The instruction for medical use
the Trade name
the International unlicensed
name Bromocriptinum Dosage Form
of the Tablet, 2.5 mg
One tablet contains
active agent – Bromocriptinum of 2.5 mg (in the form of Bromocriptinum of the mezilat of 2.87 mg),
excipients: silicon dioxide colloidal anhydrous, magnesium stearate, talc, povidone, cellulose microcrystalline, starch corn, lactoses monohydrate.
of the Tablet of round shape, with a flat surface, almost white color, with risky on one party and with an engraving 2.5 on another, with a diameter about 7 mm.
Drugs for treatment of diseases of urogenital bodies and sex hormones. Other drugs for treatment of gynecologic diseases. Secretion prolactin inhibitors. Bromocriptinum
the ATX G02CB01 Code
Pharmacokinetics Absorption properties, distribution, removal
Bromocriptinum is quickly and well absorbed from digestive tract after intake. Initial substance and its metabolites are metabolized in a liver and removed with a stake, only 6% of a dose are removed with urine. Extent of linking with proteins of blood plasma reaches 96%. The maximum levels in blood plasma are reached in 1-3 hours after reception. The prolactin-reducing effect develops within 1-2 hours after administration of drug, reaching a maximum approximately in 5 hours, and lasts for 8-12 hours. Removal of initial substance from blood plasma has two-phase character, with terminal elimination half-life lasting about 15 hours.
Direct change of pharmacokinetic properties of Bromocriptinum at elderly people is not noted. Nevertheless, at patients with an abnormal liver function, the delay of removal of drug can lead to increase in its levels in blood plasma, demanding dose adjustment.
Bromocriptinum povdergatsya active biotransformation at the first passing through a liver that finds reflection in a difficult profile of metabolites and almost total absence of initial substance in urine and Calais. It shows high affinity to CYP3A, and the main way of metabolism is hydroxylation of a prolinovy ring of a cyclopeptide molecule. Therefore, it is possible to expect that inhibitors and/or powerful CYP3A4 substrates are capable to slow down removal of Bromocriptinum and to lead to increase in its concentration in blood plasma. Bromocriptinum is also powerful CYP3A4 inhibitor. Nevertheless, taking into account low therapeutic concentration of free Bromocriptinum at patients, it is not necessary to expect considerable disturbance of metabolism of the second drug which clearance is mediated by CYP3A4.
Active agent of the drug Bromocriptinum Richter is Bromocriptinum which suppresses secretion of prolactin and stimulates dopamine receptors. Drug is used in endocrinological and neurologic practice.
Drug blocks secretion of prolactin without influence on the normal level of other anterior pituitary hormones. Bromocriptinum Richter prevents or suppresses already begun lactation, restores a menstrual cycle, dependent on prolactin, and an ovulation. Thus, it is effective in treatments of an amenorrhea and anovulation (with a galactorrhoea or without it). Bromocriptinum Richter reduces the sizes of the adenoma of a hypophysis cosecreting prolactin. Drug improves a clinical picture at a syndrome of polycystic ovaries. Drug does not increase risk of appearance of thromboembolic diseases. At patients with an acromegalia drug reduces growth hormone level in blood plasma, thus, positively influences a clinical picture of a disease and tolerance to glucose.
Bromocriptinum Richter in connection with dopaminergic activity is applied to treatment of Parkinson’s disease, but in the doses exceeding the doses appointed in endocrinology. Parkinson’s disease is characterized by specific nigrostrialny deficit of a dopamine. Drug stimulates receptors of a dopamine and restores neurochemical balance. Clinically, Bromocriptinum reduces expressiveness of manifestations of parkinsonism (including a tremor, rigidity, a bradykinesia) and depressions at all stages of a disease. It is possible to appoint Bromocriptinum Richter in monotherapy or in a combination with other antiparkinsonichesky drugs. Use of drug allows to lower doses of other antiparkinsonichesky means, (for example, levodopas) and to avoid a possibility of emergence of such by-effects as aggravation of symptoms by the end of action of a dose, a phenomenon of inclusion switching off, and dyskinesia.
