▶Risk factors for arterial diseaseUse withcautionif any one of
following factors present butavoidif two or more factors
present:
.family history of arterial diseaseinfirst degree relative
aged under 45 years (avoid if atherogenic lipid profile);
.diabetes mellitus(avoid if diabetes complications
present);
.hypertension; blood pressure abovesystolic 140 mmHgor
diastolic 90 mmHg(avoid if blood pressure abovesystolic
160 mmHgordiastolic 95 mmHg); (in adolescents, avoid
if blood pressure very high);
.smoking(avoid if smoking 40 or more cigarettes daily);
.ageover 35 years (avoid if over 50 years);
.obesity(avoid if body mass index 35 kg/m^2 unless no
suitable alternative); (in adolescents, caution if obese
according to BMI (adjusted for age and gender); in those
who are markedly obese, avoid unless no suitable
alternative);
.migraine without aura(avoid ifmigraine with aura(focal
symptoms),orsevere migraine frequently lasting over
72 hours despite treatment,ormigraine treated with
ergot derivatives).
▶MigraineWomen should report any increase in headache
frequency or onset of focal symptoms (discontinue
immediately and refer urgently to neurology expert if focal
neurological symptoms not typical of aura persist for more
than 1 hour).
Combined hormonal contraceptives should be stopped
(pending investigation and treatment), if serious
neurological effects occur, including unusual severe,
prolonged headache especially iffirst time or getting
progressively worseorsudden partial or complete loss of
visionorsudden disturbance of hearing or other
perceptual disordersordysphasiaorbad fainting attack or
collapseorfirst unexplained epileptic seizureorweakness,
motor disturbances, very marked numbness suddenly
affecting one side or one part of body.
lSIDE-EFFECTS
▶Common or very commonAcne.fluid retention.headaches
.menstrual cycle irregularities.nausea.weight increased
▶UncommonAlopecia.hypertension
▶Rare or very rareVenous thromboembolism
SIDE-EFFECTS, FURTHER INFORMATION
Breast cancerThere is a small increase in the risk of
having breast cancer diagnosed in women taking the
combined oral contraceptive pill; this relative risk may be
due to an earlier diagnosis. In users of combined oral
contraceptive pills the cancers are more likely to be
localised to the breast. The most important factor for
diagnosing breast cancer appears to be the age at which
the contraceptive is stopped rather than the duration of
use; any increase in the rate of diagnosis diminishes
gradually during the 10 years after stopping and
disappears by 10 years.
Cervical cancerUse of combined oral contraceptives for
5 years or longer is associated with a small increased risk of
cervical cancer; the risk diminishes after stopping and
disappears by about 10 years. The possible small increase
in the risk of breast cancer and cervical cancer should be
weighed against the protective effect against cancers of
the ovary and endometrium.lPREGNANCYNot known to be harmful.
lBREAST FEEDINGAvoid until weaning or for 6 months
after birth (adverse effects on lactation).
lHEPATIC IMPAIRMENTAvoid in active liver disease
including disorders of hepatic excretion (e.g. Dubin-
Johnson or Rotor syndromes), infective hepatitis (until
liver function returns to normal), liver tumours.
lDIRECTIONS FOR ADMINISTRATION
▶With oral useEach tablet should be taken at approximately
same time each day; if delayed, contraceptive protection
may be lost. 21 -day combined preparations, 1 tablet daily
for 21 days; subsequent courses repeated after a 7 -day
interval (during which withdrawal bleeding occurs); if
reasonably certain woman is not pregnant,first course can
be started on any day of cycle—if starting on day 6 of cycle
or later, additional precautions (barrier methods)
necessary duringfirst 7 days.Every day (ED) combined
preparations, 1 activetablet daily for 21 days, followed by 1
inactivetablet daily for 7 days; subsequent courses
repeated without interval (withdrawal bleeding occurs
wheninactivetablets being taken); if reasonably certain
woman is not pregnant,first course can be started on any
day of cycle—if starting on day 6 of cycle or later,
additional precautions (barrier methods) necessary during
first 7 days.
Changing to combined preparation containing different
progestogenIf previous contraceptive used correctly, or
pregnancy can reasonably be excluded, start thefirst active
tablet of new brand immediately. See individual
monographs for requirements of specific preparations.
Changing from progestogen-only tabletIf previous
contraceptive used correctly, or pregnancy can reasonably
be excluded, start new brand immediately, additional
precautions (barrier methods) necessary forfirst 7 days.
Secondary amenorrhoea (exclude pregnancy)Start any day,
additional precautions (barrier methods) necessary during
first 7 days ( 9 days forQlaira®).
After childbirth (not breast-feeding)Start 3 weeks after birth
(increased risk of thrombosis if started earlier); later than
3 weeks postpartum additional precautions (barrier
methods) necessary forfirst 7 days ( 9 days forQlaira®).
After abortion or miscarriageStart same day.
lPATIENT AND CARER ADVICE
TravelWomen taking oral contraceptives are at an
increased risk of deep vein thrombosis during travel
involving long periods of immobility (over 3 hours). The
risk may be reduced by appropriate exercise during the
journey and possibly by wearing graduated compression
hosiery.
Diarrhoea and vomitingVomiting and persistent, severe
diarrhoea can interfere with the absorption of combined
oral contraceptives. If vomiting occurs within 2 hours of
taking a combined oral contraceptive another pill should
be taken as soon as possible. In cases of persistent
vomiting or severe diarrhoea lasting more than 24 hours,
additional precautions should be used during and for
7 days after recovery. If the vomiting and diarrhoea occurs
during the last 7 tablets, the next pill-free interval should
be omitted (in the case of ED tablets the inactive ones
should be omitted).
Missed dosesThe critical time for loss of contraceptive
protection is when a pill is omitted at thebeginningorend
of a cycle (which lengthens the pill-free interval).
If a woman forgets to take a pill, it should be taken as
soon as she remembers, and the next one taken at the
normal time (even if this means taking 2 pills together). A
missed pill is one that is 24 or more hours late. If a woman
misses only one pill, she should take an active pill as soon
as she remembers and then resume normal pill-taking. No
additional precautions are necessary.
If a woman misses 2 or more pills (especially from the
first 7 in a packet), she may not be protected. She should
take an active pill as soon as she remembers and then
resume normal pill-taking. In addition, she must either
abstain from sex or use an additional method of
contraception such as a condom for the next 7 days. If
these 7 days run beyond the end of the packet, the next
packet should be started at once, omitting the pill-free
interval (or, in the case ofeveryday(ED) pills, omitting the
7 inactive tablets).
Emergency contraception is recommended if 2 or more
combined oral contraceptive tablets are missed from theBNFC 2018 – 2019 Contraception, combined 499
Genito-urinary system7