PENGESIC SR Tablet

Pengesic SR tablet is indicated for the management of moderate to severe pain.

Dosage and Administration

The dosage should be adjusted to the intensity of the pain and the sensitivity of the individual patient. Unless otherwise prescribed, Pengesic SR tablet 100mg should be taken as follows - with or without meals:

Single dose for adults and adolescents over 12 years of age: 1-2 tablets should be swallowed whole (not divided or chewed) with sufficient liquid, preferably mornings and evenings. If in severe pain the analgesic demand is likely to higher, 2 tablets can be taken as initial dose.

The lowest analgesically effective dose should generally be selected. Daily doses of 400mg tramadol hydrochloride should not be exceeded, except in special clinical circumstances. The dosage interval should not be less than 8 hours.

Children: On account of the dosage strength, Pengesic SR tablet 100mg are not recommended for children below the age of 12 years.

See the package insert about the details below.

- Geriatric patients

- Hepatic and renal insufficiency/dialysis

Duration of Treatment: This tablet must not be given for longer than therapeutically absolutely necessary. If long-term pain treatment is necessary, checks should be carried out at regular and brief intervals (if necessary with breaks in treatment) as to whether and in what doses further treatment with Pengesic SR is necessary.

- 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 Monoamine Oxidase (MAO) inhibitors.

- Previous hypersensitivity to Pengesic SR tablet.

- It should not be used during pregnancy.

- Tramadol can produce drug dependence of the mu-opioid type and may potentially be abused. Tolerance development, drug-seeking behavior and craving have been associated with the use of tramadol.

- The commonest side effects include abdominal or stomach pain, anorexia, asthenia, central nervous system (CNS) stimulation, constipation, diarrhea, dizziness or vertigo, drowsiness, dry mouth, dyspepsia, headache, nausea, pruritus, skin rash, sweating and vomiting.

- It should be given with extreme caution in patients taking MAO 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.

Contraindicated.

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 as 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, 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.

Tramadol is a centrally-acting analgesic that is not chemically related to opiates. The mechanism of action of tramadol has not been fully determined, but it may bind to mu-opioid receptors and inhibit the reuptake of norepinephrine (NE) and serotonin. The ability of tramadol to inhibit the neuronal uptake of monoamines in the same concentration range at which it binds to mu-opioid receptors differentiates it from typical opioids.