البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ETHINYLESTRADIOL; GESTODEN
PFIZER (MALAYSIA) SDN. BHD.
ETHINYLESTRADIOL; GESTODEN
21Tablet Tablets
PFIZER IRELAND PHARMACEUTICALS
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 اقرأ الوثيقة كاملة
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 اقرأ الوثيقة كاملة