Zellmine 28 0,03 mg/3 mg Tablett

Land: Sverige

Sprog: svensk

Kilde: Läkemedelsverket (Medical Products Agency)

Aktiv bestanddel:

drospirenon; etinylestradiol

Tilgængelig fra:

Campus Pharma AB

ATC-kode:

G03AA12

INN (International Name):

drospirenone; ethinyl estradiol

Dosering:

0,03 mg/3 mg

Lægemiddelform:

Tablett

Sammensætning:

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

Klasse:

Apotek

Recept type:

Receptbelagt

Terapeutisk område:

Drospirenon och etinylestradiol

Autorisation status:

Avregistrerad

Autorisation dato:

2014-10-30

Indlægsseddel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZELLMINE 28 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 28 is and what it is used for
2.
What you need to know before you take Zellmine 28
3.
How to take Zellmine 28
4.
Possible side effects
5.
How to store Zellmine 28
6.
Contents of the pack and other information
1.
WHAT DROSPIRENONE/ETHINYLESTRADIOL IS AND WHAT IT IS USED FOR
• Zellmine 28 is a contraceptive pill and is used to prevent
pregnancy.
• Each yellow tablet contains a small amount of two different female
hormones, namely
drospirenone and ethinylestradiol.
• Each white to off white tablets contain no active ingredient are
called “Placebo
tablets”.
• Contraceptive pills that contain two hormones are called "combined
oral
contraceptives".
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZELLMINE 28
2
GENERAL COMMENTS
Before you start using Zellmine 28 you should read the information on
blood clots
(thrombosis) in section 2

Produktets egenskaber

1
SUMMARY OF PRODUCTS CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Zellmine 28 0.03 mg / 3 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each active 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
Each placebo tablet contains no active substance
EXCIPIENTS:
Each tablet contains 79 mg of lactose monohydrate.
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Tablet.
Active tablets are round, yellow, 6.00 mm, biconvex tablets with
‘143’ debossed on one
side and other side plain.
Placebo tablets are round, white to off white, 6.00 mm, biconvex
tablets with ‘303’
debossed on one side and other side plain.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Zellmine 28 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 28 compares with other CHCs (see
sections 4.3 and
4.4).
2
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION:
Oral use.
HOW TO TAKE ZELLMINE 28
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 28
consecutive days. Each subsequent pack is started after completion of
first strip there is
no gap period between two strips, during placebo tablet intake time a
withdrawal bleed
usually occurs. This usually starts on 2
nd
to 3
rd
day after the last active tablet from strip
and may not have finished before the next pack is started.
HOW TO START TAKING ZELLMINE 28

No preceding hormonal contraceptive use in the previous month
Start taking Zellmine 28 on the first day of the woman’s menstrual
cycle (i.e. the first d