Equazen^® Capsules

CONTENT TO BE ADDED HERE

Twist-off capsules
Product Information Leaflet

120 mg Omega-3 and 42 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® baby is available without a doctor’s prescription and is intended for the maintenance of your baby’s health.

Please take note of the following information:

• Keep this leaflet. You may need to read it again.
• Do not share EQUAZEN® baby with any other person.
• Ask your doctor or pharmacist if you need more information or advise.

WHAT IS IN THIS LEAFLET:

1. What EQUAZEN® baby is and what it is used for.
2. What you need to know before you take EQUAZEN® baby.
3. How to take EQUAZEN® baby.
4. Possible side effects.
5. How to store EQUAZEN® baby.
6. Contents of the pack and other information.

1. WHAT EQUAZEN® BABY IS AND WHAT IT IS USED FOR:
EQUAZEN® baby is a scientifically developed formulation of essential omega-3 and omega-6 that can help to provide a balanced supplementation of essential fatty acids for babies once breastfeeding has stopped.

2.WHAT YOU NEED TO KNOW BEFORE YOU TAKE EQUAZEN® BABY:
Do not use EQUAZEN® baby:

• In case your baby has a known hypersensitivity to fish, or allergy to any of the ingredients of EQUAZEN® baby (listed in section 6);
• In neonates younger than 6 months.

Warnings and precautions:
This product is not intended to be a replacement of a varied and balanced diet and a healthy lifestyle for your baby. Don’t exceed the recommended dose. Keep out of the reach of young children.
Consult your doctor in case of any doubt, if your baby has any medical condition or if your baby is already taking any medications as drugs, herbals or other products.

In particular, if you are already giving your baby anticoagulant or antiplatelet agents inform your doctor that, you would like to start using EQUAZEN® baby. 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.

If your baby for some reason needs to undergo a surgical procedure or a diagnostic invasive procedure or in case of other condition with the risk of bleeding episodes, inform your doctor your baby is taking EQUAZEN® baby, as the bleeding time might be in some cases increased.

As no data have been collected on baby with liver, cardiac or renal impairment, special caution and monitoring is advised, ask your doctor whether EQUAZEN® baby can be used.

Other medicines and EQUAZEN® baby:
Always inform your healthcare professional if your baby is taking any other medicine before starting supplementation with EQUAZEN® baby.
There are no know interactions with other products. However, always inform your healthcare provider, if your baby is taking any other medicine before starting supplementation with EQUAZEN® baby.
There is no evidence to date supporting an increased risk of bleeding when EQUAZEN® baby is used at the recommended daily doses, even with concurrent anticoagulant agents.
However, some babies 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® baby is not intended for use in pregnant and breastfeeding women.

Driving and using machines:
EQUAZEN® baby is for infants from 6 months up to 3 years.
Therefore this section is not applicable for them.

3. HOW TO TAKE EQUAZEN® BABY:
Do not share EQUAZEN® baby with any other person.
Always take EQUAZEN® baby as advised in this leaflet or as your
healthcare doctor or pharmacist has told you.

Patient population and dosage:

• Suitable for use in neonates starting from 6 months and up to 3 years.
• Dosage: 1 twist off capsule per day.
• Don’t use the twist off capsule as a whole. Capsules have a tip to be twisted off to squeeze out the oily content. Only the content squeezed out from the capsule is to be mixed into 200 ml liquid or 200 g of baby food, including formula milk.

If your baby has been given more EQUAZEN® baby than the daily dosage:
No reports of overdose have been reported with EQUAZEN® baby.
However, symptoms expected are the ones listed in section 4 maybe with greater severity. In case of severe overdosing while on concomitant use of anticoagulant/antiplatelet agents, risk of prolonged bleeding time cannot be excluded.
Suspension or withdrawal of the product are recommended and should normally revert the unwanted effects spontaneously.
Overdosing with EQUAZEN® baby is unlikely to require special treatment and in any case is on symptomatic basis.
A doctor or pharmacist should be consulted promptly for advice and assistance.
If neither is available, contact the nearest hospital or poison control centre.

If you have forgotten to give EQUAZEN® baby to your baby:
Do not give your baby a double dose to make up for forgotten individual doses.

If you stop giving EQUAZEN® baby to your baby:
You can stop giving EQUAZEN® baby to your baby whenever you prefer or as your doctor or pharmacist has told you.

