Paracetamol; Tramadol Hydrochloride

Visa No.: 893111495324

Product: Tatanol Ultra

API: Paracetamol; Tramadol Hydrochloride

Product Category: Pain Relief

Version approved leaflet: 36789e/QLD - ĐK_17/10/2025

INDICATIONS

• Tatanol Ultra is indicated for the symptomatic treatment of moderate to severe pain.
• Use of Tatanol Ultra should be restricted to patients with moderate to severe pain requiring combination therapy with paracetamol and tramadol (see Pharmacodynamic properties).
   

DOSAGE AND ADMINISTRATION

Dosage
Use of Tatanol Ultra should be restricted to patients with moderate to severe pain requiring combination therapy with paracetamol and tramadol.
The dosage should be adjusted according to the intensity of pain and the inpidual patient’s sensitivity. In general, the lowest effective dose that provides adequate analgesia should be selected. The total daily dose must not exceed 8 tablets (equivalent to 300 mg tramadol hydrochloride and 2600 mg paracetamol). The dosing interval must not be less than 6 hours.
Adults and adolescents aged 16 years and older: The maximum single dose of Tatanol Ultra is 1–2 tablets every 4–6 hours as needed for pain relief, up to a maximum of 8 tablets per day. The lowest effective dose should be used for the shortest possible duration. The dosing interval must not be less than 6 hours. 
In general, Tatanol Ultra should not be used for longer than absolutely necessary. If repeated dosing or long-term treatment is required due to the nature and severity of the condition, careful and regular monitoring (with treatment-free intervals where possible) is required to assess whether continued treatment is necessary.

Special populations:
Children under 16 years of age:
Tatanol Ultra is contraindicated in children under 12 years of age. The safety and efficacy of the tramadol 37.5 mg/paracetamol 325 mg combination have not been established in children aged 12 to under 16 years (see Contraindications and Warnings and Precautions – Other risk factors for life-threatening respiratory depression in children).

Elderly
No dose adjustment is generally required in patients up to 75 years of age in the absence of clinical signs of hepatic or renal impairment. In patients over 75 years of age, drug elimination may be prolonged; therefore, if necessary, the dosing interval may be extended according to inpidual patient requirements.

Renal impairment/dialysis:
The elimination of tramadol is delayed in patients with renal impairment; therefore, careful consideration should be given to extending the dosing interval according to inpidual patient needs.

Hepatic impairment:
The elimination of tramadol is delayed in patients with hepatic impairment; therefore, careful consideration should be given to extending the dosing interval according to inpidual patient needs (see Warnings and Precautions). Due to the presence of paracetamol, Tatanol Ultra should not be used in patients with severe hepatic impairment.

Method of administration: Oral use. Tablets should be swallowed whole with a sufficient amount of water and must not be broken or chewed.

Treatment objectives and discontinuation:
Before initiating treatment with Tatanol Ultra, a treatment strategy should be agreed with the patient, including the duration and goals of therapy, as well as a plan for treatment discontinuation, in accordance with pain management guidelines. During treatment, regular communication between the physician and the patient is required to assess the need for continued treatment, consider discontinuation, and adjust the dosage if necessary. When treatment with tramadol is no longer required, the dose should be tapered gradually to prevent withdrawal symptoms. In cases of inadequate pain control, the possibility of hyperalgesia, tolerance, or progression of the underlying disease should be considered (see Warnings and Precautions).
 

CONTRAINDICATIONS

Tatanol Ultra is contraindicated in the following cases:
- All children under 12 years of age.
- Postoperative pain management in children under 18 years of age following tonsillectomy and/or adenoidectomy.
- Patients with known hypersensitivity to tramadol, paracetamol, any other component of this product, or opioids.
- Acute intoxication with alcohol, hypnotics, narcotics, centrally acting analgesics, opioids, or psychotropic drugs.

• Patients receiving monoamine oxidase inhibitors (MAOIs) concomitantly or within the previous 14 days.
• Patients with significant respiratory depression (see Warnings and Precautions).
   

WARNINGS AND PRECAUTIONS

Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children.