Femostone mini, 28 pcs.

Genital gland hormones and drugs used in the pathology of the sexual sphere.

Combination drugs containing progestagens and estrogens.

Indications

Hormone replacement therapy (HRT) to relieve symptoms due to estrogen deficiency in postmenopausal women no earlier than 12 months after the last menstrual period.

Active ingredient

Dydrogesterone, Estradiol

Composition

acting ingredients:

1 tablet contains didrogesterone micronized 2.5 mg

estradiol hemihydrate micronized, which is equivalent to 0.5 mg of estradiol;

accompaniettes:

lactose, monohydrate;

hypromellose (HPMC 2910);

corn starch;

silica colloidal anhydrous;

p> magnesium stearate;

film jacket Yellow 1 (macrogol 3350, polyvinyl alcohol, talc, titanium dioxide (E171),

iron oxide yellow (E172)).

How to take, the dosage

To be taken orally.

The long term use of the combination estrogen and progestogen should be taken daily without interruption, one tablet daily for a 28-day cycle.

Femostone® Conti Mini should be taken continuously, without interruption of tablets from different packs.

To begin and continue treatment of postmenopausal symptoms, the lowest effective dose should be used for the shortest period of time.

Long-term combination therapy may be started with Femostone® Conti Mini or Femostone® Conti depending on the time since the onset of menopause and the severity of symptoms. Depending on the clinical response, the dosage can subsequently be adjusted according to individual needs.

Patients who are transitioning from long-term sequential or cyclical use of other medications should complete a 28-day treatment cycle, after which they may switch to Femostone® Conti Mini. Patients who are transitioning from long-term combination medications can begin treatment with Femostone® Conti Mini at any time.

If the Femoston® Conti Mini tablet is missed, it should be taken as soon as possible. If more than 12 hours have passed, treatment should be continued with the next tablet without taking the missed dose. In such cases, the chance of breakthrough bleeding or bleeding may be increased.

Femoston® Conti Mini can be taken regardless of meals.

Interaction

There have been no studies of drug interactions.

The effectiveness of estrogens and progestagens may be impaired

• Metabolism of estrogens and progestagens may be enhanced with concomitant use of substances with a known ability to induce enzymes involved in drug metabolism, especially the 2B6, WA4, WA5, WA7 cytochrome P450 enzymes. These include anticonvulsants (e.g. phenobarbital, carbamazepine, phenytoin) and antimicrobials (e.g. rifampicin, rifabutin, nevirapine, efavirenz).
• Although ritonavir and nelfinavir are known to be potent inhibitors of CYP450, ZA4, A5, A7, when used simultaneously with steroid hormones, they, in contrast, activate these enzymes.
• The herbal preparations with Hypericum perforatum as a component may increase estrogen and progestagen metabolism through effects on CYP450, WA4.
• It has been clinically proven that increased metabolism of estrogens and progestagens can lead to attenuation of their effects and altered uterine bleeding profiles.

Estrogens can interfere with the metabolism of other drugs

Estrogens can inhibit CYP450 enzymes involved in drug metabolism through competitive inhibition. This should especially be considered for drugs with a narrow therapeutic index, such as:

• tacrolimus and cyclosporine A (CYP450 3A4, 3A3);
• fentanyl (CYP450 3A4);
• theophylline (CYP450 1A2).

Clinically, this may lead to increased plasma levels of such substances in toxic concentrations. Thus, close monitoring of the medication over an extended period of time may be required, as well as dose reduction of tacrolimus, fentanyl, cyclosporine A, and theophylline.

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Contraindications

• High sensitivity to active ingredients or any of the excipients.
• Past or suspected breast cancer.
• Investigated or suspected estrogen-dependent malignancies (e.g., endometrial cancer).
• Positive or suspected progestagen-tumor neoplasia (e.g., meningioma).
• Genital bleeding of unknown etiology.
• Untreated endometrial hyperplasia.
• Venous thromboembolism (deep vein thrombosis, pulmonary embolism) past or present.
• Present thrombophiliac disorders (e.g. protein C protein S or antithrombin deficiency).
• Acute or recent arterial thromboembolic disease (e.g., angina pectoris, myocardial infarction).
• Acute liver disease or a history of liver disease if liver function has not returned to normal values.
• Porphyria.

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Side effects

In clinical trials in patients treated with estradiol/didrogesterone combination therapy, the most common problems were: headache, abdominal pain, breast tension/pain, and back pain.

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Overdose

Both estradiol and dydrogesterone are low-toxicity substances.

In an overdose, symptoms such as nausea, vomiting, breast sensitivity, dizziness, abdominal pain, drowsiness/fatigue, and bleeding withdrawal may occur.

It is unlikely that overdose will require any specific symptomatic treatment. This is also true in cases of overdose in children.

Similarities

Femoston 1/10, Femoston 1/5, Femoston 2/10