PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S0
VITAMINME SKIN CLARITY + GLOW (film-coated tablets)
L-Glutamine, Ascorbic Acid, L-Lysine, Curcuma longa L. (Turmeric), Arcticum lappa (Burdock), Silica, Sophora japonica L. (Quercetin), Zingiber officinale Roscoe (Ginger), Pyridoxine Hydrochloride, Pantothenic Acid (Vitamin B5), Aloe vera (L.) Burm.f (Aloe), Zinc Citrate, Nicotinamide, Alpha-Tocopherol, Calendula officinalis L. (Marigold), Vitamin A Acetate, Piper nigrum L. (Black Pepper)
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 SKIN CLARITY + GLOW is available without a doctor’s prescription, for you to maintain your health. Nevertheless, you still need to use VITAMINME SKIN CLARITY + GLOW carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Do not share VITAMINME SKIN CLARITY + GLOW with any other person.
- Ask your healthcare provider or pharmacist if you need more information or advice.
What is in this leaflet
- What VITAMINME SKIN CLARITY + GLOW is and what it is used for
- What you need to know before you use VITAMINME SKIN CLARITY + GLOW
- How to use VITAMINME SKIN CLARITY + GLOW
- Possible side effects
- How to store VITAMINME SKIN CLARITY + GLOW
- Contents of the pack and other information
1. What VITAMINME SKIN CLARITY + GLOW is and what it is used for
VITAMINME SKIN CLARITY + GLOW is a complementary medicine that helps with collagen formation and the maintenance of healthy skin.
2. What you need to know before you use VITAMINME SKIN CLARITY + GLOW
Do not use VITAMINME SKIN CLARITY + GLOW:
- If you are hypersensitive (allergic) to any of the active ingredients or any of the other ingredients of VITAMINME SKIN CLARITY + GLOW (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 are hypersensitive (allergic) to members of the Asteraceae/Compositae family (members of this plant family include ragweed, chrysanthemums, marigolds, daises, and many other herbs) as you may be at increased risk of having an allergic reaction to VITAMINME SKIN CLARITY + GLOW.
- If you are scheduled for an elective surgical procedure. You should stop taking VITAMINME SKIN CLARITY + GLOW at least 2 weeks before any elective surgical procedures.
- If you have gallstones, a bile duct obstruction, stomach ulcers, excess stomach acid or liver disease.
Children and adolescents
VITAMINME SKIN CLARITY + GLOW is not recommended for individuals below the age of 18 years.
Other medicines and VITAMINME SKIN CLARITY + GLOW
Always tell your healthcare provider if you are taking any other medicine. This includes all complementary or traditional medicines.
VITAMINME SKIN CLARITY + GLOW contains piperine (derived from black pepper) which can increase the levels and alter the effectiveness of many other medications or natural health products (e.g. nevirapine, phenytoin, propranolol, rifampin, theophylline).
The following medicines may cause an interaction with VITAMINME SKIN CLARITY + GLOW:
- Anticoagulant/antiplatelet medicine: Turmeric may have antiplatelet effects and thereby increase the risk of bruising and bleeding when used with anticoagulant/antiplatelet medicine.
- Amlodipine: Taking turmeric with amlodipine may increase levels of amlodipine.
- Antidiabetes medicine: Taking turmeric with antidiabetes medicine may increase the risk of hypoglycaemia.
- Chemotherapy medicines: Turmeric has antioxidant effects. There is some concern that this may reduce the active of chemotherapy medicines that generate free radicals (e.g. alkylating agents, antitumor antibiotics, topoisomerase I inhibitors).
- Digoxin: Aloe latex may increase the risk of adverse effects when taken with cardiac glycosides.
- Sulfasalazine: Turmeric might increase the therapeutic effects and adverse effects of sulfasalazine.
- Tacrolimus: Turmeric might increase the therapeutic effects and adverse effects of tacrolimus.
- Talinolol: Turmeric may reduce the absorption of talinolol in some situations.
- Theophylline: Black pepper might increase blood levels of theophylline
- Warfarin: Turmeric might increase the risk of bleeding with warfarin.
VITAMINME SKIN CLARITY + GLOW with food and drink
VITAMINME SKIN CLARITY + GLOW 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 SKIN CLARITY + GLOW.
Safety for use during pregnancy and lactation has not been established.
Driving and using machinery
VITAMINME SKIN CLARITY + GLOW 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 SKIN CLARITY + GLOW does not adversely affect their performance.
