Amitriptyline hydrochloride 10mg/5ml Oral solution

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

Amitriptyline hydrochloride

Available from:

Wockhardt UK Ltd

ATC code:

N06A A

INN (International Name):

Amitriptyline hydrochloride

Dosage:

10 mg/5ml

Pharmaceutical form:

Oral Solution

Administration route:

Oral use

Units in package:

Bottle holding 150 ml of solution

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

CP Pharmaceuticals Ltd

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:

2014-08-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Amitriptyline Hydrochloride 10mg/5ml Oral Solution
23LF00785PW
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE THIS
MEDICINE.  
-   Keep this leaflet. You may need to read it again while you are
receiving your 
treatment. 
-  If you have any further questions, please ask your doctor or
pharmacist.
-
  This medicine has been prescribed for you. Do not pass it
on to others. It may 
harm them, even if their symptoms are the same as yours.
-   If any of the side effects get serious, or if you notice any
side effects not listed 
in this leaflet, please tell your doctor or pharmacist. 
IN THIS LEAFLET: 
1.  What Amitriptyline Oral Solution is and what it is used for
2.  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.  Further information 
  1.   WHAT AmITrIPTYLIne
OrAL SOLuTIOn IS AnD WHAT IT IS uSeD FOr
The name of your medicine is Amitriptyline Oral Solution.
Amitriptyline belongs 
to a group of medicines known as tricyclic antidepressants. everybody
has 
substances called serotonin and noradrenaline in their brains. It is
thought 
that people with depression (and some other conditions) have less of
these 
substances compared to those without depression (or other
conditions). 
Amitriptyline works by increasing the amounts of these substances in
the brain. 
Amitriptyline also affects the muscles in the bladder and reduces the
need to 
pass urine.

Amitriptyline Oral Solution is used in the treatment of:
•  depression (especially when associated with sleep disturbance)
•  night-time bed-wetting.
  2.  BeFOre YOu TAKe AmITrIPTYLIne OrAL SOLuTIOn
YOU SHOULD NOT TAKE AMITRIPTYLINE ORAL SOLUTION IF YOU: 
•   are allergic (hypersensitive) to amitriptyline or to any of
the other ingredients 
in Amitriptyline Oral Solution (see section 6, Further information)
•   are tak

Summary of Product characteristics

Amitriptyline Hydrochloride 10mg/5ml Oral Solution
Summary of Product Characteristics Updated 03­Jul­2015 | Wockhardt UK Ltd
1. Name of the medicinal product
Amitriptyline Hydrochloride 10mg/5ml Oral Solution
2. Qualitative and quantitative composition
Each 5ml of solution contains 10mg amitriptyline hydrochloride.
_Excipients_
Each 5ml of solution contains:
1mg propyl hydroxybenzoate (E216)
6mg methyl hydroxybenzoate (E218)
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 pale yellow solution. It has an orange/tangerine odour.
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
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