Nalgezin tablets p / o, No. 20

- Diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis (ankylosing spondylitis); gouty arthritis, rheumatic lesions of soft tissues, osteoarthritis of the peripheral joints and spine, including those with radicular syndrome, tendovaginitis).

- Pain syndrome of mild or moderate severity: neuralgia, ossalgia, myalgia, lumboischialgia, post-traumatic pain syndrome (sprains and bruises), accompanied by inflammation, postoperative pain (in
traumatology, orthopedics, gynecology, maxillofacial surgery), headache, migraine headache, algoda , adnexitis, toothache.

- As part of the complex therapy of infectious and inflammatory diseases of the ear, throat, nose with severe pain syndrome (pharyngitis, tonsillitis, otitis media).

- Feverish syndrome with 'colds' and infectious diseases.

Nalgezin is used for symptomatic therapy (to reduce pain, inflammation and reduce fever) and does not affect the progression of the underlying disease.

Inside. The tablets should be taken with sufficient water. Follow your doctor's instructions strictly. You should not stop treatment or change your dosage without first consulting your doctor.

Ask your doctor for the duration of the drug.

The usual daily dose used for pain relief is 2-4 tablets (550-1100 mg).

With very severe pain and no history of gastrointestinal diseases, the doctor may increase the daily dose to 6 tablets (1650 mg), but not more than 2 weeks.

When using the drug as an antipyretic agent, the initial dose is 2 tablets of Nalgezin, then 1 tablet of Nalgezin (275 mg) is taken every 6-8 hours.

To prevent migraine attacks, 2 tablets (550 mg) twice a day are recommended. However, treatment should be discontinued if the frequency, intensity and duration of migraine attacks do not decrease within 4-6 weeks. At the first sign of a migraine attack, you should take 3 tablets (825 mg), and if necessary, another 1-2 tablets (275 - 550 mg) after 30 minutes.

To relieve menstrual cramps and cramps, pain after the introduction of the IUD (intrauterine devices) and other gynecological pains, it is recommended to prescribe the drug in an initial dose of 2 tablets (550 mg), then 1 tablet (275 mg) every 6-8 hours.

In an acute attack of gout, the initial dose is 3 tablets (825 mg), then 2 tablets (550 mg) after 8 hours, and then 1 tablet (275 mg) every 8 hours until the attack stops.

In rheumatoid diseases (rheumatoid arthritis, osteoarthritis and ankylosing spondylitis), the usual initial dose of the drug is 2-4 tablets (550-1100 mg), twice a day in the morning and in the evening. An initial daily dose of 3 (825 mg) - 6 tablets (1650 mg) is recommended for patients with severe night pain and / or severe morning stiffness, for patients switching to naproxen sodium treatment from high doses of other non-steroidal anti-inflammatory drugs, and for patients with of which pain is the leading symptom. The usual daily dose is 2 tablets (550 mg) - 4 tablets (1100 mg), given in two divided doses.

Morning and evening doses may not be the same. With the consent of the attending physician, you can change them depending on the prevalence of symptoms, i.e. night pain and / or morning stiffness.

For children over 9 years old and / or weighing more than 27 kg, a daily dose of 10 mg / kg is recommended in 1-2 doses.

If you have the impression that the effect of the drug is very strong or weak, inform your doctor or pharmacist.

Active ingredient: naproxen sodium 275.00 mg

Excipients: povidone 12.0 mg, microcrystalline cellulose 97.00 mg, talc 15.0 mg, magnesium stearate 3.00 mg, purified water 18.00 mg

- Hypersensitivity to naproxen or naproxen sodium; with anamnestic data about an attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs (complete or incomplete syndrome of acetylsalicylic acid intolerance - rhinosinusitis, urticaria, nasal mucosa polyps, bronchial asthma);

- The period after coronary artery bypass grafting;

- Erosive and ulcerative changes in the mucous membrane of the stomach or duodenum 12, active gastrointestinal bleeding;

- Inflammatory bowel disease, in the acute phase (ulcerative colitis (NUC), Crohn's disease);

- Cerebrovascular bleeding or other bleeding and hemostasis disorders;

- Severe liver failure or active liver disease;

- Severe renal failure (creatinine clearance less than 20 ml / min), including confirmed hyperkalemia, progressive kidney disease;

- Oppression of bone marrow hematopoiesis;

- Pregnancy, breastfeeding period;

- One tablet of Nalgezin contains 275 mg of naproxen, therefore the drug is not recommended for children under 9 years of age and / or weighing less than 27 kg.

Carefully :

Ischemic heart disease, cerebrovascular disease, congestive heart failure, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, creatinine clearance less than 60 ml / min; anamnestic data on the development of ulcerative lesions of the gastrointestinal tract (GIT), the presence of Helicobacter pylori infection, advanced age, prolonged use of NSAIDs, frequent alcohol consumption, severe physical illness, concomitant therapy with the following drugs: anticoagulants (for example,
warfarin), antiplatelet agents (for example,
acetylsalicylic acid, clopidogrel), oral glucocorticoids (eg,
prednisolone), selective serotonin reuptake inhibitors (eg,
citalopram,
fluoxetine,
paroxetine,
sertraline).

To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used with the minimum possible course. For children aged 9 to 12 years, the drug is prescribed only on the recommendation of a doctor.

