Haloperidol

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

haloperidol

Available from:

Arpimed LLC

INN (International Name):

haloperidol

Dosage:

5mg

Pharmaceutical form:

tablets

Prescription type:

Prescription

Summary of Product characteristics

SUMMARY PRODUCT CHARACTERISTIC (SPC)
HALOPERIDOL
1.5 MG AND 5 MG TABLETS
1.1 BRAND NAME – HALOPERIDOL
1.2 INTERNATIONAL NON-PROPERTY NAME - HALOPERIDOL
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Haloperidol 1.5 mg tablet contains:
_ACTIVE INGREDIENT:_ haloperidol – 1.5 mg
_For a full list of excipients, see section 6.1. _
Each Haloperidol 5 mg tablet contains:
_ACTIVE INGREDIENT:_ haloperidol - 5 mg
_For a full list of excipients, see section 6.1. _
3. PHARMACEUTICAL FORM
_Haloperidol, 1.5 mg tablets _
White or off white scored cylindrical tablets with a few small darker
spots and with a risk on one
side and a facet on both sides.
_Haloperidol, 5 mg tablets _
White or off white scored cylindrical tablets with a few small darker
spots and with a risk on one
side and a facet on both sides.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults

Schizophrenia: treatment of symptoms and prevention of relapse.

Other psychoses: especially paranoid.

Mania and hypomania.

Mental or behavioural problems such as aggression, hyperactivity and
self
mutilation in the mentally retarded and in patients with organic brain
damage.

As an adjunct to short term management of moderate to severe
psychomotor agitation, excitement, violent or dangerously impulsive
behaviour.

Intractable hiccup.

Restlessness and agitation in the elderly.

Gilles de la Tourette syndrome and severe tics.
Children (Oral Administration Only)

Childhood
behavioural
disorders,
especially
when
associated
with
hyperactivity
and
aggression.

Gilles de la Tourette syndrome.

Childhood schizophrenia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
For oral administration.
Dosage for all indications should be individually determined and is
best initiated and titrated under
close clinical supervision. To determine initial dose, consideration
should be given to the patient’s
age, severity of symptoms and previous response to neuroleptic drugs.
Patients who are elderly or debilitated or those with previously
rep