MICRODIOL

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

DESOGESTREL; ETHINYLESTRADIOL

Disponibil de la:

MERCK SHARP & DOHME ISRAEL LTD

Codul ATC:

G03AA09

Forma farmaceutică:

TABLETS

Compoziție:

DESOGESTREL 150 MCG; ETHINYLESTRADIOL 30 MCG

Calea de administrare:

PER OS

Tip de prescriptie medicala:

Required

Produs de:

N.V. ORGANON, THE NETHERLANDS

Grupul Terapeutică:

DESOGESTREL AND ESTROGEN

Zonă Terapeutică:

DESOGESTREL AND ESTROGEN

Indicații terapeutice:

Oral contraceptive.

Data de autorizare:

2013-07-31

Prospect

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
THIS MEDICINE CAN BE SOLD UNDER DOCTOR'S PRESCRIPTION ONLY
MICRODIOL
®
Tablets
COMPOSITION:
EACH TABLET CONTAINS:
Desogestrel 0.15 mg
Ethinyl estradiol 0.03 mg
For a list of inactive ingredients see section 6.1, "WHAT MICRODIOL
CONTAINS".
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 MICRODIOL is right for you.

To prevent pregnancy it is important to take MICRODIOL 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.

This leaflet contains concise information about MICRODIOL. 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,
even if their medical condition seems similar to yours.

Keep this leaflet. You may need to read it again.

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.
1.
WHAT MICRODIOL IS AND WHAT IT IS USED FOR?
1.1 WHAT IS MICRODIOL?
THERAPEUTIC GROUP: Estrogen-progestogen combination.
1.2 WHAT IS MICRODIOL USED FOR?
MICRODIOL is a combined oral contraceptive pill (“the Pill”). YOU
TAKE IT TO PREVENT PREGNAN

Caracteristicilor produsului

1
1
NAME OF THE MEDICINAL PRODUCT
MICRODIOL
®
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Desogestrel B.P. 0.150 mg
Ethinylestradiol Ph. Eur. 0.030 mg
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets.
Tablets are white, round, biconvex and 6 mm in diameter. They are
coded on one side TR
above 5 and on the reverse side Organon*.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Microdiol should take into consideration the
individual woman’s
current risk factors, particularly those for venous thromboembolism
(VTE), and how the risk of
VTE with Microdiol compares with other CHCs (see sections 4.3 and
4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
4.2.1 HOW TO TAKE MICRODIOL
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 MICRODIOL
_ _
_No preceding hormonal contraceptive use [in the past month]:_
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.
2
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 Microdiol.
_Changing from a 21 day pill or another 22 day pill to Microdiol:_
All tablets in the old pack should be finished. The first Microdiol
tablet is taken the