Data on serious complications in the event of an overdoseprovirin no. The following symptoms may occur in cases of overdose include nausea, vomiting, bloody discharge from the vagina. There is no antidote, and treatment should be symptomatic.
Interactions between oral contraceptives and other drugs may lead to an acyclic bleeding and / or reduce the effectiveness of contraceptives.
The literature describes the following interactions. Hepatic metabolism: interactions may occur with drugs that induce microsomal enzymes, which can lead to increased clearance of sex hormones (such as hydantoins, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and products containing St. John’s wort). Maximal enzyme induction is generally not observed in the first 2-3 weeks of taking the drug, but may persist until at least 4 weeks after discontinuation of the drug. cases of reducing the effectiveness of contraception, while the appointment of certain antibiotics, such as ampicillin and tetracycline. The mechanism of this effect is unclear. Women who are taking any of the above drugs should temporarily use an additional method of barrier contraception or choose another method of contraception. With simultaneous use of inducers of microsomal enzymes barrier method of contraception should be used throughout the course of treatment and for 28 days after stopping treatment.
With long-term course of treatment with drugs that induce microsomal enzymes, should consider choosing another method of contraception. Women who use antibiotics (except rifampicin and griseofulvin, which also induce microsomal enzymes), should apply a barrier method of contraception during treatment and for 7 days after the end of therapy. If the period during which the applied barrier method continues and after the tablets in the package the next pack the drug should start without the usual interval of administration. The oral contraceptives may affect the metabolism of other drugs. Accordingly, their concentration in plasma and tissues may increase (eg, cyclosporin) or decrease (eg, lamotrigine). Note: In the treatment of other medications to determine possible interactions should be familiar with the instructions for medical use of these drugs.
Cautions Vascular disease
- Epidemiological studies have found an association between the use of provirin and an increased risk of venous or arterial thrombotic and thromboembolic events such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism. These complications are rare.
- The use of any is associated with an increased risk of venous thromboembolism , manifesting as deep venous thrombosis and / or pulmonary embolism, sometimes with fatal consequences.The risk is higher in the first year of administration, than in women taking for more than 1 year.
- A number of epidemiological studies suggest that women using containing third generation progestogens, including desogestrel, have an increased risk of VTE compared with women using with second-generation progestogen. These studies indicate, approximately doubling the risk, which may correspond to an additional 1-2 cases of VTE per 10,000 women per year. However, other studies did not show a 2-fold increase in risk.
- In general, the exemplary frequency in women using h low estrogen dose (<0.05 mg ethinyl estradiol), up to 4 cases per 10,000 woman-years as compared with the cases of 0.5-3 per 10 000 woman-years women who do not use oral contraceptives. However, the frequency significantly lower frequency of complications during pregnancy (m. E. 6 cases per 10,000 women-years).
- Thrombosis occurs very rarely in other blood vessels (such as veins and arteries, liver, mesentery, kidney, brain or retina). There is no single point of view, whether this is a consequence of the use of provirin thrombosis.
- Symptoms of venous or arterial thrombosis / embolism or stroke may include: unilateral leg pain and / or swelling; sudden severe chest pain radiating to the left arm or without it; sudden shortness of breath; sudden cough; unusually strong prolonged headache; sudden partial or complete loss of vision; diplopia; blurred vision; aphasia; dizziness; collapse with or without focal seizures them; weakness or very severe numbness suddenly affecting one side or one part of the body; motor disturbances; “Acute” abdomen.
- It is necessary to take into account the increased risk of thromboembolism during the postpartum period.
- Other diseases that increase the risk of cardiovascular disease include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) and sickle cell anemia.
- Increased frequency and intensity of migraine headaches when takin (which may be a sign of cerebrovascular disorders) may serve as a basis for the immediate withdrawal of the drug.
- Biochemical parameters, which may be indicative of hereditary or acquired predisposition for venous or arterial thrombosis are: resistance of activated protein , hyperhomocysteinemia, antithrombin III deficiency, deficiency of protein C, protein deficiency , antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant) ;
- In assessing the positive and negative effects use, the physician should be remembered that adequate treatment of the disease may reduce the associated risk of thrombosis and that the risk of thrombosis associated with pregnancy may be higher than the risk associated with the use of low-dose.
