PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S0
VITAMINME HAIR GROWTH + STRENGTH (capsules)
Ascorbic Acid, Zinc Gluconate, Biotin, L-5-Methyltetrahydrofolic Acid, Ecklonia maxima (Kelp), Selenium Amino Acid Chelate
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 HAIR GROWTH + STRENGTH is available without a doctor’s prescription, for you to maintain your health. Nevertheless, you still need to use VITAMINME HAIR GROWTH + STRENGTH carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Do not share VITAMINME HAIR GROWTH + STRENGTH with any other person.
- Ask your healthcare provider or pharmacist if you need more information or advice.
What is in this leaflet
- What VITAMINME HAIR GROWTH + STRENGTH is and what it is used for
- What you need to know before you use VITAMINME HAIR GROWTH + STRENGTH
- How to use VITAMINME HAIR GROWTH + STRENGTH
- Possible side effects
- How to store VITAMINME HAIR GROWTH + STRENGTH
- Contents of the pack and other information
1. What VITAMINME HAIR GROWTH + STRENGTH is and what it is used for
VITAMINME HAIR GROWTH + STRENGTH is a health supplement that contributes to the maintenance of healthy hair and hair pigmentation.
2. What you need to know before you use VITAMINME HAIR GROWTH + STRENGTH
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 HAIR GROWTH + STRENGTH:
- If you are hypersensitive (allergic) to ascorbic acid, zinc gluconate, biotin, L-5-Methyltetrahydrofolic acid, Ecklonia maxima (Kelp), selenium or any of the other ingredients of VITAMINME HAIR GROWTH + STRENGTH (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 history of kidney stones or are prone to developing kidney stones.
- If you have an autoimmune disease such as multiple sclerosis, systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA).
- If you are scheduled for an elective surgical procedure. You should stop taking VITAMINME HAIR GROWTH + STRENGTH at least 2 weeks before any elective surgical procedures.
- If you have thyroid dysfunction.
- If you have dermatitis herpetiformis.
Children and adolescents
Consult a healthcare provider prior to using VITAMINME HAIR GROWTH + STRENGTH for individuals below the age of 18 years.
Other medicines and VITAMINME HAIR GROWTH + STRENGTH
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 HAIR GROWTH + STRENGTH:
Vitamin C:
- Alkylating agents: The antioxidant effects of vitamin C might reduce the effectiveness of alkylating agents.
- Aluminium: Vitamin C can increase the amount of aluminium absorbed from aluminium compounds.
- Antitumour antibiotics: The antioxidant effects of vitamin C might reduce the effectiveness of antitumour antibiotics.
- Estrogens: Vitamin C might increase blood levels of estrogens.
- Fluphenazine: Vitamin C might decrease levels of fluphenazine.
- Indinavir: Vitamin C can modestly reduce indinavir levels.
- Levothyroxine: Vitamin C can increase levothyroxine absorption.
- Warfarin: High dosages of vitamin C might reduce the levels and effectiveness of warfarin.
Zinc:
- Cephalexin: Zinc might decrease cephalexin levels by chelating with cephalexin in the gut and preventing its absorption.
- Penicillamine: Zinc might reduce the levels and clinical effects of penicillamine.
- Quinolone antibiotics: Zinc can decrease the levels and clinical effects of quinolone antibiotics.
- Ritonavir: Zinc modestly reduces levels of ritonavir.
- Tetracycline antibiotics: Zinc might reduce levels of tetracycline antibiotics.
Folic Acid:
- Methotrexate: Folic acid might reduce the efficacy of methotrexate as a cancer treatment when given concurrently.
- Phenobarbital: Folic acid might have antagonistic effects on phenobarbital and increase the risk for seizures.
- Primidone: Folic acid might have antagonistic effects on primidone and increase the risk for seizures.
- Pyrimethamine: Folic acid might antagonize the effects of pyrimethamine.
Selenium:
- Anticoagulant/anti-platelet medication: Selenium may have antiplatelet effects which can increase the risk of bleeding when used with anticoagulant/antiplatelet medication.
- Barbiturates: Theoretically, selenium might prolong the sedating effects of barbiturates.
- Immunosupressants: Selenium may reduce the effectiveness of immunosuppressant therapy.
- Warfarin: Selenium might interfere with warfarin activity.
