Yasmin tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Drospirenone; Ethinylestradiol

Available from:

Bayer Plc

ATC code:

G03AA12

INN (International Name):

Drospirenone; Ethinylestradiol

Dosage:

3mg ; 30microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07030100; GTIN: 5016703008224

Patient Information leaflet

Page:
1
of
18
Yasmin PIL
V031_0
Page 1 of 18
Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
PACKAGE LEAFLET: INFORMATION FOR THE USER
YASMIN 0.03 MG / 3 MG FILM-COATED TABLETS
Ethinylestradiol / Drospirenone
READ ALL OF THIS BOOKLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this booklet. 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 “Blood clots”).
WHAT IS IN THIS BOOKLET
1.
What Yasmin is and what is it used for
.....................................................................................
2
2.
What you need to know before you take Yasmin
......................................................................
2
When you should not use Yasmin
.............................................................................................
3
Warnings and precautions
.........................................................................................................
4
Page

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Yasmin 0.03 mg/3 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3 mg drospirenone and 0.030 mg ethinylestradiol.
Excipient with known effect: lactose 46 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets
Light yellow, round tablets with convex faces, one side embossed with
the letters
"DO" in a regular hexagon.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Yasmin should take into consideration the
individual woman’s
current risk factors, particularly those for venous thromboembolism
(VTE), and how the risk
of VTE with Yasmin compares with other combined hormonal
contraceptives (CHCs), see
sections 4.3 and 4.4.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION _
Oral use
_DOSAGE REGIMEN _
HOW TO TAKE YASMIN
The tablets must be taken every day at about the same time, if
necessary with a little
liquid, in the order shown on the blister pack. 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 usually
starts on day 2-3
after the last tablet and may not have finished before the next pack
is started.
HOW TO START YASMIN
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).
•
Changing from a combined hormonal contraceptive (combined oral
contraceptive
(COC), vaginal ring, or transdermal patch)
The woman should start with Yasmin preferably on the day after the
last active tablet
(the last tablet containing the active substances) of her previous
COC, but at the latest
on the day following the usual tablet-free or placebo tablet interval
of her previous
COC. In case a vaginal ring or transdermal patch has been used, the
woman should
start using Yasmin pref