Налгезин® FORTE

General characteristics. Structure:

Active ingredient: 550 mg of Naproxenum of sodium.

Excipients: povidone; MKTs; talc; magnesium stearate; the water purified.

cover: Opadry YS-1-4216 dye (ready mix of titanium of dioxide (E171), macrogoal, dye indigo carmine (E132) and gipromelloza).

The symptomatic drug having the expressed anesthetic and febrifugal effect.

Pharmacological properties:

Pharmacodynamics. Nalgezin forte represents Naproxenum drug, possesses anesthetic, febrifugal and antiinflammatory action. The mechanism of action is connected with non-selective inhibition of activity of TsOG-1 and TsOG-2. Tablets, film coated, Nalgezin are well dissolved, quickly soaked up from a GIT and provide bystry approach of analgesic effect.

Pharmacokinetics. Absorption from a GIT — bystry and full, bioavailability — 95% (meal practically does not influence neither completeness, nor absorption speed). Tmax is 1–2 h, communication with proteins of plasma> 99%, T1/2 is 12–15 h. Metabolism — in a liver to dimethylnaproxenum with participation of the fermental CYP2C9 system. Clearance — 0,13 ml/min. It is brought to 98% by kidneys (from them 10% — in not changed look), with bile — 0,5–2,5%. Css is defined to reception of 4-5 doses of drug (2–3 days). At a renal failure cumulation of metabolites is possible.

Indications to use:

• musculoskeletal system diseases (a pseudorheumatism, the psoriasis, juvenile chronic arthritis ankylosing a spondylarthritis (Bekhterev's disease); gouty arthritis, rheumatic defeat of soft tissues, an osteoarthrosis of peripheral joints and a backbone, including with a radicular syndrome, a tendovaginitis, a bursitis);
• pain syndrome of weak or moderate expressiveness: neuralgia, an ossalgiya, a mialgiya, a lumbar ishialgia, the posttraumatic pain syndrome (stretching and bruises) which is followed by an inflammation, postoperative pain (in traumatology, orthopedics, gynecology, maxillofacial surgery), a headache, migraine, альгодисменорея, an adnexitis, a dentagra;
• as a part of complex therapy of infectious and inflammatory diseases of an ear, a throat, a nose with the expressed pain syndrome (pharyngitis, tonsillitis, otitis);
• a feverish syndrome at catarrhal and infectious diseases.

Nalgezin is forte used for symptomatic therapy (for reduction of pain, an inflammation and decrease in the increased body temperature) and does not influence progressing of a basic disease.

Route of administration and doses:

Inside, with enough water. It is necessary to follow strictly instructions of the doctor, not to stop treatment and not to change a dosage without preliminary consultation with the doctor.

The recommended scheme of therapy. The usual daily dose used for pain relief makes 1–2 tab. (550–1100 mg).

At very severe pains and absence in the anamnesis of gastrointestinal diseases the doctor can increase a daily dose to 3 tab. (1650 mg), but no more than by 2 weeks.

When using drug as an antipyretic the initial dose makes 1 tablet (550 mg), further is accepted on ½ tablet (275 mg) each 6–8 h.

For the prevention of attacks of migraine 1 tab. (550 mg) twice a day is recommended. However treatment has to be stopped if frequency, intensity and duration of attacks of migraine do not decrease during 4–6 weeks. At the first signs of a migrenozny attack it is necessary to accept 1½ the tab. (825 mg), and if necessary — ½ more tab. (275–550 mg) 30 min. later.

For simplification of menstrual pains and spasms, pains after introduction of Naval Forces (intrauterine spirals) and other gynecologic pains purpose of drug in the initial dose making 1 tab. (550 mg), further on ½ tab. (275 mg) each 6–8 h is recommended.

At a bad attack of gout the initial dose makes 1½ the tab. (825 mg), further 1 tab. (550 mg) later 8 h, and then ½ tab. (275 mg) each 8 h before the termination of an attack.

