PATIENT INFORMATION LEAFLET

SCHEDULING STATUS: S0

VITAMINME ANXIETY RELIEF + DE-STRESS (capsules)

L-Theanine, Withania somnifera (L.) Dunal (Ashwagandha), Gamma-Aminobutyric Acid (GABA), Melissa officinalis L. (Lemon Balm), Passiflora incarnata L. (Passion Flower)

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

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

1. What VITAMINME ANXIETY RELIEF + DE-STRESS is and what it is used for   

VITAMINME ANXIETY RELIEF + DE-STRESS is a complementary medicine that is used as a calmative/sedative for the relief of nervousness and to promote a state of relaxation. 

2. What you need to know before you use VITAMINME ANXIETY RELIEF + DE-STRESS

Do not use VITAMINME ANXIETY RELIEF + DE-STRESS:

  • If you are hypersensitive (allergic) to L-Theanine, Ashwagandha, GABA, Lemon Balm, Passion Flower or any of the other ingredients of VITAMINME ANXIETY RELIEF + DE-STRESS (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 ANXIETY RELIEF + DE-STRESS at least 2 weeks before any elective surgical procedures.
  • If your symptoms persist or worsen you should consult with your healthcare provider.
  • Not to take VITAMINME ANXIETY RELIEF + DE-STRESS with alcohol.
  • If you have an autoimmune disease.
  • If you have hyperthyroidism. 

Children and adolescents 

VITAMINME ANXIETY RELIEF + DE-STRESS is not recommended for individuals below the age of 18 years. 

Other medicines and VITAMINME ANXIETY RELIEF + DE-STRESS

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

The use of VITAMINME ANXIETY RELIEF + DE-STRESS with alcohol or medicines to calm you, make you less anxious, or help you sleep (e.g. benzodiazepines, CNS depressants) may have additive sedative effects. 

The following medicines may also cause an interaction with VITAMINME ANXIETY RELIEF + DE-STRESS:

  • Antidiabetes medication: Taking ashwagandha with antidiabetes medication may increase the risk of hypoglycaemia.
  • Antihypertensive medication: Theanine, GABA and ashwagandha might lower blood pressure, potentiating the effects of antihypertensive medication and thereby increasing the risk of hypotension.
  • Estrogens: Concomitant use of large amounts of hops might interfere with hormone replacement therapy due to competition for estrogen receptors.
  • Glucuronidated medications: Valerian might weakly inhibit glucuronidation and increase concentrations of medications metabolized by UGT1A1 and UGT2B7.
  • Immunosuppressants: Ashwagandha might decrease the effects of immunosuppressants.
  • Thyroid hormone: Ashwagandha and lemon balm might increase the effects and adverse effects of thyroid hormone.

VITAMINME ANXIETY RELIEF + DE-STRESS with food, drink and alcohol

Avoid drinking alcohol if you are taking VITAMINME ANXIETY RELIEF + DE-STRESS.

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 ANXIETY RELIEF + DE-STRESS.

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

Driving and using machinery 

VITAMINME ANXIETY RELIEF + DE-STRESS 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 ANXIETY RELIEF + DE-STRESS affects you.  

3. How to use VITAMINME ANXIETY RELIEF + DE-STRESS

Do not share medicines with any other person. 

Always use VITAMINME ANXIETY RELIEF + DE-STRESS 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 ANXIETY RELIEF + DE-STRESS 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 ANXIETY RELIEF + DE-STRESS

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

4. Possible side effects  

VITAMINME ANXIETY RELIEF + DE-STRESS can have side effects. 

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

If any of the following happens, stop using VITAMINME ANXIETY RELIEF + DE-STRESS 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 ANXIETY RELIEF + DE-STRESS. You may need urgent medical attention or hospitalisation. 

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

  • dizziness; headache; tiredness; impaired muscle control; muscle weakness; confusion; fast heartbeat; wheezing; increased appetite; burning in your throat; diarrhoea; nausea; vomiting; abdominal pain; flatulence; 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 ANXIETY RELIEF + DE-STRESS.  

