Aliane 0.02mg/3mg Film-coated Tablets

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

DROSPIRENONE, ETHINYLESTRADIOL

Disponible depuis:

Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland

Code ATC:

G03AA12

DCI (Dénomination commune internationale):

DROSPIRENONE 3 mg ETHINYLESTRADIOL 0.02 mg

forme pharmaceutique:

FILM-COATED TABLET

Composition:

DROSPIRENONE 3 mg ETHINYLESTRADIOL 0.02 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Statut de autorisation:

Withdrawn

Date de l'autorisation:

2006-08-04

Notice patient

Page 1 of 13 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

Aliane 0.02 mg / 3 mg film-coated tablets 
Ethinylestradiol / Drospirenone 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 

_ _
_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, do not pass it on to
others. It may harm them. _

_ _
_If any of the side effects gets serious, or if you
notice any side effects not listed in this _
_leaflet, please tell your doctor or pharmacist_.
_ _

IN THIS LEAFLET 

1.  [/PIL_MA639_00201.html#2]
WHAT ALIANE IS AND WHAT IT IS USED
FOR ..................................................... 2 
[/PIL_MA639_00201.html#2]
2.  [/PIL_MA639_00201.html#2]
BEFORE YOU TAKE
ALIANE ..................................................................................... 2 
[/PIL_MA639_00201.html#2]
When you should not
use Aliane ............................................................................................... 2 
[/PIL_MA639_00201.html#2]
When  to take special care with
Aliane ..................................................................................... 3 
[/PIL_MA639_00201.html#3]
Aliane and venous and arterial blood
clots ................................................................................ 3 
[/PIL_MA639_00201.html#3]
Aliane and
cancer ...................................................................................................................... 5 
[/PIL_MA639_00201.html#5]
Bleeding between
periods .......................................................................................................... 5 
[/PIL_MA639_00201.html#5]
What to do if no bleeding occurs
during the gap week ............................................................. 5 
[/PIL_MA639_00201.html#5]
Aliane and
using other medicines .....................

Résumé des caractéristiques du produit

Page 1 of 16 
SUMMARY OF PRODUCT CHARACTERISTICS 
1. 
NAME OF THE MEDICINAL PRODUCT 
Aliane 0.02 mg / 3 mg film-coated tablets 
2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each tablet contains 0.020
mg ethinylestradiol (as betadex clathrate) and
3 mg drospirenone. 
Excipient: lactose 46 mg 
For a full list of excipients, see section 6.1. 
3. 
PHARMACEUTICAL FORM 
Film-coated tablet 
Light pink, round tablet with convex faces, one side embossed with
the letters "DS" in a regular 
hexagon. 
4. 
CLINICAL PARTICULARS 
4.1 
THERAPEUTIC INDICATIONS 
Oral contraception. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Route of administration: oral use 
HOW TO TAKE ALIANE 
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 ALIANE 

  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). 
Page 2 of 16 

  Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC), 
vaginal ring, or transdermal patch 
The woman should start with Aliane 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 Aliane preferably on the day of 
removal, but at the latest when the next applica