Land: Malta
Språk: engelska
Källa: Medicines Authority
PROGESTERONE
Gedeon Richter Plc Gyomroi ut 19-21 1103 Budapest, Hungary
G03DA04
PROGESTERONE 400 mg
PESSARY
PROGESTERONE 400 mg
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Authorised
2017-03-24
Page 1 of 5 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER CYCLOGEST 400 MG PESSARIES Progesterone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Cyclogest 400 mg pessaries is and what it is used for 2. What you need to know before you use Cyclogest 400 mg pessaries 3. How to use Cyclogest 400 mg pessaries 4. Possible side effects 5. How to store Cyclogest 400 mg pessaries 6. Contents of the pack and other information 1. WHAT CYCLOGEST 400 MG PESSARIES IS AND WHAT IT IS USED FOR Cyclogest 400 mg pessaries contains progesterone which is a natural, female sex hormone, produced in the body. Cyclogest 400 mg pessaries is for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) programme. Progesterone acts on the lining of the womb and it helps you to become and to stay pregnant when you are treated for infertility. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CYCLOGEST 400 MG PESSARIES DO NOT USE CYCLOGEST 400 MG PESSARIES: - if you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6), - have unusual vaginal bleeding that has not been evaluated by the doctor, - have known or suspected tumour that is hormone sensitive, - have porphyria disorders (a group of inherited or acquired disorders of certain enzymes), - have or have had blood clots in the legs, lungs, eyes or elsewhere in the body, - currently have or have had severe liver problems. - have a miscarriage and your physician su Läs hela dokumentet
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 7 1. NAME OF THE MEDICINAL PRODUCT Cyclogest 400 mg pessaries 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pessary contains 400 mg progesterone For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pessary Off-white, approximately 10mm x 30mm, torpedo shaped pessary 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cyclogest is indicated for luteal phase support as part of an Assisted Reproductive Technology (ART) treatment for women. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ One 400 mg pessary administered vaginally twice a day starting at oocyte retrieval. If pregnancy has been confirmed, the administration of Cyclogest should be continued for 38 days from the start of therapy. _Paediatric population _ There is no relevant use of Cyclogest in the paediatric population. _Elderly _ No clinical data have been collected in patients over age 65. _Use in special populations _ There is no experience with use of Cyclogest in patients with impaired liver or renal function. Method of administration For vaginal insertion. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Page 3 of 7 Undiagnosed vaginal bleeding. Known or suspected progesterone sensitive malignant tumours. Porphyria. Known missed abortion or ectopic pregnancy. Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events. Severe hepatic dysfunction or disease. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Cyclogest should be discontinued if any of the following conditions are suspected: myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary embolism), thrombophlebitis or retinal thrombosis. Although risk of thromboembolism has been associated with estrogens, a link with progestogens remains questionable. Therefore, in women with generally recognised risk factors for thromboembolic events, such Läs hela dokumentet