DEANXIT TABLET

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Flupentixol Dihydrochloride eqv Flupentixol; Melitracen Hydrochloride eqv Melitracen

Available from:

LUNDBECK SINGAPORE PTE. LTD.

ATC code:

N06CA02

Dosage:

0.5 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Flupentixol Dihydrochloride eqv Flupentixol 0.5 mg; Melitracen Hydrochloride eqv Melitracen 10 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

H. Lundbeck A/S

Authorization status:

ACTIVE

Authorization date:

1988-05-09

Patient Information leaflet

Anaesthetics given during
tri/tetracyclic antidepressant therapy may 
increase the risk of arrhythmias and hypotension. If possible,
discontinue 
Deanxit several days before surgery;
if emergency surgery is unavoidable, the 
anaesthetist should be informed that the patient is being so
treated.
Use in children and adolescents under the age of 18
Deanxit is not recommended for use in children and
adolescents due 
to lack of data on efficacy and safety. Treatment with
Deanxit is 
associated with a risk of cardiovascular adverse events in all age
groups. 
Excipients
The tablets contain lactose monohydrate and sucrose. Patients with 
rare hereditary problems of galactose or fructose intolerance,
the 
Lapp lactase deficiency or glucose-galactose malabsorption or
sucrase-
isomaltase insufficiency should not receive this medicine.
4.5 
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS 

OF INTERACTIONS
Contraindicated combinations
Simultaneous administration of MAO-inhibitors may cause
hypertensive 
crises.
MAOIs (non-selective as well as selective A (moclobemide) and B 
(selegiline))- _risk of “serotonin syndrome”_ (see section
4.3).
Inadvisable combinations
_Sympathomimetic agents_: Melitracen may potentiate the
cardiovascular 
effects of adrenaline, ephedrine, isoprenaline, noradrenaline,
phenylephrine, 
and phenylpropanolamine (e.g. as contained in local and general 
anaesthetics and nasal decongestants).
_Adrenergic neurone blockers_: Deanxit may counteract the
antihypertensive 
effects of guanethidine, betanidine, reserpine,
clonidine and methyldopa. 
It is advisable to review
all antihypertensive therapy during treatment with 
tricyclic antidepressants.
_Anticholinergic agents_: Tricyclic antidepressants may potentiate
the 
effects of these drugs on the eye, central nervous system,
bowel and 
bladder; concomitant use of these should be avoided due to an
increased 
risk of paralyt

Summary of Product characteristics

PACKAGE INSERT
DEANXIT FILM-COATED TABLET
1. NAME OF THE MEDICINAL PRODUCT
Deanxit film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Flupentixol 0.5 mg (as 0.584mg flupentixol dihydrochloride)
Melitracen 10 mg (as 11.25mg melitracen hydrochloride)
_Excipients with known effect:_
Lactose monohydrate
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
Round, biconvex, cyclamen, film-coated tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anxiety − Depression − Asthenia.
Psychogenic depression. Depressive neuroses. Masked depression.
Psychosomatic affections
accompanied by anxiety and apathy. Menopausal depressions. Dysphoria
and depression in
alcoholics and drug-addicts.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults
Usually 2 tablets daily: morning and noon.
In severe cases the morning dose may be increased to 2 tablets.
Older people (> 65 years)
1 tablet in the morning.
Maintenance dose: Usually 1 tablet in the morning.
In cases of insomnia or severe restlessness additional treatment with
a sedative in the acute
phase is recommended.
Paediatric population
Children and adolescents (<18 years)
Deanxit is not recommended for use in children and adolescents due to
lack of data on safety and
efficacy
Reduced renal function
No clinical data of exposure in patients with reduced renal function
are available.
Reduced liver function
No clinical data of exposure in patients with reduced liver function
are available.
Method of administration
The tablets are swallowed with water.
4.3 CONTRA-INDICATIONS
Hypersensitivity to flupentixol and melitracen or to any of the
excipients.
Circulatory collapse, depressed level of consciousness due to any
cause (e.g. intoxication with
alcohol, barbiturates or opiates), coma, blood disorders,
phaeochromocytoma.
Recent myocardial infarction. Any degree of atrioventricular block or
disorders of cardiac rhythm
and coronary artery insufficiency.
Untreated narrow angle glaucoma.
Concomitant treatment wi