Patient Management Guide - Oral Contraceptive Care - Know Your Contraceptives
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
CONSULTATION CHECKLIST Factors to discuss during initial consultation: Consult UK Medical Eligibility Criteria for contraceptive use Patient suitability for contraceptive care: • Age • Personal & family medical history • BMI • History of Depression • Blood pressure • Migraine with aura • Smoking status • Other medications Patients’ personal preferences • Allergies (e.g. soya/peanuts) Contraceptive pill information: • What is the pill and what does it do • How to take the pill correctly • Pill effectiveness • Please encourage your patient to read the Patient Information Leaflet Missed pill guidance: • What to do if a pill is missed For missed pill guidance visit www.knowyourcontraceptives.ie Sexual Health & the risks of unprotected sex CONSULTATION CHECKLIST
CONSULTATION CHECKLIST Factors to discuss during review consultation: Consult UK Medical Eligibility Criteria for contraceptive use Has anything changed? • Age • Personal & family medical history • BMI • Migraine with aura • Blood pressure • Depressive Symptoms • Smoking status • Other medications Patients’ satisfaction: • Side effects (please refer to Side Effects Management section for reporting) • Compliance • Cost Missed pill guidance: • What to do if a pill is missed For missed pill guidance visit www.knowyourcontraceptives.ie Sexual health & the risks of unprotected sex CONSULTATION CHECKLIST
EMERGENCY CONTRACEPTION • If restarting regular hormonal contraception • The length of time a barrier method is required immediately after emergency contraception, for protection depends on the method of patients should use a barrier method emergency contraception used. (condoms) or avoidance of sex should be advised. Warnings & Precautions for use of Emergency Contraception 1,2 • If vomiting occurs within 3 hours of taking an • E mergency contraception does not prevent Emergency Contraceptive tablet, another a pregnancy in every instance tablet should be taken immediately • Women who present for repeated courses • Emergency contraception is an occasional of emergency contraception should be method. It should in no instance replace a advised to consider long-term methods of regular contraceptive method contraception • Concomitant use of UPA or LNG in one • Use of emergency contraception does not menstrual cycle is not recommended replace the necessary precautions against sexually transmitted diseases Levonorgestrel LNG • L evonorgestrel LNG prevents ovulation and • L NG does not contraindicate the continuation fertilisation if intercourse has taken place in of regular hormonal contraception the preovulatory phase, when the likelihood of • After taking LNG it is recommended to use fertilisation is the highest barrier methods or abstain from sex until the next menstrual period starts EMERGENCY CONTRACEPTION
EMERGENCY CONTRACEPTION Ulipristal acetate UPA • Ulipristal acetate (UPA) is a selective progesterone-receptor modulator. Its mechanism of action is to delay ovulation until sperm from unprotected sex are no longer viable 3 nlike Levonorgestrel (LNG) UPA binds to progesterone receptors & may reduce the efficacy of • U progestogen-containing contraceptives 4 fter taking UPA, a patient should not start a hormonal contraceptive method for at least 5 days • A & should use barrier methods or abstain from sex until effective hormonal contraceptive cover has been achieved 3 – see guidance below: Requirement for additional Methods contraceptive cover Combined oral contraceptive pill (except Qlaira®) 7 Days UPA then Qlaira® Combined oral contraceptive pill 9 Days wait at 7 days Combined vaginal ring/ transdermal patch least 5 days Progestogen-only pill (traditional/ desogestrel) 2 Days Progestogen-only implant or injectable 7 Days EMERGENCY CONTRACEPTION
