LOETTE 21 TABLET

Țară: Malaezia

Limbă: engleză

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

Ingredient activ:

ESTRADIOL; LEVONORGESTREL

Disponibil de la:

PFIZER (MALAYSIA) SDN. BHD.

INN (nume internaţional):

ESTRADIOL; LEVONORGESTREL

Unități în pachet:

21Tablet Tablets

Produs de:

PFIZER IRELAND PHARMACEUTICALS

Prospect

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
LOETTE
®
21 TABLET
Levonorgestrel/Ethinylestradiol (100 mcg/20 mcg)
PLD TITLE
: LOETTE 21 Tablet
PLD DATE
: 13 December 2019
COUNTRY
: Malaysia
REFERENCE DOCUMENT
: Malaysia LPD, Dated 15 October 2018
REASON FOR CHANGE
: Updated as per the new PIL template and reference Malaysia LPD dated
15 October 2018
: Addition of contraindication on concomitant use with hepatitis C
antiviral for medicines
: PfLEET 2019-0054272 - To update as per BOH comments
Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
LOETTE
®
21 TABLET
Levonorgestrel/Ethinylestradiol (100 mcg/20 mcg)
1
WHAT IS IN THIS LEAFLET
1.
What LOETTE 21 is used for
2.
How LOETTE 21 works
3.
Before you use LOETTE 21
4.
How to use LOETTE 21
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of LOETTE 21
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT LOETTE 21 IS USED FOR
LOETTE 21 is a combined oral
contraceptive pill for the prevention of
pregnancy. It is also used to treat
moderate acne in women when this
condition is not improved with acne
treatments (such as medicines applied to
the skin and oral antibiotics), and in
women above 14 years of age who are
willing to be on a contraceptive.
HOW LOETTE 21 WORKS
LOETTE 21 contains two different
female hormones (a progestin and an
estrogen), similar to the hormones that
your body normally produces.
LOETTE 21 prevents pregnancy by
suppressing sex hormones called
gonadotropins and it prevents the
production of egg.
BEFORE YOU USE LOETTE 21
-
_When you must not use it_
Do not take LOETTE 21:
- if you have, previously had tendency
to have blood clots;
- if you have, diseases of the blood
vessels of brain or heart;
- if you have a heart rhythm disorder or
a heart valve disorder;
- if you suffer from severe types of
headache or migraine;
- if you have diabetes along with a
disease of the blood vessels;
- if you have uncontrolled high blood
pressure;
- if you have breas

Caracteristicilor produsului

Pfizer Confidential
- 1 -
1. Description
1.1 Active ingredients, active moieties
Levonorgestrel 100 μg; ethinylestradiol 20 μg
1.2 Representative trade names
Loette 21 Tablets
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
Loette is a combined oral contraceptive (COC) tablet containing the synthetic
progestin, levonorgestrel, and the synthetic estrog en, ethinylestradiol.
Round, pink biconvex tablet with ‘W’ debossed on one side and ‘912’ debossed on
the other.
1.6 Physical characteristics
Levonorgestrel is a white, odorless, crystalline powder. It is practically insoluble in
water, slightly soluble i n alcohol, acetone, ether, and soluble in chloroform.
Ethinylestradiol 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 .
2. Indications
Loette is indicated for the prevention of pregnancy.
Loette is also indicated for the treatment of moderate acne vulgaris not controlled by
conventional therapy (e.g. topical preparations and oral antibiotics) in
postmenarchal, premenopausal women ≥14 years who accept contraception.
3. Dosage and administration
The recommended dose for the prevention of pregnancy and the treatment of acne
is the same.
To achieve maximum contraceptive effectiveness, Loette must be administered as
direct ed and at the same time every day, preferably after the evening meal or at
bedtime.
Do not initiate or continue the use of " Loette " if pregnancy is known or suspected.