Zaldiar( tramadol hydrochloride, paracetamol)

Zaldiar( tramadol hydrochloride, paracetamol) analogues:

Zaldiar( tramadol hydrochloride, paracetamol) Instruction:


Grunenthal GmbH, Germany

Active ingredient Zaldiara

TRamadol hydrochloride, paracetamol

Forms of Zaldiara

Tablets 37.5 mg / 325 mg No. 10, No. 20, No. 30, No. 50

To whom is indicated

Zaldiar Pain of moderate to severe intensity of different etiology( including inflammatory, traumatic,vascular origin).
Anesthesia for painful diagnostic or therapeutic manipulation.

How to use Zaldiar

How to use and dose
Zaldiar is used under the supervision of a doctor.
Dosage regimen and duration of treatment are selected separately depending on the

severity of the pain syndrome and the sensitivity of the patient. Do not prescribe the drug for longer than a certain period of treatment.
For adults and children over 14 years of age, the recommended initial single dose is 1 to 2 tablets, the interval between doses is at least 6 hours. Apply regardless of eating, swallow tablets need to be whole( can not be broken or chewed), squeezed with liquid.
The maximum daily dose is 8 tablets( 300 mg of tramadol and 2.6 g of paracetamol).Patients of advanced age( from 75 years and more) can be prescribed usual doses. However, due to delayed excretion, the interval between doses of the drug can be increased. In patients with moderate renal insufficiency( creatinine clearance from 10 to 30 ml / min), the drug should be taken with observance of 12-hour intervals between doses.
Since tramadol is very slowly excreted during hemodialysis or haemofiltration, postdialysis of its use to maintain analgesic action is usually not required.
In patients with severe impairment of liver function, the drug is not used.
In moderate conditions, the interval between taking the drug should be increased. The risk associated with paracetamol overdose is higher in patients with non-cirrhosis of the liver caused by alcoholism.

Features of application
Use with caution in patients:

  • in shock;
  • who suffered craniocerebral injury;
  • with increased intracranial pressure;
  • with a tendency to convulsive syndrome;
  • with impaired consciousness of unknown etiology, respiratory function;
  • with a single use of psychotropic and other analgesics of the central action, local anesthesia;
  • for patients with diseases of the biliary tract;
  • for benign hyperbilirubinemia( including Gilbert's syndrome);
  • viral hepatitis;
  • deficiency of glucose-6-phosphate dehydrogenase.

Not recommended for use in local anesthesia. Avoid using the drug when using small doses of anesthesia. In patients with epilepsy, or those prone to epileptic seizures, the drug can only be used for life indications. Patients should be informed about the need to adhere to the dosing regimen and that they do not take other drugs that contain tramadol and paracetamol.
With prolonged uncontrolled use, symptoms of dependence may appear: irritability, phobias, nervousness, sleep disturbance, psychomotor activity, tremor, discomfort in the stomach or intestine. In patients prone to drug abuse or dependence, treatment should be performed under close supervision of the doctor for a short period. During treatment, the drug is not allowed to drink alcoholic beverages.
During treatment Zaldiar should refrain from driving and practicing potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Side effects of Zaldiara

From the side of the nervous system: sweating, dizziness, headache, weakness, fatigue, inhibition, paradoxical stimulation of the CNS( nervousness, hallucinations), drowsiness, sleep disturbance, confused consciousness, coordination disorders, convulsions of the central genesisconcomitant administration of antipsychotics), depression, amnesia, cognitive impairment, paresthesia, unsteadiness of gait.
On the part of the digestive system: dryness in the oral cavity, nausea, vomiting, flatulence, abdominal pain, constipation, diarrhea, difficulty swallowing.
From the cardiovascular system: tachycardia, orthostatic hypotension, syncope, collapse. Allergic reactions: urticaria, pruritus, Quincke's edema, exanthema, bullous eruptions.
From the side of the urinary system: difficulty urinating, dysuria, urinary retention.
From the senses: impaired vision, taste.
From the respiratory system: dyspnoea.
Other: menstrual cycle disorders, blood system disorders( anemia, thrombocytopenia, methemoglobinemia).
With prolonged use - the development of medical dependence.
With a sharp cancellation - the "cancellation" syndrome.

To whom it is contraindicated Zaldiar

Hypersensitivity to the components of the preparation.
Acute alcohol intoxication, drugs that suppress the central nervous system, hypnotics and psychotropic drugs, which is accompanied by respiratory depression or severe central nervous system depression;simultaneous use of MAO inhibitors( and 2 weeks after their withdrawal);severe hepatic and / or renal failure( creatinine clearance less than 10 ml / min);epilepsy, which is not controlled by treatment;withdrawal syndrome;children under 14 years;pregnancy and lactation.

Interaction of Zaldiar

Simultaneous use with opioid agonist antagonists( buprenorphine, nalbuphine, pentazocine) is not recommended, since the analgesic effect is reduced as a result of competing effects on the receptors and there is a risk of withdrawal syndrome.
When treating the drug with other drugs that have a depressing effect on the central nervous system( for example, hypnotics or tranquilizers), and when used with alcohol, the side effects of tramadol may be most pronounced.
Microsomal oxidation inductors( including carbamazepine) reduce the analgesic effect and its duration. Simultaneous use with agents that reduce the epileptic threshold, for example selective inhibitors of serotonin uptake, tricyclic antidepressants, neuroleptics, may increase the risk of seizures.
Drugs that inhibit CYP3A4, such as ketoconazole and erythromycin, can slow the metabolism of tramadol( N-demethylation) and the active O-demethylated metabolite.
Quinidine increases plasma concentration of tramadol and reduces the concentration of M1 metabolite through competitive inhibition of isoenzyme CYP2D6.
Inhibitors of microsomal oxidation( cimetidine) reduce the risk of hepatotoxic effects. The rate of absorption can be increased by taking metoclopramide or domperidone and lowered with cholestyramine. The drug, when taken for a long time, increases the effect of indirect anticoagulants( warfarin and other coumarins), which increases the risk of bleeding.

Overdose Zaldiara

Symptoms: miosis, nausea, vomiting, pain, in the stomach, sweating, pallor of the skin, collapse, coma, convulsions, respiratory center depression, apnea.
In severe cases, hepatic failure, encephalopathy and coma are developing. Treatment: usual emergency measures are taken: gastric lavage, reception of activated charcoal, polyphepan, support of cardiovascular system function. When breathing is depressed, naloxone is used. Seizures can be eliminated with diazepam.
There is no specific antidote.