PMS Support + Hormone Balance

Relieve PMS symptoms + promote a healthy hormone balance

• Reduces PMS-related cramps, headaches, fatigue + breakouts

• Lessens mood swings + irritability

• Regulates your menstrual cycle

• Promotes a healthy hormone balance

• Hormone balance + menstrual cycle health
• PMS symptoms (cramps, fatigue, headaches)
• Mood stability + irritability
• Hormonal skin concerns (breakouts)
• Bloating + water retention

Take 1-2 tablets daily after food

Dong Quai
Also known as the “female ginseng”, Dong Quai is widely used as a natural remedy for period cramps, irregular menstrual cycles as well as menopausal symptoms, due to its effect on modulating oestrogen levels.
St Johns Wort
St John’s Wort is primarily known as an effective natural solution for low mood commonly linked with PMS and menopause. Its anti-inflammatory properties
can also ease hormonal cramps and breast tenderness.
Chasteberry
Chasteberry is regularly used as a natural treatment for PMS and menopausal symptoms like migraines, low mood and breast pain. Its power is in its ability to
decrease prolactin levels, helping to rebalance other reproductive hormones.
Calcium
PMS symptoms are often linked with insufficient calcium levels in your diet. Studies have also concluded that calcium supplementation can assist with decreasing mood related symptoms associated with hormonal fluctuations.

PATIENT INFORMATION LEAFLET

SCHEDULING STATUS: S0

VITAMINME PMS SUPPORT + HORMONE BALANCE (tablets)

Vitex agnus-castus L. (Chaste Tree), Hypericum perforatum L. (St. John’s Wort), Calcium Lactate, Angelica sinensis (Oliv.) Diels (Dong Quai), Paenoia lactiflora Pall. (Chinese Peony), Viburnum opulus L. (Cramp Bark), Withania somnifera (L.) Dunal (Ashwagandha), Ginkgo biloba L. (Ginkgo Biloba), Zingiber officinale Roscoe (Ginger), Zinc Citrate, L-5-Methyltetrahydrolic Acid, Methylcobalamin, Chromium Polynicotinate, Cholecalciferol, DIM (Diindolylmethaneas Brassica oleracea var. botrytis)

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

• Keep this leaflet. You may need to read it again. 
• Do not share VITAMINME PMS SUPPORT + HORMONE BALANCE 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 PMS SUPPORT + HORMONE BALANCE is and what it is used for
2. What you need to know before you use VITAMINME PMS SUPPORT + HORMONE BALANCE
3. How to use VITAMINME PMS SUPPORT + HORMONE BALANCE 
4. Possible side effects
5. How to store VITAMINME PMS SUPPORT + HORMONE BALANCE
6. Contents of the pack and other information

 1. What VITAMINME PMS SUPPORT + HORMONE BALANCE is and what it is used for   

VITAMINME PMS SUPPORT + HORMONE BALANCE is a complementary medicine that may help to stabilise menstrual cycle irregularities and relieve premenstrual symptoms. VITAMINME PMS SUPPORT + HORMONE BALANCE supports healthy estrogen metabolism and balance.  

2. What you need to know before you use VITAMINME PMS SUPPORT + HORMONE BALANCE

Do not use VITAMINME PMS SUPPORT + HORMONE BALANCE:

• • If you are hypersensitive (allergic) to any of the active ingredients or to any of the other ingredients of VITAMINME PMS SUPPORT + HORMONE BALANCE (listed in section 6).  
  • If you have a bleeding disorder or are taking any other medicines that affect blood coagulation (e.g. blood thinners). 
  • If you have diarrhoea.
  • If you are pregnant or breastfeeding (see Pregnancy, breastfeeding and fertility). 
  • If you have hypermenorrhoea (menstrual periods with an excessively heavy flow). 
  • If you are taking anti-cancer, anti-depressant, cardiovascular or contraceptive medications, anti-HIV agents and/or medications used to suppress the immune system (immunosuppressants) (see Other medicines and VITAMINME PMS SUPPORT + HORMONE BALANCE).

Warnings and precautions 

Take special care:

• • • If you have a medical condition or if you are currently taking any other medicine. 
    • If you are scheduled for an elective surgical procedure. You should stop taking VITAMINME PMS SUPPORT + HORMONE BALANCE at least 2 weeks before any elective surgical procedures. 
    • If your symptoms persist or worsen you should consult with your healthcare provider.
    • If you are taking hormone-containing medications such as progesterone preparations or hormone replacement therapy. 
    • If you are taking antipsychotic medications such as medications for Parkinson disease, schizophrenia or other psychiatric disorders. 
    • To avoid prolonged exposure to sunlight, ultraviolet light (UV) or UV therapy while taking VITAMINME PMS SUPPORT + HORMONE BALANCE. 
    • Not to take VITAMINME PMS SUPPORT + HORMONE BALANCE with alcohol or other medications that may cause drowsiness. 
    • If you have an allergy to poison ivy, poison oak, poison sumac, mango rinds or cashews as you may at increased risk of experiencing an allergic reaction to VITAMINME PMS SUPPORT + HORMONE BALANCE. 
    • To consult a relevant healthcare provider prior to using VITAMINME PMS SUPPORT + HORMONE BALANCE if any of the following applies to you:
      1. You are taking anti-anxiety or seizure medication, antihistamines, bronchodilators, muscle relaxants, opiates, hormone replacement therapy (HRT), medications for diabetes or high blood pressure. 
      2. You suffer from a psychological disorder such as anxiety or depression, schizophrenia, bipolar disorder, Alzheimer’s disease. 
      3. You have an autoimmune disease. 
      4. You have hyperthyroidism or are taking thyroid hormone medications. 
      5. You are trying to fall pregnant.
      6. You have symptoms of low estrogen (such as joint pain, mood changes, changes in libido, hot flashes, night sweats, vaginal dryness or irregular menstruation). 
      7. You have a liver disorder. 
    • To stop using VITAMINME PMS SUPPORT + HORMONE BALANCE if you notice any of the following while using VITAMINME PMS SUPPORT + HORMONE BALANCE:
      1. Your menstrual period is delayed or absent, or if you experience an increase in the length of your menstrual period.
      2. You develop signs and symptoms of liver problems (such as yellowing of the eyes or skin, dark urine and abdominal pain). 

