Amitriptyline hydrochloride 10mg/5ml Oral solution
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
19-04-2024
Summary of Product characteristics
(SPC)
19-04-2024
Active ingredient:
Amitriptyline hydrochloride
Available from:
Syri Limited t/a Thame Laboratories
ATC code:
N06AA09
INN (International Name):
Amitriptyline hydrochloride
Dosage:
10 mg/5ml
Pharmaceutical form:
Oral Solution
Administration route:
Oral use
Units in package:
Bottle of 150ml, 200ml, 300ml and 500ml
Prescription type:
Product subject to prescription which may not be renewed (A)
Manufactured by:
Syri Limited t/a Thame Laboratories
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:
2015-04-24
Patient Information leaflet
PIL/IE/MFG006/01/v2
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 hydochloride 10mg/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 heartbeats, heart block or
have recently
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Summary of Product characteristics
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 0.01g methyl parahydroxybenzoate
Each 5ml solution contains 0.001g propyl parahydroxybenzoate
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
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