Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Estriol
Laboratoires Besins International
G03CA; G03CA04
Estriol
0.03 milligram(s)
Pessary
Product subject to prescription which may not be renewed (A)
Natural and semisynthetic estrogens, plain; estriol
Marketed
2018-03-16
PACKAGE LEAFLET: INFORMATION FOR THE USER IMVAGGIS 0.03 MG PESSARY Estriol 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, please ask your doctor or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What IMVAGGIS is and what it is used for 2. What you need to know before you use IMVAGGIS 3. How to use IMVAGGIS 4. Possible side effects 5. How to store IMVAGGIS 6. Contents of the pack and other information 1. WHAT IMVAGGIS IS AND WHAT IT IS USED FOR IMVAGGIS belongs to a group of medicines called vaginal Hormone Replacement Therapy (HRT). It is used to relieve menopausal symptoms in the vagina such as dryness or irritation. In medical terms this is known as ‘vaginal atrophy’. It is caused by a drop in the levels of oestrogen in your body. This happens naturally after the menopause. IMVAGGIS works by replacing the oestrogen which is normally produced in the ovaries of women. It is inserted into your vagina, so the hormone is released where it is needed. This may relieve discomfort in the vagina. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE IMVAGGIS MEDICAL HISTORY AND REGULAR CHECK-UPS The use of HRT carries risks which need to be considered when deciding whether to start using it, or whether to carry on using it. The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor. Before you start (or restart) HRT, your doctor will ask about your own and your family’s medical history. Your doctor may decide to perform a physical e Pročitajte cijeli dokument
Health Products Regulatory Authority 04 April 2022 CRN00CSTP Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT IMVAGGIS 0.03 mg pessary 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 pessary contains 0.03 mg estriol. Excipient with known effect: Each pessary contains a maximum of 0.008 mg butylhydroxytoluene. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pessary White, homogenous pessaries. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Local treatment of vaginal symptoms of estrogen deficiency in postmenopausal women. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology During the first 3 weeks of treatment one pessary is administered daily. Thereafter a maintenance dose of 1 pessary twice a week is recommended. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used (see also section 4.4). For estrogen products for vaginal application of which the systemic exposure to the estrogen is very low, it is not recommended to add a progestagen (but see section 4.4). Method of administration The pessary should be introduced deeply into the vagina, preferably in the evening before going to bed. Missed dose _During daily use within the first 3 weeks of treatment:_ If a missed dose is not realized before the next day, it should not be replaced. In that case the usual dosing schedule should be resumed. _During twice-weekly use: _ If the administration of the medicinal product has been forgotten at a scheduled date during the twice-weekly maintenance treatment, the missed dose should be administered as soon as possible. 4.3 CONTRAINDICATIONS - Known, past or suspected breast cancer; - Known or suspected estrogen-dependent malignant tumours (e. g. endometrial cancer); - Undiagnosed genital bleeding; - Untreated endometrial hyperplasia; - Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism); - Known thrombophilic disorders (e. g. protein C, protein S, or a Pročitajte cijeli dokument