1. Active Substance:

• Tramadol: Tramadol is the active pharmaceutical ingredient in Tramadol Retard tablets. It is a centrally acting opioid analgesic used to manage moderate to severe pain. Tramadol works by binding to opioid receptors in the brain and spinal cord, inhibiting the transmission of pain signals and altering the perception of pain.

2. Indications:

• Tramadol Retard is indicated for the treatment of moderate to severe pain that requires continuous, around-the-clock opioid analgesia.
• It may be prescribed for various conditions causing chronic pain, such as osteoarthritis, rheumatoid arthritis, neuropathic pain, and cancer pain.

3. Dosage:

• Each Tramadol Retard tablet contains 200 mg of tramadol hydrochloride.
• The dosage regimen and frequency of administration should be determined by a healthcare professional based on the individual patient’s pain intensity, medical history, and response to treatment.
• Tramadol Retard is an extended-release formulation designed for once or twice daily dosing.

4. Administration:

• Tramadol Retard tablets should be swallowed whole with a sufficient amount of water and should not be crushed, chewed, or split.
• The tablets can be taken with or without food, but should be taken consistently to maintain steady blood levels of tramadol.

5. Effectiveness:

• Tramadol Retard provides long-lasting pain relief by gradually releasing tramadol into the bloodstream over an extended period, resulting in sustained analgesic effects.
• It helps improve patients’ quality of life by effectively managing chronic pain and reducing the need for frequent dosing.

6. Safety Profile:

• Tramadol Retard is generally well-tolerated when used as prescribed. Common side effects may include nausea, vomiting, constipation, dizziness, drowsiness, and headache.
• Serious side effects such as respiratory depression, serotonin syndrome, and dependence may occur, particularly with misuse or overdose of tramadol.
• Patients should be monitored for signs of respiratory depression, especially when initiating treatment or adjusting dosage.

7. Contraindications:

• Tramadol Retard is contraindicated in patients with known hypersensitivity to tramadol or any of the excipients in the formulation.
• It should not be used in patients with severe respiratory depression, acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic drugs.

8. Precautions:

• Tramadol Retard should be used with caution in patients with a history of substance abuse, psychiatric disorders, or seizures.
• It should be avoided in pregnant or breastfeeding women unless the potential benefits outweigh the risks.
• Abrupt discontinuation of tramadol may precipitate withdrawal symptoms, so gradual tapering of the dosage is recommended when discontinuing treatment.

9. Storage:

• Tramadol Retard should be stored at room temperature (15°C to 30°C) in a dry place, away from moisture and heat.
• Keep the medication out of reach of children and pets.

Tramadol Retard 50x 200mg, manufactured by Sandoz, is a prolonged-release formulation of tramadol hydrochloride designed to provide continuous pain relief for patients with moderate to severe chronic pain. Treatment with Tramadol Retard should be initiated and supervised by a qualified healthcare professional, and patients should be closely monitored for efficacy and safety throughout the treatment period.