Lydisilka

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

estetrol monohydrate, drospirenone

Available from:

Estetra SPRL

ATC code:

G03

INN (International Name):

estetrol, drospirenone

Therapeutic group:

Sex hormones and modulators of the genital system,

Therapeutic area:

Contraceptives, Oral

Therapeutic indications:

Oral contraception.The decision to prescribe Lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Lydisilka compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).

Product summary:

Revision: 3

Authorization status:

Authorised

Authorization date:

2021-05-19

Patient Information leaflet

23
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET: INFORMATION FOR THE USER
LYDISILKA 3 MG/14.2 MG FILM-COATED TABLETS
drospirenone/estetrol
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES
(CHCS):
•
They are one of the most reliable reversible methods of contraception
if used correctly.
•
They slightly increase the risk of having a blood clot in the veins
and arteries, especially in the
first year or when restarting a combined hormonal contraceptive
following a break of 4 or more
weeks.
•
Please be alert and see your doctor if you think you may have symptoms
of a blood clot (see
section 2 ‘Blood clots’).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
-
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 Lydisilka is and what it is used for
2.
What you need to know before you take Lydisilka
3.
How to take Lydisilka
4.
Possible side effects
5.
How to store Lydisilka
6.
Contents of the pack and other information
1.
WHAT LYDISILKA IS AND WHAT IT IS USED FOR
Lydisilka is a contraceptive pill that is used to prevent pregnancy.
-
The 24 pink film-coated tablets are active tablets that contain a
small amount of two different
female hormones, namely estetrol and drospirenone.
-
The 4 white film-coated tablets are inactive tablets that do not
contain hormones and are called
placebo tablets.
-
Contraceptive pills that contain two different hormones, like
Lydisilka, are c

Summary of Product characteristics

23
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Lydisilka 3 mg/14.2 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pink active tablet contains 3 mg drospirenone and estetrol
monohydrate equivalent to 14.2 mg
estetrol.
Each white placebo tablet does not contain active substances.
Excipient with known effect
Each pink active tablet contains 40 mg lactose monohydrate.
Each white placebo tablet contains 68 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
The active film-coated tablet is pink, 6 mm diameter, round, biconvex
with a drop-shaped logo
embossed on one side.
The placebo film-coated tablet is white to off-white, 6 mm diameter,
round, biconvex with a
drop-shaped logo embossed on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Lydisilka should take into consideration the
individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with
Lydisilka compares with other combined hormonal contraceptives (CHCs)
(see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology and method of administration
_How to take Lydisilka _
Oral use.
3
One tablet is to be taken daily for 28 consecutive days. The tablets
must be taken every day at about
the same time, if necessary, with a little liquid, in the order shown
on the blister pack. Each pack starts
with 24 pink active tablets, followed by 4 white placebo tablets. Each
subsequent pack is started the
day after the last tablet of the previous pack.
Stickers marked with the 7 days of the week are provided, and the
relevant weekday sticker should be
stuck on the