Medicinal Products

DOSTINEX 0.5 mg

Generic drug of the therapeutic class: Endocrinology
active ingredients: Cabergoline
laboratory: Pfizer Holding France

Compressed
Box of 1 Bottle of 8
All forms

Indication

· Idiopathic hyperprolactinemia.

· Hyperprolactinemia related to the presence of a pituitary microadenoma or macroadenoma, and their clinical manifestations:

o in women: galactorrhea, oligo- or amenorrhea, infertility;

o in man: gynecomastia, impotence.

DOSTINEX Dosage 0.5 mg Tablet Box of 1 Bottle of 8

The starting dose is 0.5 mg per week in a single dose, ie 1 tablet per week.

This dosage of 0.5 mg per week will be maintained for 4 weeks and then adapted according to the prolactinemia dosage to be performed the day before taking a tablet. The dosage will be maintained or increased in increments of 0.5 mg as a function of prolactin, measured at most once every four weeks until an optimal response to treatment is obtained.

After equilibration of the dosage, a quarterly dose of prolactin is sufficient. Most patients are controlled by a dose less than or equal to 1 mg / week. In this case, a single weekly catch is sufficient. The dosage may vary from 0.25 to 2 mg or even up to 4.5 mg per week. When the dosage exceeds 1 mg, it is recommended to split the weekly dose into two or more doses depending on the patient's tolerance.

To improve tolerance, the medication should be given in the middle of the meal, preferably in the evening, or at bedtime with a light snack.

Against indications

This medicine MUST NEVER BE prescribed in the following cases:

· Known hypersensitivity to cabergoline, to any of the constituents of this drug, or to any ergot derivative,

· A history of pulmonary, pericardial and retroperitoneal fibrosis,

· Combination with antipsychotic and antipsychotic neuroleptics (except clozapine) (see section Interactions with other medicinal products and other forms of interaction ),

· For long-term treatment: sign of cardiac valvulopathy detected during pre-treatment echocardiography (see Warnings and precautions for use section ).

Dostinex side effects

The following side effects have been observed and reported during treatment with DOSTINEX at the following frequencies: very common (1/10), frequent (1/100 to <1/10), uncommon (1/1) 000 to <1/100), rare (1/10 000 to <1/1000), very rare (<1 / 10, 000), not known (can not be estimated based on available data).

General

Class Organ System

Frequency

Side effects

Vascular disorders

Frequent

Generally, DOSTINEX exerts a hypotensive effect in patients treated in the long term,

orthostatic hypotension

Rare

Digital vasospasm,

loss of consciousness

Musculoskeletal and systemic disorders

Rare

Cramps in the legs

investigations

Rare

A decrease in hemoglobin levels was observed in amenorrheic women in the first few months following the re-emergence of menstrual bleeding.

hyperprolactinemia

Class Organ System

Frequency

Side effects

Psychiatric disorders

Frequent

Depression

Nervous system disorders

Very common

Dizziness / vertigo, headache

Rare

paresthesia

Vascular disorders

Frequent

Hot flashes

Gastrointestinal disorders

Very common

Abdominal pain / dyspepsia / gastritis, nausea

Frequent

Constipation, vomiting

Reproductive organs and breast disease

Frequent

Breast pain

General disorders and administration site conditions

Very common

Asthenia / fatigue

Adverse reactions reported since marketing

Class Organ System

Frequency

Side effects

Immune system disorders

Unknown

Hypersensitivity reaction

Psychiatric disorders

Rare

Increased libido

Unknown

Aggressiveness, delirium, hypersexuality, pathological gambling, psychotic disorders

Eye disorders

Unknown

Abnormal vision

Heart conditions

Very common

Valvulopathy (including regurgitation) and associated disorders (pericarditis and pericardial effusion)

Respiratory, thoracic and mediastinal disorders

Rare

Dyspnea

Very rare

Fibrosis

Unknown

Respiratory disorders, respiratory failure

Hepatobiliary disorders

Unknown

Abnormal liver function

Skin and subcutaneous tissue disorders

Rare

Alopecia, rash

General disorders and administration site conditions

Rare

edema

investigations

Unknown

Increased creatinine phosphokinase in the blood, abnormal liver function tests

Impulse control disorders

Pathological gambling, increased libido, hypersexuality, compulsive spending or shopping, binge eating, and compulsive eating, are disorders that can occur in patients treated with dopamine agonists., including cabergoline (see section Warnings and Precautions ).

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