3. How to use VITAMINME SKIN CLARITY + GLOW
Do not share medicines with any other person.
Always use VITAMINME SKIN CLARITY + GLOW 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 – 2 tablets daily after food, or as recommended by a healthcare provider.
Swallow the tablets whole and do not chew or crush.
Do not exceed the recommended dose.
If you take more VITAMINME SKIN CLARITY + GLOW 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 SKIN CLARITY + GLOW
Do not take a double dose to make up for individual forgotten doses.
4. Possible side effects
VITAMINME SKIN CLARITY + GLOW can have side effects.
Not all side effects reported for VITAMINME SKIN CLARITY + GLOW are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VITAMINME SKIN CLARITY + GLOW, please consult your healthcare provider for advice.
If any of the following happens, stop using VITAMINME SKIN CLARITY + GLOW 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 SKIN CLARITY + GLOW. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice any of the following:
- nausea or vomiting; constipation; flatulence; yellow and/or hard stools; diarrhoea or loose stools; dyspepsia (indigestion); distended stomach; abdominal fullness or pain; stained tongue; burning aftertaste; liver problems (characterised by stomach pain, nausea and yellow discolouration of your skin and eyes).
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 SKIN CLARITY + GLOW.
5. How to store VITAMINME SKIN CLARITY + GLOW.
- 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).
- Contents of the pack and other information
What VITAMINME SKIN CLARITY + GLOW contains
Each tablet contains: L-Glutamine Ascorbic Acid (Vitamin C) L-Lysine Curcuma longa L. (Turmeric) [rhizome, 8:1 extract standardised to 12,5 % curcuminoids providing 640,00 mg dried herb equivalent] Arctium lappa L. (Burdock) Silica [from Bamboo extract standardised to 70 % silica providing 70,00 mg silicon] Sophora japonica L. (Quercetin) Zingiber officinale Roscoe (Ginger) [root, 4:1 extract providing 160,00 mg dried herb equivalent] Pyridoxine Hydrochloride (Vitamin B6) Pantothenic Acid (Vitamin B5) Aloe vera (L.) Burm.f. (Aloe) Zinc Citrate Providing 12,50 mg elemental Zinc Nicotinamide (Vitamin B3) Alpha-Tocopherol (Vitamin E) Calendula officinalis L. (Marigold) [flower, standardised to 5 % lutein, providing 2,00 mg lutein] Vitamin A Acetate Providing 750,00 µg All-Trans Retinol (Vitamin A) BioPerine ™ Piper nigrum L. (Black Pepper) [fruit, 50:1 extract providing 100,00 mg dried herb equivalent] | 200,00 mg 150,00 mg 120,00 mg 80,00 mg 75,00 mg 100,00 mg 60,00 mg 40,00 mg 25,00 mg 20,00 mg 20,00 mg 36,76 mg 12,50 mg 8,38 mg 40,00 mg 5,00 mg 2,00 mg |
The other ingredients are microcrystalline cellulose, magnesium stearate, silicon dioxide, maize starch, green film-coating.
Sugar free
What VITAMINME SKIN CLARITY + GLOW looks like and contents of the pack
Oval, green/olive film-coated tablets. The tablets are packed in a clear, amber glass jar with a pressure seal and a white, ribbed screw cap 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 SKIN CLARITY + GLOW (film-bedekte tablette)
L-Glutamien, Askorbiensuur, L-Lysien, Curcuma longa L. (Borrie), Arcticum lappa (Burdock), Silika, Sophora japonica L. (Kwersitien), Zingiber officinale Roscoe (Gemmer), Piridoksienhidrochloried, Pantoteensuur (Vitamien B5) Aloe vera (L.) Burm.f (Aalwyn), Sinksitraat, Nikotinamied, Alfa-Tokoferol, Calendula officinalis L. (Goudsbloem), Vitamien A Asetaat, Piper nigrum L. (Swartpeper)
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 SKIN CLARITY + GLOW is beskikbaar sonder ‘n dokter se voorskrif, om jou gesondheid te handhaaf. Nietemin moet VITAMINME SKIN CLARITY + GLOW versigtig gebruik word ten einde die beste resultate te verkry.
- Hou hierdie inligtingsblad. Dit kan nodig wees dat jy dit weer lees.
