Bromocriptine - kv: detailed information

I N S T R U C T I O N for medical use of the medicinal product BROMKRIPTEIN-KV (Bromcriptin-KV)

Composition:

Active substance: bromocriptine;

1 tablet contains 2.5 mg of bromocriptine;

Excipients: lactose monohydrate; colloidal anhydrous silicon dioxide; disodium edetate; magnesium stearate; maleic acid; maize starch.

Pharmaceutical form. Tablets.

Main physicochemical properties: white or almost white, round-shaped tablets with a flat surface, bevelled edges and a score line.

Pharmacotherapeutic group.

Other agents for treatment of gynecological disorders. Prolactin inhibitors. ATC code G02C B01.

Antiparkinson agents. Dopamine receptor agonists. ATC code N04B C01.

Pharmacological properties.

Pharmacodynamics.

Bromocriptine is an inhibitor of prolactin secretion and a dopamine receptor agonist. The therapeutic applications of bromocriptine include endocrine and neurological indications. The pharmacological properties of the drug will be discussed separately for each type of indication.

Mechanism of action

Endocrine properties

Bromocriptine inhibits the secretion of prolactin, a hormone produced by the anterior pituitary gland, without affecting the normal levels of other hormones released by the anterior pituitary.

In patients with acromegaly, bromocriptine reduces the elevated levels of growth hormone (somatotropic hormone, GH). These effects are mediated by stimulation of dopamine receptors.

During the postpartum period, prolactin is essential for the initiation and maintenance of lactation. At other times, increased prolactin secretion leads to pathological lactation (galactorrhea) and/or disturbances in ovulation and menstruation.

As a specific inhibitor of prolactin secretion, bromocriptine can be used to prevent or suppress physiological lactation, as well as to treat prolactin-induced pathological conditions. In amenorrhea and/or anovulation (with or without galactorrhea), bromocriptine can be used to restore the menstrual cycle and ovulation.

When bromocriptine is used, conventional measures for lactation suppression, such as fluid restriction, are not required. Furthermore, bromocriptine does not delay postpartum uterine involution and does not increase the risk of thromboembolism. Bromocriptine has been shown to halt the growth or reduce the size of prolactin-secreting pituitary adenomas (prolactinomas).

In patients with acromegaly, in addition to reducing plasma levels of growth hormone and prolactin, bromocriptine favorably affects clinical symptoms and glucose tolerance.

Bromocriptine alleviates the clinical symptoms of polycystic ovary syndrome by restoring normal luteinizing hormone (LH) secretion patterns.

Neurological properties

Due to its dopaminergic activity, bromocriptine is effective in the treatment of Parkinson's disease when administered in doses usually exceeding those recommended for endocrine indications. This disorder is characterized by a specific nigrostriatal dopamine deficiency. Under these conditions, stimulation of dopamine receptors by bromocriptine can restore the neurochemical balance in the striatum.

From a clinical perspective, bromocriptine alleviates tremor, muscle rigidity, bradykinesia, and other symptoms of Parkinson's disease at all stages. The therapeutic effect typically persists for many years (good outcomes have been documented in patients treated for up to 8 years). Bromocriptine can be used as monotherapy or, at both early and late stages, in combination with other anti-Parkinson drugs.

Combination therapy with levodopa enhances the anti-Parkinson effect and often allows for a reduction in the required levodopa dose. Bromocriptine is particularly beneficial in patients who experience a diminishing therapeutic response or develop complications during levodopa treatment, such as abnormal involuntary movements (choreoathetoid dyskinesia and/or painful dystonia), end-of-dose deterioration, or the "on-off" phenomenon.

Bromocriptine reduces the severity of depression commonly observed in patients with Parkinson's disease. This is due to its intrinsic antidepressant properties, which have been confirmed in controlled studies in patients with endogenous or psychogenic depression, even in the absence of parkinsonism.

Pediatric population

The safety and efficacy of bromocriptine in children have been established only for the treatment of prolactinoma and acromegaly in patients aged 7 years and older (see sections «Special instructions» and «Method of administration and dosage»).

The use of bromocriptine for the treatment of prolactinoma and acromegaly in children has been described in published case studies and retrospective cohort studies. However, data on the use of bromocriptine in children under 7 years of age are limited to only a few individual cases.

