PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S0
VITAMINME DAILY MULTIVITAMIN (film-coated tablets)
Ascorbic Acid, Echinacea purpurea (L.) Moench (Echinacea), Calcium D-Pantothenate, Nicotinamide, Thiamine Hydrochloride, Pyridoxine Hydrochloride, Zinc Gluconate, Alpha-Tocopherol, Ferrous Fumarate, Copper Sulphate, Riboflavin, Manganese, Vitamin A Acetate, Biotin, L-5-Methyltetrahydrofolic Acid, Methylcobalamin, Potassium Iodide, Selenium Amino Acid Chelate, Molybdenum, Chromium Polynicotinate, Cholecalciferol
Sugar free
Complementary Medicine: Combination Product
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 DAILY MULTIVITAMIN is available without a doctor’s prescription, for you to maintain your health. Nevertheless, you still need to use VITAMINME DAILY MULTIVITAMIN carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Do not share VITAMINME DAILY MULTIVITAMIN with any other person.
- Ask your healthcare provider or pharmacist if you need more information or advice.
What is in this leaflet
- What VITAMINME DAILY MULTIVITAMIN is and what it is used for
- What you need to know before you use VITAMINME DAILY MULTIVITAMIN
- How to use VITAMINME DAILY MULTIVITAMIN
- Possible side effects
- How to store VITAMINME DAILY MULTIVITAMIN
- Contents of the pack and other information
1. What VITAMINME DAILY MULTIVITAMIN is and what it is used for
VITAMINME DAILY MULTIVITAMIN is a complementary medicine that supports the maintenance of good health.
2. What you need to know before you use VITAMINME DAILY MULTIVITAMIN
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 DAILY MULTIVITAMIN:
- If you are hypersensitive (allergic) to any of the active ingredients or any of the other ingredients of VITAMINME DAILY MULTIVITAMIN (listed in section 6).
Warnings and precautions
Take special care:
- If you have a medical condition or if you are currently using any other medication.
- If you have atopy (a genetic tendency toward allergic conditions).
- If you have an autoimmune disease such as multiple sclerosis (MS), systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), or pemphigus vulgaris.
Children and adolescents
VITAMINME DAILY MULTIVITAMIN is not recommended for individuals below the age of 18 years.
Other medicines and VITAMINME DAILY MULTIVITAMIN
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 DAILY MULTIVITAMIN:
- Caffeine: Echinacea can increase plasma levels of caffeine by inhibiting its metabolism.
- Etoposide: Echinacea may increase levels of etoposide.
- Immunosuppressants: Echinacea has immunostimulant activity which may interfere with immunosuppressant therapy.
VITAMINME DAILY MULTIVITAMIN with food and drink
VITAMINME DAILY MULTIVITAMIN has no known interactions with food or 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 DAILY MULTIVITAMIN.
Safety for use during pregnancy and lactation has not been established.
Driving and using machinery
VITAMINME DAILY MULTIVITAMIN 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 DAILY MUTLIVITAMIN does not adversely affect their performance.
3. How to use VITAMINME DAILY MULTIVITAMIN
Do not share medicines with any other person.
Always use VITAMINME DAILY MULTIVITAMIN 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 tablet daily after food, or as recommended by a healthcare provider.
Swallow the tablet whole and do not chew or crush it.
Do not exceed the recommended dose.
If you take more VITAMINME DAILY MULTIVITAMIN 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 DAILY MULTIVITAMIN
Do not take a double dose to make up for individual forgotten doses.
4. Possible side effects
VITAMINME DAILY MULTIVITAMIN can have side effects.
Not all side effects reported for VITAMINME DAILY MULTIVITAMIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VITAMINME DAILY MULTIVITAMIN, please consult your healthcare provider for advice.
If any of the following happens, stop using VITAMINME DAILY MULTIVITAMIN 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 DAILY MULTIVITAMIN. You may need urgent medical attention or hospitalisation.
Tell your doctor as soon as possible if you notice any of the following:
- nausea; vomiting; abdominal pain; stomach upset; heartburn; diarrhoea; constipation; unpleasant taste; dry mouth; burning, tingling or numbness of the tongue; headache; dizziness; itching; urticaria (hives); allergic rashes.
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 DAILY MULTIVITAMIN.
5. How to store VITAMINME DAILY MULTIVITAMIN.
- 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 thelabel.
