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NORINYL-1 is a brand name for Norethindrone (also known as Norethisterone). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Norinyl-1 is indicated for oral contraception.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology 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. 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 of their period will be protected at once. Those patients delaying therapy up to day 5 may not be protected immediately and it is recommended that another method of contraception is used for the first 7 days of tablet-taking.
Suitable methods are condoms, caps plus spermicides and intra-uterine devices. The rhythm, temperature and cervical-mucus methods should not be relied upon. Tablet omissions Tablets must be taken daily in order to maintain adequate hormone levels and contraceptive efficacy.
If a tablet is missed within 12 hours of the correct dosage time then the missed tablet should be taken as soon as possible, even if this means taking 2 tablets on the same day, this will ensure that contraceptive protection is maintained.
If one or more tablets are missed for more than 12 hours from the correct dosage time it is recommended that the patient takes the last missed tablet as soon as possible and then continues to take the rest of the tablets in the normal manner.
In addition, it is recommended that extra contraceptive protection, such as a condom, is used for the next 7 days. e. without the normal seven day gap between treatments). This reduces the risk of contraceptive failure resulting from tablets being missed close to a 7 day tablet free period.
Changing from another oral contraceptive In order to ensure that contraception is maintained it is advised that the first dose of Norinyl-1 tablets is taken on the day immediately after the patient has finished the previous pack of tablets.
Use after childbirth, miscarriage or abortion Providing the patient is not breast feeding the first dose of Norinyl-1 tablets should be taken on the 21st day after childbirth. This will ensure the patient is protected immediately. If there is any delay in taking the first dose, contraception may not be established until 7 days after the first tablet has been taken.
As with all oral contraceptives, there may be slight nausea at first, weight gain or breast discomfort, which soon disappear. Other side-effects known or suspected to occur with oral contraceptives include gastro-intestinal symptoms, changes in libido and appetite, headache, exacerbation of existing uterine fibroid disease, depression, and changes in carbohydrate, lipid and vitamin metabolism.
Spotting or bleeding may occur during the first few cycles. Usually menstrual bleeding becomes light and occasionally there may be no bleeding during the tablet-free days. Hypertension, which is usually reversible on discontinuing treatment, has occurred in a small percentage of women taking oral contraceptives.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Assessment of women prior to starting oral contraceptives (and at regular intervals thereafter) should include a personal and family medical history of each woman. 4) for this product. The frequency and nature of these assessments should be based upon relevant guidelines and should be adapted to the individual woman, but should include measurement of blood pressure and, if judged appropriate by the clinician, breast, abdominal and pelvic examination including cervical cytology.
Women taking oral contraceptives require careful observation if they have or have had any of the following conditions: breast nodules; fibrocystic disease of the breast or an abnormal mammogram; uterine fibroids; a history of severe depressive states; varicose veins; sickle-cell anaemia; diabetes; hypertension; cardiovascular disease; migraine; epilepsy; asthma; otosclerosis; multiple sclerosis; porphyria; tetany; disturbed liver functions; gallstones; kidney disease; chloasma; any condition that is likely to worsen during pregnancy.
The worsening or first appearance of any of these conditions may indicate that the oral contraceptive should be stopped. Discontinue treatment if there is a gradual or sudden, partial or complete loss of vision or any evidence of ocular changes, onset or aggravation of migraine or development of headache of a new kind which is recurrent, persistent or severe.
Gastro-intestinal upsets, such as vomiting and diarrhoea, may interfere with the absorption of the tablets leading to a reduction in contraceptive efficacy. Patients should continue to take Norinyl-1, but they should also be encouraged to use another contraceptive method during the period of gastro-intestinal upset and for the next 7 days.
Progestogen oestrogen preparations should be used with caution in patients with a history of hepatic dysfunction or hypertension. Risk of venous thromboembolism (VTE) The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use.
