Crinone 8% w/w progesterone vaginal gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Progesterone

Available from:

Imbat Limited

ATC code:

G03DA; G03DA04

INN (International Name):

Progesterone

Dosage:

8 percent

Pharmaceutical form:

Vaginal gel

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Pregnen (4) derivatives; progesterone

Authorization status:

Authorised

Authorization date:

2014-08-15

Patient Information leaflet

Page 1 of 2
CRINONE
® 8% W/W PROGESTERONE VAGINAL GEL
(progesterone)
PATIENT INFORMATION LEAFLET
Your medicine is available using the name Crinone 8% w/w progesterone
vaginal gel but will be
referred to as Crinone throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or 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 or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT CRINONE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CRINONE
3.
HOW TO USE CRINONE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CRINONE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT CRINONE IS AND WHAT IT IS USED FOR
Crinone contains progesterone and is used for the treatment of
infertility due to a deficiency of
the female hormone progesterone during the menstrual cycle.
During the menstrual cycle, an egg develops in the ovary during the
first 14 days. This is called
the follicular phase of the menstrual cycle. Ovulation then occurs and
leaves a corpus luteum in
the ovary. This is called the luteal phase of the menstrual cycle.
This corpus luteum produces
progesterone for 12-16 days which helps to thicken and maintain the
lining of the uterus
(womb) ready for a fertilised egg. If fertilisation of the egg does
not occur, the progesterone
level falls and the lining of the uterus is shed (menstruation). If
the egg is fertilised and the
embryo implants in the lining of the uterus, the corpus luteum
continues to produce
progesterone to support the pregnancy until the embryos placenta takes
over at 10 weeks into
the pregnancy. In some women the progesterone produced i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Crinone 8% w/w progesterone vaginal gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients: Contains sorbic acid
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal gel
_Product imported from the UK & Czech Republic:_
White to off white gel contained in a white plastic applicator.
4 CLINICAL PARTICULARS
As per PA0654/021/001.
5 PHARMACOLOGICAL PROPERTIES
As per PA0654/021/001.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Glycerin
Light Liquid Paraffin
Hydrogenated Palm Oil Glycerides
Carbomer 974P
Sorbic acid
Polycarbophil
Sodium hydroxide
Purified water
6.2 INCOMPATIBILITIES
No incompatibilities were found with the usual contraceptive devices.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the foil overwraps and outer carton of the product
as marked in the country of origin.
Active Ingredient
Mg/dose
% w/w
Progesterone
90
8.0
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Do not freeze.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing single use, one piece applicators in foil
overwraps.
Pack size: 15 applicators
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUC