AGNUCASTON

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AGNI CASTI FRUCTUS DRY EXTRACT: 20% (7-11:1) EXTRACTION SOLVENT ETHANOL 70% V/V)

Available from:

DR.SAMUELOV IMPORTING & MARKETING LTD, ISRAEL

ATC code:

G02CX03

Pharmaceutical form:

FILM COATED TABLETS

Composition:

AGNI CASTI FRUCTUS DRY EXTRACT: 20% (7-11:1) EXTRACTION SOLVENT ETHANOL 70% V/V) 4 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

BIONORICA SE, GERMANY

Therapeutic area:

AGNI CASTI FRUCTUS

Therapeutic indications:

Premenstrual syndrome, mastodynia.

Authorization date:

2022-12-31

Patient Information leaflet

PATIENT PACKAGE INSERT ACCORDING
TO PHARMACISTS’ REGULATIONS
(PREPARATIONS)- 1986
This medicine can be sold without a doctor’s
prescription
AGNUCASTON
FILM-COATED TABLETS
ACTIVE INGREDIENT AND ITS QUANTITY IN DOSAGE
UNIT:
EACH FILM-COATED TABLET CONTAINS:
Agnus castus fruit dry extract (7-11:1) 4.0 mg;
extraction solvent: Ethanol 70 % (V/V)
For a list of all inactive ingredients and allergens
in the medicine - see section 6.
For important information about some of the
ingredients of the medicine- see section 2.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING
THIS MEDICINE.
This leaflet contains concise information about
the medicine. If you have any further questions,
refer to the doctor or pharmacist.
You
should
take
the
medicine
Agnucaston
according
to
the
instructions
in
the
dosage
section in this leaflet. Consult the pharmacist if
you need any further information. You should
refer to the doctor in case the illness symptoms
worsen or do not improve after 3 months.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine Agnucaston is intended for:
−
Treatment of premenstrual syndrome characterized
by the following symptoms: fatigue, breast swelling
and sensitivity, pain in the abdominal region,
mood swings, restlessness, joint and muscle pain.
−
Treatment
of
breast
pain
and
sensitivity
(Mastodynia).
The medicine Agnucaston is intended for women
18 years of age and above.
THERAPEUTIC
GROUP:
herbal
medicine
for
the
treatment of menstrual complaints.
2. BEFORE USING THE MEDICINE
X DO NOT USE THE MEDICINE:
• If you are hypersensitive (allergic) to the active
ingredient or to any of the additional ingredients
contained in the medicine. Additional ingredients
are listed in section 6.
• If you are pregnant.
SPECIAL WARNINGS REGARDING THE USE OF THIS
MEDICINE:
!
The use of the active ingredient contained
in this medicine may mask the symptoms of a
prolactin secreting tumor of the pituitary gland.
INFORM YOUR DOCTOR IN CASE:
!
You suffer or suffered in the past from an
oestrogen-sensitive malignant tumor.
!
You t

Summary of Product characteristics

Page 1 of 5
This leaflet format has been determined by the Ministry of Health and
the content thereof has
been checked and approved in January 2018
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Agnucaston
®
Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains:
AgnI casti fructus dry extract (7-11:1) 4.0 mg
Extraction solvent: ethanol 70 % (v/v)
Excipients:
Lactose monohydrate
25.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
The film-coated tablets are green-blue, round, biconvex with a dull
surface.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Premenstrual syndrome, mastodynia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
1 film-coated tablet once daily.
Agnucaston should be taken over a period of several months (3 months)
without
interruption even during mensturation.
A doctor has to be consulted if Agnucaston is taken for more than 3
months.
Renal impairment: no data is available
Hepatic impairment: no data is available
Agnucaston 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.
Page 2 of 5
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Pregnancy.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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 (see section 4.5 Interaction with other medicinal products
and other forms
of interaction).
-
patients with a history of a pituitary disorder. Agnucaston is thought
to act on the
pituitary-hypothalamic axis.
-
patients with prolactin secreting tumours