Trazodone Hydrochloride 50mg/5ml Oral Solution

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Trazodone hydrochloride

Dostępny od:

Key Pharmaceuticals Ltd

Kod ATC:

N06AX; N06AX05

INN (International Nazwa):

Trazodone hydrochloride

Dawkowanie:

50/5 milligram(s)/millilitre

Forma farmaceutyczna:

Oral solution

Dziedzina terapeutyczna:

Other antidepressants; trazodone

Status autoryzacji:

Marketed

Data autoryzacji:

2019-06-07

Ulotka dla pacjenta

PACKAGE LEAFLET
KEY PHARMACEUTICALS LTD.
TRAZODONE HYDROCHLORIDE 50MG/5ML ORAL SOLUTION PA0343/007/001
Version no 04 (June 2018)
Page
1
of
6
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAZODONE HYDROCHLORIDE 50MG/5ML ORAL SOLUTION
Trazodone Hydrochloride
YOU AND YOUR CAREGIVER SHOULD 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 Oral Solution is and what it is used for
2.
What you need to know before you take Trazodone Oral Solution
3.
How to take Trazodone Oral Solution
4.
Possible side effects
5.
How to store Trazodone Oral Solution
6.
Contents of the pack and other information
1.
WHAT TRAZODONE ORAL SOLUTION IS AND WHAT IT IS USED FOR
The name of your medicine is Trazodone 50mg/5ml Oral Solution (called
Trazodone Oral Solution
throughout this leaflet).
The active substance is trazodone hydrochloride. This belongs to a
group of medicines called
antidepressants.
Trazodone Oral Solution can be used to treat anxiety and depression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAZODONE ORAL SOLUTION
_ _
DO NOT TAKE TRAZODONE ORAL SOLUTION:
•
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:red and lumpy skin rash,
swallowing or breathing
problems, swelling of your eyelids, lips, face, throat or tongue,
unexplained high temperature
(fever) and feeling faint
•
if you have recently had a heart attack
•
if you are a heavy drinker or are taking sleeping tablets
•
if yo

Charakterystyka produktu

Health Products Regulatory Authority
10 June 2019
CRN008KLQ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trazodone Hydrochloride 50mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains 50mg of trazodone hydrochloride.
Excipients with known effect:
Sorbitol (E420): 199.5 mg per ml.
Sodium: 0.27 mg per ml.
Glycerol (E422): 370.0 mg per ml.
Sodium benzoate (E211): 1.0 mg per ml.
Propylene glycol: 1.9 mg per ml.
Ethanol: 0.01mg per ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear, colourless to yellowish solution with a characteristic odour of
orange.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Relief of symptoms in all types of depression including depression
accompanied by anxiety.
Symptoms of depression likely to respond in the first week of
treatment include depressed mood, insomnia, anxiety, somatic
symptoms and hypochondriasis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
Starting dose is 150mg/day (15ml) in divided doses after food or as a
single dose before retiring. This may be increased to
300mg/day (30ml), the major portion of which is preferably taken on
retiring. In hospitalised patients dosage, may be further
increased to 600mg/day (60ml).
Children and adolescents
There are insufficient data on safety to recommend the use of
trazodone in children below the age of 18 years.
Elderly or Frail
For very elderly or frail patients, the recommended initial starting
dose is reduced to 100mg/day (10 ml) 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 (10 ml) should be avoided in these patients. Doses above
300mg/day (30 ml) are unlikely to be required.
Health Products Regulatory Authority
10 June 2019
CRN008KLQ
Page 2 of 9
A decrease in side-effects (increase of the resorption and decrease of
the peak plasma concentration) can be reac