MINULET TABLET

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

ETHINYLESTRADIOL; GESTODEN

Διαθέσιμο από:

PFIZER (MALAYSIA) SDN. BHD.

INN (Διεθνής Όνομα):

ETHINYLESTRADIOL; GESTODEN

Μονάδες σε πακέτο:

21Tablet Tablets

Κατασκευάζεται από:

PFIZER IRELAND PHARMACEUTICALS

Φύλλο οδηγιών χρήσης

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
MINULET
®
TABLET
Gestodene/Ethinyl estradiol (75 mcg/30 mcg)
1
WHAT IS IN THIS LEAFLET
1.
What MINULET is used for
2.
How MINULET works
3.
Before you use MINULET
4.
How to use MINULET
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of MINULET
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT MINULET IS USED FOR
MINULET is an oral contraceptive or
birth control pill and is used to prevent
pregnancy.
HOW MINULET WORKS
MINULET contains two hormones
(gestodene and ethinyl estradiol), which
are similar to the hormones that your
body normally produces. If taken
correctly, MINULET prevents you from
becoming pregnant in several ways:
-
It inhibits the egg from maturing and
stopping it from being released.
BEFORE YOU USE MINULET
-_ When you must not use it_
Do not take MINULET
• If you are allergic to gestodene,
ethinyl estradiol or any of the
ingredients of MINULET.
• If you have hepatitis C and are taking
the medicinal products containing
ombitasvir / paritaprevir / ritonavir
and dasabuvir.
• If you have or have had a blood clot
disorder.
• If you have disease related to the
blood vessels in the brain or heart.
• If you have uncontrolled high blood
pressure.
• If you have diabetes with blood
vessel damage.
• If you have headache with aura
(sensitivity to light and sound).
• If you are pregnant or think you
might be pregnant.
• If you have or have had liver cancer
(tumour) or disease.
• If you have vaginal bleeding of
unknown cause.
• If you have any other inherited
bleeding disorder.
• If you have or are suspected of
having breast cancer or cancer that is
sensitive to female sex hormones.
• If you have or known to have had
inflammation of the pancreas, which
is associated with very high blood
levels of triglycerides (fatty
substances).
_Pregnancy and lactation_
If you become pregnant while taking
MINULET, stop taking the pill and
consult your

Αρχείο Π.Χ.Π.

Pfizer Confidential
CLD Title
: Minulet 21 tablet
CLD Date
: 06 August 2020
Country
: Malaysia
Reference Documents
: CDS version 15.0 dated 11 February 2019, EU SPC dated 13
September 2019
Reason for change
: PfLEET: 2017-0034160 (M) - E+P COC CDS: Clarification of the
mode of action
: To update sections 4. Contraindications, 5. Special warnings and 11.
Interactions,
as
per
BOH
directive
No.
13
Year
2018.
Ref.
BPFK/PPP/07/25(13)Jld 2
: PfLEET: 2020-0060465 (S2) – To include information for effects on
ability to drive and use machines
: To amend product name under section 1.2 to MINULET TABLET
as per BOH suggestion
Pfizer Confidential
1
1.
DESCRIPTION
1.1
ACTIVE INGREDIENTS, ACTIVE MOIETIES
Gestodene 75 mcg and ethinyl estradiol 30 mcg
1.2
REPRESENTATIVE TRADE NAME
MINULET TABLET
1.3
PHARMACOLOGICAL CLASS, THERAPEUTIC CLASS
Estrogen-progestin combination oral contraceptive (COC)
1.4
DOSAGE FORMS AND INTENDED ROUTES OF ADMINISTRATION
Tablets for oral use
1.5
COMPOSITION AND PHARMACEUTICAL CHARACTERISTICS
Each MINULET package contains 21 tablets, each containing 30 mcg
ethinyl estradiol and
75 mcg gestodene.
1.6
PHYSICAL CHARACTERISTICS
Ethinyl estradiol is a white to creamy white, odorless, crystalline
powder. It is insoluble in
water and soluble in alcohol, chloroform, ether, vegetable oils, and
aqueous solutions of
alkali hydroxides.
Gestodene is a white to off-white crystalline powder that is easily
soluble in chloroform and
dioxane and soluble in acetone and methanol.
2.
INDICATIONS
MINULET is indicated for the prevention of pregnancy.
3.
DOSAGE AND ADMINISTRATION
Do not initiate or continue the use of "MINULET" if pregnancy is known
or suspected.
3.1
HOW TO TAKE "MINULET"
TABLETS 1-21 CONTAIN ACTIVE INGREDIENTS (ACTIVE TABLETS).
Tablets must be taken in the order directed on the package every day
at about the same time.
One active tablet is to be taken daily for 21 consecutive days, a
7-day tablet-free interval.
Each subsequent pack is started on the day after the tablet-free
interval. A withdrawal bleed
usu