Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
Piperazine oestrone sulfate
Pfizer Australia Pty Ltd
Medicine Registered
GENORAL(R) 1 GENORAL(R) _Piperazine oestrone sulfate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before taking GENORAL. This leaflet answers some common questions about GENORAL. It does not contain all the available information and it does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the expected benefits it will have for you. Take GENORAL as instructed and follow the advice given in this leaflet. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT GENORAL IS USED FOR GENORAL belongs to a group of medicines called oestrogens. Oestrogens are female hormones produced by the body and are necessary for the sexual development of the female and for the control of the menstrual cycle during child bearing years. GENORAL is used to treat one or more of the following: * to provide additional hormone when the body does not produce enough of its own * to manage signs of menopause such as hot flashes, itching, burning or dryness in or around the vagina. Other hormones called progestogens may be prescribed at the same time as GENORAL. This is known as Hormone Replacement Therapy or HRT. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is only available with a doctor's prescription. BEFORE YOU TAKE GENORAL See your doctor for a physical examination before you start to take GENORAL. In deciding to give you GENORAL, your doctor has weighed the benefits of taking GENORAL against the possible side effects and risks. _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE GENORAL IF: * you are allergic to GENORAL, any other oestrogen o Прочетете целия документ
PRODUCT INFORMATION GENORAL ® TABLETS NAME OF DRUG Non-proprietary name: piperazine oestrone sulfate Chemical name: oestra-1,3,5(10)-trien-17-one,3-(sulphoxy) compounded with piperazine (1:1) CAS No: [7280-37-7] DESCRIPTION GENORAL (piperazine oestrone sulfate) is an oestrogenic substance prepared from purified crystalline oestrone, solubilised as the sulfate and stabilised with piperazine. It is appreciably soluble in water and has almost no odour or taste. The amount of piperazine in GENORAL is not sufficient to exert a pharmacological action. Its addition ensures solubility, stability and uniform potency of the oestrone sulfate. The structural formula is shown below: H H N N H H H HO O O S O O C 3 H In addition to piperazine oestrone sulfate, these tablets also contain lactose anhydrous, lactose monohydrate, hydroxypropylcellulose, cellulose microcrystalline, potassium phosphate, trometamol, sodium starch glycollate, silica colloidal anhydrous, magnesium stearate, vegetable oil and sunset yellow/quinoline yellow dyes. PHARMACOLOGY The active component, oestrone, is presented as piperazine oestrone sulfate, an oestrogenic substance. Oestrogen drug products act by regulating the transcription of a limited number of genes. Oestrogens diffuse through the cell membranes, distribute themselves throughout the cell and bind to and activate the nuclear oestrogen receptor, a DNA binding protein which is found in oestrogen-responsive tissues. The activated oestrogen receptor binds to specific DNA sequences, or hormone-response elements, which enhance the transcription of adjacent genes and in turn lead to the observed effects. Oestrogen receptors have been identified in tissues of the reproductive tract, breast, pituitary, hypothalamus, liver, and bone of women. Endogenous oestrogens are known to cause growth stimulation and maintain mature sexual development of the ovaries, the uterus and cervix, the vagina, the fallopian tube Прочетете целия документ