Trazodone 100mg/5ml oral solution sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Trazodone hydrochloride

Available from:

Zentiva Pharma UK Ltd

ATC code:

N06AX05

INN (International Name):

Trazodone hydrochloride

Dosage:

20mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030100; GTIN: 5060222601367

Patient Information leaflet

804354
Measurement Bar (mm)
CUST. SPEC. DATE: N.A.
Approved date and signature:
FILE REF. & REVISION: N.A.
SIZE: 135 x 550 mm
FOLDED LEAFLET SIZE: 135 x 34,375 mm
CUSTOMER: RAFARM
MATERIAL SPEC: 40 g/m
2
PRODUCT NAME: TRAZODONE 100mg/5ml
PHARMA CODE: 693 ( I X I XX I XX I )
FIBER DIRECTION: parallel to 550 mm side
PRODUCT CODE: 804354
NOTES:
Colors:
Black
SPECIAL REQUEST
THE FOLLOWING HAS BEEN CHECKED:
FOLDING
1. Text
2. Graphic drawing up
3. Size
4. Color reference
5. Technical specifications
Tel. [phone] Fax. [phone]
e-mail: [e-mail]
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05/12/2017
J.Vlajic
Measurement Bar (mm)
CUST. SPEC. DATE: N.A.
Approved date and signature:
FILE REF. & REVISION: N.A.
SIZE: 135 x 550 mm
FOLDED LEAFLET SIZE: 135 x 34,375 mm
CUSTOMER: RAFARM
MATERIAL SPEC: 40 g/m
2
PRODUCT NAME: TRAZODONE 100mg/5ml
PHARMA CODE: 693 ( I X I XX I XX I )
FIBER DIRECTION: parallel to 550 mm side
PRODUCT CODE: 804354
NOTES:
Colors:
Black
SPECIAL REQUEST
THE FOLLOWING HAS BEEN CHECKED:
FOLDING
1. Text
2. Graphic drawing up
3. Size
4. Color reference
5. Technical specifications
Tel. [phone] Fax. [phone]
e-mail: [e-mail]
d1
d2
d3
d4
d5
d6
d7
d9
X
d8
05/12/2017
J.Vlajic

Summary of Product characteristics

OBJECT 1
TRAZODONE HYDROCHLORIDE 100MG/5ML ORAL
SOLUTION
Summary of Product Characteristics Updated 26-Feb-2018 | Creo Pharma
Limited
1. Name of the medicinal product
Trazodone Hydrochloride 100mg/5ml Oral Solution
2. Qualitative and quantitative composition
Each 5ml contains 100mg of trazodone hydrochloride.
Excipients with known effect:
Sorbitol (E420): 437.5 mg per 5ml dose.
Ethanol: 0. 0125 mg per 5ml dose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Solution
Clear, colourless to yellowish solution with characteristic 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
Posology
_Adults_
Starting dose is 150mg/day (7.5ml) in divided doses after food or as a
single dose before retiring. This
may be increased to 300mg/day (15ml), the major portion of which is
preferably taken on retiring. In
hospitalised patients dosage may be further increased to 600mg/day
(30ml).
_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 (5 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 (5 ml) should be avoided in these patients.
Doses above 300mg/day (15 ml) 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 severa