ZYDOL Soluble tablet Ref.[27761] Active ingredients: Tramadol

Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with tramadol in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).

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, ZYDOL soluble tablets should be administered as follows:

Adults and adolescents aged 12 years and over:

Acute Pain: An initial dose of 100mg is usually necessary. This can be followed by doses of 50 or 100mg at 4-6 hourly intervals, and duration of treatment should be matched to clinical need (see section 5.1).

Pain Associated with Chronic Conditions: An initial dose of 50mg is advised and then titration according to pain severity. The need for continued treatment should be assessed at regular intervals as withdrawal symptoms and dependence have been reported (see section 4.4).

Children

ZYDOL soluble tablets are 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 intervals should be carefully considered according to the patient’s requirements.

Method of administration

For oral administration.

The tablets should be dissolved in at least 50 ml water before administration, independently 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.

Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur.

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.

Treatment

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 ZYDOL with haemodialysis or haemofiltration alone is not suitable for detoxification.

3 years.

Do not store above 25°C.

Aluminium/Polypropylene foil blisters.

Pack sizes of 10, 20 or 100 tablets.

Not all pack sizes may be marketed.

The tablets are formulated to be dissolved in water prior to administration, producing a slightly peppermint/aniseed flavoured oral solution.

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