PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S0
VITAMINME DEBLOATING + DIGESTION (film-coated tablets)
L-Taurine, Inositol, L-Glutamine, Curcuma longa L. (Turmeric), Foeniculum vulgare Mill. (Fennel), Silybum marianum (L.) Gaertn. (Milk Thistle), L-Glycine, Choline Bitartrate, Taraxacum mongolicum Hand. -Mazz (Dandelion), Brassica oleracea L. (Broccoli), Sodium Molybdate
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 DEBLOATING + DIGESTION is available without a doctor’s prescription, for you to maintain your health. Nevertheless, you still need to use VITAMINME DEBLOATING + DIGESTION carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Do not share VITAMINME DEBLOATING + DIGESTION with any other person.
- Ask your healthcare provider or pharmacist if you need more information or advice.
What is in this leaflet
- What VITAMINME DEBLOATING + DIGESTION is and what it is used for
- What you need to know before you use VITAMINME DEBLOATING + DIGESTION
- How to use VITAMINME DEBLOATING + DIGESTION
- Possible side effects
- How to store VITAMINME DEBLOATING + DIGESTION
- Contents of the pack and other information
1. What VITAMINME DEBLOATING + DIGESTION is and what it is used for
VITAMINME DEBLOATING + DIGESTION is a complementary medicine that can help to aid digestion, and relieve digestive disturbances and digestive upset such as bloating and flatulence.
2. What you need to know before you use VITAMINME DEBLOATING + DIGESTION
Do not use VITAMINME DEBLOATING + DIGESTION:
- If you are hypersensitive (allergic) to any of the ingredients of VITAMINME DEBLOATING + DIGESTION (listed in section 6).
Warnings and precautions
Take special care:
- If you have a medical condition or are currently taking any other medicine.
- If you are hypersensitive (allergic) to celery, carrot or mugwort as you may be at increased risk of having an allergic reaction to VITAMINME DEBLOATING + DIGESTION.
- If you are hypersensitive (allergic) to members of the Asteraceae/Compositae family (members of this plant family include ragweed, chrysanthemums, marigolds, daises, and many other herbs) as you may be at increased risk of having an allergic reaction to VITAMINME DEBLOATING + DIGESTION.
- If you are scheduled for an elective surgical procedure. You should stop taking VITAMINME DEBLOATING + DIGESTION at least 2 weeks before any elective surgical procedures.
- If your symptoms persist or worsen you should consult with your healthcare provider.
- To consult a relevant healthcare provider prior to using VITAMINME DEBLOATING + DIGESTION if any of the following applies to you:
- You are following a low protein diet.
- You have gallstones.
- You have a bile duct obstruction.
- You have stomach ulcers or excess stomach acid.
- You have a liver disease.
Children and adolescents
VITAMINME DEBLOATING + DIGESTION is not recommended for individuals below the age of 18 years.
Other medicines and VITAMINME DEBLOATING + DIGESTION
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 DEBLOATING + DIGESTION:
- Anticoagulant/antiplatelet medicine: Turmeric, fennel and dandelion may have antiplatelet effects and thereby increase the risk of bruising and bleeding when used with anticoagulant/antiplatelet medicine.
- Amlodipine: Taking turmeric with amlodipine may increase levels of amlodipine.
- Antidiabetes medicine: Taking turmeric, milk thistle, or dandelion with antidiabetes medicine may increase the risk of hypoglycaemia.
- Chemotherapy medicines: Turmeric has antioxidant effects. There is some concern that this may reduce the active of chemotherapy medicines that generate free radicals (e.g. alkylating agents, antitumor antibiotics, topoisomerase I inhibitors).
- Sulfasalazine: Turmeric might increase the therapeutic effects and adverse effects of sulfasalazine.
- Sirolimus: Milk thistle might decrease the clearance of sirolimus.
- Tacrolimus: Turmeric might increase the therapeutic effects and adverse effects of tacrolimus.
- Talinolol: Turmeric may reduce the absorption of talinolol in some situations.
- Warfarin: Turmeric might increase the risk of bleeding with warfarin.
VITAMINME DEBLOATING + DIGESTION with food and drink
VITAMINME DEBLOATING + DIGESTION 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 DEBLOATING + DIGESTION.
