Ovreena 30 micrograms/150 micrograms coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ethinylestradiol; Levonorgestrel

Available from:

Gedeon Richter Plc

ATC code:

G03AA; G03AA07

INN (International Name):

Ethinylestradiol; Levonorgestrel

Dosage:

30 mcg/150 microgram(s)

Pharmaceutical form:

Coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Progestogens and estrogens, fixed combinations; levonorgestrel and ethinylestradiol

Authorization status:

Marketed

Authorization date:

2006-01-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
OVREENA 30 MICROGRAMS /150 MICROGRAMS COATED TABLETS
ethinylestradiol and levonorgestrel
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 Ovreena is and what it is used for
2.
What you need to know before you take Ovreena
3.
How to take Ovreena
4.
Possible side effects
5.
How to store Ovreena
6.
Contents of the pack and other information
1.
WHAT OVREENA IS AND WHAT IT IS USED FOR
Ovreena is a combined oral contraceptive, also called the pill. It
contains two types of female
hormones: an oestrogen, ethinylestradiol, and a progestogen,
levonorgestrel in a low dose.
The combined contraceptive pill protects you against getting pregnant
in three ways. These hormones
1.
stop the ovary from releasing an egg each month (ovulation)
2.
also thicken the fluid (at the neck of the womb) making it more
difficult for the sperm to reach
the egg
3.
alter the lining of the womb to make it less likely to accept a
fertilised egg.
GENERAL INFORMATION
If taken correctly, the pill is an effective reversible form of
contraception. However, in certain
circumstances the effectiveness of the pill may reduce or you should
stop taking the pill (see later). In
these cases either do not have sex, or use extra non-hormonal
contraceptive precautions (such as
condoms or another barrier method) during intercourse to ensure
effective contraception.
Remember, combined oral contraceptive pills like Ovreena will not
protect you against sexually-
transmitted diseases (such as AIDS). Only condoms can help to do this.
2.
WHAT YOU NEED TO KNOW BEFORE

Summary of Product characteristics

Health Products Regulatory Authority
04 October 2022
CRN00CV4Q
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ovreena 30 micrograms/150 micrograms coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 micrograms levonorgestrel and 30 micrograms
ethinylestradiol.
Excipients with known effect: Each tablet contains 33 mg of lactose
monohydrate and 22.46 mg of sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet
White, biconvex, circular tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral hormonal contraception.
The decision to prescribe Ovreena should take into consideration the
individual woman's current risk factors, particularly those
for venous thromboembolism (VTE), and how the risk of VTE with Ovreena
compares with other combined hormonal
contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HOW TO USE OVREENA?
Tablets must be taken orally in the order directed on the blister
package at about the same time every day, with some liquid if
necessary.
One tablet is to be taken daily for 21 consecutive days. Every
subsequent blister pack is started after a 7-day tablet-free interval
during which time a withdrawal bleeding usually occurs. This bleeding
will usually start on the 2nd or 3rd day after the last
tablet has been taken and it may not have stopped, before the next
blister pack is started.
HOW TO START THE USE OF OVREENA
_No preceding hormonal contraceptive use in the past month._
Tablet-taking is started on day 1 of the woman's natural cycle (= the
first day of her menstrual bleeding).
_Changing from another combined hormonal contraceptive (combined oral
contraceptive (COC) vaginal ring or transdermal patch):_
Take the first tablet the day after the dose of the last active tablet
of the previous contraceptive or, at the latest, the day after
the usual period of stopping the tablets.
In case of vaginal ring or transdermal patch, take the first tab