Pharmacokinetics:

Absorption from the gastrointestinal tract is fast and complete, bioavailability is 95% (food intake practically does not affect either the completeness or the rate of absorption). The time to reach the maximum concentration is 1-2 hours, the connection with plasma proteins is> 99%, the half-life is 12-15 hours. Metabolism is in the liver to dimethylnaproxen with the participation of the CYP2C9 enzyme system. Clearance - 0.13 ml / min / kg. It is excreted by 98% by the kidneys, 10% of them are excreted unchanged; with bile - 0.5-2.5%. The equilibrium concentration is determined by taking 4-5 doses of the drug (2-3 days). With renal failure, the accumulation of metabolites is possible.

Pregnancy and lactation:

Nalgezin is not recommended for use during pregnancy and lactation.

Side effect

Side effects are most common when using high doses of Nalgezin:

- from the digestive system: constipation, abdominal pain, dyspepsia, nausea, diarrhea, ulcerative stomatitis, erosive and ulcerative lesions and bleeding of the gastrointestinal tract, increased activity of liver enzymes, liver dysfunction, jaundice, bloody vomiting, melena;

- from the central nervous system: hearing loss, dizziness, headache, drowsiness, depression, sleep disturbances, inability to concentrate, insomnia, malaise, myalgia and muscle weakness, slowing down the reaction rate, aseptic meningitis, cognitive dysfunction;

- on the part of the skin: itching, ecchymosis, excessive sweating, purpura, alopecia, photodermatosis;

- on the part of organs: tinnitus, visual impairment, hearing impairment;

- on the part of the cardiovascular system: swelling, shortness of breath, palpitations, congestive heart failure, vasculitis;

- from the genitourinary system: glomerulonephritis, hematuria, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis, menstrual irregularities;

- from the hematopoietic organs: eosinophilia, granulocytopenia, leukopenia, thrombocytopenia, aplastic anemia;

- on the part of the respiratory system: eosinophilic pneumonitis;

- allergic reactions: skin rashes, urticaria, angioedema,

epidermal necrosis, erythema multiforme, Stevens-Johnson syndrome;

- others: thirst, hyperthermia, hyperglycemia, hypoglycemia, hemolytic anemia.

If you notice such phenomena, stop taking the drug and, if possible, consult a doctor.

Overdose:

A significant overdose of the drug can be characterized by drowsiness, dyspeptic disorders (heartburn, nausea and vomiting, abdominal pain), weakness, tinnitus, irritability, in severe cases - bloody vomiting, melena, impaired consciousness, convulsions and renal failure).

A patient who has accidentally or intentionally taken a large amount of the drug Nalgezin needs to flush the stomach and carry out symptomatic therapy:
activated charcoal, antacids, H2 receptor blockers, proton pump inhibitors. Hemodialysis is ineffective.

Interaction

When treating with anticoagulants, it should be borne in mind that
naproxen can increase bleeding time. The drug should not be used concomitantly with other NSAIDs (increased risk of side effects).

Patients concurrently receiving hydantoins, anticoagulants or other drugs that bind significantly to plasma proteins should watch for signs of potentiation of the action or overdose of these drugs.

The drug Nalgezin can reduce the antihypertensive effect of propranolol and other beta-blockers, and may also increase the risk of renal failure associated with the use of ACE inhibitors. Under the action of naproxen, the natriuretic effect of furosemide is inhibited. Inhibition of renal clearance of lithium leads to an increase in plasma lithium concentrations. Taking probenecid increases plasma levels of naproxen.
Cyclosporine increases the risk of developing renal failure.

Naproxen slows down the excretion of methotrexate, phenytoin, sulfonamides, increasing the risk of developing their toxic effects.

Antacids containing magnesium and aluminum reduce the absorption of naproxen.

Special instructions :

Do not exceed the doses indicated in the instructions. To reduce the risk of developing adverse events from the gastrointestinal tract (GIT), the minimum effective dose should be used in the smallest possible short course.

If pain and fever persist or become worse, see your doctor. Patients with bronchial asthma, with bleeding disorders, as well as patients with hypersensitivity to other analgesics should consult a doctor before taking Nalgezin.

Caution should be given to patients with liver disease and renal failure. In patients with renal insufficiency, it is necessary to monitor the level of creatinine clearance. If the creatinine clearance is below 20 ml / min:
naproxen is not recommended. In chronic alcoholic and other forms of cirrhosis, the concentration of unbound naproxen increases, so lower doses are recommended for such patients.

Nalgezin should not be taken with other anti-inflammatory and pain relievers unless directed by a doctor.

Lower doses are also recommended for elderly patients.

You should avoid taking naproxen for 48 hours before surgery. If it is necessary to determine 17-corticosteroids, the drug should be discontinued 48 hours before the study. Similarly,
naproxen may interfere with the determination of 5-hydroxyindoleacetic acid in urine.

The use of naproxen, like other drugs that block the synthesis of prostaglandins, can affect fertility, therefore it is not recommended for women wishing to become pregnant.

Each Nalgezin tablet contains approximately 25 mg sodium. When limiting salt intake, this must be taken into account.

Impact on the ability to drive a vehicle:

Naproxen slows down the reaction rate in patients. This should be taken into account when driving and performing tasks requiring increased attention.