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Zaldiar

, medical expert
Last reviewed: 03.07.2025
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An effective painkiller and anti-inflammatory drug Zaldiar, produced by the German corporation Grunenthal GmbH. This is a complex drug, the active ingredients of which are tramadol and paracetamol.

Indications Zaldiar

The drug in question has already received many positive reviews, but it should not be forgotten that the patient must be informed before taking it that the main active compound tramadol (with prolonged use) can cause opium addiction, so the prescribed doses and duration of the treatment course should be approached with particular care. Do not use without a doctor's prescription.

Indications for the use of Zaldiar are caused by the following need:

  • Moderate or high intensity pain syndrome of various etiologies.
  • Pain relief during medical and diagnostic procedures.
  • Relieving pain after injury.
  • Pain of vascular and inflammatory origin.

Release form

Ten tablets, coated with a yellow shell and “pulled” into a blister made of aluminum foil or polypropylene - this is the only form of release of the drug Zaldiar, which is offered by the pharmacy market.

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Pharmacodynamics

The active substances of the analgesic under consideration are paracetamol and tramadol. In connection with this circumstance, the pharmacodynamics of Zaldiar is outlined.

The substance tramadol is classified as an analgesic, it is a synthetic opium chemical compound and has powerful analgesic and sedative properties. An excellent agonist (when acting on nerve endings, it receives a biological response) of opiate receptors. Tramadol's characteristics act centrally. The spinal cord receives an impulse effect, which enhances the sedative properties of the drug. This component of the complex drug Zaldiar maintains membrane hyperpolarization, and also effectively blocks pain impulses, bringing analgesic properties to the characteristics of Zaldiar.

Paracetamol is a very strong analgesic with an antipyretic effect. Due to its characteristics, it actively affects the centers of the brain responsible for pain, effectively regulates the patient's body temperature, and does not irritate the mucous membrane of the gastrointestinal tract. This chemical compound is neutral in the metabolism of water and salt. It is also inert to the synthesis of prostaglandins.

Due to the complex work of chemical compounds, paracetamol helps to quickly relieve pain symptoms, while tramadol helps to maintain the duration of the analgesic effect. The two components "cooperate" together quite productively, which makes it possible to reduce the likelihood of side effects.

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Pharmacokinetics

The absorption pharmacokinetics of Zaldiar are very high. It is almost completely and in a short period of time absorbed by the mucous membrane of the gastrointestinal tract. Paracetamol absorbs much faster than tramadol. It is absorbed in the liver due to splitting (already about eleven metabolites are known) and subsequently converges with glucuronic acid. Tramadol is characterized by high pharmacological activity.

The half-life of tramadol derivatives averages 4.7 - 5.1 hours, while two to three hours are enough to eliminate paracetamol. When Zaldiar works, the maximum amount of paracetamol in the blood is observed already one hour after taking the drug. Combined work with tramadol, the bioavailability of which is 75%, does not affect the concentration of paracetamol in the plasma. In case of repeated course of taking the drug, the bioavailability of tramadol increases to 90%. This allows to bring the binding properties of tramadol and paracetamol with plasma proteins to 20%.

Approximately 30% of tramadol with paracetamol and about 60% of tramadol metabolites are excreted from the patient's body through the kidneys with urine.

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Dosing and administration

The medicine Zaldiar is taken regardless of the time when the patient eats. The tablet is administered orally (through the mouth), without chewing. If for some reason one of the doses was missed, the next time the dosage should not be doubled. The intake is carried out under the direct supervision of a doctor, who prescribes an individual schedule for each patient (depending on the intensity of the pain syndrome and the sensitivity of the patient), dosage and duration of the treatment course.

Method of administration and dosage: The starting dose of the drug is one or two tablets, while the daily amount of the drug should not exceed the following figures: for tramadol - 300 mg; for paracetamol - 2600 mg, which corresponds to approximately eight tablets. The next dose of Zaldiar should be taken no earlier than six hours after the previous administration.

