ELEVIN

Method of administration: oral use Posology How to take Ethinylestradiol/Levonorgestrel The tablets must be taken every day at about the same time, if necessary with a little liquid, in order shown on the blister pack. One tablet is to be taken daily for 21 consecutive days.

Each subsequent pack is started after a 7-day tablet-free interval, during which time a withdrawal bleed usually occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started.

e. the first day of her menstrual bleeding). It is also possible to start between the second and fifth day of the menstrual period, but in that case the woman should be advised to use an additional non-hormonal contraceptive method during the first 7 days.

• Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch The woman should start with Ethinylestradiol/Levonorgestrel preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC.

In case a vaginal ring or transdermal patch has been used, the woman should start using Ethinylestradiol/Levonorgestrel preferably on the day of removal, but at the latest when the next application would have been due. • Changing from a progestogen-only-method (progestogen-only pill, injection, implant) or from a progestogen-releasing intrauterine system (IUS) The woman may switch any day from the progestogen-only pill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due) but should in all of these cases be advised to additionally use a barrier method for the first 7 days of tablet-taking.

• Following first-trimester abortion The woman may start immediately. When doing so, she need not take additional contraceptive measures. • Following delivery or second-trimester abortion As the risk of thromboembolic events is elevated in the period immediately following childbirth, the administration of oral contraceptives should not be started earlier than 28 days after childbirth in women who are not breast-feeding or after an abortion in the second trimester.

A non-hormonal contraceptive method should also be used during the first 7 days. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of COC use or the woman has to wait for her first menstrual period.

6. 4). Management of missed tablets Ethinylestradiol/Levonorgestrel contains a low dose of both hormones. As a result, the contraceptive efficacy margin is small if a pill is missed. If the user is less than 12 hours late in taking any tablet, contraceptive protection is not reduced.

The woman should take the tablet as soon as she remembers and should take further tablets at the usual time. If she is more than 12 hours late in taking any tablet, contraceptive protection may be reduced. If the usual withdrawal bleeding following the forgotten administration fails to appear, pregnancy must be ruled out before a new blister pack is started.

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.

Accordingly the following advice can be given in daily practice: ● Week 1 The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time.

In addition, a barrier method such as a condom should be used for the next 7 days. If intercourse took place in the preceding 7 days, the possibility of a pregnancy should be considered. The more tablets are missed and the closer they are to the regular tablet-free interval, the higher the risk of a pregnancy.

● Week 2 The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time. Provided that the woman has taken her tablets correctly in the 7 days preceding the first missed tablet, there is no need to use extra contraceptive precautions.

However, if she has missed more than 1 tablet, the woman should be advised to use extra precautions for 7 days. ● Week 3 The risk of reduced reliability is imminent because of the forthcoming 7-day tablet- free interval. However, by adjusting the tablet-intake schedule, reduced contraceptive protection can still be prevented.

By adhering to either of the following two options, there is therefore no need to use extra contraceptive precautions, provided that in the 7 days preceding the first missed tablet the woman has taken all tablets correctly. If this is not the case, she should follow the first of these two options and use extra precautions for the next 7 days as well.

1. The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time. , no gap should be left between packs. The user is unlikely to have a withdrawal bleed until the end of the second pack, but she may experience spotting or breakthrough […]

g. g. focal nodular hyperplasia, hepatic adenoma) • intraepithelial cervical neoplasias and cervical carcinoma • breast cancer The most frequent (≥1/10) adverse reactions associated with use of Elevin are headache (including migraine), spotting and intermenstrual bleeding.

Furthermore, the following adverse reactions were reported with the use of ethinylestradiol/levonorgestrel-containing combined oral contraceptives. The following categories have been defined for indicating the frequency of adverse reactions: Frequency of adverse reactions: Very common: ≥ 1/10 Common: ≥ 1/100 to < 1/10 Uncommon: ≥ 1/1,000 to < 1/100 Rare: ≥ 1/10,000 to < 1/1,000 Very rare: < 1/10,000 Not known: cannot be estimated from the available data frequency of undesirable effects System Organ Class very common common uncommon Rare very rare not known Infections and infestations vaginitis, including candidiasis Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma Immune system disorders Allergic reactions angiooedema, severe anaphylactic/anaphylactoid reactions with respiratory and circulatory symptoms; hypersensitivity Exacerbation of symptoms of hereditary and acquired angioedema.

