NORDETTE 21 TABLET

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

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

Thành phần hoạt chất:

ETHINYLOESTRADIOL; LEVONORGESTREL

Sẵn có từ:

PFIZER (MALAYSIA) SDN. BHD.

INN (Tên quốc tế):

ETHINYLOESTRADIOL; LEVONORGESTREL

Các đơn vị trong gói:

21Tablet Tablets

Sản xuất bởi:

PFIZER IRELAND PHARMACEUTICALS

Tờ rơi thông tin

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
NORDETTE 21 TABLET
Levonorgestrel/Ethinylestradiol (150 micrograms/30 micrograms)
PLD TITLE
: Nordette 21 Tablet
PLD DATE
: 18 December 2019
COUNTRY
: Malaysia
REFERENCE DOCUMENT
: Malaysia LPD Dated 27 Aug 2018
REASON FOR CHANGE
: PfLEET No: 2019-0054286 (S2) To update as per Malaysia LPD dated 27
Aug 2018
:
To update serial number
Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
NORDETTE 21 TABLET
Levonorgestrel/Ethinylestradiol (150 micrograms/30 micrograms)
1
WHAT IS IN THIS LEAFLET
1.
What Nordette 21 Tablet is used
for
2.
How Nordette 21 Tablet works
3.
Before you use Nordette 21 Tablet
4.
How to use Nordette 21 Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Nordette
21 Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
11. Serial Number
WHAT NORDETTE 21 TABLET IS USED FOR
Nordette 21 Tablet is used for
prevention of pregnancy.
HOW NORDETTE 21 TABLET WORKS
Nordette 21 Tablet acts by suppressing
hormones called gonadotropins. These
hormones prevent an egg being
released from your ovaries.
BEFORE YOU USE NORDETTE 21 TABLET
-
_When you must not use it_
Do not take Nordette 21 Tablet if
any of the following apply to you as
it would put your health at risk.
- If you are pregnant, think you
might be pregnant or breast-
feeding
- If you have cancer affected by sex
hormones, such as cancers of the
breast
- If you have vaginal bleeding that
has not been explained by your
doctor
- If you or anyone in your close
family has ever had a problem
with their blood circulation. This
includes a blood clot (thrombosis)
in the legs (deep vein thrombosis),
lungs (pulmonary embolism),
heart (heart attack), brain (stroke),
hypertension (high blood pressure)
or any other parts of the body
- If you have an irregular heartbeat
(atrial fibrillation) or a heart valve
disorder
- If you have inflammation of the
pancreas, which is associated with
very high blood levels of
t

Đặc tính sản phẩm

Pfizer Confidential
1
Nordette* 21 Tablets
1. Description
1.1 Active ingredients, active moieties
Levonorgestrel 150 μg and ethinyl estradiol 30 μg
1.2 Representative trade names
Nordette* 21 Tablets
1.3 Pharmacological class, therapeutic class
Estrogen- progestin combination oral contraceptive (COC)
1.4 Dosage forms and intended routes of administ ration
Tablets for oral use
1.5 Composition and pharmaceutical characteristics
Each Nordette package contains 21 white sugar coated tablets, each containing 0.03 mg
ethinyl estradiol and 0.15 mg levonorgestrel.
1.6 Physical characteristics
Ethinyl est radiol 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.
Levonorgestrel is a white, crystalline powder that is very slig htly soluble in water, slightly
soluble in alcohol and acetone and soluble in chloroform.
2. Indications
Nordette is indicated for the prevention of pregnancy.
3. Dosage and administration
Do not initiate or continue the use of " Nordette" if pregnancy is known or suspected.
3.1 How to take “Nordette”
Tablets 1- 21 contain active ingredients (active tablets).