Pro-max.

Pro-max. – the anesthetizing, febrifugal, antiagregantny drug of group of non-steroidal anti-inflammatory drugs (NPVS); reduces expressiveness or eliminates a pain syndrome (including joint rest pains and the movements), reduces morning constraint and a turgidity of joints, increasing the volume of movements.

Form of release and structure

Dosage form of Promaks – a tablet, film coated: white color, kapsulopodobny, on one of the parties a print of "H1" (on 10 pieces in blisters from PVC and aluminum foil, in a cardboard pack on 1 blister).

Structure of 1 tablet:

• Active ingredient: sodium Naproxenum – 275 or 550 mg (that corresponds to 250 or 500 mg of Naproxenum);
• Auxiliary components: sodium lauryl sulfate, magnesium stearate, sodium of a kroskarmelloz, povidone, silicon dioxide colloid, the vegetable oil hydrogenated an emulsion of a simetikon, cellulose microcrystallic, copolymer of methacrylic acid, a gidroksipropilmetiltsellyuloz, lactose, the talc purified titanium dioxide.

Indications to use

• Pain syndrome easy and moderately severe: a dysmenorrhea, disturbances from a musculoskeletal system (backbone pain, joint and muscular pains), tooth and a headache;
• Rheumatic diseases: an osteoarthritis, the pseudorheumatism ankylosing a spondylarthritis.

Contraindications

• Digestive tract erosive cankers in an aggravation phase;
• Hemopoiesis disturbances;
• Expressed hepatic (the clearance of creatinine (CC) less than 20 ml/min.) and a renal failure;
• Heart failure;
• Pregnancy (ІІІ trimester) and breastfeeding period;
• Children's and teenage age up to 16 years;
• The increased individual sensitivity to salicylates and other NPVS (including rhinitis, an asthmatic syndrome, nasal cavity polyps, a small tortoiseshell);
• Hypersensitivity to Naproxenum and other components of Promaks.

With care, in a minimal effective dose drug is accepted at a renal and liver failure of moderate and weak severity, at advanced age, and also in I and II trimesters of pregnancy.

Route of administration and dosage

Pill is taken inside after meal.

The following mode of dosing of Promaks is recommended:

• Anesthetic: an initial dose – 500 mg, then 250 mg each 6-8 h as required; the maximum daily dose – 1500 mg;
• Antirheumatic: a daily dose – it it is possible to increase 500-1000 mg divided into 2 receptions in case of the expressed exacerbation of a rheumatic disease to 1500 mg (by a limited span); the maximum daily dose – 1750 mg.

Duration of treatment of arthritis – 2 weeks, but before achievement of the maximum result can continuously be necessary to accept Naproxenum from 2 to 4 weeks.

Without medical consultation and observation of the patient duration of a course of therapy by Promaks should not exceed 3 days.

Side effects

At observance of the recommended dosing mode Naproxenum is transferred well.

Most often, owing to reception of high doses of drug and/or the long period of therapy, there can be following side reactions:

• Digestive Tract (DT): nausea, heartburn, vomiting, diarrhea, lock, dyspepsia, meteorism, abdominal pain, perforation of a stomach and/or gastric bleedings, melena, hematemesis, stomatitis (including ulcer), exacerbation of ulcer colitis and disease Krone, stomach ulcer, gastritis, esophagitis, pancreatitis;
• System of blood and lymphatic system: thrombocytopenia, neutropenia, granulocytopenia, leukopenia, eosinophilia, aplastic and hemolitic anemias;
• Immune system: hypersensitivity reactions (Quincke's disease, bronchospasm);
• Metabolism, metabolism: hyperpotassemia;
• Frustration of mentality: sleep disorders, sleeplessness, depression, confusion of consciousness, hallucination;
• Central and peripheral nervous system: paresthesias, spasms, вертиго, drowsiness, a headache, a retrobulbar optic neuritis, disturbance of concentration of attention, cognitive frustration, the aseptic meningitis (in particular at patients with data in the anamnesis on autoimmune diseases, for example, such as Sharp's syndrome (the mixed diseases of connecting fabric) and a system lupus erythematosus) which is followed by a stiff neck, the headache raised by the body temperature, a disorientation;
• Organ of sight: opacification of a cornea, vision disorder, papilloedem (papilledema), papillitis;
• Acoustic organ: sonitus, hearing disorder;
• Cardiovascular system: heart consciousness, hypostases, heart failure, arterial hypertension (AH), vasculitis, slight increase of risk of arterial thrombosis (myocardial infarction or stroke);
• Respiratory system: short wind, eosinophilic pneumonia, asthma, fluid lungs;
• Gepatobiliarny system: increase in level of liver enzymes, jaundice;
• Skin and hypodermic cellulose: the alopecia, skin rash, an itch, a small tortoiseshell, a purpura, bruises, a hyperhidrosis, a polymorphic erythema, a malignant exudative erythema, an epidermal necrolysis, a system lupus erythematosus and reactions of a photosensitivity similar symptoms with a chronic hematoporphyria and a violent epidermolysis;
• Musculoskeletal system and connecting fabric: weakness in muscles and muscular pain;
• Urinary system: intersticial nephrite, glomerulonephritis, nephrotic syndrome, necrotic papillitis, renal failure, hamaturia;
• Reproductive system: female infertility;
• General disturbances: fever, thirst, fatigue, indisposition.

In case of heavy side reactions therapy should be stopped immediately.

Symptoms of overdose are: heartburn, abdominal pain, nausea, vomiting, gastrointestinal bleedings, headache; seldom – a disorientation, irritability, dizziness, drowsiness, a sonitus, diarrhea; in more difficult cases – a melena, a hematemesis, disorder of consciousness, disturbance of breath, a spasm, a renal failure.

For therapy of a state the gastric lavage, reception of absorbent carbon, a mizoprostol, antiacid drugs, inhibitors of the proton pump, _{H2 receptors inhibitors}, other types of a symptomatic treatment is recommended.

Special instructions

In case of existence of an infectious disease it is necessary to consider febrifugal and antiinflammatory action of Naproxenum since they can mask symptomatology of inflammatory process.

If the analysis of concentration of 17 ketosteroids is necessary, it is required to stop reception of Naproxenum at least for 48 h prior to a research.

Promaks's reception should be stopped, at least, for 48 h prior to the planned serious surgery and in case of existence of considerable fresh wounds.

The patients with a porphyria and/or epilepsy accepting Naproxenum have to be under fixed medical observation.

1 tablet of Promaks of 500 mg contains 50 mg of sodium, Promaksa of 250 mg – 25 mg of sodium that surely should be considered at observance by the patient of an electrolyte-deficient diet.

During the work with difficult mechanisms and control of vehicles it is required to be careful as it is impossible to exclude possible side reactions from Promaks's reception, such as drowsiness, dizziness, disturbance of concentration of attention, etc.

Medicinal interaction

• Furosemide – decrease in its diuretic effect is possible;
• Acetylsalicylic acid, other NPVS and analgetics (including the selection blockers of TsOG-2) – increases risk of emergence of side effects;
• Indirect anticoagulants – their action amplifies;
• Antiacid drugs with the content of aluminum and magnesium – reduce absorption of Naproxenum;
• Probenetsid – raises concentration in a blood plasma of Naproxenum and its ^T1/2 increases;
• Derivatives of hydantoin or sulphonylurea (the drugs contacting proteins of a blood plasma) – compete with Naproxenum for communication with proteins (it is necessary to apply together with with care);
• The methotrexate – decreases its tubular removal that can increase toxicity of a methotrexate;
• Cyclosporine, inhibitors of an angiotensin-converting enzyme (APF) – increase in risk of a renal failure is possible;
• The zidovudine (according to the research in vitro) – raises its concentration in a blood plasma;
• Takrolimus – nephrotoxicity development is possible;
• Mifepristone – Naproxenum, as well as other NPVS, can reduce its efficiency (it is necessary to observe an interval of 8-12 days after mifepristone reception).

Terms and storage conditions

To store at a temperature up to 25 °C. To protect from children.

Period of validity – 3 years.