Femonia Tablet, film coated 4mg

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

DRY EXTRACT, OF AGNUS, CASTUS FRUIT

Disponível em:

Florealis ehf. Síðumúla 25, 108 Reykjavík, Iceland

Código ATC:

G02CX03

DCI (Denominação Comum Internacional):

DRY EXTRACT OF AGNUS CASTUS FRUIT 4 mg

Forma farmacêutica:

FILM-COATED TABLET

Composição:

DRY EXTRACT OF AGNUS CASTUS FRUIT 4 mg

Tipo de prescrição:

OTC

Área terapêutica:

OTHER GYNECOLOGICALS

Status de autorização:

Withdrawn

Data de autorização:

2018-11-07

Folheto informativo - Bula

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FEMONIA FILM-COATED TABLETS
Agnus castus fruit extract
TRADITIONAL HERBAL MEDICINAL PRODUCT
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 3 months.
WHAT IS IN THIS LEAFLET
1.
What Femonia is and what it is used for
2.
What you need to know before you take Femonia
3.
How to take Femonia
4.
Possible side effects
5.
How to store Femonia
6.
Contents of the pack and other information
1.
WHAT FEMONIA IS AND WHAT IT IS USED FOR
Femonia is a traditional herbal medicinal product for the relief of
minor symptoms in the days before
menstruation (premenstrual syndrome).
The product is a traditional herbal medicinal product for use in the
specified indication exclusively
based upon long-standing use.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEMONIA
DO NOT TAKE THIS MEDICINE:
-
If you are allergic to agnus castus or to any of the other ingredients
of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before you take Femonia if:

you have a history of oestrogen-sensitive cancer or pituitary
disorder.

you are using dopamine agonists (e.g. levodopa or bromocriptine used
for Parkinson´s disease),
dopamine antagonists (some medicines used for schizophrenia, bipolar
disorders, nausea and
vomiting), oestrogens (e.g. used for hormone replacement therapy) and
antioestrogens (e.g.
fulvestrant, tamoxifen and toremifene used for breast cancer).

you have had prolactin secreting tumours of the pituitary gland.
If t

Características técnicas

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Femonia, film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
4 mg of extract (as dry extract) from
_Vitex agnus-castus_
L., fructus (agnus castus), equivalent to 28-52
mg of dried agnus castus fruit.
Extraction solvent: ethanol 68% (V/V)
Excipients with known effect:
One film-coated tablet contains lactose monohydrate, corresponding to
118 mg anhydrous lactose and
36 mg of liquid glucose, spray dried.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Salmon pink, round, convex curved 9.1 mm tablets and with a score mark
on one side. The score line
is only to facilitate breaking for ease of swallowing and not to
divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Traditional herbal medicinal product for the relief of minor symptoms
in the days before menstruation
(premenstrual syndrome).
The product is a traditional herbal medicinal product for use in the
specified indication exclusively
based upon long-standing use.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
One tablet daily continuously for 3 months or longer.
_Paediatric population _
The use of Femonia in children and adolescents under 18 years of age
is not recommended (see section
4.4).
Method of administration
Oral use.
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Duration of use
If the symptoms persist after a continued use over three months, a
doctor or a qualified health care
practitioner should be consulted.
4.3
CONTRAINDICATIONS
Hypersensitivity to agnus castus fruit or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients who suffer or suffered from an oestrogen-sensitive cancer
should consult their doctor before
using
_Vitex agnus-castus_
.
Patients who are using dopamine agonists, dopamine antagonists,
oestrogens and antioestrogens should
consult their doctor before using
_Vitex agnus-castus_
(see section 4.5).
If the symptoms