PATIENT INFORMATION LEAFLET

SCHEDULING STATUS: Unscheduled.

Category D: Complementary medicine.

Discipline: Discipline specific

D33.7: Combination product

PROPRIETARY NAME, STRENGTH, AND PHARMACEUTICAL FORM

HOMOCYSTEINE BALANCE , 60 Capsules

READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU

• HOMOCYSTEINE BALANCE is available without a doctor’s prescription. 
• Nevertheless, you still need to use HOMOCYSTEINE BALANCE carefully to get the best results from it.
• Do not share HOMOCYSTEINE BALANCE with any other person.
• Ask your pharmacist or healthcare practitioner if you need more information or advice.

WHAT IS IN THIS LEAFLET

• What is HOMOCYSTEINE BALANCE is and what it is used for.
• What do you need to know before you take HOMOCYSTEINE BALANCE.
• How do you take HOMOCYSTEINE BALANCE.
• Possible side effects.
• How do you store HOMOCYSTEINE BALANCE.
• Contents of the pack and other information.

WHAT DOES HOMOCYSTEINE BALANCE CONTAIN

Each 1 capsule of HOMOCYSTEINE BALANCE contains the following actives:

Other ingredients:

Calcium phosphate

Microcrystalline Cellulose

Silicon dioxide and vegetable gelatine

Contains no animal products.

Free from: Gluten, wheat, salt, sugar, dairy, soya, yeasts, preservatives, artificial flavours.

SUITABLE FOR VEGANS.

WHAT IS HOMOCYSTEINE BALANCE USED FOR

HOMOCYSTEINE BALANCE is formulated to assist in reducing homocysteine levels, thus reducing cardiovascular risk.  Homocysteine is a sulphur containing amino- acid formed during the metabolism of methionine to cysteine. At high levels it can cause damage to the lining (endothelium) of the arteries and may increase the possiblity of blood clots thus leading to an increase risk in heart attacks, blood clots and strokes.

WHAT YOU NEED TO KNOW BEFORE TAKING HOMOCYSTEINE BALANCE

Do not take HOMOCYSTEINE BALANCE  if you are hypersensitive (allergic) to any of the ingredients.  Do not take if you have a allergy or sensitivity to cobalt.

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.

PREGNANCY AND BREASTFEEDING

Safety during pregnancy and breastfeeding has not been established. If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, consult with your healthcare practitioner before use.

TAKING OTHER MEDICINES WITH HOMOCYSTEINE BALANCE

Always tell your healthcare provider if you are taking any other medicine.

HOW TO TAKE HOMOCYSTEINE BALANCE

Do not share medicines prescribed for you with any other person. Always take HOMOCYSTEINE BALANCE  exactly as described in this leaflet, or as your doctor, healthcare provider has instructed you.  You should check with your doctor, pharmacist or healthcare provider if you are unsure. 

Directions for use:  Adults: Take (1 – 2 capsules) daily with food or as advised by your healthcare provider. Not suitable for use by Children.

WHAT HAPPENS IF YOU TAKE MORE HOMOCYSTEINE BALANCE  THAN YOU SHOULD

In the event of overdosage, consult your doctor, pharmacist.  Should none of these be available, contact the nearest hospital or poison control centre.

WHAT HAPPENS IF YOU FORGET TO TAKE HOMOCYSTEINE BALANCE

Do not take a double dose to make up for a missed dose.

POSSIBLE SIDE EFFECTS

HOMOCYSTEINE 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:  post surgical stent placement, weight loss surgery, liver disease and gout.

Should you be taking any of the following medication, do not take it before consulting your healthcare practitioner:  high blood pressure medication, antibiotics and antipsychotic drugs.

If any of the following happens, stop using HOMOCYSTEINE BALANCE  and tell your doctor or go to the casualty department at your nearest hospital:

• Diarrhea, vomiting

These are serious effects. If you have them, you may have had a serious reaction to HOMOCYSTEINE BALANCE .  You may need medical attention or hospitalisation.

Not all side effects reported for HOMOCYSTEINE BALANCE  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. If you notice any side effects not mentioned in this leaflet, please inform your doctor, pharmacist or healthcare professional.

REPORTING OF SIDE EFFECTS

If you get side effects, talk to your doctor, pharmacist or other healthcare professional.  You can also report side effects to SAHPRA via “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of HOMOCYSTEINE BALANCE.

STORAGE AND DISPOSING OF HOMOCYSTEINE BALANCE

Store all medicines out of the reach of children.

Store in a cool, dark place, below 25 °C.

