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Acugesic


DESCRIPTION:

ACUGESIC TABLET 50 MG is a 7 mm square shape, apple green in colour tablet with marking 'duo 861'.

ACUGESIC CAPSULE 50 MG is a black/green size 3 capsule with marking 'DUO 861'.

COMPOSITION

ACUGESIC TABLET 50 MG : Each tablet contains Tramadol Hydrochloride 50 mg.

ACUGESIC CAPSULE 50 MG: Each capsule contains Tramadol Hydrochloride 50 mg.

INDICATIONS

Severe acute and chronic pain.

RECOMMENDED DOSAGE

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


Single dose for adults and adolescents over 14 years of age: 1 capsule/tablet to be taken with a little liquid. This is usually sufficient to relieve the pain. If, however, pain relief is unsatisfactory, a further TRAMADOL capsule/tablet can be taken after about 30-60 minutes. In general the daily dose should not exceed 400 mg Tramadol HCI (equivalent to 8 TRAMADOL capsules/tablets). In impaired renal or hepatic function it may be necessary to adjust the dose.


Duration of treatment: During long-term treatment with TRAMADOL 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 Therefore, the physician is to decide on the duration of treatment and whether the preparation is to be withdrawn temporarily. TRAMADOL should not be given for longer than therapeutically necessary.

CONTRAINDICATIONS

Acute intoxication with alcohol, hypnotics, analgesics or other CNS-acting drugs and hypersensitivity to tramadol or any excipients.
Note: In accordance with currently prevailing recommendation medication with the preparation during pregnancy should only be resorted to after careful consideration of the risks. So far no reports are available on its use during lactation. The preparation should be used with care in patients with increased reactivity to opioids.

WARNING & PRECAUTIONS

Even when administered according to instruction the preparations may affect the reaction ability of the patient to such an extent that his capacity to drive or operate machines may be impaired. This applies particularly in conjunction with alcohol. Should be used with caution in patients with myasthenia gravis.


Caution with patients with severe renal and hepatic impairment, head injury, increased intracranial pressure, and shock.

 

Children: Under 12 is not recommended.

INTERACTION WITH OTHER MEDICATIONS

On the concomitant administration of TRAMADOL with substances which also act on the central nervous system (eg. tranquillizers, hypnotics) the sedative effects (fatigue) may be intensified. At the same time, however, combining TRAMADOL with tranquillizer, for example will probably have a favourable effects on pain sensation. TRAMADOL should not be used in patients receiving MAO inhibitors.

Information for the patient: TRAMADOL is a potent drug for relief of pain, eg. in wound pain, fractures, severe nerve pain, tumor pain, heart attack. It should not be used for minor pain. The effect sets in quickly and lasts for some hours.

USE IN PREGNANCY & LACTATION

There are no adequate and well-controlled studies with TRAMADOL in pregnant women. TRAMADOL should be used during pregnancy only if the potential benefit outweighs the potential risk to the foetus.

TRAMADOL is not recommended for obstetric preoperative or for post-delivery analgesia in nursing mothers, because its safety in infants and newborns has not been studied. Low level of TRAMADOL have been detected in breast milk.

SIDE EFFECTS

Sweating, dizziness, nausea, vomiting, dry mouth, and fatigue may occur after TRAMADOL administration. It is also possible that the preparation may affect the cardiovascular system in rare cases. Undesirable effects occur particularly when the patient is under physical strain.

Special note: Respiratory depression has so far not been observed during treatment with TRAMADOL. However, it cannot definitely be ruled out if the recommended dosage is considerably exceeded or on the concomitant administration of other centrally depressant drugs.

STORAGE CONDITIONS

Store below 25C. Protect from light.


PACK SIZE

Containers of 100; 500; 1000 capsule/tablets

Strip packing of 10x10's; 50x10's; 100x10's

SHELF LIFE

3 years.

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