Trazodone 100mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Trazodone hydrochloride

Available from:

IVAX Pharmaceuticals 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

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 Hydrochloride 100mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trazodone Hydrochloride 100mg
(For the full list of excipients, see section 6.1)
3
PHARMACEUTICAL FORM
Capsules
Hard gelatin, size 2, yellow-violet coloured capsules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Anxiety
Depression
Mixed anxiety and depression.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Depression:
a)
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.
b)
Older people: For very elderly or frail patients, the recommended
initial dose is
reduced to 100 mg a day, administered in divided doses or as a single
night time dose.
This may be incrementally increased, as described under Adults, under
supervision,
according to tolerance and efficacy. In general, single doses above
100 mg should be
avoided in these patients. It is unlikely that a dose of 300 mg per
day will be
exceeded.
c) Paediatric population: Trazodone is not recommended for use in
children below the
age of 18 years due to a lack of data on safety.
Decrease of the side-effects (increase of the resorption and decrease
of the peak
plasma concentration) can be reached by taking trazodone hydrochloride
after a meal.
Patients with hepatic Impairment:
Trazodone 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.
Patients with renal Impairment:
No dosage adjustment is usually necessary, but caution should be
exercised when
prescribing for patients with severe renal impa