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Ethinylestradiol with norethisterone oral


Tablets containing ethinylestradiol and norethisterone

Drugs List

  • BREVINOR tablets
  • norethisterone 1mg and ethinylestradiol 35microgram tablets
  • norethisterone 500microgram and ethinylestradiol 35microgram tablets
  • norethisterone 500microgram and ethinylestradiol 35microgram tablets and norethisterone 1mg and ethinylestradiol 35microgram tablets and norethisterone 500microgram and ethinylestradiol 35microgram tablets
  • NORIMIN tablets
  • SYNPHASE tablets
  • Therapeutic Indications


    Oral contraception - oestrogen and progestogen



    Regardless of the preparation, tablet-taking should be initiated on the first day of menstruation. If menstruation has already started then the first tablet may be taken up to and including day 5 of the menstrual cycle, in this case additional (non-hormonal) contraceptive precautions are required for the first 7 days. One tablet to be taken daily at the same time (preferably evening) without interruption for 21 days, followed by a break of 7 days. Subsequent packs are started after the 7 tablet-free day interval. Sequential preparation should be taken in the order directed on the package.
    After childbirth (not breastfeeding) or 2nd trimester abortion or miscarriage Tablet taking can start 21 days after a vaginal delivery provided that the patient is fully ambulant and there are no puerperal complications (increased risk of thrombosis if started earlier). If the tablets are started later than 21 days after delivery, alternative (non-hormonal) methods of contraception are required for the first 7 days of tablet-taking. Since the first post-partum ovulation may precede the first bleeding, another method of contraception should be used in the interval between childbirth and the first course of tablets. If unprotected intercourse has taken place during this period, then pregnancy should be excluded or the woman should wait for her first menstrual period before tablet taking may commence. After 1st trimester abortion or miscarriage After a first trimester abortion or miscarriage, oral contraception may be started immediately in which case no additional contraceptive precautions are required. Changing from a combined oral contraceptive pill All active tablets in the current previous combined oral contraceptive pack should be finished. The first new tablet should be taken the next day, or at the latest the day after usual tablet-free (or placebo) period. No additional contraceptive precautions are required. Any inactive tablets should be discarded. Changing from a combined hormonal contraceptive vaginal ring or transdermal patch The first tablet should be taken on the day of removal, but no later than when the next application would have been due. Changing from a progestogen-only pill The first tablet may be taken on any day, additional (non-hormonal) contraceptive precautions should be taken for the first 7 days of tablet-taking. If the tablet is taken on the first day of menstruation no additional contraception is required. Changing from a progestogen implant, injection or intrauterine system (IUS) The first tablet should be taken on the day the implant or IUS is due for removal or the next injection is due. Additional (non-hormonal) contraceptive precautions should be taken for the first 7 days of tablet-taking.

    Additional Dosage Information

    Missed tablets
    It is important to bear in mind that the critical time for loss of protection is when a tablet is omitted at the beginning or end of a cycle (and therefore the tablet-free interval is lengthened). A missed tablet is defined as being 12 hours or more late. Advise patients that missing tablets or starting the pack late may make the tablet less effective. The missed tablet should be taken as soon as remembered, even if this means taking 2 tablets at the same time. The remaining tablets in the pack should be taken at the usual time and the next pack should be started as soon as the current pack is finished i.e. no tablet-free interval. A non-hormonal method of contraception is required for the next 7 days. If intercourse took place in the preceding 7 days, the possibility of pregnancy should be considered If two or more tablets are missed (i.e. more than 48 hours late) anywhere in the pack, then the patient should: Take last missed tablet as soon as remembered, even if it means taking 2 tablets at the same time and leave any earlier missed tablets. Continue taking the rest of the pack as usual and use an additional (non-hormonal) method of contraception for the next 7 days. Emergency contraception may be needed. The next pack of tablets may be needed to be taken without a break. Emergency Contraception If unprotected sexual intercourse has taken place in the previous 7 days and two or more tablets have been missed (i.e. more than 48 hours late) in the first week of a pack, emergency contraception may be needed. Advise the patient to seek guidance from a contraception clinic, family doctor or a pharmacist. Diarrhoea and vomiting Vomiting up to 4 hours after taking a dose or severe diarrhoea can interfere with absorption and limit effectiveness. Another tablet should be taken as soon as possible. If more than 12 hours� elapse from the usual time of tablet-taking then the missed tablet advice should be taken. Additional precautions should therefore be used during and for 7 days after recovery. Other methods of contraception should be considered if the gastro-intestinal disorder is likely to be prolonged.


