Lutinus 100 mg vaginal tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Progesterone

Available from:

Ferring Ireland Ltd

ATC code:

G03DA; G03DA04

INN (International Name):

Progesterone

Dosage:

100 milligram(s)

Pharmaceutical form:

Vaginal tablet

Prescription type:

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

Therapeutic area:

Pregnen (4) derivatives; progesterone

Authorization status:

Marketed

Authorization date:

2010-02-05

Patient Information leaflet

Package leaflet: Information for the user
100 mg vaginal tablets
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 or pharmacist.
- 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.
This includes any possible side effects not listed
What is in this leaflet:
1. What Lutinus is and what it is used for
2. What you need to know before you use Lutinus
3. How to use Lutinus
4. Possible side effects
5. How to store Lutinus
6. Contents of the pack and other information
1. What Lutinus is and what it is used for
This medicine is provided as a vaginal tablet that contains the
natural female sex hormone progesterone.
Lutinus
is
for
women
who
need
extra
progesterone
while
undergoin
g 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 Lutinus
Lutinus can be used only in women who are undergoing infertility
treatment
in
an
Assisted
Reproductive
Technology
(ART)
programme. The treatment is started on the day of egg retrieval.
Your doctor will tell you when the treatment is started.
Do not u
se Lutinus
•
if you are allergic to progesterone or any of the other ingredients
of this medicine (listed in section 6).
•
if
you
have
unusual
vaginal
bleeding
that
has
not
been
evaluated by the doctor.
•
if you have a miscarriage and your physician suspects some
tissue is still in the uterus or pregnancy outside of the womb.
•
if you currently have or have had severe liver problems.
•
if you have known or suspected breast or genital tract
cancer.
•
if you have or have had blood clots in the legs, l

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lutinus 100mg vaginal tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vaginal tablet contains 100 mg progesterone.
Excipient with known effect: 1 vaginal tablet contains approximately
760 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal tablet
White to off-white flat
convex and oblong tablets debossed with
“FPI” on one side and “100” on the other side.
The vaginal tablets are supplied with one polyethylene vaginal
applicator.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lutinus is indicated for luteal support as part of an Assisted
Reproductive Technology (ART) treatment program for
infertile women.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS
The dose of Lutinus is 100 mg administered vaginally three times daily
starting at oocyte retrieval. The administration
of Lutinus should be continued for 30 days, if pregnancy has been
confirmed.
_Paediatric population_
There is no relevant use of Lutinus 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 Lutinus in patients with impaired
liver or renal function.
METHOD OF ADMINISTRATION
Lutinus is to be placed directly into the vagina by the applicator
provided.
4.3 CONTRAINDICATIONS
Lutinus should not be used in individuals with any of the following
conditions:
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Undiagnosed vaginal bleeding
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