Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
levonorgestrel, Quantity: 150 microgram; ethinylestradiol, Quantity: 30 microgram
Theramex Australia Pty Ltd
ethinylestradiol,Levonorgestrel
Tablet, film coated
Excipient Ingredients: lactose; hypromellose; microcrystalline cellulose; magnesium stearate; polysorbate 80; titanium dioxide; macrogol 400; allura red AC aluminium lake; brilliant blue FCF aluminium lake
Oral
91 film coated tablets in a composite pack containing 84 levonorgestrel/ethinyloestradiol film coated tablets and 7 ethinyloestradiol film coated tablets
(S4) Prescription Only Medicine
Seasonique is indicated for use as an oral contraceptive.
Visual Identification: Pink, round, biconvex tablets embossed 172 on one side and T on the other side; Container Type: Blister Pack; Container Material: Other plastic laminate/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-05-24
SEASONIQUE ® S E A S O N I Q U E ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING SEASONIQUE? Seasonique contains the active ingredient Levonorgestrel and Ethinylestradiol. Seasonique is used to prevent pregnancy. For more information, see Section 1. Why am I using Seasonique? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE SEASONIQUE? Do not use if you have ever had an allergic reaction to Seasonique or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Seasonique? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Seasonique and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE SEASONIQUE? • The daily dosing regimen should start with the first tablet (#1) of Month 1 blister. • Take one tablet about the same time every day. Tablet taking is continuous for 91 days. You may take the tablets with or without food, and if necessary with a little liquid in the order shown at the blister pack • More instructions can be found in Section 4. How do I use Seasonique? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING SEASONIQUE? THINGS YOU SHOULD DO • Remind any doctor or dentist you visit that you are using Seasonique. • If you become pregnant while taking Seasonique, see your doctor immediately. • Use of Seasonique is generally not advisable when a woman is breast- feeding. If you want to take the pill while you are breast-feeding you should contact your doctor. • If you are about to have any blood tests, tell your doctor you are taking Seasonique. • Have regular check ups from your doctor, including a Pap smear. TH Read the complete document
Theramex Australia Pty Ltd Version 0.0 1 AUSTRALIAN PRODUCT INFORMATION SEASONIQUE ® (LEVONORGESTREL AND ETHINYLESTRADIOL) FILM COATED TABLET 1 NAME OF THE MEDICINE Levonorgestrel and Ethinylestradiol . 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Seasonique is a 91-day extended-regimen oral contraceptive (OC) tablet. • Each pink tablet contains 150 µg levonorgestrel and 30 µg ethinylestradiol • Each white tablet contains 10 µg ethinylestradiol LIST OF EXCIPIENTS WITH KNOWN EFFECT: Lactose For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Film coated tablet Each Seasonique composite pack contains: • 84 round pink, round, biconvex film coated tablets embossed “172” on one side and “T” on the other side containing 150 µg levonorgestrel and 30 µg ethinylestradiol and • 7 white, round, biconvex film-coated tablets embossed “173” on one side and “T” on the other side containing 10 µg ethinylestradiol . 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Seasonique is indicated for use as an oral contraceptive. 4.2 D OSE AND METHOD OF ADMINISTRATION Seasonique is an extended-regimen oral contraceptive where tablets are taken continuously for 91 days. Each subsequent 91-day pack is started the day after the last tablet of the previous pack. Seasonique pack consists of 84 combination tablets of 150 µg levonorgestrel and 30 µg ethinylestradiol and 7 tablets of 10 µg ethinylestradiol. _HOW TO USE SEASONIQUE _ Tablet taking is continuous for 91 days. One tablet is to be taken by mouth at the same time every day in the order shown at the blister pack. One pink tablet containing levonorgestrel and ethinylestradiol is taken daily for 84 consecutive days, followed by one white ethinylestradiol tablet for 7 days, during which time withdrawal bleeding usually occurs. Theramex Australia Pty Ltd Version 0.0 2 _HOW TO START SEASONIQUE _ THE DAILY DOSING REGIME SHOULD START WITH THE FIRST TABLET (#1) OF _ MONTH 1 _BLISTER, CONSISTENT WITH THE PACKAGING PRESENTAT Read the complete document