Absolute Organix
ABSOLUTE ORGANIX (AO) COD LIVER OIL

ABSOLUTE ORGANIX (AO) COD LIVER OIL

PATIENT INFORMATION LEAFLET

SCHEDULING STATUS: [S0]

ABSOLUTE ORGANIX (AO) COD LIVER OIL

Cod liver oil, Vitamin A, Vitamin D

Sugar free

Category D 34.12 Multiple Substance Formulation. Complementary Medicine – Health Supplements

This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety and intended use. A varied diet is the most effective and safe way to achieve good nutrition, health, body composition as well as mental and physical performance.

Read this entire leaflet carefully because it contains important information for you.

AO COD LIVER OIL is available without a doctor’s prescription for you to maintain your health. Nevertheless, you still need to use AO COD LIVER OIL carefully to get the best results from it.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your health care provider.
  • Do not share AO COD LIVER OIL with any other person.
  • If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your health care provider.

In this leaflet:

  1. What AO COD LIVER OIL is and what it is used for
  2. What you need to know before you take AO COD LIVER OIL
  3. How to take AO COD LIVER OIL
  4. Possible side effects
  5. How to store AO COD LIVER OIL
  6. Contents of the pack and other information
  1. WHAT AO COD LIVER OIL IS AND WHAT IT IS USED FOR

AO COD LIVER OIL is comprised of the oil extracted from the liver of the Gadus morhua, Atlantic cod fish. It is commonly used as a dietary supplement that provides a source of omega-3 fatty acids (EPA and DHA), vitamin A and vitamin D.  Cod liver oil is believed to have the potential to support cognitive health and brain function.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AO COD LIVER OIL

Do NOT take AO COD LIVER OIL

Do not take AO COD LIVER OIL if you have a known hypersensitivity to any of the ingredients (see What AO COD LIVER OIL contains).

Warnings and precautions

AO COD LIVER OIL should be used with care in:

  • Haemophiliacs and patients scheduled for surgery (see Other medicines and AO COD LIVER OIL).

Other medicines and AO COD LIVER OIL

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

AO COD LIVER OIL may interact with the following medications. Caution is advised when used concurrently.

Anticoagulants/Antiplatelet medicines:

AO COD LIVER OIL may interact with anticoagulant/antiplatelet medications which may contribute to increased risk of bleeding. Patients taking warfarin must monitor for INR changes.

Antihypertensive medicines:

AO COD LIVER OIL may interact with antihypertensive medications which may contribute to a further reduced blood pressure.

AO COD LIVER OIL with food

AO COD LIVER OIL can be taken with or without food (see HOW TO TAKE AO COD LIVER OIL).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, please consult your doctor, pharmacist, or other health care provider for advice before taking AO COD LIVER OIL.

Driving and using machines

No specific studies have been conducted. Given its side-effect profile, it is unlikely that AO COD LIVER OIL will influence your ability to drive or use machines (see Possible side effects).

It is not always possible to predict to what extent AO COD LIVER OIL may interfere with your daily activities. Please ensure that you do not engage in the above activities until you are aware of the measure to which AO COD LIVER OIL affects you.

3. HOW TO TAKE AO COD LIVER OIL

Always take AO COD LIVER OIL exactly as described in this leaflet or as your doctor, pharmacist, or health care provider has told you. Check with your doctor, pharmacist, or health care provider if you are not sure.

Adults and children 14 years and older: Take 2 ml (one medicine measure) daily with a glass of water. AO COD LIVER OIL can be taken with or without food.

DO NOT EXCEED THE RECOMMENDED DOSE.

If you take more AO COD LIVER OIL 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 centre.

If you forget to take AO COD LIVER OIL

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

4. POSSIBLE SIDE EFFECTS

AO COD LIVER OIL can have side effects. Not all side effects are included in this leaflet.  Should your general health worsen or if you experience any untoward effects while taking AO COD LIVER OIL, please consult your healthcare provider for advice.

General side effects include abdominal discomfort, diarrhea, flatulence, and nausea/vomiting.

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

REPORTING SIDE EFFECTS

If you get side effects, talk to your healthcare professional. You can also report side effects to SAHPRA via the ‘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 AO COD LIVER OIL.

5. HOW TO STORE AO COD LIVER OIL

Store at or below 25 °C. Do not expose to direct sunlight. Refrigerate after opening. Use within 60 days after opening. KEEP OUT OF REACH OF CHILDREN.

6. CONTENTS OF THE PACK AND OTHER INFORMATION  

What AO COD LIVER OIL contains

Each 2 ml of AO COD LIVER OIL contains:

Cod Liver Oil (Gadidae)………………………………………………………1800 mg

Providing:

Total Omega 3 Fatty Acids……………………………………..432 mg

EPA (Eicosapentaenoic Acid)……………………………..……144 mg

DHA (Docosahexaenoic Acid)…………………………………180 mg

Vitamin A……………………………………………..1350 mcg RAE

Cholecalciferol (Vitamin D3)…………………..………………20 mcg

What AO COD LIVER OIL looks like and contents of the pack

A pale-yellow oil. Labelled Light amber bottle with white disc lid. Package size of 237 ml available.

