Marvelon 28

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Desogestrel 0.15mg;  ; Ethinylestradiol 0.03mg;  

Fáanlegur frá:

Organon (New Zealand) Limited

INN (Alþjóðlegt nafn):

Desogestrel 0.15 mg

Lyfjaform:

Tablet

Samsetning:

Active: Desogestrel 0.15mg   Ethinylestradiol 0.03mg   Excipient: Colloidal silicon dioxide DL-alpha Tocopheryl acetate Lactose monohydrate Magnesium stearate Potato starch Povidone Stearic acid Lactose monohydrate Magnesium stearate Potato starch

Einingar í pakka:

Calendar pack, 1 x (21+7), Sample pack, 28 tablets

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Aspen Oss B.V

Vörulýsing:

Package - Contents - Shelf Life: Calendar pack, 1 x (21+7), Sample pack - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Calendar pack, 3x(21+7) - 84 tablets - 36 months from date of manufacture stored at or below 25°C

Leyfisdagur:

1982-03-11

Upplýsingar fylgiseðill

New Zealand Consumer Medicine Information
MARVELON
® 28
Desogestrel and ethinyloestradiol
Tablets for oral use
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING MARVELON
28.
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, pharmacist, or
professional health care provider.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
Marvelon 28 against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR,
PHARMACIST OR
HEALTH CARE PROVIDER.
Keep this leaflet with the medicine. You may need to read it again.
WHAT MARVELON 28 IS TAKEN FOR
Marvelon 28 is a combined oral hormonal contraceptive, commonly known
as a ‘Birth Control
Pill’ or ‘the Combined Pill’ that has been prescribed to prevent
you from getting pregnant.
Oral contraceptives are a very effective method of birth control. When
taken correctly
(without missing tablets) the chance of becoming pregnant is very low.
Marvelon 28 consists of 21 large white tablets, each containing 2
active ingredients:
30 micrograms of ethinyloestradiol (an oestrogen) and 150 micrograms
of desogestrel (a
progestogen) and 7 small white inactive tablets (first row of the
strip).
Because of the small amounts of different female hormones in the
active tablets, Marvelon
28 is considered a low-dose combined oral contraceptive.
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 sperm
to reach the egg;
and

Changing the lining of the uterus making it less suitable for
implantation.
The following non-contraceptive health benefits have been associated
with the Combined
Pill:

Your periods may be lighter and shorter. As a result, the risk of
anaemia may be lower.
Your period pains may become less severe or may completely

Vara einkenni

S-CCDS-MK8276A- TB-112018
Page 1 of 15
NEW ZEALAND DATA SHEET
1
MARVELON
® 28 0.15 MG/0.03 MG TABLETS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Desogestrel 0.15 mg; ethinyloestradiol 0.03 mg.
Excipients with known effect:
-
lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tablets
Each pack of Marvelon 28 consists of:

21 large (6 mm diameter), white, round, biconvex tablets coded TR/5 on
one side, and
ORGANON and a star on the other side, and containing desogestrel (a
progestogen)
0.15 mg, ethinyloestradiol (an oestrogen) 0.03 mg.

7 small (4.5 mm diameter), white, round, flat tablets with bevelled
edges, coded KH/2
on one side and a square on the other side, and containing no active
ingredients.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
Treatment of moderate to mild acne and symptoms of other androgenic
skin disorders.
4.2
DOSE AND METHOD OF ADMINISTRATION
HOW TO TAKE MARVELON 28
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, starting
with the large (active)
tablets for 21 consecutive days followed by the small (placebo)
tablets for 7 days. Each
subsequent pack is started immediately following the last placebo
tablet. During the placebo
days a withdrawal bleed usually occurs. This usually starts on day 2-3
after the last active
tablet and may not have finished before the next pack is started.
HOW TO START TAKING MARVELON 28
_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 2-5 is allowed, but during the
first cycle a barrier method
is recommended in addition for the first 7 days of tablet-taking.
_Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC), _
_vaginal ring, or transdermal patch) _
The woman should start with Marvelon 28 preferab