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. Every day (ED) combined

preparations, 1 active tablet daily for 21 days, followed by 1

inactive tablet daily for 7 days; subsequent courses

repeated without interval (withdrawal bleeding occurs

when inactive tablets 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

progestogen If previous contraceptive used correctly, or

pregnancy can reasonably be excluded, start the first active

tablet of new brand immediately. See individual

monographs for requirements of specific preparations.

Changing from progestogen-only tablet If previous

contraceptive used correctly, or pregnancy can reasonably

be excluded, start new brand immediately, additional

precautions (barrier methods) necessary for first 7 days.

Secondary amenorrhoea (exclude pregnancy) Start any day,

additional precautions (barrier methods) necessary during

first 7 days (9 days for Qlaira ®).

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 for first 7 days (9 days for Qlaira ®).

After abortion or miscarriage Start same day.

l PATIENT AND CARER ADVICE

Travel Women taking oral contraceptives or using the

patch or vaginal ring 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 vomiting Vomiting and severe diarrhoea can

interfere with the absorption of combined oral

contraceptives. The FSRH advises following the

instructions for missed pills if vomiting occurs within

3 hours of taking a combined oral contraceptive or severe

diarrhoea occurs for more than 24 hours. Use of non-oral

contraception should be considered if diarrhoea or

vomiting persist.

Missed doses The critical time for loss of contraceptive

protection is when a pill is omitted at the beginning or end

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 of everyday (ED) pills, omitting the

7 inactive tablets).

Emergency contraception is recommended if 2 or more

combined oral contraceptive tablets are missed from the

first 7 tablets in a packet and unprotected intercourse has

occurred since finishing the last packet.

eiiiF 795i

Dienogest with estradiol valerate

l INDICATIONS AND DOSE

Contraception with 28-day combined preparations |

Menstrual symptoms with 28-day combined

preparations

▶ BY MOUTH

▶ Females of childbearing potential: 1 active tablet daily for

26 days, followed by 1 inactive tablet daily for 2 days, to

be started on day 1 of cycle with first active tablet

(withdrawal bleeding may occur during the 2-day

interval of inactive tablets); subsequent courses

repeated without interval

l INTERACTIONS → Appendix 1: combined hormonal

contraceptives

l SIDE-EFFECTS

▶ Common or very common Breast abnormalities . gastrointestinal discomfort. increased risk of infection . menstrual cycle irregularities

▶ Uncommon Appetite increased . cervical abnormalities . crying . depression . diarrhoea . dizziness . fatigue . haemorrhage . hot flush . hyperhidrosis . mood altered . muscle spasms . neoplasms . oedema . ovarian and

fallopian tube disorders . painful sexual intercourse . pelvic

disorders . sexual dysfunction . skin reactions . sleep

disorders . uterine cramps . vomiting . vulvovaginal

disorders . weight decreased

▶ Rare or very rare Aggression . anxiety . arterial

thromboembolism . asthma . chest pain . cholecystitis

chronic . concentration impaired . constipation . contact

lens intolerance . dry eye . dry mouth . dyspnoea . eye

swelling .fever. galactorrhoea . gastrooesophageal reflux

disease . genital discharge . hair changes . hypertriglyceridaemia . hypotension . lymphadenopathy . malaise . myocardial infarction . pain . palpitations . paraesthesia . seborrhoea . sensation of pressure . urinary

tract pain . vascular disorders . vertigo

l DIRECTIONS FOR ADMINISTRATION

Changing to Qlaira® Start the first active Qlaira ® tablet on

the day after taking the last active tablet of the previous

brand.

l PATIENT AND CARER ADVICE

Diarrhoea and vomiting In cases of persistent vomiting or

severe diarrhoea lasting more than 12 hours in women

taking Qlaira ®, refer to product literature.

Missed doses A missed pill for a patient taking Qlaira ® is

one that is 12 hours or more late; for information on how

to manage missed pills in women taking Qlaira ®, refer to

product literature.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

▶ Qlaira (Bayer Plc)

Qlaira tablets | 84 tablet P £25.18

eiiiF 795i

Estradiol with nomegestrol

l INDICATIONS AND DOSE

Contraception

▶ BY MOUTH

▶ Females of childbearing potential: 1 active tablet daily for

24 days, followed by 1 inactive tablet daily for 4 days, to

be started on day 1 of cycle with first active tablet

(withdrawal bleeding occurs when inactive tablets

being taken); subsequent courses repeated without

interval

BNF 78 Contraception, combined 797

Genito-urinary system

7

l INTERACTIONS → Appendix 1: combined hormonal

contraceptives

l SIDE-EFFECTS

▶ Common or very common Breast abnormalities . depression . menstrual cycle irregularities . mood altered . pelvic pain . sexual dysfunction

▶ Uncommon Abdominal distension . appetite abnormal . galactorrhoea . hot flush . hyperhidrosis . oedema . painful

sexual intercourse . seborrhoea . sensation of pressure . skin reactions . uterine cramps . vulvovaginal disorders

▶ Rare or very rare Cerebrovascular insufficiency . concentration impaired . contact lens intolerance . dry eye . dry mouth . gallbladder disorders . hypertrichosis

l PREGNANCY Toxicity in animal studies.

l DIRECTIONS FOR ADMINISTRATION Zoely ® (every day (ED)

combined (monophasic) preparation), 1 active tablet daily

for 24 days, followed by 1 inactive tablet daily for 4 days,

starting on day 1 of cycle with first active tablet;

subsequent courses repeated without interval (withdrawal

bleeding occurs when inactive tablets being taken).