1. As with all combined progestogen/oestrogen hormonal contraceptives, the following conditions should be regarded as contra-indications: i. History of confirmed venous thromboembolic disease (VTE), family history of idiopathic VTE and other known risk factors of VTE ii.
Thrombophlebitis, cerebrovascular disorders, coronary artery disease, myocardial infarction, angina, hyperlipidaemia or a history of these conditions. iii. Acute or severe chronic liver disease, including liver tumours, Dubin-Johnson or Rotor syndrome.
iv. History during pregnancy of idiopathic jaundice, severe pruritus or pemphigoid gestationis. v. Known or suspected breast or genital cancer vi. Known or suspected oestrogen-dependent neoplasia vii. Undiagnosed abnormal vaginal bleeding viii.
A history of migraines classified as classical focal or crescendo ix. Pregnancy x. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Norethindrone in United Kingdom.
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In these circumstances patients should be advised that extra contraceptive methods will be necessary. After a miscarriage or abortion patients can take the first dose of Norinyl-1 tablets on the next day; in this way they will be protected immediately.
Method of administration Oral administration
Products that contain norethisterone (including Norinyl-1) are associated with the lowest risk of VTE. The decision to use Norinyl-1 should be taken after a discussion with the woman to ensure she understands the risk of VTE with Norinyl-1, how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use.
There is also some evidence that the risk is increased when a CHC is re-started after a break in use of 4 weeks or more. In women who do not use a CHC and are not pregnant about 2 out of 10,000 will develop a VTE over the period of one year.
However, in any individual woman the risk may be far higher, depending on her underlying risk factors (see below). It is estimated that out of 10,000 women who use a low dose CHC that contains levonorgestrel, about 61 will develop a VTE in one year.
Current evidence suggests that the risk of VTE with use of norethisterone-containing CHCs is similar to the risk with levonorgestrel-containing CHCs. This number of VTEs per year is fewer than the number expected in women during pregnancy or in the postpartum period.
VTE may be fatal in 1-2% of cases. Number of VTE events per 10,000 women in one year The level of all of these risks of VTE increases with age and is likely to be further increased in women with other known risk factors for VTE such as obesity).
Patients receiving oral contraceptives should be kept under regular surveillance, in view of the possibility of development of such conditions as thromboembolism. The risk of coronary artery disease in women taking oral contraceptives is increased by the presence of other predisposing factors such as cigarette smoking, hypercholesterolemia, obesity, diabetes, history of pre-eclamptic toxaemia and increasing age.
After the age of thirty-five years, the patient and physician should carefully re-assess the risk/benefit ratio of using combined hormonal contraceptives as opposed to alternative methods of contraception. Norinyl-1 should be discontinued at least four weeks before, and for two weeks following, elective operations and during immobilisation.
Patients undergoing injection treatment for varicose veins should not resume taking Norinyl-1 until 3 months after the last injection. 6. Benign and malignant liver tumours have been associated with oral contraceptive use. The relationship between occurrence of liver tumours and use of female sex hormones is not known at present.
These tumours may rupture causing intra-abdominal bleeding. If the patient presents with a mass or tenderness in the right upper quadrant or an acute abdomen, the possible presence of a tumour should be considered. The risk of arterial thrombosis associated with combined hormonal contraceptives increases with age, and this risk is aggravated by cigarette smoking.
The use of combined hormonal contraceptives by women in the older age group, especially those who are cigarette smokers, should therefore be discouraged and alternative methods advised. The use of this product in patients suffering from epilepsy, migraine, asthma or cardiac dysfunction may result in exacerbation of these disorders because of fluid retention.
Caution should also be observed in patients who wear contact lenses. Decreased glucose tolerance may occur in diabetic patients on this treatment, and their control must be carefully supervised. The use of oral contraceptives has also been associated with a possible increased incidence of gall bladder disease.
Women with a history of oligomenorrhoea or secondary amenorrhoea or young women without regular cycles may have a tendency to remain anovulatory or to become amenorrhoeic after discontinuation of oral contraceptives. Women with […]