PATIENT INFORMATION LEAFLET

SCHEDULING STATUS: S0 

VITAMINME ENERGY + MOOD (capsules)

L-5 Hydroxytryptophan (5-HTP) as Griffonia simplicifolia (Griffonia), Pyridoxine Hydrochloride (Vitamin B6), L-Methyltetrahydrofolic Acid (Folic Acid), Methylcobalamin (Vitamin B12)

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 ENERGY + MOOD is available without a doctor’s prescription, for you to maintain your health. Nevertheless, you still need to use VITAMINME ENERGY + MOOD carefully to get the best results from it. 

  • Keep this leaflet. You may need to read it again.
  • Do not share VITAMINME ENERGY + MOOD with any other person.
  • Ask your healthcare provider or pharmacist if you need more information or advice.

What is in this leaflet  

  1. What VITAMINME ENERGY + MOOD is and what it is used for
  2. What you need to know before you use VITAMINME ENERGY + MOOD
  3. How to use VITAMINME ENERGY + MOOD  
  4. Possible side effects
  5. How to store VITAMINME ENERGY + MOOD
  6. Contents of the pack and other information

1. What VITAMINME ENERGY + MOOD is and what it is used for   

VITAMINME ENERGY + MOOD is a health supplement that helps to promote a healthy mood balance, contributes to the normal functioning of the nervous system and energy-yielding metabolism, assists with normal psychological function, and contributes to the reduction of tiredness and fatigue.

2. What you need to know before you use VITAMINME ENERGY + MOOD

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 ENERGY + MOOD:

  • If you are hypersensitive (allergic) to 5-HTP (Griffonia simplicifolia),pyridoxine hydrochloride (vitamin B6), L-methyltetrahydrofolic acid(folic acid), methylcobalamin (vitamin B12)or any of the other ingredients of VITAMINME ENERGY + MOOD (listed in section 6). 
  • If you have scleroderma (tightening and hardening of the skin).

Warnings and precautions 

Take special care:

  • If you have a medical condition or if you are currently using any other medication.
  • If you have been scheduled for an elective surgical procedure. Discontinue using VITAMINME ENERGY + MOOD at least 2 weeks prior to any elective surgical procedures. 
  • If you are scheduled to receive a coronary stent. 

Children and adolescents 

VITAMINME ENERGY + MOOD is not recommended for individuals below the age of 18 years. 

Other medicines and VITAMINME ENERGY + MOOD

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 ENERGY + MOOD:

  • Amiodarone: Vitamin B6 might increase the photosensitivity caused by amiodarone.
  • Antihypertensive medicine: Vitamin B6 may have additive effects when used with antihypertensive medicine.
  • Carbidopa: 5-HTP may increase the risk of serotonergic side effects and tightening and hardening of the skin (scleroderma) when used with carbidopa.
  • Central nervous system depressants: 5-HTP may have additive effects when used with central nervous system depressants.
  • Phenobarbital: High doses of vitamin B6 may reduce the levels and clinical effects of phenobarbital. Furthermore, folic acid might have antagonistic effects on phenobarbital and increase the risk for seizures.
  • Phenytoin: High doses of vitamin B6 may reduce the levels and clinical effects of phenytoin.
  • Primidone: Folic acid might have antagonistic effects on primidone and increase the risk for seizures.
  • Pyrimethamine: Folic acid might antagonize the effects of pyrimethamine.
  • Serotonergic medicines (such as antidepressants, pain relievers, cough and cold medicines containing dextromethorphan, anti-nausea medicines and anti-migraine medicines): 5-HTP can increase the risk of serotonergic side-effects when used with serotonergic medicines.

VITAMINME ENERGY + MOOD with food, drink and alcohol

Avoid taking VITAMINME ENERGY + MOOD with alcohol. 

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 ENERGY + MOOD.

Safety for use during pregnancy and lactation has not been established.

Driving and using machinery 

VITAMINME ENERGY + MOOD may make you feel drowsy or sleepy. Do not drive a vehicle, operate machinery or do anything else that requires your attention until you know how VITAMINME ENERGY + MOOD affects you.

3. How to use VITAMINME ENERGY + MOOD

Do not share medicines with any other person. 

Always use VITAMINME ENERGY + MOOD 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 ENERGY + MOOD 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 ENERGY + MOOD

Do not take a double dose to make up for individual forgotten doses.

4. Possible side effects  

VITAMINME ENERGY + MOOD can have side effects. 

Not all side effects reported for VITAMINME ENERGY + MOOD are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VITAMINME ENERGY + MOOD, please consult your healthcare provider for advice. 

If any of the following happens, stop using VITAMINME ENERGY + MOOD 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 ENERGY + MOOD. You may need urgent medical attention or hospitalisation. 

