CHOLESTEROL BALANCE
SCHEDULING STATUS
Unscheduled
PROPRIETARY NAME (dosage form)
CHOLESTEROL BALANCE (30 capsules)
DISCIPLINE
Complementary medicine
Health supplement
Category D: 34.12 Multiple substance formulation
COMPOSITION
Each 1 capsule of CHOLESTEROL BALANCE contains the following actives:
Red Rice yeast extract (Monascus purpureus) | 400 mg |
Red Rice yeast extract 5% Lovastatin | |
Red Rice yeast extract 0.4 % Lovastatin | |
Coenzyme Q10 (Ubiquinone) | 100 mg |
Policosanol | 10 mg |
Other ingredients:
Microcrystalline
Cellulose
Magnesium stearate
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
CHOLESTEROL BALANCE is formulated to assist with decreased absorption of cholesterol from the small intestines. It may assist in decreasing production of endogenous cholesterol and replaces an essential enzyme Co-Q10 that is often depleted with use of chronic medication.
Ingredients | Uses for ingredient |
Red Rice yeast extract | The extracts of red yeast rice (RYR) are currently the most effective cholesterol-lowering nutraceuticals. This activity is mainly due to monacolin K, a weak reversible inhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase, whose daily consumption causes a reduction in low-density lipoprotein (LDL)-cholesterol plasma levels up to 15% to 25% within 6 to 8 weeks. |
Coenzyme Q10 (Ubiquinone) | Coenzyme Q10 is vital for the proper transfer of electrons within the mitochondrial oxidative respiratory chain, whose main function is adenosine triphosphate production. Coenzyme Q10 also appears to increase adenosine triphosphate levels by preventing the loss of the adenine nucleotide pool from cardiac cells. |
Policosanol | Policosanol’s impact on cholesterol is mediated through a reduction in the synthesis and degradation of the rate-limiting step of cholesterol biosynthesis, the enzyme 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase. |
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
Should you be taking any of the following medication, do not take before consulting your healthcare practitioner before use: antibiotics, antidepressants, statins, blood thinners, insulin and other chronic cholesterol medication.
If any of the following happens, stop using CHOLESTEROL BALANCE and tell your doctor or go to the casualty department at your nearest hospital:
- Rash, headache
- Insomnia, fatigue
These are all serious effects. If you have them, you may have had a serious reaction to CHOLESTEROL BALANCE. You may need urgent medical attention.
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.
- Keep this leaflet. You may need to read it again.
- 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 capsule daily with meals. This dosage can be increased to 1 capsule twice daily on the advice of your health care practitioner.
It should be noted that taking CoQ10 close to bedtime may cause insomnia in some people, so it’s best to take it in the morning or afternoon.
Not suitable for use by Children.
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
Vegetable capsule
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 CHOLESTEROL 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.
SKEDULERINGSTATUS
Ongeskeduleer
EIE NAAM (doseervorm)
CHOLESTEROL BALANS (30 kapsules)
DISSIPLINE
Komplementêre medisyne
Gesondheidsaanvulling
Kategorie D: 34.12 Meervoudige stofformulering
SAMESTELLING
Elke 1 kapsule van CHOLESTEROL BALANCE bevat die volgende aktiewe:
Rooi rys gis uittreksel (Monascus purpureus) | 400 mg |
Rooi Rys gis uittreksel 5% Lovastatin | |
Rooi rys gis uittreksel 0,4 % Lovastatin | |
Koënsiem Q10 (Ubiquinoon) | 100 mg |
Policosanol | 10 mg |
Ander bestanddele:
Mikrokristallyne
Sellulose
Magnesium stearaat
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
CHOLESTEROL BALANCE is geformuleer om te help met verminderde absorpsie van cholesterol uit die dunderm. Dit kan help om die produksie van endogene cholesterol te verminder en vervang ‘n noodsaaklike ensiem Co-Q10 wat dikwels uitgeput is met die gebruik van chroniese medikasie.
Bestanddele | Gebruike vir bestanddeel |
Rooi Rys gis uittreksel | Die uittreksels van rooi gis rys (RYR) is tans die mees effektiewe cholesterolverlagende voedingsmiddels. Hierdie aktiwiteit is hoofsaaklik te wyte aan monacolin K, ‘n swak omkeerbare inhibeerder van 3-hidroksie-3-metiel-glutaryl-koënsiem A reduktase, waarvan die daaglikse verbruik ‘n vermindering in laedigtheid lipoproteïen (LDL) -cholesterol plasmavlakke tot 15% tot 25% binne 6 tot 8 weke veroorsaak. |
Koënsiem Q10 (Ubiquinoon) | Koënsiem Q10 is noodsaaklik vir die behoorlike oordrag van elektrone binne die mitochondriale oksidatiewe respiratoriese ketting, waarvan die hooffunksie adenosientrifosfaatproduksie is. Koënsiem Q10 blyk ook adenosientrifosfaatvlakke te verhoog deur die verlies van die adeniennukleotiedpoel uit hartselle te voorkom. |
Policosanol | Policosanol se impak op cholesterol word bemiddel deur ‘n vermindering in die sintese en agteruitgang van die tempobeperkende stap van cholesterolbiosintese, die ensiem 3-hidroksi-3-metielglutaryl koënsiem A (HMG CoA) reduktase. |
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
Indien jy enige van die volgende medikasie neem, moenie neem voordat jy jou gesondheidsorgpraktisyn raadpleeg voor gebruik nie: antibiotika, antidepressante, statiene, bloedverdunners, insulien, chroniese cholesterolmedikasie.
As een van die volgende gebeur, stop met die gebruik van CHOLESTEROL BALANCE en vertel jou dokter of gaan na die ongevalle-afdeling by jou naaste hospitaal:
- Uitslag, hoofpyn
- Insomnia, moegheid
Dit is alles baie ernstige gevolge. As u dit het, het u moontlik ‘n ernstige reaksie op CHOLESTEROL 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.
- Moeniesy pakkie 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: Neem daagliks 1 kapsule met etes. Hierdie dosis kan twee keer per dag verhoog word tot 1 kapsule op advies van u gesondheidsorgpraktisyn.
Daar moet kennis geneem word dat CoQ10 naby slaaptyd slapeloosheid by sommige mense kan veroorsaak, daarom is dit die beste om dit soggens of namiddag te neem.
Nie geskik vir gebruik deur kinders nie.
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
Groente kapsule
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 CHOLESTEROL 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
Aansoeker:
Sparta Pharmaceuticals (Pty) Ltd
20 Plane Road,
Spartan,
Kempton Park,
1619
DATUM VAN PUBLIKASIE
Om deur die regulerende owerheid toegeken te word.