국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
levonorgestrel, Quantity: 1.5 mg
Lupin Australia Pty Limited
Levonorgestrel
Tablet, uncoated
Excipient Ingredients: maize starch; magnesium stearate; lactose monohydrate; povidone; colloidal anhydrous silica
Oral
1's blister in carton
(S3) Pharmacist Only Medicine
Emergency contraception within 72 hours of unprotected intercourse.
Visual Identification: White to off-white round shaped, tablets debossed with ?LV1" on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-11-20
Levonorgestrel-1 GH v3 1 LEVONORGESTREL-1 GH 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 LEVONORGESTREL-1 GH? Levonorgestrel-1 GH contains the active ingredient levonorgestrel. Levonorgestrel-1 GH is used as an emergency contraceptive. For more information, see Section 1. Why am I using Levonorgestrel-1 GH? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE LEVONORGESTREL-1 GH? Do not use if you have ever had an allergic reaction to Levonorgestrel-1 GH or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR OR PHARMACIST 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 Levonorgestrel-1 GH? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Levonorgestrel-1 GH 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 LEVONORGESTREL-1 GH? • Take one tablet as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after you have had unprotected sex. More instructions can be found in Section 4. How do I use Levonorgestrel-1 GH? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING LEVONORGESTREL-1 GH? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Levonorgestrel-1 GH. THINGS YOU SHOULD NOT DO • Do not this medicine if you had unprotected intercourse more than 72 hours earlier in the same menstrual cycle. • Do not use this medicine if you are pregnant. DRIVING OR USING MACHINES • Do not drive or operate machinery if you feel drowsy or dizzy after using Levonorgestrel-1 GH. DRINKING ALCOHOL • Tell your doctor or pharmacist if you drink alcohol. LOOKING AFTER YOUR MEDICINE • Store the medicine in a cool d 전체 문서 읽기
AUSTRALIAN PRODUCT INFORMATION – LEVONORGESTREL-1 GH (LEVONORGESTREL) UNCOATED TABLET 1 NAME OF THE MEDICINE Levonorgestrel. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Levonorgestrel-1 GH tablet contains 1.5 mg of levonorgestrel. List of excipients with known effect: lactose monohydrate (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE - EXCIPIENTS). For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Levonorgestrel-1 GH is a white to off-white, round shaped tablet debossed with ‘LV1’ on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levonorgestrel is an oral emergency contraceptive indicated for use within 72 hours of unprotected intercourse. It should be used only as an emergency measure. Women who present for repeated courses of emergency contraception should be advised to consider long-term methods of contraception. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE One 1.5 mg tablet to be taken as soon as possible (and not later than 72 hours) after unprotected intercourse. The highest efficacy is achieved if the tablet is taken as early as possible. Therefore, treatment should not be delayed as efficacy declines with time. If the patient vomits within two hours of taking the tablet, she should return to her pharmacist, doctor or clinic where an additional tablet may be given. Levonorgestrel can be used at any time during the menstrual cycle unless menstrual bleeding is overdue. Levonorgestrel-1 GH v5.0 Page 2 of 13 (levonorgestrel) uncoated tablet Children Levonorgestrel is not recommended in children. Only limited data are available in young women of child-bearing potential aged 14-16 years. No data are available about use in young women aged less than 14 years or children. METHOD OF ADMINISTRATION For oral administration. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in SECTION 6.1 LIST OF EXCIPIENTS. Levonorgestrel should not be given to pregnant women. If menstrual 전체 문서 읽기