Nazione: Paesi Bassi
Lingua: olandese
Fonte: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ETHINYLESTRADIOL 0,03 mg/stuk ; GESTODEEN 0,075 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
G03AA10
ETHINYLESTRADIOL 0,03 mg/stuk ; GESTODEEN 0,075 mg/stuk
Tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLACRILINE KALIUM ; POVIDON K 30 (E 1201),
Oraal gebruik
Gestodene And Ethinylestradiol
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); POLACRILINE KALIUM; POVIDON K 30 (E 1201);
2015-12-28
Sandoz B.V. Kosidina 0,075 mg/0,030 mg, tabletten Page 1/19 RVG 116278 1313-V8 1.3.1.3 Bijsluiter Oktober 2022 BIJSLUITER: INFORMATIE VOOR DE PATIËNT KOSIDINA 0,075 MG/0,030 MG, TABLETTEN Gestodene / Ethinylestradiol IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES (CHCS): - They are one of the most reliable reversible methods of contraception if used correctly. - They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks. - Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”) _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [nationally completed name] is and what it is used for 2. What you need to know before you use [nationally completed name] 3. How to take [nationally completed name] 4. Possible side effects 5. How to store [nationally completed name] 6. Contents of the pack and other information 1 WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR • [nationally completed name] is a contraceptive tablet and is used to prevent pregnancy. • Each tablet contains a small amount of two different female hormones, namely ethinylestradiol and gestodene. • Contraceptive tablets as [nationally completed name] that contain two hormones are called “combination” contraceptives. Sandoz B.V. Kosidina 0,075 mg/0,030 mg, tabletten Page 2/19 RVG 116278 Leggi il documento completo
Sandoz B.V. Kosidina 0,075 mg/0,030 mg, tabletten Page 1/21 RVG 116278 1311-v8 1.3.1.1 Samenvatting van de Productkenmerken Mei 2023 1. NAAM VAN HET GENEESMIDDEL Kosidina 0,075 mg/0,030 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each white tablet contains 0.075 mg (equivalent to 75 micrograms) gestodene and 0.030 mg (equivalent to 30 micrograms) ethinylestradiol Excipient(s) with known effects Each tablet contains 59.12 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Round, white tablets, with a diameter of 5.7 mm approximately. The tablet is debossed with a ‘ _C’ _ on one side and ‘ _33’ _ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. The decision to prescribe [nationally completed name] should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with [nationally completed name] compares with other CHCs (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _How to take [nationally completed name] _ The tablets must be taken every day at approximately the same time, if necessary with a little liquid, in the order indicated on the blister pack. One tablet per day should be taken for 21 days. Each subsequent pack should be started after a 7-day tablet-free interval during which time a withdrawal bleeding will occur. This bleeding usually starts on the 2nd or 3rd day after taking the last tablet, and may not stop until the next pack is started. _How to start taking [nationally completed name] _ _If no preceding hormonal contraceptive was used in the past month_ Sandoz B.V. Kosidina 0,075 mg/0,030 mg, tabletten Page 2/21 RVG 116278 1311-v8 1.3.1.1 Samenvatting van de Productkenmerken Mei 2023 Taking of the tablets should begin on the first day of the woman’s natural cycle (i.e. on the first day of the woman’s menstrual bleeding). One may begin taking the pills on day 2-5, Leggi il documento completo