4. POSSIBLE SIDE EFFECTS:

EQUAZEN® baby can have side effects.
Not all side effects reported for EQUAZEN® baby are included in this leaflet. Should the general health of your baby worsen or if your baby experience any untoward effects while taking EQUAZEN® baby, please consult your health care provider for advice.
The list below includes the typical side effects reported with EQUAZEN® baby 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 your baby gets any side effects not mentioned in this leaflet, please inform your doctor or pharmacist. Reporting of side effects If your baby gets side effects, talk to your doctor or pharmacist. By reporting side effects, you can help provide more information on the safety of Equazen® baby.

5. HOW TO STORE EQUAZEN® BABY:

• Store the product out of reach of children.
• Store below 25°C in a dry place.

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® BABY CONTAINS:
The active substances are:
Fish oil concentrated 200 mg omega-3 fatty acids 120 mg of which:

• EPA (eicosapentaenoic acid) 14 mg
• DHA (docosahexaenoic acid) 100 mg

Evening Primrose oil (Onenothera biennis L.) 50 mg omega-6 fatty acids 42 mg of which:

• GLA (gamma-linolenic acid) 5 mg
• ARA (arachidonic acid) 5 mg
  Vitamin E (d-alpha tocopherol) 1.4 mg

The ingredients of the capsule shell are:
bovine gelatin, humectant: glycerol.

What EQUAZEN® baby look like and contents of the pack
EQUAZEN® baby pack contains 30 twist off capsules.

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

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Equazen^® Baby
Oopdraai kapsules
Pasiëntinligtingsblaadjie

120 mg Omega-3 and 42 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® baby 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® baby met enige ander persoon deel nie.
• Vra jou dokter of apteker indien jy verdere inligting of raad nodig het.

WAT IS IN HIERDIE BLAADJIE
1. Wat is EQUAZEN® baby en waarvoor word dit gebruik.
2. Wat jy moet weet voordat jy EQUAZEN® baby neem.
3. Hoe om EQUAZEN® baby te neem.
4. Moontlike newe-effekte.
5. Hoe om EQUAZEN® baby te stoor.
6. Inhoud van die verpakking en ander inligting.

1. WAT IS EQUAZEN® BABY EN WAARVOOR WORD DIT GEBRUIK:
EQUAZEN® baby is ‘n wetenskaplik ontwikkelde formulering van essensiële omega-3- en omega-6-vetsure wat help om ‘n gebalanseerde aanvulling van noodsaaklike vetsure te voorsien vir baba sodra borsvoeding gestop het.

2. WAT JY MOET WEET VOORDAT JY EQUAZEN® BABY NEEM:
Moenie EQUAZEN® baby gebruik nie:
• As jou baba hipersensitief is vir vis, of allergies is vir enige van die bestanddele van EQUAZEN® baby (gelys in afdeling 6);
• By pasgeborenes jonger as 6 maande.

Waarskuwings en voorsorgmaatreëls:
Hierdie produk is nie bedoel om ‘n vervanging van ‘n gevarieerde en gebalanseerde dieet en ‘n gesonde leefstyl vir jou baba te wees nie. Moenie die aanbevele dosis oorskry nie. Hou buite bereik van jong kinders. Raadpleeg jou dokter in geval van twyfel, as jou baba ‘n mediese toestand het, of as jou baba reeds medikasie gebruik (soos dwelms, kruie of ander produkte). Indien jou baba reeds antikoagulant of antiplaatjies middels gebruik, moet jy jou dokter laat weet as jy EQUAZEN® baby wil begin gebruik. Die dosis van die antikoagulant of die antiplaatjies middel moet moontlik gemonitor word tydens gelyktydige vetsuuraanvulling en in sommige gevalle aangepas om ongewenste newe-effekte te voorkom, maw die verhoging van die bloedingstyd. As jou baba om een of ander rede ‘n chirurgiese prosedure of ‘n diagnostiese indringende prosedure of enige ander toestand te ondergaan met die risiko van bloeding, lig jou dokter in kennis dat jou baba EQUAZEN® baby neem, aangesien die bloedingstyd in sommige gevalle kan toeneem. Aangesien daar geen data versamel is oor babas met ‘n lewer-, hart- of nierinkorting nie, word spesiale omsigtigheid en kontrole aanbeveel, vra jou dokter of EQUAZEN® baby gebruik kan word.

