NapaDol

Indications

This tablet is used for:

• Managing moderate to moderately severe pain in adults.
• Short-term relief (up to five days) of acute pain.

Pharmacology

The combination of Paracetamol and Tramadol provides effective pain relief. Paracetamol, known for its analgesic and antipyretic properties, works mainly in the central nervous system by inhibiting COX enzymes involved in prostaglandin synthesis, making it a safe and fast-acting option. Tramadol, a synthetic opioid analgesic, operates through multiple mechanisms including μ-opioid receptor binding and the inhibition of norepinephrine and serotonin reuptake, contributing to its overall analgesic effects.

Dosage & Administration

• For moderate to moderately severe pain: Take 1 or 2 tablets every 4 to 6 hours as needed, with a maximum of 8 tablets per day.
• For short-term acute pain relief (up to five days): Take 2 tablets every 4 to 6 hours as needed, up to a maximum of 8 tablets per day.

Can be taken with or without food.

Contraindications

Do not use if you have a known hypersensitivity to tramadol, paracetamol, opioids, or any components of this product. Avoid in situations where opioid use is contraindicated.

Side Effects

Possible side effects include:

• Asthenia, fatigue, and dizziness
• Headache, tremor, and abdominal pain
• Constipation, diarrhea, and nausea
• Dry mouth, anxiety, confusion
• Euphoria, insomnia, and rash

Pregnancy & Lactation

• Pregnancy Category C: Use only if the potential benefits justify the potential risks to the fetus. Not recommended for use in obstetrical preoperative medication or post-delivery analgesia in nursing mothers due to insufficient safety data for infants and newborns.

Precautions & Warnings

• May impair abilities required for tasks like driving or operating machinery.
• Avoid consumption with alcohol.
• Do not combine with other tramadol or paracetamol-containing products.
• Use with caution if taking tranquilizers, hypnotics, or other opioid analgesics.

Use in Special Populations

• Pediatric Use: Safety and effectiveness not established in children.
• Geriatric Use: Caution advised due to increased likelihood of decreased organ function and concurrent medications.
• Renal Disease: Adjust dosing interval for patients with creatinine clearance <30 ml/min, with a maximum of 2 tablets every 12 hours.
• Hepatic Disease: Not recommended for patients with impaired hepatic function.

Therapeutic Class

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Storage Conditions

Store in a cool, dry place. Do not freeze. Keep out of reach of children.