PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S0
PROPRIETARY NAME: HERBAL SOLUTIONS CBD OIL 300mg
(AND DOSAGE FORM) OIL
COMPOSITION:
Each 1ml (15 drops) contains:
Cannabis sativa L. (CBD isolate) 10mg
(Hemp leaves and flowers, standardised to 99% cannabidiol (CBD) isolate)
Sugar free.
Contains sweetener: stevia 0,57mg/ml.
PHARMACOLIGICAL CLASSIFICATION:
Complementary Medicine: Heath supplement
PHARMACOLOGICAL ACTION:
HERBAL SOLUTIONS CBD OIL 300mg is a complementary medicine containing cannabidiol (CBD) which may assist with the relief of symptoms associated with pain, stress as well as maintenance of general health and well-being.
INDICATIONS:
HERBAL SOLUTIONS CBD OIL 300mg may assist with the relief of symptoms associated with pain, stress as well as maintenance of general health and well-being.
CONTRAINDICATIONS:
Hypersensitivity to CBD.
WARNINGS:
No recommended for use by pregnant or breastfeeding women.
Do not exceed the daily recommended dosage.
DOSAGE AND DIRECTIONS FOR USE:
Adults (18 years and older). Individual dosage
may vary from 5mg to 20mg CBD daily depending on the individual requirement.
Recommended daily dosage: Take 1ML (15 drops at night). Do not exceed the maximum daily dose of 2ML (20 mg CBD).
Not suitable for persons under 18 years old.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Frequent: decrease appetite, somnolence, drowsiness, nausea, vomiting, diarrhoea, dry mouth, fatigue
Cannabidiol may worsen symptoms of Parkinson’s disease in some patients. Caution is advised.
Concomitant use of HERBAL SOLUTIONS CBD OIL 300mg and clobazam is associated with an increased occurrence of drowsiness. Caution is advised.
Caution is advised with the concomitant use of HERBAL SOLUTIONS CBD OIL 300mg with medicines and herbal supplements with sedative and anaesthetic properties as it may cause additive therapeutic and adverse effects
Valproate: Due to potential elevation of liver transaminases, this combination should be avoided.
IDENTIFICATION:
Oil.
Oil with a yellow to green colour.
PRESENTATION:
30ml oil is packed in a round clear-brown glass container with a black polypropylene (PP) dropper.
STORAGE CONDITIONS:
Store below 25 C.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER:
Will be allocated by SAHPRA upon registration.
NAME AND ADDRESS:
Herbal Solutions CC
5 Acorn Road,
Durban, Kwazulu-Natal, 4067
DATE OF PUBLICATION:
August 2021.This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.
PASIËNTINGLIGTINGSBLAD
SKEDULERINGSTATUS: S0
HANDELSNAAM: HERBAL SOLUTIONS CBD OLIE 300mg (DOSERINGS FORM) OLIE
SAMESTELLING:
Elke 1ml (15 druppels) bevat:
Cannabis sativa (CBD isolate) 10mg
(Hemp blare en blomme, tot ‘n 99% standard cannabidiol (CBD) isolate)
Suikervry
Bevat versoeter: stevia 0,57mg/ml
FARMAKOLOGIESE KLASSIFIKASIE:
Komplimentêre Medikasie: Gesondheids aanvulling.
FARMAKOLOGIESE WERKING:
HERBAL SOLUTIONS CBD OLIE 300mg is ‘n komplimentêre medikasie wat cannabidiol (CBD) bevat wat help met die verligting van simptome wat met pyn geassosieer word, spanning sowel as die instandhouding van algemene gesondheid en welstand.
INDIKASIES:
HERBAL SOLUTIONS CBD OLIE 300mg mag help met die verligting van simptome wat gepaard gaan met pyn, stres sowel as die instandhouding van algemene gesondheid en welstand.
KONTRA-INDIKASIES:
Hiper sensitiwiteit tot CBD.
WAARSKUWINGS:
Die gebruik van hierdie produk is nie aan te beveel vir vroue tydens swangerskap of borsvoeding nie.
Die daaglikse dosis moet nie oorskry word nie.
DOSIS EN GEBRUIKSAANSWYSINGS:
Volwassenes (18 jaar en ouer). Individuele dosisse mag wissel van 5mg tot 20mg CBD per dag afhandende van die individu se behoefte.
Voorgestelde daaglikse dosis: Neem 1ml (15 druppels in die aand.) Moenie maksimum daaglikse dosis van 2ml (20mg CBD) oorskry nie.
Nie vir persone onder 18 jaar oud nie.
NEWE-EFFEKTE EN SPESIALE VOORSORGMAATREËLS:
Gereeld: die afname in eetlus, slaperigheid, lomerigheid, naarheid, braking, diarree, droeë mond, moegheid.
Cannabidiol mag die simptome van Parkinsons siekte in sommige pasiënte vererger. Versigtigheid word aanbeveel.
Gelyktydige gebruik van HERBAL SOLUTIONS CBD OIL 300mg en clobazam word geassosieer met ‘n verhoogde voorkoms van lomerigheid. Versigtigheid word aanbeveel.
Versigtigheid word aanbeveel met die gelyktydige gebruik van HERBAL SOLUTIONS CBD KAPSULES 150mg met medisyne en kruie-aanvullings wat kalmerende en narkotiese eienskappe het, aangesien dit addisionele nadelige terapeutiese gevolge kan veroorsaak.
Valproaat: As gevolg van moontlike verhoogde lewertransaminases, moet hierdie kombinasie vermy word.
IDENTIFIKASIE:
Olie.
Olie met ‘n geel tot groen kleur.
AANBIEDING:
30ml verpak in ‘n ronde, helderbruin glashouer met ‘n swart polipropileen (PP) drupper.
BEWARINGS INSTRUKSIES
Berg teen of onder 25o C.
HOU BUITE BERYK VAN KINDERS.
REGISTRASIE NOMMER:
Sal deur SAHPRA by registrasie verskaf word.
NAAM EN ADRES:
Herbal Solutions CC
5 Acorn Road,
Durban, Kwasulu-Natal, 4067
DATUM VAN PUBLIKASIE:
Augustus 2021. Hierdie on-geregistreerde medikasie is nie deur SAHPRA ge-evalueer vir kwaliteit, veiligheid of beoogde gebruik daarvan nie.