Equazen® Liquid
Liquid
Product Information Leaflet
SCHEDULING STATUS: S0
300 mg Omega-3 and 410 mg Omega-6
Sugar free
- Complementary medicine Health supplement
- This unregistered medicine has not been evaluated by SAHPRA for its quality, safety or intended use.
Read this leaflet carefully because it contains important information for you.
EQUAZEN® liquid is available without a doctor’s prescription and is intended for you to maintain health.
Please take note of the following information:
- Keep this leaflet. You may need to read it again.
- Do not share EQUAZEN® liquid with any other person.
- Ask your doctor or pharmacist if you need more information or advice.
WHAT IS IN THIS LEAFLET
- What EQUAZEN® liquid is and what it is used for.
- What you need to know before you take EQUAZEN® liquid.
- How to take EQUAZEN® liquid.
- Possible side effects.
- How to store EQUAZEN® liquid.
- Contents of the pack and other information.
1. WHAT EQUAZEN® LIQUID IS AND WHAT IT IS USED FOR:
EQUAZEN® liquid is a scientifically developed formulation of essential omega-3 and omega-6 that can help to:
- Provide a balanced supplementation of essential omega-3 and omega-6 fatty acids (EPA, DHA and GLA) to mainstream population who may be deficient in such macronutrients;
- Support during growth those metabolic processes that are dependant from fatty acids intake, like neurodevelopment and brain functions;
- Sustain those conditions associated with low organic fatty acids presence, like attention and concentration problems, hyperactivity, learning difficulties, delayed speech development and all symptoms present in neurodevelopmental disorders (Attention-deficit/hyperactivity Disorders (ADHD), Autism spectrum Disorder (ASD), dyslexia and dyspraxia).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EQUAZEN® LIQUID:
Do not use EQUAZEN® liquid:
- If your child has a known hypersensitivity to fish or allergy to any of the ingredients of EQUAZEN® liquid (listed in section 6).
- In children younger than 3 years old.
Warnings and precautions:
This product is not intended to be a replacement of a varied and balanced diet and a healthy lifestyle. Don’t exceed the recommended dose. Keep out from reach of children.
Consult your doctor in case of any doubt, if your child has any medical condition or are already taking any medications (as drugs, herbals or other products).
In particular, if your child is already using anticoagulant or antiplatelet agents such as warfarin, inform your doctor if your child would like to start using EQUAZEN® liquid. The dosage of the anticoagulant or antiplatelet may need to be monitored while on concurrent fatty acid supplementation and in some cases adjusted to avoid unwanted side effects i.e. increase of the bleeding time, see also “Other medicine and EQUAZEN® liquid”.
However you may know that this above has been reported more frequently with omega-3 medications used at high doses, in support of cardiovascular disorders (therefore not the case of EQUAZEN® liquid).
If your child is planning to undergo a surgical procedure (e.g. dental surgeries) or a diagnostic invasive procedure or any other condition with the risk of bleeding episodes, inform your doctor you are taking EQUAZEN® liquid, as the bleeding time might be in some cases increased.
As no data have been collected on subjects with liver, cardiac or renal impairment, special caution and monitoring is advised; ask your doctor whether EQUAZEN® liquid can be used.
Other medicines and EQUAZEN® liquid:
There are no known interactions with other products.
However, always inform your healthcare provider, if your child is taking any other medicine before starting supplementation with EQUAZEN® liquid.
There is no evidence to date supporting an increased risk of bleeding when EQUAZEN® liquid is used at the recommended daily doses, even with concurrent anticoagulant agents such as warfarin.
However, some patients using anticoagulants or antiplatelets, may require additional monitoring and or dose adjustment to avoid adverse events when on fatty acid supplementation.
Pregnancy and Breastfeeding:
EQUAZEN® liquid is not intended for use in pregnant and breastfeeding women.
Driving and using machines:
EQUAZEN® liquid is for children aged 3 years onwards. Therefore this section is not applicable for them.
3. HOW TO TAKE EQUAZEN® LIQUID:
Do not share EQUAZEN® liquid with any other person.
Always take EQUAZEN® liquid as advised in this leaflet or as your doctor or pharmacist has told you.
Patient population and dosage:
- Suitable for use in children aged 3 years onwards.
- Starting dose: the recommended dosage is 15 ml daily (5 ml x 3 times daily) for the first 3 months. 5 ml correspond to a full teaspoon.
- Maintenance dose: the recommended dosage is 5 ml daily.
Liquid to be swallowed as it is or mixed with liquid food.
