FEMODEN

Active material: Ethinylestradiol, Gestodene
When ATH: G03AA10
CCF: Monophasic oral contraceptive
When CSF: 15.11.04.01
Manufacturer: SCHERING AG (Germany)

Pharmaceutical form, composition and packaging

21 PC. – упаковки ячейковые контурные с календарной шкалой (1) – пачки картонные.

Pharmacological properties

Femoden is monophasic oral low-dose progestogen-estrogenic drug to prevent pregnancy. Gestagennym component Femodena is a derivative of 19-nortestosterone — gestodene, superior strength and selectivity of action is not only a natural hormone progesterone luteum, but modern synthetic gestagens (Levonorgestrel, etc.). Due to the high activity of gestodene use very low dosages (in t. no. in Femodene), in which it does not exhibit androgenic properties and has practically no effect on the lipid and carbohydrate exchanges, differing in this regard from natural progestogens, that long-term use can cause metabolic changes in the body, contributing to some extent to the development of cardiovascular and other diseases.
Estrogenic component Femodena is a highly effective oral tool is ethinyl estradiol.

Distinctive features of the Femodena are low levels of steroid hormones and their optimal ratio, that makes not only high reliability contraceptive effect, but a good tolerance of the drug.

The contraceptive effect of Femodena is implemented through blocking the impact of incoming ingredients gestagennogo and estrogen components on the hypothalamic-pituitary-âičnikovuû system, governing the normal menstrual cycle. First of all the mechanism of action of Femodena gestodena is the ability to inhibit the synthesis of follicle stimulating and luteinizing hormone by the pituitary gland (preventing follicle maturation) and thus block ovulation. Its contraceptive effect is enhanced ethinylestradiol - the synthetic analogue of the follicular hormone estradiol, also involved in the regulation of the menstrual cycle. Along with said central and peripheral mechanisms, preventing the maturation of the ability to fertilize the egg, the contraceptive effect of Femodena due to endometrial receptivity and reduced to blastocitu, as well as an increase in the viscosity of mucus, located in the cervix, which makes it relatively impenetrable to sperm.

The used dosages of estrogen and gestagennogo components Femoden practically does not affect the basic functions of the Central and peripheral nervous system, blood circulation, activities of other body systems.

After intake suction Femodena components quickly and completely takes place in the upper divisions of the small intestine, (a) the maximum concentration in plasma is a 0,5-1,3 o'clock. In the future, going 2-phase reduction of the drug with a half-life 0,3 and 22 hours for gestodena and 1-3 and 24 hours for ethinyl estradiol. Daily re-taking the drug is not accompanied by a noticeable cumulation of active substances and their metabolites. After entering the main part of the blood gestodena and ethinyl estradiol binds to albumin and globulin plasma, that makes them a lasting effect. Gestodene is not subjected to metabolize the first passage through the liver, However, in this body, he completely metabolised education inactive metabolites almost, displayed mainly kidneys and to a small degree through the intestines. Its complete excretion after ingestion 1 dose observed in the period up to 7 Nights. To 40% contained in Femodene ethinyl estradiol passes through the portal system to the liver, where its metabolism to sulphides and glukuronidov (the primary effect of passage) with their continued receipt in intestines. Under the influence of intestinal bacteria occurs chip away sulfate and glûkuronovyh groups and repeated intake of ethinyl estradiol. Drugs, that inhibit bacterial intestinal flora (eg, broad-spectrum antibiotics), in this regard, can reduce the amount of active ethinyl estradiol and its level in the blood. To 40% This estrogen is secreted through the kidneys and 60% — through the liver and intestines. In both cases the half-life is about 24 hours.

Testimony

Contraception.

Contraindications

Pregnancy, severe liver dysfunction, Dubin-Johnson syndrome and Rotor (hereditary benign giperbili-rubinemii), the available or existing liver tumors, embolic processes, in t. no. violations of cerebral circulation and other cardiovascular diseases, severe diabetes with vascular complications, drepanocytemia, available or available breast cancer and endometrium, idiopathic jaundice and itching during pregnancy, a history of herpes, otosclerosis with deterioration during pregnancy occurred.

