PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S0
VITAMINME OMEGA 3 + POWER (soft gelatine capsules)
Fish Oil
[Sardina pilchardus, Scomber scombrus, Engraulis encrasicolus, Engraulis ringens]
Sugar-free
Complementary Medicine: Health Supplement
This unregistered medicine has not been evaluated by SAHPRA for its quality, safety or intended use.
Read all of this leaflet carefully because it contains important information for you.
VITAMINME OMEGA 3 + POWER is available without a doctor’s prescription, for you to maintain your health. Nevertheless, you still need to use VITAMINME OMEGA 3 + POWER carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Do not share VITAMINME OMEGA 3 + POWER with any other person.
- Ask your healthcare provider or pharmacist if you need more information or advice.
What is in this leaflet
- What VITAMINME OMEGA 3 + POWER is and what it is used for
- What you need to know before you use VITAMINME OMEGA 3 + POWER
- How to use VITAMINME OMEGA 3 + POWER
- Possible side effects
- How to store VITAMINME OMEGA 3 + POWER
- Contents of the pack and other information
1. What VITAMINME OMEGA 3 + POWER is and what it is used for
VITAMINME OMEGA 3 + POWER is a health supplement that provides a source of omega-3 fatty acids for the maintenance of good health, helps to maintain cardiovascular health, and helps to support cognitive health and brain function.
2. What you need to know before you use VITAMINME OMEGA 3 + POWER
A varied diet is the most effective and safe way to achieve good nutrition, health, body composition as well as mental and physical performance.
Do not use VITAMINME OMEGA 3 + POWER:
- If you are hypersensitive (allergic) to fish or any of the other ingredients of VITAMINME OMEGA 3 + POWER (listed in section 6).
Warnings and precautions
Take special care:
- If you have a medical condition or if you are currently taking any other medicine.
- If you have a bleeding disorder or are taking blood thinners.
- If you are asthmatic with sensitivity to aspirin.
Children and adolescents
VITAMINME OMEGA 3 + POWER is not recommended for individuals below the age of 18 years.
Other medicines and VITAMINME OMEGA 3 + POWER
Always tell your healthcare provider if you are taking any other medicine. This includes all complementary or traditional medicines.
The following medicines may cause an interaction with VITAMINME OMEGA 3 + POWER:
- Anticoagulant/antiplatelet medicine: Fish oil may have antiplatelet effects and may increase the risk of bleeding if used with anticoagulant/antiplatelet medicine.
- Antihypertensive medicine: Fish oil may increase the risk of hypotension when used with antihypertensive medicine.
- Contraceptive medicine: Contraceptive medicine may decrease the triglyceride-lowering effects of fish oil when taken concomitantly.
- Cyclosporine: Fish oil might increase levels and adverse effects of cyclosporine.
- Orlistat: Taking fish oil with orlistat might decrease the absorption of fish oil fatty acids.
- Sirolimus: Fish oil might increase levels and adverse effects of sirolimus .
- Tacrolimus: Fish oil might increase levels and adverse effects of tacrolimus.
VITAMINME OMEGA 3 + POWER with food and drink
VITAMINME OMEGA 3 + POWER has no known interaction with food and drink (see section 3).
Pregnancy, breastfeeding and fertility
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 healthcare provider for advice before using VITAMINME OMEGA 3 + POWER.
Safety for use during pregnancy and lactation has not been established.
Driving and using machinery
VITAMINME OMEGA 3 + POWER is unlikely to have an effect on your ability to drive a vehicle and operate machinery.
Patients should exercise caution before driving or using machinery until they are reasonably certain that VITAMINME OMEGA 3 + POWER does not adversely affect their performance.
3. How to use VITAMINME OMEGA 3 + POWER
Do not share medicines with any other person.
Always use VITAMINME OMEGA 3 + POWER exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults 18 years and older
Take 1 capsule daily after food, or as recommended by a healthcare provider.
Do not exceed the recommended dose.
If you take more VITAMINME OMEGA 3 + POWER than you should
In the event of an overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take this leaflet and the remaining capsules with you so the doctor will know what you have taken.
If you forget to take VITAMINME OMEGA 3 + POWER
Do not take a double dose to make up for individual forgotten doses.
4. Possible side effects
VITAMINME OMEGA 3 + POWER can have side effects.
