Trazodone 150mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Trazodone hydrochloride

Verfügbar ab:

Creo Pharma Ltd

ATC-Code:

N06AX05

INN (Internationale Bezeichnung):

Trazodone hydrochloride

Dosierung:

150mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 04030100; GTIN: 5060222600605

Gebrauchsinformation

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAZODONE HYDROCHLORIDE 150 MG 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 is and what it is used for
2.
What you need to know before you take trazodone
3.
How to take trazodone
4.
Possible side effects
5.
How to store trazodone
6.
Contents of the pack and other information
1.
WHAT TRAZODONE IS AND WHAT IT IS USED FOR
The name of your medicine is Trazodone hydrochloride 150 mg tablets
(called trazodone in this
leaflet). This belongs to a group of medicines called antidepressants.
Trazodone can be used to treat anxiety and depression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAZODONE
_ _
DO NOT TAKE TRAZODONE:
-
if you are allergic to trazodone or any of the other ingredients of
this medicine
(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.
-
if you have recently had a heart attack.
-
if you are a heavy drinker or are taking sleeping tablets.
-
if 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.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking trazodone.
THOUGHTS OF SUICIDE AND WORSENING OF YOUR DEPRESSION OR ANXIETY
DISORDER
If you are depressed and/or have anxiety disorders you can sometimes
have thoughts of harming or
killing yourself. These may be increa

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trazodone 150 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150mg of trazodone hydrochloride
Excipient with known effect
Each tablet contains 106.430 mg of Lactose monohydrate, less than 1
mmol of
Sodium (23 mg), 0.95 mg of Propylene glycol.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Relief of symptoms in all types of depression, including 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 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, under
supervision,
according to efficacy and tolerance. In general, single doses above
100mg
should be avoided in these patients. It is unlikely that 300mg/day
will be
exceeded.
_Paediatric population_
There are insufficient data to recommend the use of Trazodone
hydrochloride
in children below the age of 18 years.
DEPRESSION ACCOMPANIED BY ANXIETY:
As for depression.
ANXIETY:
75mg/day increasing to 300mg/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:_
Trazodone hydrochloride 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 prescribing for patients
with
hepatic
impairment,
particularly
in
cases
of
severe
hepat