Amitriptyline hydrochloride 25mg/5ml Oral Solution

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

amitriptyline hydrochloride

Available from:

Syri Limited

ATC code:

N06AA09

INN (International Name):

amitriptyline hydrochloride

Dosage:

25mg/5ml

Pharmaceutical form:

Oral Solution

Administration route:

Oral use

Units in package:

Pack size: 150ml, 200ml, 300ml and 500ml

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Syri Limited

Therapeutic group:

Antidepressants

Therapeutic indications:

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

Authorization status:

Authorised

Authorization date:

2015-04-21

Patient Information leaflet

PIL/UK/MFG006/03/V1 
TURN OVER 
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 25mg/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 
This product contains an active 
substance called amitriptyline (as 
hydrochloride). This belongs to a group 
of medicines called tricyclic 
antidepressants. These medicines alter 
the levels of chemicals in the brain to 
relieve the symptoms of depression. 
AMITRIPTYLINE IS USED: 
►
to treat the symptoms of 
depression 
►
for the relief of bed-wetting at night 
by children. 
2.  WHAT YOU NEED TO KNOW 
BEFORE YOU TAKE 
AMITRIPTYLINE 

DO NOT TAKE AMITRIPTYLINE                  
         IF: 
you are ALLERGIC (hypersensitive) 
to amitriptyline, other tricyclic 
antidepressants or any of the other 
ingredients (see section 6) 
you have HEART DISEASE such as 
irregular

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Amitriptyline hydrochloride 25mg/5ml Oral Solution 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each 5ml solution contains 25mg amitriptyline hydrochloride 

Excipients with known effect: 
Each 5ml solutions contains 0.01g methyl hydroxybenzoate 
Each 5ml solution contains 0.001g propyl hydroxybenzoate 

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: 
Symptoms of depression (especially where sedation is required). 
Nocturnal enuresis where organic pathology is excluded. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Posology 

For oral administration only 

Therapy should be started with a low
dosage and increased gradually, according to 
the clinical response and any evidence of intolerance. 

_Adults_ -initial dosage: Usually 75mg a day in
divided doses (or a single dose at night). 
If necessary, this may be increased to a total of 150mg a
day, the additional doses 
being given in the late afternoon and/or at bedtime. The
sedative effect is usually 
rapidly apparent. The antidepressant activity may be seen
within three or four days or 
may take up to 30 days to develop adequately. 

_Adults_ - maintenance dosage: Usually 50 - 100mg a day. For
maintenance therapy, 
the total dosage may be given in a single dose preferably in the
evening or at bedtime. 
When satisfactory improvement has been reached, dosage should be
reduced to the 
lowest amount that will maintain relief of symptoms. Maintenance
therapy should be 
continued for three months or longer to lessen the chances
of relapse. 

_Children_: Due to lack of clinical experience amitriptyline
is not