PENGESIC Capsule

In the treatment of moderate to severe acute or chronic pain and in painful diagnostic or therapeutic measures.

DOSAGE AND ADMINISTRATION

Oral, 50mg orally.

The dosage should be adjusted to the intensity of the pain. Unless otherwise prescribed, Pengesic should be taken as follows - independent of meals:

Single dose:

For adults and adolescents over 14 years of age:

One 50mg capsule to be taken with a little liquid. This is usually sufficient to relieve the pain. However, if pain relief is unsatisfactory, a further 50mg capsule may be taken after about 30-60 minutes.

In general the daily dose:

Should not exceed 400mg 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 Therefore the physician is to decide on the duration of treatment and whether the preparation is to be withdrawn temporarily.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.

It is generally contraindicated in the following conditions:

- respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion.

- in the presence of acute alcoholism, head injuries and conditions in which intracranial pressure is raised.

- it should not be used in patients receiving MAO inhibitors.

- previous hypersensitivity to Pengesic.

- it should not be used during pregnancy.

- it should not be administered during lactation as tramadol and its metabolites have been detected in breast milk.

 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.

 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 and phenothiazines.

 Opioid analgesics with some antagonist activity such as buprenorphine, butorphanol, nalbuphine or pentazocine may precipitate withdrawal symptoms in patients who have recently used pure agonists such as Pengesic.

 On the concomitant administration of Pengesic with substances 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 inhibitors.

- 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 infant.

- 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 alcohol.

- 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.

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 pan. 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.