Trazodone Hydrochloride 50mg/5ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Trazodone hydrochloride

Available from:

Amdipharm Limited

ATC code:

N06AX; N06AX05

INN (International Name):

Trazodone hydrochloride

Dosage:

50 mg/5ml

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, What you
need
to know 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 CAREFULLY BEFORE YOU START USING 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, as

Summary of Product characteristics

Health Products Regulatory Authority
19 January 2021
CRN009VHH
Page 1 of 9
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 with known effect:
Benzoic acid 5mg/5ml, propylene glycol max.9.86mg/5ml, benzyl alcohol
0.1-0.2mg/5ml, ethanol 0.04-0.079mg/5ml, sorbitol
500mg/5ml
and
sodium
3mg/5ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution.
Colourless to yellowish clear to slightly opalescent solution with a
characteristic odour of orange.
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
Posology
_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.
_ELDERLY:_
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_ (See Section 4.4)._
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 gradual.
_HEPATIC IMPAIRMENT_
Trazodone unde