Cleonita 0,02 mg/3 mg Filmdragerad tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

drospirenon; etinylestradiol

Tillgänglig från:

Ebb Medical AB

ATC-kod:

G03AA12

INN (International namn):

drospirenone; ethinyl estradiol

Dos:

0,02 mg/3 mg

Läkemedelsform:

Filmdragerad tablett

Sammansättning:

laktos (vattenfri) Hjälpämne; drospirenon 3 mg Aktiv substans; laktosmonohydrat Hjälpämne; etinylestradiol 0,02 mg Aktiv substans

Klass:

Apotek

Receptbelagda typ:

Receptbelagt

Terapiområde:

Drospirenon och etinylestradiol

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2015-05-27

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLEONITA 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.
-
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 Cleonita is and what it is used for
2.
What you need to know before you take Cleonita
3.
How to take Cleonita
4.
Possible side effects
5.
How to store Cleonita
6.
Contents of the pack and other information
1.
WHAT CLEONITA IS AND WHAT IT IS USED FOR
Cleonita 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 CLEONITA
GENERAL NOTES
Before you start using Cleonita 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 “Blood clots”). Your
doctor will ask you some questions about y

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cleonita 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:
Each film-coated tablet contains 44 mg lactose monohydrate.
4 white placebo (inactive) film-coated tablets:
The tablet does not contain active substances
Excipient with known effect:
Each film-coated tablet contains 89.5 mg lactose.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Active tablets: Pink, plain, 5.7x3.5 mm, round film-coated tablets.
Placebo tablets: White, plain, 5.7x3.5 mm, round film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Cleonita should take into consideration the
individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Cleonita
compares with other Combined Hormonal Contraceptives (CHCs) (see
sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_How to take Cleonita_
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. Tablet taking is continuous. One
tablet is to be taken daily for
28 consecutive days. Each subsequent pack is started the day after the
last tablet of the previous pack.
Withdrawal bleeding usually starts on day 2-3 after starting the
placebo tablets (last row) and may not
have finished before the next pack is started.
_How to start Cleonita_
-
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 Cleonita preferably
on the day