Progynorm Ovo soft capsules 100 mg blister No. 30

Instructions for use Progynorm Ovo soft capsules 100 mg blister No. 30

Composition

active ingredient: progesterone;

1 soft capsule contains 100 mg or 200 mg of progesterone;

excipients: peanut oil, soy lecithin;

capsule shell: gelatin 150 Bloom, glycerin 99%, titanium dioxide (E 171).

Dosage form

Soft capsules.

Main physicochemical properties: soft, opaque, oval-shaped capsules of almost white color.

Pharmacotherapeutic group

Hormones of the sex glands and drugs used in cases of pathology of the genital sphere. Progestogens. Derivatives of pregnenol (4). Progesterone. ATX code G03D A04.

Pharmacological properties

Pharmacodynamics.

The pharmacological properties of the drug PROGINORM OVO are due to progesterone - one of the hormones of the corpus luteum, which contributes to the formation of a normal secretory endometrium in women. Causes the transition of the uterine mucosa from the proliferation phase to the secretory phase, and after fertilization promotes its transition to the state necessary for the development of a fertilized egg. Reduces the excitability and contractility of the muscles of the uterus and fallopian tubes. Does not have androgenic activity. Has a blocking effect on the secretion of hypothalamic LH and FSH releasing factors, inhibits the formation of gonadotropic hormones by the pituitary gland and ovulation.

Pharmacokinetics.

Absorption

The level of progesterone in the blood plasma increases from the first hour after absorption of the drug in the digestive tract. The highest level of progesterone in the blood plasma is observed 1-3 hours after taking the drug (after 1 hour - 4.25 ng/ml, after 2 hours - 11.75 ng/ml, after 4 hours - 8.37 ng/ml, after 6 hours - 2 ng/ml and 1.64 ng/ml after the 8th hour).

Metabolism

The main metabolites of progesterone in blood plasma are 20α-hydroxy, δ4α-pregnanolone and 5α-dihydroprogesterone. The drug is excreted in the urine in the form of glucuronic metabolites, the main of which is 3α,5β-pregnanediol (pregnanediol). These metabolites are identical to those found during the physiological secretion of the ovarian corpus luteum.

Indication

Gynecological:

1. Disorders associated with progesterone deficiency, namely:

premenstrual syndrome;

menstrual cycle disorders (dysovulation, anovulation);

fibrocystic mastopathy;

premenopause.

2. Hormone replacement therapy in menopause (in combination with estrogen therapy).

3. Infertility due to luteal insufficiency.

Obstetric:

1. Prevention of habitual miscarriage or threatened miscarriage due to luteal insufficiency.

2. Threat of premature birth.

Contraindication

Hypersensitivity to any component of the drug.

Severe liver dysfunction.

Suspected or confirmed breast or genital neoplasia.

Undiagnosed vaginal bleeding.

Failed or incomplete abortion.

Thrombophlebitis. Thromboembolic disorders.

Brain hemorrhage.

Porphyria.

Interaction with other medicinal products and other types of interactions

When using estrogen for menopausal hormone therapy, it is strongly recommended to administer progesterone no later than the 12th day of the cycle.

If Progynorm Ovo is used in combination with beta-adrenomimetics in the treatment of threatened preterm labor, the doses of the latter can be reduced.

Concomitant use of other drugs may alter progesterone metabolism, causing an increase or decrease in progesterone plasma concentrations and, consequently, altering the drug's action.

Strong inducers of liver enzymes, namely: barbiturates, antiepileptic drugs (phenytoin), rifampicin, phenylbutazone, spironolactone, griseofulvin, cause increased metabolism at the hepatic level.

Some antibiotics (ampicillins, tetracyclines) can cause changes in the intestinal microflora, resulting in a change in the enterohepatic steroid cycle.

It is known that such drug interactions are individual and may vary significantly in different patient groups, therefore it is not possible to unequivocally predict any clinical manifestations of such interactions. All progestins may reduce glucose tolerance, which may require an increase in the daily dose of insulin and other antidiabetic agents in patients with diabetes.

Progesterone bioavailability can be reduced by smoking and increased by alcohol.

Application features

Treatment at recommended doses has no contraceptive effect.

If the course of treatment is started very early in the menstrual cycle, especially before

On the 15th day of the cycle, you may experience a shortened cycle or bleeding.

In case of uterine bleeding, do not prescribe the drug without clarifying the cause, in particular during endometrial examination.

Before prescribing the drug, patients with a family history of neoplasms and patients with recurrent cholestasis or persistent itching during pregnancy, liver dysfunction, heart or kidney failure, fibrocystic mastopathy, epilepsy, asthma, otosclerosis, diabetes mellitus, multiple sclerosis, systemic lupus erythematosus should be carefully examined.

Due to the thromboembolic and metabolic risk, which cannot be completely ruled out, the drug should be discontinued in the event of:

visual disturbances, such as vision loss, double vision, retinal vascular lesions, proptosis, optic disc edema;

thromboembolic venous or thrombotic complications, regardless of the site of involvement;

severe headache, migraine.

If amenorrhea occurs during treatment, pregnancy, which may be the cause of amenorrhea, should be confirmed or ruled out.

More than half of early spontaneous abortions are caused by genetic complications. In addition, infectious manifestations and mechanical disorders can be the cause of early abortions; the only justification for prescribing progesterone would then be to delay the expulsion of a dead egg. Therefore, the prescription of progesterone on the recommendation of a doctor should be reserved for cases where progesterone secretion is insufficient.

Before starting treatment, the patient should undergo a thorough medical and accurate gynecological examination, including intravaginal and mammological examination, Papanicolaou smear, taking into account the anamnesis, contraindications and precautions for use. Regular check-ups with a doctor are recommended during treatment. Women receiving hormone replacement therapy (HRT) should carefully assess all the risks/benefits associated with therapy.

In patients with postmenopausal symptoms who are receiving or have received HRT, there is a slight to moderate increase in the likelihood of being diagnosed with breast cancer. This may be due to early diagnosis of patients or the actual benefit of HRT, as well as a combination of both. The risk of being diagnosed with breast cancer increases with increasing duration of treatment and returns to baseline values 5 years after stopping HRT. Breast cancer diagnosed in patients who are receiving or have recently received HRT is less invasive than that occurring in women who have not received HRT. The doctor should discuss the higher likelihood of developing breast cancer with patients who will receive long-term hormone therapy when assessing the benefits of HRT.

The drug should not be taken with food, but should be taken before bedtime. Simultaneous intake of food increases the bioavailability of the drug.

This medicine contains peanut oil and soy lecithin. If the patient is allergic to peanut or soy, PROGYNORM OVO should not be used.

Use during pregnancy or breastfeeding

The use of the drug PROGYNORM OVO is not contraindicated during pregnancy, including the first weeks (see the section "Indications" (Obstetric indications)).

During the period of use of the drug, no case of adverse effects of the drug on the fetus was observed.

When using the drug in the II and III trimesters of pregnancy, liver function monitoring is required.

The excretion of progesterone into breast milk has not been studied in detail. Therefore, its use should be avoided during breastfeeding.

There is evidence of the possible development of hypospadias when progestogens are used during pregnancy to prevent spontaneous abortion or threatened abortion due to luteal insufficiency, which the patient should be informed about.

Ability to influence reaction speed when driving vehicles or other mechanisms

For drivers and machine operators: drowsiness and dizziness are possible when taking the drug orally.

Taking the capsules before bedtime helps to avoid these unpleasant consequences.

Cases of drowsiness and dizziness were observed only during oral administration of progesterone.

Method of administration and doses

The duration of treatment depends on the nature of the disease.

It is recommended to take the capsules with a glass of water on an empty stomach, preferably in the evening, before bedtime.

In most cases, the average daily dose is 200-300 mg in 1 or 2 doses (200 mg in the evening, before bedtime, and 100 mg in the morning, if necessary).

For luteal phase insufficiency (premenstrual syndrome, menstrual cycle disorders, premenopause, fibrocystic breast disease): take for 10 days (usually from the 17th to the 26th day of the cycle, inclusive).

In menopausal hormone replacement therapy: since estrogen therapy alone is not recommended, progesterone should be used as a supplement to it for the last 2 weeks of each therapeutic course, which follow a one-week maintenance of any replacement therapy, during which withdrawal bleeding may occur.

The use of progesterone after 36 weeks of pregnancy is not recommended.

Children

The drug is not intended for use in pediatric practice.

Overdose

Symptoms of overdose may manifest as symptoms of adverse reactions, including drowsiness, dizziness, euphoria, dysmenorrhea, decreased cycle length, and metrorrhagia.

In some individuals, the usual dose may be excessive due to existing or secondary unstable endogenous progesterone secretion, hypersensitivity to the drug, or very low concomitant blood estradiol levels.

In such cases, it is sufficient to:

reduce the dose of progesterone or prescribe progesterone in the evening before bedtime for 10 days per cycle in case of drowsiness or transient dizziness;

postpone the start of treatment to a later date in the cycle (for example, day 19 instead of day 17) in case of its shortening or bleeding;

to check whether the estradiol level is sufficient in a premenopausal patient receiving HRT.

Side effects

The following phenomena were observed:

Adverse reactions such as changes in libido, breast discomfort, premenstrual symptoms, hyperthermia, insomnia, alopecia, hirsutism, venous thromboembolism, pulmonary embolism, fluid retention, weight changes, gastrointestinal disorders, and anaphylactic reactions may also occur.

Drowsiness and/or a brief feeling of dizziness are observed, especially in the case of concomitant hypoestrogenism. Reducing the dose of the drug or increasing the dose of estrogen immediately eliminates these phenomena, without reducing the therapeutic effect.

If treatment is started too early in the menstrual cycle, especially before day 15, there may be a shortening of the cycle or spotting.

Expiration date

3 years.

Storage conditions

Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Packaging

15 soft capsules in a blister; 2 blisters in a pack.

Vacation category

According to the recipe.

Producer

LABORATORIOS LEON PHARMA, S.A.

Location of the manufacturer and address of its place of business

La Vallina Street, Polígono Industrial Navatechera, Villaquilambre, 24193 Leon, Spain.

Applicant

CJSC "Farmlyga" / UAB "Farmlyga".

Applicant's location

Antakalnio g. 48A-304, Vilnius, Republic of Lithuania.