Amitriptyline hydrochloride 10mg/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:

10 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

TURN OVER
PIL/IE/MFG006/01/PHA/v4

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.



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






you have taken MAOIs within the last 14 days

you have taken moclobemide the day before

you have a severe liver disease.
WARNINGS AND PRECAUTIONS
Prolonged QT interval

have slow heart rate





Thoughts of suicide and worsening of your depression
You may be more likely to think like this:



narrow angle glaucoma (loss of vision due to
abnormally high pressure in the eye)


difficulty in passing urine

enlarged prostate

thyroid disease

bipolar disorder

schizophrenia

severe liver disease

severe heart disease


CHILDREN AND ADOLESCENTS



OTHER MEDICINES AND AMITRIPTYLINE





thioridazine (used to treat schizophrenia)

tramadol (painkiller)





cimetidine (used to treat stomach ulcers)

methylphenidate (used to treat ADHD)

ritonavir (used to treat HIV)

oral contraceptives


phenytoin and carbamazepine (used to treat epilepsy)


thyroid medication

valproic acid.





halofantrine (used to treat malaria)

methadone (used to treat pain and for detoxification)

diuretics (“water tablets” e.g. furosemide).
AMITRIPTYLINE WITH ALCOHOL
DRIVING AND USING MACHINES
AMITRIPTYLINE CONTAINS:
3. HOW TO TAKE AMITRIPTYLINE
_DEPRESSION _
_Adults _
_Use in children and adolescents_
_Adults _
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMITRIPTYLINE HYDROCHLORIDE 10MG/5ML ORAL SOLUTION
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

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 10mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml solution contains 10mg 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 – 25