Metabolism and nutrition disorders changes in appetite (increase or decrease) glucose intolerance Psychiatric disorders mood shifts, including depression; changes in libido Nervous system Headaches (including nervousness, stupor, dizziness frequency of undesirable effects System Organ Class very common common uncommon Rare very rare not known disorders migraines) Eye disorders incompati-bility with contact lenses Gastro- intestinal disorders nausea, vomiting, abdominal pain abdominal cramps and bloating; diarrhoea Hepato-biliary disorders cholestatic jaundice Skin and sub- cutaneous tissue disorders acne rash, chloasma (meliasma) possibly persistent, hirsutism, alopecia; urticaria erythema nodosum erythema multiforme Reproductive system and reast disorders Spotting, breakthrough bleeding breast pain, sensitivity of the breasts, breast enlargement, mammary gland secretion, dysmenorrhoea, changes in the menstruation flow, changes on the cervix and in cervical secretion, amenorrhoea General disorders and administration site conditions fluid retention/ oedema Vascular disorders VTE ATE Investigations changes in weight (increase or decrease) increased blood pressure, changes in the blood lipid levels, including hyper- triglyceri- daemia Decreased serum folic acid level (serum folic acid levels can be decreased by COC therapy.

) Furthermore, the following adverse events have been reported with the use of COCs. The frequency of the adverse reactions cannot be calculated from the reports. g. hepatitis, liver dysfunction) – gallbladder disease, including gallstones (COCs can result in the occurrence of a gallbladder disorder or exacerbate an existing gallbladder disease) – haemolytic-uraemic syndrome – gestational herpes – otosclerosis – exacerbation of systemic lupus erythematodes – exacerbation of porphyria – exacerbation of Sydenham's chorea – exacerbation of depression – chronic inflammatory bowel disease (Crohn’s disease, ulcerative colitis) – Endometriosis, uterine fibroid – Epilepsy Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

3): • pregnancy or suspected pregnancy • initial symptoms of inflammation of the veins or symptoms of a possible thrombosis (including retinal thrombosis), embolism or myocardial infarction (see “Warnings” further below) • consistently elevated blood pressure with values above 140/90 mmHg.

Renewed administration of COCs can be considered as soon as the blood pressure values have normalised under antihypertensive treatment. g. after accidents). Administration should be restarted no earlier than 2 weeks after complete remobilisation.

• first occurrence or worsening of a migraine • if headaches occur unusually often, continuously or strongly, or sudden focal neurological symptoms develop (possible first signs of a stroke) • severe upper abdominal pain, liver enlargement or symptoms of intra-abdominal bleeding (possible indications of a liver tumour) • occurrence of jaundice, hepatitis, generalised pruritus, cholestasis and abnormal liver values.

Steroid hormones are metabolised to a decreased extent in patients with impaired liver function. • acute derailment of diabetes mellitus • appearance or reappearance of porphyria Diseases/risk factors that require special medical monitoring: • smoking • women over the age of 35 (see “Warnings” further below) Warnings • If any of the conditions/risk factors mentioned below is present, the suitability of Elevin should be discussed with the woman • In the event of aggravation, or first appearance of any of these conditions or risk factors, the woman should be advised to contact her doctor to determine whether the use of Elevin should be discontinued.

Risk of venous thromboembolism (VTE) The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use. Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE.

The VTE risk is highest in the first ever year of use. There is also some evidence that the risk is increased when a CHC is re-started after a break in use of 4 weeks or more. In women who do not use a CHC and are not pregnant about 2 out of 10,000 will develop a VTE over the period of one year.

However, in any individual woman the risk may be far higher, depending on her underlying risk factors (see below). About 61 out of 10,000 women who use a levonorgestrel-containing CHC and are not pregnant suffer VTE over the course of a year.

The number of VTEs per year is fewer than the number expected during pregnancy or in the postpartum period. VTE may be fatal in 1-2% of the cases. g. hepatic, mesenteric, renal or retinal veins and arteries. Risk factors for VTE The risk for venous thromboembolic complications in CHC users may increase substantially in a woman with additional risk factors, particularly if there are multiple risk factors (see table).

3). If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors – in this case her total risk of VTE should be considered. 3).

Table:

Risk factors for VTE Risk factor Comment Obesity (body mass index over 30 kg/m²) Risk increases substantially as BMI rises. Particularly important to consider if other risk factors also present. Risk factor Comment Prolonged immobilisation, major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma Note: temporary immobilisation including air travel >4 hours can also be a risk factor for VTE, particularly in women with other risk factors In these situations it is advisable to discontinue use of the pill (in the case of elective surgery at least four weeks in advance) and not resume until two weeks after complete remobilisation.

Another method of contraception should be used to avoid unintentional pregnancy. Antithrombotic treatment should be considered if Elevin  has not been discontinued in advance. g. before 50). 2 There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the onset or progression of venous thrombosis.

6). Symptoms of VTE (deep vein thrombosis and pulmonary embolism) In the event of symptoms women should be advised to seek urgent medical attention and to inform the healthcare professional that she is taking a CHC. Symptoms of deep vein thrombosis (DVT) can include: • unilateral swelling of the leg and/or foot or along a vein in the leg; • pain or […]

Combined hormonal contraceptives (CHCs) should not be used in the presence of any of the following conditions. Should any of the conditions appear for the first time during CHC use, the product should be stopped immediately. g. deep venous thrombosis [DVT] or pulmonary embolism [PE]).

g. g. g. transient ischaemic attack, TIA) o Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant), thrombogenic valvulopathy or thrombogenic arrhythmia.

g. 5).