Tramadol hydrochloride BP

To be submitted at the time of inclusion.

Capsule
Each Capsule contains Tramadol hydrochloride BP 50 mg.

Tramadol is indicated for the management of moderate to moderately severe pain.

For the treatment of painful conditions, 50 mg to 100 mg can be taken as needed for relief in every four to six hours, not to exceed 400 mg per day. For moderate pain, Tramadol 50 mg may be adequate as the initial dose, and for more severe pain, Tramadol 100 mg is usually more effective as the initial dose.

The most frequently reported side effects include constipation or diarrhea, difficulty in sleeping, dizziness, drowsiness, dry mouth, false sense of well being, feeling of unreality, mood changes, headache and indigestion. More serious side effects that may include changes in vision, difficulty in breathing, shortness of breath, fast or irregular heartbeat, hallucinations, passing urine more frequently than usual, or not passing urine as often as usual, skin reactions and seizures.

Do not drive, use machinery, or do anything that needs mental alertness until you know how Tramadol affects you. Avoid alcohol while taking Tramadol.

Known allergy to Tramadol.

There are no adequate and well-controlled studies in pregnant women. Tramadol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Tramadol should not be used by lactating mothers.

• Store in a cool and dry place, protect from light.
• Keep out of the reach of children.

To be submitted at the time of inclusion.