Protect from direct sunlight and heat.

Store in the original packaging.

Keep the bottle tightly closed.

Replace the protective cap after each use.

Do not use after the expiry date stated on the bottle/packaging.

Do not use HOMOCYSTEINE BALANCE  if you notice visible signs of deterioration.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

PRESENTATION OF HOMOCYSTEINE BALANCE

Product is presented in a bottle, with a black lid and a branded label.

IDENTIFICATION OF HOMOCYSTEINE BALANCE

Green capsule

REGISTRATION NUMBER

TBA.

NAME AND ADDRESS OF REGISTRATION HOLDER

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

www.whole-again.co.za

Applicant:

Sparta Pharmaceuticals (Pty) Ltd

20 Plane Road,

Spartan,

Kempton Park,

1619

ACCESS TO THE CORRESPONDING PROFESSIONAL INFORMATION

See information on the website above.

THIS LEAFLET WAS LAST REVISED ON

16 August 2023

PASIËNTINLIGTINGSBLAADJIE

SKEDULERINGSTATUS: Ongeskeduleer nie.

Kategorie D: Komplementêre medisyne.

Dissipline: Dissipline spesifiek

D33. 7: Kombinasie produk

EIE NAAM, STERKTE EN FARMASEUTIESE VORM

HOMOCYSTEINE BALANCE , 60 kapsules

LEES HIERDIE VOUBILJET NOUKEURIG, WANT DIT BEVAT BELANGRIKE INLIGTING VIR U

• HOMOCYSTEINE BALANCE is beskikbaar sonder doktersvoorskrif. 
• U moet steeds HOMOCYSTEINE BALANCE versigtig gebruik om die beste resultate daaruit te kry.
• Moenie HOMOCYSTEINE BALANCE met enige ander persoon deel nie.
• Vra jou apteker ofgesondheidsorgpraktisyn of jy meer inligting of advies benodig.

WAT IS IN HIERDIE VOUBILJET

• Wat HOMOCYSTEINE BALANCE is en waarvoor dit gebruik word.
• Wat jy moet weet voordat jy HOMOCYSTEINE BALANCE neem.
• Hoe om HOMOCYSTEINE BALANCE te neem.
• Moontlike newe-effekte.
• Hoe om HOMOCYSTEINE BALANCE te stoor.
• Inhoud van die pakket en ander inligting.

WATTER HOMOCYSTEINE BALANCE BEVAT

Elke 1 kapsule HOMOCYSTEINE BALANCE bevat die volgende aktiewe:

Ander bestanddele:

Kalsiumfosfaat

Mikrokristallyne Sellulose

Magnesium stearaat

Bevat geen diereprodukte nie.

Vry van: Gluten, koring, sout, suiker, suiwel, soja, giste, preserveermiddels, kunsmatige geure.

GESKIK VIR VEGANE.

WAARVOOR WORD HOMOCYSTEINE BALANCE  GEBRUIK

HOMOCYSTEINE BALANCE is geformuleer om homosisteïenvlakke te verminder en sodoende kardiovaskulêre risiko te verminder.  Homosisteïen is ‘n swael wat aminosuur bevat wat gevorm word tydens die metabolisme van metionien tot cysteïen. Op hoë vlakke kan dit skade aan die voering (endotheel) van die are veroorsaak en kan bloedstolling veroorsaak, wat lei tot ‘n toename in hartaanvalle, bloedklonte en beroertes.

VOORDAT JY HOMOCYSTEINE BALANCE NEEM

Moenie HOMOCYSTEINE BALANCE neem  as jy hipersensitief (allergies) vir enige van die bestanddele is nie.  Moenie neem as jy ‘n allergie of sensitiwiteit vir kobalt het nie.

Hierdie medisyne is nie deur SAHPRA geëvalueer vir kwaliteit, veiligheid of beoogde gebruik nie.  Hierdie   medisyne is nie bedoel om ‘n y-siekte te diagnoseer, behandel, genees of voorkom nie.

SWANGERSKAP EN BORSVOEDING

Veiligheid tydens swangerskap en breastfeeding is nie vasgestel nie.  As u swanger is of borsvoed, dink dat u swanger is of van plan is om ‘n baba te hê, raadpleeg u gesondheidsorgpraktisyn voor gebruik.

NEEM ANDER MEDISYNE MET HOMOCYSTEINE BALANCE

Vertel altyd u gesondheidsorgverskaffer of u enige ander medisyne gebruik.