HOLDER OF CERTIFICATE OF REGISTRATION

TRUE HEALTH (PTY) LTD
  UNIT 2, 8 DUIKER STREET BEACONVALE CAPE TOWN CARELINE: (021) 701 7172  

THIS LEAFLET WAS LAST REVISED ON

1 November 2021

REGISTRATION NUMBER

Will be allocated by SAHPRA upon registration.

PROFESSIONAL INFORMATION

For further information refer to the Professional Information of the product which can be found at www.absoluteorganix.co.za

__________________________________________________

PASIËNTINLIGTINGSBLAADJIE

SKEDULERINGSTATUS: [S0]

ABSOLUTE ORGANIX (AO) COD LIVER OIL

Lewertraan, Vitamien A, Vitamien D

Suikervry.

Kategorie D.34.12 Veelvuldigesubstansformulering. Aanvullende Medisyne – Gesondheidsaanvullings

Hierdie ongeregistreerde medisyne is nie deur die Suid-Afrikaanse Reguleringsowerheid vir Gesondheidsprodukte (SARGP) vir die kwaliteit, veiligheid of beoogde gebruik daarvan geëvalueer nie. ʼn Dieet ryk in verskeidenheid is die mees effektiewe en veiligste manier om goeie voeding, gesondheid, liggaamsamestelling sowel as verstandelike en fisiese prestasie te bereik.

Lees hierdie hele blaadjie sorgvuldig aangesien dit belangrike inligting vir u bevat.

AO COD LIVER OIL is sonder ʼn doktersvoorskrif vir u beskikbaar om u gesondheid te onderhou. Nogtans is dit steeds nodig dat u AO COD LIVER OIL versigtig gebruik om die beste resultate daarmee te verkry.

  • Hou hierdie blaadjie; u mag nodig kry om dit weer te lees.
  • Vra u gesondheidsorgverskaffer indien u meer inligting benodig.
  • Moenie AO COD LIVER OIL met enige ander persoon deel nie.
  • Indien enige van die newe-effekte ernstig word, of indien u enige newe-effekte opmerk wat nie in hierdie blaadjie gelys word nie, lig asseblief u gesondheidsorgverskaffer in.

In hierdie blaadjie:

  1. Wat AO cod liver oil is en waarvoor dit gebruik word
  2. Wat u nodig het om te weet voordat u AO cod liver oil neem
  3. Hoe om AO cod liver oil te neem
  4. Moontlike newe-effekte
  5. Hoe om AO cod liver oil te berg
  6. Inhoud van die pakkie en ander inligting
  1. WAT AO COD LIVER OIL IS EN WAARVOOR DIT GEBRUIK WORD

AO Cod Liver Oil is saamgestel uit olie wat uit die lewer van die Gadus morhua, die Atlantiese kabeljou, geëkstraheer is. Dit word algemeen as ʼn dieetaanvulling, wat as bron van omega 3-vetsure (EPS en DHS), vitamien A, en vitamien D dien, gebruik. Daar word geglo dat lewertraan oor die potensiaal beskik om kognitiewe gesondheid en breinfunksie te ondersteun.

2. AO COD LIVER OIL NEEM

MOENIE AO COD LIVER OIL neem nie

Moenie AO Cod Liver Oil neem indien u ʼn bekende hipersensitiwiteit vir enige van die bestanddele het nie (sien Wat AO COD LIVER OIL bevat).

Waarskuwings en voorsorgmaatreëls

AO Cod Liver Oil moet met sorg gebruik word in:

  • Ander medisyne en AO COD LIVER OIL).

Ander medisyne en AO COD LIVER OIL

Lig altyd u gesondheidsorgverskaffer in indien u enige ander medisyne neem. (Dit sluit alle aanvullende of tradisionele geneesmiddels in.)

AO Cod Liver Oil mag interaksies met die onderstaande medikasie hê. Omsigtigheid is nodig wanneer dit gesamentlik gebruik word.

Antistolmiddels/Antiplaatjiemedikasie:

AO Cod Liver Oil mag ʼn interaksie met antistolmiddels/antiplaatjiemedikasie hê wat tot ʼn verhoogde risiko vir bloeding mag bydra. Pasiënte wat warfarien neem, moet vir INR-veranderinge gemonitor word.

Antihipertensiewe medikasie:

AO Cod Liver Oil mag ʼn interaksie met antihipertensiewe geneesmiddels hê wat tot ʼn verdere daling in bloeddruk mag bydra.

AO COD LIVER OIL met voedsel

AO COD LIVER OIL kan met of sonder kos geneem word (sien HOE OM AO COD LIVER OIL TE NEEM).

