CALM COGNITION Effervescent (10s)

SCHEDULING STATUS: S0

ACTIVE SUBSTANCES

*%NRV
Glucuronolactone 500 mg
L-Theanine 75 mg
Inositol 50 mg

Bacopa Monnieri (Brahimi)
[whole herb, as 50 mg of an extract standardized to 20% Bacosides]

 

50 mg
N-Acetyl L-Tyrosine (NALT) 50 mg
Rhodiola Rosea L. (Rhodiola Rosea) [root, as 50 mg of a 10:1 extract standardized to 3% Rosavins providing 500 mg dried herb equivalent] 50 mg
Withania Somnifera L. (Ashwaghanda) [root, as 50 mg of a 15:1 extract providing 1125 mg dried herb equivalent] 50 mg
Piper Nigrum (Black Pepper) [fruit, as 5 mg of a 50:1 extract providing 250 mg dried herb equivalent] 5 mg
Vitamin B1 25 mg 2083%
Vitamin B2 5 mg 385%
Vitamin B3 5 mg 31%
Vitamin B6 5 mg 294%
Vitamin B12 25 μg 1042%
Pantothenic acid 4.6 mg 91%
*% Nutrient Reference Values for individuals 4 years and older.

Sugar free
Contains sweetener (35 mg sucralose; 850 mg isomalt)
Complementary Medicine: Discipline-specific medicine
This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.

Read all of this leaflet carefully because it contains important information for you

  • Noolit Calm Cognition is available without a doctor’s prescription, to help you sleep better and help promote relaxation. Nevertheless, you still need to use it carefully to get the best results from it.
  • Keep this leaflet. You may need to read it again.
  • Do not share Noolit Calm Cognition with any other person.
  • Ask your health care provider or pharmacist if you need more information or advice.

What is in this leaflet
1. What Noolit Calm Cognition is and what it is used for
2. What you need to know before you take Noolit Calm Cognition
3. How to take Noolit Calm Cognition
4. Possible side effects
5. How to store Noolit Calm Cognition
6. Contents of the pack and other information

1. What Noolit Calm Cognition is and what it is used for
Supports maintenance of healthy sleep and helps to temporarily promote relaxation, while temporarily promoting alertness, assisting to relieve fatigue and increase mental activity.
May also assist with memory and learning skills.

2. What you need to know before you take Noolit Calm Cognition
Noolit Calm Cognition should not be administered if you are hypersensitive (allergic) to any of the ingredients.
Avoid intake with thyroid disorder, stomach ulcers or auto-immune diseases such as multiple sclerosis (MS), lupus (systemic lupus erythematosus, SLE), rheumatoid arthritis (RA), or other conditions.

Warnings and precautions
Do not exceed the maximum recommended daily dose.
Discontinue use two weeks prior to surgery.
Might lower blood sugar. Watch for signs of low blood sugar (hypoglycemia) and monitor your blood sugar carefully if you have diabetes.
Might decrease blood pressure. 
Bacopa might cause “congestion” in the intestines. This might cause problems in people who have a blockage in their intestines. It might also increase secretions in the stomach and intestines. There is concern that this could worsen ulcers. It might further increase fluid secretions in the lung. There is concern that this could worsen lung conditions such as asthma or a lung disease that makes it harder to breathe (chronic obstructive pulmonary disease or COPD). This substance might also increase secretions in the urinary tract. There is concern that this could worsen urinary obstruction. Bacopa might slow down the heart beat. Consult a registered dietitian prior to use if you are following a low protein diet.
Do not use this product for more than 10 weeks, continuously.

Children
Not suitable for children under the age of 12 years.

Other medicines and Noolit Calm Cognition
Always tell your health care provider if you are taking any other medicine (including all complementary or traditional medicines).
Consumption of N-acetyl L-tyrosine with Levodopa or thyroid hormone medication, is not recommended.
Consult a registered healthcare professional if you are taking medications changed by the liver, anticoagulant / antiplatelet drugs, antihypertensive drugs, diabetic drugs, medications moved by pumps in cells, anticholinergic drugs (incl. scopolamine, anti-histamines and anti-depressants), sedative medications, medications for Alzheimer’s disease, medications used for glaucoma, Escitalopram, immunosuppressants, P-Glycoprotein Substrates, altretamine, amobarbital, amoxicillin, butabarbital, butalbital, carbamazepine, cefotaxime, cyclosporine, levodopa, lithium, mephobarbital, methohexital, nevirapine, pentobarbital, phenobarbital, phenytoin, primidone, propranolol, rifampin, secobarbital, theophylline, thiopental.
Pregnancy and breastfeeding
Not recommended for pregnant or lactating women.
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 health care provider for advice before taking this medicine.