- Moenie VITAMINME SKIN CLARITY + GLOW 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 SKIN CLARITY + GLOW en warvoor word dit gebruik
- Wat jy moet weet voordat jy VITAMINME SKIN CLARITY + GLOW gebruik
- Hoe om VITAMINME SKIN CLARITY + GLOW te gebruik
- Moontlike newe-effekte
- Hoe om VITAMINME SKIN CLARITY + GLOW te bêre
- Inhoud van die pak en ander inligting
1. Wat is VITAMINME SKIN CLARITY + GLOW en waarvoor word dit gebruik
VITAMINME SKIN CLARITY + GLOW is ‘n komplementêre medisyne wat help met kollageenvorming en die handhawing van gesonde vel.
2. Wat jy moet weet voordat jy VITAMINME SKIN CLARITY + GLOW gebruik
Moenie VITAMINME SKIN CLARITY + GLOW neem nie:
- Indien jy hipersensitief (allergies) is vir enige van die aktiewe bestanddele of vir enige van die ander bestanddele van VITAMINME SKIN CLARITY + GLOW (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 hy hipersensitief (allergies) is vir lede van die Asteraceae/Compositae-familie (lede van hierdie plantfamilie sluit ragwoude, krisante, gousblomme, madeliefies en baie ander kruie in), aangesien jy ‘n groter risiko het om ‘n allergiese reaksie op VITAMINME SKIN CLARITY + GLOW te hê.
- Indien jy geskeduleer is vir ‘n elektiewe chirurgiese procedure. Jy moet ten minste 2 weke voor enige elektiewe chrirurgiese prosedures ophou om VITAMINME SKIN CLARITY + GLOW te neem.
- Indien jy galstene, ‘n galbuis obstruksie, maagsere, oortollige maagsuur of ‘n lewersiekte het.
Kinders en adolessente
VITAMINME SKIN CLARITY + GLOW word nie aanbeveel by individue onder die ouderdom van 18 jaar nie.
Ander medisyne en VITAMINME SKIN CLARITY + GLOW
Lig altyd jou gesondheidsorgverskaffer in indien jy enige ander medisyne neem. Dit sluit aanvullende of tradisionele medisyne in.
VITAMINME SKIN CLARITY + GLOW bevat piperien (afgelei van swartpeper) wat die vlakke kan verhoog en die effektiwiteit van baie ander medikasie of natuurlike gesonheidsaanvullings (bv. nevirapien, fenitoïen, propranolol, rifampien, teofillien) kan verander.
Die volgende medisynes mag interaksie met VITAMINME SKIN CLARITY + GLOW hê:
- Antikoagulant/antiplaatjie-medisyne: Borrie kan anti-plaatjie-effekte hê en daardeur die risiko van kneusing en bloeding verhoog wanneer dit saam met antikoagulant/antiplaatjie-medisyne gebruik word.
- Amlodipien: Die neem van borrie saam met amlodipien kan vlakke van amlodipien verhoog.
- Atidiabetiese medisyne: Die neem van borrie saam met antidiabetiese medisyne kan die risiko van hipoglukemie verhoog.
- Chemoterapie medisyne: Borrie het antioksidante effekte. Daar is ‘n mate van kommer dat dit die aktiewe van chemoterapie-medisyne wat vrye radikale genereer kan verminder (bv. alkileringsmiddels, antitumor-antibiotika, topoisomerase I-remmers).
- Digoksien: Aloe latex kan die risiko van afkerende effekte verhoog wanneer dit saam met hartglikosiede geneem word.
- Sulfasalasien: Borrie kan die terapeutiese effekte en nadelige effekte van sulfasalasien verhoog.
- Takrolimus: Borrie kan die terapeutiese effekte en nadelige effekte van takrolimus verhoog.
- Talinolol: Borrie kan in spesifieke situasies die opname van talinolol verminder.
- Warfarin: Borrie kan die risiko van bloeding met warfarin verhoog.
VITAMINME SKIN CLARITY + GLOW met kos en drinkgoed
VITAMINME SKIN CLARITY + GLOW 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 SKIN CLARITY + GLOW neem.
Veiligheid vir gebruik tydens swangerskap en laktasie is nie vasgestel nie.
Bestuur en die gebruik van masjinerie
Dit is onwaarskynlik dat VITAMINME SKIN CLARITY + GLOW 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 SKIN CLARITY + GLOW nie hul werkverrigting nadelig beïnvloed nie.
3. Hoe om VITAMINME SKIN CLARITY + GLOW te gebruik
Moenie medisyne met enige ander persoon deel nie.
Gebruik VITAMINME SKIN CLARITY + GLOW 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 – 2 tablette daagliks na ete, of soos aanbeveel deur jou gesondheidsorgverskaffer.