Swangerskap en borsvoeding

Indien u swanger is of borsvoed, vermoed dat u swanger is, of beplan om ʼn baba te hê, raadpleeg asseblief u dokter, apteker of ander gesondheidsorgverskaffer vir advies voordat u AO COD LIVER OIL neem.

Bestuur en die gebruik van masjinerie

Geen spesifieke studies is gedoen nie. Gegewe die newe-effekprofiel daarvan, is dit onwaarskynlik dat AO COD LIVER OIL u vermoë om te bestuur of masjiene te bedryf, sal beïnvloed (sien MOONTLIKE NEWE-EFFEKTE).

Dit is nie altyd moontlik om te voorspel tot watter mate AO COD LIVER OIL met u daaglikse aktiwiteite mag inmeng nie. Maak asseblief seker dat u nie die bogenoemde aktiwiteite beoefen voordat u nie bewus is van die mate waartoe AO COD LIVER OIL u beïnvloed nie.

3. HOE OM AO COD LIVER OIL TE NEEM

Neem AO Cod Liver Oil altyd presies soos wat dit in hierdie blaadjie beskryf word of soos wat u dokter, apteker of gesondheidsorgverskaffer gesê het. Raadpleeg u dokter, apteker of gesondheidsorgverskaffer indien u onseker is.

Volwassenes en kinders 14 jaar en ouer: Neem 2 ml (een medisynemaat) daagliks met ʼn glas water. AO Cod Liver Oil kan met of sonder kos geneem word.

MOENIE DIE AANBEVOLE DOSIS OORSKRY NIE.

Indien u meer AO COD LIVER OIL geneem het as wat u moes

(Sien MOONTLIKE NEWE-EFFEKTE.)

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

Indien u vergeet om AO COD LIVER OIL te neem

Moenie ʼn dubbele dosis neem om vir ʼn vergete dosis op te maak nie.

4. MOONTILIKE NEWE-EFFEKTE

AO Cod Liver Oil kan newe-effekte hê. Nie alle newe-effekte is in hierdie blaadjie ingesluit nie. Sou u algemene gesondheid agteruitgaan of indien u enige ongunstige effekte ervaar terwyl u AO Cod Liver Oil neem, raadpleeg asseblief u gesondheidsorgverskaffer vir advies.

Algemene newe-effekte sluit buikongemak, diarree, winderigheid en naarheid/braking in.

Indien u enige newe-effekte opmerk wat nie in hierdie blaadjie genoem word nie, lig asseblief u dokter of apteker in.

AANMELDING VAN NEWE-EFFEKTE

Indien u newe-effekte kry, gesels met u professionele gesondheidsorgwerker. U kan newe-effekte ook aan die SARGP via die “6.04 Nadelige Middelreaksie-Aanmeldingsvorm” rapporteer; dit kan aanlyn onder die SARGP se publikasies by https://www.sahpra.org.za/Publications/Index/8 gevind word. Deur newe-effekte aan te meld, kan u help om meer inligting oor die veiligheid van AO COD LIVER OIL te voorsien.

5. HOE OM AO COD LIVER OIL TE BERG

Berg teen of benede 25 °C. Moenie aan direkte sonlig blootstel nie. Bewaar in die yskas na oopmaak. Gebruik binne 60 dae na oopmaak. HOU BUITE DIE BEREIK VAN KINDERS.

6. INHOUND VAN DIE PAKKI EN ANDER INLIGTING

Wat AO COD LIVER OIL bevat

Elke 5 ml AO COD LIVER OIL bevat:

Lewertraan (Gadidae)…………………………………………………………1800 mg

Wat verskaf:

Totale Omega 3 Vetsure…………………………………………..432 mg

EPA (Eicosapentaenoic Acid)…………………………………….144 mg

DHA (Docosahexaenoic Acid)……………………………………180 mg

Vitamien A……………………………………………………..1350 mcg RAE

Cholekalsiferol (Vitamien D3)………………..…………………………20 mcg

Waarna AO COD LIVER lyk en inhoud van die pakkie

ʼn Bleekgeel olie. Geëtiketteerde amberkleurige glasbottel met ʼn wit skroefdoppie. Verpakkingsgrootte van 237 ml.

HOUER VAN DIE SERTIFIKAAT VAN REGISTRASIE

TRUE HEALTH (EDMS.) BPK.
EENHEID 2, DUIKERSTRAAT 8 BEACONVALE KAAPSTAD HULPLYN: (021) 701 7172  

HIERDIE BLAADJIE WAS LAAS HERSIEN OP

01 November 2021

REGISTRASIENOMMER

Sal deur die SARGP met registrasie uitgereik word.

TOEGANG TOT DIE OOREENSTEMMENDE PROFESSIONELE INLIGTING

Vir verdere inligting verwys na die Professionele Inligting van die produk wat by www.absoluteorganix.co.za beskikbaar is.