Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Estradiol
Gedeon Richter Plc
G03CA03
Estradiol
10 microgram(s)
Vaginal tablet
estradiol
Marketed
2021-01-29
PACKAGE LEAFLET: INFORMATION FOR THE USER VAGIRUX 10 MICROGRAM VAGINAL TABLETS estradiol 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 questions, 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 Vagirux is and what it is used for 2. What you need to know before you use Vagirux 3. How to use Vagirux 4. Possible side effects 5. How to store Vagirux 6. Contents of the pack and other information 1. WHAT VAGIRUX IS AND WHAT IT IS USED FOR Vagirux contains estradiol. - Estradiol is a female sex hormone. - It belongs to a group of hormones called estrogens. - It is exactly the same as the estradiol produced by the ovaries of women. Vagirux belongs to a group of medicines called vaginal Hormone Replacement Therapy (HRT). VAGIRUX 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 estrogen in your body. This happens naturally after the menopause. VAGIRUX WORKS BY replacing the estrogen, 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 VAGIRUX MEDICAL HISTORY AND REGULAR CHECK-UPS The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking 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 d Прочитайте повний документ
Health Products Regulatory Authority 04 May 2022 CRN00CV10 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vagirux 10 microgram vaginal tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vaginal tablet contains estradiol hemihydrate equivalent to 10 microgram estradiol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Vaginal tablet. White, round, film-coated tablets embossed with "E" in one side. The diameter of the tablet is approximately 6 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of vaginal atrophy due to estrogen deficiency in postmenopausal women (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Vagirux may be used in women with or without an intact uterus. Posology Vaginal infections should be treated before start of the Vagirux therapy. Treatment may be started on any convenient day. _Initial dose_ One vaginal tablet daily for two weeks. _Maintenance dose_ One vaginal tablet twice a week. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used. For estrogen products for vaginal application of which the systemic exposure to the estrogen remains _within_the normal postmenopausal range, such as Vagirux, it is not recommended to add a progestagen (see section 4.4 'Endometrial hyperplasia and carcinoma'). If a dose is forgotten, it should be taken as soon as the patient remembers. A double dose should be avoided. Method of administration Vagirux is administered intravaginally as a local estrogen therapy by use of an applicator. _How to administer _Vagirux_:_ 1. The applicator should be removed from its sealing foil. 2. While holding the tube, the plunger of the applicator should be pulled until it comes to a stop. One vaginal tablet should be placed firmly into the holder (wide end) of the applicator tube. Health Products Regulatory Authority 04 May 2022 CRN00CV10 Page 2 of 9 3. The applicator should be carefully Прочитайте повний документ