Changing to Zoely® Start the first active Zoely ® tablet on the

day after taking the last active tablet of the previous brand

or, at the latest, the day after the tablet-free or inactive

tablet interval of the previous brand.

l PATIENT AND CARER ADVICE

Diarrhoea and vomiting In cases of persistent vomiting or

severe diarrhoea lasting more than 12 hours in women

taking Zoely ®, refer to product literature.

Missed doses A missed pill for a patient taking Zoely ® is

one that is 12 hours or more late; for information on how

to manage missed pills in women taking Zoely ®, refer to

product literature.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

▶ Zoely (Merck Sharp & Dohme Ltd) A

Estradiol (as Estradiol hemihydrate) 1.5 mg, Nomegestrol acetate

2.5 mg Zoely 2.5mg/1.5mg tablets | 84 tablet P £19.80 DT =

£19.80

eiiiF 795i

Ethinylestradiol with desogestrel

l INDICATIONS AND DOSE

Contraception with 21-day combined preparations |

Menstrual symptoms with 21-day combined

preparations

▶ BY MOUTH

▶ Females of childbearing potential: 1 tablet once daily for

21 days; subsequent courses repeated after 7-day

interval, withdrawal bleeding occurs during the 7-day

interval, 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, tablets should be taken at approximately the

same time each day

l INTERACTIONS → Appendix 1: combined hormonal

contraceptives

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

▶ Alenvona (Teva UK Ltd)

Ethinylestradiol 30 microgram, Desogestrel

150 microgram Alenvona 150microgram/30microgram tablets | 63 tablet P £6.13 DT = £4.19

▶ Bimizza (Morningside Healthcare Ltd)

Ethinylestradiol 20 microgram, Desogestrel

150 microgram Bimizza 150microgram/20microgram tablets | 63 tablet P £5.04 DT = £5.08

▶ Cimizt (Morningside Healthcare Ltd)

Ethinylestradiol 30 microgram, Desogestrel

150 microgram Cimizt 30microgram/150microgram tablets | 63 tablet P £3.80 DT = £4.19

▶ Gedarel (Consilient Health Ltd)

Ethinylestradiol 20 microgram, Desogestrel

150 microgram Gedarel 20microgram/150microgram tablets | 63 tablet P £5.08 DT = £5.08

Ethinylestradiol 30 microgram, Desogestrel

150 microgram Gedarel 30microgram/150microgram tablets |

63 tablet P £4.19 DT = £4.19

▶ Marvelon (Merck Sharp & Dohme Ltd)

Ethinylestradiol 30 microgram, Desogestrel

150 microgram Marvelon tablets | 63 tablet P £7.10 DT = £4.19

▶ Mercilon (Merck Sharp & Dohme Ltd)

Ethinylestradiol 20 microgram, Desogestrel

150 microgram Mercilon 150microgram/20microgram tablets | 63 tablet P £8.44 DT = £5.08

▶ Munalea (Lupin Healthcare (UK) Ltd)

Ethinylestradiol 20 microgram, Desogestrel

150 microgram Munalea 150microgram/20microgram tablets | 63 tablet P £5.07 DT = £5.08

Ethinylestradiol 30 microgram, Desogestrel

150 microgram Munalea 150microgram/30microgram tablets | 63 tablet P £4.18 DT = £4.19

eiiiF 795i

Ethinylestradiol with drospirenone

l INDICATIONS AND DOSE

Contraception with 21-day combined preparations |

Menstrual symptoms with 21-day combined

preparations

▶ BY MOUTH

▶ Females of childbearing potential: 1 tablet once daily for

21 days; subsequent courses repeated after 7-day

interval, withdrawal bleeding occurs during the 7-day

interval

l INTERACTIONS → Appendix 1: combined hormonal

contraceptives

l SIDE-EFFECTS

▶ Common or very common Breast abnormalities . depressed

mood . increased risk of infection . menstrual disorder. vaginal discharge

▶ Uncommon Diarrhoea . hypotension . sexual dysfunction . skin reactions . vomiting . weight decreased

▶ Rare or very rare Arterial thromboembolism . asthma . erythema nodosum . hearing impairment

l PATIENT AND CARER ADVICE

Pill-free interval Withdrawal bleeding can occur during the

7-day tablet-free interval.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

▶ Dretine (Theramex HQ UK Ltd)

Ethinylestradiol 30 microgram, Drospirenone 3 mg Dretine

0.03mg/3mg tablets | 63 tablet P £8.34 DT = £14.70

▶ ELOINE (Bayer Plc)

Ethinylestradiol 20 microgram, Drospirenone 3 mg Eloine

0.02mg/3mg tablets | 84 tablet P £14.70 DT = £14.70

▶ Lucette (Consilient Health Ltd)

