Zellmine 0,03 mg/3 mg Tablett

국가: 스웨덴

언어: 스웨덴어

출처: Läkemedelsverket (Medical Products Agency)

유효 성분:

drospirenon; etinylestradiol

제공처:

Campus Pharma AB

ATC 코드:

G03AA12

INN (International Name):

drospirenone; ethinyl estradiol

복용량:

0,03 mg/3 mg

약제 형태:

Tablett

구성:

etinylestradiol 0,03 mg Aktiv substans; drospirenon 3 mg Aktiv substans; laktosmonohydrat Hjälpämne; tartrazin aluminiumlack Hjälpämne; para-orange aluminiumlack Hjälpämne

수업:

Apotek

처방전 유형:

Receptbelagt

치료 영역:

Drospirenon och etinylestradiol

승인 상태:

Avregistrerad

승인 날짜:

2014-10-30

환자 정보 전단

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZELLMINE 0.03 MG/ 3.0 MG TABLETS
(Ethinylestradiol and 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 USING 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 or
nurse.
-
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 same as yours.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zellmine is and what it is used for
2.
What you need to know before you take Zellmine
3.
How to take Zellmine
4.
Possible side effects
5.
How to store Zellmine
6.
Contents of the pack and other information
1.
WHAT ZELLMINE IS AND WHAT IT IS USED FOR
• Zellmine is a contraceptive pill and is used to prevent pregnancy.
• Each tablet contains a small amount of two different female
hormones, namely
drospirenone and ethinylestradiol.
• Contraceptive pills that contain two hormones are called "combined
oral
contraceptives".
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZELLMINE
GENERAL COMMENTS
Before you start using Zellmine you should read the information on
blood clots
2
(thrombosis) in section 2. It is particularly important to read the
symptoms of a blood clot
– see Section 2 “Blood clots”).
Before you start taking Zellmine, your docto

제품 특성 요약

1
SUMMARY OF PRODUCTS CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Zellmine 0.03 mg / 3 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.03 mg of Ethinylestradiol and 3 mg of
Drospirenone.
EXCIPIENTS:
Each tablet contains 72 mg of lactose monohydrate, 0.120 mg of FD&C
Yellow #5/Tartarazine Aluminum Lake (E102) and 0.032 mg of FD&C Yellow
#6/Sunset Yellow FCF Aluminum Lake (E110).
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Tablet.
Round, yellow, 6.00 mm, biconvex tablets with '143' debossed on one
side and other side
plain.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Zellmine should take into consideration the
individual woman’s
current risk factors, particularly those for venous thromboembolism
(VTE), and how the
risk of VTE with Zellmine compares with other CHCs (see sections 4.3
and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION:
Oral use.
HOW TO TAKE ZELLMINE
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,
2
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 TAKING ZELLMINE

No preceding hormonal contraceptive use in the previous month
Start taking Zellmine on the first day of the woman’s menstrual
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 Zellmine 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 CO