Medicinal Products

PARLODEL 25 mg inhibition of lactation

Generic drug of the therapeutic class: Endocrinology
active ingredients: Bromocriptine, Bromocriptine
laboratory: Meda Pharma

Tablet breackable
box of 20
All forms

Indication

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

Bromocriptine is not recommended for routine lactation inhibition, nor for the relief of postpartum pain or breast engorgement that can be effectively treated in a non-pharmacological manner (for example, with the help of firm support of the chest or by the application of ice) and / or with simple analgesics.

DOSAGE PARLODEL 25 mg lactation inhibition scored tablet box of 20

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

Bromocriptine is not recommended for routine lactation inhibition, nor for the relief of postpartum pain or breast engorgement that can be effectively treated in a non-pharmacological manner (for example, with the help of firm support of the chest or by the application of ice) and / or with simple analgesics.

Against indications

Hypersensitivity to bromocriptine , other ergot alkaloids or to any of the excipients listed under Composition .

· For long-term treatment: sign of cardiac valvulopathy detected during echocardiography performed before treatment.

· Patients with vascular risk factors or peripheral arterial disease.

· Bromocriptine is contraindicated in patients with uncontrolled hypertension, hypertensive pregnancy disorders (such as pre-eclampsia, eclampsia or secondary hypertension during pregnancy) or postpartum or puerperal hypertension.

· Bromocriptine is contraindicated in the inhibition of lactation or other non-life-threatening indications in patients with a history of coronary artery disease or severe cardiovascular disorders or with symptoms / history of psychiatric disorders severe.

· 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 ).

Parlodel Inhibition Lactation Side Effects

Adverse events are ranked in descending order of frequency, as follows: very common (≥ 1/10); frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10000, <1/1000); very rare (<1/10000), including isolated cases.

Psychiatric disorders

Uncommon: confusion *, psychomotor agitation *, hallucinations *, delirium.

Rare: psychotic disorders

These psychiatric disorders can be observed more particularly at high doses and mainly in patients already showing signs of mental deterioration. These disorders require the reduction of the dosage, or even the cessation of treatment.

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 bromocriptine (see Warnings and Precautions for Use section Special warnings and precautions for use).

Nervous system disorders

Common: headache *, dizziness, slumber *.

Uncommon: dyskinesia *.

Rare: drowsiness.

Very rare: Excessive daytime sleepiness, sudden onset of sleep.

Cases of seizures were exceptionally observed in the postpartum period in women treated with PARLODEL.

Heart conditions

Rare: constrictive pericarditis.

Very rare: cardiac valvulopathy (including regurgitation) and associated disorders (pericarditis and pericardial effusion).

Cases of myocardial infarction have been exceptionally reported postpartum in women treated with PARLODEL.

Vascular disorders

Uncommon: hypotension, orthostatic hypotension * (leading in exceptional cases to collapse requiring reduction of dosage, or even discontinuation of treatment).

Cases of high blood pressure and stroke have been reported exceptionally in postpartum women treated with PARLODEL.

Very rare: reversible pallor of the extremities triggered by cold exposure, particularly in patients with a history of Raynaud's syndrome.

Respiratory, thoracic and mediastinal disorders

Common: nasal congestion *.

Rare: pleural effusion and pleuropulmonary fibrosis in Parkinsonian patients treated long-term and in high doses (see section Warnings and precautions for use ), pleurisy, dyspnea.

Gastrointestinal disorders

Common: nausea, constipation *, vomiting.

Uncommon: Dry mouth *

Rare: abdominal pain, retroperitoneal fibrosis.

Skin and subcutaneous tissue disorders

Uncommon: hair loss *, hives, eczema, maculopapular rash, erythematous rash.

Musculoskeletal and systemic disorders

Uncommon: cramps in the legs *.

General disorders and administration site conditions

Rare: peripheral edema.

Very rare: syndrome resembling the neuroleptic malignant syndrome in case of abrupt cessation of treatment.

* Usually these unwanted effects (*) are dose-dependent and can be controlled by decreasing the dosage.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

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