Sleep + Restoration

Feel refreshed + restored after a full night’s rest with VitaminMe’s Sleep + Restoration.

When you’re looking to fall asleep faster and wake up feeling revitalised, Sleep + Restoration is your go-to. Helping you overcome sleeplessness, sleep longer and deeper, and feel calm and relaxed.

Formulated with Valerian Root, Passionflower, Theanine, and Hops Flowers, it works to relax the mind and body, improve sleep quality, and support restorative rest.

Valerian Root – Studies have shown that valerian root can reduce the time it takes to fall asleep and improve length and depth of sleep. It also increases the levels of GABA in the brain, resulting in a physical and mental calming effect on the body.

Passionflower – Passionflower has been shown to possess anxiolytic properties, which help reduce anxiety levels. By promoting relaxation and reducing the time it takes to fall asleep, it improves overall sleep quality and feelings of relaxation.

Theanine – L-theanine can help reduce symptoms of anxiety and stress by influencing neurotransmitter levels in the brain. By facilitating feelings of relaxation, it supports deeper, more restful and restorative sleep.

Hops Flowers – Hops flowers are known for their natural sedative and calming properties. Their ability to alleviate feelings of anxiety and stress helps to instil an overall sense of calm, making it easier to fall asleep and stay asleep.

Why You’ll Love It:

✓ Works within an hour

✓ Sleep easier, longer, and deeper

✓ Overcome sleeplessness + insomnia

✓ Wake up refreshed + restored

✓ Feel calm + relaxed

With consistent use, Sleep + Restoration supports your nightly rest, helping you feel energised, balanced, and ready for the day ahead.

Dosage: Take 1-3 tablets in the evening after food

• Faster sleep onset
• Deeper, more restorative sleep
• Longer, uninterrupted sleep
• Calm + relaxation
• Reduced stress + anxiety

Take 1-3 tablets in the evening after food.

Valerian Root
Studies have shown that valerian root can reduce the time it takes to fall asleep and improve length and depth of sleep. It also increases the levels of GABA in
the brain, resulting in a physical and mental calming effect on the body.
Passionflower
Passionflower has been shown to possess anxiolytic properties, which help reduce anxiety levels. By promoting relaxation and reducing the time it takes to fall asleep, it improves overall sleep quality and feelings of relaxation.
Theanine
L-theanine can help reduce symptoms of anxiety and stress by influencing neurotransmitter levels in the brain. By facilitating feelings of relaxation, it
supports deeper, more restful and restorative sleep.
Hops flowers
Hops flowers are known for their natural sedative and calming properties. Their ability to alleviate feelings of anxiety and stress helps to instil an overall sense of calm, making it easier to fall asleep and stay asleep.

PATIENT INFORMATION LEAFLET

SCHEDULING STATUS: S0

VITAMINME SLEEP + RESTORATION (film-coated tablets)

Valeriana officinalis L. (Valerian), Passiflora incarnata L. (Passion Flower), Humulus lupulus L. (Hops), L-Theanine, Gamma-Aminobutyric Acid (GABA), Piper nigrum L. (Black Pepper)

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

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

1. What VITAMINME SLEEP + RESTORATION is and what it is used for   

VITAMINME SLEEP + RESTORATION is a complementary medicine that is used as a calmative/sedative for the relief of nervousness and to promote a state of relaxation. VITAMINME SLEEP + RESTORATION supports healthy sleep and can be used as a sleep aid during times of stress.

2. What you need to know before you use VITAMINME SLEEP + RESTORATION

Do not use VITAMINME SLEEP + RESTORATION:

• If you are hypersensitive (allergic) to Valerian, Passion Flower, Hops, L-Theanine, GABA, Black Pepper or any of the other ingredients of VITAMINME SLEEP + RESTORATION (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 SLEEP + RESTORATION at least 2 weeks before any elective surgical procedures.
• If your symptoms persist or worsen, or if sleeplessness persists for more than 4 weeks, you should consult with your healthcare provider.
• Not to take VITAMINME SLEEP + RESTORATION with alcohol.
• If you have a hormone sensitive condition such as breast, uterine or ovarian cancer, endometriosis or uterine fibroids.