Ethinylestradiol 30 microgram, Drospirenone 3 mg Lucette

0.03mg/3mg tablets | 63 tablet P £9.35 DT = £14.70

▶ Yacella (Morningside Healthcare Ltd)

Ethinylestradiol 30 microgram, Drospirenone 3 mg Yacella

0.03mg/3mg tablets | 63 tablet P £8.30 DT = £14.70

▶ Yasmin (Bayer Plc)

Ethinylestradiol 30 microgram, Drospirenone 3 mg Yasmin

tablets | 63 tablet P £14.70 DT = £14.70

▶ Yiznell (Lupin Healthcare (UK) Ltd)

Ethinylestradiol 30 microgram, Drospirenone 3 mg Yiznell

0.03mg/3mg tablets | 63 tablet P £8.30 DT = £14.70

798 Contraception BNF 78

Genito-urinary system

7

eiiiF 795i

Ethinylestradiol with etonogestrel

l INDICATIONS AND DOSE

Contraception | Menstrual symptoms

▶ BY VAGINA

▶ Females of childbearing potential: 1 unit, insert the ring

into the vagina on day 1 of cycle and leave in for

3 weeks; remove ring on day 22; subsequent courses

repeated after 7-day ring free interval (during which

withdrawal bleeding occurs)

l INTERACTIONS → Appendix 1: combined hormonal

contraceptives

l DIRECTIONS FOR ADMINISTRATION

Changing method of contraception to vaginal ring

Changing from combined hormonal contraception Insert ring at

the latest on the day after the usual tablet-free, patch-free,

or inactive-tablet interval. If previous contraceptive used

correctly, or pregnancy can reasonably be excluded, can

switch to ring on any day of cycle.

Changing from progestogen-only method From an implant or

intra-uterine progestogen-only device, insert ring on the

day implant or intra-uterine progestogen-only device

removed; from an injection, insert ring when next

injection due; from oral preparation, first ring may be

inserted on any day after stopping pill. For all methods

additional precautions (barrier methods) should be used

concurrently for first 7 days.

l PATIENT AND CARER ADVICE Patients or carers should be

given advice on how to administer vaginal ring.

Counselling The presence of the ring should be checked

regularly.

Missed doses

Expulsion, delayed insertion or removal, or broken vaginal

ring If the vaginal ring is expelled for less than 3 hours,

rinse the ring with cool water and reinsert immediately; no

additional contraception is needed.

If the ring remains outside the vagina for more than

3 hours or if the user does not know when the ring was

expelled, contraceptive protection may be reduced:

. If ring expelled during week 1 or 2 of cycle, rinse ring

with cool water and reinsert; use additional precautions

(barrier methods) for next 7 days;

. If ring expelled during week 3 of cycle, either insert a

new ring to start a new cycle or allow a withdrawal bleed

and insert a new ring no later than 7 days after ring was

expelled; latter option only available if ring was used

continuously for at least 7 days before expulsion.

If insertion of a new ring at the start of a new cycle is

delayed, contraceptive protection is lost. A new ring

should be inserted as soon as possible; additional

precautions (barrier methods) should be used for the first

7 days of the new cycle. If intercourse occurred during the

extended ring-free interval, pregnancy should be

considered.

No additional contraception is required if removal of the

ring is delayed by up to 1 week (4 weeks of continuous

use). The 7-day ring-free interval should be observed and

subsequently a new ring should be inserted. Contraceptive

protection may be reduced with continuous use of the ring

for more than 4 weeks—pregnancy should be ruled out

before inserting a new ring.

If the ring breaks during use, remove it and insert a new

ring immediately; additional precautions (barrier

methods) should be used for the first 7 days of the new

cycle.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Vaginal delivery system

▶ NuvaRing (Merck Sharp & Dohme Ltd)

Ethinylestradiol 2.7 mg, Etonogestrel 11.7 mg NuvaRing

0.12mg/0.015mg per day vaginal delivery system | 3 system P £29.70 DT = £29.70

▶ SyreniRing (Crescent Pharma Ltd)

Ethinylestradiol 2.7 mg, Etonogestrel 11.7 mg SyreniRing

0.12mg/0.015mg per day vaginal delivery system | 3 system P £23.76 DT = £29.70

eiiiF 795i

Ethinylestradiol with gestodene

l INDICATIONS AND DOSE

Contraception with 21-day combined preparations |

Menstrual symptoms with 21-day combined

preparations

▶ BY MOUTH

▶ Females of childbearing potential: 1 tablet once daily for

21 days; subsequent courses repeated after 7-day

interval, withdrawal bleeding occurs during the 7-day

interval, 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, tablets should be taken at approximately the

same time each day

Contraception with 28-day combined preparations |

Menstrual symptoms with 28-day combined

preparations

▶ BY MOUTH

▶ Females of childbearing potential: 1 active tablet once

daily for 21 days, followed by 1 inactive tablet daily for

7 days; subsequent courses repeated without interval,

withdrawal bleeding occurs during the 7-day interval of

inactive tablets 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, tablets should be taken at

approximately the same time each day

l INTERACTIONS → Appendix 1: combined hormonal

contraceptives

l SIDE-EFFECTS

▶ Common or very common Abdominal pain . breast

abnormalities . depression . dizziness . increased risk of

infection . menstrual cycle irregularities . mood swings . nervousness . vaginal discharge

