Zaldiar

Zaldiar – the combined drug with analgeziruyushchy action.

Form of release and structure

Zaldiar release in the form of tablets, film coated: oblong, biconvex, light yellow, on a break – almost white color: on one of the parties – an engraving of "T5", on another – a logo of the Gryunental company (on 10 pieces in blisters, on 1-3 or 5 blisters in a cardboard pack).

Active agents are a part of 1 tablet:

• Tramadol – 37,5 mg (in the form of a hydrochloride);
• Paracetamol – 325 mg.

Auxiliary components: microcrystallic cellulose, prezhelatinizirovanny starch, glycollate sodium starch, corn starch, the purified water, magnesium stearate.

Structure of a cover: Opadry light yellow YS-1-6382-G (gipromelloza, polysorbate, titanium dioxide, macrogoal (polyethyleneglycol 400), dye ferrous oxide yellow), karnaubsky wax.

Indications to use

• Pain syndrome of various etiology, including vascular, traumatic, inflammatory origin (average and strong intensity);
• Anesthesia when holding painful therapeutic or diagnostic procedures.

Contraindications

• Acute intoxication alcohol or medicines, oppressing central nervous system (psychotropic and somnolent drugs, opioid analgetics);
• Heavy liver and/or renal failure (at clearance of creatinine it is less than 10 ml in a minute);
• Withdrawal of drugs;
• Uncontrollable therapy epilepsy;
• Simultaneous use with monoamine oxidase inhibitors and for 14 days after their cancellation;
• Age up to 14 years;
• Pregnancy and period of a lactation;
• Hypersensitivity to drug components.

Zaldiar patients should apply with care 75 years are more senior, and also at the following diseases / states:

• Confusion of consciousness of an unknown etiology;
• Symptom complex "acute" stomach of not clear genesis;
• State of shock;
• Intracranial hypertensia;
• Craniocereberal injuries;
• Tendency to a convulsive syndrome (at the epilepsy controlled therapeutic Zaldiar it is possible to apply only according to vital indications);
• Disturbance of respiratory function;
• High-quality hyperbilirubinemias;
• Diseases of biliary tract;
• Deficit glyukozo-6-fosfatdegidrogenazy;
• Viral hepatitis;
• Alcoholism, drug addiction;
• Alcoholic damages of a liver;
• Simultaneous use with psychotropic drugs, local anesthetics and other analgetics of the central action.

Route of administration and dosage

Zaldiar accept inside, swallowing entirely, not chewing, without breaking and washing down with liquid. A pill can be taken regardless of meal. If the patient forgot to take a pill, it is not necessary to double the following dose.

The doctor sets duration of therapy and the mode of dosing individually depending on expressiveness of a pain syndrome and sensitivity to effect of drug. Zaldiar over the term justified from the therapeutic point of view is not recommended to appoint.

To adults and children of 14 years drug is appointed in an initial single dose by 1-2 tablets. Between receptions of single doses it is necessary to observe an interval not less than 6 hours. The maximum dose – 8 tablets a day.

Elderly patients (aged from 75 years) do not have need for correction of a single dose. However because of a possibility of the slowed-down removal of active agents of Zaldiar the interval between receptions of single doses should be increased.

The patient with functional disturbances of kidneys (at clearance of creatinine of 30-10 ml a minute) the break between receptions of single doses has to be not less than 12 hours. As when carrying out a hemodialysis or haemo filtering трамадол it is very slowly removed, post-dialysis use of Zaldiar for maintenance of analgeziruyushchy action, as a rule, is not required.

At moderate abnormal liver functions the break between receptions of single doses of drug needs to be increased. At the expressed abnormal liver functions Zaldiar it is contraindicated to apply.

