Prevention, or inhibition of physiological lactation in postpartum for medical reasons (such as death, intrauterine, neonatal death, HIV infection of the mother, …).

Bromocriptine is not recommended for routine lactation inhibition nor for the relief of postpartum pain or mammary engorgement which can be treated effectively non-pharmacologically (e.g. Using a firm chest support or by applying ice cubes) and / or with simple analgesics

In order to improve digestive tolerance, medication should always be administered in the midst of meals.

The regimen is the following

· 1/2 tablet on the first day, 1 tablet on the 2nd day, then 2 tablets daily in 2 doses, for 14 days

If discrete milk secretion reappears 2 to 3 days later, discontinuation of treatment may be resumed at the same dosage for one week
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Scored tablet.

INHIBITORS, PROLACTIN, ATC Code: G02CB01.

Bromocriptine is an agonist, dopaminergic.

At the hypothalamic-pituitary level, it inhibits the secretion of prolactin and reduces hyperprolactinemia, whether of physiological origin (pregnancy, postpartum) or pathological. Br>

The attention of vehicle drivers and machine users should be drawn to the possibility of dizziness, decreased alertness and decreased blood pressure related to the use of this drug. >

Patients treated with bromocriptine with sudden drowsiness and / or sudden onset of sleep should be advised that they should not drive or engage in any activity where alteration in their vigilance Expose themselves or others to the risk of serious accident or death (eg, the use of machinery) until such effects have ceased (see Special Warnings and Precautions d Job description.

Hypersensitivity to bromocriptine, other alkaloids of rye ergot or any of the excipients mentioned under Composition.
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· For long-term treatment: signs of valvulopathy, cardiac disease detected during an echocardiography, performed before treatment

· Patients with vascular risk factors or peripheral arterial disease.

Bromocriptine is contraindicated in patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including pre-eclampsia, eclampsia or hypertension, secondary to pregnancy) or post-partum hypertension, or Puerperale.


Combination with anti-emetic neuroleptics (see section Interactions with other medicinal products and other forms of interaction)

· Combination with phenylpropanolamine (see section Interactions with other medicinal products and other forms of interaction)

Warnings

In rare cases, serious adverse reactions such as hypertension, infarction, myocardium, seizures, stroke, cerebral or psychiatric disorders have been reported in women treated with bromocriptine, Inhibition of lactation in postpartum.

Most of the observed cardiovascular events or incidents (see Adverse Events) occurred in patients with vascular risk factors (hypertension, smoking, obesity), peripheral arterial disease, peripheral or concomitantly treated with Vasoconstrictor drugs, the association of which is not recommended. In these cases, the prescriber is advised to evaluate the relationship between the expected benefit and the risks incurred by the patient.

Sleepiness and sudden onset sleeping bouts were reported during treatment with bromocriptine, particularly in patients with Parkinson's disease.

Sudden falling asleep during daily activities, in some cases without prodrome, has been very rarely reported. Patients should be informed of the possible occurrence of these effects and should be cautioned to be cautious when driving, automobile or machine use during treatment with bromocriptine. Patients with sudden onset of drowsiness or sudden onset of sleep should not drive or use machinery, or a reduction in doses or discontinuation of treatment may be considered
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Impulse control disorders

Patients should be monitored on a regular basis to investigate the onset of impulse control disorders. Patients and caregivers should be kept informed of impulse control disorders, including pathological gambling, increased libido, hypersexuality, expenses or purchases, compulsive, excessive eating (binge eating) And compulsive diet may occur in patients treated with dopaminergic agonists including bromocriptine. A decrease in dose or a progressive stop should be considered if these symptoms appear.
In patients treated with bromocriptine, particularly in the long term and at high doses, occasional reports have been reported of pleural and pericardial effusions, pleuropulmonary fibrosis, and constrictive pericarditis. Patients with unexplained pleuropulmonary symptoms should be thoroughly investigated and discontinued treatment with bromocriptine should be considered.

In some patients on bromocriptine, especially long-term and high doses, retroperitoneal fibrosis has been reported. In order to ensure a diagnosis of retroperitoneal fibrosis at an early stage, it is recommended that these patients be monitored for signs of low back pain, edema of the lower extremities, impaired function, renal function. >

Bromocriptine should be discontinued if retroperitoneal fibrosis is diagnosed or suspected

This medicinal product contains lactose and is not recommended for use in patients with lactose intolerance

Treatment tolerance may be reduced by simultaneous absorption of alcohol

Precautions for use

Caution is advised in women recently treated or treated, together with medicines that may raise or lower blood pressure.

In some patients, the onset of seizures or stroke was preceded by headache and / or transient visual disturbances. It is recommended to monitor blood pressure carefully, especially on the days following the start of treatment. In the case of hypertension, chest pain, severe, progressive or severe headache, remission (with or without visual disturbances) or in the case of development of central nervous system toxicity, it is recommended to stop Treatment with bromocriptine and examine the patient promptly.

Associations, contraindicated

+ Anti-emetic neuroleptics (alizapride, metoclopramide and metopimazine)

Reciprocal antagonism of the dopaminergic agonist and neuroleptics.

Use an antiemetic with no extrapyramidal effects.

+; Phenylpropanolamine

Risk of vasoconstriction and / or hypertensive outbreaks

Associations, deprecated

Antipsychotic neuroleptics (except clozapine) (in patients with Parkinson's disease)

Reciprocal antagonist of the dopaminergic agonist and neuroleptics. The dopaminergic agonist can cause or aggravate psychotic disorders. If neuroleptic treatment is required in parkinsonian patients treated with dopaminergic agonists, dopaminergic dopaminergic drugs should be decreased progressively until discontinuation (abrupt discontinuation, dopaminergic drugs are at risk of malignant syndrome Of the neuroleptics ").

Vasoconstrictive ergot alkaloids (ergotamine, dihydroergotamine, methylergometrine)

Risk of vasoconstriction and / or hypertensive outbreaks

+; Macrolides (except spiramycin)

Increased plasma concentrations of dopaminergic with possible increase in activity or signs onset of overdose

+ Indirect Sympathomimetics (except phenylpropanolamine)

Risk of vasoconstriction and / or hypertensive outbreaks

+ Sympathomimetic alpha (oral and / or nasal route)

Risk of vasoconstriction and / or hypertensive outbreaks

Associations subject to precautions for use

+ Antiparkinsonniens anticholinergiques

Risk of increased neuropsychic disorders. Clinical and biological monitoring, regular, especially at the beginning, of association

Without object.

No fatal cases have been reported after acute overdose The maximum single dose ingested by an adult is 225 mg. The disorders observed were nausea, vomiting, dizziness, orthostatic hypotension, hypotension, tachycardia, lethargy, somnolence / loss of vigilance. Sweats and hallucinations.

In case of overdose, the administration of activated charcoal is recommended and in the case of very recent gastric lavage may be considered.

The treatment of acute intoxication is symptomatic.

Animal studies have not demonstrated teratogenic effect

In clinical studies, the analysis of a high number of exposed pregnancies apparently did not reveal any malformative or fetotoxic effect, especially of bromocriptine.
In the event of the occurrence of a pregnancy under this drug, there is no indication to continue treatment.
Undesirable effects are ranked in descending order of frequency as follows: very common (≥ 1/10), frequent (≥ 1/100,