Country: United Kingdom
Language: English
Source: myHealthbox
ethinylestradiol, drospirenone
Morningside Healthcare Limited
G03AA12
ethinylestradiol, drospirenone
0.03mg/3mg
Tablets
Oral use
Pack sizes: 21 tablets 3x21 tablets 6x21 tablets 13x21 tablets
POM - Prescription Only Medicine
Morningside Pharmaceutical Limited
Progestogens and estrogens, fixed combinations
Oral contraception.
Authorised
2015-03-09
Artwork No. Customer Description Market Language Size Min. Font Size Page No. Version No. Date Software 251114/3 Morningside Yacella 0.03 mg/3 mg Pil UK English 860 x 430 mm 10 pt 1 of 2 10 01-04-15 Coreldraw 12 Packaging Development Quality Assurance (QA) Quality Control (QC) Production e-mail : artworkcd@gmail.com Ph : +91-9845156610 Colours Used Black Keyline CLEARLY MARK ANY AMENDMENTS ON ONE PROOF AND RETURN TO ARTWORK CREATIVE DESIGN. Your Artwork/Disk has been translated through our Digital Artwork System into a format compatible with that of the litho Printing Process. WARNING! We cannot accept responsibility for any errors in this proof after approval. The artwork received has been significantly adjusted, revised or reset by us from disk or hard copy. Whilst we take extreme care at all times to ensure accuracy, the final responsibility must be taken by our customer. If you sign this proof you are signifying full approval of design and text. Non Printing Area Non Printing Area Non Printing Area Non Printing Area Non Printing Area Non Printing Area Non Printing Area Non Printing Area 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, even if their signs of illness are the same as yours. If you get any side effect, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES (CHCS): They are one of the most reliable reversible methods of contraception if us Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Yacella 0.03 mg/3 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.03 mg ethinylestradiol and 3 mg drospirenone. Excipients with known effect: Each tablet contains 72 mg of lactose, 0.032 mg of E110, susnset yellow FCF and 0.12 mg of E102, tartrazine. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet Round, yellow, uncoated biconvex tablet with ‘143’ debossed on one side and other side plain. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. The decision to prescribe Yacella Tablets should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Yacella Tablets compares with other CHCs (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: oral use HOW TO TAKE YACELLA TABLETS The tablets must be taken every day at about the same time, if necessary with a little liquid, in the order shown on the blister pack. One tablet is to be taken daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval, during which time a withdrawal bleed usually occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started. HOW TO START YACELLA TABLETS No preceding hormonal contraceptive use (in the past month) Tablet-taking has to start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding). • Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch) The woman should start with Yacella Tablets preferably on the day after the last active tablet (the last tablet con Read the complete document