If you take more EQUAZEN® liquid than the daily dosage:
It might be helpful for you to know that no reports of overdose have been reported with EQUAZEN® liquid so far.
However, you might experience one of the symptoms listed in section 4, maybe with greater severity.
In case of severe overdosing and while anticoagulant/antiplatelet agents are in use, risk of prolonged bleeding time cannot be excluded.
However, in any case of overdose, you are invited to stop EQUAZEN® liquid. Unwanted effects may revert spontaneously or after medical treatment.
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 a dose of EQUAZEN® liquid:
Do not give your child a double dose to make up for forgotten individual doses.
If you stop using EQUAZEN® liquid:
You can stop giving EQUAZEN® liquid to your child whenever you prefer or as your doctor or pharmacist has told you.
4. POSSIBLE SIDE EFFECTS:
EQUAZEN® liquid can have side effects.
Not all side effects reported for EQUAZEN® liquid are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking EQUAZEN® liquid, please consult your health care provider for advice.
The list below includes the typical side effects reported with EQUAZEN® liquid with frequency not known.
- Hypersensitivity
- Altered taste in the mouth
- Gastrointestinal symptoms including dyspepsia (abdominal discomfort, abdominal pain, gastritis), reflux, nausea, wind (flatulence, eructation, abdominal distension, constipation, diarrhoea)
- Skin rash, itching.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects:
If your child get side effects, talk to your doctor or pharmacist. By reporting side effects, you can help provide more information on the safety of EQUAZEN® liquid.
5. HOW TO STORE EQUAZEN® LIQUID:
- Store the product out of reach of children.
- Store below 25°C in a dry place.
- Shake the bottle before use.
- Refrigerate after opening and consume within 3 months.
- Any change in the density of the product, after resealing and returning to the refrigerator, will not compromise its quality.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
6. CONTENTS OF THE PACK AND OTHER INFORMATION:
WHAT EQUAZEN® LIQUID CONTAINS (5 ml):
The active substances are 620 mg of Fish oil concentrated:
300 mg Omega-3 fatty acids (fish oils) of which:
- EPA (eicosapentaenoic acid): 186 mg
- DHA (docosahexaenoic acid): 58 mg
Evening primrose oil, (Oenothera biennis L.): 200 mg
410 mg Omega-6 fatty acids of which:
- GLA (gamma-linolenic acid): 20 mg
Ingredients: Sunflower oil and Lemon flavours; antioxidant: tocopherol-rich extract.
What EQUAZEN® liquid looks like and contents of the pack:
EQUAZEN® liquid is a clear yellow oil. Pack sizes of 200 ml bottles.
HOLDER OF CERTIFICATE OF REGISTRATION:
SFI South Africa (Pty) Ltd
121 Mitchell Street
George, 6529
Tel: +27 (44) 874 2927
THE LEAFLET WAS LAST REVISED IN:
July 2022
Application number:
To be allocated.
Access to the corresponding Professional information:
Visit za.sfihealth.com
Equazen® Liquid
Vloeistof
Pasiëntinligtingsblaadjie
SKEDULERINGSTATUS: S0
300 mg Omega-3 and 410 mg Omega-6
Suiker vry
- Komplementêre medisyne Gesondheidsaanvulling.
- Hierdie ongeregistreerde medisyne is nie deur SAHPRA vir kwaliteit, veiligheid en sy bedoelde gebruik geëvalueer nie.
Lees asseblief hierdie inligtingsblaadjie deur aangesien dit belangrike inligting vir jou bevat.
EQUAZEN® liquid is sonder ‘n doktersvoorskrif beskikbaar om by te dra tot goeie gesondheid.
Neem kennis van die volgende inligting:
- Hou hierdie blaadjie. Jy sal dit dalk weer wil deurlees.
- Moenie EQUAZEN® liquid met enige ander persoon deel nie.
- Vra jou dokter of apteker indien jy verdere inligting of raad nodig het.
WAT IS IN HIERDIE BLAADJIE
- Wat is EQUAZEN® liquid en waarvoor word dit gebruik.
- Wat jy moet weet voordat jy EQUAZEN® liquid neem.
- Hoe om EQUAZEN® liquid te neem.
- Moontlike newe-effekte.
- Hoe om EQUAZEN® liquid te stoor.
- Inhoud van die verpakking en ander inligting.
1. WAT IS EQUAZEN® LIQUID EN WAARVOOR WORD DIT GEBRUIK:
EQUAZEN® liquid is ‘n wetenskaplik ontwikkelde formulering van essensiële omega-3- en omega-6-vetsure wat help om:
- ‘n Gebalanseerde aanvulling van essensiële omega-3- en omega-6-vetsure (EPS, DHS en GLS) aan hoofstroom populasie te verskaf, wat ‘n tekort het aan sulke makronutrïente.
