Ledibon
Producer: Zentiva (Zentiva) Czech Republic
Code of automatic telephone exchange: G03CX01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agent: тиболон 2,5 mg.
Excipients: lactoses the monohydrate (micronized) of lactose monohydrate (lactose of direct pressing), potato starch, offended palmitate, magnesium stearate.
Description: From white till almost white color flat round tablets, with an engraving "е" on one party.
Pharmacological properties:
Pharmacodynamics. Gestagenny means, has also anabolic, weak androgenic and oestrogenic activity, promotes decrease in secretion of gonadotropic hormones. Brakes a resorption of a bone tissue in the postmenopauzny period, reduces concentration of phosphates and calcium in blood serum, softens such manifestations of a menopausal syndrome as "inflows" of blood to face skin, the increased sweating, headaches. Positively influences a libido and mood (increases concentration of the central and peripheral opioids).
Has trophic effect on a mucous membrane of a vagina, without stimulating proliferation of an endometria.
Pharmacokinetics. Absorption - high. It is metabolized in a liver with formation of hydrophilic products, a part from which pharmacological is active. It is removed by kidneys (including metabolites), through intestines.
Indications to use:
• treatment of symptoms of oestrogenic insufficiency at women in a postmenopause;
• prevention of osteoporosis at the women in a postmenopause having high risk of developing of fractures and at intolerance of other groups of the drugs used for prevention of osteoporosis.
Route of administration and doses:
It is necessary to take daily one pill. At elderly patients it is not required to carry out correction of a dose. Tablets should be swallowed, washing down with water or drinks, time of day is preferable in one and too. The minimum duration of treatment - 3 months.
Administration of drug is begun in 1 year after the last periods or at once after a surgical menopause.
Begin to take a pill from the upper, led round in a frame row, the first accept that which is marked with the corresponding day of the week. In the next days - on 1 tablet a day in the direction specified by an arrow until all packaging is accepted.
Admission of reception of a tablet
If the admission makes less than 12 hours from the planned reception time, then it is necessary to take the passed pill, with the subsequent reception of the remained tablets in the usual planned time. If after the planned time of reception of a tablet there passed more than 12 hours, it is necessary to miss reception of the pill which is not taken in time, but the remained pill should be taken in the usual planned time.
Features of use:
For treatment of post-menopausal symptoms, administration of drug needs to be begun only concerning symptoms which adversely influence quality of life. It is not intended for use as a contraceptive. In the course of treatment increase in sensitivity of patients to anticoagulants owing to increase in fibrinolitic activity of blood is possible.
At emergence of symptoms of a thromboembolism, jaundice or permanent pathological changes of functional "hepatic" tests treatment is stopped. During treatment regular control of the corresponding laboratory is necessary
indicators at patients with a hypercholesterolemia, a renal failure, a diabetes mellitus. Against the background of treatment decrease in concentration of the general and free T4 and tiroksinsvyazyvayushchy globulin is possible.
In all cases it is necessary to carry out careful assessment of risk and advantage of treatment (not less than 1 time a year). Replacement hormonal therapy should be continued in a span when the advantage of therapy exceeds risk.
Influence on ability to drive the car and other mechanisms
Any effect of drug on concentration of attention and reaction, ability to drive the car and other mechanisms is noted.
Side effects:
Dizziness, headache, diarrhea, increase in activity of "hepatic" transaminases, change of body weight, hypostases, strengthening of growth of hair in the person, metrorrhagia, seborrheal dermatosis, rash, itch, dorsodynias, hands and legs, proliferation of an endometria. Visual disturbance. Depression. Arthralgia.
Interaction with other medicines:
As drug promotes increase in fibrinolitic activity of blood, it can strengthen effect of anticoagulants.
Contraindications:
Hypersensitivity to drug components, pregnancy and feeding by a breast, hormonedependent tumors (including suspicion on them), thrombophlebitis, a thrombembolia (including in the anamnesis), heavy abnormal liver functions, cardiovascular insufficiency, cerebrovascular frustration, the otosclerosis which arose during pregnancy or at treatment by steroids, the period less than 1 year after the last periods. Not treated hyperplasia of an endometria. Bleedings from a vagina of not clear etiology. Porphyria.
With care: a leiomyoma, endometriosis, an endometria hyperplasia in the anamnesis, a renal failure, disturbances of carbohydrate metabolism, a hypercholesterolemia, epilepsy, migraine or severe headaches, a system lupus erythematosus, bronkhialyy asthma.
Use during pregnancy and breastfeeding
Drug use Ledibon during pregnancy is contraindicated. In case of pregnancy during treatment by drug Ledibon, treatment by drug needs to be stopped immediately. Use of drug during feeding by a breast is not recommended.
Overdose:
Symptoms: dysfunction of digestive tract.
Treatment: symptomatic.
Storage conditions:
At a temperature not above 25 °C, in original packaging. To store in the place, unavailable to children! Period of validity 2 years. Not to use after the period of validity specified on packaging.
Issue conditions:
According to the recipe
Packaging:
Tablets of 2,5 mg. On 28 tablets in the blister from PVH/PVDH/AI. On 1 or 3 blisters are placed in a cardboard pack together with the instruction on a medical use.