COMPOSITION :

Each capsule contains : Tramadol Hydrochloride 50 mg.

DESCRIPTION :

Tamadol (Tramadol Hydrochloride) is an analgesic with moderate to potent effect. It is absorbed after oral

administration and excreted mainly in the urine with an elimination half life of about 6 hours.

INDICATIONS :

Tamadol is indicated for the treatment of :

- Severe acute and chronic pain.

- Painful diagnostic or therapeutic measures.

DOSAGE & ADMINISTRATION :

Adults & children above 12 years of age : An initial dose of 1capsule (50mg) to be taken with a little liquid.

Another doses of 50-100mg every 4-6 hours can be taken if necessary .The total daily dose should not

exceed 400mg (Equivalent to 8 Capsules).

In patients with impaired hepatic or renal function it may be necessary to adjust the dose.

RESTRICTIONS ON USE :

Contraindications

- Acute intoxication with alcohol, hypnotics, analgesics, opioid or other CNS acting drugs.

- In patients who are taking or have taken monoamine oxidase inhibitors (MAOIs) for the last two weeks.

- Patients with epilepsy not adequately controlled by treatment .

Precautions

- Caution should be taken in patients with opioid dependent , head injury , shock , a reduced level of

consciousness , respiratory depression .

- Treatment with Tramadol should be given for short period under medical supervision in patients with

tendency to drug abuse or dependence .

Use in pregnancy and lactation

Tramadol should not be used in pregnant women and not recommended during breast feeding.

Effect on the ability to drive vehicles or use machines

Tramadol may cause somnolence and dizziness, therefore may impair the ability to drive or use machines .

DRUG INTERACTIONS :

- Tamadol should not be used concomitantly with MAO inhibitors.

- Concomitant administration with CNS acting drugs (e.g tranquilizers, hypnotics) may have

a synergistic effect on the sedative effect.

- Tramadol increase convulsions when taken with selective serotonin reuptake inhibitors , tricyclic

antidepressants, antipsychotics.

- Administration of CYP3A4 inhibitors (such as Ketoconazole, Erythromycin, Ritonavir) may inhibit the

metabolism of Tramadol .

ADVERSE EFFECTS :

Sweating, dizziness, somnolence, headache, nausea, vomiting, dry mouth and fatigue may occur. Other rare

adverse effects may include sleep disturbances, anxiety and convulsions.

OVERDOSAGE :

Symptoms in case of taking overdose may develop to coma, cardiovascular collapse, convulsions, respiratory

depression. Patients should be given symptomatic treatment. The antidote for respiratory depression is

naloxone, convulsions is treated by given IV Diazepam.

STORAGE INSTRUCTIONS :

Store below 30°C, in a dry place.

PRESENTATION :

Tamadol 50 : Pack of 10 capsules and hospital packs of different sizes.