Company name: Memphis Co. for Pharm. & Chem. Ind.

Trade name: Tramadol capsules

Generic name: Tramadol Hcl

Each capsule contains:
Tramadol Hcl                                    50 mg

Excipients: Lactose, magnesium stearate.

Pharmaceutical form: Capsules.

Pharmacological actions:
Tramadol is an opioid analgesic, acting on the central nervous system.
Tramadol exerts its effect by:
- Binding to µ-opioid receptors.
- Inhibition of reuptake of noradrenaline and serotonin.
Like other products of this class, Tramadol possesses antitussive properties.

After oral administration of 50 to 100 mg Tramadol Hcl, bioavailability is between 70–90%.
Peak serum concentration after administration of 100 mg tramadol is approximately 300 ng/ml (Cmax) and is reached after about 2 hours (Tmax).
Plasma protein binding is 20% and volume of distribution is 3 to 4 L/kg.
Elimination half-life is 5–7 hours.
Tramadol and its metabolites are excreted through the renal route (95%) and the rest is eliminated through feces.

Tramadol capsules are indicated in the treatment of moderate to severe pain in adults.

Dosage & administration:
- Like all analgesics, dose of Tramadol depends on the intensity of pain and clinical response of each patient.

- Acute pain:
100 mg (2 capsules) followed by 50 or 100 mg (1 or 2 capsules) every 4 to 6 hours, without exceeding 400 mg/24 hours (8 capsules).

- Chronic pain:
50 or 100 mg (1 or 2 capsules) followed by 50 or 100 mg (1 or 2 capsules) every 4 to 6 hours, without exceeding 400 mg/24 hours (8 capsules).

- From 75 years of age: It is recommended to increase the interval between doses (every 9 hours).

- In case of hepatic insufficiency: Reduce the dose by half or increase the interval between the doses by 2 times (every 12 hours).

- In case of renal insufficiency: Increase the interval between the doses by 2 times (every 12 hours if creatinine clearance < 30 ml/min).
Avoid using Tramadol if creatinine clearance < 10 ml/min.

Tramadol capsules are contraindicated in:

- Hypersensitivity to tramadol or other opiates or any of the components of the product.

- Overdosage or acute poisoning with central nervous system depressants (alcohol, hypnotics, other analgesics).

- Severe respiratory or hepatic insufficiency.

- Children less than 15 years.

- Uncontrolled epilepsy.

Side effects:
- Neuropsychic disorders (especially in elderly) including confusion and sometimes hallucinations and/or delirium.

- Convulsions especially after administration of high doses or concomitant treatment with drugs that lower the threshold of epilepsy.

- Nausea, vomiting, somnolence, headache, vertigo, sweating, malaise, dry mouth, constipation in case of long term administration.

- Rarely: abdominal pain, rash, asthenia, euphoria, minor disorders in vision, tachycardia, hypotension, palpitations, elevated arterial pressure.

- Very rare:
Anaphylactic reactions (urticaria, edema, bronchospasm and in some cases anaphylactic shock which may be fatal), dysuria and/or urine retention.

Respiratory depression in case of administration of doses higher than the recommended doses or in case of concomitant administration with other central depressants.

Cases of dependence, symptoms of withdrawal syndrome after long term use: agitation, anxiety, nervousness, insomnia, hyperkinesia, gastrointestinal disorders and rarely panic attack, severe anxiety, hallucinations, paresthesia, tinnitus and other problems in CNS.

In some cases, increase in the level of liver enzymes may occur.

Drug interactions:
- Administration of Tramadol should be separated from non-selective MAOIs therapy by 15 days.

- Tramadol is contraindicated with selective MAOIs (A & B).

- Concurrent administration of Tramadol with morphine derivatives (buprenorphine, nalbuphine or pentazocine) may lead to diminution of analgesic effect of Tramadol.

- Avoid taking alcoholic beverages or drugs containing alcohol during treatment with Tramadol.

- Concurrent administration of Tramadol with carbamazepine may lead to decreasing plasma concentrations of Tramadol.

- Concurrent administration of Tramadol with morphine derivatives, benzodiazepines, barbiturates may increase the risk of respiratory depression which may be fatal in case of overdosage.

-  Concurrent administration of Tramadol with central nervous system depressants like morphine, barbiturates, benzodiazepines, sedative antidepressants, antihistamines, anxiolytics, hypnotics, neuroleptics, central antihypertensives or baclofen may increase the risk of central nervous system depression.

- Concurrent administration of Tramadol with citalopram, sertraline, venlafaxine, drugs that lower epileptic threshold or phenothiazines increases the risk of occurrence of convulsions.

It is recommended to avoid use of Tramadol during pregnancy.

Lactation is contraindicated in case of long term use of Tramadol.

Precautions & warnings:
- Prolonged use of Tramadol over several months may lead to a state of dependence.
In susceptible patients, treatment should be under medical supervision.

- Tramadol is not adapted for treatment of withdrawal symptoms in patients presented with dependence to opioids.
Tramadol cannot correct the symptoms of morphine withdrawal.

- Patients with controlled epilepsy or susceptible to convulsions should not be treated with Tramadol capsules unless clearly needed.

- Tramadol should be used with caution in patients with intracranial hypertension, brain trauma, alteration in consciousness without obvious cause or respiratory dysfunction.

- Alteration of vigilance may be dangerous while driving cars or operating machines, especially when administering alcohol beverages or central nervous system depressants concomitantly with Tramadol.
Signs of overdosage: miosis, vomiting, cardiovascular collapse, respiratory depression which may lead to arrest of respiration, coma and convulsions.
- Maintenance of respiratory and cardiovascular functions.
- Transfer the patient to the hospital.
- Naloxone may be used in case of respiratory depression and diazepam in case of convulsions.

Therapeutic category: Opioid analgesic.

Legal category: POM.

Box containing 20 capsules in 2 strips.

Store in a dry place, at a temperature not exceeding 30°C, protect from light.

Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.