– prevention or suppression of a lactation is exclusive on medical indications (such as abortion, the neonatal death, HIV infection of mother).
Bromocriptinum is not recommended for routine suppression of a lactation or for relief of symptoms of postnatal pain and a nagrubaniye of mammary glands when non-drug methods of influence (delicate support of a breast, cold compresses) and/or anesthetics are effective.
– a giperprolaktinemiya at women and men (with a galactorrhoea or without it)
– the infertility of women connected with a giperprolaktinemiya
– the infertility of women which is not followed by a giperprolaktinemiya
– macroadenomas of a hypophysis or as an alternative of surgical treatment of transsphenoidal hypophysectomy at patients with microadenomas
– an acromegalia (for decrease in level of growth hormone in blood), in a complex with operational treatment and/or radiation therapy
– Parkinson’s disease, in the form of monotherapy or in a combination with other protivoparkinsonichesky drugs (levodopa).
The route of administration and doses
of the Tablet need to be accepted during meal (at breakfast or a dinner). In most cases the drug begins to be taken with gradual increase in a dose to achievement of optimum therapeutic effect and the minimum manifestations of side effects. The maximum dose should not exceed 30 mg a day.
The scheme of reception
the Initial dose of drug of 1.25 mg (1/2 tablets) at meal time, at supper. In 2-3 days the dose of Bromocriptinum Richter is increased to 2.5 mg.
Further, it is possible to increase a dose of drug each 2-3 days by 1.25 mg, before achievement of a daily dose of 5 mg (on 2.5 mg 2 times a day). If necessary, further increase in a dose of drug can be carried out according to the same scheme.
Prevention of a lactation
In day of childbirth of 2.5 mg (1 tablet) of 1 times a day, and further 2 times a day on 2.5 mg of Bromocriptinum Richter within 14 days. In this case there is no need for gradual increase in a dose of drug.
Suppression of a lactation
In the first day it is necessary to accept 2.5 mg of drug, and in the next 2-3 days the dose of drug is raised to 5 mg (on 2.5 mg 2 times a day). Administration of drug is continued within 14 days. In this case there is no need for gradual increase in a dose of drug.
The galactorrhoea hypogonadism / Syndrome, infertility
Is offered gradual increase in a dose of drug according to the above-stated scheme. Most of patients with a galactorrhoea well reacts to a dose in 7.5 mg of Bromocriptinum – Richter in day which is divided into several receptions. In case of need this dose can be raised to 30 mg a day. In infertility without increase in level of prolactin in blood, the standard dose of drug – 5 mg a day which is accepted on 2.5 mg 2 times a day.
Postepenno raise Bromocriptinum dose according to the offered scheme. At achievement of a daily dose of 2.5 mg the dosage can be increased by 2.5 mg a day with 2-3-day intervals as follows: To 2.5 mg there are each 8 hours, to 2.5 mg there are each 6 hours, to 5 mg there are each 6 hours, under control of level of prolactin. The therapeutic effect is expected at achievement of a dose in 30 mg of drug a day.
Postepenno’s acromegalia raise Bromocriptinum dose according to the offered scheme. At achievement of a daily dose of 2.5 mg the dosage can be increased by 2.5 mg a day with 2-3-day intervals as follows: To 2.5 mg there are each 8 hours, to 2.5 mg there are each 6 hours, to 5 mg there are each 6 hours up to 20 mg/days (4-8 tablets).
It is necessary to carry out the scheme of gradual increase in a dose.
– 1 week: 1.25 mg a day before going to bed.
– The 2nd week: 2.5 mg a day before going to bed.
– The 3rd week: 2 times on 2.5 mg a day.
– The 4th week: 3 times on 2.5 mg a day.
Subsequently, the daily dose can be increased by 2.5 mg for 3-14 days, depending on the effect noted at the patient. Increase in a dose can be continued up to achievement of an optimum dose which usually makes from 10 to 30 mg a day. At the same time, the dose of a levodopa can be gradually reduced up to determination of optimum balance.
Use for elderly patients
Advanced age is not group of extra risk in therapy by Bromocriptinum Richter.