- 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 DAILY MULTIVITAMIN contains
Each tablet contains: Ascorbic Acid (Vitamin C) Echinacea purpurea (L.) Moench (Echinacea) [root, 4:1 extract providing 400,00 mg dried herb equivalent] Calcium D-Pantothenate (Vitamin B5) Nicotinamide (Vitamin B3) Thiamine Hydrochloride (Vitamin B1) Pyridoxine Hydrochloride (Vitamin B6) Zinc Gluconate Providing 7,00 mg elemental Zinc Alpha-Tocopherol (Vitamin E) Ferrous Fumarate Providing 8,00 mg elemental Iron Copper Sulphate Providing 0,50 mg elemental Copper Riboflavin (Vitamin B2) Manganese Vitamin A Acetate Providing All-Trans Retinol (Vitamin A) Biotin (Vitamin H) L-5-Methyltetrahydrofolic Acid (Folic Acid) Methylcobalamin (Vitamin B12) Potassium Iodide Providing 53,50 µg elemental Iodine Selenium Amino Acid Chelate Providing 60,00 µg elemental Selenium Molybdenum Chromium Polynicotinate Providing 24,90 µg elemental Chromium Cholecalciferol (Vitamin D3) |
250,00 mg 25,00 mg 10,00 mg 15,00 mg 5,00 mg 4,92 mg 53,85 mg 8,79 mg (20,40 IU) 24,34 mg 1,25 mg 1,50 mg 2,00 mg 10,00 mg 1500,00 µg (5000,00 IU) 250,00 µg 200,00 µg 100,00 µg 70,00 µg 3,00 mg 50,00 µg 200 µg 25,00 µg (1000,00 IU) |
The other ingredients are microcrystalline cellulose, magnesium stearate, silicon dioxide, maize starch, orange film-coating.
Sugar free
What VITAMINME DAILY MULTIVITAMIN looks like and contents of the pack
Oval, light orange/peach film-coated tablets. The tablets are packed in a clear, amber glass jar with a pressure seal and white, ribbed screwcap lid.
Pack size: 30 tablets.
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 DAILY MULTIVITAMIN (filmbedekte tablette)
Askorbiensuur, Echinacea purpurea (L.) Moench (Echinacea), Kalsium D-Pantotenaat, Nikotinamied; Tiamienhidrochloried, Piridoksienhidrochloried, Sinkglukonaat, Alfa-Tokoferol, Ysterfumaraat, Kopersulfaat, Riboflavien, Mangaan, Vitamien A Asetaat, Biotien, L-5-Metieltetrahidrofoliensuur, Metielkobalamien, Kaliumjodied, Selenium Aminosuurchelaat, Molibdeen, Chroompolinikotinaat, Cholekalsiferol
Suikervry
Komplementêre Medisyne: Kombinasieproduk
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 DAILY MULTIVITAMIN is beskikbaar sonder ‘n dokter se voorskrif, om jou gesondheid te handhaaf. Nietemin moet VITAMINME DAILY MULTIVITAMIN versigtig gebruik word ten einde die beste resultate te verkry.
- Hou hierdie inligtingsblad. Dit kan nodig wees dat jy dit weer lees.
- Moenie VITAMINME DAILY MULTIVITAMIN 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 DAILY MULTIVITAMIN en warvoor word dit gebruik
- Wat jy moet weet voordat jy VITAMINME DAILY MULTIVITAMIN gebruik
- Hoe om VITAMINME DAILY MULTIVITAMIN te gebruik
- Moontlike newe-effekte
- Hoe om VITAMINME DAILY MULTIVITAMIN te bêre
- Inhoud van die pak en ander inligting
1. Wat is VITAMINME DAILY MULTIVITAMIN en waarvoor word dit gebruik
VITAMINME DAILY MULTIVITAMIN is ‘n komplementêre medisyne wat die handhawing van goeie gesondheid ondersteun.
2. Wat jy moet weet voordat jy VITAMINME DAILY MULTIVITAMIN 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 DAILY MULTIVITAMIN neem nie:
- Indien jy hipersensitief (allergies) is vir enige van die aktiewe bestanddele of vir enige van die ander bestanddele van VITAMINME DAILY MULTIVITAMIN (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 atopie het (‘n genetiese neiging tot allergiese toestande).
- Indien jy ‘n outo-immuun siekte soos veelvuldige sklerose (MS), sistemiese lupus erythematosus (SLE), rumatoïede artritis (RA) of pemphigus vulgaris het.
Kinders en adolessente
VITAMINME DAILY MULTIVITAMIN word nie aanbeveel vir individue onder die ouderdom van 18 jaar nie.
Ander medisyne en VITAMINME DAILY MULTIVITAMIN
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 DAILY MULTIVITAMIN hê:
- Kafeïen: Echinacea kan plasmavlakke van kafeïen verhoog deur die metabolisme daarvan te inhibeer.
- Etoposied: Echinacea kan vlakke van etoposied verhoog.
- Immuunonderdrukkers: Echinacea het immuunstimulerende aktiwiteit wat met immuunonderdrukkers kan inmeng.
