Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Prasterone
Endoceutics S.A.
G03XX01
prasterone
Other sex hormones and modulators of the genital system
Postmenopause
Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.,
Revision: 6
Authorised
2018-01-08
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE USER INTRAROSA 6.5 MG PESSARY prasterone 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 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 Intrarosa is and what it is used for 2. What you need to know before you use Intrarosa 3. How to use Intrarosa 4. Possible side effects 5. How to store Intrarosa 6. Contents of the pack and other information 1. WHAT INTRAROSA IS AND WHAT IT IS USED FOR Intrarosa contains the active substance prasterone. What Intrarosa is used for Intrarosa is used to treat postmenopausal women having moderate to severe symptoms of vulvar and vaginal atrophy. It is used to relieve menopausal symptoms in the vagina such as dryness or irritation. It is caused by a drop in the levels of oestrogen in your body. This happens naturally after the menopause. How Intrarosa works Prasterone corrects the symptoms and signs of vulvar and vaginal atrophy by replacing the oestrogens which are normally produced before menopause by 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 INTRAROSA The use of Hormone Replacement Therapy (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 different. Please talk to your Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Intrarosa 6.5 mg pessary 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pessary contains 6.5 mg of prasterone. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pessary White to off-white, bullet-shaped pessary approximately 28 mm long and 9 mm in diameter at its widest end. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 6.5 mg prasterone (one pessary) administered once daily, at bedtime. For the treatment of postmenopausal symptoms, Intrarosa should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be reassessed at least every 6 months and Intrarosa should only be continued as long as the benefit outweighs the risk. If a dose is forgotten, it should be taken as soon as the patient remembers. However, if the next dose is due in less than 8 hours, the patient should skip the missed pessary. Two pessaries should not be used to make up for a forgotten dose. _ _ _Special populations _ _ _ _Elderly _ No dose adjustment is considered necessary in elderly women. _ _ _Patients with renal and/or hepatic impairment _ Since Intrarosa acts locally in the vagina, no dose adjustment is needed for postmenopausal women having renal or hepatic impairment or any other systemic anomaly or disease. _ _ _Paediatric population _ There is no relevant use of Intrarosa in female children of any age group for the indication of vulvar and vaginal atrophy due to menopause. 3 Method of administration Vaginal use Intrarosa can be inserted in the vagina with the finger or with an applicator provided within the identified pack. The pessary should be inserted in the vagina as far as it can comfortably go without force. If inserted with an applicator, Aqra d-dokument sħiħ