Bromocriptine is considered an effective non-invasive treatment for prolactinoma and acromegaly in children. In acromegaly, bromocriptine therapy suppresses growth hormone release (reducing IGF-1 concentration).

In hyperprolactinemia, bromocriptine effectively reduces serum prolactin levels, allowing normalization of growth and sexual maturation. The dose of bromocriptine used in children ranged from 1.25 to 20 mg per day. Dose titration in children should be initiated cautiously. The safety profile of bromocriptine in adolescent patients is likely similar to that in adults for these indications. However, data on safety and efficacy in younger patients, especially those under 7 years of age, are insufficient.

Pharmacokinetics.

Absorption

Bromocriptine is well absorbed after oral administration. In healthy volunteers, the half-absorption time of bromocriptine after tablet intake was 0.2–0.5 hours, and maximum plasma concentration was reached within 1–3 hours. After an oral dose of 5 mg bromocriptine, Cmax is 0.465 ng/mL.

Distribution

Maximum drug concentration in plasma is achieved within 1–3 hours. The effect of reduced prolactin levels is evident within 1–2 hours after oral administration, reaches a maximum (reduction in prolactin concentration by more than 80%) within 5–10 hours, and remains near maximum levels for 8–12 hours.

Elimination

Elimination of the parent compound from plasma is biphasic, with a half-life of approximately 15 hours (range 8–20 hours). The parent compound and its metabolites are almost entirely excreted in feces; only 6% is excreted in urine. Plasma protein binding of the drug is 96%.

Patient characteristics

There is no evidence that advanced age directly alters the pharmacokinetic properties or tolerability of bromocriptine. However, in patients with impaired liver function, elimination rate may be reduced and plasma drug levels may increase, necessitating dose adjustment.

Biotransformation

Bromocriptine undergoes extensive presystemic biotransformation in the liver, reflected in a complex metabolite profile and the near absence of the parent substance in urine and feces. It exhibits high affinity for CYP3A, and the primary metabolic pathway is hydroxylation of the proline ring in the cyclopeptide component. Therefore, inhibitors and/or potent substrates of CYP3A4 are expected to inhibit bromocriptine elimination and lead to increased plasma levels. Bromocriptine is also a potent inhibitor of CYP3A4, with a calculated IC50 value of 1.6 μM. However, considering the low therapeutic concentrations of free bromocriptine in patients, significant changes in the metabolism of other drugs metabolized by the CYP3A4 system are not expected.

Clinical characteristics.

Indications.

Prevention of lactation for medical reasons

Prevention or suppression of physiological lactation in the postpartum period only for medical reasons (intrauterine fetal death, neonatal death, HIV infection of the mother).

Bromocriptine is not recommended for routine suppression of lactation or for relief of postpartum symptoms of breast engorgement and pain when effective non-pharmacological measures (e.g., gentle breast support, cold compresses) and/or non-narcotic analgesics are available.

Hyperprolactinemia

Treatment of hyperprolactinemia:

in men with hypogonadism (oligospermia, loss of libido, impotence) and/or galactorrhea;
in women with hypogonadism (amenorrhea, hot flashes, vaginal dryness), menstrual cycle disorders, female infertility and/or galactorrhea.

Prolactinomas

Treatment of prolactin-secreting micro- or macroadenomas of the pituitary gland. The medicinal product Bromkriptin-KV can be used preoperatively to reduce tumor size and facilitate its removal.

Acromegaly

Bromocriptine is used as an adjunct to surgical intervention and/or radiation therapy, as well as in the treatment of patients with acromegaly who have contraindications to surgery or for whom surgery is not advisable.

Parkinson's disease

In the treatment of signs and symptoms of idiopathic Parkinson's disease, bromocriptine is used as monotherapy or in combination with levodopa, or in combination with other antiparkinsonian medicinal products in patients with motor complications and in patients with the "on-off" phenomenon. Bromocriptine may be beneficial in patients who do not respond to levodopa treatment or who do not tolerate its adverse reactions.

Additional information

There is insufficient evidence of bromocriptine efficacy in the treatment of benign breast disorders and premenstrual symptoms. Therefore, the use of bromocriptine in patients with these conditions is not recommended.

Contraindications.

Hypersensitivity to the active substance, other ergot alkaloids, or to any of the excipients of the medicinal product (see section "Composition").

Uncontrolled hypertension, hypertensive conditions associated with pregnancy (including eclampsia, pre-eclampsia or gestational arterial hypertension), arterial hypertension in the early and late postpartum period.

