Trinordiol Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levonorgestrel; Ethinyloestradiol; Levonorgestrel; Ethinyloestradiol; Levonorgestrel; Ethinyloestradiol

Available from:

Pfizer Healthcare Ireland

ATC code:

G03AA; G03AA10

INN (International Name):

Levonorgestrel; Ethinyloestradiol; Levonorgestrel; Ethinyloestradiol; Levonorgestrel; Ethinyloestradiol

Dosage:

percent volume/volume

Pharmaceutical form:

Coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Progestogens and estrogens, fixed combinations; gestodene and ethinylestradiol

Authorization status:

Not marketed

Authorization date:

1981-02-02

Patient Information leaflet

Page 1 of 12
2022-0081343
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRINORDIOL™ TABLETS
(levonorgestrel + 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 or pharmacist.
- 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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Trinordiol is and what it is used for
2. What you need to know before you take Trinordiol
3. How to take Trinordiol
4. Possible side effects
5. How to store Trinordiol
6. Contents of the pack and other information
1. WHAT TRINORDIOL IS AND WHAT IT IS USED FOR
The name of your medicine is Trinordiol Tablets. Trinordiol 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 is shed in the next
menstrual period.
Trinordiol 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.
Trinordiol is a triphasic contraceptive. This means that there are
three levels of hormones in each pack
which reflect the changing levels in your normal menstrual cycle.
These hormones stop the ovary from
releasing an egg each month (ovulation).
Medical research an

Summary of Product characteristics

Health Products Regulatory Authority
14 November 2022
CRN00D7S5
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trinordiol Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each light brown tablet contains 50 micrograms levonorgestrel and 30
micrograms ethinylestradiol.
Each white tablet contains 75 micrograms levonorgestrel and 40
micrograms ethinylestradiol.
Each ochre tablet contains 125 micrograms levonorgestrel and 30
micrograms ethinylestradiol.
Excipients with known effect:
Each tablet contains 33mg lactose monohydrate and 19mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet.
Each blister pack contains 6 light brown, 5 white, and 10 ochre,
lustrous sugar coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormonal contraception.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population _
No data are available.
Safety and efficacy of combined oral contraceptive (COCs) have been
established in adult women of reproductive age.
_Elderly_
COCs are not indicated for use in postmenopausal women.
Method of administration
How to take Trinordial
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.
Health Products Regulatory Authority
14 November 2022
CRN00D7S5
Page 2 of 14
How to start Trinordial
_No hormonal contraceptive use in the preceding month_
The user should begin taking Trinordiol on Day 1 of her natural
menstrual cycle (i.e. the first day of her menstrual bleeding).
Beginning Trinordiol use on days 2-7 of the menstrual is allowed,
ho