Trazodone Hydrochloride 50mg/5ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Trazodone hydrochloride

Available from:

Focus Pharmaceuticals Ltd

ATC code:

N06AX; N06AX05

INN (International Name):

Trazodone hydrochloride

Dosage:

50/5 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antidepressants; trazodone

Authorization status:

Not marketed

Authorization date:

2011-06-03

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAZODONE HYDROCHLORIDE 50MG/5ML ORAL SOLUTION
Trazodone Hydrochloride
SEVEN IMPORTANT THINGS YOU NEED TO KNOW ABOUT TRAZODONE ORAL SOLUTION.
You should read all of this leaflet carefully before taking your
medicine. It includes a lot
of additional important information.
•
TRAZODONE ORAL SOLUTION TREATS DEPRESSION AND DEPRESSION ACCOMPANIED
BY ANXIETY. Like all medicines it can cause side effects. Before you
start
taking your medicine it is important that you and your doctor discuss
the
benefits of treatment against the possible side effects (see section
4, Possible
side effects).
•
TRAZODONE ORAL SOLUTION SHOULD NOT BE USED BY CHILDREN AND
ADOLESCENTS UNDER 18 YEARS OLD (see section 3, How to take Trazodone
Oral
Solution).
•
SOME PEOPLE WHO ARE DEPRESSED OR ANXIOUS THINK OF HARMING OR KILLING
THEMSELVES. If you start to feel worse, or think of harming or killing
yourself,
SEE YOUR DOCTOR OR GO TO A HOSPITAL STRAIGHT AWAY (see section 4,
Possible
side effects).
•
TRAZODONE ORAL SOLUTION MAY NOT WORK STRAIGHT AWAY. Some people taking
antidepressants feel worse before feeling better. Your doctor should
ask to
see you again in a couple of weeks after you first start treatment.
Tell your
doctor if you haven’t started feeling better (see section 3, How to
take
Trazodone Oral Solution).
•
DON’T STOP TAKING TRAZODONE ORAL SOLUTION WITHOUT TALKING TO YOUR
DOCTOR
(see section 3, How to take Trazodone Oral Solution).
•
TAKING SOME OTHER MEDICINES WITH TRAZODONE ORAL SOLUTION CAN CAUSE
PROBLEMS. You may need to talk to your doctor (see section 2, Before
you
take Trazodone Oral Solution).
•
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.
READ ALL OF THIS LEAFLET. It includes a lot of important information
about this medicine.
This medicine has been prescribed for you. Do not pass it onto others.
It may harm
them, even if their symptoms are the same as yours.
Keep this leaf

Summary of Product characteristics

Health Products Regulatory Authority
19 October 2018
CRN008L49
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trazodone Hydrochloride 50mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains 50mg of Trazodone hydrochloride.
Excipients: sorbitol 350mg/5ml and sodium 3mg/5ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution.
Colourless to yellowish clear solution with an orange odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Relief of symptoms in all types of depression including depression
accompanied by
anxiety.
Symptoms of depression likely to respond in the first week of
treatment include
depressed mood, insomnia, anxiety, somatic symptoms and
hypochondriasis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral.
_ADULTS:_
Starting dose is 150mg/day in divided doses after food or as a single
dose before
retiring. This may be increased to 300mg/day, the major portion of
which is
preferably taken on retiring. In hospitalised patients dosage may be
further increased
to 600mg/day.
_CHILDREN:_
There are insufficient data on safety to recommend the use of
trazodone in children
below the age of 18 years.
Health Products Regulatory Authority
19 October 2018
CRN008L49
Page 2 of 13
_ELDERLY OR FRAIL:_
For very elderly or frail patients, the recommended initial starting
dose is reduced to
100mg/day given in divided doses or as a single night-time dose. This
may be
incrementally increased, under supervision, according to efficacy and
tolerance. In
general, single doses above 100mg should be avoided in these patients.
Doses
above 300mg/day are unlikely to be required.
A decrease in side effects (increase of the resorption and decrease of
the peak
plasma concentration) can be reached by taking trazodone hydrochloride
after a
meal.
In conformity with current psychiatric opinion, it is suggested that
trazodone be
continued for several months after remission. Cessation of trazodone
treatment
should be grad