REAGILA Hard capsule Ref.[6545] Active ingredients: Cariprazine

Posology

The recommended starting dose of cariprazine is 1.5 mg once daily. Thereafter the dose can be increased slowly in 1.5 mg increments to a maximum dose of 6 mg/day, if needed. The lowest effective dose should be maintained according to the clinical judgement of the treating physician. Because of the long half-life of cariprazine and its active metabolites, changes in dose will not be fully reflected in plasma for several weeks. Patients should be monitored for adverse reactions and treatment response for several weeks after starting cariprazine and after each dosage change (see section 5.2).

Switching from other antipsychotics to cariprazine

When switching from another antipsychotic to cariprazine gradual cross-titration should be considered, with gradual discontinuation of the previous treatment while cariprazine treatment is initiated.

Switching to another antipsychotic from cariprazine

When switching to another antipsychotic from cariprazine, no gradual cross-titration is needed, the new antipsychotic should be initiated in its lowest dose while cariprazine is discontinued. It should be considered that plasma concentration of cariprazine and its active metabolites will decline by 50% in ~1 week (see section 5.2).

Special population

Renal impairment

No dose adjustment is required in patients with mild to moderate renal impairment (Creatinine Clearance (CrCl) ≥30 mL/min and <89 mL/min). Safety and efficacy of cariprazine have not been evaluated in patients with severe renal impairment (CrCl <30 mL/min). Use of cariprazine is not recommended in patients with severe renal impairment (see section 5.2).

Hepatic impairment

No dose adjustment is required in patients with mild to moderate hepatic impairment (Child-Pugh score between 5-9). Safety and efficacy of cariprazine have not been evaluated in patients with severe hepatic impairment (Child-Pugh score between 10 and 15). Use of cariprazine is not recommended in patients with severe hepatic impairment (see section 5.2).

Elderly

Available data in elderly patients aged ≥65 years treated with cariprazine are not sufficient to determine whether or not they respond differently from younger patients (see section 5.2). Dose selection for an elderly patient should be more cautious.

Paediatric population

The safety and efficacy of cariprazine in children and adolescents aged less than 18 years have not been established. No data are available.

Method of administration

Reagila is for oral use, to be taken once daily at the same time of the day with or without food.

Symptoms

Accidental acute overdose (48 mg/day) was reported in one patient. This patient experienced orthostasis and sedation. The patient fully recovered the same day.

Management of overdose

Management of overdose should concentrate on supportive therapy including maintenance of an adequate airway, oxygenation and ventilation and management of symptoms. Cardiovascular monitoring should commence immediately, including continuous electrocardiographic monitoring for possible arrhythmias. In case of severe extrapyramidal symptoms, anticholinergic medicinal products should be administered. Since cariprazine is highly bound to plasma proteins, haemodialysis is unlikely to be useful in the management of overdose. Close medical supervision and monitoring should continue until the patient recovers. There is no specific antidote to cariprazine.

Shelf life: 5 years.

Keep the blister in the outer carton in order to protect from light.

This medicinal product does not require any special temperature storage conditions.

Transparent hard PVC/PE/PVDC blister heat-sealed with hard aluminium foil backing packed in folded carton box.

Reagila 1.5 mg and Reagila 3 mg hard capsules: Cartons contain 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.

Reagila 4.5 mg and Reagila 6 mg hard capsules: Cartons contain 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.