Amitriptyline hydrochloride 50mg/5ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amitriptyline hydrochloride

Available from:

Syri Pharma Limited t/a Thame Laboratories

ATC code:

N06AA; N06AA09

INN (International Name):

Amitriptyline hydrochloride

Dosage:

50 mg/5ml

Pharmaceutical form:

Oral solution

Therapeutic area:

Non-selective monoamine reuptake inhibitors; amitriptyline

Authorization status:

Not marketed

Authorization date:

2015-04-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMITRIPTYLINE HYDROCHLORIDE 50MG/5ML ORAL SOLUTION
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 Solution 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 wh
en 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 (myocardial
infarction)

you have

Summary of Product characteristics

Health Products Regulatory Authority
22 February 2022
CRN00CQPR
Page 1 of 12
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 10mg methyl parahydroxybenzoate and 1mg
propyl parahydroxybenzoate.
For the 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
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 –