Children and adolescents 

VITAMINME SLEEP + RESTORATION is not recommended for individuals below the age of 18 years. 

Other medicines and VITAMINME SLEEP + RESTORATION

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

The use of VITAMINME SLEEP + RESTORATION with alcohol or medicines to calm you, make you less anxious, or help you sleep (e.g. alprazolam, CNS depressants) may have additive sedative effects. 

VITAMINME SLEEP + RESTORATION contains piperine (derived from black pepper) which can increase the levels and alter the effectiveness of many other medications or natural health products (e.g. nevirapine, phenytoin, propranolol, rifampin, theophylline). 

The following medicines may also cause an interaction with VITAMINME SLEEP + RESTORATION:

• Glucuronidated medications: Valerian might weakly inhibit glucuronidation and increase concentrations of medications metabolized by UGT1A1 and UGT2B7.
• Estrogens: concomitant use of large amounts of hops might interfere with hormone replacement therapy due to competition for estrogen receptors.
• Antihypertensive medication: Theanine might lower blood pressure, potentiating the effects of antihypertensive medication. Furthermore, taking GABA with antihypertensive medication might increase the risk of hypotension.

VITAMINME SLEEP + RESTORATION with food, drink and alcohol

Avoid drinking alcohol if you are taking VITAMINME SLEEP + RESTORATION.

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 SLEEP + RESTORATION.

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

Driving and using machinery 

VITAMINME SLEEP + RESTORATION 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 SLEEP + RESTORATION affects you.  

3. How to use VITAMINME SLEEP + RESTORATION

Do not share medicines with any other person. 

Always use VITAMINME SLEEP + RESTORATION 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 in the evening 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 SLEEP + RESTORATION 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 SLEEP + RESTORATION

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

4. Possible side effects  

VITAMINME SLEEP + RESTORATION can have side effects. 

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

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

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

• restlessness; excitability; vivid dreams; dizziness; headache; tiredness; tremor; anxiety; impaired muscle control; confusion; fast heartbeat; low blood pressure; chest tightness; diarrhoea; nausea; vomiting; 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 SLEEP + CALM.  

5. How to store VITAMINME SLEEP + RESTORATION.

• 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 SLEEP + RESTORATION contains 

The other ingredients are microcrystalline cellulose, magnesium stearate, silicon dioxide, maize starch, navy film-coating

Sugar free

What VITAMINME SLEEP + RESTORATION looks like and contents of the pack

Oval, navy 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 SLEEP + RESTORATION (filmbedekte tablette)

Valeriana officinalis L. (Valeriaan), Passiflora incarnata L. (Passieblom), Humulus lupulus L. (Hop), L-Teanien, Gamma-Aminobottersuur (GABA), Piper nigrum L. (Swartpeper)

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

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

1. Wat is VITAMINME SLEEP + RESTORATION en waarvoor word dit gebruik

VITAMINME SLEEP + RESTORATION is ‘n komplementêre medisyne wat gebruik word as ‘n kalmeermiddel vir die verligting van senuweeagtigheid en om ‘n toestand van ontspanning te bevorder. VITAMINME SLEEP + RESTORATION ondersteun gesonde slaap en kan as ‘n slaaphulpmiddel tydens tye van stress gebruik word. 

2. Wat jy moet weet voordat jy VITAMINME SLEEP + RESTORATION gebruik

Moenie VITAMINME SLEEP + RESTORATION neem nie:

• Indien jy hipersensitief (allergies) is vir Valeriaan, Passieblom, Hop, L-Teanien, GABA, Swartpeper of vir enige van die ander bestanddele van VITAMINME SLEEP + RESTORATION (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 SLEEP + RESTORATION te neem.
• Indien jou simptome voortduur of vererger, of indien slapeloosheid vir langer as 4 weke voortduur, moet jy met jou gesondheidsverskaffer raadpleeg.
• Om nie VITAMINME SLEEP + RESTORATIONM saam met alkohol te neem nie.
• Indien jy ‘n hormoon-sensitiewe toestand soos bors-, baarmoeder- of eierstokkanker, endometriose of uteriene fibroïede het.

