LEDIBON

Active material: Tiʙolon
When ATH: G03CX01
CCF: Protivoklimakterichesky drug
ICD-10 codes (testimony): M81.0, M81.1, N95.1, N95.3
When CSF: 15.11.01.01
Manufacturer: ZENTIVA a.s. (Czech Republic)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Pills from white to almost white, round, flat, Engraved “it is” on one side.

Excipients: lactose monohydrate (micronized), lactose monohydrate (direct compression lactose), potato starch, ascorbyl palmitate, magnesium stearate.

28 PC. – blisters (1) – packs cardboard.
28 PC. – blisters (3) – packs cardboard.

Pharmacological action

The drug with estrogenic, progestin, anabolic and androgenic activity mild. It helps reduce the secretion of gonadotropins.

Inhibits bone resorption in post-menopausal, reduces the concentration of calcium and phosphate in the serum, mitigates these climacteric syndrome, as a rush of blood to the face, increased perspiration, headache. Positive effect on libido and mood (increases the concentration of the central and peripheral opioid).

It exerts trophic effects on the vaginal mucosa, without stimulating endometrial proliferation.

Pharmacokinetics

Absorption vыsokaya.

It is metabolized in the liver to form hydrophilic products, some of which are pharmacologically active.

Excreted in the urine (incl. metaʙolitы) and faeces.

Testimony

- The treatment of estrogen deficiency symptoms in postmenopausal women;

- Prevention of osteoporosis in postmenopausal women, have a high risk of fractures, and intolerance of other groups of drugs, used for prevention of osteoporosis.

Dosage regimen

The drug is prescribed for 1 tab. / day every day. The tablet should be swallowed, drinking water or drinks, preferably at the same time of the day. The minimum duration of treatment – 3 Months.

In elderly patients conduct dose adjustment is required.

The drug was initiated 1 a year after the last menstrual period or immediately after surgical menopause.

Terms of taking the pills

Begin taking pills from the top, encircled in a number of, first take the, which is marked by the appropriate day of the week. In the following days – by 1 tab. / day in the direction, arrow, until, until it is adopted by the whole package.

Skip taking the pill

If a pass is less than 12 hours from the scheduled time of admission, you should take the missed pill, followed by administration of the remaining tablets in the usual scheduled time. If after the scheduled time
taking the pill has been more than 12 no, skip the reception is not adopted in time to tablets, but the remaining tablets should be taken at the usual scheduled time.

Side effect

CNS: dizziness, headache, visual disturbances, depression.

From the digestive system: diarrhea, increase in liver transaminases,

On the part of the endocrine system: weight change, swelling, increased hair growth on the face.

On the part of the reproductive system: metrorragija, proliferation эndometriya.

Dermatological reactions: seborrheic dermatosis, rash, itch.

On the part of the musculoskeletal system: back pain, hands and feet, arthralgia.

Contraindications

- Hormone-dependent tumors (incl. They suspected);

- Tromboflebit, thromboembolism (incl. history);

- Severe liver;

- Heart failure;

- Cerebrovascular disorders;

- Otosclerosis, occurred during pregnancy or during steroid treatment;

- A period of at least 1 a year after the last menstrual period;

- Untreated endometrial hyperplasia;

- Vaginal bleeding of unknown etiology;

- Porphyria;

- Pregnancy;

- Lactation (breastfeeding);

- Hypersensitivity to the drug.

FROM caution should be prescribed the drug for LM, эndometrioze, history of endometrial hyperplasia, renal failure, carbohydrate metabolism disorders, hypercholesterolemia, epilepsy, migraine or severe headaches, systemic lupus erythematosus, asthma.

Pregnancy and lactation

Use of the drug is contraindicated in pregnancy Ledibon. In case of pregnancy during use of the drug Ledibon, treatment must be stopped immediately.

Use of the drug during lactation (breast-feeding) not recommended.

Cautions

In the treatment of estrogen deficiency symptoms in postmenopausal women should use the drug Ledibon only for those symptoms, which adversely affect the quality of life.

The drug Ledibon not intended for use as a contraceptive.

During treatment patients may increase sensitivity to anticoagulants due to increased blood fibrinolytic activity.

When symptoms of thromboembolism, jaundice or persistent abnormalities of liver function tests treatment ceased.

During treatment requires regular monitoring of relevant laboratory parameters in patients with hypercholesterolemia, renal failure, diabetes.

The treatment may reduce concentrations of total and free T4 and thyroxine binding globulin.

In all cases it is necessary to conduct a thorough assessment of the risks and benefits of treatment (no less 1 per year).

Hormone replacement therapy should be continued during the period, when the benefits of therapy outweigh the risks.

Effects on ability to drive vehicles and management mechanisms

There was no any action on the drug concentration and reaction, driving ability and other mechanisms.

Overdose

Symptoms: dysfunction of the gastrointestinal tract.

Treatment: symptomatic.

Drug Interactions

Unnecessarily. Ledibon drug enhances blood fibrinolytic activity, it can increase the effects of anticoagulants.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C. Shelf life – 2 year.