In case of a vital need to use the drug for a patient over 75 years of age, the single starting dose is left the same, and the duration of the break between the introduction of the next portion of the drug is significantly extended to 12 hours. This is especially true for patients with renal pathology (when the creatinine clearance level falls within the range of 10 to 30 ml/min). This is due to the fact that tramadol is excreted from the human body quite slowly.

If the patient has a history of liver pathology, then Zaldiar is not recommended. With minor deviations in liver function, the drug is prescribed in starting doses, while the interval between doses is increased. A patient suffering from alcoholism, with liver pathology, has a higher chance of getting an overdose of the drug than a patient who does not drink.

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Use Zaldiar during pregnancy

There have been no in-depth clinical studies to answer this question. It follows that the use of Zaldiar during pregnancy and breastfeeding is not recommended.

Contraindications

Despite its high pharmacological qualities and activity, and perhaps in spite of it, there are also contraindications to the use of Zaldiar.

  • Individual hypersensitivity to the active substances of the drug or its secondary components.
  • Intracranial hypertension.
  • A severe form of poisoning by alcohol, drugs, including medications that contain narcotic chemical compounds.
  • Intoxication due to the use of a significant dose of a drug that reduces the efficiency of the central nervous system.
  • The drug in question should not be prescribed together with sleeping pills and psychotropic drugs.
  • It is not recommended to use Zaldiar together with MAO inhibitors (the drug can be taken only two weeks after stopping taking the inhibitors).
  • Contraindications for the use of Zaldiar apply to children and adolescents under 14 years of age or, conversely, elderly people over 75 years of age.
  • Creatinine clearance is below 10 ml per minute, which often occurs in pathological disorders of kidney or liver function.
  • Drug withdrawal syndrome.
  • Some diseases of the biliary tract.
  • Epileptic seizures, susceptibility to periodic convulsive reflex manifestations.
  • Caution should be exercised if the patient has a history of traumatic brain injury.
  • Avoid taking Zaldiar simultaneously with other centrally acting pain relievers.
  • Viral hepatitis.
  • Alcoholism.
  • Cirrhosis.
  • And some other diseases.

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Side effects Zaldiar

Adequate use of this drug can effectively relieve pain of various etiologies. But, despite a whole bunch of positive characteristics, its use in the treatment protocol can contribute to the manifestation of some negative symptoms.

Side effects of Zaldiar:

  • Rapid fatigue.
  • Drowsiness.
  • Development of drug dependence.
  • Increased sweating.
  • Decreased overall tone of the body.
  • Insomnia.
  • Temporary amnesia or memory impairment.
  • Menstrual cycle disorders.
  • Depression and irritability.
  • Increasing headaches.
  • Increased excitability.
  • Convulsions, breathing problems.
  • Impaired vision and taste perception.
  • Abdominal pain, nausea and vomiting.
  • Inadequacy of consciousness.
  • Vestibular disorder.
  • Diarrhea and increased gas production.
  • A long course of treatment can develop nephritis, pathology of the hematopoietic function, and lead to the occurrence of necrotic ulcers.
  • Arrhythmia and tachycardia.
  • Quincke's edema.
  • Dry mouth.
  • Itching and skin rashes.
  • Problems with urination, urinary retention.
  • And some other symptoms.

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Overdose

Based on the fact that the active ingredients of Zaldiar are tramadol and paracetamol, then an overdose of this drug reveals signs and symptoms of an excess of these components.

An overdose of tramadol is manifested by the following symptoms:

  • Nausea and gag reflex.
  • Miosis (narrowing of the pupil).
  • Collapse (structural destruction).
  • Irregularities in breathing rhythm.
  • Coma (severe depression of the central nervous system, followed by brain death).
  • Reflex convulsions.
  • A significant single dose of paracetamol can cause acute symptoms to develop within six to 14 hours; with prolonged administration of the drug, similar symptoms may appear within two to four days.

Exceeding the quantitative component of paracetamol leads to the appearance of:

  • Collapse.
  • Diarrhea (watery stools).
  • Hypoglycemia (decreased blood serum glucose levels).
  • Refusal to eat.
  • Cerebral edema.
  • Arrhythmia.
  • Hypocoagulation (increased blood clotting leading to thrombosis).

Much less frequently, but still occurring, is acute, lightning-fast disruption of kidney and liver function, even to the point of failure.

The stages of bringing the patient out of this condition are carried out urgently:

  • The first thing that needs to be done is to immediately wash out the stomach.
  • Give the patient enterosorbents, for example, polyphepan, activated carbon.
  • Constant monitoring of all vital functions of the patient's body is necessary.
  • Conducting therapeutic treatment to relieve the symptoms that have appeared.
  • During this time, the patient must be under constant medical supervision.

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Interactions with other drugs

In any case, it is necessary to be very careful and pay special attention to the situation when you have to take two or more drugs at the same time. Sometimes it is quite difficult to predict how a particular substance will behave in the body of a particular patient, because each person is strictly individual. But, nevertheless, certain patterns of mutual influence of one chemical substance or element on another are still visible.

When taking Zaldiar together with pentazocine, a withdrawal syndrome occurs, since, being antagonists, these drugs begin to compete with each other, suppressing the action of each. In this case, the complex combination of these drugs is ineffective and even dangerous. A similar situation occurs when Zaldiar is used together with drugs such as nalbuphine or buprenorphine.

Zaldiar interactions with other drugs, the bioavailability of which extends to the receptors of the central nervous system, exhibit a mutually reinforcing effect. And especially in combination with any strength of alcoholic beverages, the side symptoms inherent in an overdose of tramadol are observed more acutely expressed. Such drugs include tranquilizers and sleeping pills.

A decrease in pain-relieving effects and the duration of their action is observed when Zaldiar is used in tandem with such drugs and substances as: tricyclic antidepressants, carbamazepine, ethanol, barbiturates and many others.

A long course of barbiturates has a depressing effect on the active manifestations of paracetamol. The combination of Zaldiar with other non-steroidal anti-inflammatory drugs can provoke the development of nephropathy, renal papillary necrosis, which invariably leads to sometimes irreversible pathology of kidney function (renal failure). The interaction of the drug in question with ethanol gives impetus to the progression of acute pancreatitis.

Long-term use of paracetamol in an overdose in combination with the introduction of salicylates into the patient's body sharply increases the chances of cancerous tumors developing into bladder or kidney cancer. Naloxone in combination with Zaldiar improves respiratory functions and enhances the analgesic effect.

Diflunisal can increase the likelihood of hepatotoxicity in a patient, which increases the quantitative component of paracetamol in the patient's blood system by almost one and a half times. The use of Zaldiar in combination with drugs that partially or completely block the impulse effect on neurons of the central nervous system to reduce the likelihood of epileptic seizures (such as neuroleptics, tricyclic antidepressants, selective inhibitors) often lead to reflex seizures. The absorption rate of Zaldiar can be improved by parallel administration of drugs such as domperidone or metoclopramide.

Erythromycin and ketoconazole, by their characteristics, are capable of replacing the metabolic processes of the active substance of Zaldiar, therefore their combined use is not recommended to avoid an overdose of this chemical compound. Concomitant use of quinidine contributes to an increase in the amount of tramadol and inhibits the quantitative indicator of the metabolite.

The combined use of painkillers with indirect anticoagulants increases the likelihood of bleeding.

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Storage conditions

Any medicine should be kept out of the reach of children. Temperature conditions for storing Zaldiar - the room should not be above 25°C.

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Shelf life

Zaldiar should not be used after the three-year expiration date of the drug has passed.

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Attention!

To simplify the perception of information, this instruction for use of the drug "Zaldiar" translated and presented in a special form on the basis of the official instructions for medical use of the drug. Before use read the annotation that came directly to medicines.

Description provided for informational purposes and is not a guide to self-healing. The need for this drug, the purpose of the treatment regimen, methods and dose of the drug is determined solely by the attending physician. Self-medication is dangerous for your health.

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