Utrogestan 300 mg soft vaginal capsules

Држава: Малта

Језик: Енглески

Извор: Medicines Authority

Доступно од:

Besins Healthcare SA Avenue Louise, 287-Boite 6, 1050 Brussels, Belgium

АТЦ код:

G03DA04

INN (Међународно име):

PROGESTERONE 300 mg

Фармацеутски облик:

VAGINAL SOFT CAPSULE

Састав:

PROGESTERONE 300 mg

Тип рецептора:

POM

Терапеутска област:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Резиме производа:

Licence number in the source country: NOT APPLICAPABLE

Статус ауторизације:

Authorised

Датум одобрења:

2023-04-21

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE USER
UTROGESTAN 300 MG SOFT VAGINAL CAPSULES
progesterone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor, pharmacist or nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Utrogestan 300 mg is and what it is used for
2.
What you need to know before you use Utrogestan 300 mg
3.
How to use Utrogestan 300 mg
4.
Possible side effects
5.
How to store Utrogestan 300 mg
6.
Contents of the pack and other information
1.
WHAT UTROGESTAN 300 MG IS AND WHAT IT IS USED FOR
The name of your medicine is Utrogestan 300 mg. Utrogestan 300 mg
contains a hormone called
progesterone.
WHAT UTROGESTAN 300 MG IS USED FOR
Utrogestan 300 mg can be used to support pregnancy during in vitro
fertilization (IVF) cycles.
TO SUPPORT PREGNANCY
Utrogestan 300 mg is for women who need extra progesterone while
undergoing treatment in an Assisted
Reproductive Technology (ART) program.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE UTROGESTAN 300 MG
DO NOT USE UTROGESTAN 300 MG
•
if you are allergic (hypersensitive) to soya or peanuts
•
if you are allergic to progesterone or any of the other ingredients of
this medicine (listed in section 6)
•
if you have liver problems
•
if you have yellowing of the skin or eyes (jaundice)
•
if you have unexplained vaginal bleeding
•
if you have breast cancer or genital tract carcinoma
•
if you have thrombophlebitis
•
if you have or have had blood clots in a vein (thrombosis), such as in
the leg (deep vein thrombosis) or
the lungs (pulmonary embolism)
•
if you have had a cerebral haemorrhage or stroke
•

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Utrogestan 300 mg soft vaginal capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 300 mg progesterone (micronized).
Excipient(s) with known effect: one capsule contains 3 mg of soya
lecithin.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Vaginal capsule, soft
Oblong yellowish, soft gelatin capsule (approximately 2.5 cm x 0.8 cm)
containing a whitish oily
suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Utrogestan 300 mg is indicated in adult women for supplementation of
the luteal phase during
Assisted Reproductive Technology (ART) cycles.
4.2
POSOLOGY AND ADMINISTRATION
Posology
VAGINAL USE ONLY.
The recommended dose is 600 mg/day, given in two divided doses, one in
the morning and the other at
bedtime. The treatment is started not later than the third day after
oocyte retrieval day and is
continued until at least the 7
th
week of pregnancy and not later than the 12
th
week of pregnancy or until
menstruation begins.
_Paediatric population _
There is no relevant use of Utrogestan 300 mg in the paediatric
population.
_Elderly patients _
There is no relevant use of Utrogestan 300 mg in the elderly.
Method of administration
Vaginal
Each Utrogestan 300 mg capsule must be inserted deep into the vagina.
One capsule should be inserted deep into the vagina in the morning and
the other at bedtime.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in Section 6.1
•
Jaundice
•
Severe hepatic dysfunction
•
Undiagnosed vaginal bleeding
•
Mammary or genital tract carcinoma
•
Thrombophlebitis
•
Thromboembolic diseases
•
Cerebral haemorrhage
•
Porphyria
•
Missed abortion
•
Allergy to nuts or soya (see Section 4.4)
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_WARNINGS: _
A complete medical examination must be performed before starting the
treatment and regularly during
the treatment.
Utrogestan 300 mg should only be used during