Children and adolescents 

VITAMINME PMS SUPPORT + HORMONE BALANCE is not recommended for individuals below the age of 18 years. 

Other medicines and VITAMINME PMS SUPPORT + HORMONE BALANCE

Always tell your healthcare provider if you are taking any other medicine. This includes all complementary or traditional medicines.

Do not use VITAMINME PMS SUPPORT + HORMONE BALANCE if you are taking blood thinners, anti-cancer, anti-depressant, cardiovascular or contraceptive medications, anti-HIV agents and/or medications used to suppress the immune system (immunosuppressants). 

Taking VITAMIN ME PMS SUPPORT + HORMONE BALANCE with alcohol or medicines that cause drowsiness may have additive sedative effects. 

If you are using any of the following medication you should consult with your healthcare provider prior to using VITAMINME PMS SUPPORT + HORMONE BALANCE. The active ingredients in VITAMINME PMS SUPPORT + HORMONE BALANCE may have an interaction with the following:

• • Vitex agnus-castus: antipsychotic medication (e.g. medication for Parkinson disease, schizophrenia or other psychiatric disorders); contraceptive medicine; dopamine agonists; estrogens; metoclopramide.
  • St. John’s Wort: alprazolam; aminolevulinic acid; bupropion; clopidogrel; clozapine; contraceptive medicines; cyclosporine; Cytochrome P450 3A4 (CYP3A4) substrates; digoxin; docetaxel; fexofenadine; finasteride; gliclazide; imatinib; indinavir; irinotecan; ivabradine; ketamine; mephenytoin; methadone; non-nucleoside reverse transcriptase inhibitors (NNRTIs); omeprazole; oxycodone; P-glycoprotein substrates; phenobarbital; phenprocoumon; phenytoin; photosensitizing medicines; protease inhibitors (PIs); rivaroxaban; serotonergic medicines; tacrolimus; tramadol; voriconazole; warfarin; zolpidem.
  • Dong quai: blood thinners; estrogens; warfarin. 
  • Ashwagandha: antidiabetes medication; antihypertensive medication; benzodiazepines; CNS depressants; immunosuppressants; thyroid hormones.
  • Ginkgo biloba: alprazolam, blood thinners; anticonvulsants; antidiabetes medication; cytochrome substrates; efavirenz; ibuprofen; P-glycoprotein susbtrates; risperidone; trazodone.
  • DIM: diuretics; estrogens. 

VITAMINME PMS SUPPORT + HORMONE BALANCE with food, drink and alcohol

Avoid drinking alcohol if you are taking VITAMINME PMS SUPPORT + HORMONE BALANCE.

Pregnancy, breastfeeding and fertility 

Do not use VITAMINME PMS SUPPORT + HORMONE BALANCE if you are pregnant or breastfeeding. 

Driving and using machinery 

VITAMINME PMS SUPPORT + HORMONE BALANCE 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 PMS SUPPORT + HORMONE BALANCE affects you.  

3. How to use VITAMINME PMS SUPPORT + HORMONE BALANCE

Do not share medicines with any other person. 

Always use VITAMINME PMS SUPPORT + HORMONE BALANCE 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 tablet whole and do not chew or crush. 

Do not exceed the recommended dose. 

If you take more VITAMINME PMS SUPPORT + HORMONE BALANCE 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 PMS SUPPORT + HORMONE BALANCE

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

If you stop taking VITAMINME PMS SUPPORT + HORMONE BALANCE

VITAMINME PMS SUPPORT + HORMONE BALANCE contains St. John’s Wort.

You may experience the following withdrawal effects when you stop using VITAMINME PMS SUPPORT + HORMONE BALANCE: headache, nausea, anorexia, dry mouth, thirst, cold chills, weight loss, dizziness, insomnia, paraesthesia, confusion, and fatigue.

4. Possible side effects  

VITAMINME PMS SUPPORT + HORMONE BALANCE can have side effects. 

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

If any of the following happens, stop using VITAMINME PMS SUPPORT + HORMONE BALANCE 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 PMS SUPPORT + HORMONE BALANCE. You may need urgent medical attention or hospitalisation. 

Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience any of the following:

extreme anxiety; confusion; high blood pressure; rapid heart rate; muscle rigidity or twitching muscles; shivering; dilated pupils; fever; seizures; psychosis (loss of contact with reality); delirium, very red, inflamed, itchy or painful skin all over the body that feels warm to the touch. 

These are all very serious side effects. You may need urgent medical attention or hospitalisation. 

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

gastrointestinal upset or pain; diarrhoea; nausea; vomiting; weight gain; indigestion; loss of appetite; constipation; burping; flatulence or gas; dry mouth; headache; fatigue; insomnia; vertigo; dizziness; lethargy (feeling tired and/or sluggish); drowsiness; sedation; tingling, numbness or “pins and needles”; palpitations; irregular heatbeat; high blood pressure; muscle or joint stiffness; tremors; muscle spasms or muscle pain; edema (swelling or puffiness in parts of your body due to fluid retention); irregular or prolonged menstrual bleeding or bleeding in between your menstrual periods; anorgasmia (difficulty having an orgasm); itching; rash; skin irritation; urticaria (hives); acne; eczema; hair loss; photosensitivity or photodermatitis (itchy bumps, blisters, raised areas, or dark patches on your skin that appear after exposure to sunlight or UV light); ringing in your ears (tinnitus); frequent urination; darkened urine; sore throat; aching sinuses; 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 PMS SUPPORT + HORMONE BALANCE.  

5. How to store VITAMINME PMS SUPPORT + HORMONE BALANCE.

• • • 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 the label. 
    • 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 PMS SUPPORT + HORMONE BALANCE contains 

The other ingredients are microcrystalline cellulose, povidone , maize starch, ca carb, silicon dioxide. 

Sugar free

What VITAMINME PMS SUPPORT + HORMONE BALANCE looks like and contents of the pack

Oval, uncoated tablets with flecks of grey, brown, white and black. 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 PMS SUPPORT + HORMONE BALANCE (tablette)

Vitex agnus-castus L. (Kuisboom), Hypericum perforatum L. (Sint Janskruid), Kalsiumlaktaat, Angelica sinensis (Oliv.) Diels (Dong Quai), Paenoia lactiflora Pall. (Chinese Pioenroos), Viburnum opulus L. (Gelderse Roos), Withania somnifera (L.) Dunal (Ashwagandha), Ginkgo biloba L. (Ginkgo Biloba), Zingiber officinale Roscoe (Gemmer), Sinksitraat, L-5-Metieltetrahidrofoliensuur, Metielkobalamien, Chroompolinikotinaat, Cholekalsiderol, DIM (Diindolylmetaan as Brassica oleracea var. botrytis)

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

• • Hou hierdie inligtingsblad. Dit kan nodig wees dat jy dit weer lees.
  • Moenie VITAMINME PMS SUPPORT + HORMONE BALANCE 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 PMS SUPPORT + HORMONE BALANCE en warvoor word dit gebruik
  • Wat jy moet weet voordat jy VITAMINME PMS SUPPORT + HORMONE BALANCE gebruik
  • Hoe om VITAMINME PMS SUPPORT + HORMONE BALANCE te gebruik
  • Moontlike newe-effekte
  • Hoe om VITAMINME PMS SUPPORT + HORMONE BALANCE te bêre
  • Inhoud van die pak en ander inligting

1. Wat is VITAMINME PMS SUPPORT + HORMONE BALANCE en waarvoor word dit gebruik

VITAMINME PMS ONDERSTEUNING + HORMOON BALANS is ‘n komplementêre medisyne wat kan help om onreëlmatighede in die menstruele siklus te stabiliseer en premenstruele simptome te verlig. VITAMINME PMS ONDERSTEUNING + HORMONEBALANS ondersteun gesonde estrogeenmetabolisme en balans.

2. Wat jy moet weet voordat jy VITAMINME PMS SUPPORT + HORMONE BALANCE gebruik

Moenie VITAMINME PMS SUPPORT + HORMONE BALANCE neem nie:

• • Indien jy hipersensitief (allergies) is vir enige van die aktiewe bestanddele of vir enige van die ander bestanddele van VITAMINME PMS SUPPORT + HORMONE BALANCE (gelys in afdeling 6).
  • Indien jy ‘n bloedingsversteuring het of enige ander medisyne neem wat bloedstolling beïnvloed (bv. bloedverdunners). 
  • Indien jy diarree het. 
  • Indien jy swanger is of borsvoed (sien Swangerskap, borsvoeding en vrugbaarheid). 
  • Indien jy hipermenorree het (menstruele periodes met ‘n oormatige vloei).
  • Indien jy anti-kanker, anti-depressant, kardiovaskulêre of voorbehoedmiddels, anti-MIV-middels en / of medikasie gebruik om die immuunstelsel te onderdruk (immuunonderdrukkers) (sien Ander medisyne en VITAMINME PMS SUPPORT + HORMONE BALANCE).