Your Patient’s SEXUAL HEALTH • Correct use of hormonal contraceptive care helps to prevent unintended pregnancy however they do not protect against sexually transmitted infections5-9 • The incidence of sexually transmitted infections (STIs) are on the rise in Ireland 10 • STIs are passed on from infected partner(s) during unprotected sex including vaginal, anal & oral sex 11 • Most STIs have no obvious11symptoms, so your patient may not be aware that they or their partner(s) is infected • Certain STIs can cause long-term health problems if they are not treated, such as infertility, complications in pregnancy and pelvic inflammatory disease 11 Advise your patient to reduce the risk of contracting an STI by: sing condoms correctly U L imiting the number of sexual partners your patient has – the more partners one has, the greater the chance of coming into contact with an infected person Talking to your patient about STIs & practicing safer sex dvising your patient to get regular sexual health check-ups including STI screening, A smear tests & being breast aware SEXUAL HEALTH
PRESCRIBING GUIDE 12 Oestrogen dosage No Synthetic Generation 20mcg 30mcg 35mcg 1.5mg Phasic oestrogen progestogen 1st Generation NORIDAY 350mcg Norethisterone ANDROGENICITY OVREENA 150mcg Levonorgestrel OVRANETTE HIGH VIOLITE 2nd Generation MICROLITE 100mcg Levonorgestrel LEONORE 30/75/125mcg LOGYNON Levonorgestrel MINULET 75mcg Gestodene MEDIUM MERCILON MARVIOL 150mcg Desogestrel 3rd Generation AZALIA 75mcg Desogestrel CERAZETTE CILIQUE 250mcg Norgestimate ZOELY 2.5mg Nomegestrol LOW QLAIRA 2/3mcg Dienogest 4th Generation ELVINETTE ELVINA YASMINELLE 3mg Drospirenone YASMIN YAZ PRESCRIBING GUIDE
VENOUS THROMBOEMBOLISM Risk of developing a blood clot (VTE) in a given year 13,14 Women not using a combined hormonal contraception (CHC) About 2 out of 10,000 women and are not pregnant Women who are pregnant About 29 per 10,000 women Women who are postpartum About 300–400 per 10,000 women Women using a CHC containing levonorgestrel, norethisterone About 5-7 out of 10,000 women or norgestimate Women using a CHC containing drospirenone, gestodene About 9-12 out of 10,000 women or desogestrel Women using a CHC containing dienogest or nomegestrol Not yet known* Does not appear to be associated Women using progestogen-only methods of contraception with an increased risk of VTE *Further studies are ongoing or planned to collect sufficient data to estimate the risk Conditions that increase the risk of VTE 5-9 Lifestyle Factors Medical History Current Medical Status Increasing age Personal/Family history of VTE CHC use Smoking Inherited blood clotting disorders Pregnancy/Postpartum Obesity Cancer Major surgery Other medical conditions Immobilisation & High Altitude Major trauma associated with VTE • The risk of VTE is highest in first year of CHC use • The risk of VTE is increased when a CHC is re-started after a break in use of 4 weeks or more VTE RISK
MISSED PILL Missed Pill Management COMBINED ORAL CONTRACEPTIVE PILLS 5,6,8,9 If the patient is less than 12 hours late in taking any tablet, contraceptive protection is not reduced. The patient should take the tablet as soon as she remembers & take further tablets at the usual time. If she is more than 12 hours late in taking any tablet, contraceptive protection may be reduced. The management of missed tablets can be guided by the following two basic rules: 1. Tablet-taking must never be discontinued for longer than 7 days; 2. 7 days of uninterrupted tablet-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian-axis Missed 1 pill more than 12 hours late Missed pill in Week 1 of pack Missed pill in Week 2 of pack Missed pill in Week 3 of pack • T ake the forgotten pill now, • T ake the forgotten pill now, • Take the forgotten pill now, even if it means taking 2 pills even if it means taking 2 even if it means taking 2 pills in 1 day pills in 1 day in 1 day • Take remaining pills as usual • Take remaining pills as • Take remaining pills as usual • Use barrier method (e.g. usual • Instead of a pill free week condom) for next 7 days • You are protected start your next pack to ensure protection • You are protected OR • Stop this pack immediately IMPORTANT: • Begin the pill free week (not If you’ve had unprotected longer than 7 days including sex in the previous 7 days, the forgotten pill) the possibility of pregnancy should be considered • Then start your next pack • You are protected
