Nalgesin forte, pills 550mg, 20pcs

Composition

1 film-coated tablet contains:

Core

Active ingredient:

Naproxen Sodium 550,00 mg

Excipients: povidone K 30, microcrystalline cellulose, talc, magnesium stearate, purified water

Film shell: Opadray 02F2050041

1 Opadray 02F205004: hypromellose, titanium dioxide (E 171), macrogol, indigo carmine dye (E 132).

Pharmacological action

Pharmacotherapeutic group: nonsteroidal anti-inflammatory drug

ATX code: M 01 AE 02

Pharmacological properties

Pharmacodynamics

The drug Nalgesin ® forte is a naproxen, has analgesic, antipyretic and anti-inflammatory effects. The mechanism of action is associated with non-selective inhibition of cyclooxygenase-1 and -2 activity (COX-1, COX-2).

The drug Nalgesin ® forte, film-coated tablets, dissolves well, is quickly absorbed from the gastrointestinal tract and provides a rapid onset of analgesic effect.

Pharmacokinetics

It is rapidly and completely absorbed from the gastrointestinal tract. Bioavailability – 95% (food intake practically does not affect either the fullness or the rate of absorption). The time to reach the maximum concentration is 1-2 hours. Binding to plasma proteins > 99%. The elimination half-life is 12-15 hours. Metabolism occurs in the liver to dimethylnaproxene with the participation of the CYP2C9 isoenzyme. Clearance – 0.13 ml / min / kg. It is excreted 98% by the kidneys,10% is excreted unchanged, with bile – 0.5-2.5%. Steady-state plasma concentration is determined after taking 4-5 doses of the drug (2-3 days).

In case of renal failure, accumulation of metabolites is possible.

Indications

• Diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis (Ankylosing spondylitis), gouty arthritis, rheumatic soft tissue damage, osteoarthritis of the peripheral joints and spine, including those with radicular syndrome, tendovaginitis, bursitis).
• Mild or moderate pain syndrome: neuralgia, ossalgia, myalgia, lumboishialgia, post-traumatic pain syndrome (sprains and bruises) accompanied by inflammation, pain in the postoperative period (in traumatology, orthopedics, gynecology, maxillofacial surgery), headache, migraine, algodismenorrhea, 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).
• Febrile syndrome in “colds” and infectious diseases.

The drug Nalgesin forte is used for symptomatic therapy (to reduce pain, inflammation and reduce elevated body temperature) and does not affect the progression of the underlying disease.

Use during pregnancy and lactation

Nalgesin forte is not recommended for use during pregnancy and lactation.

Contraindications

* Hypersensitivity to naproxen or naproxen sodium.

* Complete or incomplete combination of bronchial asthma, recurrent nasal or paranasal sinus polyposis, and intolerance to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs) (including in the anamnesis).

* The period after coronary artery bypass grafting.

·  Erosive and ulcerative changes in the gastric or duodenal mucosa, active gastrointestinal bleeding.

* Inflammatory bowel diseases (ulcerative colitis, Crohn’s disease) in the acute phase.

* Hemophilia and other blood clotting disorders.

* Cerebrovascular or other bleeding.

* Decompensated heart failure.

* Severe liver failure or active liver disease.

  · Severe renal insufficiency (creatinine clearance < 30 ml/min), progressive renal disease, confirmed hyperkalemia. * Pregnancy, breast-feeding period. * Children under 16 years of age.

With caution

Coronary heart disease, cerebrovascular diseases, congestive heart failure, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial diseases, smoking, impaired renal function (creatinine clearance 30-60 ml/min), history of ulcerative lesions of the gastrointestinal tract (GIT), the presence of Helicobacter pylori infection, use in elderly patients, systemic lupus erythematosus or mixed connective tissue diseases (Sharp’s syndrome), long-term use NSAIDs, frequent alcohol use, severe somatic diseases, concomitant therapy with the following medications: anticoagulants (e. g., warfarin), antiplatelet agents (e. g., acetylsalicylic acid, clopidogrel), oral glucocorticoids (e. g., prednisone), selective serotonin reuptake inhibitors (e. g., citalopram, fluoxetine, paroxetine, sertraline).