- The most important factor for cervical cancer risk is the persistence of human papillomavirus infection. Epidemiological studies report an increased risk of cervical cancer in women, long-term use the drug provirin , however, to date there are doubts about the degree of influence on the data mixing a variety of factors, such as the screening of cervical screening and differences in sexual behavior including use of barrier contraceptive methods, or causality.
- There is evidence that there is a slight increase in the relative risk of developing breast cancer in women using . The increased risk gradually decreases over 10 years after the abolition. As for women under 40 years of breast cancer is rare, the likelihood of developing cancer increase in breast cancer in women using are currently or have recently renounced their use, is small relative to the initial probability of developing cancer. In these studies, no data are given on the etiology of cancer. Increased risk of breast cancer can be explained as the fact that women taking , a breast cancer diagnosis is established at an earlier date, and the biological effects or a combination of both these factors. There is a tendency, according to which women ever , breast cancer is clinically less running than in women, never taking .
- Very rarely reported cases of benign tumors of the liver and even more rare – cases of malignant tumors in patients using . In isolated cases, these tumors have led to life threatening intra-abdominal bleeding. In case of severe pain in the upper abdomen, hepatomegaly or signs of intra-abdominal haemorrhage in women , the differential diagnosis should be considered the possibility of a liver tumor.
- If a woman or her family members diagnosed with hypertriglyceridemia, the possible increased risk of pancreatitis when .
- If women , clinically significant developing resistant hypertension, the doctor should cancel the and treat the hypertension. In some cases, after the normalization of blood pressure antihypertensive therapy can be resumed.
- 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 (chorea), herpes gestationis, hearing loss due to otosclerosis (hereditary) angioedema develop or worsen both during pregnancy , but the evidence of this in respect of the use of provirin are inconclusive.
- Acute or chronic disturbances of liver function may necessitate interruptionas long as liver function tests have not returned to normal. Recurrence of cholestatic jaundice which occurred during pregnancy or previous use of sex steroids necessitates the discontinuation use.
- Despite the fact that may affect the resistance of peripheral tissues to insulin and glucose tolerance, there is no evidence of the need to change the therapeutic regimen of using (containing less than 0.05 mg ethinyl estradiol) in women with diabetes. However, these women should be monitored closely by a doctor while.
- There is evidence that there is a relationship between use and Crohn’s disease and ulcerative colitis.
- Sometimes when taking may experience pigmentation of the skin (chloasma), especially if it has been previously during pregnancy. Women with a tendency to chloasma should avoid direct sunlight and radiation from other sources when taking . Medical examination / consultation Prior to the start or resumption of use of the drug provirin® in women need to collect detailed medical history (including family history) and to exclude pregnancy. It is necessary to measure blood pressure, and in case of detection of clinically significant signs necessary to conduct physical examination, guided by the contraindications and warnings. It should instruct the woman on the need to carefully read these instructions for use and adhere to the recommendations outlined in it. The frequency of and the list of future periodic surveys should be based on common practice and matched individually for each woman (but not less than 1 time in 6 months).
- It is necessary to inform the woman that oral contraceptives do not protect against and other sexually transmitted infections by. Reduced efficacy The efficacy may be reduced, for example, in the case of missing tablets, gastro-intestinal disorders or concurrent use of other drugs. acyclic spotting during Irregular bleeding (spotting or heavy) may be using , often in the first 3 months of adaptation. If bleeding irregularities occur after previous regular cycles, you should think about non-hormonal causes and carry out adequate diagnostic measures to exclude malignancy or pregnancy. These surveys may include including diagnostic curettage. In some women, there may be no menstrualnopodobnoe bleeding in between doses tablets. If COCs are taken in accordance with the guidelines given above, the probability of pregnancy is low. If the violation regimen before the first failed bleeding “cancel”, or in the absence of two bleeding “cancel” in a row, you need to exclude pregnancy before the resumption of the use . Laboratory tests The use of combined oral contraceptives can affect the results of some laboratory tests, including biochemical parameters of liver function thyroid, adrenal and kidney, plasma levels of carrier proteins, such as binding globulin corticosteroids, and fractions of lipids / lipoproteins, some parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. Usually, these changes are within the normal range of laboratory parameters. Lactose Each tablet formulation contains less than 65 mg lactose. Women with rare hereditary disorders such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption who comply with lactose-free diet should consider the amount of lactose in the product T .