Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
ethinylestradiol,gestodene
Pfizer Australia Pty Ltd
ethinylestradiol,Gestodene
Registered
MINULET ® _Gestodene and Ethinylestradiol Tablets_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Minulet. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Minulet against the benefits this medicine is expected to have for you. IF YOU HAVE ANY QUESTIONS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT MINULET IS USED FOR Minulet is an oral contraceptive. Minulet tablets contain two hormones (gestodene and ethinylestradiol), which prevent you from becoming pregnant if taken correctly. They are similar to the hormones that your body normally produces. Minulet prevents pregnancy in several ways: • It inhibits the egg release by stopping it maturing • It changes the cervical mucus consistency making it difficult for the sperm to reach the egg • It changes the lining of the uterus making it less suitable for implantation. Your doctor may have prescribed Minulet for another reason. Ask your doctor if you have any questions about why Minulet has been prescribed for you. Minulet is not habit-forming. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE MINULET _WHEN YOU MUST NOT TAKE_ _MINULET_ Do not take Minulet if you have an allergy to: • ANY MEDICINE CONTAINING ETHINYLESTRADIOL OR GESTODENE • ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET • ANY OTHER SIMILAR MEDICINES (SUCH AS OTHER ORAL CONTRACEPTIVES). Some of the symptoms of an allergic reaction may include: • Shortness of breath • Wheezing or difficulty breathing • Swelling of the face, lips, tongue or other parts of the body • Rash, itching or hives on the skin. DO NOT TAKE MINULET IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: • Venous thromboembolism (VTE) and are on medicines called anticoagul Citiți documentul complet
Version: pfpminut10120 Supersedes: pfpminut11018 Page 1 of 25 AUSTRALLIAN PRODUCT INFORMATION - MINULET (GESTODENE AND ETHINYLESTRADIOL) TABLETS 1. NAME OF THE MEDICINE Gestodene and Ethinylestradiol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each white active tablet contains ethinylestradiol 30 µg and gestodene 75 µg. Each red tablet is a placebo tablet. EXCIPIENTS WITH KNOWN EFFECT Sucrose Lactose monohydrate For the full list of excipients, see section 6.1, List of Excipients. 3. PHARMACEUTICAL FORM Tablets. MINULET calendar blister pack consists of 28 tablets: 21 white tablets and 7 red placebo tablets.The white active tablets are round, biconvex tablets, approximately 6 mm in diameter. The red inert tablets are round, biconvex coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MINULET is indicated for the prevention of pregnancy. 4.2 DOSE AND METHOD OF ADMINISTRATION HOW TO TAKE MINULET Each package of MINULET contains 21 active white tablets and 7 red inactive tablets. Version: pfpminut10120 Supersedes: pfpminut11018 Page 2 of 25 To achieve maximum contraceptive effectiveness, MINULET must be taken as directed and at daily intervals not exceeding 24 hours. Women should be instructed to take the tablets at the same time every day, preferably at bedtime. HOW TO START MINULET _NO PRECEDING HORMONAL CONTRACEPTIVE USE (IN THE PAST MONTH) _ On the first day of the menstrual cycle, i.e. the first day of bleeding, the woman is instructed to take a white active tablet corresponding to that day of the week from the purple section of the MINULET pack. Thereafter, one white active tablet is taken daily, following the arrows marked on the package, until all 21 white active tablets have been taken from the pink section. The woman should be instructed then to take one red inactive tablet daily for the next seven days following the arrows marked on the MINULET pack. Withdrawal bleeding should usually occur within 2 to 4 days after the last white active tablet is taken. The woman should b Citiți documentul complet