MERCILON TABLET

מדינה: דרום אפריקה

שפה: אנגלית

מקור: South African Health Products Regulatory Authority (SAHPRA)

זמין מ:

Organon South Africa (Pty) Ltd

כמות:

See ingredients

טופס פרצבטיות:

TABLET

הרכב:

EACH TABLET CONTAINS DESOGESTREL 0,15 mg ETHINYLESTRADIOL 0,02 mg

מצב אישור:

Registered

תאריך אישור:

1997-10-05

עלון מידע

Page 1 of 17
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
PRODUCT NAME, STRENGTH AND DOSAGE FORM
MERCILON
®
Tablets, contains 0,15 mg desogestrel and 0,02 mg ethinylestradiol.
Contains sugar: lactose
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING MERCILON.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or pharmacist.
•
MERCILON has been prescribed for you personally and you should not
share your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
If any side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell
your doctor or pharmacist.
WHAT IS IN THIS LEAFLET
1.
WHAT IS MERCILON AND WHAT IS IT USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MERCILON
3.
HOW TO TAKE MERCILON
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MERCILON
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT MERCILON IS AND WHAT IT IS USED FOR
MERCILON is a combined oral contraceptive (‘the combined Pill’)
used to prevent pregnancy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MERCILON
DO NOT TAKE MERCILON:
•
If you have, or have had in the past a blood clot (thrombosis) in a
blood vessel of the leg,
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Page 2 of 17
lung (embolus) or other organs.
•
If you have or have had a heart attack or stroke in the past.
•
If you have or have ever had a condition that may be a first sign of a
heart attack (such as
angina pectoris or chest pain) or stroke (such as transient ischaemic
attack or small
reversible stroke).
•
If you have a disturbance of blood clotting (e.g., protein C
deficiency).
•
If you need major surgery (e.g., an operation) and your ability to
move around is limited for a
long period of time (see THE PILL AND THROMBOSIS).
•
If you have (had) a type of migraine called “migraine with aura”.
•
If you have diabetes mellitus with blood vessel damage.
•
If you have a serious risk factor, or several risk factors for
developing thrombosis, this may
also be a reason

מאפייני מוצר

Page 1 of 16
[Organon] Proprietary
SCHEDULING STATUS
1. NAME OF MEDICINE
MERCILON
®
Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
21 larger white tablets containing 0,15 mg desogestrel and 0,02 mg
ethinylestradiol per tablet.
7 smaller white tablets that do not contain any active ingredients
(placebo tablets).
Contains sugar: lactose (< 80 mg).
For full list of excipients, see 6.1.
3. PHARMACEUTICAL FORM
MERCILON consists of two types of tablets distinguished by mark and
size. The 21 larger white tablets
contain the active ingredients and are round and biconvex. They have
bevelled edges, coded
ORGANON and a star on one side and the tablet code TR above 4 on the
reverse side. The 7 smaller
white tablets are round and flat with bevelled edges coded KH above 2
on one side and a square on the
reverse side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
Oral contraception.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
HOW TO TAKE MERCILON
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 28 consecutive
days. The first tablet should be taken
from the blister in the green section of the calendar pack marked with
the appropriate day of the week.
Each subsequent pack is started the day after the last tablet of the
current pack. During the placebo days
a withdrawal bleed usually occurs. This usually starts on day 2 to 3
after the last active tablet and may
not have finished before the next pack is started.
HOW TO START MERCILON_ _
_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). Starting on days 2 to 5 is allowed but during the first
cycle a barrier method is recommended
in addition for the first 7 days of tablet-taking.
_Changing from another combined oral contraceptive _
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Page 2 of 16
[Organon] Proprietary
The woman should start with MERCILON on the day after the last active
tablet o