Levosert 20 micrograms/24 hours Intrauterine Delivery System

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LEVONORGESTREL

Available from:

Gedeon Richter Plc Gyomroi ut 19-21 1103 Budapest, Hungary

ATC code:

G02BA03

INN (International Name):

LEVONORGESTREL 52 mg

Pharmaceutical form:

INTRAUTERINE DELIVERY SYSTEM

Composition:

LEVONORGESTREL 52 mg

Prescription type:

POM

Therapeutic area:

OTHER GYNECOLOGICALS

Authorization status:

Authorised

Authorization date:

2015-02-23

Patient Information leaflet

1
PACKAGE LEAFLET
Page 2 of 17
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOSERT 20 MICROGRAMS/24 HOURS INTRAUTERINE DELIVERY SYSTEM
levonorgestrel
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.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Levosert is and what it is used for
2.
What you need to know before you use Levosert
3.
How to use Levosert
4.
Possible side effects
5.
How to store Levosert
6.
Contents of the pack and other information
1.
WHAT LEVOSERT IS AND WHAT IT IS USED FOR
Levosert is an intrauterine delivery system (IUS) for insertion in the
womb (uterus), where it slowly
releases the hormone levonorgestrel.
It is used for:
_Contraception _
Levosert is an effective, long-term and non-permanent (reversible)
method of contraception. Levosert
prevents pregnancy by thinning the lining of your womb (uterus), by
making the normal mucus in the
opening of the womb (cervical canal) thicker, so that the sperm cannot
get through to fertilise the egg
and by preventing the release of eggs (ovulation) in some women.
Furthermore, the presence of the T-
shaped frame causes local effects on the lining of the womb.
Levosert should be removed after 6 years of use when used for
contraception.
_Treating heavy menstrual bleeding _
Levosert is also useful for reducing menstrual blood flow, so it can
be used if you suffer from heavy
menstrual bleeding (periods). This is called menorrhagia. The hormone
in Levosert acts by thinning
the lining of your uterus so that there is less bleeding every month.
Levosert should be removed or exchanged after 6 years of use, or
earlier if heavy or bothersome
menstrual bleeding returns.
_Children and adolescents _
Levosert is not indicated for use before the first m

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Levosert 20 micrograms/24 hours Intrauterine Delivery System
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is levonorgestrel.
The intrauterine delivery system contains 52 mg levonorgestrel. The
initial release of levonorgestrel is
approximately 20 micrograms per day and declines progressively by
about 60% after 6 years.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Intrauterine delivery system (IUS).
The product consists of an inserter and levonorgestrel IUS, which is
loaded at the tip of the inserter.
Inserter components are an insertion tube, plunger, flange, body and
slider. The device consists of a white
or almost white hormone-elastomer core, mounted on a T-body and
covered in opaque tubing, which
regulates the release of levonorgestrel. The T-body has a loop at the
end of the vertical stem and two
horizontal arms at the other end. Removal threads are attached to the
loop.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Contraception.
Treatment of heavy menstrual bleeding. Levosert may be particularly
useful in women with heavy
menstrual bleeding requiring (reversible) contraception.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Starting treatment _
In women of fertile age, Levosert is inserted into the uterine cavity
within seven days of the onset of
menstruation. It can be replaced by a new system at any time of the
cycle.
_Postpartum insertion:_
To reduce the risk of perforation, postpartum insertions should be
postponed until
the uterus is fully involuted. Do not insert earlier than six weeks
after delivery. If the patient is
experiencing significant postpartum bleeding and/or pain then
infection or other causes should be
excluded before insertion. Levosert can also be inserted immediately
after the first trimester abortion.
Levosert is effective for six years in the indication contraception
and has a demonstrated efficacy for
3 years for the indication heavy menstrual bleeding. Therefor