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SUMMARY OF PRODUCT CHARACTERISTICS 1

NAME OF THE MEDICINAL PRODUCT Lizinna 250 microgram /35 microgram Tablets

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QUALITATIVE AND QUANTITATIVE COMPOSITION Lizinna are tablets for oral administration. Each tablet contains norgestimate 250 microgram and ethinylestradiol 35 microgram. Excipient(s) of known effect: Each uncoated tablet contains 89.357 mg of Lactose. For the full list of excipients, see section 6.1.

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PHARMACEUTICAL FORM Tablet Round, blue, uncoated, 6.4 mm uncoated flat beveled edge tablets with ‘146’ debossed on one side and the other side plain.

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CLINICAL PARTICULARS

4.1

Therapeutic indications Oral contraception

4.2

Posology and method of administration For oral administration. Posology Paediatric population Lizinna is contraindicated in girls that have not reached pubertal age - before menarche (see section 4.3). Adults One tablet is taken daily at the same time (preferably in the evening) without interruption for 21 days, followed by a break of 7 tablet-free days. Each

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subsequent pack is started after the 7 tablet-free days have elapsed. Additional contraceptive precautions are not then required. During the tablet-free period, bleeding can be expected, usually beginning 2 to 4 days after the last tablet. Elderly Use of this product is not indicated in post-menopausal women.

Method of administration Starting treatment Tablet intake is started on day 1 of the woman´s natural cycle (i.e. the first day of her menstrual bleeding). Switching from another contraceptive Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring or transdermal patch) The woman should start with Lizinna 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 Lizinna 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. Post-partum administration Following a vaginal delivery, oral contraceptive administration to non-breastfeeding mothers can be started 21 days post-partum provided the patient is fully ambulant and there are no puerperal complications. No additional contraceptive precautions are required. If post-partum administration begins more than 21 days after delivery, additional contraceptive precautions are required for the first 7 days of pill-taking. If intercourse has taken place post-partum, oral contraceptive use should be delayed until the first day of the first menstrual period. For information on breast-feeding mothers, see sections 4.3, 4.4 and 4.6. Use after Abortion or Miscarriage Following first-trimester abortion

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The woman may start immediately. When doing so, she need not take additional contraceptive measures. Following delivery or second-trimester abortion Women should be advised to start at day 21 to 28 after delivery or secondtrimester abortion. When starting later, the woman should be advised to additionally use a barrier method for 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. For breastfeeding women see section 4.6. To skip a period To skip a period, a new pack of Lizinna should be started on the day after finishing the current pack (the patient skips the tablet-free days). Tablet-taking should be continued in the usual way. During the use of the second pack she may experience slight spotting or breakthrough bleeding but contraceptive protection will not be diminished provided there are no tablet omissions. The next pack of Lizinna is started after the usual 7 tablet-free days, regardless of whether the period has completely finished or not. Reduced reliability When Lizinna is taken according to the directions for use, the occurrence of pregnancy is highly unlikely. However, the reliability of oral contraceptives may be reduced under the following circumstances: Management of missed tablets 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. The management of missed tablets can be guided by the following two basic rules: 1. tablet-taking must never be discontinued for longer than 4 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: • Day 1-7 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

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more tablets are missed and the closer they are to the regular tablet-free interval, the higher the risk of a pregnancy. Day 8-14 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. Day 15-21 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. The next blister pack must be started as soon as the current blister pack is finished, i.e., no gap should be left between packs. The user is unlikely to have a withdrawal bleed until the end of the blister, but she may experience spotting or breakthrough bleeding on tablet-taking days. 2. The woman may also be advised to discontinue tablet-taking from the current blister pack. She should then have a tablet-free interval of up to 7 days, including the days she missed tablets and subsequently continue with the next blister pack.

If the woman missed tablets and subsequently has no withdrawal bleed in the first normal tablet-free interval, the possibility of a pregnancy should be considered. In case of severe gastro-intestinal disturbances (e.g., vomiting or diarrhoea), absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after tablet-taking, a new (replacement) tablet should be taken as soon as possible. The new tablet should be taken within 12 hours of the usual time of tablet-taking if possible. If more than 12 hours elapse, the advice concerning missed tablets, as given in section 4.2 “Management of missed tablets”, is applicable. If the woman does not want to change her normal tablet-taking schedule, she has to take the extra tablet(s) from another blister pack.

4.3

Contraindications •

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1

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Presence or history of venous thrombosis, with or without the involvement of pulmonary embolism Presence or history of arterial thrombosis (e.g., cerebrovascular accident, myocardial infarction, retinal thrombosis) or prodrome of a thrombosis (e.g., angina pectoris or transient ischaemic attack) Breast-feeding mothers less than 6 weeks post-partum. The presence of serious or multiple risk factor(s) for the occurrence of arterial thrombosis: moderate to severe hypertension (Persistent blood pressure values of ≥160 mm Hg systolic or ≥95 mm Hg diastolic) Hereditary dyslipoproteinaemia Hereditary or acquired predisposition for venous or arterial thrombosis, such as activated protein C (APC-) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia, and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant) Carcinoma of the endometrium or other known or suspected oestrogen-dependent neoplasia Undiagnosed abnormal genital bleeding Major surgery with prolonged immobilisation. Complicated valvular and congenital heart disease (e.g. with pulmonary hypertension, atrial fibrillation, history of subacute bacterial endocarditis) Migraine with focal aura. Diabetes with nephropathy/retinopathy/neuropathy or other vascular involvement or > 20 years' duration. Smoking 15 or more cigarettes per day in patients aged 35 years or more. Acute or chronic liver disease, including hepatitis (viral or non-viral) or severe cirrhosis, or a history of these conditions until at least 3 months after abnormal liver function tests have returned to normal; hepatic adenomas or carcinomas. Known or suspected carcinoma of the breast. Pancreatitis or a history thereof if associated with severe hypertriglyceridemia Lizinna is contraindicated in girls that have not reached pubertal age - before menarche.

Should any of these conditions occur for the first time during use of Lizinna, the tablets should be discontinued immediately.

4.4

Special warnings and precautions for use If any of the conditions/risk factors mentioned below is present, the benefits of COC use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using it. In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should contact her physician. The physician should then decide on whether COC use should be discontinued. Circulatory Disorders Use of any combined oral contraceptive carries an increased risk of venous thromboembolism (VTE) compared with no use. The excessive risk of VTE is highest during the first year a woman ever uses a combined oral contraceptive. Epidemiological studies have shown that the incidence of VTE in women with no known risk factors for VTE who use low dose oestrogen (1/10); common (>1/100 to 1/1,000 to 1/10,000 to