Medicinal Products

AROLAC 0.2 mg

Generic drug of the therapeutic class: Endocrinology
active ingredients: Lisuride
laboratory: Lisapharm

Tablet breackable
Bottle of 20
All forms

Indication

· Lactation period: inhibition of milky growth, cessation of lactation, breast engorgement, inflammatory breast symptomatology.

· Clinical consequences of biologically confirmed hyperprolactinemia.

in women:

o severe disorders of the menstrual cycle (with or without galactorrhea),

o sterility,

o galactorrhea;

in humans:

o Gynecomastia and impotence.

Dosage AROLAC 0.2 mg Breakable tablet Bottle of 20

To improve digestive tolerance, the administration of the drug should always be done during meals.

The tablets will be swallowed without being chewed with a large glass of water.

· Lactation period

o Inhibition of the milky rise

Start treatment immediately after delivery, at least within 24 hours, 2 tablets daily, for 14 days. In the event of a rebound effect after the AROLAC interruption, restart the treatment for one week.

o Stop lactation, inflammatory breast symptomatology

First day of treatment: one tablet in the evening.

Second day of treatment: one tablet midday and evening.

The treatment can be terminated 4 days after stopping the milk secretion.

In case of inflammatory breast symptomatology, a few days of treatment at a rate of 2 tablets a day are usually sufficient. As soon as you get better, stop the treatment.

It is usually possible to resume breastfeeding immediately.

· Clinical consequences of hyperprolactinemia

First day of treatment: ½ tablet in the evening.

Second day of treatment: ½ tablet in the morning and evening.

From the third day: ½ tablet 3 times a day.

In case of galactorrhea, continue the treatment until the cessation of the milk flow, and in case of amenorrhea, until the appearance of regular menstruation (generally several months). It may be necessary to increase the daily dosage, but within a period of 3 - 4 days and distributing the dose in several doses.

Against indications

· Hypersensitivity to lisuride maleate or other ergot alkaloids.

· Combination with antipsychotic and neuroleptic antipsychotic neuroleptics (except clozapine) (see section 4.5 Interaction with other medicinal products and other forms of interaction ).

Although no vascular action of AROLAC has been demonstrated so far, the indication should be rigorously applied in patients with severe peripheral and cardiac arterial circulatory disorders ( coronary insufficiency).

· In patients who have or have had a history of mental disorders (intellectual deterioration, confusional attacks, visual hallucinations) or psychiatric disorders, the indication should be made by weighing the expected benefit against the risk incurred, as it can not be Exclude a worsening of the clinical picture or the reappearance of symptoms.

· In combination with phenylpropanolamine.

Lactation period

· Pregnancy, postpartum or postpartum hypertension.

· Coronary insufficiency.

Arolac side effects

Those dopamine agonists:

Digestive disorders (nausea, vomiting, headache) may occur more particularly at the beginning of treatment. They can be improved or prevented by taking domperidone. The occurrence of orthostatic hypotension is possible. Exceptionally, a collapse may occur.

Psychological disorders (confusion, hallucinations, delirium, psychomotor excitement) can be observed, especially at high doses and mainly in patients with a psychiatric history (see sections Contraindications and Warnings and precautions for use ).

Heart conditions

Very rarely: pericarditis and pericardial effusion have been reported.

In patients treated with ergot derivatives, cases of cardiac valvulopathy (including regurgitation) have been reported.

The occurrence of pleuro-pulmonary fibrosis (fibrosis, effusion) or retroperitoneal fibrosis has been observed in isolated cases after long-term use of dopaminergic agonists including lisuride. The occurrence of dyspnoea, persistent coughing, coughing, increased serum creatinine during treatment should lead to a diagnosis and, if necessary, cessation of treatment.

Somnolence has been reported with lisuride treatment.

Also reported: decreased alertness, dryness of the mouth, constipation, cutaneous or mucosal reactions of allergic type and oedemas of the lower limbs.

Cases of myocardial infarction, arterial hypertension, or psychic disturbances (confusion, hallucinations, delusions, psychomotor excitement) have been reported exceptionally in postpartum in women treated with ergot analogues. Cases of seizures or strokes have been observed exceptionally in postpartum in women treated with this class of drug; these cases require stopping 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 lisuride (see Warnings and Precautions for Use section Special warnings and precautions for use).

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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