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KATYA is a brand name for Gestodene. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Oral contraception and the recognised gynaecological indications for such oestrogen- progestogen combinations. The decision to prescribe Katya 30/75 coated tablets should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE…
Verbatim from this product's MHRA label. Tap a section to expand.
How to take Katya 30/75 coated tablets The tablets should be taken in the order indicated on the package, every day at approximately the same time. One tablet per day should be taken for 21 days. Each subsequent pack should be started after a 7-day tablet-free interval during which time a withdrawal bleeding will occur.
This bleeding usually starts on the 2nd or 3rd day after taking the last tablet, and may not stop until the next pack is started. e. on the first day of the woman’s menstrual bleeding). One may begin taking the pills on day 2-5, but in these cases, it is recommended that a barrier method also be used for the first 7 days on which pills are taken during the first cycle.
When replacing another contraceptive pill of the combination type (COC), vaginal ring or transdermal patch The woman should start taking Katya 30/75 coated tablets on the next day after taking the last active tablet in her previous package of contraceptive pills – but no later than the day after the usual tablet-free or placebo-tablet period of her previous contraceptive pill.
In case a vaginal ring or transdermal patch has been used, the woman should preferably start taking Katya 30/75 coated tablets one day before scheduled removal of the ring or patch, or at the latest, when the next application would have been due.
When changing from progestogen-only preparations (progestogen-only pills, injection, implant, or from a progestogen-releasing intrauterine system (IUS)) The woman may change from progestogen-only pills (POPs) on any day. The first tablet should be taken on the day after any tablet of the POP package.
When changing from an implant or the IUS, Katya 30/75 coated tablets should be started on the day the implant is removed. When changing from injections, Katya 30/75 coated tablets should be started when the next injection is due to be given.
In all these cases, the woman is advised to also use a barrier method for the first 7 days of taking the pills. After an abortion in the first trimester The woman may start taking the pills immediately. If she does so, no further contraceptive steps need be taken.
6. The woman should be advised to begin taking the tablets on day 21- 28 after delivery in non- lactating women or after abortion in the second trimester. If she starts later, she should be advised to also use a barrier method during the first 7 days of taking the pills.
The most commonly reported adverse reactions are irregular bleeding, nausea, abdominal pain, weight increase, headache, depression, mood changes, breast pain, breast tenderness. They occur in ≥ 1% of users. Serious adverse reactions include arterial and venous thromboembolism.
System organ class (MedDRA) 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 kno (cannot estimated from available data) Infections and infestations Vaginitis, including candidiasis Neoplasms benign, malignant and unspecified (incl cysts and polyps) hepatic adenomas, hepatocellula r carcinoma Immune system disorders Lupus erythematosus, Anaphylactic/ana phylactoid reactions, including very rare cases of urticaria, angioedema and severe reactions with respiratory and circulatory symptoms Exacerba of symp of hered and acq angioede Metabolism and nutrition disorders Fluid retention Hyperlipidaemia glucose intolerance Changes in glucose tolerance or effect on peripheral insulin resistance, exacerbation of porphyria Psychiatric disorders Mood swings, including depression; changes in libido Nervous system disorders Headache, Nervousnes s Migraine, vertigo Chorea Eye disorders Visual disturbances Contact lens intolerance optic neuritis*, retinal vascular thrombosis.
Ear and labyrinth disorders Otosclerosis Vascular disorders Hypertension Venous thromboembolism (VTE), Arterial thromboembolism (ATE) Gastrointestinal disorders Nausea, Abdominal pain Vomiting Pancreatitis Hepatobiliary disorders Cholelithiasis cholestatic jaundice Skin and subcutaneous tissue disorders Acne Skin rash, hirsutism, alopecia Chloasma, erythema nodosum erythema multiforme Renal and urinary disorders haemolytic uraemic syndrome Reproductive system and breast disorders Spotting, breakthrough bleeding Irregular bleeding Amenorrhoea Hypomenorrh oea Breast tenderness Changes in vaginal secretion Investigations Weight increase Changes in serum lipid levels, including hypertriglycerida emia decreased serum folate levels** (*) Optic neuritis can lead to complete or partial loss of vision.
If any of the conditions or risk factors mentioned below are present, the suitability of Katya 30/75 coated tablets 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 Katya 30/75 coated tablets 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.
Other products such as Katya 30/75 coated tablets 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 Katya 30/75 coated tablets, 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 gestodene between 9 and 12 women will develop a VTE in one year; this compares with 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.
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. g. hepatic, mesenteric, renal or retinal veins and arteries.
Combined hormonal contraceptives (CHCs) should not be used in the following conditions. g. 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. g. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If she has already had intercourse, the possibility of pregnancy should be excluded before she begins taking the pills, or she should wait for her first menstruation. Missed tablets Missing a tablet for less than 12 hours does not diminish the contraceptive protection.
The woman should take the tablet as soon as she remembers, and continue taking the rest of the tablets as usual. Missing a tablet for more than 12 hours can diminish the contraceptive protection. The two following rules may be helpful in dealing with missed tablets.
1. Taking of the tablets should never be discontinued for longer than 7 days. 2. It takes 7 days of uninterrupted ingestion of the tablets to achieve sufficient suppression of the hypothalamus-pituitary-ovarian axis.
Thus, the following advice can be given in daily practice:
Week 1 The user should take the last missed tablet as soon as she remembers, even if this means that she needs to take 2 tablets at the same time. From then on, she should continue to take the tablets at the usual time. e. a condom, for the next 7 days.
If she had intercourse during the past 7 days, she should consider the possibility that she might be pregnant. The more tablets have been missed, and the closer this happened to the monthly tablet-free period, the higher the risk of pregnancy.
Week 2 The user should take the last missed tablet as soon as she remembers, even if this means that she needs to take 2 tablets at the same time. From then on, she should continue to take the tablets at the usual time. If the tablets have been taken correctly for the 7 days prior to the missed tablet, it is not necessary to take any additional contraceptive precautions.
e. a condom for the next 7 days. Week 3 The risk of reduced protection is imminent because of the approaching tablet-free period. The reduced contraceptive protection can be prevented, however, by adjusting the intake of the tablets. By adhering to either of the following two options, it is, therefore, not necessary to take any additional contraceptive precautions, provided that the tablets have been taken correctly for the 7 days prior to the missed tablet.
e. a condom for the next 7 days. 1. The user should take the last missed tablet as soon as she remembers even if this means that she needs to take 2 tablets at the same time. From then on, she should continue to take the tablets at the usual time.
She begins the next pack immediately after she took the last tablet from the current package; that means no pause between packages. The user will probably not get her menstruation before the end of the second package, but she may experience spotting or withdrawal bleeding on the days when she takes the tablets.
2. The woman can also be advised to stop taking tablets from the current package. In that case, she should have a tablet-free period for up to 7 days, including the days when she missed the tablets, and subsequently continue with the next pack.
If the woman missed the tablets, and subsequently […]
(**) Serum folate levels may be decreased by oral contraceptive therapy. This may be of clinical significance in women who become pregnant soon after discontinuing the medicine. 4. 4): Tumours • The frequency of breast cancer diagnosis among COC users is very slightly increased.
Since breast cancer is rare in women under 40, this increase is low in relation to the overall risk of breast cancer. Causality related to COC use is unknown. 5). 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard
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. 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 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 Katya 30/75 coated tablets have not been discontinued in advance. g. before 50). If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any CHC use Other medical conditions associated with VTE Cancer, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) and sickle cell disease Increasing age Particularly above 35 years 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 tenderness in the leg which may be felt only when standing or walking, - increased warmth in the affected leg; red or discoloured skin on the leg.
Symptoms of pulmonary embolism (PE) can include: - sudden onset of unexplained shortness of breath or rapid breathing; - sudden coughing which may be associated with haemoptysis; - sharp chest pain; - severe light headedness or dizziness; - rapid or irregular heartbeat.
g. g. respiratory tract infections). Other signs of vascular occlusion can include: sudden pain, swelling and slight blue discoloration 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. Risk of arterial thromboembolism (ATE) Epidemiological studies have associated […]