Elvina 0.03mg/3mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Drospirenone; Ethinylestradiol

Available from:

Gedeon Richter Plc

ATC code:

G03AA; G03AA12

INN (International Name):

Drospirenone; Ethinylestradiol

Dosage:

0.03mg/3 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

Authorization status:

Marketed

Authorization date:

2010-08-20

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELVINA 0.03MG/3MG FILM-COATED TABLETS
ethinylestradiol and drospirenone
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 effect, 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 Elvina is and what it is used for
2.
What you need to know before you use Elvina
3.
How to take Elvina
4.
Possible side effects
5.
How to store Elvina
6.
Contents of the pack and other information
1.
WHAT ELVINA IS AND WHAT IT IS USED FOR
-
Elvina is a contraceptive pill and is used to prevent pregnancy.
-
Each tablet contains a small amount of two different female hormones,
namely drospirenone
and ethinylestradiol.
-
Contraceptive pills that contain two hormones are called
“combination” pills.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ELVINA
GENERAL NOTES
Before you start using Elvina you should read the information on blood
clots in section 2. It is
particularly important to read the symptoms of a blood clot – see
Section 2 “Blood clots”.
Before you can begin taking Elvina, your doctor will ask you some
questions about your personal
health history and that of your close relatives. The doctor will a

Summary of Product characteristics

Health Products Regulatory Authority
08 March 2023
CRN00D7P9
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Elvina 0.03mg/3mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.03 mg ethinylestradiol and 3 mg drospirenone.
Excipients with known effect:
Each film-coated tablet contains 48.17 mg of lactose monohydrate and
0.070 mg of soya lecithin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White or almost white, round, biconvex film-coated tablet. Engraving
on one side: “G63”, other side is without engraving.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Elvina should take into consideration the
individual woman’s current risk factors, particularly those for
venous thromboembolism (VTE), and how the risk of VTE with Elvina
compares with other combined hormonal contraceptives
(CHCs) (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration: oral use
Posology
_How to take Elvina _
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. One tablet is to be taken daily for 21 consecutive days. Each
subsequent pack is started after a 7-day tablet-free interval,
during which time a withdrawal bleed usually occurs. This usually
starts on day 2-3 after the last tablet and may not have
finished before the next pack is started.
_How to start Elvina _
- No preceding hormonal contraceptive use (in the past month)
Tablet-taking has to start on day 1 of the woman's natural cycle (i.e.
the first day of her menstrual bleeding).
- Changing from another combined hormonal contraceptive (combined oral
contraceptive (COC), vaginal ring or transdermal
patch)
The woman should start with Elvina preferably on the day after the
last active tablet (the last tablet containing the active
substances) of her previous COC; but at the latest on the day
following