Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ESTRADIOL; LEVONORGESTREL
PFIZER (MALAYSIA) SDN. BHD.
ESTRADIOL; LEVONORGESTREL
21Tablet Tablets
PFIZER IRELAND PHARMACEUTICALS
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 Belgenin tamamını okuyun
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. Belgenin tamamını okuyun