Marvelon

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

DESOGESTREL, ETHINYLESTRADIOL

थमां उपलब्ध:

Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

ए.टी.सी कोड:

G03AA09

INN (इंटरनेशनल नाम):

DESOGESTREL 150 µg ETHINYLESTRADIOL 30 µg

फार्मास्यूटिकल फॉर्म:

TABLET

रचना:

DESOGESTREL 150 µg ETHINYLESTRADIOL 30 µg

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

प्राधिकरण का दर्जा:

Withdrawn

प्राधिकरण की तारीख:

2005-11-18

सूचना पत्रक

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MARVELON®
Desogestrel (150 micrograms)
Ethinyl estradiol (30 micrograms)
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”).

Some women should not take the Pill because of current medical
problems or illnesses.
Please read this leaflet to make sure Marvelon is right for you.

To prevent pregnancy it is important to take Marvelon as instructed
and to start each pack
on time. Please make sure that you understand what to do if you miss a
pill or if you think
you are pregnant.
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 or need more advice, ask your
doctor, family planning
nurse or pharmacist.

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 the same as yours.

If you get any side effects, talk to your doctor, family planning
nurse or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT MARVELON IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MARVELON
3.
HOW TO TAKE MARVELON
3.3 A MISSED PILL
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MARVELON
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT MARVELON IS AND WHAT IT IS USED FOR
Marvelon is a combined oral contraceptive pill (‘the Pill’). YOU
TAKE IT TO PREVENT PREGNANCY.
This low-dose contraceptive contains two types of female

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Marvelon
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Desogestrel B.P.
150 micrograms
Ethinylestradiol Ph.Eur
30 micrograms
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets.
Tablets are round, biconvex and 6 mm in diameter. They are coded on
one side TR5 and on the
reverse side Organon*.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Marvelon should take into consideration the
individual woman’s
current risk factors, particularly those for venous thromboembolism
(VTE), and how the risk of
VTE with Marvelon compares with other CHCs (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
4.2.1
HOW TO TAKE MARVELON
Tablets must be taken in the order directed on the package every day
at about the same time with
some liquid as needed. 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.
4.2.2
HOW TO START MARVELON
_ _
_No preceding hormonal contraceptive use [in the past month]:_
Page 1 of 19
It is preferable that tablet intake from the first pack is started on
the first day of menstruation in
which case no extra contraceptive precautions are necessary.
If menstruation has already begun, (that is 2, 3, or 4 days
previously), tablet taking should
commence on day 5 of the menstrual period. In this case additional
contraceptive precautions
must be taken for the first 7 days of tablet taking.
If menstruation began more than 5 days previously then the patient
should be advised to wait
until her next menstrual period before starting to take Marvelon.
_Changing from a 21 day pill or another 22 day pill to Marvelon:_
All tablets in the old pack should be finished. The first Marvelon
tablet is take