VITAMINME DAILY MULTIVITAMIN met kos en drinkgoed
VITAMINME DAILY MULTIVITAMIN het geen bekende interaksies 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 DAILY MULTIVITAMIN neem.
Veiligheid vir gebruik tydens swangerskap en laktasie is nie vasgestel nie.
Bestuur en die gebruik van masjinerie
Dit is onwaarskynlik dat VITAMINME DAILY MULTIVITAMIN 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 DAILY MULTIVITAMIN nie hul werkverrigting nadelig beïnvloed nie.
3. Hoe om VITAMINME DAILY MULTIVITAMIN te gebruik
Moenie medisyne met enige ander persoon deel nie.
Gebruik VITAMINME DAILY MULTIVITAMIN 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 tablet daagliks na ete, of soos aanbeveel deur jou gesondheidsorgverskaffer.
Sluk die tablet heel in en moet dit nie kou of opbreek nie.
Moenie die aanbevole dosis oorskry nie.
Wat om te doen indien jy meer VITAMINME DAILY MULTIVITAMIN 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 DAILY MULTIVITAMIN te neem
Moenie ‘n dubbele dosis neem om op te maak vir die individuele dosisse wat oorgeslaan is nie.
4. Moontlike newe-effekte
VITAMINME DAILY MULTIVITAMIN kan newe-effekte hê.
Nie alle newe-effekte wat vir VITAMINME DAILY MULTIVITAMIN gerapporteer is, word in hierdie inligtingsblad ingesluit nie. Indien jou algemene gesondheid verswak of indien jy enige ongunstige effekte onderwind terwyl VITAMINME DAILY MULTIVITAMIN geneem word, raadpleeg asseblief jour gesondheidsverskaffer.
Indien jy enige van die volgende ervaar, hou op om VITAMINME DAILY MULTIVITAMIN 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 DAILY MULTIVITAMIN gehad het. Jy mag dringende mediese bystand of hospitalisasie benodig.
Sê so gou as moontlik vir jou dokter indien jy enige van die volgende opmerk:
- naarheid; braking; buikpyn; omgekrapte maag; sooibrand; diarree; hardlywigheid; onaangename smaak; droë mond; brand, tinteling of gevoelloosheid van die tong; hoofpyn; duiseligheid; jeuk; urtikaria (korwe); allergiese uitslag.
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 DAILY MULTIVITAMIN te verskaf.
5. Hoe omVITAMINME DAILY MULTIVITAMIN 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.
6. Inhoud van die verpakking en ander inligting
Wat VITAMINME DAILY MULTIVITAMIN bevat
Elke tablet bevat: Askorbiensuur (Vitamien C) Echinacea purpurea (L.) Moench (Echinacea) [wortel, 4:1 ekstrak wat 400,00 mg gedroogde kruie ekwivalent lewer] Kalsium D-Pantotenaat (Vitamien B5) Nikotinamied (Vitamien B3) Tiamienhidrochloried (Vitamien B1) Piridoksienhidrochloried (Vitamien B6) Sinkglukonaat Verskaf 7,00 mg elementale Sink Alfa-Tokoferol (Vitamien E) Ysterfumaraat Verskaf 8,00 mg elementale Yster Kopersulfaat Verskaf 0,50 mg elementale Koper Riboflavien (Vitamien B2) Mangaan Vitamien A Asetaat Verskaf All-Trans Retinol (Vitamien A) Biotien (Vitamien H) L-5-Metieltetrahidrofoliensuur (Foliensuur) Metielkobalamien (Vitamien B12) Kaliumjodied Verskaf 53,50 µg elementale Jodium Selenium Aminosuurchelaat Verskaf 60,00 µg elementale Selenium Molibdeen Chroompolinikotinaat Verskaf 24,90 µg elementale Chroom Cholekalsiferol (Vitamien D3) | 250,00 mg 25,00 mg 10,00 mg 15,00 mg 5,00 mg 4,92 mg 53,85 mg 8,79 mg (20,40 IU) 24,34 mg 1,25 mg 1,50 mg 2,00 mg 10,00 mg 1500,00 µg (5000,00 IU) 250,00 µg 200,00 µg 100,00 µg 70,00 µg 3,00 mg 50,00 µg 200 µg 25,00 µg (1000,00 IU) |
Die ander bestanddele is mikrokristallyne sellulose, magnesiumstearaat, silikondioksied, mieliestysel, oranje film-bedekking.
Suikervr
Hoe VITAMINME DAILY MULTIVITAMIN lyk en inhoud van die verpakking
Ovaal, ligte oranje/perske film-bedekte tablette. Die tablette word verpak in ‘n deursigtige, bruinkleurige glasfles et ‘n drukseël en ‘n wit, geribde skroefdop deksel.