Use of drug for patients with an abnormal liver function
In an abnormal liver function can be observed a delay of removal and increase in concentration of Bromocriptinum – Richter in blood plasma. In this regard drug dose adjustment can be required.
The children’s and teenage age
Bromocriptinum is not recommended for use for children up to 18 years because of limited amount of data on bezopasnot and efficiency of drug, except for use cases according to the recommendation of the endocrinologist.
Nausea, vomiting, a loss of appetite, a headache, dizziness and increased fatigue can arise for the first days of treatment, nevertheless, these reactions usually do not demand the treatment termination by Bromocriptinum.
Risk of development of side reactions can be reduced due to gradual increase in a dose and reception of tablets of Bromocriptinum at meal time. If necessary, the daily dose can be reduced, a treatment is continued on this reduced dose for several days. After disappearance of side reactions, it is possible to make a repeated attempt of increase in a dose.
Bromocriptinum can cause development of orthostatic hypotension therefore the level of arterial blood pressure at ambulatory patients should be measured in vertical position.
At patients with parkinsonism, during treatment by high doses of drug drowsiness, hallucinations, confusion of consciousness, a disorder of vision, dryness in a mouth, myotonia of legs and retroperitoneal fibrosis can develop. All these side effects are dose-dependent.
At long treatment there were cases of reversible blanching or albication of fingers of hands and legs on cold, especially at patients with Reynaud’s phenomenon in the anamnesis.
In extremely exceptional cases (at the women in a puerperal period receiving Bromocriptinum for prevention of a lactation), serious side effects, including arterial hypertension, a myocardial infarction or a stroke can develop though their relationship of cause and effect using drug is not established. In certain cases development of a stroke was preceded by a heavy headache and/or passing disorders of vision.
It was seldom or never reported about pathology of valves of heart (including regurgitation) and the connected disturbances (a pericarditis and existence of an exudate in a pericardium cavity).
Patients with cirrhosis can have a hyponatremia and portosistemny encephalopathy.
In extremely exceptional cases, Bromocriptinum can provoke cases of sudden backfilling for day.
The patients receiving treatment by dopamine agonists, including Bromocriptinum Richter, can have a pathological addiction to gamblings, the raised sexual desire, hyper sexuality, compulsive squandering or addiction to purchases, the constant need for food and compulsive gluttony.
The dopamine agonists relating to group of alkaloids of an ergot can increase risk of development of regurgitation on heart valves.
Undesirable effects are generalized on the frequency of their emergence:
Often (≥1/100 to & lt, 1/10)
– a headache
– a loss of appetite
– nausea, constipations
– congestion of a nose
Infrequently (≥1/1000 to & lt, 1/100)
– confusion of consciousness, a hallucination
– dyskinesia, psychomotor excitement
– dizziness, orthostatic hypotension
– dryness in a mouth, vomiting
– skin allergic reaction, allergic dermatitis, an alopecia
– muscular spasms, weakness
Seldom (≥1/10000 to & lt, 1/1000)
– insomnia, psychotic disorders, paresthesias
– a pericardiac exudate, chronic cardial compression, tachycardia, bradycardia, arrhythmia
– a pleural exudate, pleural fibrosis, pulmonary fibrosis, pleurisy, an asthma
– retroperitoneal fibrosis, gastrointestinal bleedings, ulcers on a mucous membrane of digestive tract
– peripheral hypostases
Very seldom (& lt, 1/10000)
– a disorder of vision, illegibility of sight
– an acute disorder of cerebral circulation, a malignant antipsychotic syndrome (Bromocriptinum withdrawal)
– suddenly coming dream in the middle of the day
– a rhinorrhea of cerebrospinal fluid
– pathological thirst for gamblings, the raised libido and hyper sexuality
– a myocardial infarction, diseases of the valve device of heart
– arterial hypertension
– pallor of integuments
the Contraindication hyponatremia
– hypersensitivity to Bromocriptinum or to other alkaloids of an ergot (derivatives of an ergokriptin) and also to drug excipients
– the hypertensive states connected with pregnancy: the gestosis of pregnant women, a preeclampsia or gestational arterial hypertension