VITAMINME HAIR GROWTH + STRENGTH with food and drink
VITAMINME HAIR GROWTH + STRENGTH 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 HAIR GROWTH + STRENGTH.
Safety for use during pregnancy and lactation has not been established.
Driving and using machinery
VITAMINME HAIR GROWTH + STRENGTH 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 HAIR GROWTH + STRENGTH does not adversely affect their performance.
3. How to use VITAMINME HAIR GROWTH + STRENGTH
Do not share medicines with any other person.
Always use VITAMINME HAIR GROWTH + STRENGTH 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 HAIR GROWTH + STRENGTH 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 HAIR GROWTH + STRENGTH
Do not take a double dose to make up for individual forgotten doses.
4. Possible side effects
VITAMINME HAIR GROWTH + STRENGTH can have side effects.
Not all side effects reported for VITAMINME HAIR GROWTH + STRENGTH are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VITAMINME HAIR GROWTH + STRENGTH, please consult your healthcare provider for advice.
If any of the following happens, stop using VITAMINME HAIR GROWTH + STRENGTH 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 HAIR GROWTH + STRENGTH. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice any of the following:
- nausea; vomiting; esophagitis (inflammation of the esophagus, characterised by difficult or painful swallowing, swallowed food become stuck, chest pain behind the breastbone that occurs with eating, heartburn, acid regurgitation); abdominal cramps; diarrhoea; metallic taste in the mouth; indigestion; dry mouth; mouth irritation; fatigue; headache; insomnia; sleepiness; kidney stones (characterised by severe pain in your back or side; blood in your urine; nausea and vomiting; fever and chills).
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 HAIR GROWTH + STRENGTH.
5. How to store VITAMINME HAIR GROWTH + STRENGTH.
- 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 HAIR GROWTH + STRENGTH contains
|
Each capsule contains: Ascorbic Acid (Vitamin C) Zinc Gluconate Providing 15,00 mg elemental Zinc Biotin (Vitamin H) L-5-Methyltetrahydrofolic Acid (Folic Acid) Ecklonia maxima (Kelp) Providing 150,00 µg elemental Iodine Selenium Amino Acid Chelate Providing 60,00 µg elemental Selenium |
250,00 mg 78,86 mg 500,00 µg 400,00 µg 21,40 mg 3,00 mg |
The other ingredients are maize starch, vegetable capsule.
Sugar free
What VITAMINME HAIR GROWTH + STRENGTH looks like and contents of the pack
Clear, vegetarian capsules containing an off-white powder that has small flecks of green/grey. The capsules are packed in a clear, amber glass jar with a pressure seal and a white, ribbed screw cap lid.
Pack size: 30 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 HAIR GROWTH + STRENGTH (kapsules)
Askorbiensuur, Sinkglukonaat, Biotien, L-5-Metieltetrahidrofoliensuur, Ecklonia maxima (Kelp), Selenium Aminosuurchelaat
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 HAIR GROWTH + STRENGTH is beskikbaar sonder ‘n dokter se voorskrif, om jou gesondheid te handhaaf. Nietemin moet VITAMINME HAIR GROWTH + STRENGTH versigtig gebruik word ten einde die beste resultate te verkry.
- Hou hierdie inligtingsblad. Dit kan nodig wees dat jy dit weer lees.
- Moenie VITAMINME HAIR GROWTH + STRENGTH 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 HAIR GROWTH + STRENGTH en warvoor word dit gebruik
- Wat jy moet weet voordat jy VITAMINME HAIR GROWTH + STRENGTH gebruik
- Hoe om VITAMINME HAIR GROWTH + STRENGTH te gebruik
- Moontlike newe-effekte
- Hoe om VITAMINME HAIR GROWTH + STRENGTH te bêre
- Inhoud van die pak en ander inligting
1. Wat is VITAMINME HAIR GROWTH + STRENGTH en waarvoor word dit gebruik
VITAMINME HAIR GROWTH + STRENGTH is ‘n gesondheidsaanvulling wat bydra tot die handhawing van gesonde hare en hare pigmentasie.
2. Wat jy moet weet voordat jy VITAMINME HAIR GROWTH + STRENGTH 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 HAIR GROWTH + STRENGTH neem nie:
- Indien jy hipersensitief (allergies) is vir askorbiensuur, sinkglukonaat, biotien, L-5-Metieltetrahidrofoliensuur,Ecklonia maxima (Kelp), seleneium of vir enige van die ander bestanddele van VITAMINME HAIR GROWTH + STRENGTH (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 geskiedenis van nierstene het of geneig is om nierstene te ontwikkel.
- Indien jy ‘n out-immuun siekte soos veelvuldige sklerose, sistemiese lupus erythematosus (SLE) of rumatoïede artritis (RA) het.
- Indien jy geskeduleer is vir ‘n elektiewe chirurgiese procedure. Jy moet ten minste 2 weke voor enige elektiewe chirurgiese prosedures ophou om VITAMINME HAIR GROWTH + STRENGTH te neem.
- Indien jy skildklierdisfunksie het.
- Indien jy dermatitis herpetiformis het.
Kinders en adolessente
Raadpleeg ‘n gesondheidsorgverskaffer voordat VITAMINME HAIR GROWTH + STRENGTH gebruik word by individue onder die ouderdom van 18 jaar.
Ander medisyne en VITAMINME HAIR GROWTH + STRENGTH
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 HAIR GROWTH + STRENGTH hê:
Vitamien C:
- Alkileringsmiddels: Die antioksidant-effekte van vitamien C kan die effektiwiteit van alkileringsmiddels verminder.
- Aluminium: Vitamien C kan die hoeveelheid aluminium wat deur aluminiumverbindings geabsorbeer word, verhoog.
- Antitumor-antibiotika: Die antioksidante-effekte van vitamien C kan die effektiwiteit van antitumor-antibiotika verminder.
- Estrogeen: Vitamien C kan bloedvlakke van estrogeen verhoog.
- Flufenasien: Vitamien C kan vlakke van flufenasien verlaag.
- Indinavir: Vitamien C kan vlakke van indinavir matig verlaag.
- Levotiroksien: Vitamien C kan die absorpsie van levotiroksien verhoog.
- Warfarin: Hoë dosisse vitamien C kan die vlakke en effektiwiteit van warfarin verlaag.
Sink:
- Kefaleksien: Sink kan kefaleksienvlakke verlaag deur met kefaleksien in die ingewande te chelaat en die absorpsie daarvan te voorkom.
- Penisillamien: Sink kan die vlakke en kliniese effekte van penisillamien verminder.
- Kinoloon-antibiotika: Sink kan die vlakke en kliniese effekte van kinoloon-antibiotika verlaag.
- Ritonavir: Sink verlaag die vlakke van ritonavir matig.
- Tetrasiklien-antibiotika: Sink kan dalk die vlakke van tetrasiklien-antibiotika verlaag.
Foliensuur:
- Metotreksaat: Foliensuur kan die effektiwiteit van metotreksaat as ‘n kankerbehandeling verminder wanner dit gelyktydig toegedien word.
- Fenobarbital: Foliensuur kan antagonistiese effekte op fenobarbital hê en die risiko vir aanvalle verhoog.
- Primidoon: Foliensuur kan antagoniestiese uitwerking op primidoon hê en die risiko vir aanvalle verhoog.
- Pirimetamien: Foliensuur kan die effekte van pirimetamien antagoniseer.
Selenium:
- Antikoagulante/antiplaatjie-medikasie: Selenium kan anti-plaatjie-effekte hê wat die risiko van bloeding kan verhoog wanneer dit saam met antikoagulant/antiplaatjie-medikasie gebruik word.
- Barbiturate: Teoreties kan selenium die kalmerende effek van barbiturate verleng.
- Immuunonderdrukkers: Selenium kan die effektiwiteit van immuunonderdrukkende terapie verminder.
- Warfarin: Selenium kan inmeng met warfarin-aktiwiteit.
VITAMINME HAIR GROWTH + STRENGTH met kos en drinkgoed
VITAMINME HAIR GROWTH + STRENGTH 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 HAIR GROWTH + STRENGTH neem.
Veiligheid vir gebruik tydens swangerskap en laktasie is nie vasgestel nie.
Bestuur en die gebruik van masjinerie
Dit is onwaarskynlik dat VITAMINME HAIR GROWTH + STRENGTH 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 HAIR GROWTH + STRENGTH nie hul werkverrigting nadelig beïnvloed nie.
3. Hoe om VITAMINME HAIR GROWTH + STRENGTH te gebruik
Moenie medisyne met enige ander persoon deel nie.
