Trazodone Hydrochloride 150 mg Film-Coated Tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

TRAZADONE HYDROCHLORIDE

Boleh didapati daripada:

Azure Pharmaceuticals Ltd

Kod ATC:

N06AX05

INN (Nama Antarabangsa):

TRAZADONE HYDROCHLORIDE

Dos:

150 milligram(s)

Borang farmaseutikal:

Film-coated tablet

Kawasan terapeutik:

trazodone

Status kebenaran:

Not marketed

Tarikh kebenaran:

2020-07-03

Risalah maklumat

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 Tablets are and what they are used for
2.
What you need to know before you take Trazodone Tablets
3.
How to take Trazodone Tablets
4.
Possible side effects
5.
How to store Trazodone Tablets
6.
Contents of the pack and other information
1.
WHAT TRAZODONE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Trazodone Hydrochloride 150 mg
Film-coated Tablets (called
‘Trazodone Tablets’ in this leaflet). Trazodone Tablets contain a
medicine called trazodone
hydrochloride. This belongs to a group of medicines called
antidepressants.
Trazodone Tablets can be used to treat anxiety and depression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAZODONE TABLETS
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR
IF:
•
You are allergic (hypersensitive) to trazodone hydrochloride or any of
the other ingredients
of Trazodone Tablets (listed in section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of
your lips, face, throat or tongue.
•
You consume alcohol or are taking sleeping tablets.
•
You have recently had a heart attack.
Do not take this medicine if any of the above applies to you. If you
are not sure, talk to your doctor
or pharmacist before taking Trazodone Tablets.
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH TRAZODONE TABLETS
THOUGHTS OF SUICIDE AND

Ciri produk

Health Products Regulatory Authority
11 April 2023
CRN00D80G
Page 1 of 8
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
_Adults_
The usual initial daily dose is 75 to 150 mg as a single evening dose
or in divided doses after food during the day, with
subsequent slow increments to the level of optimal control which may
be as high as 600 mg. Doses above 300 mg should only
be administered to hospitalised patients.
A starting dose of 75 mg is not achievable with this formulation,
therefore another formulation should be used.
_Elderly_
For very elderly or frail patients the recommended initial dose is
reduced to 100 mg a day administered 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 tolerance and efficacy. In general, single doses above
100 mg should be avoided in these patients. It is unlikely
that 300 mg per day will be exceeded.
A dose of 100 mg is not achievable with this formulation, therefore
another formulation should be used.
_Paediatric population_
The safety and efficacy of Trazodone hydrochloride in children below
the age of 18 years has not yet been established
therefore Trazodone hydrochloride is not recommended for use in this
age group .
_Hepat