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. Jy moet ten minste 2 weke voor enige elektiewe chrirurgiese prosedures ophou om VITAMINME PMS SUPPORT + HORMONE BALANCE te neem. 
  • Indien jou simptome voortduur of vererger moet jy met jou gesondheidsverskaffer raadpleeg.
  • Indien jy hormoonbevattende medikasie soos progesteroonpreparate of hormoonvervangingsterapie neem. 
  • Indien jy antipsigotiese medikasie gebruik soos medikasie vir Parkinson-siekte, skisofrenie of ander psigiatriese afwyings. 
  • Om langdurige blootstelling aan sonlig, ultravioletlig (UV) of UV-terapie te vermy terwyl VITAMINME PMS SUPPORT + HORMONE BALANCE geneem word. 
  • Om nie VITAMINME PMS SUPPORT + HORMONE BALANCE saam met alkohol of ander medikasie wat lomerigheid kan verooksaak, te neem nie. 
  • Indien jy ‘n allergies is vir gif klimopplant, gif eikebome, gifsumak, mango skil of kasjoeneute, aangesien jy ‘n verhoogde risiko het om ‘n allergiese reaksie op VITAMINME PMS SUPPORT + HORMONE BALANCE te ervaar. 
  • Om ‘n relevante gesondheidsorgverskaffer te raadpleeg voordat VITAMINME PMS SUPPORT + HORMONE BALANCE gebruik word indien enige van die volgende op jou van toepassing is:
    1. Jy neem medikasie vir angs of aanvalle, antihistamiene, brongodilators, spierverslappers, opiate, hormoonvervangingsterapie (HVT), medikasie vir diabetes of hoë bloeddruk. 
    2. Jy ly aan ‘n sielkundige afwying soos angs of depressie, skisofrenie, bipolêre versteuring, of Alzheimer se siekte. 
    3. Jy het ‘n outo-immuun siekte. 
    4. Jy het hipertireose of neem skildklierhormoon-medikasie. 
    5. Jy probeer om swanger te raak. 
    6. Jy het simptome van lae estrogeen (soos gewrigspyn, buiveranderinge, veranderinge in libido, warm gloede, nagsweet, vaginale droogheid of onreëlmatige menstruasie).
    7. Jy het ‘n lewerafwyking. 
  • Om op te hou om VITAMINME PMS SUPPORT + HORMONE BALANCE te gebruik as jy enige van die volgende opmerk tydens die gebruik van VITAMINME PMS SUPPORT + HORMONE BALANCE:
    1. Jou menstruasieperiode is vertraag of afwesig, of as jy ‘n toename in die lengte van jou menstruasie ervaar. 
    2. Jy tekens en simptome van lewerprobleme ontwikkel (soos vergeling van die oë of vel, donker urine en buikpyn). 

Kinders en adolessente

VITAMINME PMS SUPPORT + HORMONE BALANCE word nie aanbeveel vir individue onder die ouderdom van 18 jaar nie.

Ander medisyne en VITAMINME PMS SUPPORT + HORMONE BALANCE 

Lig altyd jou gesondheidsorgverskaffer in indien jy enige ander medisyne neem. Dit sluit aanvullende of tradisionele medisyne in.

Moenie VITAMINME PMS SUPPORT + HORMONE BALANCE gebruik as jy bloedverdunners, anti-kanker, anti-depressante, kardiovaskulêre of voorbehoedmiddels, anti-MIV-middels en/of medikasie gebruik om die immuunstelsel te onderdruk (immuunonderdrukkers) nie. 

Die gebruik van VITAMINME PMS SUPPORT + HORMONE BALANCE saam met alkohol of medisyne wat lomerigheid veroorsaak, kan bykomende kalmerende effekte hê.

As jy enige van die volgende medikasie gebruik, moet jy met jou gesondheidsorgverskaffer raadpleeg voordat jy VITAMINME PMS SUPPORT + HORMONE BALANCE gebruik. Die aktiewe bestanddele in VITAMINME PMS SUPPORT + HORMONE BALANCE kan ‘n interaksie hê met die volgende:

• • Vitex agnus-castus: antipsigotiese medikasie (bv. medikasie vir Parkinson-siekte, skisofrenie of ander psigiatriese afwykings); voorbehoedmiddels; dopamienagoniste; estrogeen; metoklopramied.
  • Sint Janskruid: alprazolam; aminolevuliensuur; bupropion; klopidogrel; klozapien; voorbehoedmiddels; siklosporien; Sitochroom P450 3A4 (CYP3A4) substrate; digoksien; docetaxel; fexofenadien; finasteried; gliklasied; imatinib; indinavir; irinotekaan; ivabradien; ketamien; mefenitoïen; metadoon; nie-nukleosied-omgekeerde transkriptase-inhibeerders (NNRTI’s); omeprazol; oksikodoon; P-glikoproteïen substrate; fenobarbital; fenprokoumon; fenitoïen; fotosensibiliserende medisyne; protease-inhibeerders (PI’s); rivaroksaban; serotonergiese medisyne; takrolimus; tramadol; vorikonasool; warfarin; zolpidem.
  • Dong quai: bloedverdunners; estrogeen; warfarin.
  • Ashwagandha: antidiabetese medikasie; antihipertensiewe medikasie; bensodiasepiene; SSS-onderdrukkers; immuunonderdrukkers; skildklierhormone.
  • Ginkgo biloba: alprazolam, bloedverdunners; antikonvulsiewe middels; antidiabetiese medikasie; sitochroom substrate; efavirens; ibuprofen; P-glikoproteïen substrate; risperidoon; trasodoon.
  • DIM: diuretika; estrogeen.

VITAMINME PMS SUPPORT + HORMONE BALANCE met kos, drinkgoed en alkohol

Vermy die gebruik van alkohol terwyl u VITAMINME PMS SUPPORT + HORMONE BALANCE neem.

Swangerskap, borsvoeding en vrugbaarheid

Moenie VITAMINME PMS SUPPORT + HORMONE BALANCE gebruik indien jy swanger is of borsvoed nie. 

Bestuur en die gebruik van masjinerie

VITAMINME PMS SUPPORT + HORMONE BALANCE mag u lomerig of slaperig laat voel. Moenie ‘n voertuig bestuur, masjinerie gebruik of enigiets anders doen wat jou aandag verg totdat jy weet hoe VITAMINME PMS SUPPORT + HORMONE BALANCE jou raak nie. 

Hoe om VITAMINME PMS SUPPORT + HORMONE BALANCE te gebruik

Moenie medisyne met enige ander persoon deel nie. 

Gebruik VITAMINME PMS SUPPORT + HORMONE BALANCE 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 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 PMS SUPPORT + HORMONE BALANCE 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 PMS SUPPORT + HORMONE BALANCE te neem

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

Indien jy ophou om VITAMINME PMS SUPPORT + HORMONE BALANCE te neem

VITAMINME PMS SUPPORT + HORMONE BALANCE bevat Sint Janskruid. 

Jy kan die volgende onttrekkingseffekte ervaar wanneer jy ophou om VITAMINME PMS SUPPORT + HORMONE BALNCE te gebruik: hoofpyn, naarheid, anoreksie, droë mond, dors, koue kouekoors, gewigsverlies, duiseligheid, slapeloosheid, parestesie, verwarring en moegheid.

4. Moontlike newe-effekte

VITAMINME PMS SUPPORT + HORMONE BALANCE kan newe-effekte hê. 

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

Indien jy enige van die volgende ervaar, hou op om VITAMINME PMS SUPPORT + HORMONE BALANCE 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 PMS SUPPORT + HORMONE BALANCE gehad het. Jy mag dringende mediese bystand of hospitalisasie benodig.

Sê dadelik vir jou dokter of gaan na die ongevalle-afdeling by jouse naase hospital indien jy enige van die volgende ervaar:

oormatige angs; verwarring; hoë bloeddruk; vinnige hartklop; spierstyfheid of spiertrekkings; bewe; verwyde pupille; koors; aanvulle; psigose (verlies van kontak met die werklikheid); delirium; baie rooi, ontsteekte, jeukerige of pynlike vel oor die hele liggaam wat warm voel om aan te raak.

Hierdie is alles baie ernstige newe-effekte. Jy mag dringende mediese bystand of hospitalisasie benodig. 

Sê so gou as moontlik vir jou dokter indien jy enige van die volgende opmerk: 

gastroïntestinale onsteltenis of pyn; diarree; naarheid; braking; gewig optel; indigestie (slegte spysvertering); verloor van eetlus; hardlywigheid; winde opbreek; winderigheid of gas; droë mond; hoofpyn; moegheid; slapeloosheid; vertigo; duiseligheid; lusteloosheid (moeg en/of traag voel); lomerigheid; sedasie; tinteling, gevoelloosheid of “naalde en spelde” sensasie; hartkloppings; onreëlmatige hartklop; hoë bloeddruk; spier- of gewrigstyfheid; bewing; spierspasmas of spierpyn; edeem (swelling of opgeblase in dele van jou liggaam as gevolg van vloeistofretensie); onreëlmatige of langdurige mestruele bloeding of bloeding tussen jou menstruasieperiodes; anorgasmia (moeilikheid om ‘n orgasme te kry); jeuk; uitslag; velirritasie; urtikaria (korwe); aknee; ekseem; haarverlies; fotosensitiwiteit of fotodermatitis (jeukerige knoppe, blase, verhewe areas of donker kolle op jou vel wat na blootstelling aan sonlig of UV-lig verskyn); gelui in jou ore (tinnitus); gereelde urinering; donker urine; seer keel; seer sinusse;  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 PMS SUPPORT + HORMONE BALANCE te verskaf.

5. Hoe om VITAMINME PMS SUPPORT + HORMONE BALANCE 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 die etiket nie.
  • 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 PMS SUPPORT + HORMONE BALANCE bevat

Die ander bestanddele is mikrokristallyne sellulose, magnesiumstearaat, silikondioksied, mieliestysel.

Suikervry

Hoe VITAMINME PMS SUPPORT + HORMONE BALANCE lyk en inhoud van die verpakking

Ovaal, onbedekte tablette met vlekke van grys, bruin, wit en swart.  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 PMS SUPPORT + HORMONE BALANCE (tablets)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Sugar free.

For full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablets.  
19 mm, oval uncoated tablets with flecks of grey, brown, white and black. 

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

VITAMINME PMS SUPPORT + HORMONE BALANCE is a complementary medicine that may help to stabilise menstrual cycle irregularities and relieve premenstrual symptoms. VITAMINME PMS SUPPORT + HORMONE BALANCE supports healthy estrogen metabolism and balance.  

The above has been aligned with claims from Health Canada monographs. Please note that the monographs are based on individual substances only, not on this specific combination.