Kinders en adolessente

VITAMINME SLEEP + RESTORATION word nie aanbeveel vir individue onder die ouderdom van 18 jaar nie.

Ander medisyne en VITAMINME SLEEP + RESTORATION

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

Die gebruik van VITAMINME SLEEP + RESTORATION saam met alkohol of medisyne om jou te kalmeer, minder angstig te laat voel of om jou te help slaap (bv. alprazolam, SSS-onderdrukkers) mag jou meer lomerig of slaperig maak. 

VITAMINME SLEEP + RESTORATION bevat piperien (afgelei van swartpeper) wat die vlakke kan verhoog en die effektiwiteit van baie ander medikasie of natuurlike gesonheidsaanvullings (bv. nevirapien, fenitoïen, propranolol, rifampien, teofillien) kan verander. 

Die volgende medisynes kan ook interaksie met VITAMINME SLEEP + RESTORATION hê:

• Glukoronideerde medikasie: Valeriaan kan glukuronidasie swak inhibeer en konsentrasies van medikasie wat deur UGT1A1 en UGT2B7 gemetaboliseer word, verhoog.
• Estrogeen: Gelyktydige gebruik van groot hoeveelhede hop kan inmeng met hormoonvervangingsterapie as gevolg van mededinging vir estrogeenreseptore.
• Antihipertensiewe medikasie: Teanien kan bloeddruk verlaag, wat die effekte van antihipertensiewe medikasie versterk. Verder kan die neem van GABA met antihipertensiewe medikasie die risiko van hipotensie verhoog.

VITAMINME SLEEP + RESTORATION met kos, drinkgoed en alkohol

Vermy die gebruik van alkohol terwyl u VITAMINME SLEEP + RESTORATION 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 SLEEP + RESTORATION neem.

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

Bestuur en die gebruik van masjinerie

VITAMINME SLEEP + RESTORATION 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 SLEEP + RESTORATION jou raak nie. 

3. Hoe om VITAMINME SLEEP + RESTORATION te gebruik

Moenie medisyne met enige ander persoon deel nie. 

Gebruik VITAMINME SLEEP + RESTORATION 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 tabletts in die aand 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 SLEEP + RESTORATION 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 SLEEP + RESTORATION te neem

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

4. Moontlike newe-effekte

VITAMINME SLEEP + RESTORATION kan newe-effekte hê. 

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

Indien jy enige van die volgende ervaar, hou op om VITAMINME SLEEP + RESTORATION 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 SLEEP + RESTORATION 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: 

• rusteloosheid; opgewondenheid; realistiese drome; duiseligheid; hoofpyn; moegheid; bewe; angstigheid; verlies van beheer oor spiere; verwarring; vinnige hartklop; lae bloeddruk; diarree; naarheid; braking; 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 SLEEP + RESTORATION te verskaf.

5. Hoe om VITAMINME SLEEP + RESTORATION 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 SLEEP + RESTORATION bevat

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

Suikervry

Hoe VITAMINME SLEEP + RESTORATION lyk en inhoud van die verpakking

Ovaal, blou filmbedekte 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 SLEEP + RESTORATION (film-coated tablets)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Sugar-free.

For full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablets. 
19 mm, oval, navy film-coated tablets. 

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

VITAMINME SLEEP + RESTORATION is a complementary medicine that is used as a calmative/sedative for the relief of nervousness and to promote a state of relaxation. VITAMINME SLEEP + RESTORATION supports healthy sleep and can be used as a sleep aid during times of stress.

4.2 Posology and method of administration

Posology

Adults 18 years and older: Take 1 – 3 tablets in the evening 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 Valerian, Passion Flower, Hops, L-Theanine, GABA, Black Pepper 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 SLEEP + RESTORATION at least 2 weeks before elective surgical procedures. Valerian and Passion Flower have central nervous system (CNS) depressant effects and might cause additive CNS depression when combined with anaesthesia and other medications during and after surgical procedures.
• Patients should be advised to consult with their relevant healthcare provider should symptoms persist or worsen and/or if sleeplessness persists for more than 4 weeks (chronic insomnia). 
• Patients should use caution if they are taking any other medications or natural health products, as black pepper/piperine may alter their effectiveness.
• VITAMINME SLEEP + RESTORATION should not be taken with alcohol.
• Hops may have adverse effects in patients with hormone-sensitive conditions (breast, uterine and ovarian cancer; endometriosis; uterine fibroids), as some constituents of Hops has estrogenic activity.