Not all side effects reported for VITAMINME OMEGA 3 + POWER are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VITAMINME OMEGA 3 + POWER, please consult your healthcare provider for advice.
If any of the following happens, stop using VITAMINME OMEGA 3 + POWER and tell your doctor immediately, or go to the casualty department at your nearest hospital:
- swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing; rash or itching; fainting.
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to VITAMINME OMEGA 3 + POWER. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice any of the following:
Common side effects:
- gastrointestinal upset; nausea; diarrhoea; loose stools; burping more than usual; vomiting; fishy breath odour and aftertaste.
Side effects occurring with an unknown frequency:
- acid reflux; heartburn; abdominal bloating; abdominal or gastrointestinal pain; anorexia; flatulence; constipation; steatorrhea; fishy hiccups; metallic taste; headache; dizziness; inability to sleep; skin rashes; itching; skin irritation; exacerbation of asthma and apnea.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get side effects, inform your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of VITAMINME OMEGA 3 + POWER.
5. How to store VITAMINME OMEGA 3 + POWER.
- Store at or below 25 °C in a dry place away from moisture and direct sunlight.
- Store all medicines out of reach of children.
- Store in the original container until required for use.
- Do not use after the expiry date stated on the label.
- 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 VITAMINME OMEGA 3 + POWER contains
Each capsule contains: Fish Oil Providing Eicosapentaenoic Acid (EPA) Providing Docosahexaenoic Acid (DHA) | 1000,00 mg 180,00 mg 120,00 mg |
The other ingredients are : Bovine gelatine, Purified water
Sugar-free
What VITAMINME OMEGA 3 + POWER looks like and contents of the pack
Off-yellow, oval soft gelatin capsules. The capsules are packed in a clear, amber glass jar with a pressure seal and a white, ribbed screw cap lid.
Pack size: 30 softgel capsules.
Holder of Certificate of Registration
VitaminMe (Pty) Ltd
32 Fricker Road
Illovo
Johannesburg
South Africa
2196
This leaflet was last revised in
Will be allocated by SAHPRA upon registration.
Registration number
Will be allocated by SAHPRA upon registration.
PASIËNTINLIGTINGSBLAD
SKEDULERINGSTATUS: S0
VITAMINME OMEGA 3 + POWER (sagte gelatienkapsules)
Visolie
[Sardina pilchardus, Scomber scombrus, Engraulis encrasicolus, Engraulis ringens]
Suikervry
Komplementêre Medisyne: Gesondheidsaanvulling
Hierdie ongeregistreerde medisyne is nie deur SAHPRA vir gehalte, veiligheid of beoogde gebruik geëvalueer nie.
Lees hierdie inligtingsblad noukeurig deur want dit bevat inligting wat belangrik is vir u.
VITAMINME OMEGA 3 + POWER is beskikbaar sonder ‘n dokter se voorskrif, om jou gesondheid te handhaaf. Nietemin moet VITAMINME OMEGA 3 + POWER versigtig gebruik word ten einde die beste resultate te verkry.
- Hou hierdie inligtingsblad. Dit kan nodig wees dat jy dit weer lees.
- Moenie VITAMINME OMEGA 3 + POWER met enige ander persoon deel nie.
- Vra jou gesondheidsorgverskaffer of apteker indien jy meer inligting of advies nodig het.
Wat is in hierdie inligtingsblad
- Wat is VITAMINME OMEGA 3 + POWER en warvoor word dit gebruik
- Wat jy moet weet voordat jy VITAMINME OMEGA 3 + POWER gebruik
- Hoe om VITAMINME OMEGA 3 + POWER te gebruik
- Moontlike newe-effekte
- Hoe om VITAMINME OMEGA 3 + POWER te bêre
- Inhoud van die pak en ander inligting
1. Wat is VITAMINME OMEGA 3 + POWER en waarvoor word dit gebruik
VITAMINME OMEGA 3 + POWER is ‘n gesondheidsaanvulling wat ‘n bron van omega-3-vetsure verskaf vir die handhawing van goeie gesondheid, help om kardiovaskulêre gesondheid te handhaaf, en help om kognitiewe gesondheid en breinfunksie te ondersteun.
Wat jy moet weet voordat jy VITAMINME OMEGA 3 + POWER gebruik
‘n Gevarieerde dieet is die doeltreffendste en veiligste manier om goeie voeding, gesondheid, liggaamsamestelling, sowel as geestelike en fisiese prestasie te behaal.