Driving and using machines
It is not always possible to predict to what extent Noolit Calm Cognition may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which Noolit Calm Cognition affects them.

3. How to take Noolit Calm Cognition:
Do not share medicines prescribed for you with any other person.
Always take Noolit Calm Cognition exactly as described in this leaflet or as your doctor told you. Check with your doctor if you are not sure.

Adults and children 12 years and older: Dissolve 1 tablet in a glass of water, and take once to twice daily to assist with cognitive function and impaired concentration. Can be used daily whenever an added boost is required to assist with stress & relaxation, mental clarity and concentration.

Important note: A varied diet is the most effective and safe way to achieve good nutrition, health, body composition as well as mental and physical performance.

If you take more Noolit Calm Cognition than you should:
In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

4. Possible side effects:
Noolit Calm Cognition can have side effects.
Not all side effects reported for Noolit Calm Cognition are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Noolit Calm Cognition, please consult your health care provider for advice.
Noolit Calm Cognition may cause stomach upset, nausea, diarrhea, and vomiting.
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, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of Noolit Calm Cognition.

5. How to store Noolit Calm Cognition
Store all medicines out of reach of children.
Store in a cool, dry place at or below 25˚C.
Keep the container tightly closed.
Do not use after the expiry date stated on the product.

6. Contents of the pack and other information
What Noolit Calm Cognition contains
Active ingredients as listed under product name.
Inactive ingredients: Citric acid, Sodium Bicarbonate, Isomalt, Polyethylene Glycol, Flavouring, Non-nutritive Sweetener (Sucralose – 35 mg), Colourant, Silicon Dioxide.

What Noolit Calm Cognition looks like and contents of the pack
White plastic tubes with 10 effervescent tablets, packed into cartons.
Light brown/orange effervescent tablets.

Holder of Certificate of Registration/Applicant
XS Health
The Innovation Hub
Office BA1 BioPark
Building C/O The Innovation Hub Drive and Allen Cormack Drive
Tel: 012 844 0569 / 086 722 7692
Email: info@xshealth.co.za
Website: www.xshealth.co.za

This leaflet was last revised in
November 2021

Registration number
To be allocated.

Please view our website for Professional Information.

CALM COGNITION Bruistablette (10s)

SKEDULERINGSTATUS: S0

Aktiewe bestanddele:

ELKE BRUISTABLET BEVAT:

*%NRV
Glukuronolaktoon 500 mg
L-Teanien 75 mg
Inositol 50 mg
Bacopa Monnieri (Brahimi) (volledige krui, as 50 mg van ‘n ekstrak vir 20% Bakosiede gestandaardiseer) 50 mg
N-Asetiel L-Tirosien (NALT) 50 mg
Rhodiola Rosea L. (Rhodiola Rosea)(wortel,
as 50 mg van ‘n 10:1 ekstrak vir 3% Rosavins
gestandaardiseer, gelykstaande aan 500 mg
gedroogde krui)
50 mg
Withania Somnifera L. (Ashwaghanda)(wortel, as 50 mg van ‘n 15:1 ekstrak, gelykstaande aan 1125 mg
gedroogde krui)
50 mg
Piper Nigrum (Swartpeper)(vrug, as 5 mg van
‘n 50:1 ekstrak, gelykstaande aan 250 mg gedroogde krui)
5 mg
Vitamien B1 25 mg 2083%
Vitamien
B2
5 mg 385%
Vitamien B3 5 mg 31%
Vitamien B6 5 mg 294%
Vitamien B12 25 μg 1042%
Pantoteensuur 4.6 mg 91%
*% Nutriëntverwysingswaardes vir individue
4 jaar en ouer.

Suikervry
Bevat versoeter (35 mg sukralose; 850 mg isomalt)

Komplementêre medikasie: Dissipline-spesifieke Medikasie
Hiedie ongeregistreerde medisyne is nie deur die SAHPRA vir sy kwaliteit, veiligheid of beoogde gebruik, geëvalueer nie.