Do not use for suppression of lactation and for other non-life-threatening indications in patients with a history of ischemic heart disease or other severe cardiovascular disorders, or symptoms / history of severe psychiatric disorders.

Do not use for long-term treatment in patients with signs of valvular heart disease detected by echocardiography performed before initiation of therapy.

Interaction with other medicinal products and other forms of interaction.

Tolerance to bromocriptine may be reduced by alcohol.

Concomitant use of macrolide antibiotics such as erythromycin or josamycin may increase bromocriptine plasma levels.

Treatment of patients with acromegaly using a combination of bromocriptine and octreotide increases bromocriptine plasma levels.

Since bromocriptine exerts its therapeutic effect by stimulating central dopamine receptors, dopamine antagonists such as antipsychotics (e.g., butyrophenones, phenothiazines, and thioxanthenes), as well as metoclopramide and domperidone, may reduce the effect of bromocriptine.

Sympathomimetic agents, e.g., phenylpropanolamine, isometheptene, increase the risk of toxicity.

Concomitant use of the drug with other ergot alkaloids should be avoided.

Bromocriptine is both a substrate and an inhibitor of CYP3A4 (see section "Pharmacokinetics").

Therefore, bromocriptine should be used with caution in combination with medicinal products that are potent inhibitors and/or substrates of CYP3A4 (e.g., azole antifungals, HIV protease inhibitors).

Special precautions for use.

General precautions

In women with conditions unrelated to hyperprolactinemia, when bromocriptine is used for treatment, the drug should be administered at the lowest effective dose required to relieve symptoms. This is necessary to avoid a possible decrease in plasma prolactin concentration below normal levels and the development of corpus luteum dysfunction as a consequence.

There have been reports of individual cases of gastrointestinal bleeding and gastric ulcers. In such cases, bromocriptine should be discontinued. Careful monitoring is required in patients suffering from peptic ulcer disease or with a history of peptic ulcer.

Pleural and pericardial effusion, as well as pleural and pulmonary fibrosis and constrictive pericarditis, have occasionally been observed in patients receiving bromocriptine, particularly during prolonged treatment and at high doses. Patients with pleuropulmonary disorders of unknown origin require careful evaluation; in such cases, discontinuation of bromocriptine therapy should be considered.

Retroperitoneal fibrosis has been observed in several patients receiving bromocriptine, particularly during prolonged treatment and at high doses. To detect retroperitoneal fibrosis at early reversible stages, monitoring for possible signs (e.g., back pain, swelling of lower extremities, renal dysfunction) is recommended in this patient group.

If retroperitoneal fibrosis is diagnosed or suspected, treatment with bromocriptine should be discontinued.

Since hypotensive reactions, which may lead to reduced alertness, may occasionally occur during drug use—especially during the first few days of treatment—patients should exercise particular caution when driving or operating machinery.

Postpartum women

Serious adverse events, including arterial hypertension, myocardial infarction, seizures, stroke, or psychiatric disorders, have been rarely reported in postpartum women receiving bromocriptine for lactation suppression. In some patients, epileptic seizures or stroke were preceded by severe headache and/or transient visual disturbances. Blood pressure should be closely monitored, especially during the first days of treatment. If arterial hypertension, suggestive chest pain, severe, progressive, and persistent headache (with or without visual disturbances), or signs of central nervous system toxicity occur, bromocriptine treatment should be immediately discontinued and the patient should be urgently evaluated.

Particular caution is required in patients who are using (or have recently used) concomitant medications capable of altering blood pressure, such as vasoconstrictors, including sympathomimetics or ergot alkaloids (e.g., ergometrine or methylergometrine). Although definitive evidence of interaction between bromocriptine and these drugs is lacking, their concomitant use during the postpartum period is not recommended.

Prolactin-secreting adenomas

In patients with pituitary macroadenomas, the disease may be associated with hypopituitarism due to compression or destruction of pituitary tissue. Therefore, a complete assessment of pituitary function should be performed before initiating bromocriptine therapy, and appropriate replacement therapy should be initiated. Corticosteroid replacement therapy is particularly important in patients with secondary adrenal insufficiency.