MISSED PILL Missed Pill Management COMBINED ORAL CONTRACEPTIVE PILLS 15 Missed 2 pills in a row If you’ve missed two pills anywhere in the pack or started a new pack two days late, your protection against pregnancy will be affected. Please consult with your doctor or nurse for further advice. You will need to use a barrier method (e.g. a condom) for the next 7 days to ensure you remain protected. Missed 2 pills in Missed 2 pills in Missed 2 pills in Week 1 of pack Week 2 of pack Week 3 of pack • Take the forgotten pill now, • Take the forgotten pill now, • Take the forgotten pill now, even if it means taking 2 pills even if it means taking even if it means taking 2 pills in 1 day 2 pills in 1 day in 1 day • Leave any earlier missed pills • Leave any earlier missed • Leave any earlier missed pills pills • Take remaining pills as usual • Take remaining pills as usual • Take remaining pills • Use barrier method (e.g. • Instead of a pill free week as usual condoms) for next 7 days start your next pack • Use barrier method (e.g. • Use barrier method (e.g. condoms) for next 7 days condoms) for next 7 days IMPORTANT: If you’ve had unprotected sex in the previous 7 days, the possibility of pregnancy should be considered
Missed Pill Management MISSED PILL PROGESTOGEN ONLY PILLS containing 75mcg desogestrel 7,16 ontraceptive protection may be reduced if more than 36 hours have elapsed between • C two tablets. • If the patient is less than 12 hours late in taking any tablet, she should take the tablet as soon as she remembers & take further tablets at the usual time. • If she is more than 12 hours late, she should use barrier method of contraception for the next 7 days. • If tablets were missed in the first week & intercourse took place in the week before the tablets were missed, the possibility of pregnancy should be considered. Missed 1 pill more than 12 hours late • T ake the forgotten pill now, even if it means taking 2 pills in 1 day • Take remaining pills as usual • Use barrier method (e.g. condom) for next 7 days to ensure protection IMPORTANT: If you’ve had unprotected sex in the previous 7 days, the possibility of pregnancy should be considered
Missed Pill Management MISSED PILL PROGESTOGEN ONLY PILLS containing 75mcg desogestrel 15 Missed 2 pills in a row If you’ve missed two pills anywhere in the pack or started a new pack two or more days late, you are not protected against pregnancy. Please consult with your doctor or nurse for further advice. You will need to use a barrier method (e.g. a condom) for the next 7 days to ensure you remain protected for the duration of the pack. Missed 2 pills in Missed 2 pills in Week 1 of pack anywhere else in the pack • Take the forgotten pill now, even if it • Take the forgotten pill now, even means taking 2 pills in 1 day if it means taking 2 pills in 1 day • Leave any earlier missed pills • Leave any earlier missed pills • Take remaining pills as usual • Take remaining pills as usual • Use barrier method (e.g. condoms) • Use barrier method (e.g. condoms) for next 7 days for next 7 days IMPORTANT: If you’ve had unprotected sex in the previous 7 days, the possibility of pregnancy should be considered
SIDE EFFECT MANAGEMENT • Side effects usually diminish within 3 months with continued use of same method 17 SIDE EFFECT •R eassure & educate patients to help establish realistic expectations & decrease the chance of unanticipated side effects 17 • Identify which component is likely to be at fault, but it can be difficult to ascertain which portion (either the oestrogen or progestogen or both) is responsible Oestrogen Related Side Effects Progestogen Related Side Effects The oestrogen used in COCs (usually Degree of androgenicity is likely to ethinylestradiol) is linked to some minor cause negative side effects side effects A higher amount of oestrogen helps to To resolve, lower the oestrogen dose reduce androgen related side effects Change to a more dominant Change type of progestogen to one progestogen with lower androgenic properties Try progestogen only options that do Increase the oestrogen strength not contain oestrogen Most common side effects: acne, Most common side effects: nausea, vaginal dryness, sustained weight headache, thrush, excess bleeding, increase & low mood fluid retention, breast tenderness Adverse events & product complaints should be reported to the Health Products Regulatory Authority. Reporting forms & information can be found at www.hpra.ie. Reproduced with the kind permission of Dr. Deirdre Lundy