5. How to store VITAMINME ANXIETY RELIEF + DE-STRESS.

  • 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 ANXIETY RELIEF + DE-STRESS contains 

Each capsule contains:

L-Theanine

Withania somnifera (L.) Dunal (Ashwagandha) [root, as a 15:1 extract providing 1875,00 mg dried herb equivalent]

Gamma-Aminobutyric Acid (GABA)

Melissa officinalis L. (Lemon Balm) [leaf, as a 5:1 extract providing 375,00 mg dried herb equivalent]

Passiflora incarnata L. (Passion Flower) [fruit, 4:1 extract providing 160,00 mg dried herb equivalent]

150,00 mg

125,00 mg

 

75,00 mg

75,00 mg

40,00 mg

  

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

Sugar free

What VITAMINME ANXIETY RELIEF + DE-STRESS looks like and contents of the pack

Clear, oval vegetable capsules containing a light 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 ANXIETY RELIEF + DE-STRESS (kapsules)

L-Teanien, Withania somnifera (L.) Dunal (Ashwagandha), Gamma-Aminobottersuur (GABA), Melissa officinalis L. (Suurlemoenbalsem), Passiflora incarnata L. (Passieblom)

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

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

1. Wat is VITAMINME ANXIETY RELIEF + DE-STRESS en waarvoor word dit gebruik

VITAMINME ANXIETY RELIEF + DE-STRESS is ‘n komplementêre medisyne wat gebruik word as ‘n kalmeermiddel vir die verligting van senuweeagtigheid en om ‘n toestand van ontspanning te bevorder.  

2. Wat jy moet weet voordat jy VITAMINME ANXIETY RELIEF + DE-STRESS gebruik

Moenie VITAMINME ANXIETY RELIEF + DE-STRESS neem nie:

  • Indien jy hipersensitief (allergies) is vir L-Teanien, Ashwagandha, GABA, Suurlemoenbalsem, Passieblom of vir enige van die ander bestanddele van VITAMINME ANXIETY RELIEF + DE-STRESS (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 prosedure. Jy moet ten minste 2 weke voor enige elektiewe chrirurgiese prosedures ophou om VITAMINME ANXIETY RELIEF + DE-STRESS te neem.
  • Indien jou simptome voortduur of vererger moet jy met jou gesondheidsverskaffer raadpleeg.
  • Om nie VITAMINME ANXIETY RELIEF + DE-STRESS saam met alkohol te neem nie.
  • Indien jy ‘n outo-immuun siekte het.
  • Indien jy hipertireose het. 

Kinders en adolessente

VITAMINME ANXIETY RELIEF + DE-STRESS word nie aanbeveel vir individue onder die ouderdom van 18 jaar nie.

Ander medisyne en VITAMINME ANXIETY RELIEF + DE-STRESS 

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

Die gebruik van VITAMINME ANXIETY RELIEF + DE-STRESS saam met alkohol of medisyne om jou te kalmeer, minder angstig te laat voel of om jou te help slaap (bv. bensodiasepiene, SSS-onderdrukkers) kan bykomende kalmerende effekte hê.

Die volgende medisynes kan ook interaksie met VITAMINME ANXIETY RELIEF + DE-STRESS hê:

  • Antidiabetiese medikaise: Die neem van ashwagandha saam met antidiabetiese medikasie kan die risiko van hipoglukemie verhoog.
  • Antihipertensiewe medikasie: Tianien, GABA en ashwagandha kan bloeddruk verlaag, wat die effekte van antihipertensiewe medikasie versterk en sodoende die risiko van hipotensie verhoog.
  • Glukoronideerde medikasie: Valeriaan kan glukuronidasie swak inhibeer en konsentrasies van medikasie wat deur UGT1A1 en UGT2B7 gemetaboliseer word, verhoog.
  • Immuunonderdrukkers: Ashwagandha kan die effekte van immuunonderdrukkers verminder.
  • Skildklierhormoon: Ashwagandha en suurlemoenbalsem kan die effekte en nadelige effekte van skildklierhoormon verhoog.

VITAMINME ANXIETY RELIEF + DE-STRESS met kos, drinkgoed en alkohol

Vermy die gebruik van alkohol terwyl u VITAMINME ANXIETY RELIEF + DE-STRESS neem.

