PATIENT INFORMATION LEAFLET

SCHEDULING STATUS: S0

VITAMINME LIBIDO + DRIVE (capsules)

Epimedium sagittatum (Siebold & Zucc.) Maxim. (Horny Goat Weed), Tribulus terrestris L. (Tribulus), Lepidium meyenii Welp. (Maca), Panax ginseng C.A. Mey. (Panax ginseng)

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

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

1. What VITAMINME LIBIDO + DRIVE is and what it is used for   

VITAMINME LIBIDO + DRIVE is a complementary medicine that helps to enhance physical capacity and performance as well as supports the emotional aspects of sexual health. 

2. What you need to know before you use VITAMINME LIBIDO + DRIVE

Do not use VITAMINME LIBIDO + DRIVE:

  • If you are hypersensitive (allergic) to Horny Goat Weed, Tribulus, Maca, Panax ginseng or any of the other ingredients of VITAMINME LIBIDO + DRIVE (listed in section 6).  

Warnings and precautions 

Take special care:

  • If you have a medical condition or if you are currently taking any other medicine.
  • If you are scheduled for an elective surgical procedure. You should stop taking VITAMINME LIBIDO + DRIVE at least 2 weeks before any elective surgical procedures.
  • If you have a hormone sensitive condition such as breast, uterine or ovarian cancer, endometriosis or uterine fibroids.
  • If you have a bleeding disorder or are taking blood thinning medications.
  • If you have an autoimmune disease or are taking immunosuppressants.
  • If you have a cardiac condition.
  • If you have insomnia.
  • If you have schizophrenia.
  • If you suffer from any psychological disorder or condition such as anxiety or depression, you should consult with a healthcare provider prior to using VITAMINME LIBIDO + DRIVE.

Children and adolescents 

VITAMINME LIBIDO + DRIVE is not recommended for individuals below the age of 18 years. 

Other medicines and VITAMINME LIBIDO + DRIVE

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 LIBIDO + DRIVE:

  • Anticoagulant/antiplatelet medicine: Horny goat weed might increase the risk of bleeding.
  • Antidiabetes medicine/insulin: Tribulus and Panax ginseng may increase the risk of hypoglycaemia when taken with antidiabetes medicine.
  • Antihypertensive medicine: Horny goat weed and Tribulus may increase the risk of hypotension when taken with antihypertensive medicine.
  • Caffeine: Concomitant use of Panax ginseng and caffeine might increase the risk of adverse stimulant effects.
  • Estrogens: Horny goat weed might potentiate the therapeutic and adverse effects of estrogens. Large amounts of Panax ginseng might interfere with hormone replacement therapy.
  • Furosemide: Panax ginseng might reduce the effects of furosemide.
  • Imatinib: Panax ginseng might increase the effects and adverse effects of imatinib.
  • Immunosuppressants: Panax ginseng might interfere with immunosuppressive therapy.
  • Lithium: Tribulus may increase the levels and clinical effects of lithium.
  • Midazolam: Panax ginseng may increase the clearance of midazolam.
  • Monoamine Oxidase Inhibitors (MAOIs): Panax ginseng can interfere with MAOI therapy.
  • Nifedipine: Panax ginseng may increase serum levels of nifedipine and the risk of hypotension.
  • QT interval-prolonging medication: Panax ginseng can have additive effects with medicines that prolong the QT interval and potentially increase the risk of ventricular arrhythmias.
  • Raltegravir: Taking Panax ginseng with raltegravir might increase the risk of liver toxicity.
  • Selegiline: Panax ginseng might increase or decrease the levels of selegiline, possibly altering the effects and adverse effects of selegiline.
  • Stimulants: Taking Panax ginseng with other stimulants may increase the risk of adverse stimulant effects.
  • Warfarin: Panax ginseng might affect the clearance of warfarin.

VITAMINME LIBIDO + DRIVE with food and drink

LIBIDO + DRIVE 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 LIBIDO + DRIVE.

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

Driving and using machinery 

VITAMINME LIBIDO + DRIVE 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 LIBIDO + DRIVE does not adversely affect their performance. 

3. How to use VITAMINME LIBIDO + DRIVE

Do not share medicines with any other person. 

Always use VITAMINME LIBIDO + DRIVE 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 capsules daily after food, or as recommended by a healthcare provider.

Do not exceed the recommended dose. 

If you take more VITAMINME LIBIDO + DRIVE 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 LIBIDO + DRIVE

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

4. Possible side effects  

VITAMINME LIBIDO + DRIVE can have side effects. 

