Yasmin 0.03mg/3mg film-coated tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Drospirenone; Ethinylestradiol

제공처:

Imbat Limited

ATC 코드:

G03AA; G03AA12

INN (International Name):

Drospirenone; Ethinylestradiol

복용량:

0.03/3 milligram(s)

약제 형태:

Film-coated tablet

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

승인 상태:

Authorised

승인 날짜:

2015-02-06

환자 정보 전단

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
YASMIN
®
0.03MG/3MG FILM-COATED TABLETS
(ethinylestradiol / drospirenone)
Your medicine is available using the above name but will be
referred to as Yasmin throughout this leaflet.
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.
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 LEAFLET
1.
What Yasmin is and what it is used for
2.
What you need to know before you take Yasmin
When you should not use Yasmin
Warnings and precautions
Blood clots
Yasmin and cancer
Bleeding between periods
What to do if no bleeding occurs during the gap week
Other medicines and Yasmin
Yasmin with food and drink
Laboratory tests
Pregnancy
Breast-feeding
Driving and using machines
Yasmin contains lactose monohydrate
3.
How to take Yasmin
When can you start with the first strip?
If you take more Yasmin than you should
If you forget to take Yasmin
What to do in the case of vomiting or severe diarrhoea
Delaying your period: what you need to know
Changing the first day of your period: what you need to
know
If you stop taking Yasmin
4.
Possible side effects
5.
How to store Yasmin
6.
Contents of

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Yasmin 0.03mg/3mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.03mg ethinylestradiol and 3mg
drospirenone.
Excipient with known effect: lactose monohydrate - see leaflet for
further information.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
_Product imported from The Netherlands:_
Light yellow, round film-coated tablets with convex faces, embossed
with the letters "DO" in a regular hexagon on one
face and plain on the reverse.
4 CLINICAL PARTICULARS
As per PA1410/023/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/023/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Tablet core:_
Lactose monohydrate
Corn starch
Pregelatinised maize starch
Povidone K25
Magnesium stearate (E470b)
_Tablet coating:_
Hypromellose (E464)
Macrogol 6000
Talc (E553b)
Titanium dioxide (E171)
Yellow iron oxide (E172)
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister strip and outer carton of the product as
marked in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C.
Store in the original package.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard