Product Information:

TREVIA R2 15+100 Tablets is a fixed-dose combination containing:

1. Tapentadol Hydrochloride 100mg – a centrally acting dual-mechanism analgesic (mu-opioid agonist + norepinephrine reuptake inhibitor)
2. Rabeprazole Sodium 15mg – a proton pump inhibitor (PPI) that reduces gastric acid secretion

This combination is designed to provide effective pain relief while protecting the stomach from opioid-induced gastric irritation, acidity, or ulcer risk—particularly in patients requiring short-term management of moderate to severe acute pain.

⚠️ Important Note:

Tapentadol is a Schedule H1 controlled substance in Pakistan due to its opioid properties. Use only as prescribed for short-term pain relief.

Uses of (TREVIA R2 15+100 TABLETS):

1. Short-term treatment of moderate to severe acute pain (e.g., postoperative, dental, musculoskeletal injury)
2. Pain management in patients at increased risk of gastric irritation (e.g., history of dyspepsia, NSAID/steroid use)
3. Alternative to tramadol or traditional opioids when better GI tolerability is desired

Key Benefits of (TREVIA R2 15+100 TABLETS):

1. Dual-action pain relief: Tapentadol offers potent analgesia with lower nausea/vomiting than classic opioids
2. Gastric protection: Rabeprazole reduces risk of acid-related complications during opioid therapy
3. No active metabolites (unlike tramadol)—safer in hepatic impairment
4. Once- or twice-daily dosing flexibility based on pain severity

How To Use (TREVIA R2 15+100 TABLETS):

1. Take one tablet 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: Typically not exceeding 500mg tapentadol/day (i.e., 5 tablets), but individualized by physician.
4. Use the lowest effective dose for the shortest duration (usually ≤5–7 days).

When Not to Use (TREVIA R2 15+100 TABLETS):

Do not use if you have:

1. Significant respiratory depression or acute asthma
2. Paralytic ileus or severe GI obstruction
3. Hypersensitivity to tapentadol, rabeprazole, or any excipients
4. Concurrent use of MAO inhibitors (or within 14 days)
5. Severe hepatic impairment (Child-Pugh C)

🚫 Not approved for children <18 years.

Side Effects of (TREVIA R2 15+100 TABLETS):

Common:

1. Nausea, dizziness, headache
2. Drowsiness, dry mouth
3. Constipation (less than morphine/tramadol)
4. Abdominal pain, flatulence (from rabeprazole)

Less common:

1. Vomiting, fatigue, sweating
2. Diarrhea, rash

Serious (require monitoring):

1. Respiratory depression (especially with overdose or CNS depressants)
2. Serotonin syndrome (if combined with SSRIs, SNRIs, MAOIs)
3. Seizures (rare; higher risk with high doses)
4. Hypomagnesemia or vitamin B12 deficiency (with prolonged rabeprazole use >1 year)
5. Discontinue and seek emergency help if slow breathing, confusion, hallucinations, or severe diarrhea occur.

Dosage: (TREVIA R2 15+100 TABLETS):

1. Adults: 1 tablet (tapentadol 100mg + rabeprazole 15mg) every 4–6 hours as needed
2. Elderly or mild hepatic/renal impairment: Start with longer intervals (e.g., every 6–8 hours)
3. Maximum daily dose: 5 tablets (500mg tapentadol + 75mg rabeprazole)
4. Duration: Short-term only (≤7 days for acute pain)

Who It’s For (TREVIA R2 15+100 TABLETS):

Adults requiring short-term management of moderate to severe acute pain who are at risk of gastric side effects from analgesics.

Warnings & Precautions:

1. Avoid alcohol or other CNS depressants (benzodiazepines, sedatives)—↑ risk of respiratory depression
2. Use caution in elderly, COPD, or debilitated patients
3. Risk of dependence—even at prescribed doses—limit to short-term use
4. Do not discontinue abruptly after prolonged use—taper to avoid withdrawal
5. Monitor for C. difficile diarrhea if used >3 days

Drug Interactions:

1. CNS depressants: ↑ Sedation, respiratory depression
2. SSRIs, SNRIs, MAOIs: ↑ Risk of serotonin syndrome
3. Clopidogrel, methotrexate, digoxin: Altered absorption due to rabeprazole-induced pH changes
4. Atazanavir, rilpivirine: ↓ Absorption—avoid concomitant use
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).