VEYANN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DROSPIRENONE ; ETHINYL ESTRADIOL

Available from:

Teva Pharma B.V.

ATC code:

G03AA12

INN (International Name):

DROSPIRENONE ; ETHINYL ESTRADIOL

Dosage:

0.02/3.0 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

drospirenone and ethinylestradiol

Authorization status:

Not Marketed

Authorization date:

2012-11-16

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VEYANN 0.02 MG/3 MG FILM-COATED TABLETS
Ethinylestradiol/Drospirenone
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 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 Veyann is and what it is used for
2.
What you need to know before you take Veyann
3.
How to take Veyann
4.
Possible side effects
5.
How to store Veyann
6.
Contents of the pack and other information
1.
WHAT VEYANN IS AND WHAT IT IS USED FOR

Veyann is a contraceptive pill and is used to prevent pregnancy.

Each of the 24 pink tablets contains a small amount of two different
female hormones,
namely drospirenone and ethinylestradiol.

The 4 white tablets contain no active substances and are also called
placebo tablets.

Contraceptive pills that contain two hormones are called
“combination” pills.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VEYANN
GENERAL NOTES
Before you start using Veyann 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 �

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Veyann 0.02 mg/3 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
24 pink film-coated tablets (active tablets):
Each film-coated tablet contains 0.02 mg ethinylestradiol and 3 mg
drospirenone.
Excipient with known effect: Lactose monohydrate 44 mg
4 white placebo (inactive) film-coated tablets:
The tablet does not contain active substances
Excipient with known effect: Lactose anhydrous 89.5 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
The active tablet is pink, round film-coated tablet of 5.7 mm
diameter.
The placebo tablet is white, round film-coated tablet of 5.7 mm
diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Veyann should take into consideration the
individual
woman’s
current
risk factors,
particularly those for venous thromboembolism (VTE),
and how the risk of VTE with Veyann compares with other
CHCs (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_How to take Veyann_
The tablets must
be taken every day at
about
the same time,
if necessary with a little liquid,
in the order shown on
blister.
Tablet taking is continuous. One tablet is to be taken daily for 28
consecutive days. Each subsequent blister is
started the day after the last tablet of the previous blister.
Withdrawal bleeding usually starts on day 2-3 after starting
the placebo tablets (last row) and may not have finished before the
next blister is started.
_How to start Veyann_
No preceding hormonal contraceptive use (in the past month)
Tablet-taking has to start on day 1 of the woman’s natural cycle
(i.e. the first day of her menstrual bleeding).
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