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TRIREGOL COATED is a brand name for Ethinyl Estradiol (also known as Ethinylestradiol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Oral contraception
Verbatim from this product's MHRA label. Tap a section to expand.
Posology. 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 bleeding will usually begin on the 2nd or 3rd day after ingestion of the last tablet and it may not have ceased, before the next pack is started.
How to start the use of Triregol No preceding intake of hormonal contraceptives (within the last month) Tablet-taking started on day 1 of the woman's natural cycle (=the first day of her menstrual bleeding). Starting intake on day 2-5 is allowed, but during the first cycle the concurrent use of barrier method during the first 7 days of tablet intake is advisable.
Changing from another combined hormonal contraceptive (combined oral contraceptive, contraceptive vaginal ring, contraceptive transdermal patch) The woman should start with Triregol on the day after she took the last active tablet in her previous blister pack of contraceptive pills (or removed the transdermal patch or vaginal ring), or no later than on the day after the usual pill-free (or placebo, patch-free or ring-free) interval with her previous contraceptive.
Changing from a progestogen-only method (progestogen-only pills, injectable, implant) The woman can change from progestogen-only pills on any day (changing from implant on the day of its removal; changing from injection when the next injection should have been given).
In all these cases concurrent use of a barrier method during the first 7 days of tablet intake is advisable. After abortion in 1st trimester The woman may begin intake of tablets immediately. If she so does, it is not necessary to take further contraceptive measures.
6. The woman should be advised to start on day 21-28 after delivery or abortion in 2nd trimester, since there is an increased risk of thromboembolism during the post-partum period. She should be advised to use a barrier method concurrently during the first 7 days of tablet intake if she starts later.
If she has already had intercourse, pregnancy must be excluded before she starts tablet intake, or she must await her first menstrual bleeding. Missed tablets If a tablet is delayed by less than 12 hours, additional contraception is unnecessary and the remaining tablets are taken as usual.
The most frequently adverse reactions do usually not demand interruption of treatment and include: depression, mood altered headache nausea, vomiting, abdominal pain, cholelithiasis, acne, chloasma, breast tenderness, breast pain, metrorrhagia and weight increased.
4. The following adverse effects have been reported during use of ethinylestradiol/levonorgestrel: System Organ Class 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 known (cannot be estimated from the available data) Immune system disorders Hypersensi- tivity Exacerbation of symptoms of hereditary and acquired angioedema Neoplasms benign, malignant and unspecified (incl.
5). 4 Special warnings and precautions for use: - Venous thromboembolic disorders - Arterial thromboembolic disorders - Hypertension - Liver tumours - Crohn’s disease, ulcerative colitis, porphyria, systemic lupus erythematosus, herpes gestationis, Sydenham's chorea, haemolytic uremic syndrome, cholestatic jaundice.
The frequency of diagnosis of breast cancer is slightly increased among COC users. As breast cancer is rare in women under 40 years of age the excess number is small in relation to the overall risk of breast cancer. Causation with COC use is unknown.
4 Special warnings and precautions for use. 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.
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Warnings 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 and discussed with the woman before she decides to 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 whether COC use should be discontinued. Circulatory disorders Epidemiological studies have shown that the incidence of venous thromboembolism (VTE) in users of oral contraceptives with low oestrogen content (<50 microgram ethinylestradiol) ranges from about 20 to 40 cases per 100,000 women-years, but this risk estimate varies according to the progestogen.
This compares with 5 to 10 cases per 100,000 women-years for non-users. The use of any combined oral contraceptive carries an increased risk of VTE compared with no use. The excess risk of VTE is highest during the first year a woman ever uses a combined oral contraceptive.
This increased risk is less than the risk of VTE associated with pregnancy, which is estimated as 60 cases per 100,000 pregnancies. VTE is fatal in 1-2% of the cases. The overall absolute risk (incidence) of VTE for levonorgestrel containing combined oral contraceptives with 30 microgram ethinylestradiol is approximately 20 cases per 100,000 women-years of use.
Epidemiological studies have also associated the use of COCs with an increased risk for myocardial infarction, transient ischaemic attack and for stroke. g. hepatic, mesenteric, renal, retinal veins and arteries, in contraceptive pill users.
There is no consensus as to whether the occurrence of these events is associated with the use of hormonal contraceptives. Symptoms of venous or arterial thrombotic/thromboembolic events or of a cerebrovascular accident can include: - unusual unilateral leg pain and/or swelling - sudden severe pain in the chest, whether or not it radiates to the left arm - sudden breathlessness - sudden onset of coughing - vertigo - collapse with or without focal seizure - weakness or very marked numbness suddenly affecting one side or one part of the body - motor disturbances - ‘acute’ abdomen.
Combined oral contraceptives (COCs) are not to be used in the presence of any of the following conditions listed below. Should any of the conditions appear for the first time during COC use, the product must be stopped immediately. 4).
g. g. angina pectoris and transient ischaemic attack). g. transient ischaemic attack, angina pectoris). - Cerebrovascular accident present or in history. 4). - History of migraine with focal neurological symptoms. - Diabetes mellitus with vascular involvement.
- Severe hepatic disease, current or previous, as long as liver function values have not returned to normal. - Presence or history of liver tumours (benign or malignant). g. of the genital organs or the breasts). - Undiagnosed vaginal bleeding.
6). - Severe hypertension. - Ocular disorder of vascular origin. 1. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ethinyl Estradiol in United Kingdom.
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If the delay exceeds 12 hours, contraceptive protection may be reduced. Handling of missed tablets may be managed by the following two basic rules: - Tablets must never be discontinued for longer than 7 days. - Seven days of uninterrupted tablet taking are required to maintain adequate suppression of the hypothalamic-pituitary-ovarian-axis.
Thus, the following advice may be given for daily practice:
Week 1 The user must take the last missed tablet as soon as she remembers, even if this means that she has to take 2 tablets at the same time. Thereafter, she should continue taking the tablets at the usual time of the day. g. a condom, for the next 7 days.
If intercourse has taken place during the preceding 7 days the possibility of pregnancy must be considered. The more missed tablets and the closer to the tablet-free interval this happens, the greater the risk of pregnancy. Week 2 The user must take the last missed tablet as soon as she remembers even if this means that she has to take 2 tablets at the same time.
Thereafter, she continues taking the tablets at the usual time of the day. Provided that the tablets have been taken in a correct manner during the 7 days preceding the missed tablet, it is not necessary to take further contraceptive measures.
However, if this is not the case, or if more than 1 tablet has been missed, the woman should be advised to use an other contraceptive method for 7 days. Week 3 The risk of contraceptive failure is imminent because of the ensuing tablet-free interval.
Thus, it is not necessary to take further contraceptive measures if one of the two alternatives below is followed, provided that all tablets have been taken in a correct manner during the 7 days preceding the missed tablet. If this is not the case, the woman should be advised to follow the first of the two alternatives and concurrently use an other contraceptive method for the next 7 days.
The user should take the last missed tablet as soon as she remembers, even if it means that she has to take 2 tablets at the same time. Thereafter she should continue taking the tablets at the usual time of the day. e. without a tablet-free interval between the packs.
Withdrawal bleeding is unlikely until the end of the second pack, but there may be some spotting, or break-through bleeding, on the days she is taking tablets. The woman may also be advised to stop taking tablets from the current pack.
In that case, she should keep a period without tablets of up to 7 days, including those days when she forgot to take her tablets, and thereafter continue with the next pack. If a woman has missed tablets and then does not get a withdrawal bleed in the first normal tablet-free interval, the possibility of pregnancy must be considered.
Advice in case of gastro-intestinal disturbances In case of severe gastro-intestinal symptoms, absorption of the active ingredients may not be complete and additional contraceptive measures should be taken. If vomiting or severe diarrhoea occurs within 3 to 4 hours after taking a tablet, the woman should apply the advice concerning missed tablets.
How to delay or shift a period The woman should continue with the last 10 ochre tablets of the second pack Triregol without keeping the period without tablets, in order to delay the menstrual bleeding. If the woman wishes to delay for more than 10 days, she should use a pack of a monophasic COC with similar or higher progestogen dose.
After the […]
The risk for venous thromboembolic complications in COCs users increases with: - increasing age - a positive family history (venous thromboembolism ever in a sibling or parent at a relatively early age). If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any hormonal contraceptive use.
- prolonged immobilisation, major surgery, any surgery to the legs, or major trauma. In these situations it is advisable to discontinue the pill (in the case of elective surgery at least four weeks in advance) and not to resume until two weeks after complete remobilisation.
- obesity (body mass index over 30 kg/m²). - there is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the onset or progression of venous thrombosis. The risk of arterial thromboembolic complications or of a cerebrovascular accident in COC users increases with: - increasing age, - smoking (women over 35 years should be strongly advised not to smoke if they wish to use an COC), - dyslipoproteinemia, - hypertension, - migraine, - valvular heart disease, - atrial fibrillation.
6). Other medical conditions which have been associated with adverse vascular events include diabetes mellitus, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell disease.
An increase in frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of the COC. Biochemical factors that may be indicative of hereditary or acquired predisposition for venous or arterial thrombosis include Activated Protein C (APC) resistance, hyperhomocysteinemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
There is no consensus for the possible role of varicose veins and superficial thrombophlebitis in venous thromboembolism. When weighing benefits/disadvantages the physician must take into consideration that adequate treatment of a given condition may lower the risk related to thrombosis and that the risk of developing thrombosis during pregnancy is higher compared to using contraceptive pills.
Tumours An increased risk of cervical cancer in long-term users of COC has been reported in some epidemiological studies, but there continues to be controversy about the extent to which this finding is attributable to the confounding effects of sexual behaviour and other factors such as human papilloma virus (HPV).
24) of having breast cancer diagnosed in women who are currently using COCs. The excess risk gradually disappears during the course of the 10 years after cessation of COC use. 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 […]