Agnucaston Film-Coated Tablets

/ Dr. Samuelov

One film-coated tablet once daily.
Renal impairment: no data is available.
Hepatic impairment: no data is available.
The drug should not be used in children and adolescents under 18 years of age.
Oral administration. The film-coated tablets should be swallowed unchewed with sufficient liquid (e.g. a glass of water). There is no information available regarding the crushing/splitting of the product. It is recommended that the film coated tablet is not chewed, split or crushed.

Premenstrual syndrome, mastodynia.

Hypersensitivity to the active substance or to any of the excipients.

Use with caution in:
Patients who suffer or suffered from an oestrogen-sensitive malignant tumour.
Patients using dopamine agonists, dopamine antagonists, oestrogens and anti-oestrogens.
Patients with a history of a pituitary disorder. This drug  is thought to act on the pituitary-hypothalamic axis.
Patients with prolactin secreting tumours of the pituitary gland. Agni casti fructus may mask symptoms of the tumour.
Product specific special warnings: This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Children and Adolescents: There is insufficient data on the use of this medicinal product in children. It should not therefore be used in children and adolescents under 18 years of age.
See prescribing information for full details.

Severe allergic reactions with face swelling, dyspnoea and swallowing difficulties have been reported. (Allergic) skin reactions (including rash, urticaria), headache, dizziness, gastrointestinal complaints (including nausea, abdominal pain), acne, as well as menstrual irregularities may occur.
There is no data on the frequency of these potential undesirable effects.
See prescribing information for full details.

Please refer to the license holder for further details.

Pregnancy: There are no data from the use of this product in pregnant women.
Lactation: It is unknown whether the active substance or metabolites are excreted in human milk. A risk to the newborns cannot be excluded.
See prescribing information for full details.

No case of overdose has been reported.
Treatment of overdose: In case of overdose, symptomatic treatment should be initiated.