Reagila

5 mg once daily. 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.

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.

2). Missed dose If the patient misses a dose, the patient should take the missed dose as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped and the next dose should be taken according to the regular schedule.

It is not recommended to take a double dose to make up for the forgotten dose. 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). 2). 4 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). 2). 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. Reagila orodispersible tablets may be used as an alternative to Reagila hard capsules for patients who have difficulty swallowing the hard capsules or for whom there is a preference for orodispersible tablets.

5%). Most events were mild to moderate in severity. Tabulated list of adverse reactions ADRs based upon pooled data from cariprazine schizophrenia studies are shown by system organ class and by preferred term in Table 1. Adverse reactions are ranked by MedDRA system organ class and by frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000) very rare (<1/10 000), not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 3). Therefore, cataract formation was closely monitored with slit lamp examinations in the clinical studies and patients with existing cataracts were excluded.

4%). Some of these patients had confounding factors. 1%). 1% in patients treated with cariprazine, placebo, risperidone and aripiprazole respectively. 9% in patients treated with cariprazine, placebo, risperidone and aripiprazole respectively.

3% in patients treated with cariprazine, placebo, risperidone and aripiprazole respectively. 7% in patients on cariprazine, placebo, risperidone and aripiprazole, respectively. 0% in the placebo treated patients. 0% in the placebo group.

0% in cariprazine and placebo group respectively. 7% in the risperidone treated patients. 2% in the risperidone group. 4% in cariprazine and risperidone treated patients respectively. Most EPS cases were mild to moderate in intensity and could be handled with common anti-EPS medicinal products.

The rate of discontinuation due to EPS related ADRs was low. Venous thromboembolism (VTE) Cases of VTE, […]

Suicidal ideation and behaviour The possibility of suicidality (suicidal ideation, suicide attempt and completed suicide) is inherent in psychotic illnesses and, generally, it is reported early after initiation or switch of antipsychotic therapy.

Close supervision of high-risk patients should accompany antipsychotic therapy. Akathisia, restlessness Akathisia and restlessness are frequently occurring adverse reactions of antipsychotics. Akathisia is a movement disorder characterized by a feeling of inner restlessness and a compelling need to be in constant motion, as well as by actions such as rocking while standing or sitting, lifting the feet as if marching on the spot, and crossing and uncrossing the legs while sitting.

As cariprazine causes akathisia and restlessness, it should be used cautiously in patients who are prone to or already exhibit symptoms of akathisia. Akathisia develops early in treatment. Therefore, close monitoring in the first phase of treatment is important.

8). Tardive dyskinesia Tardive dyskinesia is a syndrome consisting of potentially irreversible, rhythmical, involuntary movements, predominantly of the tongue and/or face that can develop in patients treated with antipsychotics. If signs and symptoms of tardive dyskinesia appear in a patient treated with 5 cariprazine, discontinuation should be considered.

Parkinson's disease If prescribed to patients with Parkinson's disease, antipsychotic medicinal products may exacerbate the underlying disease and worsen symptoms of Parkinson’s disease. Physicians should, therefore, weigh the risks versus the benefits when prescribing cariprazine to patients with Parkinson's disease.

3). However, a causal relationship between lenticular changes / cataracts observed in human studies and cariprazine use has not been established. Nevertheless, patients who would develop symptoms potentially related to cataract should be advised to ophthalmologic examination and re-evaluated for treatment continuation.

1. 5). 5).