Amitriptyline 25mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Amitriptyline hydrochloride

Disponible des:

Sandoz Ltd

Codi ATC:

N06AA09

Designació comuna internacional (DCI):

Amitriptyline hydrochloride

Dosis:

25mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 04030100

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amitriptyline 25 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg of Amitriptyline Hydrochloride.
For excipients see 6.1
3
PHARMACEUTICAL FORM
Film coated tablet.
Appearance: Yellow, circular, biconvex, film coated tablet with A2
embossed on one
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amitriptyline is indicated for:
•
the treatment of major depressive disorder in adults
•
the treatment of neuropathic pain in adults
•
the prophylactic treatment of chronic tension type headache (CTTH) in
adults
•
the prophylactic treatment of migraine in adults
•
the treatment of nocturnal enuresis in children aged 6 years and above
when organic pathology, including spina bifida and related disorders,
have been excluded and no response has been achieved to all other
non-drug and drug treatments, including antispasmodics and
vasopressin-related products. This medicinal product should only be
prescribed by a healthcare professional with expertise in the
management of persistent enuresis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Not all dosage schemes can be achieved with all the pharmaceutical
forms/strengths.
The appropriate formulation/strength should be selected for the
starting doses and any
subsequent dose increments.
_Major depressive disorder: _
Dosage should be initiated at a low level and increased gradually,
noting carefully the
clinical response and any evidence of intolerability.
_Adults_
Initially 25 mg 2 times daily (50 mg daily). If necessary, the dose
can be increased by
25 mg every other day up to 150 mg daily divided into two doses.
The maintenance dose is the lowest effective dose.
_Elderly patients over 65 years of age and patients with
cardiovascular disease _
Initially 10 mg – 25 mg daily.
The daily dose may be increased up to 100 mg – 150 mg divided into
two doses,
depending on individual patient response and tolerability.
Doses above 100 mg should be used with caution.
The