Zaldiar

/ Tec-O-Pharm

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. 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 people: 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. Because of the presence of paracetamol Zaldiar should not be used in patients with severe hepatic impairment.
Method of administration: Oral use. Tablets must be swallowed whole, with a sufficient quantity of liquid. They must not be broken or chewed.

Symptomatic treatment of moderate to severe pain. The use should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol.

Hypersensitivity, concurrent use with MAOI’s or within 14 days of taking, children under 14 years, pregnancy, lactation, rehabilitation from narcotics, acute alcohol intoxication, sedatives, sleeping pills, analgesic or other psychotropic drugs, epilepsy not controlled by treatment, severe kidney or liver disease.

For adults and adolescents 12 years and older. The maximum dose of 8 tablets should not be exceeded. Not recommended in severe renal insufficiency (creatinine clearance <10 ml/mm).

Tramadol may cause drowsiness or dizziness, which may be enhanced by alcohol or other CNS depressants. If affected, the patient should not drive or operate machinery. Dizziness, somnolence, headache, trembling. Confusion, mood changes, sleep disorders. Nausea, vomiting, constipation, dry mouth, diarrhea, abdominal pain, dyspepsia, flatulence. Sweating, pruritus.

Alcohol, carbamazepine and other enzyme inducers, opioid agonists-antagonists. Other opioid derivatives (including antitussive drugs and substitutive treatments), benzodiazepines and barbiturates. Other serotoninergics, other central nervous system depressants, such as other opioid derivatives (including antitussive drugs and substitutive treatments), barbiturates, benzodiazepines, other anxiolytics, hypnotics, sedative antidepressants, sedative antihistamines, neuroleptics, centrally-acting antihypertensive drugs, thalidomide and baclofen. Warfarin like compounds. Other drugs known to inhibit CYP3A4, such as ketoconazole and erythromycin.