▶ Uncommon Appetite abnormal . diarrhoea . hirsutism . hypertriglyceridaemia . sexual dysfunction . skin reactions . vomiting

▶ Rare or very rare Angioedema . chorea exacerbated . ear

disorders . embolism and thrombosis . erythema nodosum . eye irritation . gallbladder disorders . gastrointestinal

disorders . haemolytic uraemic syndrome . hepatic

disorders . hypersensitivity . inflammatory bowel disease . neoplasms . optic neuritis . pancreatitis . systemic lupus

erythematosus exacerbated . varicose veins exacerbated . weight decreased

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

▶ Ethinylestradiol with gestodene (Non-proprietary)

Ethinylestradiol 30 microgram, Gestodene

50 microgram Ethinylestradiol 30microgram / Gestodene

50microgram tablets | 18 tablet P s

Ethinylestradiol 40 microgram, Gestodene

70 microgram Ethinylestradiol 40microgram / Gestodene

70microgram tablets | 15 tablet P s

BNF 78 Contraception, combined 799

Genito-urinary system

7

Ethinylestradiol 30 microgram, Gestodene

100 microgram Ethinylestradiol 30microgram / Gestodene

100microgram tablets | 30 tablet P s

▶ Aidulan (Lupin Healthcare (UK) Ltd)

Ethinylestradiol 30 microgram, Gestodene 75 microgram Aidulan

30microgram/75microgram tablets | 63 tablet P £4.11 DT = £6.73

Ethinylestradiol 20 microgram, Gestodene 75 microgram Aidulan

20microgram/75microgram tablets | 63 tablet P £5.40 DT = £8.85

▶ Femodene (Bayer Plc)

Ethinylestradiol 30 microgram, Gestodene

75 microgram Femodene tablets | 63 tablet P £6.73 DT = £6.73

▶ Femodette (Bayer Plc)

Ethinylestradiol 20 microgram, Gestodene

75 microgram Femodette tablets | 63 tablet P £8.85 DT = £8.85

▶ Juliperla (Actavis UK Ltd)

Ethinylestradiol 20 microgram, Gestodene

75 microgram Juliperla 75microgram/20microgram tablets | 63 tablet P £5.41 DT = £8.85

▶ Katya (Stragen UK Ltd)

Ethinylestradiol 30 microgram, Gestodene 75 microgram Katya

30/75 tablets | 63 tablet P £5.03 DT = £6.73

▶ Millinette (Consilient Health Ltd)

Ethinylestradiol 30 microgram, Gestodene

75 microgram Millinette 30microgram/75microgram tablets | 63 tablet P £4.12 DT = £6.73

Ethinylestradiol 20 microgram, Gestodene

75 microgram Millinette 20microgram/75microgram tablets |

63 tablet P £5.41 DT = £8.85

▶ Sofiperla (Actavis UK Ltd)

Ethinylestradiol 30 microgram, Gestodene

75 microgram Sofiperla 75microgram/30microgram tablets | 63 tablet P £4.12 DT = £6.73

▶ Sunya (Stragen UK Ltd)

Ethinylestradiol 20 microgram, Gestodene 75 microgram Sunya

20/75 tablets | 63 tablet P £6.62 DT = £8.85

eiiiF 795i

Ethinylestradiol with levonorgestrel

l INDICATIONS AND DOSE

Contraception with 21-day combined preparations |

Menstrual symptoms with 21-day combined

preparations

▶ BY MOUTH

▶ Females of childbearing potential: 1 tablet once daily for

21 days; subsequent courses repeated after 7-day

interval, withdrawal bleeding occurs during the 7-day

interval, 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, tablets should be taken at approximately the

same time each day

Contraception with 28-day combined preparations |

Menstrual symptoms with 28-day combined

preparations

▶ BY MOUTH

▶ Females of childbearing potential: 1 active tablet once

daily for 21 days, followed by 1 inactive tablet once

daily for 7 days, withdrawal bleeding occurs during the

7-day interval of inactive tablets 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, tablets should

be taken at approximately the same time each day.

Subsequent courses repeated without interval

l INTERACTIONS → Appendix 1: combined hormonal

contraceptives

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

▶ Ethinylestradiol with levonorgestrel (Non-proprietary)

Ethinylestradiol 30 microgram, Levonorgestrel

50 microgram Ethinylestradiol 30microgram / Levonorgestrel

50microgram tablets | 6 tablet P s

Ethinylestradiol 40 microgram, Levonorgestrel

75 microgram Ethinylestradiol 40microgram / Levonorgestrel

75microgram tablets | 5 tablet P s

Ethinylestradiol 30 microgram, Levonorgestrel

125 microgram Ethinylestradiol 30microgram / Levonorgestrel

125microgram tablets | 10 tablet P s

▶ Elevin (MedRx Licences Ltd)

Ethinylestradiol 30 microgram, Levonorgestrel

150 microgram Elevin 150microgram/30microgram tablets | 63 tablet P £29.25 DT = £2.82

▶ Leandra (Genesis Pharmaceuticals Ltd)