Side effects

Adverse events that may occur during treatment with naproxen are classified according to the following frequency of occurrence: very common (3 1/10), common (3 1/100 to < 1/10), uncommon (3 1/1 000 to <1/100), rare (3 1/10 000 to < 1/1 000), very rare (

Disorders of the gastrointestinal tract: the most common adverse events were observed from the gastrointestinal tract. Peptic ulcer, perforation or gastrointestinal bleeding may occur, sometimes with fatal outcome, especially in elderly patients (see section “Special instructions”).

In each group, adverse events are listed in descending order of severity.

Disorders of the blood and lymphatic system:

infrequently: eosinophilia, granulocytopenia, leukopenia, thrombocytopenia.

Nervous system disorders:

common: headache, vertigo, dizziness, drowsiness;

uncommon: depression, sleep disorders, inability to concentrate, insomnia, malaise.

Visual disturbances:

common: visual impairment.

Hearing disorders and labyrinth disorders:

common: tinnitus, hearing loss;

infrequent: hearing loss.

Cardiac disorders:

common: swelling, palpitations;

uncommon: congestive heart failure.

Respiratory, thoracic and mediastinal disorders:

common: shortness of breath;

uncommon: eosinophilic pneumonia.

Disorders of the gastrointestinal tract:

common: constipation, abdominal pain, dyspepsia, nausea, diarrhea, stomatitis, flatulence;

uncommon: gastrointestinal bleeding and/or gastric perforation, bloody vomiting, melena, vomiting;

very rare: relapse or exacerbation of ulcerative colitis or Crohn’s disease;

frequency unknown: gastritis.

Liver and biliary tract disorders:

infrequently: increased activity of “liver” enzymes, jaundice.

Skin and subcutaneous tissue disorders:

common: pruritus, skin rash, ecchymosis, purpura;

uncommon: alopecia, photodermatosis;

very rare: bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Musculoskeletal and connective tissue disorders:

infrequently: myalgia and muscle weakness.

Kidney and urinary tract disorders:

infrequently: glomerulonephritis, hematuria, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis.

General disorders and disorders at the injection site:

often: thirst, increased sweating;

infrequently: hypersensitivity reactions, menstrual irregularities, hyperthermia (chills and fever).

During NSAID therapy, edema and symptoms of heart failure, as well as increased blood pressure, have been reported.

Clinical studies and epidemiological data suggest that the use of certain NSAIDs (especially at high doses and during long-term therapy) may be associated with a small increase in the risk of arterial thrombosis (for example, myocardial infarction or stroke).

Undesirable effects that are not causally related to the use of naproxen have not been established

Blood and lymphatic system disorders: aplastic anemia, hemolytic anemia.

Nervous system disorders: aseptic meningitis, cognitive dysfunction.

Skin and subcutaneous tissue disorders: erythema multiforme, photosensitivity reactions similar to late cutaneous porphyria and epidermolysis bullosa, urticaria.

Vascular disorders: vasculitis.

General disorders and disorders at the injection site: angioedema, hyperglycemia, hypoglycemia.

If you notice these symptoms, stop taking the drug and, if possible, consult a doctor.

Interaction

When using anticoagulants, it should be borne in mind that naproxen may increase the bleeding time.Do not use Nalgesin forte concomitantly with acetylsalicylic acid, other NSAIDs, including selective cyclooxygenase-2 inhibitors (increased risk of side effects).

According to clinical pharmacodynamics, concomitant use of naproxen and acetylsalicylic acid for more than one day may inhibit the effect of a low dose of acetylsalicylic acid on platelet activity, and inhibition may persist for several days after discontinuation of naproxen therapy. The clinical significance of this interaction is unknown.

Patients receiving concomitant treatment with hydantoins, anticoagulants, or other drugs that bind significantly to plasma proteins should monitor for signs of potentiation or overdose of these drugs.

