CAMCOLIT

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

LITHIUM CARBONATE

Mevcut itibaren:

Essential Pharma Ltd

ATC kodu:

N05AN01

INN (International Adı):

LITHIUM CARBONATE

Doz:

250 mg Milligram

Farmasötik formu:

Film Coated Tablet

Reçete türü:

Product subject to prescription which may not be renewed (A)

Terapötik alanı:

lithium

Yetkilendirme durumu:

Not Marketed

Yetkilendirme tarihi:

1978-04-01

Bilgilendirme broşürü

5
060334 120039
39025_1_163646
FM-H8013114 proof 1
03/06/2015
39025_1_163646
FM-H8013114 proof 1
03/06/2015
FM-H8013114
39025_1_163646
FM-H8013114 proof 1
03/06/2015

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CAMCOLIT 250 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg Lithium Carbonate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White film-coated tablets
The tablets are engraved "CAMCOLIT" around one face and having a
scoreline on the reverse.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment
and prophylaxis of mania,
bipolar affective disorders and recurrent
depression,
and the treatment
of
aggressive or self mutilating behaviour.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
CAMCOLIT 250mg film coated tablets are usually administered according
to a twice daily regimen. When lithium
levels have stabilised, a once daily regimen may be preferred.
4.2.1 DOSAGE
Lithium carbonate has a narrow therapeutic window. The dose required
for treatment must be titrated and adjusted on
the basis of regular monitoring of the serum concentration of lithium
(See Section 4.4.1). Lithium therapy should not be
initiated unless adequate facilities for routine monitoring of plasma
concentrations are available. On initiation of
treatment, plasma therapy concentrations should be measured weekly
until stabilisation is achieved, then weekly for one
month and at monthly intervals thereafter.
Additional measurements should be made if signs of lithium toxicity
occur, on dosage alteration, development of
significant intercurrent disease, signs of manic depressions or
depressive relapse and if significant change in sodium or
fluid intake occurs. More frequent monitoring is required if patients
are receiving any drug treatment that affects renal
clearance of lithium e.g. diuretics and NSAID (See section 4.4 and
section 4.5). As bioavailability may vary between
formulations, should a change of preparations be made, blood levels
should be monitored weekly until restabilisatio