Country: মাল্যাশিয়া
ভাষা: ইংরেজি
সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ETHINYLOESTRADIOL; LEVONORGESTREL
PFIZER (MALAYSIA) SDN. BHD.
ETHINYLOESTRADIOL; LEVONORGESTREL
21Tablet Tablets
PFIZER IRELAND PHARMACEUTICALS
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 সম্পূর্ণ নথি পড়ুন
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). সম্পূর্ণ নথি পড়ুন