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 ANXIETY RELIEF + DE-STRESS neem.

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

Bestuur en die gebruik van masjinerie

VITAMINME ANXIETY RELIEF + DE-STRESS 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 ANXIETY RELIEF + DE-STRESS jou raak nie. 

3. Hoe om VITAMINME ANXIETY RELIEF + DE-STRESS te gebruik

Moenie medisyne met enige ander persoon deel nie. 

Gebruik VITAMINME ANXIETY RELIEF + DE-STRESS 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 ANXIETY RELIEF + DE-STRESS 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 ANXIETY RELIEF + DE-STRESS te neem

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

4. Moontlike newe-effekte

VITAMINME ANXIETY RELIEF + DE-STRESS kan newe-effekte hê. 

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

Indien jy enige van die volgende ervaar, hou op om VITAMINME ANXIETY RELIEF + DE-STRESS 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 ANXIETY RELIEF + DE-STRESS 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: 

  • duiseligheid; hoofpyn; moegheid; verlies van beheer oor spiere; spierswakheid; verwarring; vinnige hartklop; hyg; verhoogde eetlus; brandende sensasie in jou keel; diarree; naarheid; braking; buikpyn; winderigheid; 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 ANXIETY RELIEF + DE-STRESS te verskaf.

5. Hoe omVITAMINME ANXIETY RELIEF + DE-STRESS 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 ANXIETY RELIEF + DE-STRESS bevat

Elke kapsule bevat:

L-Teanien

Withania somnifera (L.) Dunal (Ashwagandha) [wortel, as ‘n 15:1 ekstrak wat 1875,00 mg gedroogde kruie ekwivalent lewer]

Gamma-Aminobottersuur (GABA)

Melissa officinalis L. (Suurlemoenbalsem) [blaar, as ‘n 5:1 ekstrak wat 375,00 mg gedroogde kruie ekwivalent lewer]

Passiflora incarnata L. (Passieblom) [vrug, as ‘n 4:1 ekstrak 160,00 mg gedroogde kruie ekwivalent lewer]

150,00 mg

125,00 mg

75,00 mg

75,00 mg

40,00 mg

  

Die ander bestanddele is magnesiumstearaat, mieliestysel, groentekapsule.

Suikervry

Hoe VITAMINME ANXIETY RELIEF + DE-STRESS lyk en inhoud van die verpakking

Deursigtige, ovaal groentekapsules wat ‘n ligbruin 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

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 ANXIETY RELIEF + DE-STRESS (capsules)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains:

L-Theanine

Withania somnifera (L.) Dunal (Ashwagandha) [root, as a 15:1 extract providing 1875,00 mg dried herb equivalent]

Gamma-Aminobutyric Acid (GABA)

Melissa officinalis L. (Lemon Balm) [leaf, as a 5:1 extract providing 375,00 mg dried herb equivalent]

Passiflora incarnata L. (Passion Flower) [fruit, 4:1 extract providing 160,00 mg dried herb equivalent]

150,00 mg

125,00 mg

75,00 mg

75,00 mg

40,00 mg

Sugar free.

For full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Capsules.  
Size 0, clear vegetable capsule containing a light brown powder. 

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

VITAMINME ANXIETY RELIEF + DE-STRESS is a complementary medicine that is used as a calmative/sedative for the relief of nervousness and to promote a state of relaxation. 

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 L-Theanine, Ashwagandha, GABA, Lemon Balm, Passion Flower, 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 using VITAMINME ANXIETY RELIEF + DE-STRESS at least 2 weeks before elective surgical procedures. Passion Flower, Lemon Balm and Ashwagandha have central nervous system (CNS) depressant effects and might cause additive CNS depression when combined with anesthesia and other medications during and after surgical procedures.
  • Patients should be advised to consult with their relevant healthcare provider should symptoms persist or worsen.
  • VITAMINME ANXIETY RELIEF + DE-STRESS should not be taken with alcohol.
  • Ashwagandha has immunostimulant effects and may exacerbate autoimmune disease by stimulating immune activity.
  • Ashwagandha may exacerbate hyperthyroidism by increasing thyroid hormone levels.

