Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
ESTRADIOL
Gedeon Richter Plc Gyomroi ut 19-21 1103 Budapest, Hungary
G03CA03
ESTRADIOL 1.53 mg
Transdermal spray, solution
ESTRADIOL 1.53 mg
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Authorised
2015-07-23
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LENZETTO 1.53 MG/SPRAY TRANSDERMAL SPRAY, SOLUTION 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 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 Lenzetto is and what it is used for 2. What you need to know before you use Lenzetto 3. How to use Lenzetto 4. Possible side effects 5. How to store Lenzetto 6. Contents of the pack and other information 1. WHAT LENZETTO IS AND WHAT IT IS USED FOR Lenzetto is a Hormone Replacement Therapy (HRT). It contains the female hormone oestrogens. Lenzetto is used in postmenopausal women with at least 6 months since their last natural period. Lenzetto can also be used in women who have had surgery to remove their ovaries as this causes instant menopause. Lenzetto is a spray solution which contains small amounts of a medicine called estradiol. When sprayed onto the skin as directed, it passes through the skin into your bloodstream. Lenzetto is used for: RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest (“hot flushes”). Lenzetto alleviates these symptoms after menopause. You will only be prescribed Lenzetto if your symptoms seriously hinder your daily life. Lenzetto is indicated to treat oestrogen deficiency symptoms after menopause; when menstruation has ceased following menopause. Symptoms of oestrogen deficiency include hot flushes (sudden waves of heat and sweating in the whole body), sleeping problems, irritabilit Đọc toàn bộ tài liệu
1 1. NAME OF THE MEDICINAL PRODUCT Lenzetto 1.53 mg/spray, transdermal spray, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each spray delivers 90 microliter of transdermal spray, solution containing 1.53 mg of estradiol (equivalent to 1.58 mg of estradiol hemihydrate). Excipient with known effect: each spray contains 65.47 mg ethanol. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Transdermal spray, solution. The solution is clear, colourless to pale yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women (in women at least 6-months since last menses or surgical menopause, with or without a uterus). The experience in treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Lenzetto is administered once daily, either as a monotherapy or as a continuous sequential treatment (when combined with a progestogen). One metered-dose spray is administered once daily to the dry and healthy skin of the forearm as a starting dose. The dose may be increased to two metered-dose sprays daily to the forearm based on clinical response. Dose increase should be based on the degree of the woman’s menopausal symptoms and should be made only after at least 4 weeks of continuous treatment with Lenzetto. The maximum daily dose is 3 metered-dose sprays (4.59 mg/day) to the forearm. Dose increase should be discussed with the physician. For patients who have difficulty applying the prescribed dose to distinct, non-overlapping areas of the same forearm, Lenzetto may also be applied to sites on the alternate forearm, or to sites on the inner thigh. 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. When the degree of the woman’s menopausal symptoms is not reduced after a dose increase, the patient should be back-titrated to the previous dose. Patients should be Đọc toàn bộ tài liệu