Tumor size changes should be carefully monitored in patients with pituitary macroadenomas, and surgical intervention should be considered if tumor growth occurs. If pregnancy develops in a patient with a pituitary adenoma during bromocriptine treatment, close monitoring is required. Prolactin-secreting adenomas may enlarge during pregnancy. In such patients, bromocriptine treatment often leads to tumor shrinkage and rapid improvement of visual field defects. In severe cases of optic and other cranial nerve compression, emergency surgery may be necessary.

Visual field defects are a known complication of macroprolactinoma. Effective bromocriptine treatment leads to reduction of hyperprolactinemia and often to resolution of visual disturbances. However, in some patients, secondary visual field defects may later develop despite normalized prolactin levels and reduced tumor size. This may result from displacement of the optic chiasm, which descends into the nearly empty sella turcica. In such cases, visual field defects may improve after reducing the bromocriptine dose, although this may be associated with slightly elevated prolactin levels and minor tumor regrowth. Therefore, regular monitoring of visual fields is recommended in patients with macroprolactinoma to enable early detection of secondary visual field loss due to chiasmal herniation and to allow bromocriptine dose adjustment.

Cerebrospinal fluid rhinorrhea has been observed in some patients with prolactin-secreting adenomas treated with bromocriptine. According to available data, this may result from tumor shrinkage with invasive growth.

Parkinson’s disease

When dose reduction or discontinuation of this medicinal product is required, it should be done gradually. Rapid dose reduction or abrupt discontinuation may lead to neuroleptic malignant syndrome. In addition, rapid dose reduction or discontinuation of dopamine receptor agonists may result in withdrawal syndrome (characterized by apathy, anxiety, depression, fatigue, increased sweating, and pain).

Sudden sleep episodes

Bromocriptine treatment may be associated with somnolence and sudden sleep episodes, particularly in patients with Parkinson’s disease. Sudden sleep during daily activities, rarely even without patient awareness and without prior warning signs, has been very rarely observed. Patients should be informed of this possibility and advised to avoid driving or operating machinery during bromocriptine treatment. Patients who experience somnolence and/or sudden sleep episodes should refrain from driving or operating complex machinery (see section "Ability to affect reaction speed when driving or operating machinery"). Furthermore, dose reduction or discontinuation of treatment should be considered in such cases.

Impulse control disorders (compulsive urges)

Patients should be regularly monitored for the development of impulse control disorders. Patients and caregivers should be informed about the possibility of behavioral symptoms of impulse control disorders in patients receiving dopamine agonists, including Bromocriptine-KV, such as pathological gambling, increased libido, hypersexuality, impulsive spending or compulsive shopping, constant food craving, or compulsive overeating. If such symptoms occur, dose reduction or gradual discontinuation of the drug should be considered.

Children and adolescents (aged 7 to 17 years)

The safety and efficacy of bromocriptine in children have been studied only for prolactinoma and acromegaly in patients aged 7 years and older. Data on bromocriptine use in children under 7 years of age are limited to isolated cases. However, clinical experience, including post-marketing reports of adverse reactions, has not revealed differences in tolerability between adults and children. Although no differences in adverse reactions have been observed in children receiving bromocriptine, increased sensitivity in some young individuals cannot be completely ruled out, and cautious dose titration is recommended in children.

Bromocriptine-KV should be prescribed to children only by a pediatric endocrinologist.

Elderly patients

Clinical studies of bromocriptine have not included sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. However, other clinical experience, including post-marketing reports of adverse reactions, has not revealed differences in tolerability between elderly patients and those under 65 years of age.

Although no differences in efficacy or adverse reactions have been observed in elderly patients receiving bromocriptine, increased sensitivity in some elderly individuals cannot be completely excluded. In general, cautious dose titration is recommended in elderly patients, starting at the lowest dose range, considering the higher prevalence of impaired hepatic, renal, or cardiac function and concomitant diseases or therapies in this patient group.

Excipients

Bromocriptine-KV tablets contain lactose monohydrate. Patients with rare hereditary conditions such as galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.

Use during pregnancy or breastfeeding.

Pregnancy.

Bromocriptine, like all other medicinal products, should be discontinued after pregnancy is confirmed in patients wishing to become pregnant, except when there are medical reasons for continuing therapy. Discontinuation of bromocriptine during pregnancy has not been associated with an increased rate of spontaneous abortion. Clinical experience indicates that bromocriptine use during pregnancy does not negatively affect pregnancy course or outcome.

If pregnancy occurs in a patient with a pituitary adenoma and bromocriptine treatment is discontinued, careful monitoring throughout pregnancy is required. If signs of significant prolactinoma enlargement, such as headache or visual field constriction, occur, bromocriptine treatment may be resumed or surgical intervention performed.

Breastfeeding period.

Since bromocriptine suppresses lactation, it should not be administered to mothers who have chosen to breastfeed.

Fertility

Fertility may be restored with bromocriptine treatment. Therefore, women of reproductive age who do not wish to become pregnant should be advised to use a reliable method of contraception.

Ability to affect reaction speed when driving or operating machinery.

Since hypotensive reactions, which may lead to reduced alertness, may occasionally occur during drug use—especially during the first few days of treatment—patients should exercise extreme caution when driving or operating machinery.

Patients receiving bromocriptine who experience somnolence and/or sudden sleep episodes should be advised to refrain from driving or engaging in activities where reduced attention could increase the risk of serious injury or fatality (e.g., operating machinery) until these recurrent episodes and somnolence resolve (see section "Special precautions for use").

Method of Administration and Dosage

Dosage

The maximum dose should not exceed 30 mg per day.

Adults

Since bromocriptine is used to treat various conditions, the recommended dosing regimens differ accordingly. In most cases, regardless of the final dose, optimal response with minimal adverse reactions is best achieved by gradually increasing the dose of bromocriptine.

Recommended dosing regimen

At the beginning of treatment, the dose is half a tablet (1.25 mg) taken at bedtime. After 2–3 days, increase the dose to 1 tablet (2.5 mg) at bedtime. The dose may then be increased by 0.5 to 1 tablet (1.25 mg – 2.5 mg) every 2–3 days until reaching a daily dose of 2×2.5 mg. Further dose increases, if necessary, should be carried out in a similar manner.

Suppression of lactation for medical reasons

Prevention or suppression of lactation: on the day of delivery, take 1.25 mg (half a tablet) with food in the morning and evening, followed by 2.5 mg twice daily for 14 days. For this indication, gradual dose escalation of bromocriptine is not required.

Administration of the medicinal product for prevention of lactation after childbirth or termination of pregnancy should begin within a few hours, but not earlier than when vital signs are stabilized. Occasionally, slight milk secretion may occur 2 or 3 days after discontinuation of treatment. This can be stopped by resuming treatment at the same dose for the following week.

Hyperprolactinemia

Women: bromocriptine should be administered according to the proposed regimen, gradually increasing the dose to 5–10 mg per day.

In most patients with hyperprolactinemia, an adequate response is achieved with a daily dose of 7.5 mg administered in several doses. Treatment should continue until complete cessation of milk secretion; in cases of associated amenorrhea, until normalization of the menstrual cycle.

Men: bromocriptine should be administered according to the proposed regimen, with gradual dose escalation. Doses up to 15 mg per day have been clinically studied. Treatment should continue until optimal therapeutic response is achieved.

Prolactinomas

Bromocriptine should be administered gradually according to the proposed regimen. The dose may then be increased by 2.5 mg per day every 2–3 days as follows: 2.5 mg every 8 hours, 2.5 mg every 6 hours, 5 mg every 6 hours. Patients have responded to doses up to 30 mg per day.

Acromegaly

Bromocriptine should be administered gradually according to the proposed regimen. The dose may then be increased by 2.5 mg per day every 2–3 days as follows: 2.5 mg every 8 hours, 2.5 mg every 6 hours, 5 mg every 6 hours, increasing to 10–20 mg per day depending on clinical response and adverse effects.

Parkinson's disease

To ensure optimal tolerability, the dose of bromocriptine should be gradually increased as follows:

Week 1: 1.25 mg at bedtime.
Week 2: 2.5 mg at bedtime.
Week 3: 2.5 mg twice daily.
Week 4: 2.5 mg three times daily.

After achieving three-times-daily administration, the daily dose may be increased by 2.5 mg every 3–14 days, depending on patient response.

The dose of bromocriptine should be increased slowly to reach the minimum effective dose for each patient. Adequate therapeutic response may be achieved within 6–8 weeks; if not, the daily dose may be further increased by 2.5 mg per week.

Dose escalation may continue until the optimal dose is reached. In monotherapy or combination therapy, this dose usually ranges from 10–30 mg per day. In patients already receiving levodopa, the levodopa dose may be gradually reduced while increasing the bromocriptine dose until optimal balance is achieved. Some patients may eventually discontinue levodopa completely.

