REAGILA Hard capsule (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Reagila 1.5 mg hard capsules. Reagila 3 mg hard capsules. Reagila 4.5 mg hard capsules. Reagila 6 mg hard capsules.
Qualitative and quantitative composition
Reagila 1.5 mg hard capsules: Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine. Reagila 3 mg hard capsules: Each hard capsule contains cariprazine hydrochloride ...
Pharmaceutical form
Hard capsule. Reagila 1.5 mg hard capsules: Size 4 (approximately 14.3 mm in length) hard gelatin capsule with white opaque cap and white opaque body imprinted with GR 1.5 on the capsule body with black ...
Therapeutic indications
Reagila is indicated for the treatment of schizophrenia in adult patients.
Posology and method of administration
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 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant administration of strong or moderate CYP3A4 inhibitors (see section 4.5). Concomitant administration ...
Special warnings and precautions for use
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 ...
Interaction with other medicinal products and other forms of interaction
Potential for other medicinal products to affect cariprazine Metabolism of cariprazine and its major active metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR), is mediated mainly ...
Fertility, pregnancy and lactation
Women of childbearing potential/contraception Women of childbearing potential must be advised to avoid pregnancy while on Reagila. Female patients of child-bearing potential must use highly effective contraceptive ...
Effects on ability to drive and use machines
Cariprazine has minor or moderate influence on the ability to drive and use machines. Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably ...
Undesirable effects
Summary of the safety profile The most frequently reported ADRs with cariprazine in the dose range (1.5-6 mg) were akathisia (19%) and parkinsonism (17.5%). Most events were mild to moderate in severity. ...
Overdose
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Psycholeptics, other antipsychotics ATC code: N05AX15 Mechanism of action The mechanism of action of cariprazine is not fully known. However the therapeutic effect of cariprazine ...
Pharmacokinetic properties
Cariprazine has two pharmacologically active metabolites with similar activites as cariprazine, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR). Total cariprazine (sum of cariprazine + ...
Preclinical safety data
Cariprazine caused bilateral cataract and secondary retinal changes (retinal detachment and cystic degeneration) in the dog. The exposure (AUC of total cariprazine) at the no-observed-adverse-effectlevel ...
List of excipients
Capsule contents: Pregelatinized (maize) starch Magnesium stearate Capsule shell (1.5 mg capsule): Titanium dioxide (E171) Gelatin Capsule shell (3 mg capsule): Allura red AC (E129) Brilliant blue FCF ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 5 years.
Special precautions for storage
Keep the blister in the outer carton in order to protect from light. This medicinal product does not require any special temperature storage conditions.
Nature and contents of container
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, ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Gedeon Richter Plc., Gyömrői út 19-21., 1103, Budapest, Hungary
Marketing authorization number(s)
EU/1/17/1209/001-040
Date of first authorization / renewal of the authorization
13 July 2017
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