Violite 100/20 micrograms film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levonorgestrel; Ethinylestradiol

Available from:

Gedeon Richter Plc

ATC code:

G03AA; G03AA07

INN (International Name):

Levonorgestrel; Ethinylestradiol

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Progestogens and estrogens, fixed combinations; levonorgestrel and ethinylestradiol

Authorization status:

Marketed

Authorization date:

2016-06-24

Patient Information leaflet

PIL
595x400mm
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Violite
UK-IE
Proc Black
K-34855-1.1
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Cronos Pro, (8.55 pt [10.26 pt]
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2023.07.24.
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v_01
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VIOLITE
100/20 MICROGRAMS FILM-COATED TABLETS
LEVONORGESTREL/ETHINYLESTRADIOL
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES
(CHCS).
•
y are one of the most reliable reversible methods of contraception if
used correctly.
•
y 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.
•
s medicine has been prescribed for you only. Do not pass it on to
others. It may harm them.
• I
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. P
5. How to store Violite
6. Contents of the pack and other information
1. WHAT VIOLITE IS AND WHAT IT IS USED FOR
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”).
Before you can start taking Violite your doctor will ask you some
questions around your personal health history and
that of your clos
e relatives. Your doctor will also measure your blood pressure and may
also carry out some other tests
for example a breast exam

Summary of Product characteristics

Health Products Regulatory Authority
04 August 2023
CRN00DJ0W
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