MINIPIL 20 Film-coated Tablets

Land: Maleisië

Taal: Engels

Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Werkstoffen:

LEVONORGESTREL; ETHINYLESTRADIOL

Beschikbaar vanaf:

EURODRUG LABORATORIES (M) SDN. BHD.

INN (Algemene Internationale Benaming):

LEVONORGESTREL; ETHINYLESTRADIOL

Eenheden in pakket:

21tablet Tablets

Geproduceerd door:

LABORATORIO LEON FARMA, S.A.

Bijsluiter

Consumer Medication Information Leaflet (RiMUP)
1
MINIPIL 20
Film-coated Tablets
Levonogestrel 0.10mg / Ethinyloestradiol 0.02mg
IN THIS LEAFLET
1. WHAT MINIPIL 20 IS
USED FOR
2. HOW MINIPIL 20 WORKS
3. BEFORE YOU USE
MINIPIL 20
4. HOW TO USE MINIPIL 20
5. WHILE YOU ARE USING
IT
6. SIDE EFFECTS
7. STORAGE AND
DISPOSAL OF MINIPIL
20
8. PRODUCT
DESCRIPTION
9. MANUFACTURER AND
PRODUCT
REGISTRATION
HOLDER
10. DATE OF REVISION
1. WHAT MINIPIL 20 IS
USED FOR
MINIPIL 20 is a combined oral
contraceptive (COC) pill that is
used to prevent pregnancy. It is
also
used
to
treat
mild
to
moderate acne in postmenarchal
and premenopausal women who
can accept contraception.
2. HOW MINIPIL 20 WORKS
The hormones in the pill help in
preventing
pregnancy
by
maintaining a constant level of
hormones in the body.
3. BEFORE YOU USE
MINIPIL 20
WHEN YOU MUST NOT USE IT
Do not take MINIPIL 20 if you
have or have had:

Formation of blood clots in
veins in any part of the body

Liver malignancies

Known or suspected breast
cancer

Disorders
of
lipid
metabolism

Irregular
heartbeat
or
disorder of the valves of the
heart

Sickle-cell anemia

Diabetes with blood vessels
abnormalities

Undiagnosed
vaginal
bleeding

Known
or
suspected
pregnancy

Stroke
or
heart-related
disorder

Uncontrolled blood pressure

Blood coagulation disorder

Migraine

Disorder
of
the
pancreas
with
severe
hypertriglyceridemia

Hypersensitivity
to
the
active
substances
levonorgestrel,
ethinylestradiol or to any of
the excipients in MINIPIL
20 tablets.
Do not use MINIPIL 20 if you
have Hepatitis C and are taking
the
medicinal
products
containing
ombitasvir
/
paritaprevir
/
ritonavir
and
dasabuvir.
BEFORE YOU START TO USE IT
Tell your doctor if:

you have allergies

you smoke

any
other
medical
conditions
If
you
are
not
sure
when
to
commence
this
medication,
please
consult
your
doctor
or
pharmacist.
Tell
doctor
if
you
are
breastfeeding.
TAKING OTHER MEDICINES
Inform
your
doctor
if
you
are
taking
any
other
medicines
includi

Productkenmerken

FRONT SIDE / PLEASE, INCLUDE YOUR DESIGN ON THIS KEYLINE
BACK SIDE / PLEASE, INCLUDE YOUR DESIGN ON THIS KEYLINE
10 mm
10 mm
490 mm
510 mm
10 mm
202 mm
222 mm
10 mm
340 mm
170 mm
148 mm
LAETUS CENTERED WITHIN FINAL FOLDED LAETUS CENTERED WITHIN FINAL
FOLDED
37 mm
37 mm
10 mm
10 mm
490 mm
510 mm
10 mm
202 mm
222 mm
10 mm
.
.
583965-01
MINIPIL 20 film-coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet
contains 0.10 mg levonorgestrel
and 0.02
mg ethinylestradiol
PHARMACEUTICAL FORM
Pink and rounded film-coated tablets.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Oral Contraceptive.
Treatment of moderate acne vulgaris not controlled by conventional
therapy
(e.g.
topical
preparations
and
oral
antibiotic)
in
postmenarchal, premenopausal women ≥ 14 years who accept
contraception.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration
The recommended dose for the prevention of pregnancy and the
treatment of acne is the same.
To achieve maximum contraceptive effectiveness, MINIPIL 20 must
be administered as directed and at the same time every day,
preferably after the evening meal or bedtime.
HOW TO TAKE MINIPIL 20?
Tablets 1 – 21 contain active ingredient (active tablets).
Tablet must be taken in the order directed on the package every
day at about the same time. One tablet is to be taken daily for 21
consecutive days, followed by a 7-day tablet-free interval. Each
subsequent pack is started on the day after the tablet-free interval.
A withdrawal bleed usually starts on days 2 – 3, after the last
active
tablet, and may not have finished before the next pack is
started.
HOW TO START MINIPIL 20?
_No hormonal contraceptive use within the preceding month_
The user should begin taking MINIPIL 20 on Day 1 of her natural
menstrual
(i.e., the first day of menstrual bleeding). Beginning
MINIPIL 20 use on days 2 – 7 of the menstrual cycle (e.g.,
Sunday
start)
is
allowed;
however,
a
non-hormonal
back-up
method
of
birth
control
(e.g.,
condom,
spermicide)
is
recommended during the first 7