– arterial hypertension in labor or in a puerperal period
– uncontrollable arterial hypertension
– a peptic ulcer of a stomach and a 12-perstny gut
– an idiopathic or family tremor
– a chorea of Huntington
– at not life-threatening indications at patients (including suppression of a lactation) in cardiovascular diseases (including coronary heart disease) or other cardiovascular pathology now and in the anamnesis
– for long-term treatment in the presence of diseases of the valve device of heart
– a disease of connective tissue, including in the anamnesis
– a serious mental illness now or in the anamnesis
– hereditary intolerance of a galactose, lactose, a lactose intolerance, malabsorption of glucose, a galactose
– combined use with oral contraceptives
– along with other alkaloids of an ergot
– the breastfeeding period
– ethanol leads Medicinal interactions At combined use of the drug Bromocriptinum Richter to development of disulfiramopodobny reactions (stethalgia, hyperaemia of integuments, tachycardia, nausea, vomiting, reflex cough, the pulsing headache, indistinct sight, weakness, spasms), the tolerance of the drug Bromocriptinum Richter
– antihypertensives decreases: enhances effect of antihypertensives
– erythromycin, klaritromitsiny, troleandomitsiny concentration and bioavailability of the drug Bromocriptinum Richter in blood plasma can increase
– antagonists of a dopamine (for example: phenyl propyl ketones, fenotiazina) – can reduce prolactin – the reducing and protivoparkinsonichesky effects of Bromocriptinum.
– Metoclopramidum and domperidony – can reduce expressiveness prolactin – the reducing effect of Bromocriptinum.
– sympathomimetic drugs, including fenilpropanolamin and izometepten – increase risk of toxicity.
It is necessary to avoid simultaneous use of drug with other alkaloids of an ergot.
It is necessary to be careful at simultaneous use of Bromocriptinum with CYP3A4 inhibitors (for example, antifungal drugs of group of azoles, HIV protease inhibitors).
instructions Bromocriptinum Richter Use at patients with premenstrual a syndrome and at benign new growths of mammary glands are not recommended in connection with insufficiency of proofs of efficiency in treatment.
It was in rare instances reported about development of the serious undesirable phenomena, including arterial hypertension, a myocardial infarction, a stroke or mental disorders at the women in a puerperal period receiving Bromocriptinum for suppression of a lactation. Development of epileptic seizures or a stroke in some patients was preceded by a heavy headache and/or passing visual disturbances.
At drug use after the delivery, especially in the first days of reception, it is regularly and carefully necessary to control arterial blood pressure. It is especially necessary to control patients who accept or in the nearest future took the drugs affecting arterial blood pressure.
In case of development of arterial hypertension, thorax pain, a heavy and indefatigable headache with disorders of vision or without those and also any signs of toxic action on central nervous system, drug treatment it is necessary to stop immediately and the patient should be examined immediately.
Simultaneous use of Bromocriptinum with vasoconstrictors, such as sympathomimetics or alkaloids of an ergot, including ergometrine or methylergometrine, throughout a puerperal period is not recommended.
The idiopathic giperprolaktinemiya caused by intake of medicines or connected with a disease of a gipotalamo-hypophysial system can be observed. Bromocriptinum Rich effectively reduces prolactin level at patients who suffer from a hypophysis tumor, but in an acromegalia it does not exclude need for radiation therapy or for surgical intervention.
At treatment of women of fertile age without giperprolaktinemiya symptoms, it is necessary to appoint drug in the smallest effective dose for prevention of decrease in level of prolactin in blood below normal value and for prevention of disturbance of functioning of a yellow body. During a therapy course Bromocriptinum Richter needs to use reliable, non-hormonal methods of contraceptive protection as oral hormonal contraceptives increase prolactin level in blood serum.
At prolonged use of drug it is necessary to perform gynecologic inspection of the woman with an intake of cytologic material. This survey it is necessary to spend each 6 months at treatment of women in the post-menopausal period and annually at treatment of women of fertile age.