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 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. 
  • Ginkgo biloba is contraindicated in patients taking other medicines (including traditional or complementary medicines) that affect blood coagulation (e.g. blood thinners), as this may increase the risk of spontaneous bleeding. 
  • Dong quai is contraindicated in patients with diarrhoea or hemorrhagic diseases.
  • Dong quai is contraindicated in patients that are pregnant or breastfeeing (see section 4.6).
  • Dong quai is contraindicated in patients with hypermenorrhoea/profuse menstrual flow/heavy periods. 
  • St. John’s Wort is contraindicated in patients taking anti-cancer, anti-depressant (e.g. SSRI), cardiovascular, contraceptive medications, anti-HIV agents and/or medications to suppress the immune system (immunosuppressants). 

4.4 Special warnings and precautions for use

General:

• • Patients should be advised to discontinue VITAMINME PMS SUPPORT + HORMONE BALANCE at least 2 weeks before elective surgical procedures. Ginkgo biloba has antiplatelet effects and may cause excessive bleeding if used perioperatively. Ashwagandha has central nervous system (CNS) depressant effects and might cause additive CNS depression when combined with anaesthesia and other medications during and after surgical procedures. St. John’s Wort might affect serotonin levels and may interfere with surgical procedures due to serotonergic central nervous system effects or serotonergic effects on the vascular system, and there is also concern that St. Joh’s Wort can cause cardiovascular collapse during anesthesia. 
  • Patients should be advised to consult with their relevant healthcare provider should symptoms persist or worsen.

Vitex agnus-castus:

• • Patients should be advised to consult with their relevant healthcare provider prior to using VITAMINME PMS SUPPORT + HORMONE BALANCE if they are taking hormone-containing medications such as progesterone preparation or hormone replacement therapy. 
  • Vitex-agnus-castus might interfere with the action of dopamine antagonists, such as antipsychotic medications, due to its dopaminergic effects. Therefore, vitex agnus-castus can theoretically affect therapy for Parkinson disease, schizophrenia or other psychotic disorders. 

St. John’s Wort:

• • Avoid prolonged exposure to sunlight, ultraviolet light (UV) or UV therapy. 
  • Patients should be advised to consult with their relevant healthcare provider prior to using VITAMINME PMS SUPPORT + HORMONE BALANCE if they are taking anti-anxiety or seizure medicine, antihistamines, bronchodilators, muscle relaxants and/or opiates. 
  • Patients should be advised to consult with their relevant healthcare provider prior to using VITAMINME PMS SUPPORT + HORMONE BALANCE if they suffer from psychological disorders such as anxiety or depression, schizophrenia and bipolar disorder.
  • St. John’s Wort might induce psychosis in patients with Alzheimer dementia. 

Dong Quai:

• • Ashwagandha may exacerbate hyperthyroidism by increasing thyroid hormone levels. 
  • Patients should be advised to consult with their relevant healthcare provider prior to using VITAMINME PMS SUPPORT + HORMONE BALANCE if they are taking hormone replacement therapy (HRT). 
  • Patients should stop using VITAMINME PMS SUPPORT + HORMONE BALANCE if menstruation is delayed or absent, or if they experience increased menstrual bleeding time. 

Ashwagandha:

• • Ashwagandha has immunostimulant effects and may exacerbate autoimmune disease by stimulating immune activity. 
  • Ashwagandha may exacerbate hyperthyroidism by increasing thyroid hormone levels. 
  • VITAMINME PMS SUPPORT + HORMONE BALANCE should not be taken with alcohol or products that cause drowsiness.

Ginkgo biloba:

• • Patients should be advised to consult with their relevant healthcare provider prior to using VITAMINME PMS SUPPORT + HORMONE BALANCE if they are taking medications for diabetes, high blood pressure or seizures. 
  • Patients who are hypersensitive (allergic) to poison ivy, poison oak, poison sumac, mango rind and cashew shell oil may be at increased risk of having an allergic reaction to ginkgo, an active ingredient in VITAMINME PMS SUPPORT + HORMONE BALANCE. 

DIM:

• • Patients who are trying to conceive should consult a relevant healthcare provider before using VITAMINME PMS SUPPORT + HORMONE BALANCE. 
  • Patients should be advised to consult with their relevant healthcare provider prior to using VITAMINME PMS SUPPORT + HORMONE BALANCE if they have symptoms of low estrogen (e.g. joint pain, mood changes, changes in libido, hot flashes, night sweats, vaginal dryness or irregular menstruation). 
  • Patients should be advised to consult with their relevant healthcare provider prior to using VITAMINME PMS SUPPORT + HORMONE BALANCE if they have a liver disorder. 
  • Patients should discontinue use and consult a healthcare provider as soon as possible should they develop signs and symptoms of liver problems (e.g. yellowing of the eyes or skin, dark urine, abdominal pain). 

4.5 Interaction with other medicines and other forms of interaction

The vitamins and minerals in VITAMINME PMS SUPPORT + HORMONE BALANCE are generally well-tolerated at the recommended dosage. 

Vitex agnus-castus:

• • Antipsychotic medication: vitex agnus-castus may interfere with the activity of antipsychotic medication such as therapy for Parkinson disease, schizophrenia or other psychotic disorders.
  • Contraceptive medication: vitex agnus-castus could interfere with oral contraceptives.
  • Dopamine agonists: vitex agnus-castus could interfere with dopamine agonists. 
  • Estrogens: vitex agnus-castus could interfere with the activity of estrogens. 
  • Metoclopramide: vitex agnus-castus could interfere with metoclopramide. 

