Instructions Flutafarm Femina tablets 125 mg blister No. 30
Composition
active ingredient: flutamide;
1 tablet contains flutamide in terms of 100% substance – 125 mg (0.125 g);
Excipients: potato starch, lactose monohydrate, colloidal anhydrous silicon dioxide, calcium stearate.
Dosage form
Pills.
Main physicochemical properties: light yellow tablets, with a flat surface, with a score on one side and a bevel.
Pharmacotherapeutic group
Hormone antagonists and similar agents. Antiandrogenic agents. ATX code L02B B01.
Pharmacological properties
Pharmacodynamics
Flutapharm® Femina is a non-steroidal drug with antiandrogenic effects.
In women with hyperandrogenic conditions accompanied by infertility and disorders of the ovarian-menstrual cycle (e.g., polycystic ovary syndrome), Flutafarm® Femina blocks the pathogenic effect of endogenous androgens on the ovaries and other reproductive organs, as well as on the hypothalamic-pituitary system. As a result, the symptoms of hyperandrogenism (hirsutism) are reduced in patients, menstruation is restored, folliculogenesis and the menstrual cycle are improved, which probably leads to the restoration of fertile potential in some patients.
Pharmacokinetics
Flutamide is well absorbed from the digestive tract. The maximum concentration in the blood is observed 2 hours after oral administration. It is rapidly metabolized with the formation of the active metabolite - 2-hydroxyflutamide and other substances. The half-life of the active metabolite is 5-6 hours. It is eliminated mainly with urine. In 2 days, 91% of the administered dose is excreted from the body, in 3 days - 98%.
Indication
Treatment of women with functional hyperandrogenism accompanied by ovarian-menstrual cycle disorders, hirsutism, polycystic ovary syndrome, and infertility.
Contraindication
Hypersensitivity to flutamide or to any of the other ingredients of the drug. Organic hyperandrogenism (ovarian and adrenal tumors). Severe hepatic insufficiency (baseline liver enzymes should be assessed before starting treatment).
Childhood.
Interaction with other medicinal products and other types of interactions
No interaction of flutamide with leuprolide has been observed. If flutamide and LHRH agonists are used concomitantly, the potential for adverse effects of both drugs should be considered.
In patients receiving long-term warfarin therapy, an increase in prothrombin time has been observed after the use of flutamide. Therefore, it is necessary to select the optimal dose of the anticoagulant.
With the combined use of flutamide and theophylline, an increase in theophylline concentrations in blood plasma is possible.
The concomitant use of flutamide and potentially hepatotoxic drugs should be avoided.
When used simultaneously, there is a possibility of interaction with paracetamol and opioid analgesics.
Flutamide may slow the metabolism of corticosteroids.
You should not drink alcohol during treatment.
The concomitant use of flutamide with drugs that prolong the QT interval or drugs that can induce flutter/flicker, such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic drugs, methadone, moxifloxacin, neuroleptics, should be carefully evaluated.
Application features
Patients should be under constant medical supervision. Particular attention should be paid to the effect of flutamide on liver function.
In case of liver function disorders, the use of flutamide as long-term therapy is possible only after a careful assessment of the expected benefits and possible risks.
Liver function tests should be performed before starting treatment. Treatment with the drug should not be initiated in patients with serum transaminase levels 2 to 3 times the upper limit of normal.
Appropriate laboratory testing should be performed monthly for the first 4 months of treatment and periodically thereafter and at the first symptoms/signs of liver dysfunction (itching, dark urine, persistent loss of appetite, jaundice, moderate right upper quadrant abdominal tenderness, or general weakness).
Liver dysfunction is usually reversible after discontinuation of flutamide treatment. However, there are reports of fatalities due to severe liver injury caused by flutamide.
Flutamide is excreted primarily by the kidneys, so dosage adjustment may be required for patients with renal insufficiency.
The physician should assess the risk-benefit ratio, including the likelihood of developing flutter/flicker, before initiating treatment with flutamide in patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medications that may prolong the QT interval.
In patients with latent or actual glucose-6-phosphate deficiency, methemoglobinemia may develop. In the event of cyanosis or methemoglobinemia, the possible factor of overdose should be considered.