Lees die hele pamflet aandagtig deur, want dit bevat belangrike inligting vir u aandag.

  • Noolit Calm Cognition is beskikbaar sonder ‘n voorskrif van ‘n dokter, om u te help om beter te slaap en ontspanning te bevorder. U moet dit egter steeds versigtig gebruik om die beste resultate te verkry.
  • Hou hierdie pamflet. Miskien moet u dit weer lees.
  • Moenie Noolit Calm Cognition met enige ander persoon deel nie.
  • Vra u gesondheidsorgverskaffer of apteker as u meer inligting of advies benodig.

Wat is in hierdie pamflet
1. Wat Noolit Calm Cognition is en waarvoor dit gebruik word
2. Wat u moet weet voordat u Noolit Calm Cognition neem
3. Hoe om Noolit Calm Cognition te neem
4. Moontlike newe-effekte
5. Hoe om Noolit Calm Cognition te berg
6. Inhoud van die verpakking en ander inligting

1. Wat Noolit Calm Cognition is en waarvoor dit gebruik word
Ondersteun die handhawing van gesonde slaap en help om tydelik ontspanning te bevorder, terwyl dit tydelik waaksaamheid bevorder, help om moegheid te verlig en geestelike aktiwiteit te verhoog.
Kan ook geheue en leervaardighede help bevorder.

2. Wat u moet weet voordat u Noolit Calm Cognition neem
Noolit Calm Cognition moet nie toegedien word as u hipersensitief (allergies) vir enige van die bestanddele is nie.
Vermy inname met skildklierversteuring, maagsere of outo-immuunsiektes soos veelvuldige sklerose (MS), lupus (sistemiese lupus eritematose, SLE), rumatoïede artritis (RA) of ander toestande.

Waarskuwings en voorsorgmaatreëls
Moenie die maksimum aanbevole daaglikse dosering oorskry nie.
Staak gebruik twee weke voor chirurgie.
Kan bloedsuiker verlaag. Let op tekens van lae bloedsuiker (hipoglukemie) en monitor u bloedsuiker noukeurig as u diabetes het.
Kan bloeddruk verlaag.
Bacopa kan “opeenhoping” in die ingewande veroorsaak. Dit kan probleme veroorsaak by mense wat ‘n verstopping in hul ingewande het. Dit kan ook afskeiding in die maag en ingewande verhoog. Daar is kommer dat dit ulkusse kan vererger. Dit kan die vloeistofafskeiding in die long verder verhoog. Daar is kommer dat dit longtoestande soos asma of ‘n longsiekte kan vererger wat dit moeiliker maak om asem te haal (chroniese obstruktiewe longsiekte of COPD). Hierdie stof kan ook afskeiding in die urienweg verhoog. Daar is kommer dat dit urinêre obstruksie kan vererger. Bacopa kan die hartklop vertraag.
Raadpleeg ‘n geregistreerde dieetkundige voor gebruik as u ‘n lae-proteïen dieet volg.
Moenie hierdie produk vir meer as 10 weke aaneenlopend gebruik nie.

Kinders
Nie geskik vir kinders jonger as 12 jaar nie.

Ander medisyne en Noolit Calm Cognition
Raadpleeg altyd u gesondheidsorgverskaffer as u ander medisyne gebruik (insluitend alle aanvullende of tradisionele medisyne).
Die gebruik van N-asetiel L-tirosien saam met Levodopa of tiroïedhormoonmedikasie, word nie aanbeveel nie.
Raadpleeg ‘n geregistreerde gesondheidswerker as u medisyne wat deur die lewer verander word, antistollings- /bloedplaatjie-middels, hoë bloeddrukmedikasie, diabetesmedikasie, medisyne wat deur pompe in selle beweeg, antikolinergiese middels (insluitend skopolamien, antihistamiene en antidepressante), kalmeermiddels, medisyne vir Alzheimer se siekte, medisyne wat gebruik word vir gloukoom, Escitalopram, immuunonderdrukkers, P-glikoproteïensubstrate, altretamine, amobarbital, amoxicilline, butabarbital, butalbital, carbamazepine, cefotaxime, cyclosporine, levodopa, litium, mefobarbital, metefobarbital, fenobarbital, fenitoïen, primidoon, propranolol, rifampien, sekobarbital, teofillien, tiopental.