4.5 Interaction with other medicines and other forms of interaction

Valerian:

• Alcohol: Valerian can have additive sedative effects when used concomitantly with alcohol.
• Alprazolam: Valerian can have additive sedative effects when used with alprazolam.
• CNS depressants: Valerian can have additive sedative effects when used with CNS depressants.
• Glucuronidated medications: Valerian might weakly inhibit glucuronidation and increase concentrations of medications metabolized by UGT1A1 and UGT2B7.

Passion Flower:

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

Hops:

• CNS depressants: concomitant use of hops with other sedative medications may cause additive sedation.
• Estrogens: concomitant use of large amounts of hops might interfere with hormone replacement therapy due to competition for estrogen receptors.

L-Theanine:

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

GABA:

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

Black Pepper:

• Nevirapine: Black pepper might increase blood levels of nevirapine.
• Phenytoin: Black pepper might increase blood levels of phenytoin.
• Propranolol: Black pepper might increase blood levels of propranolol.
• Rifampin: Black pepper might increase blood levels of rifampin.
• Theophylline: Black pepper might increase blood levels of theophylline.

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 SLEEP + RESTORATION may cause drowsiness. Exercise caution if operating heavy machinery, driving a motor vehicle or involved in activities requiring mental alertness.

4.8 Undesirable effects 

VITAMINME SLEEP + RESTORATION is generally well tolerated. 

Valerian:

Psychiatric disorders

Frequency unknown: restlessness, excitability, uneasiness, agitation, vivid dreams.

Nervous system disorders

Frequency unknown: dizziness, headache, fatigue, tremor.

Cardiac disorders

Less frequent: tachycardia.

Vascular disorders

Less frequent: hypotension, chest tightness.

Gastrointestinal disorders

Frequency unknown: diarrhoea, abdominal pain.

Hepato-biliary disorders

Less frequent: hepatoxicity.

Skin and subcutaneous tissue disorders

Less frequent: rash.

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.

Hops:

Nervous system disorders

Frequency unknown: drowsiness, sedation. 

L-Theanine:

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

GABA:

Gastrointestinal disorders

Less frequent: minor throat burning, nausea, constipation. 
Nervous system disorders

Less frequent: drowsiness, tiredness. 

Musculoskeletal disorders

Less frequent: muscle weakness.

Black Pepper:

Gastrointestinal disorders

Less frequent: burning aftertaste, dyspepsia. 

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.  

Valerian:

Valerian’s anxiolytic, and sedative properties may be due to the effects of its constituents on gamma-aminobutyric acid (GABA), adenosine A1, and serotonin (5-HT) receptors. Valerenic acid and other constituents of valerian are GABA-agonists. Valerian constituents may inhibit the enzyme system responsible for the central catabolism of GABA, increasing GABA concentrations and decreasing CNS activity. Valerian may also bind directly to GABA-A receptors and stimulate the release and reuptake of GABA. In addition to the effects on GABA, valerian might affect sleep regulation via activity on adenosine and serotonin (5-HT1) receptors.

Passion Flower:

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

Hops:

Hops are stated to possess sedative properties and may assist with mood disturbances such as restlessness as well as sleep disturbances. 

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.

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.

Black Pepper:

Piperine, a constituent of black pepper, seems to increase oral absorption of drugs and other substances by forming a complex with them.

5.2 Pharmacokinetic properties

Valerian:

Maximum valerenic acid serum concentrations usually occur within 1 – 2 hours. The elimination half-life of valerenic acid is about 1.1 hours.

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 exreted 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

Core:

Microcrystalline cellulose
Magnesium stearate
Silicon dioxide
Maize starch

Navy 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.