País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
cyproterone acetate, Quantity: 2 mg; ethinylestradiol, Quantity: 35 microgram
Bayer Australia Ltd
Tablet, sugar coated
Excipient Ingredients: povidone; calcium carbonate; maize starch; sucrose; lactose monohydrate; macrogol 6000; purified talc; magnesium stearate; glycol montanate
Oral
1 x 28 tablets (1 x 21 beige, 1 x 7 white), 3 x 28 tablets (3 x 21 beige, 3 x 7 white)
(S4) Prescription Only Medicine
Diane-35 ED is indicated for: The treatment of signs of androgenisation in women, such as severe acne (involving inflammation or nodularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree. Diane-35 will also provide effective oral contraception in this patient group. It should not be used in combination with other hormonal contraceptives (see CONTRAINDICATIONS).,If the hirsutism has only recently appeared or has lately intensified to a considerable extent the cause (androgen-producing tumour or an adrenal-enzyme defect) must be clarified by differential diagnosis.
Visual Identification: White, round tablets.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1992-07-22
DIANE®-35 ED CMI VX1.0 1 RESTRICTED DIANE® -35 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 DIANE®-35 ED? DIANE®-35 ED contains the active ingredient cyproterone acetate and ethinylestradiol. DIANE®-35 ED is used for treatment of signs of androgenization in women. For more information, see Section 1. Why am I using DIANE®-35 ED? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE DIANE®-35 ED? Do not use if you have ever had an allergic reaction to Diane 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 if breastfeeding. For more information, see Section 2. What should I know before I use DIANE®-35 ED? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with DIANE®-35 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 DIANE®-35 ED? Take one tablet daily at about the same time every day. TAKE YOUR FIRST TABLET FROM THE RED AREA ON THE BLISTER PACK CORRESPONDING TO THE DAY OF THE WEEK. FOLLOW THE DIRECTION OF THE ARROWS ON THE BLISTER PACK UNTIL ALL THE TABLETS HAVE BEEN TAKEN. FOLLOW THE INSTRUCTIONS PROVIDED AND USE DIANE®-35 ED UNTIL YOUR DOCTOR TELLS YOU TO STOP More instructions can be found in Section 4. How do I use DIANE®-35 ED? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING DIANE®-35 ED? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit and if you are going to have surgery, tell the surgeon or anesthetist beforehand that you are using DIANE®-35 ED • IF YOU ARE ABOUT TO HAVE ANY BLOOD TESTS, TELL YOUR DOCTOR THAT YOU ARE TAKING THIS MEDICINE. • STOP TAKING DIANE-35 ED AND SEE YOUR DOCTOR IMMEDIATELY OR GO TO THE EMERGENCY DEPARTMENT AT YOUR NEAREST HOSPI Leer el documento completo
210122 Diane-35 ED PI 1 Australian Product Information DIANE ® -35 ED (CYPROTERONE ACETATE / ETHINYLESTRADIOL) TABLETS 1 NAME OF THE MEDICINE Cyproterone acetate and ethinylestradiol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DIANE-35 ED contains the synthetic progestogen, cyproterone acetate and the synthetic estrogen, ethinylestradiol. Each beige active tablet contains cyproterone acetate 2 mg and ethinylestradiol 35 µg. 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 DIANE-35 ED tablets are available in blister packs of 28 tablets. Each blister contains 21 round beige active tablets followed by 7 round white placebo tablets. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS DIANE 35 ED is indicated for: • The treatment of signs of androgenisation in women, such as severe acne (involving inflammation or nodularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree. • DIANE-35 ED will also provide effective oral contraception in this patient group. It should not be used in combination with other hormonal contraceptives (see SECTION 4.3 CONTRAINDICATIONS). If the hirsutism has only recently appeared or has lately intensified to a considerable extent the cause (androgen-producing tumour or an adrenal-enzyme defect) must be clarified by differential diagnosis. 4.2 D OSE AND METHOD OF ADMINISTRATION Combined oral contraceptives, when taken correctly have a failure rate of approximately 1% per year. 210122 Diane-35 ED PI 2 DIANE-35 ED is to be taken regularly in order to achieve therapeutic efficacy and the required contraceptive protection. Previously used hormonal contraception should be discontinued. The dose regimen of DIANE-35 ED is similar to the usual regimen of most of the COCs. Thus, the same administration rules must be considered. The irregular intake of DIANE-35 ED can lead to int Leer el documento completo