Violite 100/20 micrograms film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levonorgestrel; Ethinylestradiol

Available from:

Consilient Health Limited

ATC code:

G03AA; G03AA07

INN (International Name):

Levonorgestrel; Ethinylestradiol

Dosage:

100/20 microgram(s)

Pharmaceutical form:

Film-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:

2016-06-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VIOLITE 100/20 MICROGRAMS FILM-COATED TABLETS
levonorgestrel/ethinylestradiol
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
“Blood clots”).
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.
-
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 Violite is and what it is used for
2.
What you need to know before you take Violite
3.
How to take Violite
4.
Possible side effects
5.
How to store Violite
6.
Contents of the pack and other information
1.
WHAT VIOLITE IS AND WHAT IT IS USED FOR
Violite is a combined oral contraceptive pill for the prevention of
pregnancy. It contains two different female
hormones, levonorgestrel and ethinylestradiol.
Each of the 21 round pink tablets contains 100 micrograms of
levonorgestrel and 20 micrograms of
ethinylestradiol.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIOLITE
GENERAL NOTES
Before you start using Violite you should read the information on
blood clots in section 2. It is particularly
important to read the symptoms of a blood clot – see Section 2
“Blood clots”).
WHEN YOU SHOULD NOT USE VIOLITE
You should not use Violite if you have any of the conditions listed
below. If you do hav

Summary of Product characteristics

Health Products Regulatory Authority
28 January 2022
CRN00CJNJ
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Violite 100/20 micrograms film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 micrograms levonorgestrel and 20
micrograms ethinylestradiol.
For the full list of excipients, see section 6.1.
Excipients with known effect:
Each film-coated tablet contains 66.94 mg of lactose
3 PHARMACEUTICAL FORM
Film coated tablets.
Pink, cylindrical, biconvex, film coated tablet of 6 mm approximately.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Violite should take into consideration the
individual woman's current risk factors, particularly those
for venous thromboembolism (VTE), and how the risk of VTE with Violite
compares with other combined hormonal
contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_How to take Violite_
Combined oral contraceptives, when taken correctly, have a failure
rate of approximately 1% per year. The failure rate may
increase when pills are missed or taken incorrectly
_ _
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 occurs. This usually starts on
days 2-3 after the last tablet and may not have finished
before the next pack is started.
_How to start Violite_
_No preceding hormonal contraceptive use [in the past month]_
Tablet-taking should start on day 1 of the woman's natural cycle (i.e.
the first day of her menstrual bleeding). Starting on days
2-5 is allowed, but during the first cycle a barrier method of birth
control is recommended in addition for the first 7 days of
tablet-taking.
_ _
_Changing from another combined oral contraceptive (COC), vaginal
ring, or transdermal patch)_
The w