HOE OM HOMOCYSTEINE BALANCE TE NEEM

Moenie medisyne wat vir u voorgeskryf is, met enige ander persoon deel nie.  Neem altyd HOMOCYSTEINE BALANCE presies soos beskryf in hierdie voubiljet, of soos u dokter, gesondheidsorgverskaffer u opdrag gegee het.  Jy moet met jou dokter, apteker of gesondheidsorgverskaffer gaan kyk as jy onseker is. 

Aanwysings vir gebruik: Volwassenes: Neem (1 – 2 kapsules) daagliks saam met kos of soos aangeraai deur jou gesondheidsorgverskaffer.  Nie geskik vir gebruik deur kinders nie.

AS JY MEER HOMOCYSTEINE BALANCE NEEM  AS WAT JY MOET

In die geval van overdosage, raadpleeg u dokter, apteker.  Indien nie een hiervan beskikbaar is nie, kontak die naaste hospitaal of gifbeheersentrum.

AS JY VERGEET OM HOMOCYSTEINE BALANCE TE NEEM

Moenie ‘n dubbele dosis neem om ‘n gemiste dosis op te maak nie.

MOONTLIKE NEWE-EFFEKTE

HOMOCYSTEINE BALANCE  kan newe-effekte hê.

As jy enige van die volgende mediese toestande het, moet dit asseblief nie neem voordat jy met jou gesondheidsorgpraktisyn konsulteer nie:  post-chirurgiese stentplasing, gewigsverliesoperasies, lewersiekte, jig.

Indien jy enige van die volgende medikasie neem, moenie neem voordat jy jou gesondheidsorgpraktisyn raadpleeg voor gebruik nie: hoë bloeddrukmedikasie, antibiotika, antipsigotiese middels.

As een van die volgende gebeur, stop met die gebruik van HOMOCYSTEINE BALANCE  en vertel jou dokter of gaan na die ongevalle-afdeling by jou naaste hospitaal:

• Diarree, braking

Dit is ernstige gevolge. As jy dit het, het jy dalk ‘n ernstige reaksie op HOMOCYSTEINE BALANCE gehad  . Miskien het u mediese hulp of hospitalisasie nodig.

Nie alle newe-effekte wat vir HOMOCYSTEINE BALANCE gerapporteer  word, is by hierdie voubiljet ingesluit nie. 

Indien jou algemene gesondheid vererger of as jy enige onaantasbare gevolge ervaar tydens die gebruik van hierdie medisyne, raadpleeg asseblief jou dokter, apteker of andergeneeskundige vir raad.  As jy enige newe-effekte opmerk wat nie in hierdie leafle t genoemword nie, stel asseblief jou dokter, apteker of gesondheidswerker in kennis.

VERSLAGDOENING VAN NEWE-EFFEKTE

As jy newe-effekte kry, praat met jou dokter, apteker of ander gesondheidswerker.  U kan ook newe-effekte aan SAHPRA rapporteer via “6.04 Adverse Drug Reaction Reporting Form”, wat aanlyn gevind word onder SAHPRA se publikasies: https://www.sahpra.org.za/Publications/Index/8. Deur newe-effekte aan te meld, kan u help om meer inligting oor die veiligheid van HOMOCYSTEINE BALANCE te verskaf.

BERGING EN WEGDOEN VAN HOMOCYSTEINE BALANCE

Stoor alle medisyne buite bereik van kinders.

Hou in ‘n koel, donker plek, onder 25 °C.

Beskerm teen direkte sonlig en hitte.

Stoor in die oorspronklike verpakking.

Hou die bottel styf toe.

Vervang die beskermende pet na elke gebruik.

Moet nie gebruik word na die vervaldatum wat op die bottel / verpakking aangedui word nie.

Moenie HOMOCYSTEINE BALANCE gebruik  as u sigbare tekens van agteruitgang opmerk nie.

Moenie ongebruikte medisyne in dreine of rioolstelsels (bv. toilette) weggooi nie.

AANBIEDING VAN HOMOCYSTEINE BALANCE

Produk word aangebied in ‘n bottel, met ‘n swart deksel en ‘n handelsmerketiket.

IDENTIFISERING VAN HOMOCYSTEINE BALANCE

Groen kapsule

REGISTRATION NOMMER

TBA.

NAAM EN ADRES VAN REGISTRASIEHOUER

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

www.whole-again.co.za

Applicant:

Sparta Pharmaceuticals (Pty) Ltd

20 Plane Road,

Spartan,

Kempton Park,

1619

TOEGANG TOT DIE OOREENSTEMMENDE PROFESSIONELE INLIGTING

Sien inligting op die webwerf hierbo.