Gebruik VITAMINME HAIR GROWTH + STRENGTH 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 HAIR GROWTH + STRENGTH 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 HAIR GROWTH + STRENGTH te neem
Moenie ‘n dubbele dosis neem om op te maak vir die individuele dosisse wat oorgeslaan is nie.
4. Moontlike newe-effekte
VITAMINME HAIR GROWTH + STRENGTH kan newe-effekte hê.
Nie alle newe-effekte wat vir VITAMINME HAIR GROWTH + STRENGTH gerapporteer is, word in hierdie inligtingsblad ingesluit nie. Indien jou algemene gesondheid verswak of indien jy enige ongunstige effekte onderwind terwyl VITAMINME HAIR GROWTH + STRENGTH geneem word, raadpleeg asseblief jour gesondheidsverskaffer.
Indien jy enige van die volgende ervaar, hou op om VITAMINME HAIR GROWTH + STRENGTH 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 HAIR GROWTH + STRENGTH gehad het. Jy mag dringende mediese bystand of hospitalisasie benodig.
Sê vir jou dokter indien jy enige van die volgende opmerk:
- naarheid; braking; esofagitis (onsteking van die slukderm, gekenmerk deur moeilike of pynlike sluk, ingeslukte kos raak vas, pyn op die bors agter die borsbeen wat voorkom met eet, sooibrand, suur opblaas); abdominale krampe; diarree; metaal smaak in die mond; spysvertering; droë mond; mond irritasie; moegheid; hoodpyn; slapeloosheid; slaperigheid; nierstene (gekenmerk deur pyn in jou rug of sy; bloed in jou urine; naarheid en braking; koors en kouekoors).
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 HAIR GROWTH + STRENGTH te verskaf.
5. Hoe omVITAMINME HAIR GROWTH + STRENGTH 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 HAIR GROWTH + STRENGTH bevat
|
Elke kapsule bevat: Askorbiensuur (Vitamien C) Sinkglukonaat Verskaf 15,00 mg elementale Sink Biotien (Vitamien H) L-5-Metieltetrahidrofoliensuur (Foliensuur) Ecklonia maxima (Kelp) Verskaf 150,00 µg elementale Jodium Selenium Aminosuurchelaat Verskaf 60,00 µg elementale Selenium |
250,00 mg 78,86 mg 500,00 µg 400,00 µg 21,40 mg 3,00 mg |
Die ander bestanddele is mieliestysel, groentekapsule
Suikervry
Hoe VITAMINME HAIR GROWTH + STRENGTH lyk en inhoud van die verpakking
Deursigtige, groentekapsules wat ‘n af-wit poeier bevat wat klein vlekkies groen/grys het. Die kapsules word verpak in ‘n deursigtige, bruinkleurige glasfles met ‘n drukseël en ‘n wit, geribde skroefdop deksel.
Verpakkingsgrootte: 30 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 HAIR GROWTH + STRENGTH (capsules)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
|
Each capsule contains: Ascorbic Acid (Vitamin C) Zinc Gluconate Providing 15,00 mg elemental Zinc Biotin (Vitamin H) L-5-Methyltetrahydrofolic Acid (Folic Acid) Ecklonia maxima (Kelp) Providing 150,00 µg elemental Iodine Selenium Amino Acid Chelate Providing 60,00 µg elemental Selenium |
250,00 mg 78,86 mg 500,00 µg 400,00 µg 21,40 mg 3,00 mg |
Sugar free.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsules.
Size 0, clear vegetarian capsule containing an off-white power with small flecks of green/grey.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
VITAMINME HAIR GROWTH + STRENGTH is a health supplement that contributes to the maintenance of healthy hair and hair pigmentation.
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 ascorbic acid, zinc gluconate, biotin, L-5-Methyltetrahydrofolic acid, Ecklonia maxima (Kelp), selenium or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
- Large amounts of vitamin C can increase the risk of oxalate kidney stones, especially in those prone to oxalate stone formation.
- Theoretically, selenium may exacerbate autoimmune disease by stimulating disease activity. Caution is advised in those with autoimmune disease such as multiple sclerosis, systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).
- Selenium may cause excessive bleeding if use perioperatively due to its antiplatelet effects. Patients should be advised to discontinue using VITAMINME HAIR GROWTH + STRENGTH at least two weeks prior to any elective surgical procedures.
- Excessive iodine can exacerbate thyroid dysfunction.
- Iodine can exacerbate dermatitis herpetiformis.