Side effects

During Zaldiar's reception development of disturbances from some systems of an organism which are shown with various frequency is possible:

• Alimentary system: diarrhea, dryness in a mouth, an abdominal pain, nausea, difficulty when swallowing, a meteorism, vomiting, a lock, increase in activity of liver enzymes (as a rule, without development of jaundice);
• Central and peripheral nervous system: a headache, dizziness, weakness, block, increased fatigue, paradoxical stimulation of the central nervous system (agitation, nervousness, a tremor, uneasiness, spasms of muscles, emotional lability, euphoria, hallucinations), a sleep disorder, drowsiness, a lack of coordination of movements, confusion of consciousness, a spasm of the central genesis (at co-administration with antipsychotic means), instability of gait, amnesia, a depression, paresthesias, disturbance of cognitive function, disturbance of taste and sight;
• Urinary system: dysuria, difficulty of an urination, ischuria. At long reception in the doses considerably exceeding recommended – nephrotoxicity (a papillary necrosis, intersticial nephrite);
• Respiratory system: диспноэ;
• Endocrine system: a hypoglycemia up to a hypoglycemic coma;
• Cardiovascular system: collapse, orthostatic hypotension, tachycardia, faints;
• Bodies of a hemopoiesis: sulfhemoglobinemia. At long reception in the doses considerably exceeding recommended – a pancytopenia, aplastic anemia, an agranulocytosis;
• Dermatological reactions: toxic epidermal necrolysis (Lyell's disease), violent rash, dieback, mnogoformny erythema (including Stephens-Johnson's syndrome);
• Allergic reactions: itch, urticaria, Quincke's edema;
• Others: disturbance of a menstrual cycle, increase in sweating.

Special instructions

It is not necessary to exceed the recommended dosing mode. During Zaldiar's reception without appointment of the doctor it is impossible to apply other medicines with the maintenance of a tramadol or paracetamol.

At long uncontrollable reception of Zaldiar development of the symptoms of medicinal dependence which are shown in the form of phobias, irritability, nervousness, sleep disorders, a tremor, psychomotor activity and discomfort from digestive tract is possible. At sharp drug withdrawal withdrawal signs can appear.

At patients with tendency to emergence is to dependence or abuse therapy it is necessary to carry out during a short span under careful medical observation.

Alcohol intake during use of drug is prohibited. The risk of development of functional disturbances of a liver increases at patients with an alcoholic hepatosis.

At long reception of Zaldiar it is necessary to control a pattern of a functional condition of a liver and peripheral blood.

During therapy it is recommended to refrain from control of motor transport and performance of potentially dangerous types of the works demanding the increased concentration of attention and bystry psychomotor reactions.

Medicinal interaction

At simultaneous use of Zaldiar with some medicines there can be undesirable effects:

• Opioid agonists antagonists (buprenorphine, налбуфин, pentazocine): decrease in analgeziruyushchy effect, emergence of risk of a withdrawal (such combination of drugs is undesirable);
• Barbiturates (at prolonged use): decrease in efficiency of paracetamol;
• Naloxonum: decrease in analgeziruyushchy action;
• The drugs exerting the oppressing impact on the central nervous system (tranquilizers or hypnagogues), ethanol: strengthening of expressiveness of side effects, characteristic of tramadol;
• Inductors of a microsomal oxidation (barbiturates, carbamazepine, ethanol, Phenytoinum, rifampicin, tricyclic antidepressants, phenylbutazone): reduction of expressiveness and duration of analgeziruyushchy effect;
• Inhibitors of a microsomal oxidation (Cimetidinum): decrease in risk of development of a hepatotoxic action of Zaldiar;
• Non-steroidal anti-inflammatory drugs (at prolonged use): increase in risk of development of a renal papillary necrosis and nephropathy, approach of an end-stage of a renal failure;
• Salicylates (at prolonged use): increase in risk of development of cancer of bladder or kidney;
• Quinidine: increase in concentration of a tramadol in a blood plasma, decrease in concentration _{of M1} of a metabolite;
• The drugs lowering a threshold of convulsive readiness (tricyclic antidepressants, selective serotonin reuptake inhibitors, neuroleptics): increase in danger of development of spasms;
• Indirect anticoagulants, including warfarin and other coumarins (at prolonged use): strengthening of their effect that increases risk of development of bleedings;
• Metoclopramidum, домперидон: increase in speed of absorption of paracetamol;
• The drugs inhibiting CYP3A4 isoenzyme (erythromycin, кетоконазол): delay of metabolism of a tramadol and active O-demetilirovannogo metabolite;
• Diflunisal: increase in concentration of paracetamol in a blood plasma, strengthening of risk of development of a gepatoksichnost;
• Colestyraminum: reduction in the rate of absorption of paracetamol.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 25 °C.

Period of validity – 3 years.