Flutafarm® Femina contains lactose, therefore patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use the drug.
You should not drink alcohol during treatment.
Use during pregnancy or breastfeeding
When using the drug, women should pay special attention to preventing pregnancy using non-hormonal, in particular barrier, contraceptive methods. In the event of a positive pregnancy test, the drug should be discontinued immediately.
Sexual intercourse with the aim of achieving a desired pregnancy can be resumed no earlier than 48 hours after the last dose of Flutafarm® Femina.
Ability to influence reaction speed when driving vehicles or other mechanisms
Usually the drug does not affect the reaction speed when driving or working with other mechanisms, but in rare cases, increased fatigue, dizziness, partial impairment of consciousness are possible. In such cases, it is necessary to refrain from driving or working with other mechanisms.
Method of administration and doses
Women with hyperandrogenic conditions are prescribed Flutafarm® Femina orally, 1 tablet (125 mg) 3 times a day for 3-6 months. Take during or after meals. It is mandatory to use non-hormonal contraceptives, including barrier ones.
Children
The drug is not used to treat children.
Overdose
In animal experiments, flutamide caused hypoactivity, piloerection, slowed respiratory rate, caused ataxia and/or lacrimation, anorexia, sedation, vomiting, and methemoglobinemia.
Clinical data indicate that flutamide taken at a daily dose of up to 1500 mg for 36 weeks does not cause serious side effects. Sometimes breast engorgement and transient changes in liver transaminase levels occur. A single dose of flutamide (up to 5 g) does not cause symptoms of overdose and is not life-threatening.
Symptoms of overdose that would threaten a person's life are unknown.
Due to the high degree of binding of flutamide to plasma proteins, it cannot be removed by dialysis. As in the treatment of overdose of any drug, the possibility of simultaneous administration of several drugs by the patient should be taken into account. General measures to monitor and maintain vital parameters of the body are indicated. Gastric lavage may be required.
Adverse reactions
The adverse reactions described below are typical for the active substance flutamide.
Infections and invasions.
Herpes zoster.
On the part of the hematopoietic and lymphatic systems.
Lymphedema, anemia, leukopenia, thrombocytopenia, methemoglobinemia, ecchymoses.
From the nutritional and metabolic point of view.
Increased appetite, anorexia.
From the psychological side.
Insomnia, depression, anxiety.
From the nervous system.
Dizziness, headache, drowsiness.
From the immune system.
Lupus-like syndrome.
From the organs of vision.
Blurred vision.
From the cardiovascular system.
Hot flashes, QT prolongation, cardiovascular disorders.
Respiratory disorders.
Dyspnea, cough.
From the gastrointestinal tract.
Diarrhea, nausea, vomiting, increased appetite, nonspecific complaints about the functioning of the gastrointestinal tract, heartburn, constipation, impaired gastrointestinal function, pain in the stomach area, stomach disorders, ulcer-like pain, stomatitis.
From the liver and biliary tract.
Hepatitis, jaundice, increased liver function tests.
Liver disorders usually resolve after discontinuation of flutamide; severe toxic hepatitis, hepatic necrosis, and hepatic encephalopathy (these adverse reactions are usually reversible and resolve upon discontinuation of therapy). Isolated fatalities associated with liver injury due to flutamide have been reported.
On the part of the kidneys and urinary tract.
Increased levels of urea and creatinine in the blood (the severity of this side effect usually does not require dose reduction or discontinuation of the drug), change in urine color to green.
On the skin and subcutaneous tissue.
Itching, subcutaneous hemorrhages, photosensitivity, rash, alopecia, at the beginning of flutamide therapy, reversible changes in hair structure may develop.
From the reproductive system and mammary glands.
Breast pain, galactorrhea, decreased libido.
General violations.
Increased fatigue, swelling, weakness, anxiety, thirst, chest pain, fever.
Research.
Transient liver dysfunction.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister. 3 blisters in a pack.
Vacation category
According to the recipe.
Producer
JSC "Farmak".
Location of the manufacturer and its business address
Ukraine, 04080, Kyiv, Kyrylivska St., 74