Ethinylestradiol 30 microgram, Levonorgestrel

150 microgram Leandra 30microgram/150microgram tablets | 63 tablet P £2.82 DT = £2.82

▶ Levest (Morningside Healthcare Ltd)

Ethinylestradiol 30 microgram, Levonorgestrel

150 microgram Levest 150/30 tablets | 21 tablet P £0.85

(Hospital only) | 63 tablet P £1.80 DT = £2.82

▶ Maexeni (Lupin Healthcare (UK) Ltd)

Ethinylestradiol 30 microgram, Levonorgestrel

150 microgram Maexeni 150microgram/30microgram tablets | 63 tablet P £1.88 DT = £2.82

▶ Microgynon 30 (Bayer Plc)

Ethinylestradiol 30 microgram, Levonorgestrel

150 microgram Microgynon 30 tablets | 63 tablet P £2.82 DT =

£2.82

▶ Ovranette (Pfizer Ltd)

Ethinylestradiol 30 microgram, Levonorgestrel

150 microgram Ovranette 150microgram/30microgram tablets | 63 tablet P £2.20 DT = £2.82

▶ Rigevidon (Consilient Health Ltd)

Ethinylestradiol 30 microgram, Levonorgestrel

150 microgram Rigevidon tablets | 63 tablet P £1.89 DT = £2.82

eiiiF 795i

Ethinylestradiol with norelgestromin

08-Feb-2019

l INDICATIONS AND DOSE

Contraception | Menstrual symptoms

▶ BY TRANSDERMAL APPLICATION

▶ Females of childbearing potential: Apply 1 patch once

weekly for 3 weeks, apply first patch on day 1 of cycle,

change patch on days 8 and 15; remove third patch on

day 22 and apply new patch after 7-day patch-free

interval to start subsequent contraceptive cycle,

subsequent courses repeated after a 7-day patch free

interval (during which withdrawal bleeding occurs)

l INTERACTIONS → Appendix 1: combined hormonal

contraceptives

l SIDE-EFFECTS

▶ Common or very common Anxiety . breast abnormalities . diarrhoea . dizziness . fatigue . gastrointestinal discomfort. increased risk of infection . malaise . menstrual cycle

irregularities . mood altered . muscle spasms . skin

reactions . uterine cramps . vaginal haemorrhage . vomiting . vulvovaginal disorders

▶ Uncommon Appetite increased . dyslipidaemia . insomnia . lactation disorders . oedema . photosensitivity reaction . sexual dysfunction

▶ Rare or very rare Embolism and thrombosis . gallbladder

disorders . genital discharge . neoplasms . stroke . swelling

▶ Frequency not known Anger. angioedema . cervical

dysplasia . colitis . contact lens intolerance . erythema

nodosum . hepatic disorders . hyperglycaemia . intracranial

haemorrhage . myocardial infarction . pulmonary artery

thrombosis .taste altered

800 Contraception BNF 78

Genito-urinary system

7

l DIRECTIONS FOR ADMINISTRATION Adhesives or bandages

should not be used to hold patch in place. If no longer

sticky do not reapply but use a new patch.

Changing to a transdermal combined hormonal contraceptive

Changing from combined oral contraception Apply

patch on the first day of withdrawal bleeding; if no

withdrawal bleeding within 5 days of taking last active

tablet, rule out pregnancy before applying first patch.

Unless patch is applied on first day of withdrawal bleeding,

additional precautions (barrier methods) should be used

concurrently for first 7 days.

Changing from progestogen-only method

. from an implant, apply first patch on the day implant

removed

. from an injection, apply first patch when next injection

due

. from oral progestogen, first patch may be applied on any

day after stopping pill

For all methods additional precautions (barrier methods)

should be used concurrently for first 7 days.

After childbirth (not breast-feeding) Start 4 weeks

after birth; if started later than 4 weeks after birth

additional precautions (barrier methods) should be used

for first 7 days.

After abortion or miscarriage Before 20 weeks’

gestation start immediately; no additional contraception

required if started immediately. After 20 weeks’ gestation

start on day 21 after abortion or on the first day of first

spontaneous menstruation; additional precautions (barrier

methods) should be used for first 7 days after applying the

patch.

l PATIENT AND CARER ADVICE Patients and carers should be

given advice on how to administer patches.

Travel Women using patches 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.

Missed doses

Delayed application or detached patch If a patch is partly

detached for less than 24 hours, reapply to the same site or

replace with a new patch immediately; no additional

contraception is needed and the next patch should be

applied on the usual ‘change day’. If a patch remains

detached for more than 24 hours or if the user is not aware

when the patch became detached, then stop the current

contraceptive cycle and start a new cycle by applying a new

patch, giving a new ‘Day 1’; an additional non-hormonal

contraceptive must be used concurrently for the first

7 days of the new cycle.

If application of a new patch at the start of a new cycle is

delayed, contraceptive protection is lost. A new patch

should be applied as soon as remembered giving a new

‘Day 1’; additional non-hormonal methods of

contraception should be used for the first 7 days of the new

cycle. If application of a patch in the middle of the cycle is

delayed (i.e. the patch is not changed on day 8 or day 15):

. for up to 48 hours, apply a new patch immediately; next

patch ‘change day’ remains the same and no additional

contraception is required;

. for more than 48 hours, contraceptive protection may

have been lost. Stop the current cycle and start a new

4-week cycle immediately by applying a new patch

giving a new ‘Day 1’; additional non-hormonal

contraception should be used for the first 7 days of the

new cycle.

