MARVELON 150/30* TABLET

Kraj: Republika Południowej Afryki

Język: angielski

Źródło: South African Health Products Regulatory Authority (SAHPRA)

Dostępny od:

Organon South Africa (Pty) Ltd

Dawkowanie:

See ingredients

Forma farmaceutyczna:

TABLET

Skład:

EACH TABLET CONTAINS DESOGESTREL 0,15 mg ETHINYLESTRADIOL 0,03 mg

Status autoryzacji:

Registered

Data autoryzacji:

1986-09-06

Ulotka dla pacjenta

Page 1 of 13
PATIENT INFORMATION LEAFLET
INFORMATION FOR THE PATIENT ABOUT MARVELON
® 150/30
SCHEDULING STATUS
PRODUCT NAME, STRENGTH AND DOSAGE FORM
MARVELON
®
150/30 Tablets, contains 0,15 mg desogestrel and 0,03 mg
ethinylestradiol.
Contains sugar: lactose.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING MARVELON
150/30
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or pharmacist.
•
MARVELON 150/30 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 THE LEAFLET
1.
WHAT MARVELON 150/30 IS AND WHAT IS IT USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MARVELON 150/30
3.
HOW TO TAKE MARVELON 150/30
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MARVELON 150/30
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT MARVELON 150/30 IS AND WHAT IS IT USED FOR
MARVELON 150/30 is a combined oral contraceptive (‘the combined
Pill’) used to prevent pregnancy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MARVELON 150/30
DO NOT TAKE MARVELON 150/30:
•
If you have, or have had in the past a blood clot (thrombosis) in a
blood vessel of the leg, 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.
S3

Charakterystyka produktu

Page 1 of 16
SCHEDULING STATUS
1. NAME OF MEDICINE
MARVELON
®
150/30 Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
21 larger white tablets containing 0,15 mg desogestrel and 0,03 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
MARVELON 150/30 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 5 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 MARVELON 150/30
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 MARVELON 150/30
_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
The woman should start with MARVELON 150/30 on the day after the last
active tablet of her
previo