Agnucaston®

SCHEDULING STATUS: CO
PROPRIETARY NAME (and dosage form):
Agnucaston®
Film-Coated Tablets
COMPOSITION:
1 film-coated tablet contains:
4.0 mg dry extract of chaste tree fruits (Special extract BNO 1095) (7-11:1);
extracting agent: ethanol 70 % (v/v)
Other ingredients:
Lactose-monohydrate 25.0 mg
PHARMACOLOGICAL CLASSIFICATION:
A 32.16 Other.
PHARMACOLOGICAL ACTION:
Pharmacological investigations suggest that aqueous alcoholic Agnus castus extracts exerts
their effects via a dopaminergic principle of action thereby inhibiting prolactin release.
Bicyclic diterpenes have been shown to contribute to the dopaminergic effects of Agnus
castus extract BNO 1095. These substances bind to the human dopamine receptor subtype
2 and dose-dependently lower the prolactin release in cultured rat pituitary cells. Several
clinical investigations show that administration of Agnus castus extract to women displaying
latent hyperprolactinemia or increased prolactin resulted in a reduction of prolactin levels.
The prolactin-suppressive effect of Agnucaston has shown to be an effective treatment for
PMS (premenstrual syndrome) and associated symptoms.
INDICATIONS:
For the treament of premenstrual syndrome and associated symptoms such as breast
tenderness and mood changes
CONTRA-INDICATIONS:
Do not take AGNUCASTON® Film-Coated Tablets:
- in case of known allergy against chaste tree fruit or any other component of the medicine
- in case of pituitary tumors
- in case of mastocarcinoma.
WARNINGS:
A regulation of the menstrual cycle also increases the probability of becoming pregnant.
Patients with the rare hereditary galactose intolerance, lactase deficiency or glucosegalactose
malabsorption should not take AGNUCASTON® Film-Coated Tablets.
INTERACTIONS:
There are no known interactions with other medicinal products. A reciprocal attenuation of
effects during simultaneous administration of dopamine receptor antagonists is possible.
PREGNANCY AND LACTATION:
Pregnant and lactating women should not take/ should discontinue taking AGNUCASTON®
Film-Coated Tablets because there are no adequate data for its use.
DOSAGE AND DIRECTIONS FOR USE:
Take 1 film-coated tablet daily. Do not chew but take tablet whole with ample liquid. It is
recommended that it should be taken continuously for several months.
After the complaints have improved or subsided, the treatment should still be continued for
several weeks.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
After taking medicines that contain chaste tree fruit, symptoms such as headache, itching
or abdominal pain like nausea, stomach ache or lower abdominal pain have been reported.
Additionally, cases of systemic hypersensitivity reactions with exanthema, urticaria, Quincke‘s
disease, dyspnea and swallowing problems have been described.
Temporary psychomotor restlessness, confusion and hallucinations have been observed.
There are no data available on the frequency of these possible undesirable effects.
Special precautions:
See “Contra-indications“ and “Warnings“.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
No known symptoms of overdosage. In the event of overdosage seek medical attention.
Treatment is supportive and symptomatic.
IDENTIFICATION:
AGNUCASTON® Film-Coated Tablets are green-blue, round, biconvex with a dull surface.
PRESENTATION:
AGNUCASTON® Film-Coated Tablets are available as:
Package with 30 film-coated tablets.
Package with 60 film-coated tablets.
Package with 90 film-coated tablets
Not all package sizes may be marketed.
STORAGE INSTRUCTIONS:
KEEP OUT OF REACH OF CHILDREN
REGISTRY NUMBER
138906
NAME AND BUSINESS ADDRESS OF REGISTRATION HOLDER
CAMOX PHARMACEUTICALS (PTY) LTD
30 Periet Street
Amalgam, Johannesburg,
South Africa
DATE OF PUBLICATION OF THIS PACKAGE INSERT
29 September 2009
gbpz-agn-drg-1821702-za.indd 1 15.11.10 15:11

SKEDULERINGSTATUS: C0
EIENDOMSNAAM (en doseervorm):
Agnucaston®
Filmbedekte Tablette
SAMESTELLING:
1 filmbedekte tablet bevat: 4.0 mg droë ekstrak van die vrugte van die Agnus Castus boom
(Spesiale ekstrak BNO 1095) (7-11:1); ekstrasiemiddel: etanol 70% (v/v)
Ander bestanddele: Laktosemonohidraat 25.0 mg
FARMAKOLOGIESE KLASSIFIKASIE:
A 32.16 Ander.
