Product Information:

TRELAGET 100mg Tablets contain Tramadol Hydrochloride 100mg, a centrally acting synthetic opioid analgesic that works through dual mechanisms:

1. Weak mu-opioid receptor agonism
2. Inhibition of serotonin and norepinephrine reuptake

It is used for the management of moderate to moderately severe acute or chronic pain in adults when non-opioid analgesics are insufficient.

⚠️ Important Safety Note:

Tramadol is a Schedule H1 controlled substance in Pakistan due to its potential for dependence, abuse, and misuse. It carries risks of respiratory depression, seizures, and serotonin syndrome, especially at high doses or when combined with other serotonergic drugs.

Uses of (TRELAGET 100MG TABLETS):

1. Relief of moderate to severe acute pain (e.g., postoperative, dental, musculoskeletal injury)
2. Management of chronic pain conditions (e.g., osteoarthritis, neuropathic pain) when appropriate
3. Alternative to stronger opioids when lower risk of respiratory depression is desired

Key Benefits of (TRELAGET 100MG TABLETS):

1. Effective analgesia with lower respiratory depression risk than morphine
2. Dual mechanism enhances pain relief, especially in neuropathic pain
3. Oral formulation with predictable pharmacokinetics
4. Lower abuse potential than classic opioids (though still significant)

How To Use (TRELAGET 100MG TABLETS):

1. Take every 4–6 hours as needed for pain, with or without food.
2. Swallow whole with water—do not crush, chew, or split.
3. Maximum daily dose: 400mg/day (i.e., 4 tablets of 100mg) in adults with normal liver/kidney function.
4. Elderly or hepatic/renal impairment: Max 300mg/day (e.g., 100mg every 8 hours).
5. Use the lowest effective dose for the shortest duration.

When Not to Use (TRELAGET 100MG TABLETS):

Do not use if you have:

1. Hypersensitivity to tramadol or opioids
2. Acute intoxication with alcohol, hypnotics, or CNS depressants
3. Uncontrolled epilepsy or seizure disorder
4. Concurrent use of MAO inhibitors (or within 14 days)
5. Severe respiratory depression or asthma exacerbation

🚫 Not recommended for children <12 years; avoid in adolescents <18 years with obesity, obstructive sleep apnea, or compromised respiratory function.

Side Effects of (TRELAGET 100MG TABLETS):

Common:

1. Nausea, dizziness, headache
2. Constipation, dry mouth
3. Somnolence (drowsiness), sweating

Less common:

1. Vomiting, abdominal pain
2. Fatigue, itching

Serious (require monitoring):

1. Seizures (risk increases with dose >400mg/day or in epilepsy)
2. Serotonin syndrome (agitation, hallucinations, rapid heart rate)—especially with SSRIs, SNRIs, triptans
3. Respiratory depression (especially with overdose or concomitant CNS depressants)
4. Physical dependence and withdrawal (anxiety, insomnia, tremors on abrupt discontinuation)
5. Discontinue and seek emergency help if confusion, muscle rigidity, high fever, or slow/shallow breathing occurs.

Dosage: (TRELAGET 100MG TABLETS):

1. Adults: 50–100mg every 4–6 hours as needed
2. Starting dose: Often 50mg; 100mg may be used in opioid-tolerant patients
3. Maximum single dose: 100mg
4. Maximum daily dose: 400mg (300mg in elderly or impaired)

Who It’s For (TRELAGET 100MG TABLETS):

Adults requiring short- or long-term management of moderate to severe pain who have not responded adequately to non-opioid therapies.

Warnings & Precautions:

1. Avoid alcohol or other CNS depressants (benzodiazepines, sedatives)—↑ risk of respiratory depression
2. Use extreme caution in patients with seizure disorders, head injury, or drug/alcohol dependence
3. Do not discontinue abruptly after prolonged use—taper gradually
4. Monitor for signs of addiction or misuse

Drug Interactions:

1. SSRIs, SNRIs, MAOIs, triptans: ↑ Risk of serotonin syndrome
2. CNS depressants (alcohol, benzodiazepines): ↑ Sedation, respiratory depression
3. Carbamazepine: May reduce tramadol efficacy
4. Quinidine: May increase tramadol levels
5. Always inform your doctor about all medications.

Additional Information:

Store below 30°C in a dry place, protected from light and moisture. Keep in a secure location away from children and unauthorized persons. Do not use after the expiration date. Available by prescription only in Pakistan (Schedule H1).