Triregol coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ethinyloestradiol; Levonorgestrel; Levonorgestrel; Ethinylestradiol; Levonorgestrel; Ethinylestradiol

Available from:

Gedeon Richter Plc

ATC code:

G03AB; G03AB03

INN (International Name):

Ethinyloestradiol; Levonorgestrel; Levonorgestrel; Ethinylestradiol; Levonorgestrel; Ethinylestradiol

Dosage:

. milligram(s)

Pharmaceutical form:

Coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Progestogens and estrogens, sequential preparations; levonorgestrel and ethinylestradiol

Authorization status:

Not marketed

Authorization date:

2005-02-11

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIREGOL COATED 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
-
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.
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 “The pill and thrombosis”)
WHAT IS IN THIS LEAFLET:
1.
What Triregol is and what it is used for
2.
What you need to know before you take Triregol
3.
How to take Triregol
4.
Possible side effects
5.
How to store Triregol
6.
Contents of the pack and other information
1.
WHAT TRIREGOL IS AND WHAT IT IS USED FOR
Triregol is a combined oral contraceptive, one of a group of drugs
often referred to as the Pill. The
Pill provides a reliable, reversible method of contraception. Triregol
contains two types of hormone:
an oestrogen, ethinylestradiol, and a progestogen, levonorgestrel. It
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. They also
thicken the mucus at the neck of the womb making it more difficult for
the sperm to reach the egg, and
alter the lining of the womb to make it less likely to accept a
f

Summary of Product characteristics

Health Products Regulatory Authority
22 September 2023
CRN00CTGL
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Triregol coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
6 pink tablets: each tablet contains 50 microgram levonorgestrel and
30 microgram ethinylestradiol
5 white tablets: each tablet contains 75 microgram levonorgestrel and
40 microgram ethinylestradiol
10 ochre tablets: each tablet contains 125 microgram levonorgestrel
and 30 microgram ethinylestradiol
Excipient with known effect: each tablet contains 31.35 mg of lactose
(as lactose monohydrate, which is 33 mg) and 22 mg of
sucrose.
_ _
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet.
Pink, bright, biconvex, circular tablets
White, bright, biconvex, circular tablets
Ochre, bright, biconvex, circular tablets
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 bleeding
will usually begin on the 2
nd
or 3
rd
day after ingestion of the
last tablet and it may not have ceased, before the next pack is
started.
HOW TO START THE USE OFTRIREGOL
_ _
_No preceding intake of hormonal contraceptives (within the last
month)_
Tablet taking started on day 1 of the woman's natural cycle (= the
first day of her menstrual bleeding. Starting intake on day
2-5 is allowed, but during the first cycle the concurrent use of
barrier method during the first 7 days of tablet intake is
advisable.
_Changing from another combined hormonal contraceptive (combined oral
contraceptive, contarceptive vaginal ring,contarceptive _
_transdermal patch)_
The woman should start with Triregol on the day after she took the
last active tablet in her previous blister pack of
contraceptive pills (or removed the transdermal patch or vaginal
ring), or no later than on the