Alexette 0.02mg/3mg film-coated tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Drospirenone; Ethinylestradiol

제공처:

Gedeon Richter Plc

ATC 코드:

G03AA; G03AA12

INN (International Name):

Drospirenone; Ethinylestradiol

복용량:

0.02 mg/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:

Not marketed

승인 날짜:

2012-05-25

환자 정보 전단

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALEXETTE 0.02MG/3MG FILM-COATED 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 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 Alexette 0.02mg/3mg film-coated tablets is and what it is used
for
2.
What you need to know before you use Alexette 0.02mg/3mg film-coated
tablets
3.
How to take Alexette 0.02mg/3mg film-coated tablets
4.
Possible side effects
5.
How to store Alexette 0.02mg/3mg film-coated tablets
6.
Contents of the pack and other information
1.
WHAT ALEXETTE 0.02MG/3MG FILM-COATED TABLETS AND WHAT IT IS USED FOR
-
Alexette 0.02mg/3mg film-coated tablets is a contraceptive pill and is
used to prevent
pregnancy.
-
Each of the 24 white tablets contains a small amount of two different
female hormones, namely
drospirenone and ethinylestradiol.
-
The 4 green 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 USE ALEXETTE 0.02MG/3MG FILM-COATED
TABLETS
GENERAL NOTES:
Before you sta

제품 특성 요약

Health Products Regulatory Authority
08 March 2023
CRN00D7P9
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alexette 0.02mg/3mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
24 white or almost white _(active)_ film-coated tablets:
Each film-coated tablet contains 0.02 mg ethinylestradiol and 3 mg
drospirenone.
Excipients with known effect:
Each film-coated tablet contains 48.53 mg of lactose monohydrate and
0.070 mg of soya lecithin.
4 green placebo (inactive) film-coated tablets:
The tablet does not contain active substances.
Excipients with known effect:
Each film-coated tablet contains 37.26 mg of lactose and 0.003 mg of
sunset yellow FCF (E110).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
The active tablet is white or almost white, round, biconvex
film-coated tablet, diameter about 6 mm. Engraving on one side:
“G73”, the other side is without engraving.
The placebo tablet is green, round, biconvex film-coated tablet,
diameter about 6 mm, without engraving.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Alexette 0.02mg/3mg film-coated tablets
should take into consideration the individual woman’s
current risk factors, particularly those for venous thromboembolism
(VTE), and how the risk of VTE with Alexette 0.02mg/3mg
film-coated tablets compares with other combined hormonal
contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration:
Oral use
Posology
HOW TO TAKE ALEXETTE
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 green placebo
tablets (last row) and may not have finished before the n