If any of the following diseases / conditions / risk factors are present, the benefits and potential risk of taking the drug should be carefully weighed Modell® Ovule. This issue should be discussed with the patient even before taking the drug. In case of aggravation of the disease, worsening of the condition or appearance of the first symptoms of the above conditions or risk factors, the patient should immediately consult a doctor. The doctor decides whether to cancel the drug individually.
Diseases of the heart and blood vessels
In epidemiological studies, it was found that there may be a link between the use of COCs and an increased risk of arterial and venous thrombosis and thromboembolism, such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism. These diseases are extremely rare.
The use of any COC is associated with an increased risk of venous thromboembolism (VTE), manifested as deep vein thrombosis and / or pulmonary embolism. The risk is higher in the first year of admission than in women taking COC more than 1 year.
When taking a combination of desogestrel and ethinyl estradiol, there is an increased(almost 2-fold) the risk of developing VTE in comparison with preparations containing as a progestogen component levonorgestrel, norgestimate or norethisterone.
Very rarely thrombosis occurs in other blood vessels (for example, in veins and arteries of the liver, mesentery, kidneys, brain or retina).
At the moment there is no unequivocal opinion on the possible role of varicose veins and superficial thrombophlebitis in the etiology of venous thromboembolism.
If a suspected predisposition to thromboembolic diseases is suspected, a woman should be referred for advice to a specialist before deciding on the appointment of any hormonal contraceptives.
Risk factors for venous and arterial thrombosis, thromboembolism
Factors of high risk of venous thrombosis are:
- age over 35 years,
- air travel lasting more than 4 hours (especially if there are other risk factors),
- Overweight (body mass index more than 30 kg / m2),
The risk of complications increases with increasing body mass index, it is especially important to take this into account when there are other risk factors.
- long-term immobilization,
- extensive surgical interventions,
- Neurosurgical operations,
- surgical interventions in the pelvic or lower extremities,
- Severe trauma,
With prolonged immobilization and the above surgical interventions, it is recommended to stop the use of the drug, with planned surgical interventions no later than 4 weeks before surgery, and not to resume reception within 2 weeks after complete rehabilitation. Other methods of contraception should be used to prevent unwanted pregnancies. If taking Model® Ovule was not stopped in advance, then in this case, antithrombotic therapy is indicated.
- the presence of thromboembolic diseases in a family history (venous thrombosis / thromboembolism in brothers, sisters or parents at a young age),
- Other conditions / diseases associated with the development of venous thrombosis (oncological diseases, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), sickle cell anemia).
The risk of venous thromboembolism increased both with the initial use of COCs and with the resumption of COCs after a break of 4 weeks or more.
The development of venous thromboembolism can lead to a lethal outcome in 1-2% of cases.
Symptoms of venous thromboembolism (deep vein thrombosis and thromboembolism of the pulmonary artery)
Symptoms of deep vein thrombosis may include:
- unilateral swelling of the foot, including the feet, or along the course of the affected vein;
- pain in the leg or soreness when touching the leg, which can be felt, including, only when standing or walking;
- a feeling of warmth in the aching limb, reddening or discoloration of the skin of the foot.
Symptoms of thromboembolism of the pulmonary artery:
- a sudden attack of difficulty breathing or rapid breathing of unknown etiology;
- a sudden attack of cough, which can be accompanied by hemoptysis;
- a sharp pain in the chest;
- a feeling of severe weakness or dizziness;
- Frequent or irregular heart rhythm.
Some of these symptoms (eg, difficulty breathing, coughing) are nonspecific, which can make it difficult to diagnose.It is possible to diagnose a more frequent or less dangerous disease (for example, an infectious airway disease).
Other signs of blockage of the vessel: sudden pain, swelling and blueing of the limb.
In the case of occlusion of the vessel of the eye, the symptoms can vary from a painless blurred vision that can progress to a complete loss of vision. Sometimes a complete loss of vision can occur suddenly.
Epidemiological studies have revealed a link between the use of COCs and an increased risk of developing arterial thrombosis (myocardial infarction) or cerebral circulatory disorders (eg, transient ischemic attack, stroke). Arterial thromboembolism can be fatal.
Factors of high risk of developing arterial thrombosis are:
- age over 35 years;
- Smoking;
Women who take COC are advised to refrain from smoking. Smoking women over 35 should not take COC.
- arterial hypertension;
- Overweight (BMI more than 30 kg / m2);
The risk of complications increases with an increase in BMI, especially if other risk factors are present.
- presence of thromboembolic diseases in a family history (arterial thrombosis / thromboembolism in brothers, sisters or parents at a young age);
- Migraine;
Increasing the frequency and intensity of migraine with COC (which may be indicative of cerebrovascular disorders) is the reason for discontinuation Modell® ovulation.
- other conditions / diseases associated with the development of adverse events from the vascular (diabetes, hyperhomocysteinemia, heart valves and atrial fibrillation, dislipoproteinemia and systemic lupus erythematosus).
Symptoms of arterial thromboembolism
Symptoms of cerebral circulation disorders:
- sudden numbness or weakness of the facial muscles, arms or legs, affecting one side or part of the body;
- sudden gait disturbance, dizziness, imbalance or coordination of movement;
- a sudden confusion, a violation of speech or understanding;
- sudden impaired vision of one or both eyes;
- sudden strong or prolonged headache of unknown etiology;
- loss of consciousness or severe weakness with cramps or without.
Temporary symptoms may indicate the development of a transient ischemic attack.
