País: Malta
Idioma: anglès
Font: Medicines Authority
ESTRADIOL
NovoNordisk A/S Novo Alle, DK – 2880 Bagsvaerd, Denmark
G03CA03
ESTRADIOL 10 µg
VAGINAL TABLET
ESTRADIOL 10 µg
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Authorised
2011-04-08
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER VAGIFEM 10 MICROGRAMS 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, ‘Possible side effects’. WHAT IS IN THIS LEAFLET 1. What Vagifem is and what it is used for 2. What you need to know before you use Vagifem 3. How to use Vagifem 4. Possible side effects 5. How to store Vagifem 6. Contents of the pack and other information 1. WHAT VAGIFEM IS AND WHAT IT IS USED FOR Vagifem contains estradiol • Estradiol is a female sex hormone. • It belongs to a group of hormones called oestrogens. • It is exactly the same as the estradiol produced by the ovaries of women. Vagifem 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. VAGIFEM 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. The experience of treating women older than 65 years is limited. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VAGIFEM 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 menopa Llegiu el document complet
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vagifem 10 micrograms vaginal tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vaginal tablet contains: Estradiol hemihydrate equivalent to estradiol 10 micrograms. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Vaginal tablet. White, film-coated, biconvex tablet, engraved with NOVO 278 on one side. Diameter 6 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women (see section 5.1). The experience treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Vagifem is administered intravaginally as a local oestrogen therapy by use of an applicator. Initial dose: One vaginal tablet daily for two weeks. Maintenance dose: One vaginal tablet twice a week. Treatment may be started on any convenient day. If a dose is forgotten, it should be taken as soon as the patient remembers. A double dose should be avoided. 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 oestrogen products for vaginal application of which the systemic exposure to the oestrogen remains WITHIN the normal postmenopausal range, such as Vagifem, it is not recommended to add a progestagen (but see section 4.4, ‘Special warnings and precautions for use’, ‘Endometrial hyperplasia and carcinoma’). Vagifem may be used in women with or without an intact uterus. Vaginal infections should be treated before start of the Vagifem therapy. Page 2 of 12 Administration: 1. Open the blister pack at the plunger end. 2. Insert the applicator in the vagina until resistance is met (8-10 cm). 3. Release the tablet by pressing the plunger. 4. Withdraw the applicator and discard. 4.3 CONTRAINDICATIONS • Known, past or suspected breast cancer • Known, past or suspected oestrogen-dependent malignant tumours (e.g. endometrial can Llegiu el document complet