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

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

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

  • bluish coloration on your lips, fingertips or toes; shortness of breath; increased breathing rate; urinating less often or too little urine leaving the body; swelling in legs, ankles and around the eyes; priapism (prolonged and painful erection of the penis that lasts more than four hours or is unrelated to sexual interest or stimulation);

Tell your doctor if you notice any of the following:

  • nosebleeds; vomiting; dry mouth; thirst;  dizziness; abdominal pain or cramps; nausea; diarrhoea; constipation; a state of intense excitement; mania (extreme changes in mood); euphoria (extreme happiness); insomnia; weakness in your lower limbs; decreased appetite; vertigo; migraine; somnolence or drowsiness; amenorrhea (absence of menstruation); postmenopausal vaginal bleeding; swollen or tender breasts; itching; rash. 

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 LIBIDO + DRIVE.  

5. How to store VITAMINME LIBIDO + DRIVE.

  • 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 LIBIDO + DRIVE contains 

Each capsule contains:

Epimedium sagittatum (Siebold & Zucc.) Maxim. (Horny Goat Weed) [leaf powder]

Tribulus terrestris L. (Tribulus) [whole herb powder]

Lepidium meyenii Walp. (Maca) [root, as a 10:1 extract providing 1000 mg dried herb equivalent]

Panax ginseng C.A. Mey. (Panax ginseng) [root, as 5:1 extract providing 375,00 mg of dried herb equivalent]

200,00 mg

200,00 mg

100,00 mg

75,00 mg

  

The other ingredients are magnesium stearate, maize starch, vegetable capsule.

Sugar free

What VITAMINME LIBIDO + DRIVE looks like and contents of the pack

Clear vegetable capsules containing a brown powder. The capsules are packed in a clear, amber glass jar with a pressure seal and a white, ribbed screw cap lid.

Pack size: 30 capsules.

Holder of Certificate of Registration 

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

This leaflet was last revised in 

Will be allocated by SAHPRA upon registration. 

Registration number 

Will be allocated by SAHPRA upon registration.

 

PASIËNTINLIGTINGSBLAD

SKEDULERINGSTATUS: S0

VITAMINME LIBIDO + DRIVE (kapsules)

Epimedium sagittatum (Siebold & Zucc.) Maxim. (Geil Bokkruid), Tribulus terrestris L. (Tribulus), Lepidium meyenii Welp. (Maca), Panax ginseng C.A. Mey. (Panax ginseng)

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

  • Hou hierdie inligtingsblad. Dit kan nodig wees dat jy dit weer lees.
  • Moenie VITAMINME LIBIDO + DRIVE 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 LIBIDO + DRIVE en warvoor word dit gebruik
  2. Wat jy moet weet voordat jy VITAMINME LIBIDO + DRIVE gebruik
  3. Hoe om VITAMINME LIBIDO + DRIVE te gebruik
  4. Moontlike newe-effekte
  5. Hoe om VITAMINME LIBIDO + DRIVE te bêre
  6. Inhoud van die pak en ander inligting

1. Wat is VITAMINME LIBIDO + DRIVE en waarvoor word dit gebruik

VITAMINME LIBIDO + DRIVE is ‘n komplementêre medisyne wat help om fisiese kapasiteit en prestasie te verbeter, asook die emosionele aspekte van seksuele gesondheid te ondersteun

2. Wat jy moet weet voordat jy VITAMINME LIBIDO + DRIVE gebruik

Moenie VITAMINME LIBIDO + DRIVE neem nie:

  • Indien jy hipersensitief (allergies) is vir Geil Bokkruid, Tribulus, Maca, Panax ginseng of vir enige van die ander bestanddele van VITAMINME LIBIDO + DRIVE (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 geskeduleer is vir ‘n elektiewe chirurgiese procedure. Jy moet ten minste 2 weke voor enige elektiewe chrirurgiese prosedures ophou om VITAMINME LIBIDO + DRIVE te neem.
  • Indien jy ‘n hormoon-sensitiewe toestand soos bors-, baarmoeder- of eierstokkanker, endometriose of uteriene fibroïede het.
  • Indien jy ‘n bloedingsversteuring het of bloedverdunners neem.
  • Indien jy ‘n outo-immuun siekte het of immuunonderdrukkers neem.
  • Indien jy ‘n harttoestand het.
  • Indien jy insomnie (slapeloosheid) het.
  • Indien jy skisofrenie het.
  • Indien jy aan enige sielkundige afwykings of toestande soos angs of depressive ly, moet jy ‘n gesondheidsorgverskaffer raadpleeg voordat jy VITAMINME LIBIDO + DRIVE gebruik.

