📌 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 and children above 12 years of age: An initial dose of 1 capsule (50 mg) to be taken with a little liquid. Another dose of 50-100 mg every 4-6 hours can be taken if necessary. The total daily dose should not exceed 400 mg (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, opioids 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 dependence, head injury, shock, a reduced level of consciousness, or respiratory depression.
• Treatment with Tramadol should be given for a short period under medical supervision in patients with a tendency to drug abuse or dependence.

Use in pregnancy and lactation

Tramadol should not be used in pregnant women and is not recommended during breastfeeding.

Effect on the ability to drive vehicles or use machines

Tramadol may cause somnolence and dizziness, therefore it 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., tranquillisers, hypnotics) may have a synergistic effect on the sedative effect.
• Tramadol increases convulsions when taken with selective serotonin reuptake inhibitors, tricyclic antidepressants, or 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 an overdose may develop into coma, cardiovascular collapse, convulsions, and respiratory depression. Patients should be given symptomatic treatment. The antidote for respiratory depression is naloxone; convulsions are treated by giving IV diazepam.

📌 STORAGE INSTRUCTIONS

Store below 30°C in a dry place.

📌 PHARMACEUTICAL FORMS

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