4.5 Interaction with other medicines and other forms of interaction
Vitamin C:
- Alkylating agents: The antioxidant effects of vitamin C might reduce the effectiveness of alkylating agents.
- Aluminium: Vitamin C can increase the amount of aluminium absorbed from aluminium compounds.
- Antitumour antibiotics: The antioxidant effects of vitamin C might reduce the effectiveness of antitumour antibiotics.
- Estrogens: Vitamin C might increase blood levels of estrogens.
- Fluphenazine: Vitamin C might decrease levels of fluphenazine.
- Indinavir: Vitamin C can modestly reduce indinavir levels.
- Levothyroxine: Vitamin C can increase levothyroxine absorption.
- Warfarin: High dosages of vitamin C might reduce the levels and effectiveness of warfarin.
Zinc:
- Cephalexin: Zinc might decrease cephalexin levels by chelating with cephalexin in the gut and preventing its absorption.
- Penicillamine: Zinc might reduce the levels and clinical effects of penicillamine.
- Quinolone antibiotics: Zinc can decrease the levels and clinical effects of quinolone antibiotics.
- Ritonavir: Zinc modestly reduces levels of ritonavir.
- Tetracycline antibiotics: Zinc might reduce levels of tetracycline antibiotics.
Folic Acid:
- Methotrexate: Folic acid might reduce the efficacy of methotrexate as a cancer treatment when given concurrently.
- Phenobarbital: Folic acid might have antagonistic effects on phenobarbital and increase the risk for seizures.
- Primidone: Folic acid might have antagonistic effects on primidone and increase the risk for seizures.
- Pyrimethamine: Folic acid might antagonize the effects of pyrimethamine.
Selenium:
- Anticoagulant/anti-platelet medication: Selenium may have antiplatelet effects which can increase the risk of bleeding when used with anticoagulant/antiplatelet medication.
- Barbiturates: Theoretically, selenium might prolong the sedating effects of barbiturates.
- Immunosuppressants: Selenium may reduce the effectiveness of immunosuppressant therapy.
Warfarin: Selenium might interfere with warfarin activity.
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 HAIR GROWTH + STRENGTH does not adversely affect their performance.
4.8 Undesirable effects
VITAMINME HAIR GROWTH + STRENGTH is generally well tolerated.
Gastrointestinal disorders
Frequency unknown: nausea, vomiting, esophagitis, heartburn, abdominal cramps, gastrointestinal obstruction, diarrhoea, metallic taste in the mouth, indigestion, dry mouth, mouth irritation.
Nervous system disorders
Frequency unknown: fatigue, headache, insomnia, sleepiness.
Renal and urinary system disorders
Frequency unknown: precipitation of urate, oxalate, or cysteine stones or medicines in the urinary tract.
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 34.12 Multiple Substance Formulation
VITAMINME HAIR GROWTH + STRENGTH is a health supplement that contributes to the maintenance of healthy hair and hair pigmentation.
5.2 Pharmacokinetic properties
Vitamin C:
Vitamin C is well absorbed orally at lower does, but absorption decreases as the dose increases. Most vitamin C that is absorbed is excreted in the urine.
Zinc:
Zinc is absorbed in the small intestine by a carrier-mediated mechanism. Most zinc is excreted in the faeces, with a small amount eliminated in the urine.
Biotin:
Biotin is completed absorbed after oral administration and reaches peak concentrations after 1 – 2 hours.
Folic Acid:
Folic acid is absorbed rapidly from the small intestine, primarily from the proximal portion. Unmetabolised folic acid is also found in both plasma and breast milk when folic acid is consumed. Folic acid is excreted mainly in the urine; however, it is also found in the faeces.
Selenium:
Oral bioavailability of selenium is around 90% when given as L-selenomethionine with a Tmax of 9.17h. Mainly excreted in the urine as 1beta-methylseleno-N-acetyl-d-galactosamine and trimethylselenonium. Some selenium is also excreted in faeces when given orally.
6. PHARMACEUTICAL PARTICULARS
6.2 List of excipients
Capsule contents:
Maize starch
Capsule shell:
6.3 Incompatibilities
Not applicable.
6.4 Shelf Life
24 months.
6.5 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.
6.6 Nature and contents of container
Clear, amber glass jar with a pressure seal and a white, ribbed screw cap lid.
Pack size: 30 capsules.
6.7 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.