If the patch is not removed at the end of the cycle (day

22), remove it as soon as possible and start the next cycle

on the usual ‘change day’, the day after day 28; no

additional contraception is required.

l NATIONAL FUNDING/ACCESS DECISIONS

Scottish Medicines Consortium (SMC) decisions

SMC No. 48/03

The Scottish Medicines Consortium has advised (September

2003) that Evra ® patches should be restricted for use in

women who are likely to comply poorly with combined oral

contraceptives.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Transdermal patch

▶ Evra (Janssen-Cilag Ltd)

Ethinylestradiol 33.9 microgram per 24 hour, Norelgestromin

203 microgram per 24 hour Evra transdermal patches | 9 patch P £19.51 DT = £19.51

eiiiF 795i

Ethinylestradiol with norethisterone

l INDICATIONS AND DOSE

Contraception with 21-day combined preparations |

Menstrual symptoms with 21-day combined

preparations

▶ BY MOUTH

▶ Females of childbearing potential: 1 tablet once daily for

21 days; subsequent courses repeated after 7-day

interval, withdrawal bleeding occurs during the 7-day

interval, 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, tablets should be taken at approximately the

same time each day

l INTERACTIONS → Appendix 1: combined hormonal

contraceptives

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

▶ Ethinylestradiol with norethisterone (Non-proprietary)

Ethinylestradiol 35 microgram, Norethisterone

500 microgram Ethinylestradiol 35microgram / Norethisterone

500microgram tablets | 5 tablet P s

Ethinylestradiol 35 microgram, Norethisterone

750 microgram Ethinylestradiol 35microgram / Norethisterone

750microgram tablets | 21 tablet P s

Ethinylestradiol 35 microgram, Norethisterone

1 mg Ethinylestradiol 35microgram / Norethisterone 1mg tablets |

9 tablet P s

▶ Brevinor (Pfizer Ltd)

Ethinylestradiol 35 microgram, Norethisterone

500 microgram Brevinor 500microgram/35microgram tablets | 63 tablet P £1.99 DT = £1.99

▶ Loestrin 20 (Galen Ltd)

Ethinylestradiol 20 microgram, Norethisterone acetate

1 mg Loestrin 20 tablets | 63 tablet P £2.70 DT = £2.70

▶ Loestrin 30 (Galen Ltd)

Ethinylestradiol 30 microgram, Norethisterone acetate

1.5 mg Loestrin 30 tablets | 63 tablet P £3.90 DT = £3.90

▶ Norimin (Pfizer Ltd)

Ethinylestradiol 35 microgram, Norethisterone 1 mg Norimin

1mg/35microgram tablets | 63 tablet P £2.28 DT = £2.28

eiiiF 795i

Ethinylestradiol with norgestimate

l INDICATIONS AND DOSE

Contraception with 21-day combined preparations |

Menstrual symptoms with 21-day combined

preparations

▶ BY MOUTH

▶ Females of childbearing potential: 1 tablet once daily for

21 days; subsequent courses repeated after 7-day

interval, withdrawal bleeding occurs during continued→

BNF 78 Contraception, combined 801

Genito-urinary system

7

the 7-day interval, 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, tablets should be taken at approximately the

same time each day

l INTERACTIONS → Appendix 1: combined hormonal

contraceptives

l SIDE-EFFECTS

▶ Common or very common Anxiety . asthenic conditions . breast abnormalities . chest pain . constipation . depression . diarrhoea . dizziness . gastrointestinal

discomfort. gastrointestinal disorders . genital discharge . hypersensitivity . increased risk of infection . insomnia . menstrual cycle irregularities . mood altered . muscle

complaints . oedema . pain . skin reactions . vomiting

▶ Uncommon Appetite abnormal . cervical dysplasia . dry eye . dyspnoea . embolism and thrombosis . hirsutism . hot

flush . libido disorder. ovarian cyst. palpitations . paraesthesia . syncope . visual impairment. vulvovaginal

disorders . weight changes

▶ Rare or very rare Hepatic disorders . pancreatitis . photosensitivity reaction . sweat changes .tachycardia . vertigo

▶ Frequency not known Angioedema . contact lens

intolerance . dyslipidaemia . erythema nodosum . neoplasms . seizure . suppressed lactation

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

▶ Cilest (Janssen-Cilag Ltd)

Ethinylestradiol 35 microgram, Norgestimate

250 microgram Cilest 35microgram/250microgram tablets |

63 tablet P £7.16 DT = £7.16 | 126 tablet P £14.32

▶ Cilique (Consilient Health Ltd)

Ethinylestradiol 35 microgram, Norgestimate

250 microgram Cilique 250microgram/35microgram tablets | 63 tablet P £4.65 DT = £7.16

▶ Lizinna (Morningside Healthcare Ltd)

