TRAMADOL HYDROCHLORIDE KRKA Prolonged-release tablet Ref.[110008] Active ingredients: Tramadol

Posology

The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. The total daily dose of 400 mg active substance should not be exceeded, except in special circumstances.

Unless otherwise prescribed, Tramadol hydrochloride Krka should be administered as follows:

Adults and adolescents above the age of 12 years

The usual initial dose is 50-100 mg tramadol hydrochloride twice daily, morning and evening. If an initial dose lower than 100 mg is required, alternative tramadol hydrochloride containing product should be used. If pain relief is insufficient, the dose may be titrated upwards to 150 mg or 200 mg tramadol hydrochloride twice daily (see section 5.1).

Children

Tramadol hydrochloride Krka is not suitable for children below the age of 12 years.

Geriatric patients

A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient’s requirements.

Renal insufficiency/dialysis and hepatic insufficiency

In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed. In these patients prolongation of the dosage interval should be carefully considered according to the patients requirements. In cases of severe renal and/or severe hepatic insufficiency Tramadol hydrochloride Krka prolonged-release tablets are not recommended.

Method of administration

Oral use.

The tablets are to be taken whole, not divided or chewed, with sufficient liquid, independent of meals.

Duration of administration

Tramadol should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with tramadol is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary

Symptoms

In principle, on intoxication with tramadol symptoms similar to those of other centrally acting analgesics (opioids) are to be expected. These include in particular miosis, vomiting, cardiovascular collapse, consciousness disorders up to coma, convulsions and respiratory depression up to respiratory arrest. Serotonin syndrome has also been reported.

Management

The general emergency measures apply. Keep open the respiratory tract (aspiration!), maintain respiration and circulation depending on the symptoms. The antidote for respiratory depression is naloxone. In animal experiments naloxone had no effect on convulsions. In such cases diazepam should be given intravenously.

In case of intoxication orally, gastrointestinal decontamination with activated charcoal or by gastric lavage is only recommended within 2 hours after tramadol intake. Gastrointestinal decontamination at a later time point may be useful in case of intoxication with exceptionally large quantities or prolonged-release formulations.

Tramadol is minimally eliminated from the serum by haemodialysis or haemo-filtration. Therefore treatment of acute intoxication with Tramadol hydrochloride Krka with haemodialysis or haemofiltration alone is not suitable for detoxification.

2 years.

This medicinal product does not require any special storage conditions.

Child-resistant blister (PVC/PVDC white film//heat sealing paper/Alu foil): 10, 20, 28, 30, 50, 60, 90, 100 prolongedrelease tablets, in a box.

Perforated unit dose child-resistant blister (PVC/PVDC white film//heat sealing paper/Alu foil): 10 × 1, 20 × 1, 28 × 1, 30 × 1, 50 × 1, 60 × 1, 90 × 1, 100 × 1 prolonged-release tablet, in a box.

Not all pack sizes may be marketed.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.