The patients with an acromegalia having a peptic ulcer of a stomach in the anamnesis whenever possible should be treated by other methods. If treatment by Bromocriptinum is necessary, the patient has to be instructed about need to immediately inform the doctor on emergence of the undesirable phenomena from digestive tract.
The patients with a serious cardiovascular illness or mental disorders accepting Bromocriptinum concerning macroadenomas have to receive it only if the expected advantage of treatment outweighs the related potential risks.
As at patients with macroadenomas of a hypophysis the accompanying hypopituitarism because of compression or destruction of tissue of hypophysis can be noted, it is necessary to carry out an omnibus estimate of a functional condition of a hypophysis and to appoint adequate replacement therapy before prescribing of Bromocriptinum. At patients with secondary adrenal insufficiency the purpose of replacement therapy by corticosteroids is obligatory.
It is necessary to control carefully changes of the size of a tumor at patients with hypophysis macroadenomas, and with signs of growth of a tumor it is necessary to consider expediency of surgical intervention.
The prolactin-cosecreting adenomas can increase in sizes during pregnancy. In such cases the observation of patients with macroadenoma is necessary. At such patients the treatment by Bromocriptinum often leads to reduction of the sizes of a tumor and fast restoration of the narrowed fields of vision. In hard cases, compression visual or other cranial nerves can demand performing urgent surgical intervention on a hypophysis.
Disturbance of fields of vision is the known complication of a prolaktinoma. Effective treatment by Bromocriptinum leads to reduction of the size of a tumor and expressiveness of a giperprolaktinemiya, and often – to disappearance of disturbances from sight. Nevertheless, at some patients the secondary disturbance of fields of vision, despite normalization of levels of prolactin and reduction of a tumor in sizes can develop subsequently. In these cases, the defect of a field of vision can decrease against the background of intake of Bromocriptinum in a reduced dosage, despite the available some increase in level of prolactin and some repeated increase in a tumor. Thus, monitoring of fields of vision for early identification of secondary loss of fields of vision and individual selection of a dose of Bromocriptinum is recommended.
At some patients about prolactin – the cosecreting adenomas receiving treatment by Bromocriptinum noted a rhinorrhea of cerebrospinal fluid that can arise owing to reduction of the sizes of a tumor with invasive growth.
For the first several days of treatment, in isolated cases the arterial hypotension can develop.
It is necessary to be careful when prescribing Bromocriptinum in high doses to patients with presence of psychotic disorders or serious cardiovascular illness in the anamnesis.
Drug treatment in high doses in parkinsonism demands care from patients with presence of psychosis or a serious cardiovascular illness in the anamnesis.
At the patients receiving Bromocriptinum, especially in high doses or throughout a long time, it was reported about isolated cases of an exudate in a pleural cavity and in a cavity of a pericardium, an also of fibrosis of a pleura and lungs and chronic cardial compression. Patients with inexplicable plevropulmonalny disorders should be examined carefully, and if necessary to cancel therapy by Bromocriptinum.
At several patients receiving Bromocriptinum, especially in high doses or throughout a long time it was reported about development of retroperitoneal fibrosis. For timely recognition of retroperitoneal fibrosis at an early reversible stage, it is recommended to monitor its manifestations (such as dorsodynia, hypostasis of the lower extremities, renal failure).
Bromocriptinum should be cancelled at the diagnosed or suspected fibroziruyushchy changes of retroperitoneal space.
It is necessary to pay attention to the following signs and symptoms:
– diseases of the lungs which are shown short wind, suffocation, persistent cough or thorax pain
– renal failures or obstruction of urethras/vessels of an abdominal cavity which can be followed by pain in lumbar area / side departments of a stomach and hypostasis of the lower extremities, an also of existence of any volume formations in an abdominal cavity or its morbidity at a palpation which can indicate retroperitoneal fibrosis
– the heart failure caused by pericardiac fibrosis (at emergence of such symptoms, it is necessary to exclude chronic cardial compression).
