Cyclogest Pessary 400mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PROGESTERONE

Available from:

Actavis Group PTC ehf

ATC code:

G03DA04

INN (International Name):

PROGESTERONE

Pharmaceutical form:

PESSARY

Composition:

PROGESTERONE 400 mg

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Authorised

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
CYCLOGEST 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 Cyclogest is and what it is used for
2.
What you need to know before you use Cyclogest
3.
How to use Cyclogest
4.
Possible side effects
5.
How to store Cyclogest
6.
Contents of the pack and other information
1.
WHAT CYCLOGEST IS AND WHAT IT IS USED FOR
Cyclogest contains progesterone which is a natural, female sex
hormone, produced in the body.
Cyclogest 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
CYCLOGEST
DO NOT USE CYCLOGEST:
-
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 away if you

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cyclogest 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
Cyclogest 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. The
administration of Cyclogest should be continued for 38 days, if
pregnancy has been confirmed.
_Paediatric population _
There is no relevant use of Cyclogest 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 Cyclogest 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.
2
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
Cyclogest should be discontinued if any of the following conditions
are suspected:
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 progestins
remains questionable. Therefore, in women with generally recognised
risk factors for
thromboembolic events, such as personal or family history, treatment
with Cyc