ELEVIN

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).