Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
Norethisterone
PRIMOLUT N ® CMI 1 PRIMOLUT ® N (PREE·MOE·LOOT) _norethisterone _ _CONSUMER MEDICINE INFORMATION _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Primolut N. It does not contain all the available information. 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 Primolut N against the benefits they expect it will have for you. 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 PRIMOLUT N IS USED FOR Primolut N contains norethisterone, a hormonal product having similarity with the natural female hormone progesterone. Because the active ingredient in Primolut N, norethisterone, is converted to oestrogen in the body, some of the information in this leaflet is based on experience with oestrogen containing oral contraceptives. However, Primolut N is not to be used as a contraceptive. It will not prevent you from falling pregnant. Primolut N is used to treat • irregular menstrual periods with heavy and/or persistent bleeding that has no identified cause • lack of menstrual bleeding • premenstrual complaints (premenstrual syndrome) • menopausal complaints in combination with oestrogen as part of hormone replacement therapy, • endometriosis (a disease leading to complaints caused by womb- lining tissue growing outside the womb 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. BEFORE YOU TAKE PRIMOLUT N _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE PRIMOLUT N IF YOU HAVE AN AL Διαβάστε το πλήρες έγγραφο
130408 Primolut N_PI Page 1 PRODUCT INFORMATION PRIMOLUT ® N NAME OF THE MEDICINE Primolut N Each tablet of Primolut N contains 5 mg norethisterone. Norethisterone is 17 β-Hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one CAS 68-22-4 O H CH 3 H H H OH C CH C 20 H 26 0 2 MW=298.4 DESCRIPTION Norethisterone is a white or yellowish-white odourless crystalline powder. It is practically insoluble in water; slightly to sparingly soluble in alcohol; soluble in chloroform and in dioxan; slightly soluble in ether. Primolut N also contains the inactive excipients lactose, maize starch, magnesium stearate. PHARMACOLOGY PHARMACOLOGICAL ACTIONS Norethisterone is a progestogen with negligible androgenic effects. Complete transformation of the endometrium from a proliferative to a secretory state was achieved in oestrogen- primed castrated or climacteric women who were administered oral doses of 100-150 mg norethisterone per cycle. The progestogenic effects of norethisterone on the endometrium is the basis of the treatment of dysfunctional bleeding, primary and secondary amenorrhea, and endometriosis with Primolut N. 130408 Primolut N_PI Page 2 Gonadotropin secretion inhibition and anovulation can be achieved with a daily intake of 0.5 mg of norethisterone. Positive effects of Primolut N on premenstrual symptoms can be traced back to suppression of ovarian function. Due to the stabilising effects of norethisterone on the endometrium, administration of Primolut N can be used to shift the timing of menstruation. Like progesterone, norethisterone is thermogenic and alters the basal body temperature. PHARMACOKINETICS Absorption In a single ora Διαβάστε το πλήρες έγγραφο