At rhematoid diseases (a pseudorheumatism, an osteoarthritis and an ankilozirushchy spondylitis) the usual initial dose of drug makes 1-2 tab. (550–1100 mg), twice a day in the morning and in the evening. The initial daily dose making from 1½ (825 mg) of-3 tab. (1650 mg), is recommended to patients with the expressed night pain and/or the expressed morning constraint, to the patients transferred to treatment by sodium Naproxenum from high doses of other NPVS and patients at whom pain is the leading symptom. Usually daily dose makes 1 tab. (550 mg) of-2 tab. (1100 mg) appointed in two steps.

Morning and evening doses can be not identical. With the consent of the attending physician it is possible to change them depending on dominance of symptoms, i.e. night pain and/or morning constraint.

Features of use:

It is not recommended to exceed the doses specified in the instruction. For decrease in risk of development of the undesirable phenomena from a GIT it is necessary to use a minimal effective dose minimum possible short course.

If pain and fever remain or become more severe, it is necessary to see a doctor.

Patients with bronchial asthma, with disturbances of coagulability of blood, and also to patients with hypersensitivity to other analgetics before Nalgezin's reception should consult with the doctor.

With care patients should appoint with diseases of a liver and a renal failure. At patients with a renal failure it is necessary to control the level of clearance of creatinine. At the creatinine Cl level lower than 20 ml/min. are not recommended to appoint Naproxenum. At chronic alcoholic and other forms of cirrhosis concentration of untied Naproxenum increases therefore lower doses are recommended to such patients.

Nalgezin forte it is not necessary to accept together with other antiinflammatory and soothing drugs, except for appointments of the doctor.

Lower doses are also recommended to patients of advanced age.

It is necessary to avoid reception of Naproxenum during 48 h to surgical intervention. In need of definition of 17 corticosteroids drug should be cancelled for 48 h prior to a research. Similarly, Naproxenum can exert impact on definition of 5-hydroxyindolacetic acid in urine.

Use of Naproxenum, as well as other drugs blocking synthesis of PG can influence fertility therefore it is not recommended to the women wishing to become pregnant.

Each tablet of Nalgezin forte contains about 50 mg of sodium. At salt consumption restriction it needs to be considered.

Nalgezin forte is not recommended to apply during pregnancy and feeding by a breast.

Naproxenum slows down speed of response at patients. It should be considered when driving the car and performing the tasks requiring special attention.

Side effects:

Side effects are most frequent when using high doses of Nalgezin forte:

From the alimentary system: lock, abdominal pain, dyspepsia, nausea, diarrhea, stomacaces, erosive cankers and bleedings of a GIT, increase in activity of liver enzymes, abnormal liver function, jaundice, hematemesis, melena.

From TsNS: decrease in hearing, dizziness, a headache, drowsiness, a depression, sleep disorders, impossibility to concentrate, sleeplessness, an indisposition, a mialgiya and muscular weakness, delay of speed of response, aseptic meningitis, cognitive dysfunction.

From integuments: an itch, ecchymomas, the increased perspiration, a purpura, an alopecia, photodermatoses.

From sense bodys: sonitus, vision disorder, hearing disorder.

From cardiovascular system: puffiness, asthma, heartbeat, congestive heart failure, vasculitis.

From urinogenital system: glomerulonephritis, hamaturia, intersticial nephrite, nephrotic syndrome, renal failure, renal papillary necrosis, disturbances of a menstrual cycle.

From the hemopoietic bodies: eosinophilia, granulocytopenia, leukopenia, thrombocytopenia, aplastic anemia.

From respiratory system: eosinophilic pneumonites.

Allergic reactions: skin rash, small tortoiseshell, Quincke's disease, epidermal necrolysis, erythema multiformny, Stephens-Johnson's syndrome.

Others: thirst, hyperthermia, hyperglycemia, hypoglycemia, hemolitic anemia.

In case of the similar phenomena it is necessary to stop administration of drug and, whenever possible, to see a doctor.

Interaction with other medicines:

At treatment by anticoagulants it must be kept in mind that Naproxenum can increase a bleeding time. It is not necessary to use drug along with other NPVP (increase of risk of development of side effects).

The patients who are at the same time receiving the hydantoins, anticoagulants or other medicines contacting substantially proteins of plasma have to watch signs of potentiation of action or overdose of these drugs.

Drug Nalgezin forte can reduce anti-hypertensive effect of propranolol and other beta adrenoblockers, and also can increase risk of the renal failure connected using APF inhibitors. Under the influence of Naproxenum the natriuretic effect of furosemide is inhibited.

The inhibition of renal clearance of lithium leads to increase in concentration of lithium in plasma.

Reception of a probenetsid increases Naproxenum level in plasma.

Cyclosporine increases risk of development of a renal failure.

Naproxenum slows down excretion of a methotrexate, Phenytoinum, streptocides, increasing risk of development of their toxic action.

The antiacid drugs containing magnesium and aluminum reduce absorption of Naproxenum.

It is necessary to inform your attending physician if you have other diseases or an allergy, or you accept any other medicines (including released without recipe of the doctor).

Contraindications:

• hypersensitivity to Naproxenum or Naproxenum of sodium; with anamnestic data on an attack of a bronkhoobstruktion, rhinitis, a small tortoiseshell after reception of acetylsalicylic acid or other NPVP (the full or incomplete syndrome of intolerance of acetylsalicylic acid — rinosinusit, a small tortoiseshell, polyps mucous a nose, bronchial asthma);
• the period after performing aortocoronary shunting;
• erosive and ulcer changes mucous stomach or duodenum, active gastrointestinal bleeding;
• inflammatory diseases of intestines in an aggravation phase (nonspecific ulcer colitis, a disease Krone);
• cerebrovascular bleeding or other bleedings and disturbances of a hemostasis;
• the expressed liver failure or an active disease of a liver;
• the expressed renal failure (creatinine Cl less than 20 ml/min.), including the confirmed hyperpotassemia, the progressing disease of kidneys;
• oppression of a marrowy hemopoiesis;
• pregnancy, breastfeeding period;
• children and teenagers are younger than 15 years (the maintenance of Naproxenum in 1 tab. — 550 mg).

With care: Ischemic heart disease, cerebrovascular diseases, congestive heart failure, дислипидемия / lipidemia, diabetes mellitus, diseases of peripheral arteries, smoking, creatinine Cl less than 60 ml/min.; anamnestic data on development of a canker of a GIT, existence of an infection of Helicobacter pylori, advanced age, long use of NPVP, frequent alcohol intake, heavy somatopathies, the accompanying therapy by the following drugs: anticoagulants (for example warfarin), antiagregant (for example acetylsalicylic acid, klopidogret), peroral groups of companies (for example Prednisolonum), SIOZS (for example to tsitalopra, fluoxetine, пароксетин, sertraline). For decrease in risk of development of the undesirable phenomena from a GIT it is necessary to use a minimal effective dose minimum possible course. To children 16 years are younger drug is appointed only according to the recommendation of the doctor.

Overdose:

The considerable overdose by drug can be characterized by the following symptoms: drowsiness, dispeptic frustration (heartburn, nausea and vomiting, abdominal pain), weakness, sonitus, irritability; in hard cases — a hematemesis, a melena, disturbance of consciousness, a spasm and a renal failure).

The patient who accepted accidentally or purposely large amount of drug Nalgezin forte needs a gastric lavage and performing symptomatic therapy — absorbent carbon, antacids, H2 receptors blockers, inhibitors of a proton pomp. The hemodialysis is inefficient.

Storage conditions:

To store at a temperature not above 25 °C. To store in    the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated, 550 mg. On 10 tablets in the blister. On 1 blister in a cardboard pack together with the application instruction.