Presentation and Status in Health Basket
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Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. 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.
No preceding hormonal contraceptive use [in the past month]
It is preferable that tablet intake from the first pack is started on the first day of menstruation in which case no extra contraceptive precautions 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 Feminet.
Changing from a 21 day pill or another 22 day pill to Feminet: All tablets in the old pack should be finished. The first Feminet tablet is taken the next day i.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 Feminet. Additional contraceptive precautions are not required. The patient will not have a period until the end of the first Feminet pack, but this is not harmful, nor does it matter if she experiences some bleeding on tablet-taking days.
Changing from a combined Every Day Pill (28 day tablets) to Feminet: Feminet should be started after taking the last active tablet from the ‘Every Day Pill’ pack (i.e. after taking 21 or 22 tablets). The first Feminet tablet is taken the next day i.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. Remaining tablets from the Every Day
(ED) pack should be discarded. The patient will not have a period until the end of the first Feminet pack, but this is not harmful, nor does it matter if she experiences some bleeding on tablet-taking days.
Changing from a Progestogen-only Pill (POP or Mini Pill) to Feminet: The first Feminet tablet should be taken on the first day of the period, even if the patient has already taken a mini pill on that day. 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 then required. All the remaining Progestogen-only pills in the mini pill pack should be discarded.
If the patient is taking a (mini) pill, then she may not always have a period, especially when she is breast feeding. The first Feminet tablet should be taken on the day after stopping the mini pill. All remaining pills in the mini pill packet must be discarded. Additional contraceptive precautions must be taken for the first seven days.
Changing from a progestogen-only injection, implant or from a progestogen- releasing intrauterine system [IUS]
The woman may switch any day from an implant (or the IUS on the day of its removal, from an injectable when the next injection would be due). Additional contraceptive precautions must be taken for the first seven days.
Post-Partum Administration: Following childbirth hormonal contraceptive administration to non-breast feeding mothers should be started 21 days post-partum in which case no additional contraceptive precautions are required. If intercourse has taken place post-partum, hormonal contraceptive use should be delayed until the first day of the menstrual period.
If post-partum administration of Feminet begins more than 21 days after delivery then additional contraceptive precautions are required for the first 7 days.
N.B. (Nota Bene): Mothers who are breast feeding should be advised not to use the combined pill since this may reduce the amount of breast-milk, but may be advised instead to use a progestogen-only pill (POP).
After miscarriage or abortion: administration should start immediately in which case no additional contraceptive precautions are required.
Additional contraceptive precautions
When additional contraceptive precautions are required the patient should be advised either not to have sex, or to use a cap plus spermicide, or for her partner to use a condom.
Rhythm methods should not be advised as the pill disrupts the usual cyclical changes associated with the natural menstrual cycle e.g. changes in temperature and cervical mucus.
How to skip a period: To skip a period, a new pack of Feminet 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 Feminet is started after the usual 7 tablet-free days, regardless of whether the period has completely finished or not.
Management of missed tablets: Advice in case of missed pills
The reliability of Feminet may be reduced if tablets are forgotten:
If the forgotten tablet is taken within 12 hours, no further precautions are necessary, further tablets should be taken at the usual time.
If one or more tablets are forgotten for more than 12 hours, contraceptive protection will be reduced.
The patient should take the last forgotten tablet, even if this means taking two tablets in one day, and then continue to take tablets at the normal time. Additional contraceptive precautions should be taken for the next seven days, and the patient should follow ‘the 7-day rule’.
The 7-Day rule: If one tablet is forgotten for more than 12 hours
If the patient has vomiting or diarrhoea for more than 12 hours:
If the patient is taking any of the drugs listed under ‘Interactions’:
The patient should continue to take her tablets as usual and:
Additional contraceptive precautions must be taken for the next 7 days
But – if these 7 days run beyond the end of the current pack, the next pack must be started as soon as the current one is finished, i.e. no gap should be left between packs. (This prevents an extended break in tablet taking which may increase the risk of the ovaries releasing an egg and thus reducing contraceptive protection). The patient will not have a period until the end of 2 packs but this is not harmful nor does it matter if she experiences some bleeding on tablet taking days.
Advice in case of Vomiting or severe Diarrhoea: In case of severe gastro-intestinal disturbance, absorption may not be complete and additional contraceptive measures should be taken. Unless diarrhoea is extremely severe, it does not affect steroidal absorption. If vomiting occurs within 3-4 hours after tablet taking, or in cases of severe or prolonged diarrhoea, the advice concerning 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) needed from another pack.
Combined hormonal contraceptives (CHCs) should not be used in the following conditions.
Pregnancy or suspected pregnancy (that cannot yet be excluded). Presence or risk of venous thromboembolism (VTE). Venous thromboembolism – current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE]). 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. Major surgery with prolonged immobilization. A high risk of venous thromboembolism due to the presence of multiple risk factors. Presence or risk of thromboembolism (ATE). Arterial thromboembolism – current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris). Cerebrovascular disease – current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA). Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant). History of migraine with focal neurological symptoms. A high risk of arterial thromboembolism due to multiple risk factors or to the presence of one serious risk factor such as: diabetes mellitus with vascular symptoms, severe hypertension, severe dyslipoproteinaemia.
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.Undiagnosed vaginal bleeding. Hypersensitivity to the active substances or to any of the excipients.
If any of the conditions or risk factors mentioned below is present, the suitability of Feminet 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 Feminet should be discontinued.
1. Circulatory Disorders
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. Other products such as Feminet 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 Feminet, 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 the same or a different 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. It is estimated 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 6 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.