Side effect

Femoden is usually well tolerated. However, in some cases, the use of drugs has been accompanied by out of focus expressed headaches, discomfort or pain in the stomach, nausea, feelings of tension of the mammary glands, changes in body weight and sex drive, depressed mood. Sometimes with long-term use have predisposed women may appear on the skin pigmentation (chloasma), which are amplified for long term stays in the Sun.

Dosing and Administration

• Inwards to Femoden 1 pills a day.
  Start taking the drug: Welcome Femodena begin in 1-St day cycle (1-the 5th day of the cycle = 1-5th day menstrual bleeding), using pellets of cells, marked the appropriate day of the week (например “Пн.” для понедельника). Drops accept, without chewing, and washed down with a little water. Reception time is irrelevant, However, subsequent reception should be performed in the same selected hour, preferably after breakfast or užinav Reception Femodena during exercise 21 day, daily, using bean from the calendar package consistently in the direction of the arrow until the, until you have taken all the pills. After the end of the reception 21 drop (the entire package) in preparation admission is done on break 7 days. Usually in this break, through 2-4 days after taking the last Tablet starts menstrualnopodobnoe bleeding.
• Continued reception: After 7-day break, regardless of Togo, ended up bleeding or just beginning, continue receiving Femodena from the next Pack. This installs easily reproducible rhythm: 3 week-admission of tablets, 1 week-break. Method of preparation of each package start at one and the same day of the week.
• Stopping: After the closure of receipt of Femodena function of sexual glands quickly restored in full, allowing normal fertility. Usually the first menstrual cycle after stopping treatment extended by one week. If during the 2-3 months of a normal cycle can not be restored, necessary to consult with your doctor.

Interaction with other agents

It should be taken into account, derivatives of barbituric acid (barbiturates), antiepileptic means (for example, carbamazepine, fenition et al.) able to amplify metabolizatia included in Femodena of steroid hormones. Reduction in effective concentrations of the drug can also be observed when using Femodena with some antibiotics (for example, ampicillin, rifampicin), due to the change of intestinal microflora. The decrease under the influence of steroid hormones, glucose tolerance, When receiving a progestogen-estrogenic drugs can be adjusted the dosage of antidiabetic means.

Further instructions

• Containing the drug begins to emerge from the first day of administration and lasts for the period 7-day pause to use Femodena.
  Estradiol progestogen-estrogenic drugs, which include Femoden, no influence on the course of puberty during the formation of a normal menstrual cycle. In this regard, young women and young can optionally use this type of oral contraceptives.
• Application of Femodena after birth, abortion or lactation period is determined by the physician.
• В случаях появления “промежуточных” кровотечений в период 3-х недельного приема препарата не следует прерывать курс. Usually, light bleeding take place independently. In an unusually strong and heavy bleeding menstrual′nopodobnyh to consult with a physician.
• If there is no occurrence of bleeding during 7-day pause between taking the drug should not continue to use it without the advice of a doctor.
• In case of admission Femodena drug should be taken within the next 12 hours, t. to. otherwise the contraceptive effect in this cycle may be reduced. When an interval, exceeding 12 hours, You should not use the tablet a given day. You should continue taking the drug at a set time, Using pellet corresponding day of the week. In these cases, in order to achieve reliable contraceptive effect, you should use an additional non-hormonal methods of contraception (with the exception of the calendar method for Knaus-Ogino or temperature method).
• With diarrhea or intestinal disorders, vomiting and taking certain drugs (cm. раздел “Взаимодействие с другими средствами”) contraceptive effect may be reduced. In such cases, while receiving Femodena, you must use an additional non-hormonal methods of contraception (cm. higher).

Cautions

Before and every 6 It is recommended to take Femodena months obŝemedicinskoe and gynaecological examination (including the study of the breast). In cases of Femodena migrenepodobnykh for the first time when hiring headaches or unusually severe headaches, sudden visual and hearing impairment, thrombophlebitis or thromboembolic symptoms, a significant increase in blood pressure, hepatitis, generalized itching, increased frequency of seizures, severe pain in the epigastric region should immediately stop taking the drug and seek medical advice.

Release form and storage conditions

The calendar package with 21 drop. Store at room temperature out of reach of children.