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REAGILA Hard capsule (2018)

Active ingredients: Cariprazine

Product Name and Form

Reagila 1.5 mg hard capsules.
Reagila 3 mg hard capsules.
Reagila 4.5 mg hard capsules.
Reagila 6 mg hard capsules.

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 ink. The capsules are filled with white to yellowish white powder mixture.

Reagila 3 mg hard capsules: ‘Size 4’ (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and white opaque body imprinted with “GR 3” on the capsule body with black ink. The capsules are filled with white to yellowish white powder mixture.

Reagila 4.5 mg hard capsules: ‘Size 4’ (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and green opaque body imprinted with “GR 4.5” on the capsule body with white ink. The capsules are filled with white to yellowish white powder mixture.

Reagila 6 mg hard capsules: ‘Size 3’ (approximately 15.9 mm in length) hard gelatin capsule with purple opaque cap and white opaque body imprinted with “GR 6” on the capsule body with black ink. The capsules are filled with white to yellowish white powder mixture.

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 corresponding to 3 mg cariprazine.

Excipients with known effect: Each hard capsule contains 0.0003 mg Allura red AC (E129).

Reagila 4.5 mg hard capsules: Each hard capsule contains cariprazine hydrochloride corresponding to 4.5 mg cariprazine.

Excipients with known effect: Each hard capsule contains 0.0008 mg Allura red AC (E129).

Reagila 6 mg hard capsules: Each hard capsule contains cariprazine hydrochloride corresponding to 6 mg cariprazine.

Excipients with known effect: Each hard capsule contains 0.0096 mg Allura red AC (E129).

For the full list of excipients, see section 6.1.

Chemical substance
Description
Cariprazine

Cariprazine is indicated for the treatment of schizophrenia in adult patients. The mechanism of action of cariprazine is not fully known. However the therapeutic effect of cariprazine may be mediated through a combination of partial agonist activity at dopamine D3, D2 (Ki values of 0.085-0.3 nM versus 0.49-0.71 nM respectively) and serotonin 5-HT1A receptors (Ki values of 1.4-2.6 nM), and antagonist activity at serotonin 5-HT2B, 5-HT2A and histamine H1 receptors (Ki values of 0.58-1.1 nM, 18.8 nM and 23.3 nM, respectively).

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 (E133)
Titanium dioxide (E171)
Yellow iron oxide (E172)
Gelatin

Capsule shell (4.5 mg capsule):

Allura red AC (E129)
Brilliant blue FCF (E133)
Titanium dioxide (E171)
Yellow iron oxide (E172)
Gelatin

Capsule shell (6 mg capsule):

Brilliant blue FCF (E133)
Allura red AC (E129)
Titanium dioxide (E171)
Gelatin

Printing ink (black: 1.5 mg, 3 mg and 6 mg capsules):

Shellac
Black iron oxide (E172)
Propylene glycol
Potassium hydroxide

Printing ink (white: 4.5 mg capsule):

Shellac
Titanium dioxide (E171)
Propylene glycol
Simeticone

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

Gedeon Richter Plc., Gyömrői út 19-21., 1103, Budapest, Hungary

13 July 2017

Marketing authorization number:

EU/1/17/1209/001-040