Junel Fe 1.5 / 30 is a birth control preparation containing 21 active pills and 7 reminders with ferrum ferrate. The pills are prescribed for pregnancy prevention.
Contents:
Indications for use
Mechanism of action
The contraceptive effect of combined estrogen-progestin drugs is based on the synergy of the central and peripheral mechanisms, i.e. suppression of ovulation as a result of an inhibitory effect on the hypothalamic-pituitary-ovarian system, changes in the character of the cervical mucus and changes in the endometrium that prevent implantation. The degree of influence on the hypothalamic-pituitary-ovary uterine system depends on the dose, composition, the course, as well as the initial functional level of this system.
The contraceptive effect is 0-0.9 pregnancies per 100 women/years.
Mode of application and dosage
1 tablet of Junel Fe 1.5 / 30 daily is prescribed, without any interruptions. In women with regular menstrual periods or women who are on hormone replacement therapy, the application of tablets starts from the 5th day of the menstrual cycle. In the absence of menstruation or with an irregular cycle, you can start taking the drug on any day. The break is not required because the latest 7 pills contain Ferrum ferrate during which the menstruation takes place.
Before starting treatment, it is necessary to collect a family history and conduct a thorough medical examination, including measurement of blood pressure, examination of mammary glands and abdominal cavity, gynecological examination to identify the already existing endometrial hyperplasia. With long-term treatment with the drug, it is recommended to conduct preventive examinations at least once a year.
Contraindications
Junel Fe 1.5 / 30 is contraindicated in the following cases or conditions:
- venous or arterial thromboses and thromboembolism presently diagnosed or in the medical history inclusively of deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, stroke, cerebrovascular disorders (including in the medical history);
- states preceding thrombosis (including transient ischemic attacks, angina pectoris) presently diagnosed or in the medical history;
- hereditary or acquired predisposition to the development of venous or arterial thrombosis, such as resistance to activated protein C; deficiency of antithrombin III; protein C deficiency; protein S deficiency; hyperhomocysteinemia and antiphospholipid antibodies;
- presently diagnosed or prior treated migraine with focal neurologic symptoms;
- multiple or expressed risk factors for venous or arterial thrombosis, including cardiac valve dysfunction with complications, atrial fibrillation; obesity; uncontrolled arterial hypertension; severe dyslipoproteinemia; diabetes mellitus with vascular complications;
- serious surgical intervention with long-lasting immobilization;
- extensive trauma;
- air flight lasting more than 4 hours;
- smoking over the age of 35;
- pancreatitis with severe hypertriglyceridemia at present or in the medical history;
- liver failure or severe hepatic disorders;
- hepatic tumors (benign or malignant), incl. in the medical history;
- renal failure of severe form, acute kidney failure;
- hormone-dependent malignant neoplasms of the genital organs or mammary gland: diagnosed or suspected;
- vaginal bleeding of unclear genesis;
- pregnancy: diagnosed or suggested;
- breastfeeding;
- hypersensitivity to any of Junel Fe 1.5 / 30 components;
- lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Carefully
If the patient has any of the conditions/diseases/risk factors listed below, carefully weigh the possible risk and the expected benefit of using Junel Fe 1.5 / 30:
- risk factors for thrombosis and thromboembolism: smoking;
- hereditary predisposition to thrombosis (thrombosis, myocardial infarction, or impaired cerebral circulation at a young age in any of the next of kin); excess body weight; dyslipoproteinemia, controlled increase in blood pressure; a migraine without focal neurological symptoms;
- valvular heart disease with no complications;
- other diseases in which there may be violations of peripheral circulation: diabetes, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn’s disease and ulcerative colitis, sickle cell anemia, and phlebitis of superficial veins;
- hereditary angioedema;
- hypertriglyceridemia;
- hepatic disease;
- diseases that first appeared or worsened during pregnancy or on the background of previous reception of sex hormones (for example, jaundice, cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes pregnant, Sydenham’s chorea);
- the postpartum period.
Side effects
- Endocrine and gynecological system: in the first few months – sporadically occurring menstrual-like bleeding, tenderness of the mammary glands, nausea, headache and swelling. With the continuation of treatment, these phenomena pass by themselves.
- When there is altered or irregular menstruation on the background of Junel Fe 1.5 / 30 with norethindrone, diagnostic curettement should be performed to exclude malignant uterine neoplasms.
- Sexual behavior: changes in libido.
- Cardiovascular system: rarely – thrombosis, thromboembolism, increased blood pressure.
- Skin condition: alopecia is possible, skin rash, itching.
- Other: impaired vision.
The use should be stopped immediately in cases of deep vein thrombosis, thromboembolism, jaundice, increased migraine-like pain, sudden visual impairment, a significant increase in blood pressure.
Interactions
If you take other drugs or supplements concurrently with Junel FE 1/20, the effectiveness of these tablets may change. Tell your healthcare provider about all medications, vitamins and food supplements that you use. Your doctor will be capable to make the correct plan for taking the drug, which will avoid negative interactions.
Junel FE 1/20 can interact with the following products:
- Aminoglutethimide;
- Carbamazepine;
- Dicoumarol;
- Hydrocortisone;
- Itraconazole;
- Phenobarbital;
- Prednisolone;
- Rifampin;
- St. John’s wort.
What if I miss a dose?
You may ignore the missing of inactive tablets. Nonetheless, they should be thrown away, so as not to accidentally continue the period of placebo pills intake. The following recommendations apply only to the missing of tablets containing hormones (1-3 rows of the blister):
- if the delay in taking the pills was less than 12 hours, there is no reduction in contraceptive protection. The woman should take the missed tablet as soon as possible, the forthcoming pills should be taken at the usual time;
- if the delay in taking the pills is more than 12 hours, the contraceptive effect can be decreased. The more pills are missed, and the closer the missing tablets to the phase of inactive pills, the higher the probability of pregnancy is.
For keeping a contraceptive effect, the 7-day application should not be broken.
Junel Fe 1.5 / 30 and pregnancy
Pregnancy is a contraindication to Junel Fe 1.5 / 30 use. When pregnancy occurs on the background of the drug intake, the preparation should be withdrawn immediately. The conducted epidemiological studies did not reveal an increase in the risk of birth developmental defects in children whose mothers were taken hormonal contraceptives during the early stages.
The drug use during breastfeeding is contraindicated. COCs can affect the volume of breastmilk and alter its composition, so medical specialists do not recommend the use until the end of breastfeeding. A small number of sex steroids and/or their metabolites can enter the breast milk and influence the newborn health.