The package insert of the medicine Femiane

the package insert of the medicine Femiane.

what For?

oral Contraception.


When should I not use?

Pregnancy: changes in liver severe; jaundice or itching persistent during earlier gestation; syndrome, Dubin-Johnson and Rotor; liver tumours current or previous history of the same; processes thromboembolic arterial or venous or background of the same, as well as conditions that increase the tendency to such diseases (for example: disorders of the clotting system with a tendency to thrombosis, cardiovascular disease, atrial fibrillation); sickle cell anemia; cancer estrogen-dependent confirmed or suspected, such as for example: carcinoma of the breast or endometrium; diabetes mellitus severe with vascular; disorders of lipid metabolism; history of herpes gestationis; otosclerosis with deterioration during any earlier gestation; genital bleeding not diagnosed; hypersensitivity to gestódeno, ethinyl estradiol, or to any component of the product.


How to use?

1 drágea per day for 21 consecutive days, always at the same time, starting on the 1st day of the cycle (1st day of bleeding). In the cycles subsequent, you should be observed an interval of 7 days between the last drágea cycle that ends and the 1st drágea of the cycle that begins. If it does not occur the bleeding for deprivation in this range, the treatment should not be continued until it is excluded the possibility of pregnancy. Femiane is effective from the 1st day of therapy if the tablets are begun on day 1 of the cycle, as described. May occur, in isolated cases, bleeding by disruption and spotting, especially during the first 3 months of use of Femiane that generally ceases spontaneously. The patient should, however, continue the treatment with Femiane, even in the case of irregular bleeding. If the bleeding persists or use, appropriate diagnosis, including curettage, it is necessary to exclude organic causes. Should be also investigated the bleeding-irregular when they occur in several consecutive cycles or which occur for the first time after prolonged use of Femiane. If the patient forget to take a drágea at the usual time, you should take it in the period of 12 hours subsequent. If there is elapsed more than 12 hours, contraceptive protection may be reduced in this cycle, and should be employed, in addition, methods of non-hormonal contraceptives, with the exception of the methods of rhythm (Ogino-Knaus) and temperature, up to the end of the cycle. Continues taking the tablets remaining (the drágea or tablets forgotten should not be taken) in order to avoid bleeding premature for deprivation. In switching from another oral contraceptive to Femiane, the beginning of treatment should be made on the 1st day that you experience bleeding deprivation, after the ingestion of the last drágea active contraceptive previous to Femiane. Femiane can be prescribed during the period of post-childbirth or post-miscarriage, as soon as the 1st menstrual period after a cycle biphasic normal. When, for medical reasons, another pregnancy is contraindicated, treatment with Femiane should be started on the 12th day after the birth (never before the 7th day) or on the 5th day after the abortion, at the latest. One should consider that the administration of oral contraceptives in the period immediately after childbirth or miscarriage, increases the risk of occurrence of diseases thromboembolic. – Overdosage: overdosage may cause nausea and vomiting; some women may experience bleeding for deprivation. Have not been reported serious side effects after ingestion of large doses of oral contraceptives by young children. One can consider that the general procedures of gastric lavage and general treatment of support are appropriate in cases of overdose.

Side Effects

What are the evils that can cause me?

In isolated cases, can occur headaches, disturbance stomach, nausea, tension, breast tenderness, changes in weight and libido, as well as depressive states. In women predisposed, the use of oral contraceptives may cause chloasma which is exacerbated by sun exposure. Women with such a predisposition should avoid prolonged exposure to the sun. It has been observed, in isolated cases, a decrease in the tolerance front to contact lenses; in these situations, the patient should consult the ophthalmologist in.

Warnings and Precautions

what should I know before using?

