CARMENELLE 0.02/3 Milligram Film Coated Tablet

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

DROSPIRENONE, ETHINYLESTRADIOL

可用日期:

Clonmel Healthcare Ltd

ATC代码:

G03AA12

INN（国际名称）:

DROSPIRENONE, ETHINYLESTRADIOL

剂量:

0.02/3 Milligram

药物剂型:

Film Coated Tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Progestogens and estrogens, fixed combinations

授权状态:

Authorised

授权日期:

2013-08-23

资料单张

NL/H/2631/001/IB/003
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CARMENELLE 0.02 MG/3 MG FILM-COATED TABLETS
ETHINYLESTRADIOL/DROSPIRENONE
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, pharmacist or
nurse.

This medicine has been prescribed for you only. Do no pass it on to
others. It may harm them
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4
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”)
WHAT IS IN THIS LEAFLET:
1.
WHAT CARMENELLE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARMENELLE

When you should not use Carmenelle

Warnings and precautions

Carmenelle and venous and arterial blood clots

Carmenelle and cancer

Bleeding between periods

What to do if no bleeding occurs during the gap week

Other medicines and Carmenelle

Taking Carmenelle with food, drink and alcohol

Laboratory tests

Pregnancy, breast-feeding and fertility

Driving and using machines

Carmenelle contains lactose
3.
HOW TO TAKE CARMENELLE

When can you start with the first strip?

If you take more Carmenelle than you should

If you forget to take Carmenelle

What to do in the case of vomiting or severe diarrhoea
NL/H/2631/001/IB/003
2

Delaying your period: what you need to kno

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carmenelle 0.02mg/3mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.02 mg of ethinylestradiol and 3 mg
of drospirenone
Excipients with known effect:
Lactose monohydrate 44 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round film-coated tablets of 5.7 mm diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Carmenelle should take into consideration
the individual
woman’s current
risk factors,
particularly those for venous thromboembolism (VTE), and how the risk
of VTE with Carmenelle compares with other
CHCs (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral use.
HOW TO TAKE CARMENELLE
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 CARMENELLE
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 Carmenelle 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
Carmenelle preferably on the day of removal, but at the latest when
the next