Safety for use during pregnancy and lactation has not been established.
Driving and using machinery
VITAMINME DEBLOATING + DIGESTION 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 DEBLOATING + DIGESTION does not adversely affect their performance.
3. How to use VITAMINME DEBLOATING + DIGESTION
Do not share medicines with any other person.
Always use VITAMINME DEBLOATING + DIGESTION 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 – 3 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 DEBLOATING + DIGESTION 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 DEBLOATING + DIGESTION
Do not take a double dose to make up for individual forgotten doses.
4. Possible side effects
VITAMINME DEBLOATING + DIGESTION can have side effects.
Not all side effects reported for VITAMINME DEBLOATING + DIGESTION are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VITAMINME DEBLOATING + DIGESTION, please consult your healthcare provider for advice.
If any of the following happens, stop using VITAMINME DEBLOATING + DIGESTION 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 DEBLOATING + DIGESTION. You may need urgent medical attention or hospitalisation.
Tell your doctor as soon as possible if you notice any of the following:
- nausea or vomiting; constipation; flatulence; yellow and/or hard stools; diarrhoea or loose stools; dyspepsia (indigestion); distended stomach; abdominal fullness or pain; stained tongue; loss of appetite; tremor; vertigo; urticaria (hives); eczema; skin rash; 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 DEBLOATING + DIGESTION.
5. How to store VITAMINME DEBLOATING + DIGESTION.
- 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 DEBLOATING + DIGESTION contains
|
Each tablet contains: L-Taurine Inositol L-Glutamine Curcuma longa L. (Turmeric) [rhizome, 8:1 extract standardised to 10% curcuminoids providing 640,00 mg dried herb equivalent] Foeniculum vulgare Mill. (Fennel) [seed, 4:1 extract providing 300,00 mg dried herb equivalent] Silybum marianum (L.) Gaertn. (Milk Thistle) [seed, as 90,00 mg of a 75:1 extract standardised to 80 % flavones] L-Glycine Choline Bitartrate Providing 41,00 mg Choline Taraxacum mongolicum Hand. -Mazz (Dandelion) [root, 4:1 extract providing 80,00 mg of dried herb equivalent] Brassica oleracea L. (Broccoli) [sprouts, 10:1 extract standardised to 0,5 % sulforaphane providing 0,175 mg sulforaphane] Sodium Molybdate Providing Molybdenum |
160,00 mg 130,00 mg 130,00 mg 80,00 mg 75,00 mg 72,00 mg 55,00 mg 97,61 mg 20,00 mg 35,00 mg 0,13 mg 0,05 µg |
The other ingredients are microcrystalline cellulose, magnesium stearate, silicon dioxide, maize starch, brown film-coating.
Sugar free
What VITAMINME DEBLOATING + DIGESTION looks like and contents of the pack
Oval, light-brown film-coated tablets. The tablets are packed in a clear, amber glass jar with a pressure seal and a white, ribbed screw cap lid.
Pack size: 30 tablets.
Holder of Certificate of Registration
VitaminMe (Pty) Ltd
32 Fricker Road
Illovo
Johannesburg
South Africa
2196
This leaflet was last revised in
Will be allocated by SAHPRA upon registration.
Registration number
Will be allocated by SAHPRA upon registration.
PASIËNTINLIGTINGSBLAD
SKEDULERINGSTATUS: S0
VITAMINME DEBLOATING + DIGESTION (filmbedekte tablette)
L-Taurien, Inositol, L-Glutamien, Curcuma longa L. (Borrie), Foeniculum vulgare Mill. (Vinkel), Silybum marianum (L.) Gaertn. (Melkdissel), L-Glysien, Cholienbitartraat, Taraxacum mongolicum Hand. -Mazz (Paardebloem), Brassica oleracea L. (Brokkoli), Natriummolibdaat
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 DEBLOATING + DIGESTION is beskikbaar sonder ‘n dokter se voorskrif, om jou gesondheid te handhaaf. Nietemin moet VITAMINME DEBLOATING + DIGESTION versigtig gebruik word ten einde die beste resultate te verkry.
- Hou hierdie inligtingsblad. Dit kan nodig wees dat jy dit weer lees.
