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VIOLITE is a brand name for Levonorgestrel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Oral contraception. The decision to prescribe Violite should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Violite compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
Verbatim from this product's MHRA label. Tap a section to expand.
How to take Violite Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly. 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 occurs. This usually starts on days 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). Starting on days 2-5 is allowed, but during the first cycle a barrier method of birth control is recommended in addition for the first 7 days of tablet-taking. Changing from another combined oral contraceptive (COC), vaginal ring, or transdermal patch) The woman should start Violite preferably on the day after the last active tablet of her previous COC, but at the latest on the day following the usual tablet-free or inactive tablet interval of her previous COC.
In case a vaginal ring or transdermal patch has been used, the woman should start using Violite preferably on the day of removal, but at the latest when the next application would have been due. Changing from a progestin-only method (progestin-only pill, injection, implant) or from a progestogen releasing intrauterine system (IUS) The woman may switch any day from the progestogen-only pill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due).
In all of these situations, the woman should be advised to additionally use a back-up method for the first 7 days of tablet-taking. Following first trimester abortion The woman may start immediately. When doing so, she need not take additional contraceptive measures.
Following delivery or second-trimester abortion Since the immediate post-partum period is associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than day 28 after delivery or second-trimester abortion.
The woman should be advised to additionally use a back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of COC use, or the woman has to wait for her first menstrual period.
4. Special warnings and precaution for use. 4. The frequency of diagnosis of breast cancer is slightly increased among OC 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. The most frequently reported adverse events during phase III studies and postmarketing surveillance in women using Violite are headache, including migraines, depressed mood, altered mood, dysmenorrhea, abdominal pain, increased weight, nausea, breast pain, breast tenderness and breakthrough bleeding/spotting.
They occur in ≥ 1 % of users.
Other adverse events have been reported in women taking Violite*:
System organ class Frequency of adverse events Common (>1/100 to <1/10) Uncommon (>1/1,000 to <1/100) Rare (>1/10,000 to <1/1,000) Not known (Frequency cannot be estimated from the available data) Immune system disorders Hypersensitivity Exogenous estrogens may induce or exacerbate symptoms of hereditary and acquired angioedema.
0) to describe a certain adverse reaction is listed. Synonyms or related conditions are not listed but should be taken into account as well. ** - Estimated frequency, from epidemiological studies encompassing a group of combined oral contraceptives.
‘Venous and arterial thromboembolic events’ summarizes the following Medical Entities: Peripheral deep venous occlusion, thrombosis and embolism/Pulmonary vascular occlusion, thrombosis, embolism and infarction/Myocardial infarction/ Cerebral infarction and stroke not specified as hemorrhagic.
4. Adverse reactions with very low frequency or with delayed onset of symptoms which are considered to be related to the group of combined oral contraceptives are listed below (see also sections ”Contraindications”, “Special warnings and precautions for use”): Tumors • The frequency of diagnosis of breast cancer is very slightly increased among OC users.
Warnings If any of the conditions or risk factors mentioned below is present, the suitability of Violite 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 Violite should be discontinued.
Risk of venous thromboembolism (VTE) Epidemiological studies have suggested an association between the use of COCs and an increased risk of arterial and venous thrombotic and thromboembolic diseases such as myocardial infarction, deep venous thrombosis, pulmonary embolism and of cerebrovascular accidents.
These events occur rarely. The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use. Products that contain levonorgestrel (including Violite), norgestimate or norethisterone are associated with the lowest risk of VTE.
The decision to use Violite should be taken after a discussion with the woman to ensure she understands the risk of VTE with Violite, 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 estimated that out of 10,000 women who use a CHC that contains levonorgestrel, about 61 will develop a VTE in a year.
This number of VTEs per year is fewer than the number expected in women during pregnancy or in the postpartum period. VTE may be fatal in 1-2% of cases. g. hepatic, mesenteric, renal, cerebral or retinal veins and arteries. 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).
Combined oral contraceptives (COCs) should not be used in women with any of the following conditions listed below. 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. active viral hepatitis and severe cirrhosis, as long as liver function values have not returned to normal. g. of the genital organs or the breasts). 1. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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) Management of missed tablets Contraceptive reliability may be reduced if tablets are missed, and particularly if the missed tablets extend the tablet-free interval. If tablets were missed in the first week of the cycle and intercourse took place in the week before the tablets were missed, the possibility of a pregnancy should be considered.
• Provided that the user is less than 12 hours late in taking any tablet, she should take it as soon as she remembers, and further tablets should be taken at the usual time. • If she is more than 12 hours late in taking any tablet, contraceptive protection may be reduced.
• The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets in one day. She then continues to take tablets at her usual time. In addition, a back-up method, such as the condom, should be used for the next 7 days.
• If these 7 days run beyond the last tablet in the current pack, the next pack must be started as soon as the current pack is finished; no gap should be left between packs. This prevents an extended break in tablet-taking, which may increase the risk of escape ovulation.
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. Accordingly 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 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. Week 2 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. 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 this is not the case, or if she missed more than 1 tablet, the woman should be advised to use extra precautions for 7 days.
Week 3 The risk of reduced reliability is imminent because of the forthcoming 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, the woman should be advised to follow the first of these two options and to use extra precautions for the next 7 days as well. 1. 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. , no gap should be left between packs. 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.
2. The […]
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. • Liver tumors (benign and malignant) Other conditions • Women with hypertriglyceridemia (increased risk of pancreatitis when using COCs) • Hypertension • Occurrence or deterioration of conditions for which association with COC use is not conclusive: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Sydenham’s chorea; herpes gestationis; otosclerosis-related hearing loss • Exogenous estrogens may induce or exacerbate symptoms of hereditary and acquired angioedema • Liver function disturbances • Changes in glucose tolerance or effect on peripheral insulin resistance • Crohn’s disease, ulcerative colitis.
• Chloasma Interactions Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with oral contraceptives (see section ‘Interaction with other medicinal products and other forms of interaction’) Reporting of suspected adverse reactions – United Kingdom 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. * Reporting of suspected adverse reactions - Ireland 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. *
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. 6 or major trauma Note: temporary immobilisation including air travel >4 hours can also be a risk factor for VTE, particularly in women with other risk factors 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 Violite has 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. g. transient ischaemic […]