Goodnite Capsules
PATIENT INFORMATION LEAFLET
Ingredients
Ashwagandha (Withania omnifera), L-Theanine, Passion flower (Passiflora incarnata), Melissa Lemon Balm (Melissae folium), Magnesium (Magnesium bisglycinate), Valerian Root Extract (Valeriana officinalis)
Calcium (Calcium phosphate), Hops Extract (Humulus lupulus)
Other ingredients: Magnesium stearate, free flowing agent
Complementary Medicine: Combination Product
This unregistered medicine has not been evaluated by SAHPRA for its quality, safety or intended use.
Read all of this document carefully because it contains important information for you.
Be Bright Goodnite Capsules are available without a doctor’s prescription for you to maintain your health. Nevertheless, you still need to use Be Bright Goodnite Capsules carefully to get the best results from it.
Do not share Be Bright Goodnite Capsules with any other person.
Ask your healthcare provider or pharmacist if you need more information or advice.
Contents of this document:
1. What Be Bright Goodnite Capsules are and what they are used for
2. What you need to know before you use Be Bright Goodnite Capsules
3. How to use Be Bright Goodnite Capsules
4. Possible side effects
5. How to store Be Bright Goodnite Capsules
6. Contents of the pack and other information
1. What Be Bright Goodnite Capsules are and what they are used for
Be Bright Goodnite Capsules are a complementary medicine that is used in harmony with your body to help calm the mind and support sleep.
2. What you need to know before you use Be Bright Goodnite Capsules
Do not use Be Bright Goodnite Capsules:
If you are hypersensitive (allergic) to Ashwagandha (Withania omnifera), L-Theanine, Passion flower (Passiflora incarnata), Melissa Lemon Balm (Melissae folium) Valerian Root Extract (Valeriana officinalis), Hops Extract (Humulus lupulus), or any other ingredients listed of BE BRIGHT GOODNITE (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 your symptoms persist or worsen, or if sleeplessness persists for more than 4 weeks, you should consult with your healthcare provider.
Do not use Be Bright Goodnite Capsules with alcohol.
Not to be taken with any other sedatives, or anti-depressants
Children and adolescents
Be Bright Goodnite Capsules are not recommended for individuals below the age of 10 years.
Other medicines and Be Bright Goodnite Capsules
Always tell your healthcare provider if you are taking any other medicine. This includes all complementary or traditional medicines.
The following medicines may also cause an interaction with Be Bright Goodnite Capsules:
Alprazolam also causes sleepiness. Taking valerian along with alprazolam might cause too much sleepiness.
Sedative medications (CNS depressants) Valerian might cause sleepiness and slowed breathing. Some medications, called sedatives, can also cause sleepiness and slowed breathing.
Glucuronidated drugs. Some medications are changed and broken down by the liver. Valerian might change how quickly the liver breaks down these medications. This could change the effects and side effects of these medications.
Antihypertensive medication: Theanine can lower blood pressure, thus impacting the effect of antihypertensive medication.
Estrogen: Hops can have a negative effect on estrogen levels.
Thyroid medication, immunosuppressants, anti-convulsants, Anti-diabetic drugs, Anti-hypertensive drugs: Ashwaghanda can have an impact on these medicines.
Thyroid hormones: Melissa Lemon Balm can decrease thyroid hormone efficacy.
Anti-coagulant medication: Passion flower can decrease the effect of the medication.
Be Bright Goodnite Capsules with food, drink and alcohol
Avoid drinking alcohol if you are taking Be Bright Goodnite Capsules.
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 Be Bright Goodnite Capsules.
Safety for use during pregnancy and lactation has not been established.
Driving and using machinery
Be Bright Goodnite Capsules 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 Be Bright Goodnite Capsules affects you.
3. How to use Be Bright Goodnite Capsules
Do not share medicines with any other person.
Always use Be Bright Goodnite Capsules 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 and children over 10 years.
Take 2 capsules in the evening after food, and 30 minutes before you go to bed, or as recommended by a healthcare provider.
Swallow the capsule whole and do not open or chew.
Do not exceed the recommended dose.
If you take more Be Bright Goodnite Capsules 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 Be Bright Goodnite Capsules
Do not take a double dose to make up for individual forgotten doses.
4. Possible side effects
Be Bright Goodnite Capsules can have side effects.
Not all side effects reported for Be Bright Goodnite Capsules are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Be Bright Goodnite Capsules, please consult your healthcare provider for advice.
If any of the following happens, stop using Be Bright Goodnite Capsules and tell your doctor immediately, or go to the casualty department at your nearest hospital:
Immediate medical attention is critical. Even if you do not show symptoms of an overdose, go immediately to your nearest hospital or poison centre. The symptoms can include nausea, stomach pain, vomiting, or severe diarrhoea. In addition to these symptoms, drowsiness, tiredness, excitation, disorientation headache, blurred vision, shaky eye movement and breathing problems should be treated.
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to Be Bright Goodnite Capsules. You may need urgent medical attention or hospitalisation.
Tell your doctor as soon as possible if you notice any of the following:
Constant sleepiness, dizziness; headache; tremor; anxiety low blood pressure; chest tightness; diarrhoea; nausea; vomiting; increased heart rate.
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 Be Bright Goodnite Capsules.
5. How to store Be Bright Goodnite Capsules
- 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
Each gelatin capsule contains:
Ashwagandha (Withania omnifera) 100 mg
L-Theanine 100 mg
Passion flower (Passiflora incarnata) 100 mg
Melissa Lemon Balm (Melissae folium) 75 mg
Magnesium (Magnesium bisglycinate) 70 mg
Valerian Root Extract (Valeriana officinalis) 50 mg
Calcium (Calcium phosphate) 35 mg
Hops Extract (Humulus lupulus) 25 mg
The other ingredients are magnesium stearate, silicon dioxide
Sugar free
What Be Bright Goodnite Capsules look like and contents of the pack
White capsule. The capsules are packed in a clear, amber plastic jar with a pressure seal and a purple, smooth screw cap lid.
Pack size: 60 capsules.
Be Bright
Unit 38 Boulevard Business Park. 14 Belladonna Road, Cornubia, Durban, kwaZulu-Natal, South Africa
This leaflet was last revised in 2024
Registration number
Will be allocated by SAHPRA upon registration.
Bestandele
Ashwagandha (Withania omnifera), L-Theanine, Passion flower (Passiflora incarnata), Melissa Lemon Balm (Melissae folium), Magnesium (Magnesium bisglycinate), Valerian Root Extract (Valeriana officinalis), Calcium (Calcium phosphate), Hops Extract (Humulus lupulus)
Ander bestanddele: Magnesium stearate, vryvloeiende middel
Komplementêre Medisyne: Kombinasie Produk
Hierdie ongeregistreerde medisyne is nie deur SAHPRA vir kwaliteit, veiligheid of beoogde gebruik geëvalueer nie.
Lees die hele pamflet noukeurig deur, want dit bevat belangrike inligting jou.
Be Bright Goodnite Kapsules is beskikbaar sonder ‘n dokter se voorskrif, vir jou om jou gesondheid te handhaaf. Nietemin moet Be Bright Goodnite Kapsules steeds versigtig gebruik word om die beste resultate daaruit te kry.
Bewaar hierdie pamflet. Jy sal dit dalk weer moet lees.
Moenie Be Bright Goodnite Kapsules met enige ander persoon deel nie.
Vra jou gesondheidsorgverskaffer of apteker indien jy meer inligting of advies nodig het.
Wat is in hierdie pamflet
Wat Be Bright Goodnite Kapsules is en waarvoor dit gebruik word
Wat jy moet weet voordat jy Be Bright Goodnite Kapsules gebruik
Hoe om Be Bright Goodnite Kapsules te gebruik
Moontlike newe-effekte
Hoe om Be Bright Goodnite Kapsules te bêre
Inhoud van die pak en ander inligting
1. Wat Be Bright Goodnite Kapsules is en waarvoor dit gebruik word
Be Bright Goodnite Kapsules is 'n aanvullende medisyne wat in harmonie met jou liggaam gebruik word om die gemoed te kalmeer en slaap te ondersteun.
