Posology : מינונים

4.2        Posology and method of administration

Posology
The use of Zaldiar should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol.
The dose should be individually adjusted according to intensity of pain and response of the patient.
The lowest effective dose for analgesia should generally be selected. The total dose of 8 tablets (equivalent to 300 mg tramadol hydrochloride and 2600 mg paracetamol) per day should not be exceeded. The dosing interval should not be less than six hours.

Adults and Adolescents (14 years and older).

An initial dose of two tablets of Zaldiar is recommended Additional doses can be taken as needed, not exceeding 8 tablets (equivalent to 300 mg tramadol and 2600 mg paracetamol) per day.
The dosing interval should not be less than six hours.

Zaldiar should under no circumstances be administered for longer than is strictly necessary (see also section 4.4 - Special warnings and precautions for use). If repeated use or long term treatment with Zaldiar is required as a result of the nature and severity of the illness, then careful, regular monitoring should take place (with breaks in the treatment, where possible), to assess whether continuation of the treatment is necessary.


Paediatric population
The effective and safe use of Zaldiar has not been established in children below the age of 14 years. Treatment is therefore not recommended in this population.


Older 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

In patients with renal 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.

Hepatic impairment

In patients with hepatic impairment the elimination of tramadol is delayed. In these patients prolongation of the dosage intervals should be carefully considered according to the patient’s requirements (see section 4.4). Because of the presence of paracetamol Zaldiar should not be used in patients with severe hepatic impairment (see Section 4.3).
Method of administration

Oral use

Tablets must be swallowed whole, with a sufficient quantity of liquid. They must not be broken or chewed.