Trazodone Hydrochloride 150 mg Film-Coated Tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

TRAZADONE HYDROCHLORIDE

Доступна з:

Azure Pharmaceuticals Ltd

Код атс:

N06AX05

ІПН (Міжнародна Ім'я):

TRAZADONE HYDROCHLORIDE

Дозування:

150 milligram(s)

Фармацевтична форма:

Film-coated tablet

Терапевтична области:

trazodone

Статус Авторизація:

Marketed

Дата Авторизація:

2020-07-03

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRAZODONE HYDROCHLORIDE 150 MG FILM-COATED TABLETS
(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 Hydrochloride 150 mg Film-coated Tablets are and what
they are used for
2.
What you need to know before you take Trazodone Hydrochloride 150 mg
Film-coated Tablets
3.
How to take Trazodone Hydrochloride 150 mg Film-coated Tablets
4.
Possible side effects
5.
How to store Trazodone Hydrochloride 150 mg Film-coated Tablets
6.
Contents of the pack and other information
1.
WHAT TRAZODONE HYDROCHLORIDE 150 MG FILM-COATED TABLETS ARE AND WHAT
THEY ARE USED FOR
The name of your medicine is Trazodone Hydrochloride 150 mg
Film-coated Tablets. Trazodone
Hydrochloride 150 mg Film-coated Tablets contain a medicine called
trazodone hydrochloride. This
belongs to a group of medicines called antidepressants.
Trazodone Hydrochloride 150 mg Film-coated Tablets can be used to
treat anxiety and depression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAZODONE HYDROCHLORIDE 150 MG
FILM-COATED
TABLETS
DO NOT TAKE TRAZODONE HYDROCHLORIDE 150 MG FILM-COATED TABLETS IF:
•
You are allergic (hypersensitive) to trazodone hydrochloride or any of
the other ingredients of
Trazodone Hydrochloride 150 mg Film-coated Tablets (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

Характеристики продукта

Health Products Regulatory Authority
03 July 2020
CRN008P7C
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trazodone Hydrochloride 150 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Film coated tablet contains Trazodone Hydrochloride 150 mg.
Excipient(s) with known effect:
Each tablet contains 50mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
Nominal tablet diameter is 11mm.
White coloured, circular, film-coated tablets with score line on both
sides.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Relief of symptoms in all types of depression including depression
accompanied by anxiety.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
DEPRESSION:
_Adults_
Initially 150mg/day in divided doses after food or as a single dose on
retiring.
This may be increased up to 300mg/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 600mg/day in divided
doses in hospitalised patients.
_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, as described under Adults, under supervision,
according to efficacy and tolerance. In general, single doses above
100 mg should be avoided in these patients. It is unlikely
that 300mg/day will be exceeded.
_Children:_
Trazodone hydrochloride is not recommended for use in children below
the age of 18 years due to a lack of data on safety.
DEPRESSION ACCOMPANIED BY ANXIETY:
As for depression.
ANXIETY:
75mg/day increasing to 300mg/day as necessary.
Health Products Regulatory Authority
03 July 2020
CRN008P7C
Page 2 of 9
A decrease in side-effects (increase of the resorption and decrease of
the peak plasma concentration) can be re