Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DROSPIRENONE; ETHINYLESTRADIOL
EURODRUG LABORATORIES (M) SDN. BHD.
DROSPIRENONE; ETHINYLESTRADIOL
28tablet Tablets
LABORATORIO LEON FARMA, S.A.
_ _ _ _ PATIENT INFORMATION LEAFLET LIZ 0.02 MG/3 MG FILM-COATED TABLET ETHINYLESTRADIOL/DROSPIRENONE READ ALL OF THIS INFORMATION SHEET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this information sheet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do no pass it on to others. It may harm them. - If any of the side effects get serious, of if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET: 1. WHAT LIZ IS USED FOR 2. HOW LIZ WORKS 3. BEFORE YOU USE LIZ 4. HOW TO TAKE LIZ 5. WHILE YOU ARE USING LIZ 6. SIDE EFFECTS 7. AFTER USING LIZ 8. PRODUCT DESCRIPTION 1. WHAT LIZ USED FOR LIZ is a contraceptive pill and is used to prevent pregnancy. Contraceptive pills that contain two hormones are called “combination” pills. LIZ is indicated as a treatment of moderate acne vulgaris in women seeking oral contraception. LIZ is also indicated in the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of LIZ for PMDD when used for more than three menstrual cycles has not been evaluated. Each of the 24 peach-pink tablets contains a small quantity of two different female hormones, called ethinylestradiol and drospirenone. The 4 white tablets do not contain active ingredients and are called placebo tablets. 2. HOW LIZ WORKS The contraceptive effect of LIZ is based on the interaction of various factors, the most important of which are seen as the inhibition of ovulation and the changes in the endometrium. 3. BEFORE YOU TAKE LIZ _ _ _When you must not take it_: • if you have (or have had in the past) blood clots (thrombosis) in a blood vessel of the leg, lungs (pulmonary embolism) or other organs • if you have (or have had in the past) a heart attack or a stroke • if you have (or have had in the past) any illness which could lead to a h Prečítajte si celý dokument
FRONT SIDE / ANVERSO 222 x 680 1 mm P032 100% Dimensions: Scale: Material type: Leaflet Drawing #: Date: Version: A xxxxx 29.04.19 - PR DREE LIZ 3-0,02MG 1X24+4 EXELTIS MY Laetus #: Folded: YES NO Substitutes mat. #: Material #/ Product : LICONSA LEON FARMA X Launch: Internal change: Customer change: X Pantones: 170 X 37 mm die cut black 0000 Signature: Date: With the signed proof of this file you commit to have had reviewed and agreed with the following points as part of your review: - Keyline used. - Free varnish areas. - Colors. - Text. - Prefixes order for variable info (If the order is changed you commint to clearly comunicate this change to Chemo's artworks department, otherwise Chemo will not be responsible). - Any other info included in the file. DRAWED BY: APPROVED BY CUSTOMER (Regulatory Affair or Quality Assurance) EXAMPLE / EJEMPLO Pharma Code Read Directions xxxx Pharma Code Read Directions Pharma Code Read Directions LIZ 0.02MG/3MG FILM-COATED TABLET QUALITATIVE AND QUANTITATIVE COMPOSITION 24 PEACH-PINK FILM-COATED TABLETS (ACTIVE TABLETS): Each film-coated tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone Excipient: Lactose monohydrate 44 mg 4 WHITE PLACEBO (INACTIVE) FILM-COATED TABLETS: The tablet does not contain active substances Excipient: Lactose, anhydrous 89.5 mg PHARMACEUTICAL FORM Film-coated tablet. Active tablets: Round, peach-pink, film-coated tablets Placebo tablets:White, round film-coated tablets. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Oral contraceptive. Treatment of moderate acne vulgaris in women seeking oral contraception. Treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of LIZ for PMDD when used for more than three menstrual cycles has not been evaluated. LIZ has not been evaluated for the treatment of premenstrual syndrome (PMS). POSOLOGY AND METHOD OF ADMINISTRATION For oral administration The tablets must be taken every day at about th Prečítajte si celý dokument