St. John’s Wort:

• • Alprazolam: St. John’s Wort increases the clearance of alprazolam and decreases its effects. 
  • Aminolevulinic acid: St. John’s Wort might have additive phototoxic effects with aminolevulinic acid. 
  • Bupropion: St. John’s Wort might reduce the levels and effects of bupropion. 
  • Clopidogrel: St. John’s Wort might increase the levels and effects clopidogrel.
  • Clozapine: St. John’s Wort might reduce the levels and effects of clozapine. 
  • Contraceptive medicines: St. John’s Wort increases the clearance of contraceptive medicines and reduces their clinical effects. 
  • Cyclosporine: St. John’s Wort reduces the levels and clinical effects of cyclosporine. 
  • Cytochrome P450 3A4 (CYP3A4) substrates: St. John’s Wort increases the metabolism and reduces the levels of CYP3A4 substrates.
  • Digoxin: St. John’s Wort reduces the levels and clinical effects of digoxin.
  • Docetaxel: St. John’s Wort reduces the levels and clinical effects of docetaxel. 
  • Fexofenadine: St. John’s Wort may increase the levels and clinical effects of fexofenadine. 
  • Finasteride: St. John’s Wort might reduce the levels and effects of finasteride.
  • Gliclazide: St. John’s Wort might reduce the levels and effects of gliclazide.
  • Imatinib: St. John’s Wort reduces the levels and clinical effects of imatinib. 
  • Indinavir: St. John’s Wort might reduce the levels and effects of indinavir. 
  • Irinotecan: St. John’s Wort reduces the levels and clinical effects of irinotecan. 
  • Ivabradine: St. John’s Wort might reduce the levels and effects of ivabradine. 
  • Ketamine: St. John’s Wort reduces the levels and clinical effects of ketamine.
  • Mephenytoin: St. John’s Wort reduces the levels and clinical effects of mephenytoin.
  • Methadone: St. John’s Wort might reduce the levels and clinical effects of methadone. 
  • Non-nucleoside reverse transcriptase inhibitors (NNRTIs): St. John’s Wort decreases the levels and clinical effects of NNRTIs.
  • Omeprazole: St. John’s Wort decreases the levels and clinical effects of omeprazole.
  • Oxycodone: St. John’s Wort decreases the levels and clinical effects of oxycodone.
  • P-glycoprotein substrates: St. John’s Wort decreases the levels and clinical effects of P-glycoprotein substrates. 
  • Phenobarbital: St. John’s Wort decreases the levels and clinical effects of phenobarbital.
  • Phenprocoumon: St. John’s Wort decreases the levels and clinical effects of phenprocoumon. 
  • Phenytoin: St. John’s Wort decreases the levels and clinical effects of phenytoin. 
  • Photosensitizing medicines: St. John’s Wort might increase the likelihood for photosensitivity reactions when used with photosensitizing medicines. 
  • Protease inhibitors (PIs): St. John’s Wort decreases the levels and clinical effects of PI.s
  • Rivaroxaban: St. John’s Wort decreases the levels and clinical effects of rivaroxaban. 
  • Serotonergic medicines: St. John’s Wort may inhibit reuptake and increase levels of serotonin which may result in additive effects when taken with serotonergic medicines.
  • Tacrolimus: St. John’s Wort decreases the levels and clinical effects of tacrolimus.
  • Tramadol: St. John’s Wort might decrease the levels and clinical effects of tramadol. 
  • Voriconazole: St. John’s Wort might decrease the levels and clinical effects of voriconazole. 
  • Warfarin: St. John’s Wort decreases the levels and clinical effects of warfarin. 
  • Zolpidem: St. John’s Wort might decrease the levels and clinical effects of zolpidem. 

Dong Quai: 

• • Anticoagulant/antiplatelet medication: Dong quai may increase the risk of bleeding when used with anticoagulant/antiplatelet medication.
  • Estrogens: Dong quai may reduce the effects of estrogens. 
  • Warfarin: Dong quai may increase the risk of bleeding when used with warfarin. 

Ashwagandha:

• • Antidiabetes medication: Taking ashwagandha with antidiabetes medication may increase the risk of hypoglycaemia. 
  • Antihypertensive medication: Taking ashwagandha with antihypertensive medication may increase the risk of hypotension.
  • Benzodiazepines: Taking ashwagandha with benzodiazepines may increase the sedative effects. 
  • CNS depressants: Ashwagandha might increase the sedative effects of CNS depressants.
  • Immunosupressants: Ashwagandha might decrease the effects of immunosuppressants. 
  • Thyroid hormone: Ashwagandha might increase the effects and adverse effects of thyroid hormone. 

