Norethisterone with mestranol

Source: UK SPC for Norinyl-1 via MHRA Products. SPC §2: 'Each tablet contains 1 milligram norethisterone and 50 micrograms mestranol' (also 41.47 mg lactose as monohydrate). §4.1: 'Norinyl-1 is indicated for oral contraception.' §4.2 (verbatim): 'The dosage of Norinyl-1 for the initial cycle of therapy is 1 tablet taken at the same time each day from the first day of the menstrual cycle. For subsequent cycles, no tablets are taken for 7 days, then a new course is started of 1 tablet daily for the next 21 days. This sequence of 21 days on treatment, seven days off treatment is repeated for as long as contraception is required.' Starting day: 'Patients unable to start taking Norinyl-1 tablets on the first day of the menstrual cycle may start treatment on any day up to and including the 5th day of the menstrual cycle'; patients starting on day 1 are protected at once, those delaying to day 5 may not be protected immediately and another method of contraception is recommended for the first 7 days of tablet-taking (condoms, caps plus spermicides, intra-uterine devices; the rhythm, temperature and cervical-mucus methods should not be relied upon). Missed tablets: if a tablet is missed within 12 hours of the correct dosage time, take it as soon as possible, even if this means taking 2 tablets on the same day. If one or more tablets are missed for more than 12 hours, take the last missed tablet as soon as possible, continue the rest in the normal manner, and use extra contraceptive protection (e.g. a condom) for the next 7 days. Patients who have missed one or more of the last 7 tablets in a pack should start the next pack as soon as the present one has finished (without the normal seven day gap). Changing from another oral contraceptive: take the first dose of Norinyl-1 on the day immediately after finishing the previous pack. After childbirth (not breast feeding): first dose on the 21st day after childbirth; if the first dose is delayed, contraception may not be established until 7 days after the first tablet and extra contraceptive methods will be necessary. After a miscarriage or abortion: first dose the next day, with immediate protection. Vomiting or diarrhoea (gastro-intestinal upsets) may interfere with absorption and reduce contraceptive efficacy: continue the tablets but also use another contraceptive method during the upset and for the next 7 days (§4.4). Some drugs may modify the metabolism of Norinyl-1 and reduce effectiveness (certain sedatives, antibiotics, anti-epileptic and anti-arthritic drugs): use mechanical contraception as well while such agents are used (§4.5). Discontinue at least four weeks before, and for two weeks following, elective operations and during immobilisation; after injection treatment for varicose veins do not resume until 3 months after the last injection (§4.4). After the age of thirty-five years the patient and physician should carefully re-assess the risk/benefit ratio of combined hormonal contraceptives (§4.4). Patients who are fully breast-feeding should not take Norinyl-1 (§4.6). The SPC §4.2 gives no maximum dose and no separate paediatric or elderly dosing. TRUNCATION: the retrieved §4.4 text is cut off at the source-fetch limit, so any later §4.4 warnings were not retrieved.