Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Dienogest micronized; Ethinylestradiol micronized
Laboratorios Leon Farma, S.A.
G03FA; G03FA15
Dienogest micronized; Ethinylestradiol micronized
2 mg/0.03 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Progestogens and estrogens, fixed combinations; dienogest and estrogen
Not marketed
2018-08-10
PACKAGE LEAFLET: INFORMATION FOR THE USER RAENER 2MG/0.03 MG FILM-COATED TABLETS ethinylestradiol and dienogest 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 TAKING 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 or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Raener 2mg/0.03 mg is and what it is used for 2. What you need to know before you take Raener 2mg/0.03 mg 3. How to take Raener 2mg/0.03 mg 4. Possible side effects 5. How to store Raener 2mg/0.03 mg 6. Contents of the pack and other information 1. WHAT RAENER 2MG/0.03 MG IS AND WHAT IT IS USED FOR Raener 2mg/0.03 mg is s a medicinal product used to - prevent pregnancy (contraceptive “pill”). - treatment of women with moderately severe acne, who agree to receive a contraceptive pill after failure of suitable local or oral antibiotic treatments. It contains a small amount of female hormones progesterone namely (dienogest) and an estrogen (ethinylestradiol).Raener 2mg/0.03 mg Contraceptive pills that contain two hormones are called “combination” pills or combined oral contraceptives. Oral (orally administered) contraceptive pills are a very effective method of family planning. If taken regularly (wit Soma hati kamili
Health Products Regulatory Authority 21 November 2022 CRN00D62K Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Raener 2 mg/0.03 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: Ethinylestradiol, Dienogest 1 coated tablet contains: Ethinylestradiol 0.03 mg Dienogest 2.0 mg Excipients with known effect: Lactose monohydrate (60.90 mg) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, round film-coated tablets. Approx. 5.0 mm of diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Oral contraception. - Treatment of moderate acne after failure of suitable topical therapies or oral antibiotic treatment in women who elect to use an oral contraceptive. The decision to prescribe Raener 2 mg/0.03 mg Film-coated tablet should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Raener 2 mg/0.03 mg Film-coated tablet compares with other CHCs (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology With proper use of combined oral contraceptives, their failure is about 1% per year. If the tablet is missed or is taken incorrectly, the frequency of failure may increase. HOW TO TAKE RAENER 2MG/0.03 MG Film-coated tablets are taken daily at the same time (if necessary with some fluid), according to the sequence printed on the blister pack. One film-coated tablet a day is taken for 21 consequent days. Each subsequent pack is started after 7 tablet-free days; usually a break-through bleeding occurs in this period. Typically, it starts 2-3 days after the last pill and may still be present when the first film-coated tablet from the next blister pack is taken. Apparent improvement of acne usually takes at least three months and further improvement has been reported after six months of treatment. Women should be assessed 3-6 months after treatment initiation and periodically thereafter to rev Soma hati kamili