- Moenie VITAMINME DEBLOATING + DIGESTION 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 DEBLOATING + DIGESTION en warvoor word dit gebruik
- Wat jy moet weet voordat jy VITAMINME DEBLOATING + DIGESTION gebruik
- Hoe om VITAMINME DEBLOATING + DIGESTION te gebruik
- Moontlike newe-effekte
- Hoe om VITAMINME DEBLOATING + DIGESTION te bêre
- Inhoud van die pak en ander inligting
1. Wat is VITAMINME DEBLOATING + DIGESTION en waarvoor word dit gebruik
VITAMINME DEBLOATING + DIGESTION is ‘n komplementêre medisyne wat kan help om vertering aan te help, en probleme met spysvertering soos opgeblasenheid en winderigheid te verlig.
2. Wat jy moet weet voordat jy VITAMINME DEBLOATING + DIGESTION gebruik
Moenie VITAMINME DEBLOATING + DIGESTION neem nie:
- Indien jy hipersensitief (allergies) is vir enige van die bestanddele van VITAMINME DEBLOATING + DIGESTION (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 hipersensitief (allergies) is vir seldery, wortel of byvoet is, aangesium jy ‘n groter risiko het om ‘n allergiese reaksie op VITAMINME DEBLOATING + DIGESTION te hê.
- Indien hy hipersensitief (allergies) is vir lede van die Asteraceae/Compositae-familie (lede van hierdie plantfamilie sluit ragwoude, krisante, gousblomme, madeliefies en baie ander kruie in), aangesien jy ‘n groter risiko het om ‘n allergiese reaksie op VITAMINME DEBLOATING + DIGESTION te hê.
- Indien jy geskeduleer is vir ‘n elektiewe chirurgiese procedure. Jy moet ten minste 2 weke voor enige elektiewe chrirurgiese prosedures ophou om VITAMINME DEBLOATING + DIGESTION te neem.
- Indien jou simptome voortduur of vererger moet jy met jou gesondheidsorgverskaffer raadpleeg.
- Om ‘n relevante gesondheidsverskaffer te raadpleeg voordat VITAMINME DEBLOATING + DIGESTION gebruik word indien enige van die volgende op jou van toepassing is:
- Jy volg ‘n lae proteïen diet.
- Jy het galstene.
- Jy het ‘n galbuisobstruksie.
- Jy het maagsere of oortollige maagsuur.
- Jy het ‘n lewersiekte.
Kinders en adolessente
VITAMINME DEBLOATING + DIGESTION word nie aanbeveel vir individue onder die ouderdom van 18 jaar nie.
Ander medisyne en VITAMINME DEBLOATING + DIGESTION
Lig altyd jou gesondheidsorgverskaffer in indien jy enige ander medisyne neem. Dit sluit aanvullende of tradisionele medisyne in.
Die volgende medisynes kan interaksie met VITAMINME DEBLOATING + DIGESTION hê:
- Antikoagulant/antiplaatjie-medisyne: Borrie, vinkel en paardebloem kan anti-plaatjie-effekte hê en daardeur die risiko van kneusing en bloeding verhoog wanneer dit saam met antikoagulant/antiplaatjie-medisyne gebruik word.
- Amlodipien: Die neem van borrie saam met amlodipien kan vlakke van amlodipien verhoog.
- Atidiabetiese medisyne: Die neem van borrie, melkdissel, of paardebloem saam met antidiabetiese medisyne kan die risiko van hipoglukemie verhoog.
- Chemoterapie medisyne: Borrie het antioksidante effekte. Daar is ‘n mate van kommer dat dit die aktiewe van chemoterapie-medisyne wat vrye radikale genereer kan verminder (bv. alkileringsmiddels, antitumor-antibiotika, topoisomerase I-remmers).
- Sulfasalasien: Borrie kan die terapeutiese effekte en nadelige effekte van sulfasalasien verhoog.
- Sirolimus: Melkdissel kan die opruiming van sirolimus verminder.
- Takrolimus: Borrie kan die terapeutiese effekte en nadelige effekte van takrolimus verhoog.
- Talinolol: Borrie kan in spesifieke situasies die opname van talinolol verminder.
- Warfarin: Borrie kan die risiko van bloeding met warfarin verhoog.
VITAMINME DEBLOATING + DIGESTION met kos en drinkgoed
VITAMINME DEBLOATING + DIGESTION het geen bekende interaksies met kos of drinkgoed nie (sien afdeling 3).
Swangerskap, borsvoeding en vrugbaarheid
Indien jy swanger is of jou baba borsvoed, vermoed dat jy swanger mag wees of beplan om swanger te raak, raadpleeg asseblief jou dokter, apteker of ander gesondheidsorgverskaffer voordat jy VITAMINME DEBLOATING + DIGESTION neem.
Veiligheid vir gebruik tydens swangerskap en laktasie is nie vasgestel nie.
Bestuur en die gebruik van masjinerie
Dit is onwaarskynlik dat VITAMINME DEBLOATING + DIGESTION 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 DEBLOATING + DIGESTION nie hul werkverrigting nadelig beïnvloed nie.
3. Hoe om VITAMINME DEBLOATING + DIGESTION te gebruik
Moenie medisyne met enige ander persoon deel nie.
Gebruik VITAMINME DEBLOATING + DIGESTION 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 – 3 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 DEBLOATING + DIGESTION 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 DEBLOATING + DIGESTION te neem
Moenie ‘n dubbele dosis neem om op te maak vir die individuele dosisse wat oorgeslaan is nie.
4. Moontlike newe-effekte
VITAMINME DEBLOATING + DIGESTION kan newe-effekte hê.
Nie alle newe-effekte wat vir VITAMINME DEBLOATING + DIGESTION gerapporteer is, word in hierdie inligtingsblad ingesluit nie. Indien jou algemene gesondheid verswak of indien jy enige ongunstige effekte onderwind terwyl VITAMINME DEBLOATING + DIGESTION geneem word, raadpleeg asseblief jour gesondheidsverskaffer.
Indien jy enige van die volgende ervaar, hou op om VITAMINME DEBLOATING + DIGESTION 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 DEBLOATING + DIGESTION gehad het. Jy mag dringende mediese bystand of hospitalisasie benodig.
Sê so gou as moontlik vir jou dokter indien jy enige van die volgende opmerk:
- naarheid of braking; hardlywigheid; winderigheid; geel en / of harde stoelgang; diarree of los stoelgang; dispepsie (indigestie); uitgerekte maag; gevlekte tong; verloor van eetlus; bewing; vertigo; urtikaria (korwe); ekseem; veluitslag; 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 DEBLOATING + DIGESTION te verskaf.
5. Hoe omVITAMINME DEBLOATING + DIGESTION 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 DEBLOATING + DIGESTION bevat
|
Elke tablet bevat: L-Taurien Inositol L-Glutamien Curcuma longa L. (Borrie) [risoom, 8:1 ekstrak gestandaardiseer tot 12,5 % kurkuminoïede wat 640,00 mg gedroogde kruie ekwivalent lewer] Foeniculum vulgare Mill. (Vinkel) [saad, 4:1 ekstrak wat 300,00 mg gedroogde kruie ekwivalent lewer] Silybum marianum (L.) Gaertn. (Melkdissel) [saad, as 90,00 mg van ‘n 75:1 ekstrak gestandaardiseer tot 80 % flavone] L-Glysien Cholienbitartraat Verskaf 41,00 mg Cholien Taraxacum mongolicum Hand. -Mazz (Paardebloem) [wortel, 4:1 ekstrak wat 80,00 mg van gedroogde kruie ekwivalent lewer] Brassica oleracea L. (Brokkoli) [spruite, 10:1 ekstrak gestandaardiseer tot 0,5 % sulforafaan wat 0,175 mg sulforafaan lewer] Natriummolibdaat Verskaf Molibdeen |
160,00 mg 130,00 mg 130,00 mg 80,00 mg 75,00 mg 72,00 mg 55,00 mg 97,61 mg 20,00 mg 35,00 mg 0,13 mg 0,05 µg |
Die ander bestanddele is mikrokristallyne sellulose, magnesiumstearaat, silikondioksied, mieliestysel, bruin film-bedekking.
Suikervry
Hoe VITAMINME DEBLOATING + DIGESTION lyk en inhoud van die verpakking
Ovaal, ligbruin film-bedekte tablette. Die tablette word verpak in ‘n deursigtige, bruinkleurige glasfles met ‘n drukseël en ‘n wit, geribde skroefdop deksel.