Sluk die tablette heel in en moet dit nie kou of opbreek nie.
Moenie die aanbevole dosis oorskry nie.
Wat om te doen indien jy meer VITAMINME SKIN CLARITY + GLOW 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 SKIN CLARITY + GLOW te neem
Moenie ‘n dubbele dosis neem om op te maak vir die individuele dosisse wat oorgeslaan is nie.
4. Moontlike newe-effekte
VITAMINME SKIN CLARITY + GLOW kan newe-effekte hê.
Nie alle newe-effekte wat vir VITAMINME SKIN CLARITY + GLOW gerapporteer is, word in hierdie inligtingsblad ingesluit nie. Indien jou algemene gesondheid verswak of indien jy enige ongunstige effekte onderwind terwyl VITAMINME SKIN CLARITY + GLOW geneem word, raadpleeg asseblief jour gesondheidsverskaffer.
Indien jy enige van die volgende ervaar, hou op om VITAMINME SKIN CLARITY + GLOW 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 SKIN CLARITY + GLOW gehad het. Jy mag dringende mediese bystand of hospitalisasie benodig.
Sê vir jou dokter indien jy enige van die volgende opmerk:
- naarheid of braking; hardlywigheid; winderigheid; geel en / of harde stoelgang; diarree of los stoelgang; dispepsie (indigestie); uitgerekte maag; abdominale volheid of pyn; gevlekte tong; brandende nasmaak; lewerprobleme (gekenmerk deur maagpyn, naarheid en geel verkleuring van u vel en oë).
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 SKIN CLARITY + GLOW te verskaf.
5. Hoe omVITAMINME SKIN CLARITY + GLOW 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.
- Inhoud van die verpakking en ander inligting
Wat VITAMINME SKIN CLARITY + GLOW bevat
Elke tablet bevat: L-Glutamien Askorbiensuur (Vitamien C) L-Lysien Curcuma longa L. (Borie) [risoom, 8:1 ekstrak gestandaardiseer tot 12,5 % kurkuminoïede wat 640,00 mg gedroogde kruie ekwivalent verskaf] Arctium lappa L. (Burdock) Silika [vanaf Bamboes-esktrak gestandaardiseer tot 70 % silika wat 70,00 mg silicon verskaf] Sophora japonica L. (Kwersitien) Zingiber officinale Roscoe (Gemmer) [wortel, 4:1 ekstrak wat 160,00 mg gedroogde kruie ekwivalent lewer] Piridoksienhidrochloried (Vitamien B6) Pantoteensuur (Vitamien B5) Aloe vera (L.) Burm.f. (Aalwyn) Sinksitraat Verskaf 12,50 mg elementale Sink Nikotinamied (Vitamien B3) Alfa-Tokoferol (Vitamien E) Calendula officinalis L. (Goudsbloem) [blom, gestandaardiseer tot 5 % luteïen, wat 2,00 mg luteïen verskaf] Vitamien A Asetaat Verskaf 750,00 µg All-Trans Retinol (Vitamien A) BioPerine ™ Piper nigrum L. (Swartpeper) [vrug, 50:1 ekstrak wat 100,00 mg gedroogde kruie ekwivalent verskaf] | 200,00 mg 150,00 mg 120,00 mg 80,00 mg 75,00 mg 100,00 mg 60,00 mg 40,00 mg 25,00 mg 20,00 mg 20,00 mg 36,76 mg 12,50 mg 8,38 mg 40,00 mg 5,00 mg 2,00 mg |
Die ander bestanddele is mikrokristallyne sellulose, magnesiumstearaat, silikondioksied, mieliestyself, groen film-bedekking.