Before you start the treatment should be carried out exams clinical general and gynecological examination, fine-grained (including the breasts and cervical cytology), including a careful anamnesis of the family. They should be disposed of disorders of the coagulation system, in the case of some of the members of the family, at a young age, having suffered from illnesses thromboembolic (for example, deep vein thrombosis, stroke, myocardial infarction). The possibility of pregnancy must be excluded. During the treatment, we recommend check-ups at intervals of approximately 6-12 months. The treatment with Femiane should be stopped if they occur: headache of the migraine type, in patients who have never had this symptom, or headaches, frequent with intensity out of the ordinary; disturbances sudden vision, hearing, or other dysfunctions, perceptual; precursors of tromboflebites or tromboembolias (for example: pain is not usual in the legs or edema is not usual in the arms or legs, pain the type twinge when breathing or coughing for no apparent reason); feeling of pain and constriction in the chest. The medication must also be suspended in the event of surgery scheduled (6 weeks prior to the due date), or immobilization, forced, due, for example, accidents or surgeries. Are also reasons to suspend the medication: the appearance of jaundice or hepatitis, pruritus generalised, increase in epileptic seizures, marked elevation of blood pressure, severe depression, pain epigástricas intense or increasing the volume of the liver, pregnancy. In the following cases, the patients should be kept under careful medical surveillance, a worsening in some of these cases may indicate that the use of oral contraceptives should be discontinued: diabetes mellitus or tendency towards diabetes mellitus, hypertension, varicose veins, a history of flebites, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetania or korea less, kidney dysfunctions, family history of coagulation disorders with a tendency to thrombosis, obesity, breast lumps or a family history of cancer of the breast, a history of clinical depression, systemic lupus erythematosus, uterine fibroids, migraines. According to current knowledge, one can not exclude the association between the use of hormonal contraceptives and an increased risk of disease thromboembolic venous and arterial, such as, myocardial infarction, pulmonary embolism, thrombophlebitis, stroke, thrombosis retinal. One must be aware of the early manifestations of these disorders and, in the case of its occurrence, or suspected occurrence, the use of Femiane must be stopped. With regard to arterial thrombosis (eg, stroke, myocardial infarction) appears to occur increase in relative risk when there are concurrently the following factors: consumption, heavy cigarette smoking, advanced age and treatment with combined oral contraceptives. Women with age above 35 years who use oral contraceptives should be strictly advised not to smoke. In addition, some diseases such as hypertension, hyperlipidemia, obesity, and diabetes mellitus may increase the risk of thromboembolic events associated with the use of oral contraceptives. The suitability of the use of oral contraceptives in the presence of the pathologies described above should be evaluated and discussed with the patients before the start of the treatment. Changes in the levels of triglycerides, serum cholesterol, and lipoproteins, as well as a decrease in tolerance to glucose, have been reported with the use of oral contraceptives. Can occur increase in blood pressure with the use of oral contraceptives, which usually returns to normal value after the discontinuation of treatment. After you stop using oral contraceptives, some women may present with amenorrhea or oligomenorréia, especially if these conditions already existed before the start of the treatment. Patients should be informed about this possibility. After the treatment with hormonal substances such as those contained in Femiane, have been observed, in rare cases, changes in liver benign and, more rarely, changes to evil, which in isolated cases may lead to bleeding, intra-abdominal life-threatening for the patient. If you are experiencing disorders epigástricos serious, increasing the size of the liver or signs of bleeding intra-abdominal, should be included in the liver tumor in the considerations on the diagnostic differential. Preliminary studies have reported an increase in the risk of developing gallbladder disease, surgically confirmed, with the use of estrogens and oral contraceptives. However, more recent studies have shown that the relative risk of development can be kept to a minimum. The relationship between the use of oral contraceptives and breast cancer remains inconclusive. The results of epidemiological studies have revealed that there is no increase in the risk of breast cancer in women who ever used oral contraceptives. The results of some studies suggesting a possible increased risks in certain subgroups of women still remain conflicting. Oral contraceptives, when administered in the postpartum period may interfere with com lactation by decreasing the quantity and quality of milk secreted. In addition, a small amount of components hormone has been identified in breast milk. If you are experiencing vomiting or diarrhea within 3 to 4 hours after taking Femiane, the active substances may not have been absorbed properly. However, you should continue the treatment in order to avoid bleeding premature for deprivation, and, in addition, use of a nonhormonal contraceptive method, with the exception of the methods of rhythm (Ogino-Knaus) and temperature, up to the end of the cycle. If the gastrointestinal dysfunction is prolonged, you should consider switching to another method of contraception. – Drug interactions: inducers of hepatic enzymes, such as barbiturates, primidone, hydantoins, fenilbutazona, rifampicin, carbamazepine and griseofulvin, may decrease the effectiveness of Femiane. In prolonged treatments with inducers of liver enzymes, should be used another method of contraception. The use of antibiotics, including ampicolina and tetracycline, can also reduce the effectiveness of Femiane, possibly by altering the intestinal flora. Patients in short-term treatment with inducers enzyme or treatment with broad-spectrum antibiotics should be additionally a nonhormonal contraceptive method, with the exception of the methods of rhythm (Ogino-Knaus) and temperature, during this period the joint treatment and for 7 days after the end of the other medicine. If this period of 7 days exceed the termination of the pill, the next should be started without the completion of pause between them. In this case, the bleeding deprivation should only occur at the end of the second cartouche. If the bleeding does not occur, the possibility of pregnancy should be checked before the start of a new pack. In the case of joint administration of rifampicin, the use of additional contraceptive method must be maintained for 4 weeks after the end of treatment, even after a short period of administration. The needs of medications oral hypoglycemics or insulin may be changed, as a result of the effect of glucose tolerance. Interference in laboratory tests: the use of oral contraceptives may influence the results of some laboratory tests, including: biochemical parameters of liver, thyroid, adrenal and renal function; plasma levels of binding proteins and fractions lipid/lipoproteins; the parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis.