PREFEMIN

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

AGNI CASTI FRUCTUS

Dostępny od:

RAFA LABORATORIES LTD

Kod ATC:

G02CX03

Forma farmaceutyczna:

FILM COATED TABLETS

Skład:

AGNI CASTI FRUCTUS 20 MG

Droga podania:

PER OS

Typ recepty:

Not required

Wyprodukowano przez:

MAX ZELLER SOHNE AG, SWITZERLAND

Dziedzina terapeutyczna:

AGNI CASTI FRUCTUS

Wskazania:

For the treatment of PMS (premenstrual syndrome) complaints recurring monthly prior to menstruation in adults.

Data autoryzacji:

2020-04-19

Ulotka dla pacjenta

page 1 of 4
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is sold without a doctor's prescription
PREFEMIN
®
FILM-COATED TABLETS
ACTIVE INGREDIENT:
Each tablet of Prefemin contains: 20 mg of Agnus castus dry extract
(Agni casti fructus).
For a list of other ingredients, please see Section 6.
See also ‘Important information on some of the medicine’s
ingredients in Section 2.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further
questions, please refer to your doctor or pharmacist.
Take this medicine according to the instructions in the section on
dosage in this leaflet.
Consult with a pharmacist if you need additional information.
Refer to your doctor if your symptoms do not improve after three
months of treatment, or
if they worsen.
1.
WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment of premenstrual syndrome
(PMS), which
includes recurring monthly symptoms prior to menstruation, for women
over 18 years of
age.
THERAPEUTIC GROUP
:
A medicine of herbal origin for the treatment of premenstrual
syndrome.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
You are sensitive (allergic) to the active ingredient, or to any of
the other ingredients
this medicine contains (for a list of the other ingredients, please
see section 6).
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
BEFORE THE TREATMENT WITH PREFEMIN TELL YOUR DOCTOR IF:
•
You suffer or have suffered in the past from a tumor (especially
prolactin-
secreting tumors since the medicine may mask their symptoms; or an
estrogen-
sensitive cancerous tumor).
•
You suffer or have suffered in the past from diseases of the pituitary
gland.
YOUNG GIRLS AND ADOLESCENTS:
The medicine is not intended for young girls and adolescent under the
age of 18, since
there is not enough data on the use in this age group.
DRUG INTERACTIONS:
IF YOU ARE TAKING OR HAVE RECENTLY TAKEN OTHER MEDICINES, I

Charakterystyka produktu

1
Prefemin -DL-April2020-01
Summary of product characteristics
1
NAME OF THE MEDICINAL PRODUCT
Prefemin
®
2
QUALITATIVE UND QUANTITATIVE COMPOSITION
1 film coated tablet contains:
20 mg Agni casti fructus (agnus castus) dry extract, Native ( DER 6-12
: 1).
Excipient with known effect
40 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
film coated tablet
round, white, biconvex film coated tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of PMS (premenstrual syndrome) complaints recurring
monthly prior to
menstruation, in adults.
4.2
POSOLOGY AND METHOD ADMINISTRATION
Posology
_Adult women _
1 film coated tablet daily in the morning
2
_Children and adolescents _
Prefemin is not indicated for children and adolescents below 18 years
of age due to lack of
adequate data.
Method of administration
Oral
The film coated tablet is taken unchewed with a sufficient amount of
liquid.
The film coated tablet should preferably be taken at the same time
each day.
Duration of use
To achieve an optimal treatment effect, continued use over three
months is recommended.
If the symptoms worsen or no improvement occurs after three months, a
physician should be
consulted.
4.3
CONTRAINDICATION
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients who suffer or have suffered from an oestrogen-sensitive
cancer should consult their
physician before using Prefemin.
Patients who are using dopamine agonists, dopamine antagonists,
oestrogens or antioestrogens
should consult their physician before using Prefemin (see section
4.5).
Agnus castus fruit extracts are thought to act on the
pituitary-hypothalamic axis. Therefore,
patients with a history of a pituitary disorder should consult a
physician about the intake of this
medicinal product.
In cases of prolactin secreting tumours of the pituitary gland the
intake of Agnus castus extracts
can mask symptoms of the tumour.
The film coated