Description
INDICATIONS:
Treatment of moderate to severe pain.
CONTRAINDICATIONS:
Tramadol Hydrochloride XR is contraindicated:
- In hypersensitivity to the active substance or any of the excipients.
- In acute intoxication with alcohol, hypnotics, analgesics, opioids, or psychotropic medicinal products.
- In patients who are receiving (MAO) inhibitors or who have taken them within the last 14 days.
- In patients with epilepsy not adequately controlled by treatment.
- For use in narcotic withdrawal treatment.
SIDE EFFECTS:
Dizziness, nausea, headache, somnolence, constipation, dry mouth, vomiting, hyperhidrosis, fatigue
DOSAGE AND ADMINISTRATION:
The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected.
The total daily dose of (400 mg) active substance should not be exceeded, except in special circumstances. Unless otherwise prescribed, Tramadol XR should be administered as follows:
– Adults and adolescents above the age of 12 years:
The usual initial dose is 50-100 mg Tramadol Hydrochloride twice daily, morning and evening. If pain relief is insufficient, the dose may be titrated upwards to 150 mg or 200 mg Tramadol Hydrochloride twice daily.
– Children:
Tramadol XR is not suitable for children below the age of 12 years.
– Geriatric patients:
A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient’s requirements.
STORAGE CONDITIONS:
Store at 25°C; excursions permitted to 15-30°C.
Keep away from light and moisture.
HOW SUPPLIED:
A carton box of 20 extended release tablets.
