Crinone 8% w/w progesterone vaginal gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Progesterone

Available from:

Merck Serono (Ireland) Limited

ATC code:

G03DA; G03DA04

INN (International Name):

Progesterone

Dosage:

8 percent weight/weight

Pharmaceutical form:

Vaginal gel

Prescription type:

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

Therapeutic area:

Pregnen (4) derivatives; progesterone

Authorization status:

Marketed

Authorization date:

1997-07-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CRINONE
®
8% W/W PROGESTERONE VAGINAL GEL
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 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® 8% w/w Progesterone Vaginal Gel 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 in the luteal phase is absent
or insufficient to maintain the lining
of the uterus and support early development of the emb

Summary of Product characteristics

Health Products Regulatory Authority
25 August 2022
CRN00CXN2
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Crinone 8% w/w progesterone vaginal gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient
Mg/dose
% w/w
Progesterone
90
8.0
Excipients: Contains sorbic acid 0.08% w/w (0.9mg/1.125g dose)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal gel
White to off white gel contained in a white plastic applicator.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Infertility due to inadequate luteal phase.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Intravaginal application.
Treatment of infertility due to inadequate luteal phase:
One application (1.125g 8% gel) every day, starting after documented
ovulation or arbitrarily on the 18th-21st day of the cycle.
_Paediatric population_
Not applicable.
4.3 CONTRAINDICATIONS
Crinone should not be used in individuals with any of the following
conditions:
1. Hypersensitivity to the active substance or to any of the other
excipients listed in section 6.1.
2. Undiagnosed vaginal bleeding.
3. Known or suspected malignancy of the breast or genital organs.
4. Acute porphyria.
5. Thrombophlebitis, thromboembolic disorder, cerebral apoplexy, or
patients with a history of these conditions.
6. Missed abortion.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In cases of breakthrough bleeding, as in all cases of irregular
vaginal bleeding, non-functional causes should be considered. In
cases of undiagnosed vaginal bleeding, adequate diagnostic measures
should be undertaken.
Sorbic acid may cause local skin reactions, (e.g. contact dermatitis).
Health Products Regulatory Authority
25 August 2022
CRN00CXN2
Page 2 of 4
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Although no interaction with other drugs have been reported. Crinone
is not recommended for use concurrently with other
vaginal preparations.
4.6 FERTILITY, PREGNANCY AND LACTATION
Breast-feeding
Do not use during lactatio