Kinders en adolessente

VITAMINME LIBIDO + DRIVE word nie aanbeveel vir individue onder die ouderdom van 18 jaar nie.

Ander medisyne en VITAMINME LIBIDO + DRIVE 

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 LIBIDO + DRIVE hê:

  • Antikoagulant/antiplaatjie-medisyne: Geil bokkruid kan die risiko van bloeding verhoog.
  • Antidiabetiese medisyne/insulien: Tribulus en Panax ginseng kan die risiko van hipoglukemie verhoog wanneer dit saam met antidiabetiese medisyne geneem word.
  • Antihipertensiewe medisyne: Geil bokkruid en Tribulus kan die risiko van hipotensie wanneer dit saam met antihipertensiewe medisyne geneem word.
  • Kafeïen: Gelyktydige gebruik van Panax ginseng en kafeïen kan die risiko van nadelige stimulerende effekte verhoog.
  • Estrogeen: Geil bokkruid kan die terapeutiese en nadelige effekte van estrogeen versterk. Groot hoeveelhede Panax ginseng kan inmeng met hormoonvervangingsterapie.
  • Furosemied: Panax ginseng kan die effekte van furosemied verminder.
  • Imatinib: Panax ginseng kan die effekte en nadelige effekte van imatinib verhoog.
  • Immuunonderdrukkers: Panax ginseng kan inmeng met immuunonderdrukkers.
  • Litium: Tribulus kan die vlakke en kliniese effekte van litium verhoog.
  • Midazolam: Panax ginseng kan die opruiming van midazolam verhoog.
  • Monoamienoksidase-inhibeerders (MAOI’s): Panax ginseng kan met MAOI-terapie inmeng.
  • Nifedipien: Panax ginseng kan serumvlakke van nifedipien en die risiko van hipotensie verhoog.
  • QT-interval-verlengende medikasie: Panax ginseng kan bykomende effekte hê met medisyne wat die QT-interval verleng en moontlik die risiko van ventrikulêre aritmieë verhoog.
  • Raltegravir: Die neem van Panax ginseng saam met raltegravir kan die risiko van lewertoksisiteit verhoog.
  • Selegilien: Panax ginseng kan die vlakke van selegilien verhoog of verlaag, wat moontlik die effekte en nadelige effekte van selegilien verander.
  • Stimulante: Die neem van Panax ginseng saam met ander stimulante kan die risiko van nadelige stimulant effekte verhoog.
  • Warfarin: Panax ginseng kan die opruiming van warfarin beïnvloed.

VITAMINME LIBIDO + DRIVE met kos en drinkgoes

VITAMINME LIBIDO + DRIVE het geen bekende interaksie met kos of drinkgoed nie (sien afdeling 3).

Swangerskap, borsvoeding en vrugbaarheid

Indien jy swanger is of jou baba borsvoed, vermoed dat jy swanger mag wees of beplan om swanger te raak, raadpleeg asseblief jou dokter, apteker of ander gesondheidsorgverskaffer voordat jy VITAMINME LIBIDO + DRIVE neem.

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

Bestuur en die gebruik van masjinerie

Dit is onwaarskynlik dat VITAMINME LIBIDO + DRIVE 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 LIBIDO + DRIVE nie hul werkverrigting nadelig beïnvloed nie. 

3. Hoe om VITAMINME LIBIDO + DRIVE te gebruik

Moenie medisyne met enige ander persoon deel nie. 

Gebruik VITAMINME LIBIDO + DRIVE 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 kapsules daagliks na ete, of soos aanbeveel deur jou gesondheidsorgverskaffer.

Moenie die aanbevole dosis oorskry nie.

Wat om te doen indien jy meer VITAMINME LIBIDO + DRIVE 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 LIBIDO + DRIVE te neem

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

4. Moontlike newe-effekte

VITAMINME LIBIDO + DRIVE kan newe-effekte hê. 

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

Indien jy enige van die volgende ervaar, hou op om VITAMINME LIBIDO + DRIVE 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 LIBIDO + DRIVE 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 opmerk: 

  • blouerige kleur op jou lippe, vingerpunte of tone; kort van asem; verhoogde asemhalingtempo; minder gereel urineer of te min urine wat die liggaam verlaat; swelling in bene, enkels en om die oë; priapisme (langdurige en pynlike ereksie van die penis wat langer as vier ure aanhou of nie verband hou met seksuele belangstelling of stimulasie nie);

Sê vir jou dokter indien jy enige van die volgende opmerk:

  • neusbloeding; braking; droë mond; dors; duiseligheid; buikpyn of krampe; naarheid; diarree; hardlywigheid; ‘n toestand van instense opgewondenheid; manie (oormatige veranderinge in bui); euforie (oormatige geluk); slapeloosheid; swakheid in jou onderste ledemate; verminderde eetlus; vertigo; migraine; slaperigheid of lomerigheid; amenoree (afwesigheid van mestruasie); postmenopousale vaginale bloeding; geswelde of sensitiewe borste; jeuk; uitslag. 

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 LIBIDO + DRIVE te verskaf.

5. Hoe omVITAMINME LIBIDO + DRIVE 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 LIBIDO + DRIVE bevat

Each kapsule contains:

Epimedium sagittatum (Siebold & Zucc.) Maxim. (Geil Bokkruid) [blaarpoeier]

Tribulus terrestris L. (Tribulus) [hele kruiepoeier]

Lepidium meyenii Walp. (Maca) [wortel, as ‘n 10:1 ekstrak wat 1000 mg gedroogde kruie ekwivalent lewer]

Panax ginseng C.A. Mey. (Panax ginseng) [wortel, as 5:1 ekstrak wat 375,00 mg gedroogde kruie ekwivalent lewer]

200,00 mg

200,00 mg

100,00 mg

75,00 mg

  

Die ander bestanddele is magnesiumstearaat, mieliestysel, groentekapsule.

Suikervry

Hoe VITAMINME LIBIDO + DRIVE lyk en inhoud van die verpakking

Deursigtige groentekapsules wat ‘n bruin 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: COMBINATION PRODUCT[JD1] 

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 LIBIDO + DRIVE (capsules)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains:

Epimedium sagittatum (Siebold & Zucc.) Maxim. (Horny Goat Weed) [leaf powder]

Tribulus terrestris L. (Tribulus) [whole herb powder]

Lepidium meyenii Walp. (Maca) [root, as a 10:1 extract providing 1000 mg dried herb equivalent]

Panax ginseng C.A. Mey. (Panax ginseng) [root, as 5:1 extract providing 375,00 mg of dried herb equivalent]

 

200,00 mg

200,00 mg

100,00 mg

75,00 mg

Sugar free.

For full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Capsules. 
Size 00, clear vegetable capsules containing a brown powder. 

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

VITAMINME LIBIDO + DRIVE is a complementary medicine that helps to enhance physical capacity and performance as well as supports the emotional aspects of sexual health. 

4.2 Posology and method of administration

Posology

Adults 18 years and older: Take 1 – 2 capsules 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 Horny Goat Weed, Tribulus, Maca, Panax ginseng or to any of the excipients listed in section 6.1. 

4.4 Special warnings and precautions for use

  • Patients should be advised to discontinue VITAMINME LIBIDO + DRIVE at least 2 weeks before elective surgical procedures. Horny goat weed may decrease platelet aggregation which may increase the risk of excessive bleeding perioperatively. Furthermore, Tribulus may interfere with blood glucose and blood pressure control during and after surgical procedures. 
  • Horny goat weed, Panax ginseng, and maca may have adverse effects in patients with hormone-sensitive conditions (breast, uterine and ovarian cancer; endometriosis; uterine fibroids), due to their potential estrogenic activity.
  • Horny goat weed might decrease platelet aggregation and increase the risk of bleeding. 
  • Panax ginseng might increase bleeding as it has been reported to decrease blood coagulation.
  • Panax ginseng may exacerbate autoimmune disease and interfere with immunosuppressive therapy due to its immune system stimulating properties.
  • Panax ginseng might increase adverse cardiovascular effects, and should be avoided by those with cardiac conditions.
  • Panax ginseng may worsen insomnia.
  • Panax ginseng may worsen insomnia and agitation in people with schizophrenia.
  • Consult a healthcare provider prior to using VITAMINME LIBIDO + DRIVE if you suffer from any psychological disorder or condition such as anxiety or depression.

4.5 Interaction with other medicines and other forms of interaction

Horny Goat Weed:

  • Anticoagulant/antiplatelet medicine: Horny goat weed might increase the risk of bleeding.
  • Antihypertensive medicine: Horny goat weed might increase the risk of hypotension.
  • Estrogens: Horny goat weed might potentiate the therapeutic and adverse effects of estrogens.

Tribulus:

  • Antidiabetes medicine: Taking Tribulus with antidiabetes medicine may increase the risk of hypoglycaemia.
  • Antihypertensive medicine: Take Tribulus with antihypertensive medicine may increase the risk of hypotension.
  • Lithium: Tribulus may increase the levels and clinical effects of lithium.

Maca:

No known interactions.

Panax ginseng:

  • Antidiabetes medicine/insulin: Panax ginseng may increase the risk of hypoglycaemia when taken with antidiabetes medicine.
  • Caffeine: Concomitant use of Panax ginseng and caffeine might increase the risk of adverse stimulant effects.
  • Estrogens: Large amounts of Panax ginseng might interfere with hormone replacement therapy.
  • Furosemide: Panax ginseng might reduce the effects of furosemide.
  • Imatinib: Panax ginseng might increase the effects and adverse effects of imatinib.
  • Immunnosuppressants: Panax ginseng might interfere with immunosuppressive therapy.
  • Midazolam: Panax ginseng may increase the clearance of midazolam.
  • Monoamine Oxidase Inhibitors (MAOIs): Panax ginseng can interfere with MAOI therapy.
  • Nifedipine: Panax ginseng may increase serum levels of nifedipine and the risk of hypotension.
  • QT interval-prolonging medication: Panax ginseng can have additive effects with medicines that prolong the QT interval and potentially increase the risk of ventricular arrhythmias.
  • Raltegravir: Taking Panax ginseng with raltegravir might increase the risk of liver toxicity.
  • Selegiline: Panax ginseng might increase or decrease the levels of selegiline, possibly altering the effects and adverse effects of selegiline.
  • Stimulants: Taking Panax ginseng with other stimulants may increase the risk of adverse stimulant effects.
  • Warfarin: Panax ginseng might affect the clearance of warfarin.

4.6 Fertility, pregnancy and lactation

Safety in fertility, pregnancy and lactation has not been established. 

4.7 Effects on ability to drive and use machines

Patients should exercise caution before driving or operating machinery until they are reasonably certain that VITAMINME LIBIDO + DRIVE does not adversely affect their performance.

4.8 Undesirable effects 

VITAMINME LIBIDO + DRIVE is generally well tolerated. 

Horny Goat Weed:

Gastrointestinal disorders

Frequency unknown: vomiting, dry mouth, thirst, nosebleed. 

Musculoskeletal disorders

Frequency unknown: exaggeration of tendon reflexes. 

Nervous system disorders

Frequency unknown: dizziness.

Respiratory disorders

Frequency unknown: respiratory arrest. 

Tribulus:

Gastrointestinal disorders

Frequency unknown: abdominal pain, abdominal cramps, nausea, vomiting, diarrhoea, constipation.

Hepatobiliary disorders

Frequency unknown: hepatitis. 

Nervous system disorders

Frequency unknown: excitation, insomnia, seizures, lower limb weakness. 

Renal and urinary disorders

Less frequent: acute kidney injury. 

Reproductive system disorders:

Less frequent: priapism.

Maca:

No known adverse effects. 

Panax ginseng:

Gastrointestinal disorders

Less frequent: decreased appetite, diarrhoea, abdominal pain, nausea.

Nervous system disorders

Frequent: insomnia, headache, vertigo, euphoria, mania. 

Less frequent: migraine, somnolence.

Reproductive disorders

Frequency unknown: amenorrhea, postmenopausal vaginal bleeding, swollen and tender breasts. 

Skin and subcutaneous tissue disorders

Less frequent: systemic rash, pruritus, Stevens-Johnson syndrome.

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.  

Horny Goat Weed:

The glycosides in horny goat weed might have hormonal effects. Some research indicates it might increase testosterone secretion. 

Tribulus:

Some preliminary clinical research suggests that Tribulus can improve sexual dysfunction in males and females and erectile dysfunction in males. These effects may be due to changes in hormone levels.

Maca:

Available research suggests a significant positive effect of maca on sexual dysfunction in healthy menopausal women, and sexual desire in healthy adult men. The effects of maca in patients with erectile dysfunction have also shown significant effects. However, more rigorous studies are warranted. 

Panax ginseng:

Panax ginseng is commonly used to increase fertility and sexual arousal in both males and females. Ginsenosides improve libido and erection ability in human research. Panax ginseng has been shown to increase sperm counts in animals and humans. The constituent ginsenosides may have effects that enhance sexual function. In females, Panax ginseng increased dehydroepiandrosterone sulfate (DHEA-S) levels. In both animal and human research, Panax ginseng increased levels of testosterone in the blood.

5.2 Pharmacokinetic properties

Pharmacokinetic studies have not been conducted on VITAMINME LIBIDO + DRIVE. 

Horny Goat Weed:

The horny goat weed constituent icariin is absorbed in the duodenum and ileum. Epimedin C is primarily absorbed in the duodenum. Peak plasma levels of the icariin metabolite, icariside II, occur about 4 hours after oral intake of horny goat weed. 

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Capsule contents:

Magnesium stearate
Maize starch

Vegetable 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 screw cap 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.