Suikervry
Hoe VITAMINME SKIN CLARITY + GLOW lyk en inhoud van die verpakking
Ovaal, groen/olyf film-bedekte tablette. Die tablette word verpak in ‘n deursigtige, bruinkleurige glasfles met ‘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 SKIN CLARITY + GLOW (film-coated tablets)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: L-Glutamine Ascorbic Acid (Vitamin C) L-Lysine Curcuma longa L. (Turmeric) [rhizome, 8:1 extract standardised to 12,5 % curcuminoids providing 640,00 mg dried herb equivalent] Arctium lappa L. (Burdock) Silica [from Bamboo extract standardised to 70 % silica providing 70,00 mg silicon] Sophora japonica L. (Quercetin) Zingiber officinale Roscoe (Ginger) [root, 4:1 extract providing 160,00 mg dried herb equivalent] Pyridoxine Hydrochloride (Vitamin B6) Pantothenic Acid (Vitamin B5) Aloe vera (L.) Burm.f. (Aloe) Zinc Citrate Providing 12,50 mg elemental Zinc Nicotinamide (Vitamin B3) Alpha-Tocopherol (Vitamin E) Calendula officinalis L. (Marigold) [flower, standardised to 5 % lutein, providing 2,00 mg lutein] Vitamin A Acetate Providing 750,00 µg All-Trans Retinol (Vitamin A) BioPerine ™ Piper nigrum L. (Black Pepper) [fruit, 50:1 extract providing 100,00 mg dried herb equivalent | 200,00 mg 150,00 mg 120,00 mg 80,00 mg 75,00 mg 100,00 mg 60,00 mg 40,00 mg 25,00 mg 20,00 mg 20,00 mg 36,76 mg 12,50 mg 8,38 mg 40,00 mg 5,00 mg 2,00 mg |
Sugar free.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
19 mm, oval olive/green film-coated tablets.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
VITAMINME SKIN CLARITY + GLOW is a complementary medicine that helps with healthy collagen formation and the maintenance of healthy skin.
4.2 Posology and method of administration
Posology
Adults 18 years and older: Take 1 – 2 tablets daily after food, or as recommended by a healthcare provider.
Swallow the tablets 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 who are hypersensitive (allergic) to members of the Asteraceae/Compositae family may be at increased risk of having an allergic reaction to burdock, an active ingredient in VITAMINME SKIN CLARITY + GLOW. Members of this plant family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.
- Patients should be advised to discontinue VITAMINME SKIN CLARITY + GLOW at least 2 weeks before elective surgical procedures due to potential interference with blood glucose and bleeding control.
- Patients should use caution if they are taking any other medications or natural health products, as black pepper/piperine may alter their effectiveness.
Patients with gallstones, a bile duct obstruction, stomach ulcers, excess stomach acid or liver disease, should consult a relevant healthcare provider prior to using VITAMINME SKIN CLARITY + GLOW.
4.5 Interaction with other medicines and other forms of interaction
- Anticoagulant/antiplatelet medicine: Turmeric may have antiplatelet effects and thereby increase the risk of bruising and bleeding when used with anticoagulant/antiplatelet medicine.
- Amlodipine: Taking turmeric with amlodipine may increase levels of amlodipine.
- Antidiabetes medicine: Taking turmeric with antidiabetes medicine may increase the risk of hypoglycaemia.
- Chemotherapy medicines: Turmeric has antioxidant effects. There is some concern that this may reduce the active of chemotherapy medicines that generate free radicals (e.g. alkylating agents, antitumor antibiotics, topoisomerase I inhibitors).
- Digoxin: Aloe latex may increase the risk of adverse effects when taken with cardiac glycosides.
- Nevirapine: Black pepper might increase blood levels of nevirapine.
- Phenytoin: Black pepper might increase blood levels of phenytoin.
- Propranolol: Black pepper might increase blood levels of propranolol.
- Rifampin: Black pepper might increase blood levels of rifampin.
- Sulfasalazine: Turmeric might increase the therapeutic effects and adverse effects of sulfasalazine.
- Tacrolimus: Turmeric might increase the therapeutic effects and adverse effects of tacrolimus.
- Talinolol: Turmeric may reduce the absorption of talinolol in some situations.
- Theophylline: Black pepper might increase blood levels of theophylline
- Warfarin: Turmeric might increase the risk of bleeding with warfarin.
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 SKIN CLARITY + GLOW does not adversely affect their performance.
4.8 Undesirable effects
VITAMINME SKIN CLARITY + GLOW is generally well tolerated.
Gastrointestinal disorders
Frequency unknown: nausea, vomiting, constipation, flatulence, yellow and hard stools, diarrhoea, loose stools, dyspepsia, gastritis, abdominal distension, gastroesophageal reflux disease, abdominal fullness and pain, epigastric burning, tongue staining, burning aftertaste.
Hepatobiliary disorders
Frequency unknown: liver injury.
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 SKIN CLARITY + GLOW is a complementary medicine that helps with healthy collagen formation and the maintenance of healthy skin.
5.2 Pharmacokinetic properties
Pharmacokinetic studies have not been conducted on VITAMINME SKIN CLARITY + GLOW.
The vitamins and minerals in VITAMINME SKIN CLARITY + GLOW 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
Green 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 screw cap 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.