Progesterone 400 mg pessaries

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Progesterone

Available from:

Gedeon Richter Plc

ATC code:

G03DA; G03DA04

INN (International Name):

Progesterone

Dosage:

400 milligram(s)

Pharmaceutical form:

Pessary

Therapeutic area:

Pregnen (4) derivatives; progesterone

Authorization status:

Not marketed

Authorization date:

2017-03-31

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROGESTERONE 400 MG PESSARIES
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 any 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 Progesterone is and what it is used for
2.
What you need to know before you use Progesterone
3.
How to use Progesterone
4.
Possible side effects
5.
How to store Progesterone
6.
Contents of the pack and other information
1.
WHAT PROGESTERONE IS AND WHAT IT IS USED FOR
Progesterone contains progesterone which is a natural, female sex
hormone, produced in the body.
Progesterone is for women who need extra progesterone while undergoing
treatment in an Assisted
Reproductive Technology (ART) programme.
Progesterone acts on the lining of the womb and it helps you to become
and to stay pregnant when you are
treated for infertility.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PROGESTERONE
DO NOT USE PROGESTERONE:
-
if you are allergic to progesterone or any of the other ingredients of
this medicine (listed in section 6),
-
have unusual vaginal bleeding that has not been evaluated by the
doctor,
-
have known or suspected tumour that is hormone sensitive,
-
have porphyria disorders (a group of inherited or acquired disorders
of certain enzymes),
-
have or have had blood clots in the legs, lungs, eyes or elsewhere in
the body,
-
currently have or have had severe liver problems,
-
have a miscarriage and your physician suspects some tissue is still in
the uterus or pregnancy outside
of the womb.
WARNINGS AND PRECAUTIONS
Take special care and tell your doctor straight

Summary of Product characteristics

Health Products Regulatory Authority
04 October 2021
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Progesterone 400 mg pessaries
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pessary contains 400 mg progesterone
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pessary
Off-white, approximately 10mm x 30mm, torpedo shaped pessary.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Progesterone is indicated for luteal phase support as part of an
Assisted Reproductive Technology (ART) treatment for women.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
One 400 mg pessary administered vaginally twice a day starting at
oocyte retrieval. If pregnancy has been confirmed, the
administration of Progesterone should be continued for 38 days from
the start of therapy.
_Paediatric population_
There is no relevant use of Progesterone in the paediatric population.
_Elderly_
No clinical data have been collected in patients over age 65.
_Use in special populations_
There is no experience with use of Progesterone in patients with
impaired liver or renal function.
Method of administration
For vaginal insertion.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Undiagnosed vaginal bleeding.
Known or suspected progesterone sensitive malignant tumours.
Porphyria.
Known missed abortion or ectopic pregnancy.
Active arterial or venous thromboembolism or severe thrombophlebitis,
or a history of these events.
Severe hepatic dysfunction or disease.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Progesterone should be discontinued if any of the following conditions
are suspected:
Health Products Regulatory Authority
04 October 2021
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Page 2 of 5
myocardial infarction, cerebrovascular disorders, arterial or venous
thromboembolism (venous thromboembolism or
pulmonary embolism), thrombophlebitis or retinal thrombosis.
Although risk of thromboembolism has been associated with estrogens, a
link with