Amitriptyline Hydrochloride 50 mg/ 5 ml Oral Solution

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

AMITRIPTYLINE HYDROCHLORIDE

Dostępny od:

Pinewood Laboratories Ltd,

Kod ATC:

N06AA; N06AA09

INN (International Nazwa):

AMITRIPTYLINE HYDROCHLORIDE

Dawkowanie:

50 mg/5ml

Forma farmaceutyczna:

Oral solution

Dziedzina terapeutyczna:

Non-selective monoamine reuptake inhibitors; amitriptyline

Status autoryzacji:

Not marketed

Data autoryzacji:

2010-11-26

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
Amitriptyline Hydrochloride 25 mg/5 ml Oral Solution
Amitriptyline Hydrochloride 50 mg/5 ml Oral Solution
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE 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, please 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.
WHAT IS IN THIS LEAFLET
1.
What Amitriptyline Oral Solution is and what it is used for
2.
What you need to know before you take Amitriptyline Oral Solution
3.
How to take Amitriptyline Oral Solution
4.
Possible side effects
5.
How to store Amitriptyline Oral Solution
6.
Contents of the pack and other information
1. WHAT AMITRIPTYLINE ORAL SOLUTION IS AND WHAT IT IS USED FOR
Amitriptyline Oral Solution 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 ORAL SOLUTION
DO NOT TAKE AMITRIPTYLINE ORAL SOLUTION IF YOU:

are allergic to amitriptyline or to any of the other ingredients of
this medicine (listed in section 6)

if you recently have had a heart attack (myocardial in

Charakterystyka produktu

Health Products Regulatory Authority
11 March 2022
CRN00CQWP
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amitriptyline Hydrochloride 50 mg/ 5 ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of solution contains 50mg 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
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 yea