Ethinylestradiol 35 microgram, Norgestimate

250 microgram Lizinna 250microgram/35microgram tablets | 63 tablet P £4.64 DT = £7.16

eiiiF 795i

Norethisterone with mestranol

l INDICATIONS AND DOSE

Contraception | Menstrual symptoms

▶ BY MOUTH

▶ Females of childbearing potential: 1 tablet once daily for

21 days; subsequent courses repeated after 7-day

interval, withdrawal bleeding can occur during the

7-day interval, 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, tablets should be taken at the same time each

day

l INTERACTIONS → Appendix 1: combined hormonal

contraceptives

l SIDE-EFFECTS Appetite change . breast tenderness . depression . gastrointestinal disorder. libido disorder. metabolic disorders . uterine leiomyoma exacerbated

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

▶ Norinyl-1 (Pfizer Ltd)

Mestranol 50 microgram, Norethisterone 1 mg Norinyl-1 tablets | 63 tablet P £2.19 DT = £2.19

3.2 Contraception, devices

Other drugs used for Contraception, devices

Levonorgestrel, p. 806

CONTRACEPTIVE DEVICES

Intra-uterine contraceptive devices

(copper)

l INDICATIONS AND DOSE

Contraception

▶ BY INTRA-UTERINE ADMINISTRATION

▶ Females of childbearing potential: (consult product

literature)

IMPORTANT SAFETY INFORMATION

MHRA/CHM ADVICE (JUNE 2015) INTRA-UTERINE

CONTRACEPTION: UTERINE PERFORATION—UPDATED

INFORMATION ON RISK FACTORS

Uterine perforation most often occurs during insertion,

but might not be detected until sometime later. The risk

of uterine perforation is increased when the device is

inserted up to 36 weeks postpartum or in patients who

are breastfeeding. Before inserting an intra-uterine

contraceptive device, inform patients that perforation

occurs in approximately 1 in every 1000 insertions and

signs and symptoms include:

. severe pelvic pain after insertion (worse than period

cramps);

. pain or increased bleeding after insertion which

continues for more than a few weeks;

. sudden changes in periods;

. pain during intercourse;

. unable to feel the threads.

Patients should be informed on how to check their

threads and to arrange a check-up if threads cannot be

felt, especially if they also have significant pain. Partial

perforation may occur even if the threads can be seen;

consider this if there is severe pain following insertion

and perform an ultrasound.

l CONTRA-INDICATIONS Active trophoblastic disease (until

return to normal of urine and plasma-gonadotrophin

concentration). distorted uterine cavity . established or

marked immunosuppression . genital malignancy . medical

diathermy . pelvic inflammatory disease .recent sexually

transmitted infection (if not fully investigated and treated)

. severe anaemia . small uterine cavity . unexplained

uterine bleeding . Wilson’s disease

l CAUTIONS Anaemia . anticoagulant therapy (avoid if

possible). diabetes . disease-induced immunosuppression

(risk of infection—avoid if marked immunosuppression). drug-induced immunosuppression (risk of infection—

avoid if marked immunosuppression) . endometriosis . epilepsy (risk of seizure at time of insertion).fertility

problems . history of pelvic inflammatory disease . increased risk of expulsion if inserted before uterine

involution . menorrhagia (progestogen intra-uterine

system might be preferable). nulliparity . severe cervical

stenosis . severe primary dysmenorrhoea . severely scarred

uterus (including after endometrial resection). young age

CAUTIONS, FURTHER INFORMATION The Faculty of Sexual

and Reproductive Healthcare advises if removal is after day

3 of the menstrual cycle, intercourse should be avoided or

another method of contraception used for at least 7 days

before removal of device—emergency contraception may

need to be considered if recent intercourse has occurred

802 Contraception BNF 78

Genito-urinary system

7

and the intra-uterine device is removed after day 3 of the

menstrual cycle.

▶ Risk of infection The main excess risk of infection occurs in

the first 20 days after insertion and is believed to be related

to existing carriage of a sexually transmitted infection.

Women are considered to be at a higher risk of sexually

transmitted infections if:

. they are under 25 years old or

. they are over 25 years old and

. have a new partner or

. have had more than one partner in the past year or

. their regular partner has other partners.

In these women, pre-insertion screening (for chlamydia

and, depending on sexual history and local prevalence of

disease, Neisseria gonorrhoeae) should be performed. If

results are unavailable at the time of fitting an intrauterine device for emergency contraception, appropriate

prophylactic antibacterial cover should be given. The

woman should be advised to attend as an emergency if she

experiences sustained pain during the next 20 days.

l SIDE-EFFECTS Device complications . epilepsy (on

insertion). haemorrhage (on insertion). hypersensitivity . menstrual cycle irregularities . pain (on insertion—

alleviated by NSAID such as ibuprofen 30 minutes before

insertion). pelvic infection exacerbated . presyncope (on

insertion). uterine injuries

SIDE-EFFECTS, FURTHER INFORMATION Advise the patient

to seek medical attention promptly in case of significant

symptoms—very small risk of uterine perforation, ectopic

pregnancy and pelvic inflammatory disease.

l ALLERGY AND CROSS-SENSITIVITY Contra-indicated if

patient has a copper allergy.

