País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
levonorgestrel, Quantity: 0.05 mg; ethinylestradiol, Quantity: 0.03 mg
Bayer Australia Ltd
Tablet, sugar coated
Excipient Ingredients: purified talc; glycol montanate; lactose monohydrate; povidone; magnesium stearate; sucrose; calcium carbonate; maize starch; macrogol 6000
Oral
1 x 28 tablets, 4 x 28 tablets
(S4) Prescription Only Medicine
Oral contraception.
Visual Identification: White, biconvex, round tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1992-06-18
Logynon ® ED CMI XV1.0 1 LOGYNON ® ED 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 LOGYNON ED? Logynon ED contains the active ingredients ethinylestradiol and levonorgestrel. Logynon ED is used to prevent pregnancy. For more information, see Section 1. Why am I using Logynon ED? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE LOGYNON ED? Do not use if you have ever had an allergic reaction to Logynon ED 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 Logynon ED? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Logynon ED 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 LOGYNON ED? • Take one tablet daily at about the same time every day. You must take Logynon ED every day regardless of how often you have sex. • Swallow the tablet whole with a full glass of water. It does not matter if you take it before or after food. More instructions can be found in Section 4. How do I use Logynon ED? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING LOGYNON ED? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Logynon ED. • If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests. • Have regular check-ups with your doctor. When you are taking the Pill, your doctor will tell you to return for regular check-ups, including getting a Cervical Screening Test. THINGS YOU SHOULD NOT DO • Do not take Logynon ED to treat any other conditions, unless your doctor tells you to. • Do not give yo Leer el documento completo
LOGYNON ED PI XV1.0; CCDS 14 1 AUSTRALIAN PRODUCT INFORMATION LOGYNON ED (ETHINYLESTRADIOL, LEVONORGESTREL) TABLET 1 NAME OF THE MEDICINE Ethinylestradiol Levonorgestrel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION LOGYNON ED is a cycle-adapted combined estrogen-progestogen oral contraceptive containing the synthetic estrogen, ethinylestradiol and the synthetic progestogen, levonorgestrel. Each light brown active tablet contains 30 µg of ethinylestradiol and 50 µg of levonorgestrel. Each white active tablet contains 40 µg of ethinylestradiol and 75 µg of levonorgestrel. Each ochre active tablet contains 30 µg of ethinylestradiol and 125 µg of levonorgestrel. EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Tablet, sugar coated. Each blister pack contains 6 round light brown coated tablets each containing 30 µg ethinylestradiol and 50 µg levonorgestrel followed by 5 small round white coated tablets each containing 40 µg ethinylestradiol and 75 µg levonorgestrel followed by 10 round ochre coated tablets each containing 30 µg ethinylestradiol and 125 µg levonorgestrel followed by 7 large round white placebo tablets. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Oral contraception. 4.2 D OSE AND METHOD OF ADMINISTRATION HOW TO TAKE LOGYNON ED COCs, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly. LOGYNON ED PI XV1.0; CCDS 14 2 One tablet is to be taken daily. The tablets must be taken in the order directed on the package at about the same time every day, with some liquid as needed. Daily tablet taking should be continuous for 28 consecutive days, starting with a tablet corresponding to that day of the week from the red section of the LOGYNON ED pack. If a woman starts on a Monday, Tuesday, Wednesday, Thursday or Friday, her first tablet is a large white placebo one, while if she starts on a Saturday or Sunday her Leer el documento completo