Ovranette 150 micrograms/30 micrograms coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ethinyloestradiol; Levonorgestrel

Available from:

Pfizer Healthcare Ireland

ATC code:

G03AA; G03AA07

INN (International Name):

Ethinyloestradiol; Levonorgestrel

Dosage:

150 mcg/30 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:

1984-04-01

Patient Information leaflet

Page 1 of 13
2022-0081343
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OVRANETTE
® 150 MICROGRAMS/30 MICROGRAMS COATED TABLETS
levonorgestrel and ethinylestradiol
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ovranette is and what it is used for
2.
What you need to know before you take Ovranette
3.
How to take Ovranette
4.
Possible side effects
5.
How to store Ovranette
6.
Contents of the pack and other information
1.
WHAT OVRANETTE IS AND WHAT IT IS USED FOR
The name of your medicine is Ovranette.
Ovranette is an oral contraceptive.
HOW THE FEMALE REPRODUCTIVE SYSTEM WORKS
Once a month, an egg (or ovum) is released from
one of the ovaries and passes along the Fallopian
tube to the womb. Fertilisation, (the joining
together of the male's sperm with the female's egg)
usually takes place while the egg is still in the
Fallopian tube. The fertilised egg embeds itself in
the wall of the womb, which has been specially
prepared to receive it, and it
grows into a baby.
If fertilisation does not take place, then the egg
leaves the body in the next menstrual period.
WHAT DO YOUR TABLETS DO?
Ovranette is a combined oral contraceptive (COC), one of a group of
drugs
_ _
often referred to as the
Pill. It contains two types of hormone: an estrogen, ethinylestradiol
and a progestogen, levonorgestrel.
These hormones stop the ovary from releasing an egg each month
(ovulation).
Medical research and vast experience have shown that, if taken
correctly, the Pill is an effective
reversible form of cont

Summary of Product characteristics

Health Products Regulatory Authority
24 November 2022
CRN00D7N6
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ovranette 150 micrograms/30 micrograms coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 micrograms levonorgestrel and 30 micrograms
ethinylestradiol.
Excipients with known effect: Each tablet also contains 32.97 mg of
lactose monohydrate and 22.023 mg of sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablets
Round, white sugar-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
How to take Ovranette
Regular daily intake of tablets for 21 consecutive days is important
for the preservation of contraceptive efficacy.
Tablets must be taken in the order directed on the package every day
at about the same time with some liquid as needed.
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 Ovranette
_No hormonal contraceptive use within the preceeding month_
The user should begin taking Ovranette on Day 1 of her natural
menstrual cycle (i.e. the first day of her menstrual bleeding).
Beginning Ovranette use on days 2-7 of the menstrual cycle is allowed,
however a nonhormonal back-up method of birth
control (such as, condoms and spermicide) is recommended during the
first 7 days of Ovranette use.
_Switching from another combined oral contraceptive (COC)_
Preferably Ovranette use should begin on the day after the last active
tablet of the previous COC pack has been taken, but no
later than the day following the usual tablet-free or inactive tablet
interval of the previous COC.
_Switching from a progestin only method of birth control (pill,
implant, intrauterine device [I