Verpakkingsgrootte: 30 tablette.
Houer van Registrasiesertifikaat
VitaminMe (Edms.) Bpk.
Frickerpad 32
Illovo
Johannesburg
Suid-Afrika
2196
Hierdie inligtingsblad is laas hersien in
Sal met registrasie deur SAHPRA toegeken word.
Registrasienommer
Sal met registrasie deur SAHPRA toegeken word.
PROFESSIONAL INFORMATION
COMPLEMENTARY MEDICINE: COMBINATION PRODUCT
This unregistered medicine has not been evaluated by SAHPRA for its quality, safety or intended use.
SCHEDULING STATUS
S0
1. NAME OF THE MEDICINE
VITAMINME DEBLOATING + DIGESTION (tablets)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
|
Each tablet contains: L-Taurine Inositol L-Glutamine Curcuma longa L. (Turmeric) [rhizome, 8:1 extract standardised to 12,5 % curcuminoids providing 640,00 mg dried herb equivalent] Foeniculum vulgare Mill. (Fennel) [seed, 4:1 extract providing 300,00 mg dried herb equivalent] Silybum marianum (L.) Gaertn. (Milk Thistle) [seed, as 90,00 mg of a 75:1 extract standardised to 80 % flavones] L-Glycine Choline Bitartrate Providing 41,00 mg Choline Taraxacum mongolicum Hand. -Mazz (Dandelion) [root, 4:1 extract providing 80,00 mg of dried herb equivalent] Brassica oleracea L. (Broccoli) [sprouts, 10:1 extract standardised to 0,5 % sulforaphane providing 0,175 mg sulforaphane] Sodium Molybdate Providing Molybdenum |
160,00 mg 130,00 mg 130,00 mg 80,00 mg 75,00 mg 72,00 mg 55,00 mg 97,61 mg 20,00 mg 35,00 mg 0,13 mg 0,05 µg |
Sugar free.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets.
19 mm, oval light brown film-coated tablet.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
VITAMINME DEBLOATING + DIGESTION is a complementary medicine that can help to aid digestion, and relieve digestive disturbances and digestive upset such as bloating and flatulence.
4.2 Posology and method of administration
Posology
Adults 18 years and older: Take 1 – 3 tablets 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 any of the active ingredients or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
- Patients who are hypersensitive (allergic) to celery, carrot or mugwort may be at increased risk of having an allergic reaction to fennel, an active ingredient in VITAMINME DEBLOATING + DIGESTION.
- Patients who are hypersensitive (allergic) to members of the Asteraceae/Compositae family may be at increased risk of having an allergic reaction to dandelion, an active ingredient in VITAMINME DEBLOATING + DIGESTION. Members of this plant family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.
- Patients should be advised to discontinue VITAMINME DEBLOATING + DIGESTION at least 2 weeks before elective surgical procedures due to potential interference with blood glucose and bleeding control.
- Patients should be advised to consult with their relevant healthcare provider should symptoms persist or worsen.
- Patients following a low protein diet, or those with gallstones, a bile duct obstruction, stomach ulcers, excess stomach acid or liver disease, should consult a relevant healthcare provider prior to using VITAMINME DEBLOATING + DIGESTION.
4.5 Interaction with other medicines and other forms of interaction
- Anticoagulant/antiplatelet medicine: Turmeric, fennel and dandelion may have antiplatelet effects and thereby increase the risk of bruising and bleeding when used with anticoagulant/antiplatelet medicine.
- Amlodipine: Taking turmeric with amlodipine may increase levels of amlodipine.
- Antidiabetes medicine: Taking turmeric, milk thistle, or dandelion with antidiabetes medicine may increase the risk of hypoglycaemia.
- Chemotherapy medicines: Turmeric has antioxidant effects. There is some concern that this may reduce the active of chemotherapy medicines that generate free radicals (e.g. alkylating agents, antitumor antibiotics, topoisomerase I inhibitors).
- Sulfasalazine: Turmeric might increase the therapeutic effects and adverse effects of sulfasalazine.
- Sirolimus: Milk thistle might decrease the clearance of sirolimus.
- Tacrolimus: Turmeric might increase the therapeutic effects and adverse effects of tacrolimus.
- Talinolol: Turmeric may reduce the absorption of talinolol in some situations.
- Warfarin: Turmeric might increase the risk of bleeding with warfarin.
4.6 Fertility, pregnancy and lactation
Safety in fertility, pregnancy and lactation has not been established.
4.7 Effects on ability to drive and use machines
VITAMINME DEBLOATING + DIGESTION is not likely to cause drowsiness. Patients should take caution before performing activities requiring their attention, until they are reasonably certain that VITAMINME DEBLOATING + DIGESTION does not adversely affect their performance.
4.8 Undesirable effects
VITAMINME DEBLOATING + DIGESTION is generally well tolerated.
Gastrointestinal disorders
Frequency unknown: nausea, vomiting, constipation, flatulence, yellow and hard stools, diarrhoea, loose stools, dyspepsia, dysgeusia, gastritis, abdominal distension, gastroesophageal reflux disease, abdominal fullness and pain, epigastric burning, tongue staining, loss of appetite.
Hepatobiliary disorders
Frequency unknown: liver injury.
Musculoskeletal disorders
Frequency unknown: tremor.
Nervous system disorders
Frequency unknown: vertigo.
Respiratory disorders
Frequency unknown: bronchial asthma.
Skin and subcutaneous tissue disorders
Frequency unknown: urticaria, eczema, skin rash, pitting edema.
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 DEBLOATING + DIGESTION is a complementary medicine that can help to aid digestion, and relieve digestive disturbances and digestive upset such as bloating and flatulence.
Turmeric:
In both human and animal research, turmeric or its constituents increased bowel motility. In animal research, curcumin improved activity of digestive enzymes. In animal research, turmeric and its constituent curcumin reduced the incidence of gastrointestinal ulcers and increased intestinal wall mucus and nonprotein sulfhydryl content. Evidence from animal models also suggests that turmeric and its constituent curcumin reduce injury related to inflammatory colitis. Curcumin may exert choleretic effects by increasing biliary excretion of bile salts, cholesterol, and bilirubin, as well as increasing bile solubility.
Fennel:
Animal research suggests that fennel increases gastric acid secretion and activity of digestive enzymes. It is possible that this aids digestion.
Milk Thistle:
There is interest in using milk thistle or silymarin for ulcerative colitis (UC). UC involves an inflammatory process that is provoked by certain immune elements, microbes, and oxidative stress. Silymarin possesses antioxidant properties and reduces inflammatory cytokines.
Dandelion:
Dandelion is traditionally used to increase appetite and bile stimulation and reduce symptoms of dyspepsia, flatulence, and gallstones. As a choleretic, dandelion is thought increase both bile production and flow to the gallbladder, and as a cholagogue, it may exert a direct effect on the gallbladder, causing contraction. Also, dandelion root contains high concentrations of inulin. Oligofructans, such as inulin, are used as food sources by beneficial intestinal bacteria. Dandelion root enhances the growth of bifidobacteria and may be useful as a “prebiotic”.
5.2 Pharmacokinetic properties
Pharmacokinetic studies have not been conducted on VITAMINME DIGESTION + DEBLOATING.
The vitamins and minerals in VITAMINME DAILY DIGESTION + DEBLOATING are well absorbed from the gastrointestinal tract and are widely distributed to all tissues in the body.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Core:
Microcrystalline cellulose
Magnesium stearate
Silicon dioxide
Maize starch
Brown film-coating:
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
24 months.
6.4 Special precautions for storage
Store at or below 25 °C.
Store in a dry place away from direct sunlight and moisture.
Store in the original packaging until required for use.
6.5 Nature and contents of container
Clear, amber glass jar with a pressure seal and a white, ribbed screw cap lid.
Pack size: 30 tablets.
6.6 Special precautions for disposal
No special requirements.
7. HOLDER OF CERTIFICATE OF REGISTRATION
VitaminMe (Pty) Ltd
32 Fricker Road
Illovo
Johannesburg
South Africa
2196
8. REGISTRATION NUMBER
Will be allocated by SAHPRA upon registration.
9. DATE OF FIRST AUTHORISATION
Will be allocated by SAHPRA upon registration