Verpakkingsgrootte: 30 tablette.
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: COMBINATION PRODUCT
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 DAILY MULTIVITAMIN (film-coated tablets)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Ascorbic Acid (Vitamin C) Echinacea purpurea (L.) Moench (Echinacea) [root, 4:1 extract providing 400,00 mg dried herb equivalent] Calcium D-Pantothenate (Vitamin B5) Nicotinamide (Vitamin B3) Thiamine Hydrochloride (Vitamin B1) Pyridoxine Hydrochloride (Vitamin B6) Zinc Gluconate Providing 7,00 mg elemental Zinc Alpha-Tocopherol (Vitamin E) Ferrous Fumarate Providing 8,00 mg elemental Iron Copper Sulphate Providing 0,50 mg elemental Copper Riboflavin (Vitamin B2) Manganese Vitamin A Acetate Providing All-Trans Retinol (Vitamin A) Biotin (Vitamin H) L-5-Methyltetrahydrofolic Acid (Folic Acid) Methylcobalamin (Vitamin B12) Potassium Iodide Providing 53,50 µg elemental Iodine Selenium Amino Acid Chelate Providing 60,00 µg elemental Selenium Molybdenum Chromium Polynicotinate Providing 24,90 µg elemental Chromium Cholecalciferol (Vitamin D3) |
250,00 mg 25,00 mg 10,00 mg 15,00 mg 5,00 mg 4,92 mg 53,85 mg 8,79 mg (20,40 IU) 24,34 mg 1,25 mg 1,50 mg 2,00 mg 10,00 mg 1500,00 µg (5000,00 IU) 250,00 µg 200,00 µg 100,00 µg 70,00 µg 3,00 mg 50,00 µg 200 µg 25,00 µg (1000,00 IU) |
Sugar free.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
19 mm, oval light orange/peach film-coated tablets.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
VITAMINME DAILY MULTIVITAMIN is a complementary medicine that supports the maintenance of good health.
The above has been aligned with the most general statement in the 7.04 Health Supplement guidelines. This can be expanded further in desired.
4.2 Posology and method of administration
Posology
Adults 18 years and older: Take 1 tablet daily after food, or as recommended by a healthcare provider.
Swallow the tablet whole and do not chew or crush.
Do not exceed the recommended dose.
Method of administration
For oral use. To be taken after food.
4.3 Contraindications
- Hypersensitivity to any of the active ingredients or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
- Patients with any medical conditions or who are taking any other medications should be advised to consult with their relevant healthcare provider prior to using VITAMINME DAILY MULTIVITAMIN.
- VITAMINME DAILY MULTIVITAMIN contains Echinacea. Individuals with atopy (a genetic tendency toward allergic conditions) may be more likely to experience an allergic reaction when taking Echinacea.
- Echinacea can stimulate immune function and might exacerbate autoimmune diseases by stimulating disease activity. Caution is advised for those with autoimmune diseases such as multiple sclerosis (MS), systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), or pemphigus vulgaris.
4.5 Interaction with other medicines and other forms of interaction
- Caffeine: Echinacea can increase plasma levels of caffeine by inhibiting its metabolism.
- Etoposide: Echinacea may increase levels of etoposide.
- Immunosuppressants: Echinacea has immunostimulant activity which may interfere with immunosuppressant therapy.
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
VITAMINME DAILY MULTIVITAMIN is not likely to cause drowsiness. Patients should take caution before performing activities requiring their attention, until they are reasonably certain that VITAMINME DAILY MULTIVITAMIN does not adversely affect their performance.
4.8 Undesirable effects
VITAMINME DAILY MULTIVITAMIN is generally well tolerated.
Gastrointestinal disorders
Frequency unknown: nausea, vomiting, abdominal pain, stomach upset, heartburn, diarrhoea, constipation, unpleasant taste, dry mouth, burning, tingling, or numbness of the tongue.
Nervous system disorders
Frequency unknown: headache, dizziness.
Skin and subcutaneous tissue disorders
Frequent: itching, urticaria, allergic rashes.
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 33.7 Combination Product
VITAMINME DAILY MULTIVITAMIN is a complementary medicine that supports the maintenance of good health.
5.2 Pharmacokinetic properties
Pharmacokinetic studies have not been conducted on VITAMINME DAILY MULTIVITAMIN.
The vitamins and minerals in VITAMINME DAILY MULTIVITAMIN are well absorbed from the gastrointestinal tract and are widely distributed to all tissues in the body.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Core:
Microcrystalline cellulose
Magnesium stearate
Silicon dioxide
Maize starch
Orange film-coating
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 screwcap lid.
Pack size: 30 tablets.
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.