Trazodone hydrochloride 100 mg Capsules, Hard

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Trazodone hydrochloride

זמין מ:

Brillpharma (Ireland) Limited

קוד ATC:

N06AX; N06AX05

INN (שם בינלאומי):

Trazodone hydrochloride

כמות:

100 milligram(s)

טופס פרצבטיות:

Capsule, hard

איזור תרפויטי:

Other antidepressants; trazodone

מצב אישור:

Not marketed

תאריך אישור:

2016-12-16

עלון מידע

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PACKAGE LEAFLET: INFORMATION FOR THE
USER
TRAZODONE HYDROCHLORIDE 50 MG AND 100 MG CAPSULES, HARD
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 Capsule is and what it is used
for
2. What you need to know before you take Trazodone Capsule
3. How to take Trazodone Capsule
4. Possible side
effects
5. How to store Trazodone Capsule
6. Contents of the pack and other
information
1. WHAT TRAZODONE CAPSULE IS AND WHAT IT IS USED
FOR
The name of this medicine is Trazodone hydrochloride 50 mg and 100 mg
Capsules,
Hard (referred to as Trazodone Capsule throughout this leaflet).
Trazodone
Capsules
contain a medicine called trazodone hydrochloride. Trazodone belongs
to a group of
medicines called antidepressants.
Trazodone Capsule is used to treat depression and depression
accompanied by anxiety.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAZODONE
CAPSULE
DO NOT TAKE TRAZODONE CAPSULE IF
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
You are allergic to active substance or any of the other ingredients
of this medicine
(listed in Section 6).
The symptoms of an allergic reaction can include: a rash, swelling of
your lips,
face, throat or tongue, swallowing or breathing problems,

You have recently had a heart attack

You are taking sleeping tablets or a heavy drinker

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
your doctor or pharmacist before taking Trazodone Capsule.
WARNINGS AND
PRECAUTIONS
Talk to your

מאפייני מוצר

Health Products Regulatory Authority
05 September 2022
CRN00CYFN
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trazodone hydrochloride 100 mg Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg of Trazodone hydrochloride.
Excipients with known effect: Each capsule contains 154.00 mg of
lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Purple/yellow hard gelatin capsule of size '2' and imprinted with 'BL'
and '100' on cap/body, containing white to off white
granular powder.
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 75 mg to 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 hospitalized patients.
A starting dose of 75 mg or 150 mg is not achievable with a 100 mg
capsule, therefore another formulation/strength should be
used.
_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.
_Hepatic Impairment:_
Trazodone undergoes extensive hepatic metabolism, see section 5.2, and
has also been associated with hepatotoxicity, see
sections 4.4 and 4.8. Therefore caution should be exercised when
p