Green and pale yellow capsule
Tramadol Hydrochloride 50
Active and Pharmacology
Pengesic is an opioid analgesic.
It binds with stereospecific receptors at many sites within the central
nervous system (CNS) to alter processes affecting both the perception of
pain and the emotional response to pain. Although the precise sites and
mechanism of action have not been fully determined, alterations in release
of various neurotransmitters from afferent nerves sensitive to painful
stimuli may be partially responsible for the analgesic effects. When these
medications are used as adjuncts to anaesthesia, analgesic action may
provide dose-related protection against haemodynamic responses to surgical
stress. It is readily absorbed from the gastrointestinal tract and is
excreted mainly in urine.
In the treatment of moderate to
severe acute or chronic pain and in painful diagnostic or therapeutic
It is generally contraindicated
in the following conditions:
especially in the presence of cyanosis and excessive bronchial secretion.
in the presence of acute
alcoholism, head injuries and conditions in which intracranial pressure in
it should not be used in
patients receiving MAO inhibitors.
previous hypersensitivity to
it should not be used during
it should not be administered
during lactation as tramadol and its metabolites have been detected in
It should be used with extreme
caution in patients with the following conditions:
Decreased respiratory reserves;
and should not be given during an attack of bronchial asthma or in heart
failure secondary to chronic lung disease, hypothyroidism, adrenocortical
insufficiency, impaired kidney or liver function, prostatic hypertrophy,
shock or inflammatory or obstructive bowel disorders, myasthenia gravis.
It should be given with great
care to infants, especially neonates.
The administration of opioid
analgesics during labour may cause respiratory depression in the newborn
Even when administered
according to instructions, the preparations may affect the reaction ability
of the patients to such an extent that his capacity to drive or operate
machines may be impaired. This applies particularly in conjunction with
Information for the patients:
Pengesic is a potent drug for
the relief of pain, e.g. in wound pain, fractures, severe nerve pain, tumour
pain, heart attack. It should not be used for minor pain. The effect sets in
quickly and lasts for some hours.
The commonest side effects are
nausea, vomiting, constipation, drowsiness and confusion.
Micturition may be difficult
and there may be ureteric or biliary spasm.
Others are dry mouth, sweating,
facial flushing, vertigo, bradycardia, palpitations, orthostatic
hypotension, hypothermia, restlessness, changes of mood, hallucinations,
miosis, cardiovascular collapse and convulsions.
Undesirable effects occur
particularly when the patient is under physical strain.
Cold, clammy skin; confusion;
convulsions; severe dizziness; severe drowsiness; pinpoint pupils of eyes
slow heartbeat; slow or troubled breathing; unconsciousness; severe
Intensive supportive therapy may
be required to correct failure and shock. In addition, the specific
antagonist naloxone hydrochloride is used to counteract very rapidly the
severe respiratory depression and coma produced by excessive doses of opioid
Drug Interactions and
It should be given with extreme
caution in patients taking monoamine oxidase inhibitors or within 14 days of
stopping such treatment.
The depressant effects of
Pengesic are enhanced by depressants of the central nervous system such as
alcohol, anaesthetics, hypnotics and sedatives, tricyclic anti depressants
Opioid analgesics with some
antagonist activity such as buprenorphine, butorphanol, nalbuphene or
pentazocine may precipitate withdrawal symptoms in patients who have
recently used pure agonists such as Pengesic.
On the concomitant
administration of Pengesic with subtances which also act on the central
nervous system (e.g tranquillizers, hypnotics) the sedative effects
(fatigue) may be intensified. At the same time, however, combining Pengesic
with a tranquillizer, for example, will probably have a favourable effect on
the pain sensation. Pengesic should not be used in patients receiving MAO
Dosage and Administration
Oral, 50 mg orally.
The dosage should be adjusted to
the intensity of the pain. Unless otherwise prescribed, Pengesic should be
taken as follows independent of meals:
For adults and adolescents over
14 years of age:
One 50 mg capsule to be taken
with a little liquid. This is usually sufficient to relieve the pain. If,
however, pain relief is unsatisfactory, a further 50 mg capsule may be taken
after about 30-60 minutes.
In general the daily dose:
Should not exceed 400 mg Pengesic.
In impaired renal or hepatic
function it may be necessary to adjust the dose.
Duration of treatment
During long-term treatment with
Pengesic, the possibility of dependence cannot be entirely excluded.
Therefore the physician is to decide on the duration of treatment and
whether the preparation is to be withdrawn temporarily. Pengesic should not
be given for longer than therapeutically necessary.
Store below 25°C. Protect from moisture.
Capsules 50 mg x 500's, Blisters
of 10 x 10's.