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Name of the product: ZUCLOPENTIXOL DOSA (*)

Active ingredient: Zuclopentixol 20 mg (as zuclopentixole hydrochloride)

Dosage form: lyophilised injection

 

Name of the product: ZUCLOPENTIXOL 10 DOSA (*)

Active ingredient: Zuclopentixol 10 mg (as zuclopentixol hydrochloride)

Dosage form: film-coated tablets

 

Name of the product: ZUCLOPENTIXOL 25 DOSA (*)

Active ingredient: Zuclopentixol 25 mg (as zuclopentixol hydrochloride)

Dosage form: film-coated tablets

 

Dispensing requirements: Rx only

Argentine Industry

 

Composition:

 

ZUCLOPENTIXOL DOSA:

Each millilitre of solution contains zuclopentixol 20 mg ( as zuclopentixol hydrochloride), purified water, and alcohol.

 

ZUCLOPENTIXOL 10 DOSA:

Each film-coated tablet contains zuclopentixol 10 mg (as zuclopentixol hydrochloride), corn starch, lactose, microcrystalline cellulose, crospovidone, glycerate 85 %, talc, hydrogenated castor oil, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 6000, red colorant.

 

ZUCLOPENTIXOL 25 DOSA:

Each film-coated tablet contains zuclopentixol 25 mg (as zuclopentixol hydrochloride), corn starch, lactose, microcrystalline cellulose, crospovidone, glycerate 85 %, talc, hydrogenated castor oil, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 6000, red colorant.

 

Indications:

 

ZUCLOPENTIXOL DOSA is indicated for the treatment of paranoid schyzophrenia, chronic delusion, hallucinatory psychosis, paranoia, psychomotor agitation during the schyzohrenia onset, maniac states and certain demential and oligophrenic states.

 

Therapeutic action:

 

Neuroleptic.

 

 

Storage:

 

ZUCLOPENTIXOL DOSA drops: Keep at temperature below 15º C in the marketed packing. Protect from the light.

 

ZUCLOPENTIXOL DOSA film-coated tablets: Keep at temperature below 25º C in the marketed packing.

 

Marketed presentations:

 

ZUCLOPENTIXOL DOSA (zuclopentixol 20 mg/ml):

Packs containing one 20-ml glass bottle.

 

ZUCLOPENTIXOL 10 DOSA:

Packs containing 50 film-coated tablets.

 

ZUCLOPENTIXOL 25 DOSA:

Packs containing 50 film-coated tablets.

 

Medicinal speciality authorised by the Ministry of Health.

Certificate Nº 51010

 

Laboratorio DOSA S.A.

Girardot 1369, (C1427AKC) Buenos Aires, Argentine

Pharmaceutical Director: María C. Terzo, Pharmacist

 

 

Laboratorio DOSA S.A. - Girardot 1369 (C1427AKC) Ciudad de Buenos Aires - Argentina