-d-glukaraat sal laasgenoemde proses inhibeer. |
Betaine Watervrye | Betaine is ‘n metielgroepskenker wat funksioneer in die normale metaboliese siklus van metionien. Dit is ‘n natuurlik voorkomende cholienderivaat wat algemeen deur dieet ingeneem word, met ‘n rol in die regulering van sellulêre hidrasie en die handhawing van selfunksie. |
L-Methionine | L-metionien is ‘n voorloper van L-cysteïen. L-cysteïen self kan antioksidante aktiwiteit hê. L-cysteïen is ook ‘n voorloper van die antioksidante glutathion. Onlangse navorsing dui daarop dat metionien self vrye radikale opvangaktiwiteit het op grond van sy swael, sowel as sy chelaatvermoë. Daar word vermoed dat metabolisme van hoë dosisse asetaminofen in die lewer lei tot verminderde vlakke van hepatiese glutathion en verhoogde oksidatiewe stres. |
KONTRA-INDIKASIES:
Vermy as allergies of sensitief vir enige bestanddele wat gelys word. Moenie gebruik indien swanger of lakterend sonder om jou gesondheidsorgpraktisyn te raadpleeg.
WAARSKUWING EN SPESIALE VOORSORGMAATREËLS
OESTROGEN BALANCE kan newe-effekte hê.
As u een van die volgende mediese toestande het, moet u dit asseblief nie neem voordat u met u gesondheidsorgpraktisyn konsulteer nie: maagsere, hoë bloeddruk, aterosklerose (verharding van arteries), hoë cholesterol, niersiekte, skisofrenie, outo-immuunafwykings, asidose.
Indien jy enige van die volgende medikasie neem, moenie neem voordat jy jou gesondheidsorgpraktisyn raadpleeg voor gebruik nie: lewermedikasie, litium, bloeddrukmedikasie, sekere antibiotika, bloedverdunners, diuretika, hoë bloeddrukmedikasie, alkohol.
As een van die volgende gebeur, hou op om OESTROGEN BALANCE te gebruik en vertel jou dokter of gaan na die ongevalle-afdeling by jou naaste hospitaal:
- Swelling, korwe
- Asemhalingsprobleme
Dit is alles baie ernstige gevolge. As jy dit het, het jy dalk ‘n ernstige reaksie op OESTROGEN BALANCE gehad. Miskien het u dringende mediese hulp of hospitalisasie nodig.
Raadpleeg ‘n gesondheidsorgpraktisyn as u enige mediese toestand het. Staak gebruik onmiddellik indien enige nadelige reaksie plaasvind. Lees hierdie voubiljet aandagtig deur, want dit bevat belangrike inligting vir u. Hierdie produk is beskikbaar sonder doktersvoorskrif.
- Hou hierdie voubiljet. Miskien moet u dit weer lees.
- Moenie medikasie met enige ander persoon deel nie.
- Vra jou apteker of jy meer inligting of advies benodig.
- Jy moet ‘n dokter raadpleeg indien jou toestand vererger of nie verbeter nie.
MOENIE HIERDIE PRODUK GEBRUIK NIE:
- As jy hipersensitief (allergies) is vir enige van die bestanddele wat gelys word.
- Jy moet nie die produk aanvaar as seëls gebreek word nie.
- Vir varsheid, stoor in die verpakking wat verskaf word.
INTERAKSIES
Vertel altyd jou gesondheidswerker as jy enige ander medisyne gebruik. Dit is moontlik dat blootstelling van sekere aanvullingsbestanddele met sekere medisyne kan int erfere. (Sien Waarskuwings en Spesiale voorsorgmaatreëls)
DOSIS EN AANWYSINGS VIR GEBRUIK
Volwassenes: Volwassenes: Neem daagliks 1 (een) tablet saam met ‘n maaltyd, twee keer per dag of soos aangedui deur u gesondheidswerker, met ‘n glas (250 ml) vloeistof.
Hou op om OESTROGEN BALANCE twee weke voor elektiewe operasies te neem
NEWE-EFFEKTE
Indien jou algemene gesondheid vererger, of as jy enige onaangename gevolge ervaar terwyl jy aan hierdie produk blootgestel word, raadpleeg asseblief jou dokter, apteker of ander gesondheidswerker vir raad.
BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN DIE BEHANDELING DAARVAN
Sien newe-effekte.
Behandeling:
Staak gebruik en raadpleeg jou dokter, apteker of ander gesondheidswerker vir advies.
IDENTIFIKASIE
Bedekte tablet
AANBIEDING
Produk word in ‘n bottel aangebied, met ‘n swart deksel en ‘n handelsmerketiket
BERGING INSTRUKSIE
Hou in ‘n koel, donker plek, onder 25 °C.
Beskerm teen direkte sonlig en hitte.
Stoor in die oorspronklike bottel.
Hou die bottel styf toe.
Vervang die beskermende pet na elke gebruik.
Moet nie gebruik word na die vervaldatum wat op die bottel aangedui word nie.
Moenie OESTROGEN BALANCE gebruik as u sigbare tekens van agteruitgang opmerk nie.
STOOR BUITE BEREIK VAN KINDERS.
REGISTRASIE NOMMER
Om by registrasie deur SAHPRA toegeken te word.
Hierdie medisyne is nie deur SAHPRA geëvalueer vir kwaliteit, veiligheid of beoogde gebruik nie. Hierdie medisyne is nie bedoel om enige siekte te diagnoseer, behandel, genees of voorkom nie.
NAAM EN BESIGHEIDSADRES VAN AANSOEKER
Vervaardig vir:
Whole-Again Nutraceuticals (Edms) Bpk
PostNet Suite 216
Privaat sak X1
Melrose Arch
2076
Telefoonnommer: 010 109 6177
E-pos: info@whole-again.co.za
Applikant:
Sparta Pharmaceuticals (Pty) Ltd
20 Plane Road,
Spartan,
Kempton Park,
1619
DATUM VAN PUBLIKASIE
Om deur die regulerende owerheid toegeken te word.