- Groei te ondersteun gedurende die metabolise prosesse wat afhanklik is van vetsuurinname, byvoorbeeld neuro-ontwikkeling en breinfunksies.
- Die kondisies te ondersteun, geassosieer met lae organiese vetsuur teenwoordigheid soos aandag en konsentrasie probleme, hiperaktiwiteit, leerprobleme, vertraagde spraakontwikkeling en alle simptome teenwoordig by neuro-ontwikkeling afwykings (Aandag-afleibare sindroom (AAS), outisme spektrum afwykings (OSA), disleksie en dispraksie).
2. WAT JY MOET WEET VOORDAT JY EQUAZEN® LIQUID NEEM:
Moet nie EQUAZEN® liquid neem nie:
- As jy hipersensitief (allergies) is vir vis of enige van die bestanddele van EQUAZEN® liquid (gelys onder punt 6).
- By kinders jonger as 3 jaar.
Waarskuwings en voorsorgmaatreëls:
Die produk is nie bedoel om ‘n gevarieerde en gebalanseerde dieët en ‘n gesonde leefstyl te vervang nie. Moenie die aanbevele dosis oorskry nie. Hou buite bereik van kinders.
Raadpleeg jou dokter indien jy onseker voel oor enige medikasie, aanvullings of kruie-medisyne wat jou kind saam met Equazen neem, of indien jou kind aan ‘n mediese kondisie ly.
Indien jou kind reeds antikoagulante of antiplaatjie middels soos warfarien gebruik, moet jy jou dokter laat weet as jou kind EQUAZEN® liquid wil begin gebruik. Die dosis van die antikoagulant of die antiplaatjies middel moet moontlik gemonitor word tydens gelyktydige vetsuuraanvulling en in sommige gevalle aangepas word om ongewenste newe-effekte te voorkom bv die verhoging van die bloedingstyd, sien ook “Ander medisyne en EQUAZEN® liquid”.
Ons weet egter dat hierdie bogenoemde meer gereeld gerapporteer word met omega-3-medikasie wat in hoë dosisse gebruik word, ter ondersteuning van kardiovaskulêre afwykings (dus nie die geval met EQUAZEN® liquid nie).
As jou kind van plan is om ‘n chirurgiese prosedure te ondergaan (bv. Tandheelkundige operasies) of ‘n diagnostiese indringende prosedure met die risiko van bloeding, lig jou gesondheidsorgdeskundige / dokter in dat jy EQUAZEN® liquid neem, aangesien die bloedingstyd in sommige gevalle kan toeneem.
Aangesien daar geen data versamel is oor persone met lewer-, hart- of nierinkorting nie, word spesiale omsigtigheid en kontrole aanbeveel. Stel jou dokter in kennis indien jy lewer, hart of nier probleme het.
Ander medikasie en EQUAZEN® liquid:
Daar is geen interaksie met ander produkte nie. Maar lig altyd jou gesondheidsorgkundige in oor enige ander medisyne wat jy gebruik, voordat jou kind EQUAZEN® liquid gebruik.
Tot op datum is daar geen kliniese bewyse dat daar ‘n verhoogde risiko van bloeding kan voorkom wanner die aanbevole daaglikse dosis gebruik word nie, selfs nie saam met antikoagulante soos warfarin nie.
Sommige pasiënte, veral ouer volwassenes wat antikoagulante / antistollingsmiddels gebruik, moet gekontrolleer word en ‘n dosisaanpassing mag nodig wees om newe-effekte te beperk wanneer vetsuuraanvulling begin of verander word.
Swangerskap en borsvoeding:
EQUAZEN® liquid is nie bedoel vir gebruik deur swanger vroue en vroue wat borsvoed nie.
Bestuur en gebruik van borsvoeding:
EQUAZEN® liquid is vir kinders van 3 jaar en ouer. Daarom is hierdie afdeling nie op hulle van toepassing nie.
3. HOE OM EQUAZEN® LIQUID TE NEEM:
Moenie medisyne wat vir jou voorgeskryf is, met ander persone deel nie.
Neem EQUAZEN® liquid presies soos voorgeskryf in hierdie blaadjie, of soos voorgeskryf deur jou dokter of apteker.
Pasiëntpopulasie en dosering:
- Geskik vir gebruik in kinders vanaf 3 jarige ouderdom en ouer.
