Trazodone 50mg capsules

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Trazodone hydrochloride

Доступно од:

Waymade Healthcare Plc

АТЦ код:

N06AX05

INN (Међународно име):

Trazodone hydrochloride

Дозирање:

50mg

Фармацеутски облик:

Oral capsule

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 04030100

Информативни летак

PAGE 1 OF 2
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
50 mg or 100 mg Capsules (called trazodone in this leaflet).
Trazodone contains the active substance trazodone
hydrochloride, which 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 THIS MEDICINE AND TELL YOUR DOCTOR IF:
•
You are allergic to trazodone hydrochloride 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.
•
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 your doctor or pharmacist before
taking trazodone.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING
TRAZODONE IF YOU:
•
Have or have ever had fits or seizures (epilepsy)
•
Have severe liver, kidney or heart problems
•
Are pregnant, trying to become pregnant or are
breast-feeding
•
Have

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trazodone 50 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50mg of trazodone hydrochloride
Excipient with known effect
Each capsule contains 77.660 mg of Lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
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
hepatic
impairment.
Periodic monitoring of liver function may be considered.