PRESCRIBING GUIDE 12 Oestrogen dosage No Synthetic Generation 20mcg 30mcg 35mcg 1.5mg Phasic oestrogen progestogen 1st Generation NORIDAY 350mcg Norethisterone ANDROGENICITY OVREENA 150mcg Levonorgestrel HIGH OVRANETTE VIOLITE 2nd Generation MICROLITE 100mcg Levonorgestrel LEONORE 30/75/125mcg LOGYNON Levonorgestrel MINULET 75mcg Gestodene MEDIUM MERCILON MARVIOL 150mcg Desogestrel 3rd Generation AZALIA 75mcg Desogestrel CERAZETTE CILIQUE 250mcg Norgestimate ZOELY 2.5mg Nomegestrol LOW QLAIRA 2/3mcg Dienogest 4th Generation ELVINETTE ELVINA YASMINELLE 3mg Drospirenone YASMIN YAZ
ACNE • Generally mediated through progestogen •M ore common side effect of 2nd generation pills – switch to a 4th generation pill • f patient is on 4th generation pill & acne is persistent, increase oestrogen dose I ACNE WHICH CAUSE ACTION CONTRACEPTIVE? Elvina • Elvinette • Qlaira Too much progestagenic Try less progestagenic Yasmin • Yasminelle • Yaz potency 4th generation brands Zoely Too much androgenic Try less androgenic brands Marviol • Mercilon potency containing desogestrel Increase oestrogen Minulet • Ovreena • Ovranette Too little oestrogen • Logynon • Cilique to a higher dose Reproduced with the kind permission of Dr. Deirdre Lundy
PRESCRIBING GUIDE 12 Oestrogen dosage No Synthetic Generation 20mcg 30mcg 35mcg 1.5mg Phasic oestrogen progestogen 1st Generation NORIDAY 350mcg Norethisterone ANDROGENICITY OVREENA 150mcg Levonorgestrel HIGH OVRANETTE VIOLITE 2nd Generation MICROLITE 100mcg Levonorgestrel LEONORE 30/75/125mcg LOGYNON Levonorgestrel MINULET 75mcg Gestodene MEDIUM MERCILON MARVIOL 150mcg Desogestrel 3rd Generation AZALIA 75mcg Desogestrel CERAZETTE CILIQUE 250mcg Norgestimate ZOELY 2.5mg Nomegestrol LOW QLAIRA 2/3mcg Dienogest 4th Generation ELVINETTE ELVINA YASMINELLE 3mg Drospirenone YASMIN YAZ
BREAK THROUGH BLEEDING • Generally caused by irregular pill taking and lack of patient compliance • Can result from a change in sexual partner – therefore it is important to rule out a STI • May improve with an increase in oestrogen or a change in progestogen BREAK WHICH CAUSE ACTION CONTRACEPTIVE? THROUGH BLEEDING Counsel patient on correct Irregular pill taking No change usage Undiagnosed STI Sexual history STI screen No change Increase oestrogen Minulet • Ovreena • Ovranette Too little oestrogen to a higher dose • Logynon • Cilique Too much progestagenic Try less progestagenic Elvina • Qlaira • Yasmin • Zoely potency 4th generation brands Reproduced with the kind permission of Dr. Deirdre Lundy
PRESCRIBING GUIDE 12 Oestrogen dosage No Synthetic Generation 20mcg 30mcg 35mcg 1.5mg Phasic oestrogen progestogen 1st Generation NORIDAY 350mcg Norethisterone ANDROGENICITY OVREENA 150mcg Levonorgestrel HIGH OVRANETTE VIOLITE 2nd Generation MICROLITE 100mcg Levonorgestrel LEONORE 30/75/125mcg LOGYNON Levonorgestrel MINULET 75mcg Gestodene MEDIUM MERCILON MARVIOL 150mcg Desogestrel 3rd Generation AZALIA 75mcg Desogestrel CERAZETTE CILIQUE 250mcg Norgestimate ZOELY 2.5mg Nomegestrol LOW QLAIRA 2/3mcg Dienogest 4th Generation ELVINETTE ELVINA YASMINELLE 3mg Drospirenone YASMIN YAZ
BLOATING / BREAST TENDERNESS • Bloating is usually a progestogen side effect – change progestogen or increase oestrogen dose • Breast tenderness is usually due to oestrogen – reduce oestrogen dose • Consider copper coil as it’s hormone free WHICH CAUSE ACTION CONTRACEPTIVE? BLOATING BLOATING / BREAST Too much progestagenic Try less progestagenic Elvina • Elvinette • Qlaira TENDERNESS potency 4th generation brands Yasmin • Yasminelle • Yaz • Zoely BREAST TENDERNESS Reduce oestrogen Elvinette • Leonore • Mercilon to a lower dose Microlite • Violite • Yasminelle • Yaz Try non oestrogen Too much oestrogen Azalia • Cerazette • Noriday medicines Copper coil • Implanon Consider non oral options Jaydess • Mirena • Nuvaring Reproduced with the kind permission of Dr. Deirdre Lundy
PRESCRIBING GUIDE 12 Oestrogen dosage No Synthetic Generation 20mcg 30mcg 35mcg 1.5mg Phasic oestrogen progestogen 1st Generation NORIDAY 350mcg Norethisterone ANDROGENICITY OVREENA 150mcg Levonorgestrel HIGH OVRANETTE VIOLITE 2nd Generation MICROLITE 100mcg Levonorgestrel LEONORE 30/75/125mcg LOGYNON Levonorgestrel MINULET 75mcg Gestodene MEDIUM MERCILON MARVIOL 150mcg Desogestrel 3rd Generation AZALIA 75mcg Desogestrel CERAZETTE CILIQUE 250mcg Norgestimate ZOELY 2.5mg Nomegestrol LOW QLAIRA 2/3mcg Dienogest 4th Generation ELVINETTE ELVINA YASMINELLE 3mg Drospirenone YASMIN YAZ
HEADACHES / HEADACHES DURING PILL FREE WEEK • Ensure it is not migraine with aura • Timing of the headache is the most important thing to establish • If headache persists throughout the pill pack – likely cause is too much oestrogen • If it’s during pill free week – lower oestrogen dose or reduce pill free interval WHICH CAUSE ACTION CONTRACEPTIVE? HEADACHES THROUGHOUT PILL PACK Reduce oestrogen Elvinette • Leonore • Mercilon to a lower dose Microlite • Violite • Yasminelle • Yaz Too much oestrogen Try non oestrogen brands Azalia • Cerazette • Noriday HEADACHES Copper coil • Implanon Consider non oral options Jaydess • Mirena • Nuvaring HEADACHES DURING PILL FREE WEEK Reduce oestrogen Elvinette • Leonore • Mercilon strength to a lower dose Microlite • Violite • Yasminelle • Yaz Too much of a hormone drop Shorten or omit pill Logynon • Qlaira • Yaz • Zoely free interval Reproduced with the kind permission of Dr. Deirdre Lundy
PRESCRIBING GUIDE 12 Oestrogen dosage No Synthetic Generation 20mcg 30mcg 35mcg 1.5mg Phasic oestrogen progestogen 1st Generation NORIDAY 350mcg Norethisterone ANDROGENICITY OVREENA 150mcg Levonorgestrel OVRANETTE HIGH VIOLITE 2nd Generation MICROLITE 100mcg Levonorgestrel LEONORE 30/75/125mcg LOGYNON Levonorgestrel MINULET 75mcg Gestodene MEDIUM MERCILON MARVIOL 150mcg Desogestrel 3rd Generation AZALIA 75mcg Desogestrel CERAZETTE CILIQUE 250mcg Norgestimate ZOELY 2.5mg Nomegestrol LOW QLAIRA 2/3mcg Dienogest 4th Generation ELVINETTE ELVINA YASMINELLE 3mg Drospirenone YASMIN YAZ
IRRITABILITY / DEPRESSION / LOSS OF LIBIDO • Progestogen is a mood suppressant – change progestogen • Loss of libido – linked to androgen activity. If decrease in libido – try more androgenic pill • Can happen with any combination of oestrogen/progestogen • Consider copper coil as it is hormone free • Depressed mood and depression are well known side effects of hormonal contraceptive care. If a patient develops depression while on the pill, consideration should be given to prescribing a non-hormonal alternative. WHICH CAUSE ACTION CONTRACEPTIVE? Too much Try less progestagenic Elvinette • Qlaira • Yasmin progestagenic potency 4th generation brands Yasminelle • Yaz • Zoely IRRITABILITY / Try levonorgestrel Too little androgenic Leonore • Microlite • Violite DEPRESSION brands with androgenic properties Ovreena • Ovranette • Logynon / LIBIDO LOSS properties Increase oestrogen to Minulet • Ovreena • Ovranette Too little oestrogen a higher dose Logynon • Cilique Reproduced with the kind permission of Dr. Deirdre Lundy
PRESCRIBING GUIDE 12 Oestrogen dosage No Synthetic Generation 20mcg 30mcg 35mcg 1.5mg Phasic oestrogen progestogen 1st Generation NORIDAY 350mcg Norethisterone ANDROGENICITY OVREENA 150mcg Levonorgestrel OVRANETTE HIGH VIOLITE 2nd Generation MICROLITE 100mcg Levonorgestrel LEONORE 30/75/125mcg LOGYNON Levonorgestrel MINULET 75mcg Gestodene MEDIUM MERCILON MARVIOL 150mcg Desogestrel 3rd Generation AZALIA 75mcg Desogestrel CERAZETTE CILIQUE 250mcg Norgestimate ZOELY 2.5mg Nomegestrol LOW QLAIRA 2/3mcg Dienogest 4th Generation ELVINETTE ELVINA YASMINELLE 3mg Drospirenone YASMIN YAZ
NAUSEA • Can be caused by too much oestrogen – reduce oestrogen dose • Can also be caused by both oestrogen and progestogen • Advise patient to take pill in the evening time after food WHICH CAUSE ACTION CONTRACEPTIVE? Elvinette • Leonore • Mercilon Reduce oestrogen to a lower dose Microlite • Violite • Qlaira Yasminelle • Yaz • Zoely Too much oestrogen Try non oestrogen brands Azalia • Cerazette • Noriday Copper coil • Implanon • Jaydess Consider non oral options NAUSEA Mirena • Nuvaring Reproduced with the kind permission of Dr. Deirdre Lundy
PRESCRIBING GUIDE 12 Oestrogen dosage No Synthetic Generation 20mcg 30mcg 35mcg 1.5mg Phasic oestrogen progestogen 1st Generation NORIDAY 350mcg Norethisterone ANDROGENICITY OVREENA 150mcg Levonorgestrel HIGH OVRANETTE VIOLITE 2nd Generation MICROLITE 100mcg Levonorgestrel LEONORE 30/75/125mcg LOGYNON Levonorgestrel MINULET 75mcg Gestodene MEDIUM MERCILON MARVIOL 150mcg Desogestrel 3rd Generation AZALIA 75mcg Desogestrel CERAZETTE CILIQUE 250mcg Norgestimate ZOELY 2.5mg Nomegestrol LOW QLAIRA 2/3mcg Dienogest 4th Generation ELVINETTE ELVINA YASMINELLE 3mg Drospirenone YASMIN YAZ
THRUSH • Can be caused by too much oestrogen – reduce oestrogen dose • Consider non oral options such as the copper intrauterine device WHICH CAUSE ACTION CONTRACEPTIVE? Elvinette • Leonore Reduce oestrogen to a Mercilon • Microlite • Violite lower dose Yasminelle • Yaz Too much oestrogen Try non oestrogen brands Azalia • Cerazette • Noriday Copper coil • Implanon Consider non oral options Jaydess • Mirena THRUSH Reproduced with the kind permission of Dr. Deirdre Lundy
PRESCRIBING GUIDE 12 Oestrogen dosage No Synthetic Generation 20mcg 30mcg 35mcg 1.5mg Phasic oestrogen progestogen 1st Generation NORIDAY 350mcg Norethisterone ANDROGENICITY OVREENA 150mcg Levonorgestrel HIGH OVRANETTE VIOLITE 2nd Generation MICROLITE 100mcg Levonorgestrel LEONORE 30/75/125mcg LOGYNON Levonorgestrel MINULET 75mcg Gestodene MEDIUM MERCILON MARVIOL 150mcg Desogestrel 3rd Generation AZALIA 75mcg Desogestrel CERAZETTE CILIQUE 250mcg Norgestimate ZOELY 2.5mg Nomegestrol LOW QLAIRA 2/3mcg Dienogest 4th Generation ELVINETTE ELVINA YASMINELLE 3mg Drospirenone YASMIN YAZ
WEIGHT GAIN • There is insufficient evidence to suggest CHCs can lead to weight gain • Patients starting CHCs may find they have an increased appetite which can lead to weight gain •C yclical weight gain may be oestrogen related due to fluid retention – use low dose oestrogen pill WHICH CAUSE ACTION CONTRACEPTIVE? FLUID RETENTION Elvinette • Leonore • Reduce oestrogen to a Mercilon • Microlite • Violite lower dose Yasminelle • Yaz Too much oestrogen Try non oestrogen brands Azalia • Cerazette • Noriday Reproduced with the kind permission of Dr. Deirdre Lundy WEIGHT GAIN
PRESCRIBING INFORMATION Combined Abbreviated Prescribing Information – for full malignancies (e.g. of the genital organs or the breasts). Ovreena & one are associated with the lowest risk of VTE. Other products may have Violite: Presence or history of venous or arterial thrombosis (e.g. deep up to twice this level of risk. The decision to use any product other than and contra- indications, see relevant Summary of Product venous thrombosis, pulmonary embolism, myocardial infarction (MI) or one with the lowest VTE risk should be taken only after a discussion with Characteristics (SmPC). cerebrovascular disorder), the presence of severe or multiple risk factors the woman to ensure she understands the risk of VTE, how her current for venous or arterial thrombosis, previous prodromal symptoms of thrombosis (e.g. transient cerebral ischaemia or angina pectoris), ever year of use. There is also some evidence that the risk is increased coated tablets: 75 micrograms desogestrel. Cilique 250/ 35 cardiovascular disorders (e.g. cardiac diseases, valvulopathy, arrhythmic when a CHC is re-started after a break in use of 4 weeks or more. The risk microgram tablets: 250 micrograms of norgestimate and 35 micrograms disturbances), severe hypertension, diabetes mellitus with vascular of arterial thromboembolic complications or of a cerebrovascular accident of ethinylestradiol Elvina 0.03mg/3mg Film-coated Tablets: 0.03 mg involvement, ocular disorder of vascular origin, known or suspected in CHC users increases in women with risk factors. If a woman has more ethinylestradiol and 3 mg drospirenone. Elvinette 0.02mg/3mg than one risk factor, it is possible that the increase in risk is greater than 0.02 mg ethinylestradiol and 3 mg drospirenone. breast)present or history of benign or malignant liver tumours, the sum of the individual factors - in this case her total risk should be Ovreena 30 micrograms/150 micrograms coated tablets: 150 migraine with focal neurological symptoms. Violite is contraindicated for micrograms levonorgestrel and 30 micrograms ethinylestradiol, Violite concomitant use with the medicinal products containing ombitasvir/pari- negative a CHC should not be prescribed. Please refer to the relevant 100/20: 100 mg levonorgestrel and 20 mg ethinylestradiol. Please refer taprevir/ritonavir, and dasabuvir, glecaprevir/pibrentasvir and SmPC for a list of risk factors and symptoms for VTE and ATE. CHC users to the relevant Summary of Product Characteristics (SmPC) for a full list of sofosbuvir/velpatasvir/voxilaprevir Warnings and Precautions: excipients. Indication: Contraception. Administration: Azalia: 1 tablet Azalia: taken every day at about the same time, without taking any notice of possible risks for each individual woman. The risk of breast cancer is COC use should be discontinued. Azalia & Cilique contain lactose. possible bleeding. Each new pack to be started directly after the previous slightly increased with COC use, but for POPs the evidence is less Tumours: A possible increased risk of cervical cancer has been reported with long-term COC use. A slightly increased risk of breast cancer has bleeding. For details of usage, especially if changing from another been observed in COC users, although direct causation has not been contraceptive method or where a patient either misses a dose or has referred to a specialist if acute or chronic disturbances of liver function shown. Hepati c tumours (benign and malignant) have also been vomiting/diarrhoea, please refer to the SmPC. Elvina, Elvinette, occur. Azalia should be discontinued in the event of a thrombosis and reported. Other conditions: Possible increased risk of pancreatitis in Ovreena, Violite & Cilique: The tablets must be taken every day at women with a history of thromboembolic disorders should be made women with family history of, or current, hypertriglyceridemia. Clinically about the same time in the order shown on the blister pack. One tablet is aware of the possibility of a recurrence. Discontinuation should also be relevant increases in blood pressure may rarely occur and require to be taken daily for 21 consecutive days. Each subsequent blister started considered if there is long-term immobilization. Diabetic patients should discontinuation of COC use. If pre-existing or emergent elevated blood after a 7-day tablet-free interval, during which time a withdrawal bleed pressure does not respond adequately to antihypertensive therapy, the usually occurs. This bleeding usually starts on day 2-3 after the last tablet COC must be withdrawn, and may be resumed if normotensive values are and may not have stopped before the next pack is started. For details of achieved. The following conditions may arise or worsen during use of usage, especially if changing from another contraceptive method or not adequately respond to antihypertensive therapy, consider COCs although evidence of a relationship is inconclusive: Jaundice and/or where a patient either misses a dose or has vomiting/diarrhoea, please discontinuing use. Ectopic pregnancy should be included in the pruritus associated with cholestasis, gallstones, porphyria, system lupus refer to the relevant the SmPC. Contraindications: Hypersensitivity to erythematosus, haemolytic uraemic syndrome, Sydenham’s chorea, the active substances or any of the excipients, undiagnosed vaginal Chloasma may occasionally occur, and women with a tendency to this herpes gestationis, hearing loss due to otosclerosis. Liver function bleeding, presence or history of sever e hepatic disease (whilst liver should avoid exposure to the sun or UV radiation whilst taking Azalia. disturbance (acute or chronic) may require COC discontinuation until liver function tests are abnormal). Or with the medicines containing The following conditions have been reported during sex steroid use: ombitasvir/paritaprevir/ritonavir and dasabuvir Azalia: Active venous jaundice and/or pruritus related to cholestasis; gallstone formation; peripheral insulin resistance