Symptoms of myocardial infarction:
- pain, discomfort, feeling of constriction, heaviness or overflow in the chest; pain in the arm or below the sternum;
- unpleasant sensation (discomfort), giving in the back, jaw, throat, hand, in the area of the stomach;
- a feeling of overflow of the stomach, digestive disorders or a feeling of suffocation;
sweating, nausea, vomiting, or dizziness;
- severe fatigue, anxiety or difficulty breathing;
- Frequent or irregular heart rhythm.
The risk of thromboembolic complications increases with the combination of several risk factors for these complications.
Biochemical indicators that may indicate hereditary or acquired predisposition to venous or arterial thrombosis are: resistance to activated protein C, hyperhomocysteinemia, anthrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant).
Tumors
The most important factor for cervical cancer risk is the persistence of human papillomavirus (HPV) infection.Some epidemiological studies have noted an increase in the risk of cervical cancer in women receiving long-term COCs, but there are still contradictions as to the extent to which these factors affect the mixing of factors such as cervical screening and sexual behavior, including the less frequent use of barrier methods of contraception , or their relationship.
There is evidence that there is a slight increase in the relative risk (1.24) of breast cancer in women using COCs. The increased risk gradually decreases within 10 years after the cancellation of COC. Since breast cancer in women under 40 years is rare, an increased risk of developing breast cancer in women who are currently receiving COCs or who have recently abandoned them is small relative to the initial likelihood of developing cancer. These studies do not provide data on the etiology of cancer. The increased risk of developing breast cancer can be due to medical observation and earlier cancer diagnosis in women taking COCs (they have earlier cancer stages than women who have never taken COCs), the biological effects of COCs, or a combination of these two factors.
It is extremely rare when applying a combination desogestrel + ethinylestradiol there were cases of development of benign, and even more rarely - malignant liver tumors. In some cases, these tumors resulted in life-threatening intra-abdominal bleeding. The doctor should consider the possibility of a liver tumor in the differential diagnosis of diseases in women taking the drug Modell® Ovule, if the symptoms include acute pain in the upper abdomen, an enlarged liver, or signs of intra-abdominal bleeding.
Other diseases
If a woman or her family has hypertriglyceridemia diagnosed, an increased risk of pancreatitis may be associated with taking the drug Modell® Ovule.
If the woman taking the drug Modell® Ovule, persistent clinically significant hypertension develops, the doctor should cancel the drug and prescribe treatment for hypertension. In those cases when the normal values of blood pressure can be achieved during antihypertensive therapy, the doctor may consider it possible for the patient to resume taking the drug.
There are reports that jaundice and / or itching caused by cholestasis; the formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea (small chorea), herpes of pregnant women, hearing loss due to otosclerosis, (hereditary) angioedema, develop or worsen both during pregnancy and when taking COC, but evidence of the combination desogestrel + ethinylestradiol, are inconclusive.
Acute or chronic liver dysfunction may be the basis for the discontinuation of the drug Modell® Ovule until the liver function indicators are normalized. The recurrence of cholestatic jaundice, observed earlier in pregnancy or with the use of sex hormones, requires the discontinuation of the drug Modell® Ovule.
Although taking the drug Modell® Ovule can affect peripheral insulin resistance and glucose tolerance, as a rule, correction of the dosage regimen of hypoglycemic drugs in patients with diabetes mellitus is not required. Nevertheless, careful monitoring of blood glucose concentration is necessary,especially during the first months of taking COC.
There is evidence of a link between the administration of COC and Crohn's disease and ulcerative colitis.
Sometimes when taking the drug Modell® Ovule can be observed pigmentation of the face (chloasma), especially if it was previously in pregnancy. Women with a predisposition to chloasma should avoid direct sunlight and UV irradiation from other sources when taking the drug Modell® Ovule.
Medical examinations / consultations
Before the beginning or resumption of taking the drug Modell® Ovule the doctor should collect from the patient a detailed medical history (including family history) and conduct a thorough examination, given contraindications and warnings. It is important to repeat periodic medical examinations, because diseases that are contraindications to taking the drug Modell® Ovule (eg, transient ischemic attack) or risk factors (for example, the presence of venous or arterial thrombosis in a family history) may first appear during the administration of the drug.
Frequency and list of examinations should be based on common practice and selected individually for each woman (but at least 1 time in 6 months).In any case, special attention should be paid to the measurement of blood pressure, mammary gland, abdominal and pelvic examination, including cervical cervical examination.
It is necessary to inform the woman that KOC does not protect against HIV (AIDS) and other sexually transmitted infections.
Decreased efficiency
Effectiveness of the drug Modell® Ovule may be reduced in case of skipping of the drug, gastrointestinal disorders or with the concomitant use of certain medications (see section Interaction with other drugs).
Irregular spotting
When taking the drug Modell® Ovule, especially in the first months of use, there may be irregular "smearing" or copious spotting. Therefore, an assessment of irregular bleeding should be made only after the end of the adaptation period, lasting 3 months.
If irregular bleeding persists or appears after previous regular cycles, you should consider possible non-hormonal causes of the disorder and conduct appropriate studies to exclude malignant neoplasms or pregnancy.These measures may include diagnostic scraping.
Some women may not have menstrual bleeding during a break between taking the drug. If the drug is taken Modell® Ovule was conducted according to the above recommendations, the probability of pregnancy is low. Otherwise, or if bleeding is absent 2 times in a row, you should exclude the possibility of pregnancy and consult a doctor.
Laboratory research
COC may affect the results of some laboratory tests, including biochemical liver function tests, thyroid, adrenals and kidneys, the contents of transport proteins in the blood plasma, e.g., corticosteroid-binding globulin, fraction lipid / lipoprotein parameters of carbohydrate metabolism, coagulation parameters and fibrinolysis. Usually, these changes are within the normal values of laboratory indicators.