Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Estradiol
Waymade Healthcare Plc
G03CA03
Estradiol
1mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06040101
ZUMENON ® 1MG TABLETS/OROMONE ® 1MG TABLETS (estradiol hemihydrate) Your medicine is known by either of the above names, but will be referred to as Zumenon throughout this: PATIENT INFORMATION LEAFLET IN THIS LEAFLET: 1) What Zumenon is and what it is used for 2) Before you use Zumenon 3) How to use Zumenon 4) Possible side effects 5) How to store Zumenon 6) Further information 1) WHAT ZUMENON IS AND WHAT IT IS USED FOR Zumenon is a Hormone Replacement Therapy (HRT). It contains the female hormone oestrogen. Zumenon is used in postmenopausal women with at least 6 months since their last natural period and women switching from standard (cyclic or sequential) HRT on the advice of their doctor. Zumenon 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"). Zumenon alleviates these symptoms after menopause. You will only be prescribed Zumenon if your symptoms seriously hinder your daily life. 2) BEFORE YOU TAKE ZUMENON 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 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 examination. This may include an examination of your breasts and/or an internal examination, if necessary. Once you have started on Zumenon you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Zumenon. Go for regular breast screening, as recommended by your doctor. DO NOT TAKE ZUMENON If any of the following ap Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zumenon® 1mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg estradiol (as hemihydrate) Excipient with known effect: each tablet contains 119.1 mg lactose monohydrate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablets Round, biconvex, white tablets with inscription ‘379’ on one side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women at least 6 months since last menses. Older people The experience treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY One tablet to be taken orally Zumenon is an oestrogen only continuous HRT for women with or without a uterus. In women with a uterus, a progestogen should be added to Zumenon for 12-14 days each month to reduce the risk to the endometrium. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women. _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. _ In general, treatment should start with Zumenon 1mg. Depending on the clinical response, the dosage can afterwards be adjusted to individual need. If the complaints linked to oestrogen deficiency are not ameliorated the dosage can be increased by using Zumenon 2mg. Starting Zumenon In women who are not taking hormone replacement therapy and who are amenorrhoeic, are hysterectomised, or women who switch from a continuous combined hormone replacement therapy, treatment may be started on any convenient day. In women transferring from a cyclic or continuous sequential HRT regimen, treatment should begin the day following completion of the prior regimen. If the patient has regular menstruation periods, treatment is started on day one of bleeding. Administration The Read the complete document