Trazodone 50mg/5ml oral solution sugar free

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Trazodone hydrochloride

Fáanlegur frá:

Focus Pharmaceuticals Ltd

ATC númer:

N06AX05

INN (Alþjóðlegt nafn):

Trazodone hydrochloride

Skammtar:

10mg/1ml

Lyfjaform:

Oral solution

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04030100; GTIN: 5060064791417

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAZODONE HYDROCHLORIDE 50MG/5ML ORAL SOLUTION
Trazodone Hydrochloride
SEVEN IMPORTANT THINGS YOU NEED TO KNOW ABOUT TRAZODONE ORAL SOLUTION.
You should read all of this leaflet carefully before taking your
medicine. It
includes a lot of additional important information.
•
TRAZODONE ORAL SOLUTION TREATS DEPRESSION AND DEPRESSION
ACCOMPANIED BY ANXIETY. Like all medicines it can cause side effects.
Before you start taking your medicine it is important that you and
your
doctor discuss the benefits of treatment against the possible side
effects (see section 4, Possible side effects).
•
TRAZODONE ORAL SOLUTION SHOULD NOT BE USED BY CHILDREN AND
ADOLESCENTS UNDER 18 YEARS OLD (see section 3, How to take Trazodone
Oral Solution).
•
SOME PEOPLE WHO ARE DEPRESSED OR ANXIOUS THINK OF HARMING OR KILLING
THEMSELVES. If you start to feel worse, or think of harming or killing
yourself, SEE YOUR DOCTOR OR GO TO A HOSPITAL STRAIGHT AWAY (see
section
4, Possible side effects).
•
TRAZODONE ORAL SOLUTION MAY NOT WORK STRAIGHT AWAY. Some people
taking antidepressants feel worse before feeling better. Your doctor
should ask to see you again in a couple of weeks after you first start
treatment. Tell your doctor if you haven’t started feeling better
(see
section 3, How to take Trazodone Oral Solution).
•
DON’T STOP TAKING TRAZODONE ORAL SOLUTION WITHOUT TALKING TO YOUR
DOCTOR
(see section 3, How to take Trazodone Oral Solution).
•
TAKING SOME OTHER MEDICINES WITH TRAZODONE ORAL SOLUTION CAN CAUSE
PROBLEMS. You may need to talk to your doctor (see section 2, Before
you take Trazodone Oral Solution).
•
If any of the side effects get serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or pharmacist.
READ ALL OF THIS LEAFLET. It includes a lot of important information
about this
medicine.
This medicine has been prescribed for you. Do not pass it onto others.
It
may harm them, even if their symptoms are the same as yours.
Keep this leafle

Vara einkenni

OBJECT 1
TRAZODONE HYDROCHLORIDE 50MG/5ML ORAL
SOLUTION
Summary of Product Characteristics Updated 05-Sep-2017 | Concordia
International- formerly Focus
Pharmaceuticals Ltd
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: sorbitol 350mg/5ml and sodium 3mg/5ml.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Solution.
Colourless to yellowish clear solution with an orange odour.
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
Route of administration: Oral.
_ADULTS:_
Starting dose is 150mg/day in divided doses after food or as a single
dose before retiring. This may be
increased to 300mg/day, the major portion of which is preferably taken
on retiring. In hospitalised
patients dosage may be further increased to 600mg/day.
_CHILDREN:_
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 given in
divided doses or as a single night-time dose. This may be
incrementally increased, under supervision,
according to efficacy and tolerance. In general, single doses above
100mg should be avoided in these
patients. Doses above 300mg/day are unlikely to be required.
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.
In conformity with current psychiatric opinion, it is suggested that
trazodone be continued for several
months after remission. Cessation of trazodone treatment should be
gradual.
_HEPA