BIMIZZA

Route of administration:

Oral use How to take Bimizza Tablets must be taken every day at about the same time, with some liquid as needed, in the 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 bleeding 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) in which case no extra contraceptive precaution are necessary. If menstruation has already begun, (that is 2, 3, or 4 days previously), tablet taking should commence on day 5 of the menstrual period.

In this case additional contraceptive precautions must be taken for the first 7 days of tablet taking. If menstruation began more than 5 days previously then the patient should be advised to wait until her next menstrual period before starting to take Bimizza.

Changing from a 21 day pill or another 22 day pill to Bimizza:

All tablets in the old pack should be finished. e. no gap is left between taking tablets nor does the patient need to wait for her period to begin. Tablets should be taken as instructed in ‘How to take Bimizza’. Additional contraceptive precautions are not required.

The patient will not have a period until the end of the first Bimizza pack, but this is not harmful, nor does it matter if she experiences some bleeding on tablet-taking days. e. after taking 21 or 22 tablets). e. no gap is left between taking tablets nor does the patient need to wait for her period to begin.

One tablet is taken daily at the same time, without interruption for 21 days, followed by a 7 day tablet-free period. Each subsequent pack is started after the 7 day tablet-free period has elapsed. Additional contraceptive precautions are not required.

Description of selected adverse reactions As with all COCs, changes in vaginal bleeding patterns may occur, especially during the first months of use. These may include changes in bleeding frequency (absent, less, more frequent or continuous), intensity (reduced or increased) or duration.

4. Possibly related undesirable effects that have been reported in users of Bimizza or CHC users in general are listed in the table below1. All ADRs are listed by system organ class and frequency; common (≥1/100) , uncommon (≥1/1,000 to < 1/100), and rare (<1/1000) and not known (cannot be estimated from the available data).

Organ systems common Uncommon Rare Not Known Immune system Hypersensitivity Exacerbation of symptoms disorders of hereditary and acquired angioedema. Metabolism and nutrition disorders Fluid retention Psychiatric disorders Depressed mood, mood altered Libido decreased Libido increased Nervous system disorders Headache Migraine Eye disorders Contact lens Intolerance Vascular disorders Venous thromboembolism2 Arterial thromboembolism2 Gastrointestinal disorders Nausea, abdominal pain Vomiting diarrhoea Hepatobiliary disorders Transaminases increased Skin and subcutaneous tissue disorders Rash Urticaria Erythema Nodosum, Erythema multiforme Reproductive system and breast disorders Breast pain, breast tenderness Breast enlargement Vaginal Discharge, Breast discharge Investigations Weight increased Weight decreased 1 The most appropriate MedDRA term (version 11) to describe a certain adverse reaction is listed.

Synonyms or related conditions are not listed,but should be taken into account as well. 2 Incidence in observational cohort studies of ≥1/10000 to 1/1000 women-years.

4 Special warnings and special precautions for use: The Pill and Cancer). • Endometrial hyperplasia. • Undiagnosed vaginal bleeding. • Known or suspected pregnancy. 1. 5). 4 Special warnings and precautions for use If any of the conditions or risk factors mentioned below is present, the suitability of Bimizza 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 Bimizza should be discontinued. Circulatory disorders Risk of venous thromboembolism (VTE) The use of any combined hormonal contraceptive (CHC) carries an increased risk of venous thromboembolism (VTE) compared with no use.

Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE. Other products such as Bimizza may have up to twice this level of risk. The decision to use any product other than one with the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with Bimizza, how her current risk factors influence this risk, and that her 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). It is estimated1 that out of 10,000 women who use a CHC containing desogestrel between 9 and 12 women will develop a VTE in one year; this compares with about 62 in women who use a levonorgestrel-containing CHC.

In both cases, 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 cases. 1 These incidences were estimated from the totality of the epidemiological study data, using relative risks for the different products compared with levonorgestrel-containing CHCs.

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

o Known hereditary or acquired predisposition for venous thromboembolism, such as APC-resistance, (including Factor V Leiden), antithrombin-III- deficiency, protein C deficiency, protein S deficiency. 4). 4). 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). o History of migraine with focal neurological symptoms.

4) or to the presence of one serious risk factor such as: • diabetes mellitus with vascular symptoms • severe hypertension • severe dyslipoproteinaemia • Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.

• Presence or history of severe hepatic disease as long as liver function values have not returned to normal. • Presence or history of liver tumours (benign or malignant). • Known or suspected estrogen-dependent tumours, (See