Description:

Trexamol Tablets is a combination analgesic medication containing tramadol hydrochloride and paracetamol (acetaminophen). It is used for the symptomatic treatment of moderate to severe pain when a single-agent analgesic is insufficient (e.g., post-operative pain, musculoskeletal pain, dental pain, or chronic pain conditions requiring stronger relief). The fixed-dose combination provides synergistic pain relief: tramadol acts centrally as an opioid agonist and serotonin/norepinephrine reuptake inhibitor, while paracetamol adds peripheral analgesic and antipyretic effects.

Prescription: Prescription-only (Rx). This is a controlled medication in Ghana due to the tramadol component (opioid with abuse potential, regulated under Ghana’s narcotics laws). Requires a doctor’s prescription; often monitored for misuse (e.g., via pharmacy records or specialist oversight).

Therapeutic Category:

Analgesic / Opioid analgesic combination / Centrally acting analgesic (Step II on WHO pain ladder for moderate to severe pain).

Active Ingredients/Composition: Each tablet contains:

• Tramadol hydrochloride 37.5 mg
• Paracetamol (acetaminophen) 325 mg (standard fixed-dose ratio in most generics; film-coated tablets).

Vitamins: None.

Minerals: None.

Variant: 37.5 mg tramadol / 325 mg paracetamol strength tablets (standard adult formulation; pack of 20’s or 30’s common in Ghana; no major variants noted beyond pack size).

Consume Type:

Oral (tablet; swallow whole with water; can be taken with or without food, but food may reduce GI upset from tramadol).

Directions/Usage: Adults and adolescents over 12 years: Usually 1-2 tablets every 4-6 hours as needed, not exceeding 8 tablets per day (300 mg tramadol / 2600 mg paracetamol maximum). Start with lowest effective dose. Use for the shortest duration necessary; do not exceed recommended limits to avoid paracetamol hepatotoxicity or tramadol dependence. Not for children under 12 years. Take as prescribed; follow doctor’s exact instructions based on pain severity and patient factors. Do not crush/chew.

Common Side Effects:

• Nausea, vomiting, constipation, dry mouth
• Dizziness, drowsiness, headache, somnolence
• Sweating, fatigue
• Less common: confusion, abdominal pain, diarrhoea Serious risks include respiratory depression, addiction/dependence (tramadol opioid), serotonin syndrome (with certain drugs), or liver damage (paracetamol overdose). Seek immediate help for severe effects like difficulty breathing, seizures, rash/swelling, or confusion.

Package Type:

Blister packs or strips of 10 or 20 tablets (often 20’s or 30’s in carton; standard pharmaceutical packaging with foil blisters).

Storage Advice: Store at room temperature (below 25-30°C), in a cool, dry place away from direct sunlight, heat, and moisture. Keep in original packaging and out of reach of children.

Safety Advice:

• Contains tramadol (opioid): Risk of addiction, misuse, tolerance, and withdrawal; use only as prescribed and shortest duration.
• Paracetamol: Do not exceed dose (risk of severe liver damage); avoid other paracetamol products.
• Avoid alcohol (enhances sedation/liver risk), driving/machinery if drowsy/dizzy.
• Contraindicated in severe respiratory depression, acute alcohol intoxication, uncontrolled epilepsy, or hypersensitivity.
• Caution in elderly, liver/kidney impairment, or with antidepressants/MAOIs (serotonin syndrome risk).
• Pregnancy/breastfeeding: Consult doctor (tramadol risks fetal dependence/withdrawal).
• Do not stop abruptly after prolonged use (taper under supervision). Report persistent pain or side effects.

Product Substitutes: Other tramadol + paracetamol combinations in Ghana: Zaldiar (original), Tramacet generics, Doloforte Denk, or similar 37.5/325 mg brands (e.g., from Exeter, Entrance, or importers). Alternatives for pain: Paracetamol alone, ibuprofen, codeine combinations, or stronger opioids (e.g., morphine)—consult doctor/pharmacist for suitable options based on pain type/severity.

Manufacturer/Marketer:

Exeter Pharmaceuticals Limited.

Country of Origin:

United Kingdom