    Family history of thromboembolic disorder
    Multiple risk factors for thromboembolic disease
    Predisposition to thromboembolic disease
    Abnormal liver function test
    Atherogenic lipid profile
    Breast cancer
    Breastfeeding - until weaning or 6 months post partum
    Cerebral ischaemia
    Female genital neoplasm
    Focal migraine
    Hepatic neoplasm
    History of breast cancer
    History of hormone dependent neoplasm
    History of thromboembolic disorder
    Ischaemic heart disease
    Oestrogen dependent neoplasm
    Severe hypertension
    Undiagnosed gynaecological haemorrhage
    Venous thromboembolism

    Precautions and Warnings

    Females over 35 years
    History of chorea during pregnancy
    Prolonged immobilisation
    Recent major surgery
    Risk factor for oestrogen-dependent neoplasm
    Tobacco smoking
    Atrial fibrillation
    Cardiac valvulopathy
    Cardiovascular disorder
    Diabetes mellitus
    Epileptic disorder
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    History during pregnancy of pemphigoid gestationis
    History of chloasma
    History of cholelithiasis
    History of cholestatic jaundice during pregnancy
    History of haemolytic uraemic syndrome
    History of migraine
    History of pregnancy-related deterioration in otosclerosis
    History of pruritus during pregnancy
    History of severe depression
    History of steroid induced jaundice
    Inflammatory bowel disease
    Lactose intolerance
    Multiple sclerosis
    Non focal aura migraine
    Recent trophoblastic disorder
    Renal impairment
    Sickle cell disease
    Systemic lupus erythematosus
    Uterine fibroids

    Assess family medical history prior to commencing treatment
    Exclude breast cancer before treatment
    Exclude oestrogen dependent neoplasm before treatment
    Pre-treatment medical history and clinical examination
    Contains lactose
    Some brands contain Sunset Yellow (E110) - can trigger allergic reactions
    Some formulations contain sucrose
    Resume use only after 2wks full ambulation from surgery/immobilisation
    If upper abdominal complaints/liver enlargement consider liver tumour
    Monitor blood glucose closely in patients with diabetes mellitus
    Monitor patients with a history of depression and/or suicide attempts
    Advise patients/carers to seek medical advice if changes in behaviour/mood
    Increased risk of VTE during travel involving >5hr immobilisation
    Vomiting or severe diarrhoea may impair efficacy
    May affect results of some laboratory tests
    Discontinue 4 - 6 weeks before major surgery
    Advise patient to seek advice at first indications of pregnancy
    Discontinue at first signs of jaundice, hepatitis or whole body itching
    Discontinue if depression worsens or recurs
    Discontinue if epilepsy is exacerbated
    Discontinue if hypertension develops
    Discontinue if liver function tests become abnormal
    Discontinue if sudden, severe pain in stomach occurs
    Discontinue if symptoms of cerebrovascular accident occur
    Discontinue if symptoms of deep vein thrombosis occur
    Discontinue if symptoms of pulmonary embolism occur
    Discontinue of symptoms of myocardial infarction occur
    Advise patient grapefruit products may increase plasma level
    Advise patient concurrent St John's wort may reduce contraceptive effect
    All contraceptive pills slightly increase the risk of breast cancer
    Ensure patient is informed of risks of treatment
    Treatment does not protect against risk of sexually transmitted disease
    Women with a history of chloasma should avoid exposure to sun/UV light

    Patients should be individually assessed before commencing combined oral contraceptives and at regular intervals thereafter. Assessment should include personal and family history which should then guide physical examination. Parameters to be measured should include blood pressure, weight and body mass index (BMI) and if judged appropriate by the clinician, breast, abdominal examination, pelvic examination and cervical cytology. Specific attention should be given to conditions associated with increased risk of adverse events including migraine and cardiovascular risk factors such as obesity, smoking, hypertension, thrombophilia, hyperlipidaemia and previous venous thromboembolism. The use of any combined hormonal contraceptive increases the risk of venous thromboembolism (VTE) and arterial thromboembolism (ATE) compared with no use. Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE. Other products may have up to twice this level of risk. The risk is greatest in the first year of use. There is also some evidence that the risk is increased when a combined hormonal contraceptive is restarted after a break in use of 4 weeks or more. Combined hormonal contraceptives are contraindicated in patients with multiple risk factors for VTE and/or ATE. If the patient has more than one risk factor, it is possible that the increased risk is greater than the sum of the individual factors, in this case the total risk should be considered. If the risk outweighs the benefit, then a combined hormonal contraceptive should not be prescribed. Risk factors for venous thromboembolism Obesity; prolonged immobilisation, major surgery (especially to the legs or pelvis), major trauma; family history of venous thromboembolism (especially at a relatively early age); cancer; systemic lupus erythematosus; haemolytic uraemic syndrome; chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), sickle cell disease and increasing age (particularly above 35 years). Risk factors for arterial thromboembolism Increasing age (particularly above 35 years); smoking; hypertension; obesity; family history of arterial thromboembolism (especially at a relatively early age); migraine; diabetes mellitus, valvular heart disease; atrial fibrillation; dyslipoproteinaemia and systemic lupus erythematosus Should the patient develop symptoms of VTE or ATE, then the combined hormonal contraceptive should be discontinued. Breast cancer There is an increased risk of breast cancer with combined oral contraceptive (COC) use. Breast cancer is rare among women under 40 years of age whether or not they take COC. The most important risk factor for breast cancer in COC users is the age at which women discontinue the COC; the older the age at stopping the more breast cancers are diagnosed. Duration of use is less important and the excess risk gradually disappears during the course of the 10 years after stopping COC use such that by 10 years there appears to be no excess.

    Pregnancy and Lactation


    Ethinylestradiol with norethisterone is contraindicated in pregnancy. Pregnancy must be excluded before starting treatment and the preparation should be withdrawn immediately if pregnancy occurs while taking oral contraception. It has been suggested by some investigations that oral contraceptives taken in early pregnancy may slightly increase the risk of foetal malformations, such as cardiovascular defects, eye and ear anomalies and increased frequency of Down's syndrome, although other studies have failed to support these findings. The possibility cannot be excluded, but it is certain that if a risk exists at all, it is very small.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Ethinylestradiol with norethisterone is contraindicated in breastfeeding. The use of this preparation may lead to reduction in the volume of milk produced and to a change in its composition. Very small amounts of the active substances may be excreted in the milk. Combined oral contraceptives should be avoided until weaning (or at least 6 months post partum). Oral progestogen-only pills are preferred.
    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at


    Advise patients that taking St Johns Wort may reduce contraceptive efficacy. Advise patients to take the tablets at the same time each day (preferably in the evening). Advise patient that consuming grapefruit products may increase plasma level of the drug.

    Advise patients/carers to seek medical advice if changes in behaviour/ mood.
    If unprotected sexual intercourse has taken place in the previous 7 days and two or more tablets have been missed (i.e. more than 48 hours late) in the first week of a pack, emergency contraception may be needed. Advise patient to get advice from contraception clinic, family doctor or a pharmacist about this. When additional contraceptive precautions are required, advise patients either not to have sex or to use a cap plus spermicide, or for her partner to use a condom. Rhythm methods are not advisable as the pill disrupts the usual cyclical changes associated with the natural menstrual cycle.

    Side Effects

    "Spotting" bleeds (early cycles)
    Abdominal pain
    Absence of withdrawal bleeding
    Breast enlargement
    Breast pain
    Breast secretion
    Breast tenderness
    Cardiovascular accident
    Cerebrovascular accident
    Changes in cervical secretion
    Changes in libido
    Chest pain
    Cholestatic jaundice
    Coagulation disorders
    Contact lenses may irritate
    Cough (with blood stained sputum)
    Decreased glucose tolerance
    Deep vein thrombosis (DVT)
    Endometriosis (aggravation of)
    Epileptic seizures
    Erythema multiforme
    Erythema nodosum
    Fluid retention
    Hepatic impairment
    Hepatic tumours
    Increased blood pressure
    Increased risk of breast cancer
    Increased risk of cervical cancer
    Increased size of uterine fibroids
    Intermenstrual bleeding
    Menstrual bleeding decreased
    Mood changes
    Motor disturbances
    Pain in calf
    Post medication amenorrhoea
    Pulmonary embolism
    Skin reactions
    Suppression of lactation post-partum
    Systemic lupus erythematosus
    Visual disturbances
    Weight changes

    Effects on Laboratory Tests

    A large number of laboratory tests may be affected by combined oral contraceptives, predominantly by the oestrogenic component. These include: Biochemical parameters of thyroid, hepatic, adrenal and renal function; Plasma levels of carrier proteins and lipid/lipoprotein fractions; Parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. Changes generally remain within the normal laboratory range. Laboratory technicians should be made aware of patients who are receiving oral contraception, so that any effects on the above tests can be taken into consideration.


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: January 2017

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Joint Formulary Committee. British National Formulary. 72nd ed. London: BMJ Group and Pharmaceutical Press; 2016. Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas. Summary of Product Characteristics: Brevinor Tablets. Pfizer Limited. Revised April 2019. Summary of Product Characteristics: Loestrin 20. Galen Limited. Revised February 2019.
    Summary of Product Characteristics: Loestrin 30. Galen Limited. Revised February 2019.
    Summary of Product Characteristics: Norimin Tablets. Pfizer Limited. Revised April 2019.
    Summary of Product Characteristics: Synphase Tablets. Pfizer Limited. Revised April 2019.

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