Ginkgo biloba:

1. • Alprazolam: Ginkgo might decrease the levels and clinical effects of alprazolam.
   • Anticoagulant/antiplatelet medicine: Ginkgo has been shown to increase the risk of bleeding in some people when taken with warfarin. Ginkgo might increase the risk of bleeding if used with other anticoagulant or antiplatelet medicine.
   • Anticonvulsants: Ginkgo might reduce the effectiveness of anticonvulsants.
   • Antidiabetic medicine: Taking ginkgo with antidiabetic medicine might alter the response to the medicine.
   • Cytochrome substrates: Gingko might increase or decrease levels of medicine metabolised by cytochrome substrates.
   • Efavirenz: Ginkgo might decrease the levels and clinical effects of efavirenz.
   • Ibuprofen: Ginkgo might increase the risk of bleeding when used with ibuprofen.
   • P-glycoprotein substrates: Taking ginkgo with P-glycoprotein substrates might increase the levels and adverse effects of these substrates.
   • Risperidone: Taking ginkgo with risperidone might increase the levels and adverse effects of risperidone.
   • Seizure threshold lowering medicine: Taking ginkgo with medicine that lowers the seizure threshold might increase the risk for convulsions.
   • Trazodone: Ginkgo might increase the levels and adverse effects of trazodone.
   •  

2. DIM:

   • Diuretic medicines: DIM may increase the risk of hyponatremia if used with sodium-depleting diuretics. 
   • Estrogens: DIM might increase or decrease the effects of estrogens. 

4.6 Fertility, pregnancy and lactation

VITAMINME PMS SUPPORT + HORMONE BALANCE is contraindicated during pregnancy and breastfeeding. 

4.7 Effects on ability to drive and use machines

VITAMINME PMS SUPPORT + HORMONE BALANCE may cause drowsiness. Exercise caution if operating heavy machinery, driving a motor vehicle or involved in activities requiring mental alertness.

4.8 Undesirable effects 

Vitex agnus-castus:

Gastrointestinal disorders

Frequency unknown: gastrointestinal upset or pain, diarrhoea, nausea, vomiting. 

Metabolism and nutrition disorders

Less frequent: weight gain. 

Nervous system disorders

Frequent: headache, fatigue, insomnia.

Less frequent: confusion, vertigo. 

Reproductive disorders

Frequency unknown: irregular or prolonged menstrual bleeding. 

Skin and subcutaneous tissue disorders

Frequent: itching, skin irritation, urticaria, rash, acne, eczema, hair loss. 

St. John’s Wort:

Cardiac disorders

Frequency unknown: palpitations. 

Gastrointestinal disorders

Less frequent: dyspepsia, anorexia, diarrhoea, nausea, vomiting, constipation.

Musculoskeletal disorders

Less frequent: muscle or joint stiffness, tremor, muscle spasms, muscle pain.

Nervous system disorders

Frequent: headache, dizziness, fatigue, lethargy, insomnia.

Less frequent: paresthesia.

Psychiatric disorders

Frequent: restlessness, insomnia, panic, anxiety, hypomania in depressed patients, mania in depressed patients with occult bipolar disorder.

Less frequent: psychosis, delirium, serotonin syndrome. 

Renal and urinary system disorders

Frequency unknown: frequent urination.

Reproductive system disorders

Frequency unknown: intermenstrual or abnormal menstrual bleeding, anorgasmia.

Respiratory disorders

Less frequent: sore throat, swollen glands, laryngitis, sinus ache.

Skin and subcutaneous tissue disorders

Frequent: photodermatitis.

Less frequent: erythroderma, pruritus, skin rash.

Dong Quai:

Cardiac disorders

Frequency unknown: hypertension. 

Gastrointestinal disorders

Frequency unknown: burping, gas. 

Nervous system disorders

Frequency unknown: headache. 

Skin and subcutaneous tissue disorders

Frequency unknown: photosensitivity, photodermatitis. 

Ashwagandha:

Gastrointestinal disorders

Frequency unknown: nausea, abdominal pain, gastritis, flatulence. 

Hepatobilary disorders

Less frequent: liver injury. 

Nervous system disorders

Less frequent: drowsiness. 

Ginkgo biloba:

Blood and lymphatic disorders

Less frequent: spontaneous bleeding.

Ear and labyrinth disorders

Less frequent: tinnitus.

Cardiac disorders

Less frequent: arrhythmias.

Gastrointestinal disorders

Frequent: nausea, vomiting, gastrointestinal discomfort or pain, diarrhoea, dry mouth, constipation.

Musculoskeletal and connective tissue disorders

Less frequent: edema.

Nervous system disorders

Frequent: headache, dizziness.

Less frequent: sedation.

Skin and subcutaneous tissue disorders

Less frequent: allergic skin reactions, Stevens-Johnson syndrome.

DIM:
 Gastrointestinal disorders

Frequency unknown: nausea, vomiting, diarrhoea, gas. 

Musculoskeletal disorders

Frequency unknown: arthralgias. 

Nervous system disorders

Frequency unknown: headache. 

Renal or urinary disorders

Frequency unknown: darkened urine. 

Skin and subcutaneous tissue disorders

Frequency unknown: rash.

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 PMS SUPPORT + HORMONE BALANCE is a complementary medicine that may help to stabilise menstrual cycle irregularities and relieve premenstrual symptoms. VITAMINME PMS SUPPORT + HORMONE BALANCE supports healthy estrogen metabolism and balance. 

5.2 Pharmacokinetic properties

Pharmacokinetic studies have not been conducted VITAMINME PMS SUPPORT + HORMONE BALANCE. 

6. PHARMACEUTICAL PARTICULARS

List of excipients

Povidone 

Maize Starch 

Micro Cellulose  

Ca Carb

Silicon Dioxide

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.