- Aanvangsdosis: vir die eerste 3 maande is die aanbevele dosis 15 ml (5 ml x 3 keur daagliks) daagliks.
- Onderhoudsdosis: die aanbevele dosis is 5 ml daagliks.
Vloeistof moet ingesluk word soos dit is of gemeng word met vloeibare voedsel.
As jy meer EQUAZEN® liquid neem as wat jy behoort:
Dit kan handig te pas kom om te weet dat daar tot dusver geen oordosering met EQUAZEN® liquid aangemeld is nie. Jy kan egter een van die simptome in afdeling 4 ervaar, miskien met ‘n groter erns. In die geval van ernstige oordosering en terwyl antikoagulant / antiplatelet gebruik word, kan die risiko van langdurige bloedingstyd nie uitgesluit word nie.
In alle gevalle van oordosis word jy egter uitgenooi om EQUAZEN® liquid te stop. Ongewenste effekte kan spontaan of na mediese behandeling terugkeer. Raadpleeg jou dokter of apteker, as daar nie een beskikbaar is nie, kontak die naaste hospitaal of gifsentrum vir advies.
As jy vergeet om EQUAZEN® liquid te neem:
Moenie ‘n dubbele dosis neem om die dosisse wat vergeet is, op te maak nie.
As jy ophou om EQUAZEN® liquid te gebruik:
Jy kan ophou om EQUAZEN® liquid aan jou kind te gee wanneer jy verkies of soos deur jou dokter of apteker gesê is.
4. MOONTLIKE NEWE-EFFEKTE:
EQUAZEN® liquid kan newe-effekte hê.
Nie alle newe-effekte vir EQUAZEN® liquid is aangemeld nie, of in hierdie pamflet opgeneem nie. As jou algemene gesondheid vererger, of as jy ‘n ongunstig effek ervaar tydens die gebruik met EQUAZEN® liquid, raadpleeg jou gesondheidsorgverskaffer vir advies.
Die onderstaande lys bevat die tipiese newe-effekte van EQUAZEN® liquid en die frekwensie daarvan is nie bekend nie.
- Hipersensitiwiteit
- Veranderde smaak in die mond
- Gastriese afwyking insluitend dispepsie (ongemak in die buik, buikpyn, gastritis), refluks, naarheid, winderigheid
- Veluitslag en jeuk
Indien jy enige newe-effekte opmerk wat nie in hierdie pamflet genoem word nie, lig jou dokter of apteker in.
Rapportering van newe-effekte:
Praat met jou dokter of apteker as jou kind newe-effekte ervaar. Deur newe-effekte aan te meld, kan jy help om meer inligting te verskaf oor die veiligheid van EQUAZEN® liquid.
5. HOE OM EQUAZEN® LIQUID TE BEWAAR:
- Bewaar alle medisyne buite die bereik van kinders.
- Bewaar onder 25°C op ‘n droë plek.
- Skud die bottel voor gebruik.
- Hou binne in die yskas nadat dit oopgemaak is en gebruik binne 3 maande.
- Enige verandering in die digtheid van die produk, nadat dit heropen en teruggekeer het in die yskas, sal die kwaliteit daarvan nie in gedrang bring nie.
Besorg alle ongebruikte medisyne terug aan u apteker.
Moenie ongebruikte medisyne in dreine of rioolstelsels (bv. Toilette) weggooi nie.
6. INHOUD VAN DIE VERPAKKING EN ANDER INLIGTING:
WAT EQUAZEN® LIQUID BEVAT (5 ml):
Die aktiewe bestanddele is 620 mg Visolie gekonsentreerd:
300 mg Omega-3-vetsure (visolies) waarvan:
- EPA (eikosapentaensuur): 186 mg
- DHA (docosahexaeenzuur): 58 mg
Aandblomolie, (Oenothera biennies L.): 200 mg
410 mg Omega-6-vetsure waarvan:
- GLA (gamma-linoleensuur): 20 mg
Bestanddele: Sonneblomolie en suurlemoengeure; antioksidant: tokoferol-ryk onttrek.
Hoe EQUAZEN® liquid lyk en die inhoud van die verpakking:
EQUAZEN® liquid is ‘n duidelike geel olie. Pakgroottes van 200 ml bottels.
HOUER VAN DIE REGISTRASIESERTIFIKAAT:
SFI Suid Afrika (Pty) Ltd
Mitchellstraat 121
George, 6529
Tel: +27 (44) 874 2927
DIE BLAADJIE IS LAAS HERSIEN IN:
Julie 2022
Aansoeknommer:
Word toegeken.
Toegang tot die professionele inligting:
Besoek za.sfihealth.com