Moenie VITAMINME OMEGA 3 + POWER neem nie:
- Indien jy hipersensitief (allergies) is vir vis of vir enige van die ander bestanddele van VITAMINME OMEGA 3 + POWER (gelys in afdeling 6).
Waarskuwings en voorsorgmaatreëls
Neem spesiale sorg:
- Indien jy ‘n mediese toestand het of as jy tans enige ander medisyne gebruik.
- Indien jy ‘n bloedingsversteuring het of bloedverdunners neem.
- Indien jy asmaties is en sensitiwiteit vir aspirien het.
Kinders en adolessente
VITAMINME OMEGA 3 + POWER word nie aanbeveel vir individue onder die ouderdom van 18 jaar nie.
Ander medisyne en VITAMINME OMEGA 3 + POWER
Lig altyd jou gesondheidsorgverskaffer in indien jy enige ander medisyne neem. Dit sluit aanvullende of tradisionele medisyne in.
Die volgende medisynes mag interaksie met VITAMINME OMEGA 3 + POWER hê:
- Antikoagulant / anti-plaatjie medisyne: Visolie kan anti-plaatjie effekte hê en kan die risiko van bloeding verhoog wanneer dit saam met anticoagulant / anti-plaatjie-medisyne gebruik word.
- Antihipertensiewe medisyne: Visolie kan die risiko van hipotensie verhoog wanneer dit saam met antihipertensiewe medisyne gebruik word.
- Voorbehoedmiddels: Voorbehoedmiddels kan die trigliseriede-verlagende effekte van visolie verminder wanneer dit gelyktydig geneem word.
- Siklosporien: Visolie kan vlakke en nadelige effekte van siklosporien verhoog.
- Orlistate: Die neem van visolie saam met orlistat kan die absorpsie van visolie-vetsure verminder.
- Sirolimus: Visolie kan die vlakke en nadelige effekte van sirolimus verhoog.
- Takrolimus: Visolie kan vlakke en nadelige effekte van takrolimus verhoog.
VITAMINME OMEGA 3 + POWER met kos en drinkgoed
VITAMINME OMEGA 3 + POWER het geen bekende interaksie met kos of drinkgoed nie (sien afdeling 3).
Swangerskap, borsvoeding en vrugbaarheid
Indien jy swanger is of jou baba borsvoed, vermoed dat jy swanger mag wees of beplan om swanger te raak, raadpleeg asseblief jou dokter, apteker of ander gesondheidsorgverskaffer voordat jy VITAMINME OMEGA 3 + POWER neem.
Veiligheid vir gebruik tydens swangerskap en laktasie is nie vasgestel nie.
Bestuur en die gebruik van masjinerie
Dit is onwaarskynlik dat VITAMINME OMEGA 3 + POWER jou vermoë om ‘n voertuig te bestuur en masjinerie te gebruik sal affekteer.
Pasiënte moet versigtig wees voordat hulle bestuur of masjinerie gebruik, totdat hulle redelik seker is dat VITAMINME OMEGA 3 + POWER nie hul werkverrigting nadelig beïnvloed nie.
2. Hoe om VITAMINME OMEGA 3 + POWER te gebruik
Moenie medisyne met enige ander persoon deel nie.
Gebruik VITAMINME OMEGA 3 + POWER altyd presies soos wat in hierdie inligtingsblad aangedui word, of soos wat jou dokter of apteker vir jou aangewys het. Vra gerus jou dokter of apteker indien jy onseker is.
Volwassenes 18 jaar en ouer
Neem 1 kapsule daagliks na ete, of soos aanbeveel deur jou gesondheidsorgverskaffer.
Moenie die aanbevole dosis oorskry nie.
Wat om te doen indien jy meer VITAMINME OMEGA 3 + POWER geneem het as wat jy moet
In die geval van ‘n oordosis, raadpleeg jou dokter of apteker. Indien nie een van hulle beskikbaar is nie, kontak die naaste hospitaal of gifsentrum. Neem hierdie inligtingsblad en die res van die kapsules saam sodat die dokter weet wat jy geneem het.
Indien jy vergeet het om VITAMINME OMEGA 3 + POWER te neem
Moenie ‘n dubbele dosis neem om op te maak vir die individuele dosisse wat oorgeslaan is nie.
3. Moontlike newe-effekte
VITAMINME OMEGA 3 + POWER kan newe-effekte hê.
