Amitriptyline hydrochloride 50mg/5ml Oral solution

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

AMITRIPTYLINE HYDROCHLORIDE

Boleh didapati daripada:

SYRI Limited, t/a Thame Laboratories

Kod ATC:

N06AA; N06AA09

INN (Nama Antarabangsa):

AMITRIPTYLINE HYDROCHLORIDE

Dos:

50 mg/5ml

Borang farmaseutikal:

Oral solution

Laluan pentadbiran:

Oral use

Unit dalam pakej:

Bottle of 150ml, 200ml, 300ml and 500ml

Jenis preskripsi:

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

Dikeluarkan oleh:

Syri Limited t/a Thame Laboratories

Kumpulan terapeutik:

Antidepressants

Kawasan terapeutik:

Non-selective monoamine reuptake inhibitors; amitriptyline

Tanda-tanda terapeutik:

It is indicated for the treatment of: symptoms of depression (especially where sedation is required), nocturnal enuresis where organic pathology is excluded.

Status kebenaran:

Not marketed

Tarikh kebenaran:

2015-04-24

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMITRIPTYLINE HYDROCHLORIDE 50MG/5ML ORAL SOLUTION
(
amitriptyline 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.
The name of your medicine is Amitriptyline hydrochloride
50mg/5ml Oral Solu
tion but it will be referred to as
Amitriptyline throughout this leaflet.
WHAT IS IN THIS LEAFLET
1.
WHAT AMITRIPTYLINE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
AMITRIPTYLINE
3.
HOW TO TAKE AMITRIPTYLINE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE AMITRIPTYLINE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT AMITRIPTYLINE IS AND WHAT IT IS USED FOR
Amitriptyline belongs to a group of medicines known as
tricyclic antidepressants.
This medicine is used to treat:
►
depression in adults (major depressive episodes)
►
neuropathic pain in adults
►
chronic tension type headache prophylaxis in adults
►
migraine prophylaxis in adults
►
bed-wetting at night in children aged 6 years and
above, only when organic causes, such as spina bifida
and related disorders, have been excluded and no
response has been achieved to all other non-drug and
drug treatments, including muscle relaxants and
desmopressin. This medicine should only be prescribed
by doctors with expertise in treating patients with
persistent bed-wetting.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
AMITRIPTYLINE
DO NOT TAKE AMITRIPTYLINE IF:
►
you are allergic to amitriptyline or any of the other
ingredients of this medicine (listed in section 6)
►
you recently have had a heart attack (myoca

Ciri produk

Health Products Regulatory Authority
13 February 2019
CRN008SZR
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amitriptyline hydrochloride 50mg/5ml Oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml solution contains 50mg amitriptyline hydrochloride
Excipients with known effect:
Each 5ml solution contains 0.01g methyl parahydroxybenzoate
Each 5ml solution contains 0.001g propyl parahydroxybenzoate
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Solution
Clear, colourless to yellow coloured solution
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
Health Products Regulatory Authority
13 February 2019
CRN008SZR
Page 2 of 19
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.
_