2. Wat jy moet weet voordat jy Be Bright Goodnite Kapsules gebruik
Moenie Be Bright Goodnite Kapsules gebruik nie:
Indien jy hipersensitief (allergies) is vir Ashwagandha (Withania omnifera), L-Theanine, Passion flower (Passiflora incarnata), Melissa Lemon Balm (Melissae folium) Valerian Root Extract (Valeriana officinalis), Hops Extract (Humulus lupulus), of vir enige van die ander bestandele van BE BRIGHT GOODNITE Kapsules (gelys in afdeling 6)
Waarskuwings en voorsorgmaatreëls
Neem spesiale sorg:
Indien jy ‘n mediese toestand het of as jy tans enige ander medisyne gebruik.
As jou simptome voortduur of vererger, of as slapeloosheid vir langer as 4 weke voortduur, moet jy jou gesondheidsverskaffer raadpleeg.
Moenie Be Bright Goodnite Kapsules saam met alkohol gebruik nie.
Moet nie saam met enige ander kalmeermiddels of anti-depressante geneem word nie
Kinders en adolessente
Be Bright Goodnite Kapsules word nie aanbeveel vir individue onder die ouderdom van 10 jaar nie
Ander medisyne en Be Bright Goodnite Kapsules
Lig altyd jou gesondheidsorgverskaffer in as jy enige ander medisyne gebruik. Dit sluit alle aanvullende of tradisionele medisyne in.
Die volgende medisyne kan ook 'n interaksie met Be Bright Goodnite Kapsules veroorsaak:
Alprazolam veroorsaak ook slaperigheid. Die neem van valeriaan saam met alprazolam kan te veel slaperigheid veroorsaak.
Kalmeermiddels (SSS-depressante) Valeriaan kan slaperigheid en vertraagde asemhaling veroorsaak. Sommige medikasie, wat kalmeermiddels genoem word, kan ook slaperigheid en vertraagde asemhaling veroorsaak.
Glukuronideerde middels. Sommige medikasie word deur die lewer verander en afgebreek. Valeriaan kan verander hoe vinnig die lewer hierdie medikasie afbreek. Dit kan die effekte en newe-effekte van hierdie medikasie verander.
Antihipertensiewe medikasie: Theanine kan bloeddruk verlaag en sodoende die effek van antihipertensiewe medikasie beïnvloed.
Estrogeen: Hops kan 'n negatiewe uitwerking op estrogeenvlakke hê.
Skildkliermedikasie, immuunonderdrukkers, anti-konvulsante, Anti-diabetiese middels, Anti-hipertensiewe middels: Ashwaghanda kan 'n impak op hierdie medisyne hê.
Skildklierhormone: Melissa Lemon Balm kan skildklierhormoon doeltreffendheid verminder.
Anti-stollingsmedikasie: Passieblom kan die effek van die medikasie verminder.
Be Bright Goodnite Kapsules met kos, drinkgoed en alkohol
Vermy die drink van alkohol as jy Be Bright Goodnite Kapsules neem.
Swangerskap, borsvoeding en vrugbaarheid
As jy swanger is of borsvoed, dink jy is dalk swanger of beplan om 'n baba te hê, raadpleeg asseblief jou dokter, apteker of ander gesondheidsorgverskaffer vir advies voordat jy Be Bright Goodnite Kapsules gebruik.
Veiligheid vir gebruik tydens swangerskap en laktasie is nie vasgestel nie.
Bestuur en gebruik van masjinerie
Be Bright Goodnite Kapsules kan jou lomerig of slaperig laat voel. Moenie 'n voertuig bestuur, masjinerie gebruik of enigiets anders doen wat jou aandag verg totdat jy weet hoe Be Bright Goodnite Kapsules jou affekteer nie.
3. Hoe om Be Bright Kapsules te gebruik
Moenie medisyne met enige ander persoon deel nie.
Gebruik Be Bright Goodnite Kapsules altyd presies soos wat in hierdie pamflet aangedui word, of soos wat jou dokter of apteker vir jou aangewys het. Vra gerus jou dokter of apteker indien jy onseker is.
Volwassenes en kinders 10 jaar en ouer
Neem 2 kapsules in die aand na ete, en 30-minute voor jy gaan slaap, of soos aanbeveel deur 'n gesondheidsorgverskaffer.
Sluk die kapsule heel in en moenie oopmaak of kou nie.
Moenie die aanbevole dosis oorskry nie.
As jy meer Be Bright Goodnite Kapsules neem as wat jy behoort
In die geval van 'n oordosis, raadpleeg jou dokter of apteker. Indien nie een beskikbaar is nie, kontak die naaste hospitaal of gifsentrum.
Neem hierdie pamflet en die oorblywende kapsules saam sodat die dokter sal weet wat jy geneem het.
As jy vergeet om Be Bright Goodnite Kapsules te neem
Moenie 'n dubbele dosis neem om op te maak vir individuele vergete dosisse nie.
4. Moontlike newe-effekte
Be Bright Goodnite Kapsules kan newe-effekte hê.
Nie alle newe-effekte wat vir Be Bright Goodnite Kapsules gerapporteer is, word in hierdie pamflet ingesluit nie.
Indien jou algemene gesondheid versleg of as jy enige nadelige effekte ervaar terwyl jy Be Bright Goodnite Kapsules neem, raadpleeg asseblief jou gesondheidsorgverskaffer vir advies.
Indien enige van die volgende gebeur, hou op om Be Bright Goodnite Kapsules te gebruik en vertel jou dokter dadelik, of gaan na die ongevalle-afdeling by jou naaste hospitaal.
Onmiddellike mediese aandag is van kritieke belang. Selfs as jy nie simptome van ’n oordosis toon nie, gaan dadelik na jou naaste hospitaal of gifsentrum.
Die simptome kan naarheid, maagpyn, braking of erge diarree insluit. Benewens hierdie simptome, moet lomerigheid, moegheid, opgewondenheid, disoriëntasie hoofpyn, versteurde visie, bewerige oogbewegings en asemhalingsprobleme behandel word.
Hierdie is baie ernstige newe-effekte. Indien jy dit het, mag jy ’n ernstige allergiese reaksie op Be Bright Goodnite Kapsules gehad het. Jy mag dringende mediese bystand of hospitalisasie benodig.
Lig jou dokter so gou as moontlik in as jy enige van die volgende opmerk:
Konstante slaperigheid, duiseligheid, hoofpyn, bewing, angs, lae bloeddruk, benoudheid op die bors, diarree, naarheid, braking, verhoogde hartklop.
Indien u enige newe-effekte opmerk wat nie in hierdie pamflet genoem word nie, stel asseblief u dokter of apteker in kennis.
Rapportering van newe-effekte
As jy newe-effekte ondervind, stel jou dokter of apteker in kennis. 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 Be Bright Goodnite Kapsules te verskaf.
5.Hoe om Be Bright Goodnite Kapsules 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 Be Bright Goodnite Kapsules bevat
Elke gelatienkapsule bevat:
Ashwagandha (Withania omnifera) 100 mg
L-Theanine 100 mg
Passion flower (Passiflora incarnata) 100 mg
Melissa Lemon Balm (Melissae folium) 75 mg
Magnesium (Magnesium bisglycinate) 70 mg
Valerian Root Extract (Valeriana officinalis) 50 mg
Calcium (Calcium phosphate) 35 mg
Hops Extract (Humulus lupulus) 25 mg
Die ander bestanddele is magnesiumstearaat, silikondioksied
Suikervry
Hoe Be Bright Goodnite Kapsules lyk en inhoud van die verpakking
Wit kapsules. Die kapsules word verpak in a deursigtige, bruinkleurige plastiese bottel met ń drukseël en n pers, gladde skroefdop deksel.
Verpakkingsgrootte: 60 kapsules.
Be Bright
Eenheid 38 Boulevard Besigheidspark
Belladonnaweg 14
Cornubia, Durban
Suid-Afrika 4332
Hierdie pamflet is laas hersien in
Sal met registrasie deur SAHPRA toegeken word.
Registrasienommer
Sal met registrasie deur SAHPRA toegeken word.