Femoston mini pills, 28pcs

Composition

Active ingredients:

1 tablet contains micronized didrogesterone 2.5 mg

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

excipients:

lactose, monohydrate;

hypromellose (HPMS 2910);

corn starch;

colloidal anhydrous silicon dioxide;

magnesium stearate;

Yellow 1 film shell (macrogol 3350, polyvinyl alcohol, talc, titanium dioxide (E 171),

iron oxide yellow (E 172)).

Pharmacological action

Hormones of the sex glands and drugs used in the pathology of the sexual sphere.

Combined medications containing progestogens and estrogens.

Indications

Hormone replacement therapy (HRT) for the elimination of symptoms caused by estrogen deficiency in postmenopausal women, no earlier than 12 months after the last menstrual period.

Contraindications

• Hypersensitivity to active substances or to any of the excipients.
• Previously diagnosed or suspected breast cancer.
• Estrogen-dependent malignancies (such as endometrial cancer) have been identified or suspected.
• Identified or suspected progestogen-related neoplasms (for example, meningioma).
• Genital bleeding of unknown etiology.
• Untreated endometrial hyperplasia.
• Venous thromboembolism (deep vein thrombosis, pulmonary embolism) in the past or present.
• The presence of thrombophilic disorders (for example, protein C or antithrombin deficiency).
• Acute or recent thromboembolic diseases of the arteries (for example, angina pectoris, myocardial infarction).
• Acute liver disease or a history of liver disease, if liver function indicators have not returned to normal values.
• Porphyria.

Side effects

In clinical studies, patients treated with the combination of estradiol/didrogesterone were most likely to experience: headache, abdominal pain, tension/soreness of the mammary glands, and back pain.

Interaction

No drug interaction studies have been conducted.

The effectiveness of estrogens and progestogens may be impaired

• The metabolism of estrogens and progestogens can be enhanced with the simultaneous use of substances with a known ability to induce enzymes involved in drug metabolism, especially enzymes 2 IN 6, FOR 4, FOR 5, for 7 of the cytochrome P450 system. These substances include anticonvulsants (e. g. phenobarbital, carbamazepine, phenytoin) and antimicrobials (e. g. rifampicin, rifabutin, nevirapine, efavirenz).
• Despite the fact that ritonavir and nelfinavir are known as potent CYP450 inhibitors, EXCEPT for 4, A 5, AND A 7, when used simultaneously with steroid hormones, they, on the contrary, activate these enzymes.
• Herbal preparations containing St. John’s wort (Hypericum perforatum) can increase the metabolism of estrogens and progestogens due to their effect on CYP450, FOR 4.
• It is clinically proven that increased metabolism of estrogens and progestogens can lead to a weakening of their effect and a change in the profile of uterine bleeding.

Estrogens can interfere with the metabolism of other medications

Estrogens can inhibit the CYP450 enzymes involved in drug metabolism by competitive inhibition. This should be especially taken into account for medicinal products with a narrow therapeutic index, such as: :

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

Clinically, this can lead to increased plasma levels of such substances in toxic concentrations. Therefore, it may be necessary to carefully monitor the drug over a long period of time, as well as reduce the dose of tacrolimus, fentanyl, cyclosporine A and theophylline.

How to take, course of use and dosage

For oral use.

Long-term use of the combination: estrogen and progestogen are taken daily without interruption. You should take one tablet a day for a 28-day cycle.

Femoston ® Conti mini should be taken continuously, without interruption in taking tablets from different packages.

To start and continue treatment of postmenopausal symptoms, the minimum effective dose should be used for a minimum period of time.

Long-term combination therapy can be initiated with Femoston ® Conti mini or femoston ®Conti depends on the time elapsed since the onset of menopause and the severity of symptoms. Depending on the clinical response, the dosage can then be adjusted to suit individual needs.

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

If taking Femoston ® tablets Conti mini is missed and 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 probability of breakthrough bleeding or the appearance of spotting may be increased.

Femoston ® Conti mini can be taken regardless of food intake.

Overdose

Both estradiol and didrogesterone are substances with low toxicity.

Overdose may cause symptoms such as nausea, vomiting, breast sensitivity, dizziness, abdominal pain, drowsiness / fatigue, and withdrawal bleeding.

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

Active ingredient

: Didrogesterone, Estradiol

Conditions of release from pharmacies

By prescription

Dosage form

Tablets