Elderly patients

There are no clinical data indicating that bromocriptine poses a particular risk in elderly individuals.

Patients with hepatic impairment

In patients with impaired liver function, the elimination rate of the drug may be reduced, resulting in increased plasma levels, which necessitates dose adjustment.

Method of administration

Administer orally. This medicinal product should always be taken with food.

Children

Overdose

Symptoms and signs

In all reported cases of bromocriptine overdose (taken alone), patients have survived. The highest single dose of bromocriptine ingested to date is 325 mg. Symptoms of overdose include vomiting, nausea, dizziness, arterial hypotension, orthostatic hypotension, tachycardia, lethargy, somnolence, lethargy, and hallucinations.

There have been isolated reports of children accidentally ingesting bromocriptine. In such cases, adverse reactions included vomiting, somnolence, and fever. Patients recovered spontaneously within several hours or after appropriate treatment.

Treatment of overdose

In case of overdose, activated charcoal is recommended. If the drug was ingested very recently, gastric lavage may be considered.

Treatment of acute intoxication is symptomatic. Metoclopramide may be indicated for the treatment of vomiting or hallucinations.

Adverse reactions.

Adverse reactions are listed according to the MedDRA organ system classification and frequency of occurrence. Within each frequency category, adverse reactions are presented in order of decreasing frequency.

System organ class	Common (from ≥1/100 to <1/10)	Uncommon (from ≥1/1000 to <1/100)	Occasional (from ≥1/10000 to <1/1000)	Rare (<1/10000)	Frequency not known (cannot be estimated from available data)
Psychiatric disorders		Confusion, psychomotor agitation, hallucinations	Insomnia, psychiatric disorders	Hypersexuality, increased libido, pathological gambling, impulsive spending or compulsive shopping, binge eating, compulsive overeating
Nervous system disorders	Headache, lethargy, dizziness	Dyskinesia	Somnolence, paraesthesia	Excessive daytime sleepiness, sudden sleep attacks
Eye disorders			Visual disturbances, blurred vision
Ear and labyrinth disorders			Tinnitus
Cardiac disorders			Pericardial effusion, constrictive pericarditis, tachycardia, bradycardia, arrhythmia	Cardiac valve disorders (including regurgitation) and associated disorders (pericarditis and pericardial effusion), cardiac valve fibrosis
Vascular disorders		Arterial hypotension, orthostatic hypotension (very rarely leading to syncope)		Reversible paleness of fingers and toes induced by cold (especially in patients with a history of Raynaud's disease)
Respiratory, thoracic and mediastinal disorders	Nasal congestion		Pleural effusion, pleural fibrosis, pulmonary fibrosis, pleuritis, dyspnoea
Gastrointestinal disorders	Nausea, constipation, vomiting	Dry mouth	Retroperitoneal fibrosis, gastrointestinal haemorrhage, gastrointestinal ulcers, abdominal pain, diarrhoea
Skin and subcutaneous tissue disorders		Allergic skin reactions, hair loss
Musculoskeletal and connective tissue disorders		Leg cramps
General disorders and administration site conditions		Increased fatigue	Peripheral oedema	Syndrome resembling malignant neuroleptic syndrome upon abrupt discontinuation of bromocriptine	Withdrawal syndrome*, including apathy, anxiety, depression, fatigue, increased sweating, pain

* If any symptoms occur, appropriate measures should be taken, for example, resuming treatment or returning the dose to the level prior to dose reduction.

Description of some adverse reactions

The use of bromocriptine for suppression of physiological lactation after childbirth has been associated with isolated cases of arterial hypertension, myocardial infarction, seizures, stroke, or psychiatric disorders (see section "Special precautions for use").

Impulse control disorders

Pathological gambling, increased libido, hypersexuality, impulsive spending or compulsive shopping, as well as constant hunger and compulsive overeating may occur in patients treated with dopamine agonists, including bromocriptine (see section "Special precautions for use").

Reporting suspected adverse reactions

It is very important to report suspected adverse reactions after marketing authorization. This allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are requested to report any suspected adverse reactions through the national reporting system.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging. 10 tablets in a blister, 3 blisters in a carton.

Prescription status. Prescription only.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's address and location of business activity.

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua