Expiration date: 03/2025

Release form and composition:

Tablets are white to off-white, round, flat, engraved on one side ie.

1 tablet contains tibolone 2.5 mg

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

28 pcs. - Blisters (1) - packs cardboard.

28 pcs. - Blisters (3) - packs cardboard.

Pharmachologic effect:

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

It inhibits bone resorption in postmenopausal period, reduces the concentration of phosphate and calcium in serum softens such climacteric syndrome, a rush of blood to the face, sweating, headaches. Positive effect on libido and mood (increases the concentration of the central and peripheral opioid).

It has a trophic effect on the vaginal mucosa without stimulating the proliferation of the endometrium.

Pharmacokinetics:

Absorption high.

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

Return with urine (including metabolites), and faeces.

Testimony:

• Treatment of estrogen deficiency symptoms in postmenopausal women
  
• Prevention of osteoporosis in postmenopausal women at high risk of fractures, and intolerance of other groups of drugs used to prevent osteoporosis.
  

Dosage and administration:

The drug appoint 1 tab. / Day every day. Tablets should be swallowed with water or a drink, preferably at the same time. The minimum duration of treatment - 3 months.

In elderly patients spend correction dose is not required.

Acceptance of the drug begin 1 year after the last menstrual period, or immediately after surgical menopause.

Terms of taking the pills

Start taking pills from the top, circled in a number, take the first one that is marked with the corresponding day of the week. In the following days -. 1 tablet / day in the direction indicated by the arrow, as long as the whole package is not accepted.

Skipping taking the pill

If a pass is less than 12 hours from the scheduled reception time, it is necessary to take a pill missed, followed by administration of a conventional tablet remaining scheduled time. If after the scheduled time

taking the pill more than 12 hours, skip the reception is not taking the pill on time, but the remaining tablets should be taken at the usual scheduled time.

Side effects:

CNS: dizziness, headache, visual disturbances, depression.

From the digestive system: diarrhea, elevated liver enzymes,

From endocrine system: change of body weight, edema, increased hair growth on the face.

From the reproductive system: metrorrhagia, proliferation of the endometrium.

Dermatological reactions: seborrheic dermatosis, rash, pruritus.

From the musculoskeletal system: pain in the back, arms and legs, arthralgia.

Contraindications:

• Hormone-dependent tumors (including suspected them)
  
• Thrombophlebitis, thromboembolism (including history)
  
• Severe hepatic dysfunction
  
• Heart failure
  
• Cerebrovascular disorders
  
• Otosclerosis, arising during pregnancy or during the treatment with steroids
  
• The period of at least 1 year after the last menstrual period
  
• Untreated endometrial hyperplasia
  
• Bleeding from the vagina of unknown etiology
  
• porphyria
  
• pregnancy
  
• Lactation (breastfeeding)
  
• Hypersensitivity to the drug.
  

Precautions should be prescribed the drug for leiomyoma, endometriosis, endometrial hyperplasia in history, renal failure, disorders of carbohydrate metabolism, hypercholesterolemia, epilepsy, migraine or severe headaches, systemic lupus erythematosus, asthma.

Pregnancy and lactation:

Application Ladybon drug during pregnancy is contraindicated. In case of pregnancy during use Ladybon drug treatment should be stopped immediately.

Use of the drug during lactation (breastfeeding) is not recommended.

Special instructions:

In the treatment of estrogen deficiency symptoms in postmenopausal Ladybon drug should use only for those symptoms that adversely affect the quality of life.

Ladybon preparation is not intended for use as a contraceptive.

In the course of treatment may increase the sensitivity of patients to anticoagulants due to increased blood fibrinolytic activity.

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

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

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

In all cases it is necessary to conduct a thorough risk assessment and benefits of treatment (at least 1 times per year).

Hormone replacement therapy should be continued in the period of time when the benefits of therapy outweigh the risks.

Effects on ability to drive vehicles and management mechanisms

There was no any effect on the drug concentration and reaction ability to drive and other mechanisms.

Overdose:

Symptoms: impaired gastrointestinal function.

Treatment: symptomatic.

Drug Interactions:

Because Ladybon drug enhances blood fibrinolytic activity, it may enhance the effect of anticoagulants.

Conditions and terms:

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