MARVELON desogestrel / ethinylestradiol 28 tablets

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

desogestrel, Quantity: 150 microgram; ethinylestradiol, Quantity: 30 microgram

Pieejams no:

ORGANON PHARMA PTY LTD

Zāļu forma:

Tablet

Kompozīcija:

Excipient Ingredients: magnesium stearate; lactose monohydrate; potato starch

Ievadīšanas:

Oral

Vienības iepakojumā:

7 inert tablets, 21 active tablets

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

Oral contraception.

Produktu pārskats:

Visual Identification: White, round, biconvex tablets coded KH2 on one side and a square on the other side.; Container Type: Blister Pack; Container Material: PVC; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorizācija statuss:

Registered

Autorizācija datums:

1992-12-16

Lietošanas instrukcija

MARVELON
® 28
(MAR-VE-LON)
_Ethinylestradiol and Desogestrel_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
1.
WHAT MARVELON 28 IS USED FOR
2.
WHEN YOU MUST NOT USE
MARVELON 28
3.
WHAT YOU NEED TO KNOW BEFORE
USING MARVELON 28
4.
WHEN SHOULD YOU CONTACT YOUR
DOCTOR?
5.
HOW TO USE MARVELON 28
6.
WHAT TO DO IF...
7.
SIDE EFFECTS
8.
AFTER TAKING MARVELON 28
9.
PRODUCT DESCRIPTION
This leaflet answers some common
questions about Marvelon 28. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Marvelon 28
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
READ THIS INFORMATION CAREFULLY
BEFORE YOU START TAKING MARVELON
28 TABLETS.
KEEP THIS LEAFLET.
You may need to read it again.
1. WHAT MARVELON 28 IS
USED FOR
Marvelon 28 is an oral contraceptive,
commonly known as a "Birth Control
Pill" or "The Pill" that has been
prescribed to prevent you from
getting pregnant.
Marvelon 28 prevents pregnancy in
several ways:
•
It inhibits the egg release by
stopping it maturing.
•
Changing the cervical mucus
consistency making it difficult for
the sperm to reach the egg.
•
Changing the lining of the uterus
making it less suitable for
implantation.
Marvelon 28 consists of 21 large
white tablets, each containing 2
active ingredients: 30 micrograms of
ethinylestradiol (an estrogen) and
150 micrograms of desogestrel (a
progestogen) and 7 small white
inactive tablets (first row of the
blister pack).
Because of the small amounts of
different female hormones in the
active tablets, Marvelon 28 is
considered a low-dose combined oral
contraceptive.
Oral contraceptives are a very
effective method of birth control.
When taken correctly (without
missing tablets) the chance of
becoming pregnant is very low.
The following non-contraceptive
health benefits have been associated
with the combined

Produkta apraksts

Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION
MARVELON
®
28
(DESOGESTREL, ETHINYLESTRADIOL)
TABLETS
1
NAME OF THE MEDICINE
Desogestrel and ethinylestradiol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pack contains 21 active tablets each containing 150 micrograms
desogestrel and 30
micrograms ethinylestradiol and 7 inert (placebo) tablets.
Excipients with known effect:
-
Lactose
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Marvelon 28 has:
21 large, white, round, biconvex tablets coded TR5 on one side, and
Organon and a star on
the other; and
7 small, white, round, biconvex tablets coded KH2 on one side and a
square on the other.
These tablets do not contain active ingredients.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
4.2
DOSE AND METHOD OF ADMINISTRATION
HOW TO TAKE MARVELON

28
One tablet is to be taken daily. The tablets must be taken in the
order directed on the package
at about the same time each day, with some liquid as needed. Daily
tablet taking should be
continuous, starting with the tablet marked with the corresponding day
from the green zone.
Each subsequent pack is to be started immediately following the last
placebo (small) tablet.
During the placebo days a withdrawal bleed usually occurs. This
usually starts on day 2-3 after
the last active (large) tablet and may not have finished before the
next pack is started.
HOW TO START TAKING MARVELON

28
The tablets are taken starting with the tablet marked with the
corresponding day from the green
zone of the pack. This way, the woman will virtually always have a
menstruation-free weekend.
_No preceding hormonal contraceptive use [in the past month] _
Page 2 of 18
Tablet-taking has to start on day 1 of the woman's natural cycle (i.e.
the first day of her
menstrual bleeding). If the woman starts on a Thursday or Friday
(although these tablets are
in the green zone, they are inactive tablets), additional
contraceptive precautions are
necessary for the first 7 days of active ta