Tell your doctor as soon as possible if you notice any of the following:

euphoria (a state of intense excitement); anxiety; aggressiveness; drowsiness; light-headedness; headache; insomnia; fatigue; palpitations; nausea; vomiting; abdominal pain; anorexia; heartburn; constipation; diarrhoea; flatulence; skin rash; allergic skin reactions. 

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 ENERGY + MOOD.

5. How to store VITAMINME ENERGY + MOOD.

  • 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 ENERGY + MOOD contains 

Each capsule contains:

L-Methyltetrahydrofolic Acid (Folic Acid)

Griffonia simplicifolia (Griffonia) [seed, as 150,00 mg extract standardised to 95 % L-5 Hydroxytryptophan (5-HTP)]

Methylcobalamin (Vitamin B12)

Pyridoxine Hydrochloride (Vitamin B6)

 

400,00 µg

150,00 mg

100,00 µg

50,00 mg

The other ingredients are maize starch, vegetable capsule.

Sugar free

What VITAMINME ENERGY + MOOD looks like and contents of the pack

Clear, vegetable capsule containing and off-white powder. The capsules are packed in a clear, amber glass jar with a pressure seal and a white, ribbed screwcap 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 ENERGY + MOOD (kapsules)

L-5 Hidroksitriptofaan (5-HTP) as Griffonia simplicifolia (Griffonia), Piridoksienhidrochloried (Vitamien B6), L-Metieltetrahidrofoliensuur (Foliensuur), Metielkobalamien (Vitamien B12)[JD1] 

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 ENERGY + MOOD is beskikbaar sonder ‘n dokter se voorskrif, om jou gesondheid te handhaaf. Nietemin moet VITAMINME ENERGY + MOOD versigtig gebruik word ten einde die beste resultate te verkry.

  • Hou hierdie inligtingsblad. Dit kan nodig wees dat jy dit weer lees.
  • Moenie VITAMINME ENERGY + MOOD met enige ander persoon deel nie.
  • Vra jou gesondheidsorgverskaffer of apteker indien jy meer inligting of advies nodig het.

Wat is in hierdie inligtingsblad

  1. Wat is VITAMINME ENERGY + MOOD en warvoor word dit gebruik
  2. Wat jy moet weet voordat jy VITAMINME ENERGY + MOOD gebruik
  3. Hoe om VITAMINME ENERGY + MOOD te gebruik
  4. Moontlike newe-effekte
  5. Hoe om VITAMINME ENERGY + MOOD te bêre
  6. Inhoud van die pak en ander inligting

1. Wat is VITAMINME ENERGY + MOOD en waarvoor word dit gebruik

VITAMINME ENERGY + MOOD is ‘n gesondheidsaanvulling wat help om ‘n gesonde gemoedsbalans te bevorder, bydra tot die normale funksionering van die senuweestelsel en energie-oplewerende metabolisme, help met normale sielkundige funksie, en bydra tot die vermindering van moegheid en moegheid.

2. Wat jy moet weet voordat jy VITAMINME ENERGY + MOOD 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 ENERGY + MOOD neem nie:

  • Indien jy hipersensitief (allergies) is vir 5-HTP (Griffoniasimplicifolia), piridoksienhidrochloried (vitamien B6), L-metieltetrahidrofoliensuur (foliensuur), metielkobalamien (vitamien B12) of vir enige van die ander bestanddele van VITAMINME ENERGY + MOOD (gelys in afdeling 6).
  • Indien jy scleroderma het (vel wat verhard en styf trek).

Waarskuwings en voorsorgmaatreëls

Neem spesiale sorg:

  • Indien jy ‘n mediese toestand het of as jy tans enige ander medisyne gebruik.
  • Indien jy geskeduleer is vir ‘n elektiewe chirurgiese procedure. Hou op om VITAMINME ENERGY + MOOD ten minste 2 weke voor enige elektiewe chirurgiese prosedures te gebruik.
  • Indien jy geskeduleer is om ‘n koronêre stent te ontvang.

Kinders en adolessente

VITAMINME ENERGY + MOOD word nie aanbeveel vir individue onder die ouderdom van 18 jaar nie.

Ander medisyne en VITAMINME ENERGY + MOOD 

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 ENERGY + MOOD hê:

  • Amiodaroon: Vitamien B6 kan die fotosensitiwiteit wat deur amiodaroon veroorsaak word, verhoog.
  • Antihipertensiewe medisyne: Vitamien B6 kan bykomende effekte hê wanneer dit saam met antihipertensiewe medisyne gebruik word.
  • Karbidopa: 5-HTP kan die risiko van serotonergiese newe-effekte en verstramming en verharding van die vel (scleroderma) verhoog wanneer dit saam met karbidopa gebruik word.
  • Sentrale senuweestelsel onderdrukkers: 5-HTP kan bykomene effekte hê wanneer dit saam met sentrale senuweestelsel onderdrukkers gebruik word.
  • Fenobarbital: Hoë dosisse vitamien B6 kan die vlakke en kliniese effekte van fenobarbital verminder. Verder kan foliensuur antagonistiese effekte op fenobarbital hê en die risiko vir aanvulle verhoog.
  • Fenitoïen: Hoë dosisse vitamien B6 kan die vlakke en kliniese effekte van fenitoïen verminder.
  • Primidoon: Foliensuur kan antagonistiese effekte op primidoon hê en die risiko vir aanvalle verhoog.
  • Pirimetamien: Foliensuur kan die effekte van pirimetamien antagoniseer.
  • Serotonergiese medisyne (soos antidepressante, pynverligters, hoes- en verkouemedisyne wat dekstrometorfaan bevat, medisynes teen naarheid en vir migraine): 5-HTP kan die risiko vir serotonergiese newe-effekte verhoog wanneer dit saam met serotonergiese medisyne gebruik word.

VITAMINME ENERGY + MOOD met kos, drinkgoed en alkohol

Moenie VITAMINME ENERGY + MOOD saam met alcohol neem nie. 

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 ENERGY + MOOD neem.

Veiligheid vir gebruik tydens swangerskap en laktasie is nie vasgestel nie. 

Bestuur en die gebruik van masjinerie

VITAMINME ENERGY + MOOD mag jou lomerig of slaperig laat voel. Moenie ‘n voertuig bestuur, masjinerie hanteer of enigiets anders doen wat konsentrasie verg totdat jy weet hoe VITAMINME ENERGY + MOOD jou affekteer nie.

3. Hoe om VITAMINME ENERGY + MOOD te gebruik

Moenie medisyne met enige ander persoon deel nie. 

Gebruik VITAMINME ENERGY + MOOD 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 ENERGY + MOOD 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 ENERGY + MOOD te neem

Moenie ‘n dubbele dosis neem om op te maak vir die individuele dosisse wat oorgeslaan is nie. 

4. Moontlike newe-effekte

VITAMINME ENERGY + MOOD kan newe-effekte hê. 

Nie alle newe-effekte wat vir VITAMINME ENERGY + MOOD gerapporteer is, word in hierdie inligtingsblad ingesluit nie. Indien jou algemene gesondheid verswak of indien jy enige ongunstige effekte onderwind terwyl VITAMINME ENERGY + MOOD geneem word, raadpleeg asseblief jour gesondheidsverskaffer. 

Indien jy enige van die volgende ervaar, hou op om VITAMINME ENERGY + MOOD 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 ENERGY + MOOD 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: 

Newe-effekte wat met onbekende frekwensie voorkom:

euforie (‘n toestand van intense opgewondheid); angstigheid; aggressiwiteit; lomerigheid; lighoofdigheid; hoofpyn; slapeloosheid; moegheid; palpitasies; naarheid; braking; buikpyn; anoreksie; sooibrand; konstipasie; diarree; winderigheid; veluitslag; allergiese velreaksies. 

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 ENERGY + MOOD te verskaf.

5. Hoe omVITAMINME ENERGY + MOOD 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 ENERGY + MOOD bevat

Elke kapsule bevat:

L-Metieltetrahidrofoliensuur (Foliensuur)

Griffonia simplicifolia (Griffonia)
[saad, as 150,00 mg ekstrak gestandaardiseer tot 95 % L-5 Hidroksitriptofaan (5-HTP)]

Metielkobalamien (Vitamien B12)

Piridoksienhidrochloried (Vitamien B6)

 

400,00 µg

150,00 mg

100,00 µg

50,00 mg

Die ander bestanddele is mieliestysel, groentekapsule (xxxxx).

Suikervry

Hoe VITAMINME ENERGY + MOOD lyk en inhoud van die verpakking

Deursigtige, groentekapsule wat ‘n af-wit poeier bevat. 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 ENERGY + MOOD (capsules)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains:

L-Methyltetrahydrofolic Acid (Folic Acid)

Griffonia simplicifolia (Griffonia) [seed, as 150,00 mg extract standardised to 95 % L-5 Hydroxytryptophan (5-HTP)]

Methylcobalamin (Vitamin B12)

Pyridoxine Hydrochloride (Vitamin B6)

 

400,00 µg

150,00 mg

100,00 µg

50,00 mg

Sugar-free.

For full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Capsules.
Size 0, clear vegetable capsules filled with an off-white powder.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

VITAMINME ENERGY + MOOD is a health supplement that helps to promote a healthy mood balance, contributes to the normal functioning of the nervous system and energy-yielding metabolism, assists with normal psychological function, and contributes to the reduction of tiredness and fatigue. 

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.

Not recommended for children under the age of 18 years.  

Do not exceed the recommended dose. 

Method of administration

For oral use. To be taken after food. 

4.3 Contraindications

  • Hypersensitivity to 5-HTP (Griffonia simplicifolia), pyridoxine hydrochloride (vitamin B6), L-methyltetrahydrofolic acid(folic acid), methylcobalamin (vitamin B12) or to any of the excipients listed in section 6.1.
  • Scleroderma (tightening and hardening of the skin).

4.4 Special warnings and precautions for use

  • VITAMINME ENERGY + MOOD should be discontinued at least two weeks prior to any elective surgical procedures. 5-HTP may interfere with surgical procedures due to serotonergic central nervous system effects or serotonergic effects on the vascular system. 5-HTP is a precursor of serotonin and increases serotonin levels.  
  • There is some concern that a certain combination of B-vitamins (folic acid, vitamin B6 and vitamin B12) may increase the rate of restenosis after bare metal stent placement. Due to the potential for harm, this combination of vitamins should not be recommended for patients receiving coronary stents.

4.5 Interaction with other medicines and other forms of interaction

5-HTP:

  • Carbidopa: Combining 5-HTP and carbidopa can increase the risk of serotonergic side effects, including hypomania, restlessness, rapid speech, anxiety, insomnia, and aggressiveness. It might also increase the risk of scleroderma-like skin changes due to elevated serotonin levels.
  • Central nervous system depressants: Concomitant use of 5-HTP with medications that cause sedation might have additive effects.
  • Serotonergic medicine: Combining serotonergic medicine with 5-HTP might increase the risk of serotonergic side effects, including serotonin syndrome and cerebral vasoconstrictive disorders.

Pyridoxine hydrochloride (vitamin B6):

  • Amiodarone: Vitamin B6 might increase the photosensitivity caused by amiodarone.
  • Antihypertensive medicine: Vitamin B6 may have additive effects when used with antihypertensive medicine.
  • Phenobarbital: High doses of vitamin B6 may reduce the levels and clinical effects of phenobarbital.
  • Phenytoin: High doses of vitamin B6 may reduce the levels and clinical effects of phenytoin.

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.

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 ENERGY + MOOD may cause drowsiness, which can affect your ability to drive a vehicle and operate machinery. Patients should take caution before performing activities requiring their attention, until they are reasonably certain that VITAMINME ENERGY + MOOD does not adversely affect their performance.

4.8 Undesirable effects 

VITAMINME ENERGY + MOOD is generally well tolerated. 

Psychiatric disorders

Less frequent: Euphoria, hypomania, mania, anxiety, aggression.


Nervous system disorders

Frequent: drowsiness, light-headedness, headache, insomnia, fatigue.

Cardiac disorders

Less frequent: palpitations.

Gastrointestinal disorders

Frequent: nausea, vomiting, abdominal pain, anorexia.

Less frequent: heartburn, constipation, diarrhoea, flatulence. 

Skin and subcutaneous tissue disorders

Less frequent: urticaria, allergic skin reactions, flushing.

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

5-HTP:

5-HTP is produced in the body from the essential amino acid L-tryptophan and is a precursor to the neurotransmitter serotonin. 

Supplemental 5-HTP crosses the blood-brain barrier and increases the production of serotonin by the central nervous system.

Vitamin B6:

Vitamin B6 is required for amino acid metabolism. It is also involved in carbohydrate and lipid metabolism. In the body, vitamin B6 is converted to the coenzyme pyridoxal phosphate for a wide variety of metabolic reactions.

Folic Acid:

Helps the body to metabolise proteins. Contributes to red blood cell formulation is a factor in the maintenance of good health.

Vitamin B12:

Helps to metabolise carbohydrates, fats and proteins. Contributes to normal red blood cell formation and is a factor in the maintenance of good health.

5.2 Pharmacokinetic properties

5-HTP: 

5-HTP is well absorbed after oral administration, with a mean bioavailability of approximately 70%. The maximum measured 5-HTP plasma concentration (Tmax) occurs about 1 to 3 hours after administration. The half-life of 5-HTP is reported to be between 2 hours and 6 hours.

Vitamin B6:

Vitamin B6 is absorbed passively in the upper gastrointestinal tract and is excreted in the urine.

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 feces.

Vitamin B12:

Vitamin B12 is primarily absorbed by binding with intrinsic factor to be actively transported in the terminal ileum. In addition to active absorption, it is estimated that about 1,2 % of vitamin B12 is absorbed by passive diffusion. 

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Capsule contents:

Maize starch

Capsule shell:

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 capsules. 

6.6 Special precautions for disposal

No special requirements. 

7. HOLDER OF CERTIFICATE OF REGISTRATION

VitaminMe (Pty) Ltd
32 Fricker Road
Illovo
Johannesburg
South Africa
2196

8. REGISTRATION NUMBER

Will be allocated by SAHPRA upon registration. 

9. DATE OF FIRST AUTHORISATION

Will be allocated by SAHPRA upon registration.