Nie alle newe-effekte wat vir VITAMINME OMEGA 3 + POWER gerapporteer is, word in hierdie inligtingsblad ingesluit nie. Indien jou algemene gesondheid verswak of indien jy enige ongunstige effekte onderwind terwyl VITAMINME OMEGA 3 + POWER geneem word, raadpleeg asseblief jour gesondheidsverskaffer.
Indien jy enige van die volgende ervaar, hou op om VITAMINME OMEGA 3 + POWER te neem en sê dadelik vir jou dokter of gaan na die ongevalle-afdeling by jouse naase hospitaal:
- swelling van jou hande, voete, enkels, gesig, lippe en mond of keel, wat probleme kan veroorsaak met sluk en asemhaling; uitslag of gejeuk; floute.
Hierdie is baie ernstige newe-effekte. Indien jy dit het, mag jy ’n ernstige allergiese reaksie op VITAMINME OMEGA 3 + POWER gehad het. Jy mag dringende mediese bystand of hospitalisasie benodig.
Sê vir jou dokter indien jy enige van die volgende opmerk:
Algemene newe-effekte:
- gastroïntestinale onsteltenis; naarheid; diarree; los stoelgange; gereelde opbreek van wind (meer as gewoonlik); braking; Asem wat ‘n visagtige reuk het en visagtige nasmaak.
Newe-effekte wat met onbekende frekwensie voorkom:
- Sooibrand; abdominale opgeblasenheid; abdominale of gastroïntestinale pyn; anoreksie; winderigheid; hardlywigheid; steatoree; visagtige hik; metaalsmaak; hoofpyn; duiseligheid; onvermoë om te slaap; veluitslag; jeuk; velirritasie; verergering van asma en apnee.
Indien jy enige newe-effekte opmerk wat nie in hierdie inligtingsblad genome word nie, lig asseblief jou dokter of apteker in.
Rapportering van newe-effekte
Indien jy newe-effekte ondervind, bespreek dit met jou dokter of apteker. Jy kan ook newe-effekte aan SAHPRA rapporteer via die “6.04 Adverse Drug Reactions Reporting Form”, wat aanlyn by SAHPRA se publikasies beskikbaar is: http://www.sahpra.org.za/Publications/Index/8. Deur newe-effekte te rapporteer kan jy help om meer inligting rakende die veiligheid van VITAMINME OMEGA 3 + POWER te verskaf.
4. Hoe om VITAMINME OMEGA 3 + POWER te bêre
- Bêre by of onder 25 °C in ‘n droë plek weg van vog en direkte sonlig.
- Bêre alle medisyne buite bereik van kinders.
- Bêre in die oorspronklike houer tot benodig word vir gebruik.
- Moenie gebruik na die vervaldatum op dieetiketnie.
- Neem alle ongebruikte medisyne na u apteker terug.
- Moenie ongebruikte medisyne in afvoerpype of rioolsisteme (bv. toilette) weggooi nie.
5. Inhoud van die verpakking en ander inligting
Wat VITAMINME OMEGA 3 + POWER bevat
Elke kapsule bevat: Visolie | 1000,00 mg 180,00 mg |
Die ander bestanddele is xxxxxxxxxxxxxx
Suikervry
Hoe VITAMINME OMEGA 3 + POWER lyk en inhoud van die verpakking
Afgeel, oval sagte gelatienkapsules. Die kapsules word verpak in ‘n deursigtige, bruinkleurige glasfles met ‘n drukseël en ‘n wit, geribde skroefdop deksel.
Verpakkingsgrootte: 30 sagtegel kapsules.
Houer van Registrasiesertifikaat
VitaminMe (Edms.) Bpk.
Frickerpad 32
Illovo
Johannesburg
Suid-Afrika
2196
Hierdie inligtingsblad is laas hersien in
Sal met registrasie deur SAHPRA toegeken word.
Registrasienommer
Sal met registrasie deur SAHPRA toegeken word.
PROFESSIONAL INFORMATION
COMPLEMENTARY MEDICINE: HEALTH SUPPLEMENT
This unregistered medicine has not been evaluated by SAHPRA for its quality, safety or intended use.
SCHEDULING STATUS
S0
1. NAME OF THE MEDICINE
VITAMINME OMEGA 3 + POWER (soft gelatine capsules)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains: Fish Oil Providing Eicosapentaenoic Acid (EPA) Providing Docosahexaenoic Acid (DHA) | 1000,00 mg 180,00 mg 120,00 mg |
Sugar free.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Soft gelatine capsules.
25 mm, off-yellow oval soft gelatine capsule.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
VITAMINME OMEGA 3 + POWER is a health supplement that provides a source of omega-3 fatty acids for the maintenance of good health, helps to maintain cardiovascular health, and helps to support cognitive health and brain function.
4.2 Posology and method of administration
Posology
Adults 18 years and older: Take 1 capsule daily after food, or as recommended by a healthcare provider.
Do not exceed the recommended dose.
Method of administration
For oral use. To be taken after food.
4.3 Contraindications
- Hypersensitivity to fish or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
- VITAMINME OMEGA 3 + POWER should be used with caution by individuals with a bleeding disorder or on blood thinning medication, or those who are asthmatic with sensitivity to aspirin.
4.5 Interaction with other medicines and other forms of interaction
- Anticoagulant/antiplatelet medicine: Fish oil may have antiplatelet effects and may increase the risk of bleeding if used with anticoagulant/antiplatelet medicine.
- Antihypertensive medicine: Fish oil may increase the risk of hypotension when used with antihypertensive medicine.
- Contraceptive medicine: Contraceptive medicine may decrease the triglyceride-lowering effects of fish oil when taken concomitantly.
- Cyclosporine: Fish oil might increase levels and adverse effects of cyclosporine.
- Orlistat: Taking fish oil with orlistat might decrease the absorption of fish oil fatty acids.
- Sirolimus: Fish oil might increase levels and adverse effects of sirolimus.
- Tacrolimus: Fish oil might increase levels and adverse effects of tacrolimus.
4.6 Fertility, pregnancy and lactation
Safety in fertility, pregnancy and lactation has not been established.
4.7 Effects on ability to drive and use machines
Patients should exercise caution before driving or operating machinery until they are reasonably certain that VITAMINME OMEGA 3 + POWER does not adversely affect their performance.
4.8 Undesirable effects
VITAMINME OMEGA 3 + POWER is generally well tolerated.
Gastrointestinal disorders
Frequent: gastrointestinal upset, nausea, diarrhoea, loose stools, increased burping, vomiting, fishy breath odor and aftertaste.
Frequency unknown: acid reflux, heartburn, abdominal bloating, anorexia, flatulence, constipation, steatorrhea, fishy hiccups, metallic taste.
Neurological disorders
Frequency unknown: headache, dizziness, inability to sleep.
Skin and subcutaneous tissue disorders
Frequency unknown: skin rashes, itching, skin irritation.
Respiratory disorders
Frequency unknown: exacerbation of asthma and apnea.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.
4.9 Overdose
In the event of an overdose, undesirable effects as listed in 4.8 can be precipitated or be of increased severity.
Treatment of overdose is symptomatic and supportive.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Class and category: Category D 34.6 Fats, Oils and Fatty Acids
Omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), facilitate numerous important functions in the body and are required for the maintenance of good health. EPA and DHA help to maintain and support cardiovascular health, help to reduce serum triglyceride/triglycerol levels, and support cognitive health and brain function.
5.2 Pharmacokinetic properties
Omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), in fish oil are well absorbed as ethyl esters or triglycerides. The absorption process of fish oil EPA and DHA acids have been documented as being very efficient, with an absorption rate of about 95%, which is similar to that of other ingested fats. The mechanism by which EPA and DHA acids are capable of reducing serum triglyceride levels is not yet fully understood.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Softgel capsule shell:
Bovine gelatine
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
24 months.
6.4 Special precautions for storage
Store at or below 25 °C.
Store in a dry place away from direct sunlight and moisture.
Store in the original packaging until required for use.
6.5 Nature and contents of container
Clear, amber glass jar with a pressure seal and a white, ribbed screw cap lid.
Pack size: 30 soft gelatine capsules.
6.6 Special precautions for disposal
No special requirements.
7. HOLDER OF CERTIFICATE OF REGISTRATION
VitaminMe (Pty) Ltd
32 Fricker Road
Illovo
Johannesburg
South Africa
2196
8. REGISTRATION NUMBER
Will be allocated by SAHPRA upon registration.
9. DATE OF FIRST AUTHORISATION
Will be allocated by SAHPRA upon registration.