Deanxit film-coated Tablets

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

FLUPENTIXOL, MELITRACEN

Διαθέσιμο από:

H. Lundbeck A.S. 9 Ottiliavej, 2500 Valby, Copenhagen, Denmark

Φαρμακολογική κατηγορία (ATC):

N06CA02

INN (Διεθνής Όνομα):

FLUPENTIXOL 0.5 mg MELITRACEN 10 mg

Φαρμακοτεχνική μορφή:

FILM-COATED TABLET

Σύνθεση:

FLUPENTIXOL 0.5 mg MELITRACEN 10 mg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

PSYCHOANALEPTICS

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2006-05-30

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEANXIT® FILM-COATED TABLETS
Flupentixol 0,5 mg (as dihydrochloride) + Melitracen10 mg (as
hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Deanxit is and what it is used for
2.
What you need to know before you take Deanxit
3.
How to take Deanxit
4.
Possible side effects
5.
How to store Deanxit
6.
Contents of the pack and other information
1.
WHAT DEANXIT IS AND WHAT IT IS USED FOR
Deanxit contains the active substances flupentixol and melitracen.
Deanxit belongs to a group of
medicines that work by relieving the symptoms of depressed mood.
In combination the active substances render a preparation with
antidepressant, anxiolytic and activating
properties.
Deanxit is used to treat anxiety and depression in patients with or
without psychosomatic symptoms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEANXIT
DO NOT TAKE DEANXIT
•
if you are allergic to flupentixol, melitracen or any of the other
ingredients of this medicine (listed
in section 6)
•
if you have diminished consciousness
•
if you have a blood disease
•
if you have a rare abnormality of the adrenal glands
(phaeochromocytoma)
•
if you recently have had a heart attack (myocardial infarction)
•
if you have disturbances in heart rhythm which are seen on an
electrocardiogram (ECG)
•
at the same time as taking medication known as monoamine oxidase
inhibitors (MAOIs)
MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid,
nialamide, tranylcypromine and

Αρχείο Π.Χ.Π.

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Deanxit film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Flupentixol 0.5 mg (as 0.584 mg flupentixol dihydrochloride)
Melitracen 10 mg (as 11.25 mg melitracen hydrochloride)
_Excipients with known effect: _
Lactose monohydrate
For the 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.
Neurasthenia. 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
Posology
_ _
_Adults _
Usually 2 tablets daily: morning and noon.
In severe cases the morning dose may be increased to 2 tablets.
The maximum dose is 4 tablets daily.
_Older people (> 65 years) _
1 tablet in the morning.
In severe cases 1 tablet in the morning and 1 at noon.
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.
Page 2 of 10
_ _
_Reduced renal function _
Deanxit can be given in the recommended doses.
_Reduced liver function _
Deanxit can be given in the recommended doses.
Method of administration
The tablets are swallowed with water.
4.3
CONTRAINDICATIONS
Hypersensitivity to flupentixol and melitracen or to any of the
excipients listed in section 6.1.
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
dis