Amitriptyline Hydrochloride 25 mg/ 5 ml Oral Solution

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

AMITRIPTYLINE HYDROCHLORIDE

Предлага се от:

Wockhardt UK Limited

АТС код:

N06AA; N06AA09

INN (Международно Name):

AMITRIPTYLINE HYDROCHLORIDE

дозиране:

25 mg/5ml

Лекарствена форма:

Oral solution

Вид предписание :

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

Терапевтична област:

Non-selective monoamine reuptake inhibitors; amitriptyline

Статус Оторизация:

Not marketed

Дата Оторизация:

2010-11-26

Листовка

Customer
Pinewood Healthcare
Item Code
Description
Component Type
Dimensions
Language
Market
Pharma Code No.
Paper GSM
Proof By
Proof No.
Date
Colours Used
WARNING! We cannot accept responsibility for any errors in this proof
after
approval. Whilst we take extreme care at all times to ensure accuracy
to
our client’s brief, the final responsibility must be taken by our
client.
IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.
2082
45gsm
23LF01569PW
Black
Keyline (Non-Printing)
Text Free Area (Non-Printing)
Amitriptyline Hydrochloride 25mg/5ml oral solution
Leaflet
190 x 420mm
English
DBO
1
05/10/2018
UK
Customer
Pinewood Healthcare
Item Code
Description
Component Type
Dimensions
Language
Market
Pharma Code No.
Paper GSM
Proof By
Proof No.
Date
Colours Used
WARNING! We cannot accept responsibility for any errors in this proof
after
approval. Whilst we take extreme care at all times to ensure accuracy
to
our client’s brief, the final responsibility must be taken by our
client.
IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.
2082
45gsm
23LF01569PW
Black
Keyline (Non-Printing)
Text Free Area (Non-Printing)
Amitriptyline Hydrochloride 25mg/5ml oral solution
Leaflet
190 x 420mm
English
DBO
1
05/10/2018
UK

Данни за продукта

Health Products Regulatory Authority
14 February 2019
CRN008T5S
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amitriptyline Hydrochloride 25 mg/ 5 ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of solution contains 25mg amitriptyline hydrochloride.
Excipients with known effect
Each 5ml of solution contains:
1mg propyl hydroxybenzoate (E216)
6mg methyl hydroxybenzoate (E218)
100mg propylene glycol
3.35g liquid maltitol
Approximately 10.5mg ethanol
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
A clear colourless to yellow solution with an orange/tangerine odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

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
Health Products Regulatory Authority
14 February 2019
CRN008T5S
Page 2 of 16
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.