and glucose tolerance; diabetics should be thromboembolic disorder; known or suspected sex-steroid sensitive porphyria; systemic lupus erythematosus; haemolytic uraemic closely monitored, particularly in the early stage of COC use. Worsening of malignancies; Cilique: Presence or risk of venous thromboembolism syndrome; Sydenham’s chorea; herpes gestationis; otosclerosis-related endogenous depression, epilepsy, Crohn’s disease and ulcerative colitis (VTE); or arterial thromboembolism (ATE); high risk of arterial hearing loss; (hereditary) angioedema. Lactation Azalia: There have have been reported during COC use. Women with a tendency to chloasma thromboembolism due to multiple risk factors or to the presence of one been reports of a decrease in breast milk production while using Azalia. should avoid exposure to the sun or ultraviolet radiation while taking serious risk factor such as (a) diabetes mellitus with vascular symptoms, Small amounts of etonogestrel are excreted in the breast milk. As a result, COCs. With all COCs, irregular bleeding may occur, especially during the (b) severe hypertension (c) severe dyslipoproteinaemia. Elvina & 0.01 - 0.05 microgram etonogestrel per kg body weight per day may be Elvinette: Hypersensitivity to peanut or soya, presence or risk of VTE, ingested by the child (based on an estimated milk ingestion of 150 considered after approximately three cycles. If bleeding irregularities presence or risk of arterial thromboembolism (ATE), severe renal ml/kg/day) Cilique, Elvina, Elvinette, Ovreena & Violite: Circulatory occur after previously regular cycles, further diagnostic procedures should disorders: The use of any CHC increases the risk of VTE compared with no be considered. Please refer to the relevant SmPC for further information use. Products that contain levonorgestrel, norgestimate or norethister- regarding cycle control. Azalia, Cilique, Violite, Ovreena, Elvina &
Elvinette: Depression can be serious and is a well-known risk factor for two months of treatment, bleeding tends to become less frequent. The pain, papanicolaou smear suspicious, libido decreased, edema, asthenia, suicidal behavior and suicide. Women should be advised to contact their following adverse reactions have been reported: Common (≥1/100 to pain, excessive thirst, sweating increased, weight decrease; Rare ( ≥ physician in case of mood changes and depressive symptoms, including
References: 1. www.hpra.ie 10. National Medicines Information Centre (2012) Update on Sexually Transmitted Infections Volume 18 Number 2 2. ellaOne® Summary of Product Characteristics Available at www.medicines.ie 11. http://www.thinkcontraception.ie/Sexually-Transmitted-Infections-STIs.3.1.aspx Last accessed: 31/08/15 3. 12. Adapted from MIMS Ireland (June 2016) Contraception pp. 317 - 319. MPI Media Ltd, Dublin. hormonal contraception after use of ulipristal acetate 30mg (ellaOne®) for emergency contraception” 13. Adapted from Faculty of Sexual & Reproductive Healthcare Statement Venous Thromboembolism (VTE) and September 2015 Hormonal Contraception November 2014 4. 14. outweigh risks – CHMP endorses PRAC recommendation November 2013 EMA/709120/2013 5. Elvina Summary of Product Characteristics Available at www.medicines.ie 15. 6. Elvinette Summary of Product Characteristics Available at www.medicines.ie Recommendations” May 2011 7. Azalia Summary of Product Characteristics Available at www.medicines.ie 16. Cerazette Summary of Product Characteristics Available from www.medicines.ie 8. Ovreena Summary of Product Characteristics Available at www.medicines.ie 17. 9. Violite Summary of Product Characteristics Available at www.medicines.ie 2010 Dec 15;82(12):1499-1506. University of California, Los Angeles: California For further information and patient support visit www.knowyourcontraceptives.ie Acknowledgements We sincerely thank Dr. Deirdre Lundy, Bray Womens Health Centre, for sharing the We sincerely thank the Irish HCPs with a special interest in contraceptive care, who assisted Consilient Health with the development of sections 1 - 5 of this Patient Management Guide. IE-OCS-405a(1), Date of Preparation: May 2021
You can also read