Utrogestan 400 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 400 mg

Фармацеутски облик:

VAGINAL SOFT CAPSULE

Састав:

PROGESTERONE 400 mg

Тип рецептора:

POM

Терапеутска област:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Статус ауторизације:

Authorised

Датум одобрења:

2023-10-10

Информативни летак

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PACKAGE LEAFLET: INFORMATION FOR THE USER
UTROGESTAN 400 MG SOFT VAGINAL CAPSULES
progesterone
WHAT IS IN THIS LEAFLET:
1.
What Utrogestan Vaginal 400 mg Capsule, soft is and what it is used
for
2.
What you need to know before you Utrogestan Vaginal 400 mg Capsule,
soft
3.
How to use Utrogestan Vaginal 400 mg Capsule, soft
4.
Possible side effects
5.
How to store Utrogestan Vaginal 400 mg Capsule, soft
6.
Contents of the pack and other information
1.
WHAT UTROGESTAN VAGINAL 400 MG CAPSULE, SOFT IS AND WHAT IT IS USED
FOR
The name of your medicine is Utrogestan Vaginal 400 mg Capsule, soft
(called Utrogestan Vaginal 400 mg
Capsule, soft in this package leaflet). Utrogestan Vaginal 400 mg
Capsule, soft contains a hormone called
progesterone.
WHAT UTROGESTAN VAGINAL 400 MG CAPSULE, SOFT IS USED FOR
Utrogestan Vaginal 400 mg Capsule, soft can be used to help pregnancy.
TO HELP PREGNANCY
Utrogestan Vaginal 400 mg Capsule, soft can be used to help women
reduce the risk of miscarriage in
women with bleeding in the current pregnancy and a history of
recurrent miscarriages.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE UTROGESTAN VAGINAL 400 MG
CAPSULE, SOFT
DO NOT USE UTROGESTAN VAGINAL 400 MG CAPSULE, SOFT
•
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)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Use this medicine exactly as described in this package leaflet or as
your doctor, pharmacist or nurse have
instructed.
-
Keep this leaflet. You may need to read it again.
-
If you have questions, consult 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 notice any side effects, talk to your docto

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Utrogestan 400 mg soft vaginal capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 400 mg progesterone.
Excipient(s) with known effect: soyabean lecithin.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Soft vaginal capsules.
Oblong yellowish, soft capsule (approximately 2.5 cm x 0.9 cm)
containing a whitish oily suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Utrogestan Vaginal 400 mg Capsule, soft
is indicated for the prevention of miscarriage in women
presenting with bleeding in the first trimester of pregnancy and have
a history of recurrent
miscarriages (see sections 4.2 and 5.1).
4.2
POSOLOGY AND ADMINISTRATION
Treatment should always be individualised to the patient. The decision
to treat women who have
experienced recurrent miscarriages should follow further investigation
and is at the discretion of the
clinician.
Posology
VAGINAL USE ONLY.
The recommended dose is 400 mg twice a day (morning and night).
Treatment should be initiated
during the first trimester of pregnancy, at first sign of vaginal
bleeding (see Section 4.4 Special
Warnings and Precautions for Use) and should continue to the 16th week
of gestation.
_Paediatric population _
There is no relevant use of Utrogestan Vaginal 400 mg Capsule, soft
in the paediatric population.
_Elderly patients _
There is no relevant use of Utrogestan Vaginal 400 mg Capsule, soft
in the elderly.
Method of administration
Vaginal
Each Utrogestan Vaginal 400 mg Capsule, soft
capsule
must be inserted deep into the vagina.
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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 disorders
•
Cerebral haemorrhage
•
Porphyria
•
Allergy to nuts or soya (see Section 4.4)
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE