Dolaren

Dolaren – the combined anesthetizing drug.

Form of release and structure

Dolaren release in the form of tablets: biconvex, round, two-layer, on the one hand – from almost white till white color, with another – orange color with impregnations of dark orange and white color (on 10 pieces in blisters, on 1 or 10 blisters in a cardboard pack).

Active agents are a part of 1 tablet:

• Paracetamol – 500 mg;
• Sodium diclofenac – 50 mg.

Auxiliary components: starch, gelatin, talc, methylparahydroxysodium benzoate, magnesium stearate, sodium carboxymethylstarch, colloid silicon dioxide, microcrystallic cellulose, пропилпарагидроксибензоат sodium, kroskarmelloza, dye sunset yellow.

Indications to use

• Neuralgia, lyumboishalgiya, mialgiya, the posttraumatic pain syndrome which is followed by an inflammation, migraine, альгодисменорея, a proctitis, an adnexitis; postoperative, head and dentagra;
• Pain syndrome at rheumatic diseases, including an osteoarthrosis, a pseudorheumatism (for short-term therapy);
• Infectious and inflammatory diseases of an ear, throat, nose with the expressed feverish and pain syndrome, including tonsillitis, pharyngitis, otitis (along with other drugs).

Contraindications

• Digestive tract erosive cankers (in an aggravation phase);
• Bleedings from digestive tract;
• Inflammatory diseases of intestines in an aggravation phase;
• Data of the anamnesis on the attacks of a bronkhoobstruktion, rhinitis, small tortoiseshell connected with reception of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (the incomplete or full syndrome of intolerance of acetylsalicylic acid – polyps mucous a nose, rinosinusit, bronchial asthma, a small tortoiseshell);
• Active disease of a liver, the expressed liver failure;
• Disturbances of a hemopoiesis and/or hemostasis (including hemophilia);
• The progressing diseases of kidneys, the expressed renal failure (the clearance of creatinine is less than 30 ml in a minute);
• The period after performing aortocoronary shunting;
• Pregnancy and period of a lactation;
• Children's age;
• Hypersensitivity to drug components (including to other non-steroidal anti-inflammatory drugs).

Dolaren it is necessary to take with caution at the following diseases / states:

• Coronary heart disease;
• Congestive heart failure;
• Cerebrovascular diseases;
• Bronchial asthma;
• Anemia;
• Lipidemia / дислипидемия;
• Edematous syndrome;
• Arterial hypertension;
• High-quality hyperbilirubinemias (including Gilbert's syndrome);
• Renal or liver failure;
• Diseases of peripheral arteries;
• Alcoholism;
• Erosive and ulcer diseases of digestive tract out of an aggravation;
• Diabetes mellitus;
• The induced porphyria;
• State after extensive surgical interventions;
• General diseases of connecting fabric;
• Advanced age.

Route of administration and dosage

Dolaren accept inside in time or after food, without chewing and washing down with a small amount of water.

Usually appoint adult 2-3 times a day on 1 tablet.

Therapy duration – up to 7 days.

Side effects

During therapy development of disturbances from some systems of an organism which are shown with various frequency is possible (it is frequent – more than in 1% of cases, it is rare – less than in 1% of cases):

• Nervous system: often – dizziness, a headache; seldom – a depression, a sleep disorder, drowsiness, irritability, aseptic meningitis (is more often at patients with a system lupus erythematosus and other general diseases of connecting fabric), the general weakness, spasms, dreadful dreams, a disorientation, sensation of fear;
• Digestive tract: often – feeling of abdominal distention, abdominal pains, a meteorism, diarrhea, a lock, nausea, gastrointestinal bleeding, increase in level of "hepatic" enzymes, a round ulcer with possible complications (perforation, bleeding); seldom – vomiting, a melena, jaundice, aphthous stomatitis, emergence of blood to Calais, damage of a gullet, holetsistopankreatit, dryness of mucous membranes (including a mouth), a liver necrosis, hepatitis (perhaps fulminant current), cirrhosis, a gepatorenalny syndrome, pancreatitis, appetite change, colitis;
• Cardiovascular system: seldom – premature ventricular contraction, increase in arterial pressure, congestive heart failure, thorax pain;
• Respiratory system: seldom – a bronchospasm, cough, a pneumonitis, throat hypostasis;
• Immune system and bodies of a hemopoiesis: seldom – a Werlhof's disease, anemia (including hemolitic and aplastic anemias), thrombocytopenia, a leukopenia, an agranulocytosis, an eosinophilia, deterioration in a course of infectious processes (including development of a necrotic fasciitis);
• Urinogenital system: often – a liquid delay; seldom – a papillary necrosis, a nephrotic syndrome, an oliguria, a proteinuria, intersticial nephrite, a hamaturia, an azotemia, an acute renal failure;
• Integuments: often – skin rash, a skin itch; seldom – a small tortoiseshell, an alopecia, eczema, the increased photosensitivity, toxic dermatitis, a toxic epidermal necrolysis (Lyell's disease), a mnogoformny exudative erythema (including Stephens-Johnson's syndrome), punctulate hemorrhages;
• Sense bodys: often – a sonitus; seldom – a diplopia, scotoma, a sight illegibility, taste disturbance, an irreversible or reversible hearing impairment;
• Allergic reactions: seldom – anaphylactoid reactions, a paraglossa and lips, an acute anaphylaxis (as a rule, develops promptly), an allergic vasculitis.

Special instructions

During Dolaren's reception it is necessary to carry out control of function of kidneys and a liver, a picture of peripheral blood and a research a calla on availability of blood.

Because of increase in risk of development of undesirable reactions the concomitant use with non-steroidal anti-inflammatory drugs is not recommended.

At Dolaren's use distortion of laboratory indicators at quantitative definition of uric acid and glucose in plasma is possible.

The patients accepting Dolaren are recommended to abstain from performance of work, the requiring special attention and bystry motor and mental reactions, and also from alcohol intake.

Medicinal interaction

At simultaneous use of Dolaren with some medicines there can be undesirable effects (it is caused by the active agents which are a part of drug: diclofenac and paracetamol):

• Digoxin, lithium drugs: increase in their concentration in plasma;
• Anticoagulants, antiagregantny and thrombolytic medicines (Streptokinasa, alteplaza, urokinase): increase in risk of development of bleedings (is more often than digestive tract);
• Diuretics: decrease in their effect (at use of kaliysberegayushchy diuretics – strengthening of risk of emergence of a hyperpotassemia);
• Hypotensive and somnolent drugs: reduction of their effect;
• Methotrexate: increase in probability of strengthening of its toxicity (due to increase in its concentration in plasma);
• Other non-steroidal anti-inflammatory drugs and glucocorticosteroids: increase in probability of emergence of side effects (bleedings in digestive tract);
• Acetylsalicylic acid: decrease in concentration of diclofenac in blood;
• Cyclosporine: increase in probability of strengthening of its nephrotoxicity (due to increase in its concentration in plasma);
• Tsefoperazon, цефамандол, цефотстан, пликамицин and valproic acid: increase in frequency of development of a prothrombinopenia;
• Hypoglycemic medicines: reduction of their effect;
• Selective serotonin reuptake inhibitors: increase in risk of development of bleedings from digestive tract;
• Drugs of gold and cyclosporine: increase in influence of diclofenac on synthesis of prostaglandins in kidneys that leads to increase in nephrotoxicity;
• The drugs causing a photosensitization: increase in the sensibilizing effect of diclofenac to ultra-violet radiation;
• Ethanol, colchicine, corticotropin and drugs of the St. John's Wort which is made a hole: increase in risk of development of bleedings in digestive tract;
• Antibacterial drugs from group of a hinolon: increase in risk of development of spasms;
• The medicines blocking canalicular secretion: increase in concentration of diclofenac in plasma that increases its toxicity and efficiency;
• Anticoagulating medicines: increase in their effect (at use of high doses of paracetamol);
• Uricosuric medicines: decrease in their efficiency;
• Barbiturates (prolonged use): decrease in efficiency of paracetamol;
• Diflunisal: significant increase in plasma concentration of paracetamol and risk of development of a hepatotoxic;
• Inductors of a microsomal oxidation in a liver (ethanol, Phenytoinum, barbiturates, rifampicin, tricyclic antidepressants, phenylbutazone), hepatotoxic drugs: increase in products of hydroxylated active metabolites (a possibility of development of heavy intoxications even at insignificant overdose);
• Ethanol: increase in risk of development of damages of a liver and acute pancreatitis;
• Salicylates: increase in risk of development of cancer of bladder or kidney (at prolonged use of high doses of paracetamol);
• Inhibitors of a microsomal oxidation (including Cimetidinum): decrease in risk of a hepatotoxic action;
• Myelotoxic drugs: strengthening of manifestations of a gematotoksichnost of paracetamol.

Terms and storage conditions

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

Period of validity – 4 years.