Description:

Doloforte Denk is a fixed-dose combination medication used for the symptomatic treatment of moderate to severe pain, including chronic cancer pain. It combines an opioid analgesic (tramadol) with a non-opioid pain reliever and fever reducer (paracetamol) for enhanced pain relief when a single agent is insufficient.

Prescription:

Prescription-only (Rx). This is a controlled medication due to the tramadol component (an opioid), which carries risks of addiction, dependence, and withdrawal. Availability may vary by country; in places like Ghana, it is regulated and typically requires a prescription.

Therapeutic Category:

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

Active Ingredients/Composition:

Each film-coated tablet contains:

• Tramadol hydrochloride 37.5 mg
• Paracetamol (acetaminophen) 325 mg

Vitamins: None.

Minerals: None.

Variant: Standard strength: Tramadol 37.5 mg + Paracetamol 325 mg per tablet (20-tablet pack as specified).

Consume Type:

Oral (swallow whole with water; film-coated tablet).

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 the lowest effective dose. Use for the shortest duration necessary. Not for children under 12 years. Take with or without food, but avoid alcohol. Follow doctor’s exact instructions, as dosing depends on pain severity and patient factors. Do not crush or chew.

Common Side Effects:

• Nausea, vomiting, constipation, dry mouth
• Dizziness, drowsiness, headache, somnolence
• Sweating, fatigue
• Less common: confusion, abdominal pain, diarrhea Serious risks include respiratory depression, addiction, serotonin syndrome (if combined with certain drugs), or liver damage from paracetamol overdose. Seek immediate medical help for severe side effects like difficulty breathing, seizures, or allergic reactions (rash, swelling).

Package Type:

Blister pack or box containing 20 film-coated tablets (20 tabs).

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

Safety Advice:

• Contains tramadol (opioid): Risk of addiction, misuse, and withdrawal; use only as prescribed.
• Paracetamol: Do not exceed recommended dose to avoid liver damage; avoid other paracetamol-containing products.
• Avoid alcohol, driving, or operating machinery if drowsy/dizzy.
• Not for acute severe pain requiring stronger opioids or long-term use without monitoring.
• Contraindicated in severe respiratory depression, acute alcohol intoxication, uncontrolled epilepsy, or hypersensitivity.
• Consult doctor if pregnant, breastfeeding, elderly, have liver/kidney issues, or take other medications (e.g., antidepressants, MAOIs).
• Do not stop abruptly after prolonged use.

Product Substitutes: Other tramadol + paracetamol combinations (e.g., Zaldiar, Tramacet, generic Tramadol/Paracetamol 37.5/325 mg). Alternatives depend on pain type: paracetamol alone, ibuprofen, codeine combinations, or stronger opioids like morphine—consult a doctor or pharmacist for suitable options.

Manufacturer/Marketer:

Denk Pharma GmbH & Co. KG (Germany); marketed/distributed in regions like Ghana, Kenya, and others.

Country of Origin:

Germany.