Lopraxer drops oral (solution)

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

citalopram (citalopram hydrochloride)

Available from:

Help S.A.

ATC code:

N06AB04

INN (International Name):

citalopram (citalopram hydrochloride)

Dosage:

40mg/ml

Pharmaceutical form:

drops oral (solution)

Units in package:

15ml glass bottle

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-09-28

Patient Information leaflet

LOPRAXER
®
Citalopram
Oral Drops, Solution 40 mg/ml &
Film Coated Tablets 20, 30, 40 & 60 mg/tab
Name of the product: Lopraxer
Composition:
• ORAL DROPS SOLUTION: _ACTIVE INGREDIENT:_ Citalopram Hydrochloride
equiva-
lent to Citalopram. _EXCIPIENTS: _Methylparaben E218 , Propylparaben
E216,
Hydroxyethylcellulose, Ethanol 96%, Water purified.
• FILM COATED TABLETS: _ACTIVE INGREDIENT:_ Citalopram Hydrobromide
equivalent
to Citalopram. _EXCIPIENTS:_ Lactose monohydrate, Maize Starch,
Microcrystal-
line Cellulose, Glycerol, Copovidone, Croscarmellose Sodium, Magnesium
Stearate. _COATING:_ Opadry Y-1-7000 (Methocel E5 premium, titanium
dioxide
E171, Macrogol).
Drug form: Oral Drops Solution & Film Coated Tablets.
Presentation:
• OR.DR.SOL., 40MG/ML: Carton box which contains an amber glass
bottle with
7 or 15 ml of the solution. The cap consists of a vertical dropper
that gives
50μl per drop.
• F.C.TAB., 20MG/TAB: Carton box which contains a PVC / PVdC /
Aluminium foil
strip, blister with 28 tablets.
• F.C.TAB., 30MG/TAB: Carton box which contains a PVC / PVdC /
Aluminium foil
strip, blister with 28 tablets.
• F.C.TAB., 40MG/TAB: Carton box which contains a PVC / PVdC /
Aluminium foil
strip, blister with 14, 28 or 56 tablets*.
• F.C.TAB., 60MG/TAB: Carton box which contains a PVC / PVdC /
Aluminium foil
strip, blister with 14, 28, 60 or 100 tablets*.
*Not all pack sizes may be marketed.
Therapeutic category:
Selective seretonin reuptake inhibitor (SSRI).
Marketing Authorization Holder and Manufacturer: HELP S.A.,
OFFICES: 10 Valaoritou str., GR 144 52 Metamorphosis, Attika, Greece,
Tel.: [phone]
MANUFACTURING SITE: Pedini Ioanninon, GR 455 00 Ioannina, Greece,
Tel.: [phone]
WHAT YOU SHOULD KNOW ABOUT THE MEDICINE YOUR DOCTOR
HAS PRESCRIBED
General information:
Citalopram is a racemate in which the S-enantiomer is considered to be
re-
sponsible for the pharmacodynamic effect. The pharmacokinetic
information
is based on the racemate.
Therapeutic indications:
Treatment of depressive illne

Summary of Product characteristics

SUMMARY PRODUCT CHARACTERISTICS (SPC)
1. NAME OF THE MEDICINAL PRODUCT
Lopraxer
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
F.C.TAB., 20MG/TAB: Each film-coated tablet contains 20mg citalopram
(as citalopram
hydrobromide).
F.C.TAB., 30MG/TAB: Each film-coated tablet contains 30mg citalopram
(as citalopram
hydrobromide).
F.C.TAB., 40MG/TAB: Each film-coated tablet contains 40mg citalopram
(as citalopram
hydrobromide).
F.C.TAB., 60MG/TAB: Each film-coated tablet contains 60mg citalopram
(as citalopram
hydrobromide).
ORAL DROPS SOLUTION 40MG/ML: Each 1 ml of the oral drop solution
contains 40mg
citalopram (as citalopram hydrochloride). One drop of the solution
contains 2mg
citalopram.
For a full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Film-coated tablet
Oral Drops Solution
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of depressive illness in the initial phase and as
maintenance against
potential relapse/recurrence. Citalopram is also indicated in the
treatment of panic
disorder with or without agoraphobia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
MAJOR DEPRESSIVE EPISODES
_ADULTS: _
_Film Coated Tablets _
Citalopram should be administered as a single oral dose of 20 mg
daily. Dependent on
individual patient response, the dose may be increased to a maximum of
40 mg daily.
In general, improvement in patients starts after one week, but may
only become
evident from the second week of therapy.
As
with
all
antidepressant
medicinal
products,
dosage
should
be
reviewed
and
adjusted, if necessary, within 3 to 4 weeks of initiation of therapy
and thereafter as
judged clinically appropriate. Although there may be an increased
potential for
undesirable effects at higher doses, if after some weeks on the
recommended dose
insufficient response is seen, some patients may benefit from having
their dose
increased up to a maximum of 40 mg a day. Dosage adjustments should be
made
carefully on an individual patient basis, to maintain the patient at
the lowest effective
dose.
Patients with