TriRegol tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Available from:

Gedeon Richter (UK) Ltd

ATC code:

G03AA07

Pharmaceutical form:

Not applicable

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 07030100; GTIN: 5391512451158

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIREGOL®
COATED TABLETS
ETHINYLESTRADIOL / 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 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 fertilised egg.
Remember:
• TriRegol needs to be taken as directed to prevent pregnancy
• Combined oral contraceptive pills like TriRegol will not
protect you against sexually transmitted diseases (such as
AIDS). Only condoms can do this.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIREGOL
DO NOT TAKE TRIREGOL
• if you are allergic to ethinylestradiol, levonorgestrel or any of
the other ingredients of this medicine (listed in section 6);
• you have ever had a disorder affecting y

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
TriRegol coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
6 pink tablets: each tablet contains 30 micrograms ethinylestradiol
and 50 micrograms
levonorgestrel
5 white tablets: each tablet contains 40 micrograms ethinylestradiol
and 75 micrograms
levonorgestrel
10 ochre tablets: each tablet contains 30 micrograms ethinylestradiol
and 125 micrograms
levonorgestrel
Excipients with known effect: lactose monohydrate 33 mg and sucrose
(22 mg) in each tablet.
_ _
_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 of Triregol
_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 pill,
vaginal ring, _
_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 day after the usual pill-free (or placebo,
patch-free or ring-free) interval
with her previous contraceptive.
_Changing from a progestogen-only method (