Amitriptyline Hydrochloride 50mg/5ml Oral Solution

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

AMITRIPTYLINE HYDROCHLORIDE

Διαθέσιμο από:

Pinewood Laboratories Ltd BALLYMACARBRY, CLONMEL, CO. TIPPERARY, Ireland

Φαρμακολογική κατηγορία (ATC):

N06AA09

INN (Διεθνής Όνομα):

AMITRIPTYLINE HYDROCHLORIDE 50 mg/5ml

Φαρμακοτεχνική μορφή:

ORAL SOLUTION

Σύνθεση:

AMITRIPTYLINE HYDROCHLORIDE 50 mg/5ml

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

PSYCHOANALEPTICS

Καθεστώς αδειοδότησης:

Withdrawn

Ημερομηνία της άδειας:

2010-07-21

Φύλλο οδηγιών χρήσης

Page
1
of
11
PACKAGE LEAFLET: INFORMATION FOR THE USER
Amitriptyline Hydrochloride 25mg/5ml oral
solution
Amitriptyline Hydrochloride 50mg/5ml 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.
T
h
i
s
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 (myocar

Αρχείο Π.Χ.Π.

Page
1
of
14
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amitriptyline Hydrochloride 50mg/5ml 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.
Page
2
of
14
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