Страна: Сингапур
Язык: английский
Источник: HSA (Health Sciences Authority)
NORETHISTERONE
BAYER (SOUTH EAST ASIA) PTE LTD
G03DC02
5 mg
TABLET
NORETHISTERONE 5 mg
ORAL
Prescription Only
BAYER WEIMAR GMBH UND CO. KG
ACTIVE
1990-05-04
* NAME OF THE MEDICINAL PRODUCT PRIMOLUT N 5MG TABLETS * QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet Primolut N contains 5mg norethisterone. For excipients, see section 6.1 * PHARMACEUTICAL FORM Tablets * CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dysfunctional bleeding, primary and secondary amenorrhoea, premenstrual syndrome, mastopathy, timing of menstruation, endometriosis. 4.2 DOSAGE AND METHOD OF ADMINISTRATION The tablets are to be swallowed whole with some liquid. If you forget a dose, wait until it is time to take the next prescribed dose. Do not take the missed dose. If you are worried, contact your doctor or pharmacist. If contraceptive protection is required, additional non-hormonal (barrier) contraceptive methods should be used. Unless other wise prescribed by the doctor, the following dosages are recommended: * DYSFUNCTIONAL BLEEDING The administration of 1 tablet Primolut N 3 times daily over 10 days leads to the arrest of uterine bleeding not associated with organic lesions within 1 -3 days. In individual cases, bleeding diminishes during the first few days after the commencement of tablet-taking and does not stop until about 5 days later. For the treatment to be successful, Primolut N administration should be continued regularly even after arrest of bleeding (up to a total of 30 tablets). About 2 -4 days after discontinuation of treatment a withdrawal bleeding will occur resembling a normal menstruation in intensity and duration. SLIGHT BLEEDING DURING TABLET-TAKING Occasionally, slight bleeding may occur after initial arrest of bleeding. In these cases tablet-taking must not be interrupted. MISSING ARREST OF HAEMORRHAGE. HEAVY BREAK THROUGH BLEEDING If the bleeding does not stop in spite of regular tablet taking, an organic cause must be considered. This applies also in cases where after initial arrest of haemorrhage, fairly heavy bleedings still occur during tablet-taking. PREVENTION OF RECURRENCE To prevent recurrence of dysfunctional bleeding, it is recommended to administer Primo Прочитать полный документ
Primolut N PI_SG_CCDS 10_01 June 2018 1. NAME OF THE MEDICINAL PRODUCT PRIMOLUT N 5MG TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet Primolut N contains 5mg norethisterone. For excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dysfunctional bleeding, primary and secondary amenorrhoea, premenstrual syndrome, mastopathy, timing of menstruation, endometriosis. 4.2 DOSAGE AND METHOD OF ADMINISTRATION 4.2.1 METHOD OF ADMINISTRATION Oral use 4.2.2 DOSAGE REGIMEN The tablets are to be swallowed whole with some liquid. If you forget a dose, wait until it is time to take the next prescribed dose. Do not take the missed dose. If you are worried, contact your doctor or pharmacist. If contraceptive protection is required, additional non-hormonal (barrier) contraceptive methods should be used. Unless other wise prescribed by the doctor, the following dosages are recommended: 4.2.2.1 DYSFUNCTIONAL BLEEDING The administration of 1 tablet Primolut N 3 times daily over 10 days leads to the arrest of uterine bleeding not associated with organic lesions within 1 -3 days. In individual cases, bleeding diminishes during the first few days after the commencement of tablet-taking and does not stop until about 5 days later. For the treatment to be successful, Primolut N administration should be continued regularly even after arrest of bleeding (up to a total of 30 tablets). About 2 -4 days after discontinuation of treatment a withdrawal bleeding will occur resembling a normal menstruation in intensity and duration. Primolut N PI_SG_CCDS 10_01 June 2018 Slight bleeding during tablet-taking Occasionally, slight bleeding may occur after initial arrest of bleeding. In these cases tablet-taking must not be interrupted. Missing arrest of haemorrhage. Heavy break through bleeding If the bleeding does not stop in spite of regular tablet taking, an organic cause must be considered. This applies also in cases where after initial arrest of haemorrhage, fairly heavy bleeding Прочитать полный документ