4.5 Interaction with other medicines and other forms of interaction

L-Theanine:

  • Antihypertensive medication: Theanine might lower blood pressure, potentiating the effects of antihypertensive medication.

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.
  • Immunosuppressants: Ashwagandha might decrease the effects of immunosuppressants.
  • Thyroid hormone: Ashwagandha might increase the effects and adverse effects of thyroid hormone.

GABA:

  • Antihypertensive medication: Taking GABA with antihypertensive medication might increase the risk of hypotension. 

Lemon Balm:

  • CNS depressants: Concomitant use of lemon balm and CNS depressants might have additive effects with CNS depressants.
  • Thyroid hormone: Lemon balm might interfere with thyroid hormone replacement therapy.

Passion Flower:

  • CNS depressants: Concomitant use of passion flower with other sedative medications may cause additive effects and side effects.

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 ANXIETY RELIEF + DE-STRESS may cause drowsiness. Exercise caution if operating heavy machinery, driving a motor vehicle or involved in activities requiring mental alertness.

4.8 Undesirable effects 

L-Theanine:
Nervous system disorders
Frequency unknown: headache, drowsiness, increased sleep duration, increased dream activity. 

Ashwagandha:

Gastrointestinal disorders

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

Hepatobiliary disorders

Less frequent: liver injury. 

Nervous system disorders

Less frequent: drowsiness. 

GABA:

Gastrointestinal disorders

Less frequent: minor throat burning, nausea, constipation.

Nervous system disorders

Less frequent: drowsiness, tiredness.

Musculoskeletal disorders

Less frequent: muscle weakness.

Lemon Balm:

Gastrointestinal disorders

Less frequent: increased appetite, nausea, vomiting, abdominal pain.

Nervous system disorders:

Less frequent: dizziness, sedation.

Respiratory disorders

Less frequent: wheezing. 

Passion Flower:

Nervous system disorders

Less frequent: sedation, dizziness, ataxia, delirium.

Cardiac disorders

Less frequent: prolonged QT interval, tachycardia.

Gastrointestinal disorders

Less frequent: nausea, vomiting.

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.  

L-Theanine:

L-theanine has been used for its purported relaxing and anti-anxiety effects. It’s thought that L-theanine might work for anxiety by increasing levels of GABA and serotonin. L-theanine is also thought to work for stress-induced anxiety by reducing the release of glutamate, an excitatory neurotransmitter. 
L-theanine inhibits the reuptake of glutamate and is a glutamate receptor antagonist in the hippocampus.

Ashwagandha:

Preliminary research suggests ashwagandha suppresses stress-induced increases of dopamine receptors in the corpus striatum of the brain. It also appears to reduce stress-induced increases of plasma corticosterone, blood urea nitrogen, and blood lactic acid.

GABA:

The GABA(A) receptors have an established physiological role in sleep. Many sedative pharmacological agents used to treat insomnia target GABA(A) receptors. Additionally, some clinical research shows that taking non-alcoholic hops increases GABA levels in the brain and helps with sleep. GABA agonists appear to exert sleep-promoting effects at the hypothalamus, a region of the brain associated with sleep. The effects of GABA supplements are not as clear, as it is unknown whether exogenous GABA crosses the blood-brain barrier.

Lemon Balm:

Clinical research suggests that lemon balm induces a calming effect and reduces alertness.

Passion Flower:

Data suggests that passion flower inhibits uptake of gamma-aminobutyric acid (GABA), and has affinity for GABA(A) and GABA(B) receptors.

5.2 Pharmacokinetic properties

L-Theanine:

Theanine is absorbed through the intestines. Peak concentration of L-theanine in the plasma occurs at about 50 minutes after oral intake. Most L-theanine and its metabolized are excreted in the urine. 

GABA:

The GABA(A) receptors have an established physiological role in sleep. Many sedative pharmacological agents used to treat insomnia target GABA(A) receptors. Additionally, some clinical research shows that taking non-alcoholic hops increases GABA levels in the brain and helps with sleep. GABA agonists appear to exert sleep-promoting effects at the hypothalamus, a region of the brain associated with sleep. The effects of GABA supplements are not as clear, as it is unknown whether exogenous GABA crosses the blood-brain barrier.

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