Trazodone Hydrochloride Azure 50 mg Hard Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TRAZADONE HYDROCHLORIDE

Available from:

Azure Pharmaceuticals Ltd

ATC code:

N06AX05

INN (International Name):

TRAZADONE HYDROCHLORIDE

Pharmaceutical form:

Capsule, hard

Therapeutic area:

trazodone

Authorization status:

Not marketed

Authorization date:

2022-09-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAZODONE HYDROCHLORIDE AZURE 50 MG HARD CAPSULES
TRAZODONE HYDROCHLORIDE AZURE 100 MG HARD CAPSULES
Trazodone hydrochloride
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.
WHAT IS IN THIS LEAFLET
1.
What Trazodone Capsules are and what they are used for
_2._
_ _
What you need to know before you take Trazodone Capsules
_ _
_3._
_ _
How to take Trazodone Capsules
_ _
4.
Possible side effects
_5._
_ _
How to store Trazodone Capsules
_ _
6.
Contents of the pack and other information
1. WHAT TRAZODONE CAPSULES ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Trazodone Hydrochloride Azure 50 mg or
100 mg Hard Capsules
(referred to as Trazodone Capsules throughout this leaflet). It
contains a medicine called Trazodone
hydrochloride. Trazodone belongs to a group of medicines called
antidepressants.
Trazodone Capsules are indicated for anxiety, depression, mixed
anxiety and depression.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAZODONE CAPSULES
DO NOT TAKE TRAZODONE CAPSULES IF:

You are allergic (hypersensitive) to trazodone hydrochloride or any of
the other ingredients of
Trazodone Capsules (listed in Section 6). Signs of an allergic
reaction can include: a rash,
swallowing or breathing problems, swelling of your lips, face, throat
or tongue.

You have recently had a heart attack.

You are a heavy drinker or are taking sleeping tablets.

You are under 18 years of age.
Do not take this medicine if any of the above applies to you. If you
are not sure, talk to you

Summary of Product characteristics

Health Products Regulatory Authority
30 September 2022
CRN009KGJ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trazodone Hydrochloride Azure 50 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg trazodone hydrochloride.
Excipient(s) with known effect: Each capsule contains 73.75 mg of
lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
Hard gelatin capsule of size '3' with blue/opaque cap marked 'THC'
with black colour and green opaque body marked '50' with
black colour containing white to off white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anxiety, depression, mixed anxiety and depression.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Depression:
_Adults:_
Initially 150 mg/day in divided doses after food or as a single dose
on retiring.
This may be increased up to 300 mg/day in a single or divided doses.
The major portion of a divided dose to be taken on
retiring. The dose may be further increased to 600 mg/day in divided
doses in hospitalised patients.
_Elderly:_
For very elderly or frail patients the recommended initial starting
dose is reduced to 100 mg/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 100 mg should be avoided in
these patients. It is unlikely that 300 mg/day will be
exceeded.
_Children:_
There are insufficient data on safety to recommend the use of
Trazodone in children below the age of 18 years.
Depression accompanied by anxiety:
As for depression.
_ _
Anxiety:
75 mg/day increasing to 300 mg/day as necessary.
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.
_Hepatic Impairment:_
Health Products Regulatory Authority
30 September 2022
CRN009KGJ
Page 2 of 8
Trazodone hydrochloride underg