Trazodone 100mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Trazodone hydrochloride

Available from:

Teva UK Ltd

ATC code:

N06AX05

INN (International Name):

Trazodone hydrochloride

Dosage:

100mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030100; GTIN: 5017007011750

Patient Information leaflet

• weight loss
• difficulty in sleeping, unusual
behaviour (overexcited),
nervousness, agitation,
nightmares, reduced sexual desire
• feeling confused, restless,
sweating, tremor (shaking),
shivering, hallucinations (strange
visions or sounds), sudden jerks
of the muscles or a fast heart
beat. You may have something
called Serotonine syndrome.
• convulsion/fits
• feeling very unwell possibly with
shortness of breath (dyspnoea),
difficulty in walking or walking
with a shuffling gait, shaking,
uncontrolled muscle twitching,
and a high temperature (above
38ºC). This could be a rare case of
neuroleptic malignant syndrome.
• dizziness, headache, drowsiness
(this should wear off as you
continue to take Trazodone)
• eyesight problems, decreased
alertness, memory disturbances
• swelling of the brain, loss of the
ability to speak or write
• unusual skin sensations such as
numbness, tingling, pricking,
burning or creeping on the skin
(paraesthesia)
• abnormal muscle rigidity
• altered taste
• rapid or slow heart rate
• fall in blood pressure on standing
up which causes dizziness,
light-headedness or fainting,
increase in blood pressure
• nausea, vomiting, dry mouth
• constipation, diarrhoea,
indigestion, inflammation and
pain of stomach, increased
salivation, paralysis of intestine
• liver problems such as jaundice
(yellowing of the skin and whites
of the eyes caused by liver or
blood problems) and liver damage
• skin rash, itching, increased
perspiration
• joint pain, pain in the limbs, back
pain, muscle pain
• urinary disorders
• long-lasting painful erections
• weakness, oedema, fatigue, chest
pain, fever
• elevated liver enzymes
• heart problems.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. You can
also report side effects directly via
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can
help provide more information on
the safe

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trazodone 100mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100mg trazodone hydrochloride
Excipient with known effect
Each capsule contains 155.320 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.
_R