Protradon®
capsules
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- Manufacturer:
- PRO.MED.CS Praha a.s.
- Marketing authorisation holder:
- PRO.MED.CS Praha a.s.
- Composition:
- Tramadol hydrochloride 50 mg in 1 capsule.
- Indication group:
- anodyne, analgesic
The following information is for health professionals only.
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Characteristics:
Tramadol is an agent relieving pain of any etiology. Its effect is caused by the opioid mechanism (agonistic effect on opium receptors) and the non-opioid mechanism (inhibition of reverse uptake of noradrenaline and serotonin into the nerve-ending). In comparison with other analgesics-anodynes, tramadol shows only an unimportant suppressive effect on respiration and circulation, it does not cause any constipation and genesis of dependence is very unlikely to occur.
Indications:
Acute and chronic, moderate and severe pain in adults and children over 14 years.
Contraindications:
Hypersensitivity to tramadol and opiates. Acute alcohol intoxication, intoxication by other analgesics and psycho-active agents. Concurrent use of MAO inhibitors. Drug dependence. Children bellow 1 year of age. Special care must be taken when administering Tramadol patiens with head injury, high intracranial pressure, severe renal or hepatic insufficiency, muscle cramps. The use of tramadol in pregnancy and lactation is possible only of really necessary.
Undesirable effects:
In usual therapeutic doses the undesirable effects are not frequent. Indesirable effect occure particularly when the patient is under physical strain. Sedation, fatigue, dizziness, anorexia, nausea and vomitus, dryness in the mouth and profuse sweating can appear. Rarely allergic exanthema or palpitation.
Interactions:
The suppressive effect of tramadol can be enhanced by concomitant administration of CNS suppressing drugs, for example alcohol, hypnotic and psycho-active agents, etc.
Concurent use of enzyme inductors (such as carbamazepine) may reduce plasma levels of tramadol.
Caution:
Protradon® cps., inj. can negatively influence motoric co-ordination and quick decision making. During the therapy with Protradon® cps., inj., alcohol in any form is strictly forbidden. Tramadol cannot be used to eliminate withdrawal symptoms of opiates. Tramadol should not be used longer than absolutely necessary.
Dosage:
Doses should be adequate to the intensity of pain and the individual sensitivity of the patient. Adults and children over 14 years of age usually use 1 - 2 capsules 4 times a day. If no analgetic effect occurs within 1 hour, it is possible to repeat the same dose. Long-term dosage is 1 capsule about 3 - 5 times daily (150 - 300 mg). The maximum daily dose 400 mg must not be exceeded.
Doses should be adjusted in patient with kidney or liver impairment.
Package:
Capsules: 10 capsules of 50 mg, 20 capsules of 50 mg.
Complete information about the preparation is included in the drug information sheet.
Date of the latest revision of the text: April 18, 2001.
The preparation available on medical prescription only.