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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preparation is to be withdrawn temporarily.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 25°C. 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. |