In diagnosis of fibroziruyushchy disorder the determination of the blood sedimentation rate (BSR) and concentration of creatinine in blood, an also carrying out a radiographic research of bodies of a thorax is useful. Besides, it is reasonable to carry out determination of initial levels of other inflammatory markers and indicators of function of kidneys prior to treatment.
During treatment, patients have to be under careful observation for identification of manifestations of the progressing fibroziruyushchy disorders. At the diagnosed or expected retroperitoneal fibrosis the treatment by Bromocriptinum should be stopped.
Use of Bromocriptinum can be followed by drowsiness and episodes of sudden backfilling, especially at patients with Parkinson’s disease. About sudden backfilling during day activity, in certain cases without any harbingers or the warning signs, it was reported extremely seldom. Patients have to be informed on a possibility of such phenomenon and have to be careful during driving of vehicles or work with mechanisms during treatment by Bromocriptinum. Patients at whom drowsiness and/or episodes of sudden backfilling is noted have to abstain from driving of vehicles or work with mechanisms. Besides, it is necessary to consider expediency of a dose decline or the termination of treatment.
Disorder of control over motives
of Patients should be observed regularly regarding development of control disorder in them over motives. The patients and persons taking care for them have to be informed on a possibility of development in the patients receiving treatment by dopamine agonists (including Bromocriptinum Richter), behavioural symptoms of disorder of control over motives, including pathological addiction to gamblings, the raised sexual desire, hyper sexuality, compulsive squandering or addiction to purchases, the constant need for food and compulsive gluttony. In case of development of similar symptoms, it is necessary to consider expediency of decrease in a dose / gradual drug withdrawal.
In clinical trials of a kabergolin and pergolid, the increased risk of developing pathology of the valve device of heart was noted. It is possible to assume that this effect can be characteristic of other derivative alkaloids of an ergot, such as Bromocriptinum.
Drug contains 41.0 mg of lactose of monohydrate. Patients with such rare hereditary diseases as intolerance of a galactose, a lactose intolerance or malabsorption of glucose galactose, should not take this drug.
Pregnancy and a lactation
in case of pregnancy it is necessary to stop administration of drug.
At pregnant patients with hypophysis adenoma after drug withdrawal the careful control observation (including repeated definition of fields of vision) throughout pregnancy is necessary.
In case of growth of a prolaktinoma it is necessary to begin therapy again. According to the data obtained at more, than 2,000 pregnant women, use of Bromocriptinum Richter did not increase the number of spontaneous abortions, premature births and anomalies of development of newborns. According to these data Bromocriptinum Richter has no embriotoksichesky or teratogenic effect.
As Bromocriptinum suppresses a lactation and gets into breast milk, the women nursing should not appoint it.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mekhan_zma
Use of drug can cause hypotonia, a disorder of vision, dizziness, especially in the first days of therapy therefore it is necessary to be careful at control of motor transport or during the work in the conditions of the increased traumatism.
Use of Bromocriptinum Richter can cause drowsiness or a symptom of sudden backfilling which can come day without the harbingers indicating it in the afternoon. It is necessary to draw the attention of the persons running motor transport or working in the conditions of the increased traumatism to it. That patients at whom such symptoms are noted are forbidden to run motor transport.
Symptoms: nausea, vomiting, lowering of arterial pressure, headache, hallucinations, confusion of consciousness.
Treatment: removal of all not soaked up drug, in maintenance of arterial blood pressure if it is necessary.
A form of release and packing
On 30 tablets in glass bottles from brown glass.
On 1 bottle together with the instruction for medical use in the state and Russian languages put in a pack from cardboard.
To Store storage conditions in original packing, in the place protected from light at a temperature not over 25 of 0C.
To store out of children’s reach!
not to use a period of storage after expiry date.
According to the prescription
Budapest JSC Gideon Richter Producer 1103, st. Dyomryo, 19-21, Hungary
the Name of the owner of the registration certificate
of JSC Gideon Richter
1103 Budapest, Dyomryoi St., 19-21, Hungary
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products: Representative office of JSC Gideon Richter in RK E-mail: email@example.com: 8 (7272)-58-26-22, 8 (7272)-58-26-23