Vitamin d3 drops
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: Unscheduled.
Category D: Complementary medicine.
Discipline: Health supplement
D34.11: Vitamin
PROPRIETARY NAME, STRENGTH, AND PHARMACEUTICAL FORM
Vitamin D3 , 20 ml
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU
- VITAMIN D3 is available without a doctor’s prescription.
- Nevertheless, you still need to use VITAMIN D3 carefully to get the best results from it.
- Do not share VITAMIN D3 with any other person.
- Ask your pharmacist or healthcare practitioner if you need more information or advice.
WHAT IS IN THIS LEAFLET
- What is VITAMIN D3 and what it is used for.
- What do you need to know before you take VITAMIN D3.
- How do you take VITAMIN D3.
- Possible side effects.
- How to store VITAMIN D3.
- Contents of the pack and other information.
WHAT DOES VITAMIN D3 CONTAIN
Each 1 drop (0.032 ml) of VITAMIN D3 contains the following actives:
Vitamin D3 (Cholecalciferol) | 1000 IU |
Other ingredients:
Medium chain triglyceride (MCT) oil
Orange flavour
Contains no animal products.
Free from: Gluten, wheat, salt, sugar, dairy, soya, yeasts and preservatives.
WHAT IS VITAMIN D3 USED FOR
VITAMIN D3 is formulated to assist with bone health, immune function and other metabolic disorders and contributes to the maintenance of good health.
WHAT DO YOU NEED TO KNOW BEFORE TAKING VITAMIN D3
Do not take VITAMIN D3 if you are hypersensitive (allergic) to any of the ingredients.
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, please consult your healthcare practitioner before using this medicine.
TAKING OTHER MEDICINES WITH VITAMIN D3
Always tell your healthcare provider if you are taking any other medicine.
HOW TO TAKE VITAMIN D3
Do not share medicines prescribed for you with any other person. Always take VITAMIN D3 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: 1 drop per day or as directed by your health practitioner.
Never exceed dosage. Take with a meal.
This medication may interfere with certain laboratory tests (including cholesterol tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this medicine.
IF YOU TAKE MORE VITAMIN D3 THAN YOU SHOULD
In the event of overdosage, consult your doctor, pharmacist. Should none of these be available, contact the nearest hospital.
IF YOU FORGET TO TAKE VITAMIN D3
Do not take a double dose to make up for a missed dose.
POSSIBLE SIDE EFFECTS
VITAMIN D3 may have side effects.
If you have been diagnosed with hypervitaminosis D, hypercalcemia, malabsorption, heart disease, kidney disease, an electrolyte imbalance, consult your healthcare professional for advice before use.
Should you be taking any of the following medication, do not take before consulting your healthcare practitioner before use: aluminum, antacids, anticonvulsants, psoriasis medication, blood pressure, weight loss prescribed medication, diuretics, steroids, laxatives.
If any of the following happens, stop using VITAMIN D3 and tell your doctor or go to the casualty department at your nearest hospital:
- chest pain, feeling short of breath
- Diarrhoea, constipation, and stomach pain
- early signs of vitamin D overdose–weakness, metallic taste in your mouth, weight loss, muscle or bone pain, constipation, nausea, and vomiting.
These are all very serious effects. If you have them, you may have had a serious reaction to VITAMIN D3 . You may need urgent medical attention or hospitalisation.
Not all side effects reported for VITAMIN D3 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 VITAMIN D3.
STORAGE AND DISPOSING OF VITAMIN D3
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 VITAMIN D3 if you notice visible signs of deterioration.
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
PRESENTATION OF VITAMIN D3
Product is presented in a bottle, with a black lid and a branded label.
IDENTIFICATION OF VITAMIN D3
Liquid
REGISTRATION NUMBER
TBA.
NAME AND ADDRESS OF REGISTRATION HOLDER
Applicant:
Sparta Pharmaceuticals
20 Plane Road,
Spartan, 1619
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
ACCESS TO THE CORRESPONDING PROFESSIONAL INFORMATION
See information on the website above.
THIS LEAFLET WAS LAST REVISED ON
25th January 2023
PASIËNTINLIGTINGSBLAADJIE
SKEDULERINGSTATUS: Ongeskeduleer.
Kategorie D: Komplementêre Medisyne.
Dissipline: 34.11 Vitamien
EIE NAAM, STERKTE EN FARMASEUTIESE VORM
Vitamien D3 , 20 ml
LEES HIERDIE VOUBILJET NOUKEURIG, WANT DIT BEVAT BELANGRIKE INLIGTING VIR U
- VITAMIEN D3 is beskikbaar sonder die voorskrif van ‘n dokter.
- Jy moet steeds VITAMIEN D3 versigtig gebruik om die beste resultate daaruit te kry.
- Hou hierdie voubiljet. Miskien moet u dit weer lees.
- Moenie VITAMIEN D3 met enige ander persoon deel nie.
- Vra jou apteker of gesondheidsorgpraktisyn of jy meer inligting of advies benodig.
WAT IS IN HIERDIE VOUBILJET
- Wat VITAMIEN D3 is en waarvoor dit gebruik word.
- Wat jy moet weet voordat jy VITAMIEN D3 neem.
- Hoe om VITAMIEN D3 te neem.
- Moontlike newe-effekte.
- Hoe om VITAMIEN D3 te stoor.
- Inhoud van die verpakking en ander inligting.
WAT VITAMIEN D3 BEVAT
Elke 1 druppel (0,032 ml) VITAMIEN D3 bevat die volgende aktiewe middels:
Vitamien D3 (Cholecalciferol) | 1000 IE |
Ander bestanddele:
Medium ketting trigliseried (MCT) olie
Oranje geur
Bevat geen diereprodukte nie.
Vry van: Gluten, koring, sout, suiker, suiwel, soja, giste, preserveermiddels.
WAARVOOR VITAMIEN D3 GEBRUIK WORD
VITAMIEN D3 is geformuleer om te help met beengesondheid, immuunfunksie en ander metaboliese afwykings en dra by tot die handhawing van goeie gesondheid.
VOORDAT JY VITAMIEN D3 NEEM
Moenie VITAMIEN D3 inneem as jy hipersensitief (allergies) vir enige van die bestanddele is 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 voordat u hierdie medisyne gebruik.
BESTUUR EN GEBRUIK MASJIENE
Dit is nie altyd moontlik om te voorspel in watter mate VITAMIEN D3 die daaglikse aktiwiteite van ‘n pasiënt kan inmeng nie. Pasiënte moet seker maak dat hulle nie betrokke raak by aktiwiteite wat verband hou met geestelike waaksaamheid, oordeel en/of gesonde koördinasie en visie nie, byvoorbeeld bestuur, ry, vlieg, seil, masjiene / toerusting, totdat hulle bewus is van die maatstaf waarop VITAMIEN D3 jou raak.
NEEM ANDER MEDISYNE MET VITAMIEN D3
Vertel altyd u gesondheidsorgverskaffer of u enige ander medisyne gebruik.
HOE OM VITAMIEN D3 TE NEEM
Moenie medisyne wat vir u voorgeskryf is, met enige ander persoon deel nie. Neem altyd VITAMIEN D3 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: 1 druppel per day of soos aangedui deur jou gesondheidspraktisyn.
Moet nooit dosis oorskry nie. Neem saam met ‘n ete.
Hierdie medikasie kan inmeng met sekere laboratoriumtoetse (insluitend cholesteroltoetse), wat moontlik vals toetsuitslae kan veroorsaak. Maak seker laboratoriumpersoneel en al jou dokters weet jy gebruik hierdie medisyne.
AS JY MEER VITAMIEN D3 NEEM AS WAT JY MOET
In die geval van oordosis, raadpleeg u dokter, apteker. Indien nie een hiervan beskikbaar is nie, kontak die naaste hospitaal of gifbeheersentrum.
AS JY VERGEET OM VITAMIEN D3 TE NEEM
Moenie ‘n dubbele dosis neem om ‘n gemiste dosis op te maak nie.
MOONTLIKE NEWE-EFFEKTE
VITAMIEN D3 kan newe-effekte hê.
As u gediagnoseer is met hipervitaminose D, hiperkalsemie, wanabsorpsie, heart siekte, niersiekte, ‘n elektrolietwanbalans, raadpleeg u gesondheidswerker vir advies voor gebruik.
Indien jy enige van die volgende medikasie neem, moet jy nie neem voordat jy jou gesondheidsorgpraktisyn raadpleeg voor gebruik nie: aluminium, teensuurmiddels, ‘nnticonvulsants, psoriasemedikasie, bloeddruk, gewigsverlies voorgeskrewe medikasie, diuretika, steroïede, lakseermiddels.
As een van die volgende gebeur, hou op om VITAMIEN D3 te gebruik en vertel jou dokter of gaan na die ongevalle-afdeling by jou naaste hospitaal:
- borspyn, voel kort van asem
- Diarrhoea, hardlywigheid en maagpyn
- vroeë tekens van vitamien D oordosis – swakheid, metaal smaak in jou mond, gewigsverlies, spier- of beenpyn, hardlywigheid, naarheid en braking.
Dit is alles baie ernstige gevolge. As jy dit het, het jy dalk ‘n ernstige reaksie op VITAMIEN D3 gehad. Miskien het u dringende mediese hulp of hospitalisasie nodig.
Nie alle newe-effekte wat vir VITAMIEN D3 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 VITAMIEN D3 te verskaf.
BERGING EN WEGDOEN VAN VITAMIEN D3
Stoor alle medisyne buite bereik van kinders.
Berg 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 VITAMIEN D3 gebruik as jy sigbare tekens van agteruitgang sien nie.
Moenie ongebruikte medisyne in dreine of rioolstelsels (bv. toilette) weggooi nie.
AANBIEDING VAN VITAMIEN D3
Produk word aangebied in ‘n bottel, met ‘n swart deksel en ‘n handelsmerketiket.
IDENTIFIKASIE VAN VITAMIEN D3
Vloeistof.
REGISTRATION NOMMER
TBA.
NAAM EN ADRES VAN REGISTRASIEHOUER
Applikant:
Sparta Pharmaceuticals
20 Plane Weg,
Spartan, 1619
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
TOEGANG TOT DIE OOREENSTEMMENDE PROFESSIONELE INLIGTING
Sien inligting op die webwerf hierbo.
HIERDIE VOUBILJET IS LAAS HERSIEN OP
25 Januarie 2023