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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:.
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. 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. 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. The next blister pack must be started as soon as the current blister pack is finished, i. The user is unlikely to have a withdrawal bleed until the end of the second pack, but she may experience spotting or breakthrough bleeding on tablet-taking days. 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. If vomiting occurs within hours after tablet taking, a new replacement tablet should be taken as soon as possible.
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.
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To delay a period the woman should continue with another blister pack of Yasmin without a tablet-free interval. The extension can be carried on for as long as wished until the end of the second pack. During the extension the woman may experience breakthrough-bleeding or spotting. Regular intake of Yasmin is then resumed after the usual 7-day tablet-free interval. To shift her periods to another day of the week than the woman is used to with her current scheme, she can be advised to shorten her forthcoming tablet-free interval by as many days as she likes.
The shorter the interval, the higher the risk that she does not have a withdrawal bleed and will experience breakthrough-bleeding and spotting during the subsequent pack just as when delaying a period. Yasmin is only indicated after menarche. Based on epidemiological data collected on more than adolescent women aged below 18 years, there are no data indicating that safety and efficacy in this young age group is different from that known in women aged above 18 years. Combined hormonal contraceptives CHCs should not be used in the following conditions.
Should any of the conditions appear for the first time during CHC use, the product should be stopped immediately. In case anticoagulant therapy is started, adequate alternative contraception should be initiated because of the teratogenicity of anticoagulant therapy coumarins. 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. Other products such as Yasmin 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 Yasmin, 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, 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 estimated 1 that out of 10, women who use a CHC containing drospirenone between 9 and 12 women will develop a VTE in one year; this compares with about 6 2 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.
Extremely rarely, thrombosis has been reported to occur in CHC users in other blood vessels, e. 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. Yasmin is contraindicated if a woman has multiple risk factors that put her at high risk of venous thrombosis. 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.
If the balance of benefits and risks is considered to be negative a CHC should not be prescribed. Prolonged immobilisation, major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma. 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. Positive family history venous thromboembolism ever in a sibling or parent especially at a relatively early age e.
If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any CHC use. Cancer, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease Crohn's disease or ulcerative colitis and sickle cell disease. There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the onset or progression of venous thrombosis. 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.
Some of these symptoms e. Other signs of vascular occlusion can include: sudden pain, swelling and slight blue discolouration of an extremity. If the occlusion occurs in the eye symptoms can range from painless blurring of vision which can progress to loss of vision. Sometimes loss of vision can occur almost immediately. Epidemiological studies have associated the use of CHCs with an increased risk for arterial thromboembolism myocardial infarction or for cerebrovascular accident e.
Arterial thromboembolic events may be fatal. The risk of arterial thromboembolic complications or of a cerebrovascular accident in CHC users increases in women with risk factors see table. Yasmin is contraindicated if a woman has one serious or multiple risk factors for ATE that puts her at high risk of arterial thrombosis. 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 should be considered.
Women should be advised not to smoke if they wish to use a CHC. Women over 35 who continue to smoke should be strongly advised to use a different method of contraception. Positive family history arterial thromboembolism ever in a sibling or parent especially at relatively early age e. An increase in frequency or severity of migraine during CHC use which may be prodromal of a cerebrovascular event may be a reason for immediate discontinuation.
Diabetes mellitus, hyperhomocysteinaemia, valvular heart disease and atrial fibrillation, dyslipoproteinaemia and systemic lupus erythematosus. The excess risk gradually disappears during the course of the 10 years after cessation of COC use.
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Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the overall risk of breast cancer. These studies do not provide evidence for causation. The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in COC users, the biological effects of COCs or a combination of both. The breast cancers diagnosed in ever-users tend to be less advanced clinically than the cancers diagnosed in never-users.
In rare cases, benign liver tumours, and even more rarely, malignant liver tumours have been reported in users of COCs. In isolated cases, these tumours have led to life-threatening intra-abdominal haemorrhages. A hepatic tumour should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal haemorrhage occur in women taking COCs. Whether this also applies to lower-dosed COCs remains to be confirmed. The progestogen component in Yasmin is an aldosterone antagonist with potassium sparing properties.
Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs. Although small increases in blood pressure have been reported in many women taking COCs, clinically relevant increases are rare.
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Only in these rare cases an immediate discontinuation of COC use is justified. If, during the use of a COC in preexisting hypertension, constantly elevated blood pressure values or a significant increase in blood pressure do not respond adequately to antihypertensive treatment, the COC must be withdrawn. Where considered appropriate, COC use may be resumed if normotensive values can be achieved with antihypertensive therapy.
In women with hereditary angioedema exogenous oestrogens may induce or exacerbate symptoms of angioedema.
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Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal. However, diabetic women should be carefully observed, particularly in the early stage of COC use. Worsening of endogenous depression, of epilepsy, of Crohn's disease and of ulcerative colitis has been reported during COC use. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking COCs.
This medicinal product contains 46 mg lactose per tablet. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption who are on a lactose-free diet should take this amount into consideration. Prior to the initiation or reinstitution of Yasmin a complete medical history including family history should be taken and pregnancy must be ruled out. Blood pressure should be measured and a physical examination should be performed, guided by the contra-indications and warnings. It is important to draw a woman's attention to the information on venous and arterial thrombosis, including the risk of Yasmin compared with other CHCs, the symptoms of VTE and ATE, the known risk factors and what to do in the event of a suspected thrombosis.
The woman should also be instructed to carefully read the user leaflet and to adhere to the advice given. The frequency and nature of examinations should be based on established practice guidelines and be adapted to the individual woman. Women should be advised that hormonal contraceptives do not protect against HIV infections AIDS and other sexually transmitted diseases.
The efficacy of COCs may be reduced in the event of e. With all COCs, irregular bleeding spotting or breakthrough bleeding may occur, especially during the first months of use.
Therefore, the evaluation of any irregular bleeding is only meaningful after an adaptation interval of about three cycles. If bleeding irregularities persist or occur after previously regular cycles, then non-hormonal causes should be considered and adequate diagnostic measures are indicated to exclude malignancy or pregnancy. These may include curettage. In some women withdrawal bleeding may not occur during the tablet-free interval. However, if the COC has not been taken according to these directions prior to the first missed withdrawal bleed or if two withdrawal bleeds are missed, pregnancy must be ruled out before COC use is continued.
No studies on the effects on the ability to drive and use machines have been performed. No effects on ability to drive and use machines have been observed in users of COCs. An increased risk of arterial and venous thrombotic and thrombo-embolic events, including myocardial infarction, stroke, transient ischaemic attacks, venous thrombosis and pulmonary embolism has been observed in women using. Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.