FARMAKOLOGIESE WERKING:
Wetenskaplike bewyse suggereer dat waterige alkoholiese ekstrakte van Agnus castus
dopamienergiese effekte het en die vrystelling van prolaktien inhibeer. Bisikliese diterpene
is geïdentifiseer as ‘n groep stowwe wat bydra tot die dopamienergiese effekte van Agnus
castus ekstrak BNO 1095. Hierdie stowwe bind aan die menslike subtipe-2 dopamienreseptor
en verlaag die prolaktienvrystelling in pituïtêre selkulture van rotte in ‘n dosis-afhanklike
manier. Verskeie kliniese ondersoeke het egter aangedui dat die toediening van Agnus
castus ekstrak aan vrouens met effens verhoogde prolaktienkonsentrasies of verhoogde
prolaktienvrystelling as gevolg van stres, ‘n verlaging van prolaktienvlakke tot gevolg gehad
het. Die prolaktien inhiberende effek van Agnucaston het getoon dat dit ‘n effektiewe
behandeling is vir pre-menstruele gemoedsveranderings (PMS) en simptome wat daarmee
geassosieer word.
INDIKASIES:
Vir die behandeling van premenstruele sindroom en geassosieerde simptome soos
mastodinie, gevoelige borste en gemoedsveranderings.
KONTRA-INDIKASIES:
Moenie AGNUCASTON® Filmbedekte Tablette neem nie:
• in gevalle waar dit bekend is dat daar ‘n allergie teen die vrugte van die Agnus castus boom
of enige ander komponent van die medisyne
• in geval van pituïtêre tumore
• in geval van mastokarsinoom.
WAARSKUWINGS:
Regulering van die menstruele siklus verhoog ook die waarskynlikheid van swangerskap.
Pasiënte met seldsame oorgeërfde galaktose-intoleransie, laktasegebrek of glukosegalaktosewanabsorpsie
behoort nie AGNUCASTON® Filmbedekte Tablette te neem nie.
INTERAKSIES:
Geen interaksies met ander medisinale produkte is bekend nie. ‘n Wedersydse verswakking
van effekte tydens gelyktydige inname van dopamienreseptorantagoniste is moontlik.
SWANGERSKAP EN LAKTASIE:
Die veiligheid van AGNUCASTON® tydens swangerskap en laktasie is nog nie vasgestel nie en
moet vermy word of dadelik gestaak word.
DOSIS EN GEBRUIKSAANWYSINGS:
Neem 1 filmbedekte tablet een keer daagliksmet voldoende vloeistof. Moenie die tablette
kou nie. Dit word aanbeveel dat die produk aaneenlopend vir verskeie maande gebruik moet
word.
Nadat die klagtes verbeter ofverdwyn het, behoort die behandeling steeds vir etlike weke
voortgesit te word.
NEWE-EFFEKTE EN SPESIALE VOORSORGMAATREËLS:
Newe-effekte:
Simptome soos hoofpyn, jeuk of abdominale simptome soos naarheid, maagpyn of pyn in
die onderste buik is al aangemeld. Soms is gevalle van sistemiese hipersensitiwiteitsreaksies
met eksanteem, urtikarie, Quincke se siekte, dispnee en probleme met sluk, beskryf.
Tydelike psigomotoriese rusteloosheid, verwarring en hallusinasies is waargeneem.
Daar is geen data beskikbaar i.v.m. die frekwensie van hierdie moontlik ongewenste neweeffekte
nie.
Spesiale voorsorgmaatreëls:
Sien “Kontra-indikasies” en “Waarskuwings”.
BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN DIE BEHANDELING
DAARVAN:
Geen geval van oordosering is bekend nie. In die geval van oordosering moet mediese hulp
verkry word. Behandeling is simptomaties en ondersteunend.
IDENTIFIKASIE:
AGNUCASTON® Filmbedekte Tablette is groen-blou, rond, bikonveks met ‘n dowwe oppervlakte.
AANBIEDING:
AGNUCASTON® Filmbedekte Tablette is beskikbaar as:
Verpakking met 30 filmbedekte tablette.
Verpakking met 60 filmbedekte tablette.
Verpakking met 90 filmbedekte tablette.
Nie al dié verpakkingsgroottes sal noodwendig bemark word nie.
BEWARINGSINSTRUKSIES:
HOU BUITE BEREIK VAN KINDERS
REGISTRASIENOMMER:
138906
NAAM EN BESIGHEIDSADRES VAN DIE REGISTRASIEHOUER:
CAMOX PHARMACEUTICALS (EDMS) BPK
Perietstraat 30
Amalgam, Johannesburg,
Suid-Afrika
DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET:
29 September 2009
BIONORICA INTERN
Druckreif Korrektur
Abteilung Name
Datum Unterschrift
1821702 ZA
gbpz-agn-drg-1821702-za.indd 2 15.11.10 15:11