Ander medikasie en EQUAZEN® baby:
Daar is geen interaksie met ander produkte nie. Stel altyd jou gesondheidsorgkundige in kennis as jou baba op enige ander medisyne is voordat jou baba met EQUAZEN® baby begin. Daar is tot op datum geen bewyse dat daar ‘n verhoogde risiko van bloeding kan voorkom wanner die aanbevele daaglikse dosis gebruik word nie, selfs nie saam met antikoagulantia nie. Sommige babas wat antikoagulante of antistollingsmiddels gebruik, moet gekontrolleer word en ‘n dosisaanpassing mag nodig wees om newe-effekte te beperk wanner vetsuuraanvulling begin of verander word.

Swangerskap en laktasie:
EQUAZEN® baby is nie bedoel vir gebruik deur swanger vroue en vroue wat borsvoed nie.

Bestuur en gebruik van masjiene:
EQUAZEN® baby is vir babas van 6 maande tot 3 jaar. Daarom is hierdie afdeling nie op hulle van toepassing nie.

3. HOE OM EQUAZEN® BABY TE NEEM
Moenie medisyne wat vir jou voorgeskryf is, met ander persone deel nie. Neem EQUAZEN® baby presies soos voorgeskryf in hierdie blaadjie, of soos voorgeskryf deur jou dokter of apteker.

Pasiëntpopulasie en dosering:
• Geskik vir gebruik in babas vanaf 6 maande tot en met 3 jaar.
• Dosis: 1 kapsule per dag.
• Draai die kapsules se punt af om die olierige inhoud uit te pers in 200 ml vloeistof of 200 g babykos, insluitend formule-melk. Slegs die inhoud moet gebruik word en in ‘n vloeistof gegooi word, en nie die sagte gelatienkapsule nie.

As jy meer EQUAZEN® baby neem as wat jy behoort:
Geen oordosis met EQUAZEN® baby is aangemeld nie. Die verwagte simptome is egter die wat in afdeling 4 gelys word, miskien met groter erns. In die geval van ernstige oordosering tydens gelyktydige gebruik van antikoagulantia / plaagdoders kan die risiko van langdurige bloedingstyd nie uitgesluit word nie. Dit word aanbeveel om die produk op te skort of te onttrek en die ongewenste gevolge behoort normaalweg spontaan terug te draai. Oordosis met EQUAZEN® baby sal waarskynlik nie spesiale behandeling benodig nie en is in elk geval op simptomatiese basis. 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® baby vir jou baba te gee:
Moenie jou baba ‘n dubbele dosis gee om op te maak vir dosierings wat oorgeslaan is.

As jy ophou om EQUAZEN® baby aan jou baba gee:
Jy kan ophou EQUAZEN® baby aan jou baba te gee wanneer jy verkies, of soos jou dokter of apteker dit aan jou gesê het.

4. MOONTLIKE NEWE-EFFEKTE:
EQUAZEN® baby kan newe-effekte hê. Nie alle newe-effekte vir EQUAZEN® baby is aangemeld nie, of in hierdie pamflet opgeneem nie. As jou baba se algemene gesondheid vererger, of as jou baba ‘n ongunstig effek ervaar tydens die gebruik met EQUAZEN® baby, raadpleeg jou gesondheidsorgverskaffer vir advies.

Die onderstaande lys bevat die tipiese newe-effekte van EQUAZEN® baby 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 baba newe-effekte ervaar. Deur newe-effekte aan te meld, kan jy help om meer inligting te verskaf oor die veiligheid van EQUAZEN® baby.

5. HOE OM EQUAZEN® BABY TE BEWAAR:
• Bewaar alle medisyne buite die bereik van kinders.
• Bewaar onder 25 ° C, in ‘n droë plek.
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® BABY BEVAT:
Die aktiewe bestanddele is:
Visolie konsentraat 200 mg omega-3 vetsure 120 mg waarvan:
• EPS (eikosapentaenoësuur) 14 mg
• DHS (dokosaheksaenoësuur) 100 mg

Aandblomolie (Onenothera biennis L.) 50 mg
omega-6 vetsure 42 mg waarvan:
• GLS (gamma-linoleensuur) 5 mg
• AS (arakidoonsuur) 5 mg
Vitamien E (d-alfa-tokoferol) 1.4 mg

Die bestanddele van die kapselomhulsel is:
beesgelatien, bevogtigingsmiddel: gliserol.

Hoe EQUAZEN® baby lyk en die inhoud van die verpakking
EQUAZEN® baby is in pakgroottes van 30 oop draai kapsules.

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