Risk of arterial thromboembolism (ATE): Epidemiological studies have associated the use of CHCs with an increased risk for arterial thromboembolism (myocardial infarction) or for cerebrovascular accident (e.g. transient ischaemic attack, stroke). Arterial thromboembolic events may be fatal.
An increased risk of cervical cancer in long term users of combined oral contraceptives has been reported in some studies, but there continues to be controversy about the extent to which this is attributable to the confounding effects of sexual behaviour and other factors such as human papilloma virus (HPV). A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently using combined oral contraceptives (COCs). 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 additional breast cancers diagnosed in current users of COCs or in women who have used COCs in the last ten years are more likely to be localised to the breast than those in women who never used COCs. Breast cancer is rare among women under 40 years of age whether or not they take COCs. Whilst this background risk increases with 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. The most important risk factor for breast cancer in COC users is the age women discontinue the COC; the older the age at stopping, the more breast cancers are diagnosed. Duration of use is less important and the excess risk gradually disappears during the course of the 10 years after stopping COC use such that by 10 years there appears to be no excess. The possible increase in risk of breast cancer should be discussed with the user and weighed against the benefits of COCs taking into account the evidence that they offer substantial protection against the risk of developing certain other cancers (e.g. ovarian and endometrial cancer). In rare cases, benign liver tumours, and even more rarely, malignant liver tumours have been reported in users of CHCs. In isolated cases, these tumours have led to life-threatening intra-abdominal haemorrhages. A hepatic tumour should be considered in the differential diagnosis when upper abdominal pain, enlarged liver or signs of intra-abdominal haemorrhage occur in women taking CHCs.
3. Other conditions
Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using CHCs. Although small increases in blood pressure have been reported in many women taking CHCs, clinically relevant increases are rare. However, if a sustained clinically significant hypertension develops during the use of a CHC then it is prudent for the physician to withdraw the CHC and treat the hypertension. Where considered appropriate, CHC use may be resumed if normotensive values can be achieved with antihypertensive therapy. The following conditions have been reported to occur or deteriorate with both pregnancy and CHC use: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; herpes gestationis; otosclerosis-related hearing loss; hereditary angioedema. Although CHCs may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics using CHCs. However, diabetic women should be carefully observed while taking CHCs. 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 this preparation. Feminet contains less than < 80 mg lactose per tablet. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption should not use Feminet.
Relative Contraindications: Severe depression or a history of this condition. If the results of liver function tests become abnormal, use should be discontinued.
For full details see prescribing Information.
An increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, transient ischaemic attacks, venous thrombosis and pulmonary embolism has been observed in women using CHCs.
Common (> 1/100): Fluid retention; Increase in blood pressure; Headache; Migraine; Changes in libido; Depressive moods; Mood altered; Nausea; Abdominal pain; Vomiting; Change in body weight; Irregular vaginal bleeding; Breast tenderness; Breast pain; Breast secretion; Changes in vaginal secretion; Rash; Erythema nodosum; Contact lens intolerance.
Uncommon (≥1/1000 and <1/100): Diarrhea; Breast hypertrophy.
Rare (<1/1000): Hypersensitivity reaction; Systemic lupus Erythematosus; Hypertension; Sydenham’s chorea; Venous thromboembolism; Arterial thromboembolism; Pancreatitis; Crohn’s disease; Ulcerative colitis; Otosclerosis-related hearing loss; Cholelithiasis; Cholestatic jaundice; Reduced glucose tolerance; Porphyria; Breast cancer; Cervical cancer; Liver tumours (benign); Liver tumours (malignant); Venous thrombormbolic disorder; Arterial thromboembolic disorder; erythema multiforme Chloasma; Herpes gestationis.
For full details see prescribing Information.
Interactions between oral contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. The following interactions have been reported:
Hepatic metabolism: Interactions can occur with drugs that induce microsomal enzymes, which can result in increased clearance of sex hormones (e.g., phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and products containing St. John’s wort).
Interference with Enterohepatic Circulation: Some clinical reports suggest that enterohepatic circulation of estrogens may decrease when certain antibiotic agents are given, which may reduce ethinylestradiol concentrations (e.g., penicillins, tetracyclines).
Women on treatment with any of these drugs should temporarily use a barrier method in addition to the CHC or choose another method of contraception. With microsomal enzyme-inducing drugs, the barrier method should be used during the time of concomitant drug administration and for 28 days after their discontinuation. Women on treatment with antibiotics (except rifampicin and griseofulvin) should use the barrier method until 7 days after discontinuation. If the period during which the barrier method is used runs beyond the end of the tablets in the CHC pack, the next CHC pack should be started without the usual tablet-free interval.
Oral contraceptives may interfere with the metabolism of other drugs. Accordingly, plasma and tissue concentrations may be increased (e.g., ciclosporin) or decreased (e.g., lamotrigine).
Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.
For full details see prescribing Information.
Pregnancy and Lactation
Pregnancy: Combined hormonal contraceptives are not indicated for use during pregnancy. If pregnancy occurs during treatment with Feminet, further intake should be stopped. However, epidemiological studies have revealed no teratogenic effects when CHCs were taken inadvertently during early pregnancy. The increased risk of VTE during the postpartum period should be considered when re-starting Feminet.
Lactation: Lactation may be influenced by CHCs as they may reduce the quantity and change the composition of breast milk. Therefore, the use of CHCs should generally not be recommended until the nursing mother has weaned her child. Small amounts of the contraceptive steroids and/or their metabolites may be excreted with the milk but there is no evidence that this adversely affects infant health.
There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in this case are: nausea, vomiting and slight vaginal bleeding. There are no antidotes and further treatment should be symptomatic.