Swangerskap en borsvoeding
Word nie aanbeveel vir swanger of lakterende vroue nie.
As u swanger is of borsvoed, dink dat u swanger is of van plan is om ‘n baba te hê, raadpleeg u dokter, apteker of ander gesondheidsorgverskaffer vir advies voordat u hierdie medisyne neem.
Bestuur en gebruik van masjinerie
Dit is nie altyd moontlik om te voorspel in watter mate Noolit Calm Cognition met die daaglikse aktiwiteite van ‘n pasiënt kan inmeng nie. Pasiënte moet verseker dat hulle nie aan die bogenoemde aktiwiteite deelneem totdat hulle bewus is van die mate waarin Noolit Calm Cognition hulle beïnvloed.

3. Hoe om Noolit Calm Cognition te neem:
Moenie medisyne wat vir u voorgeskryf is, met enige ander persoon deel nie.
Gebruik Noolit Calm Cognition altyd presies soos beskryf in hierdie pamflet of soos u dokter u voorgesê het. Raadpleeg u dokter as u nie seker is nie.

Volwassenes en kinders van 12 jaar en ouer: Los 1 tablet in ‘n glas water op en neem een ​​tot twee keer per dag om te help met kognitiewe funksie en verswakte konsentrasie. Kan daagliks gebruik word wanneer ‘n ekstra hupstoot nodig is om te help met spanning en ontspanning, geestelike helderheid en konsentrasie.

Belangrike opmerking: ‘n Gevarieerde dieet is die doeltreffendste en veiligste manier om goeie voeding, gesondheid, liggaamsamestelling asook geestelike en fisiese prestasie, te behaal.

As u meer Noolit Calm Cognition neem as wat u behoort te doen:
Raadpleeg u dokter of apteker in geval van oordosering. As daar nie een beskikbaar is nie, kontak die naaste hospitaal of gifsentrum.

4. Moontlike newe-effekte:
Noolit Calm Cognition kan newe-effekte veroorsaak.
Nie alle newe-effekte wat vir Noolit Calm Cognition aangemeld word, word in hierdie pamflet ingesluit nie. Raadpleeg u gesondheidsorgverskaffer vir advies as u algemene gesondheid verswak of as u onaangename gevolge ondervind terwyl u Noolit Calm Cognition neem.
Noolit Calm Cognition kan maagpyn, naarheid, diarree en braking veroorsaak.
As u enige newe-effekte opmerk wat nie in hierdie pamflet genoem word nie, moet u u dokter of apteker daarvan in kennis stel.
Aaanmelding van newe-effekte
Raadpleeg u dokter of apteker as u newe-effekte ondervind. U kan ook newe-effekte by SAHPRA aanmeld via die “6.04 Adverse Drug Reaction Reporting Form”, aanlyn beskikbaar onder die publikasies van SAHPRA: https://www.sahpra.org.za/Publications/Index/8. Deur newe-effekte aan te meld, kan u help om meer inligting oor die veiligheid van Noolit Calm Cognition te verskaf.

5. Hoe om Noolit Calm Cognition te berg
Bêre alle medisyne buite bereik van kinders.
Bêre op ‘n koel, droë plek by of onder 25˚C.
Hou die houer dig toe.
Moet nie na die vervaldatum op die produk gebruik nie.

6. Inhoud van die verpakking en ander inligting
Wat Noolit Calm Cognition bevat
Aktiewe bestanddele soos gelys onder die produknaam.
Onaktiewe bestanddele: Sitroensuur, natriumbikarbonaat, isomalt, poliëtileenglikol, geurmiddels, nie-voedsame versoeter (sucralose – 35 mg), kleurstof, silikondioksied.

Hoe Noolit Calm Cognition lyk en die inhoud van die verpakking
Wit plastiekbuise met 10 bruistablette, verpak in kartonboksies.
Bruin/oranje bruistablette.

Houer van die Registrasiesertifikaat/Applikant
XS Health
The Innovation Hub
Kantoor BA1 BioPark
Gebou H/V Innovation Hub en Allen Cormack Weg
Tel: 012 844 0569 / 086 722 7692
Epos: info@xshealth.co.za
Webtuiste: www.xshealth.co.za

Hierdie pamflet is laas hersien in
November 2021

Registrasienommer
Moet toegedien word

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