l PREGNANCY If an intra-uterine device fails and the woman

wishes to continue to full-term the device should be

removed in the first trimester if possible. Remove device; if

pregnancy occurs, increased likelihood that it may be

ectopic.

l BREAST FEEDING Not known to be harmful.

l MONITORING REQUIREMENTS Gynaecological examination

before insertion, 6–8 weeks after insertion, then annually.

l DIRECTIONS FOR ADMINISTRATION The timing and

technique of fitting an intra-uterine device are critical for

its subsequent performance. The healthcare professional

inserting (or removing) the device should be fully trained in

the technique and should provide full counselling backed,

where available, by the patient information leaflet. Devices

should not be fitted during the heavy days of the period;

they are best fitted after the end of menstruation and

before the calculated time of implantation.

l PRESCRIBING AND DISPENSING INFORMATION

TT380 ® SLIMLINE For uterine length 6.5–9 cm;

replacement every 10 years.

LOAD ® 375 For uterine length over 7 cm; replacement

every 5 years.

NOVAPLUS T 380 ® AG ‘ Mini’ size for minimum uterine

length 5 cm; ‘ Normal’ size for uterine length 6.5–9 cm;

replacement every 5 years.

MULTILOAD ® CU375 For uterine length 6–9 cm;

replacement every 5 years.

GYNEFIX ® Suitable for all uterine sizes; replacement every

5 years.

UT380 STANDARD ® For uterine length 6.5–9 cm;

replacement every 5 years.

UT380 SHORT ® For uterine length 5–7 cm; replacement

every 5 years.

MULTI-SAFE ® 375 For uterine length 6–9 cm; replacement

every 5 years.

ANCORA ® 375 CU For uterine length over 6.5 cm;

replacement every 5 years.

T-SAFE ® 380A QL For uterine length 6.5–9 cm;

replacement every 10 years.

NEO-SAFE ® T380 For uterine length 6.5–9 cm;

replacement every 5 years.

MINI TT380 ® SLIMLINE For minimum uterine length 5 cm;

replacement every 5 years.

COPPER T380 A ® For uterine length 6.5–9 cm;

replacement every 10 years.

NOVAPLUS T 380 ® CU ‘ Mini’ size for minimum uterine

length 5 cm; ‘ Normal’ size for uterine length 6.5–9 cm;

replacement every 5 years.

NOVA-T ® 380 For uterine length 6.5–9 cm; replacement

every 5 years.

FLEXI-T ®+ 380 For uterine length over 6 cm; replacement

every 5 years.

FLEXI-T ® 300 For uterine length over 5 cm; replacement

every 5 years.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Intra-uterine contraceptive device

▶ Intra-uterine contraceptive devices (R.F. Medical Supplies Ltd, Farla

Medical Ltd, Durbin Plc, Williams Medical Supplies Ltd, Bayer Plc,

Organon Laboratories Ltd)

Copper T380 A intra-uterine contraceptive device | 1 device £8.95

Steriload intra-uterine contraceptive device | 1 device £9.65

Load 375 intra-uterine contraceptive device | 1 device £8.52

Novaplus T 380 Ag intra-uterine contraceptive device mini | 1 device

£12.50

T-Safe 380A QL intra-uterine contraceptive device | 1 device £10.55

UT380 Standard intra-uterine contraceptive device | 1 device £11.22

Nova-T 380 intra-uterine contraceptive device | 1 device £15.20

Flexi-T+ 380 intra-uterine contraceptive device | 1 device £10.06

Mini TT380 Slimline intra-uterine contraceptive device | 1 device

£12.46

Flexi-T 300 intra-uterine contraceptive device | 1 device £9.47

Multi-Safe 375 intra-uterine contraceptive device | 1 device £8.96

Multiload Cu375 intra-uterine contraceptive device | 1 device £9.24

Optima TCu 380A intra-uterine contraceptive device | 1 device £9.65

Novaplus T 380 Ag intra-uterine contraceptive device normal | 1 device £12.50

GyneFix intra-uterine contraceptive device | 1 device £27.11

Novaplus T 380 Cu intra-uterine contraceptive device mini | 1 device

£10.95

TT380 Slimline intra-uterine contraceptive device | 1 device £12.46

Ancora 375 Cu intra-uterine contraceptive device | 1 device £7.95

Novaplus T 380 Cu intra-uterine contraceptive device normal | 1 device £10.95

Neo-Safe T380 intra-uterine contraceptive device | 1 device £13.40

UT380 Short intra-uterine contraceptive device | 1 device £11.22

Silicone contraceptive pessaries

l SILICONE CONTRACEPTIVE PESSARIES

FemCap 22mm (Durbin Plc)

1 device . NHS indicative price = £15.29 . Drug Tariff (Part IXa)

FemCap 26mm (Durbin Plc)

1 device . NHS indicative price = £15.29 . Drug Tariff (Part IXa)

FemCap 30mm (Durbin Plc)

1 device . NHS indicative price = £15.29 . Drug Tariff (Part IXa)

3.3 Contraception, emergency

Other drugs used for Contraception, emergency Intrauterine contraceptive devices (copper), p. 802 . Levonorgestrel, p. 806

BNF 78 Contraception, emergency 803

Genito-urinary system

7

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