Nalgesin forte may reduce the antihypertensive effects of propranolol and other beta-blockers, and may also increase the risk of renal failure associated with the use of angiotensin-converting enzyme (ACE) inhibitors. NSAIDs may reduce the diuretic effect of diuretics. Naproxen inhibits the natriuretic effect of furosemide. Diuretics may increase the risk of nephrotoxicity of NSAIDs.

Inhibition of renal clearance of lithium leads to an increase in the concentration of lithium in blood plasma. Taking probenecid increases the concentration of naproxen in the blood plasma.

Cyclosporine increases the risk of developing kidney failure.

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

Antacids containing magnesium and aluminum reduce the absorption of naproxen.

Myelotoxic drugs increase the manifestations of hematoxicity of the drug.

According to in vitro studies, the concomitant use of naproxen and zidovudine increases the concentration of zidovudine in blood plasma.

Concomitant use of corticosteroids may increase the risk of ulceration or gastrointestinal bleeding.

NSAIDs may increase the effect of anticoagulants such as warfarin.

Simultaneous use of naproxen and antiplatelet drugs, selective serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding.

Concomitant use of NSAIDs for 8-12 days after mifepristone use is not recommended.

Concomitant use of NSAIDs and tacrolimus increases the risk of nephrotoxicity.

How to take, course of use and dosage

Inside.

Strictly follow your doctor’s instructions. You should not stop treatment or change the dosage without first consulting your doctor. Ask your doctor for the duration of use of the drug.

Recommended treatment regimen

Adults, children 16 years and older

Usually, the daily dose used for pain relief is 1-2 tablets (550-1100 mg).

For very severe pain and the absence of a history of gastrointestinal diseases, the doctor can increase the daily dose to 3 tablets (1650 mg), but not for more than 2 weeks.

When using Nalgesin forte as an antipyretic, the initial dose is 1 tablet (550 mg), then half a tablet (275 mg) is taken every 6-8 hours.

To prevent migraine attacks,1 tablet (550 mg) is recommended twice a day. 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 1½ tablets (825 mg), and if necessary, another ½ – 1 tablet (275-550 mg) after 30 minutes.

To relieve menstrual pain and cramps, pain after the introduction of intrauterine devices (IUD) and other gynecological pain (adnexitis, childbirth as an analgesic and tocolytic agent), it is recommended to prescribe the drug in an initial dose of 1 tablet (550 mg), then ½ tablet (275 mg) every 6-8 hours.

In an acute attack of gout, the initial dose is 1½ tablets (825 mg), then 1 tablet (550 mg) after 8 hours, and then ½ tablet (275 mg) every 8 hours until the attack stops.

In rheumatoid diseases (rheumatoid arthritis, osteoarthritis and ankylosing spondylitis), the initial dose of the drug is usually 1-2 tablets (550-1100 mg) twice a day in the morning and in the evening. An initial daily dose of 1½-3 tablets (825-1650 mg) is recommended for patients with severe nocturnal pain and / or severe morning stiffness, patients being transferred to naproxen treatment from high doses of other NSAIDs, and patients with pain as the leading symptom. Usually, the daily dose is 1-2 tablets (550-1100 mg), administered in 2 divided doses.

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

To reduce the risk of gastrointestinal adverse events, the minimum effective dose should be used in the shortest possible course.

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

Children

Nalgesin forte is contraindicated for use in children under 16 years of age.

Overdose

Symptoms

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

Treatment

Patients who have accidentally or intentionally taken a large amount of Nalgesin® forte should wash their stomach, take activated charcoal, and perform symptomatic therapy: antacids, _H2-receptor blockers, and proton pump inhibitors. Hemodialysis is ineffective.

Description

Oval biconvex tablets with a risk on one side, covered with a film-coated blue color.

View at the break: a rough mass of white color with a film shell of blue color.

Special instructions

Do not exceed the dosage indicated in the instructions. To reduce the risk of gastrointestinal adverse events, the minimum effective dose should be used in the shortest possible course.

If the pain and fever persist or become worse, you should consult a doctor.

Patients with bronchial asthma, blood clotting disorders, or hypersensitivity to other analgesics should consult their doctor before taking Nalgesin forte.

Caution should be exercised in patients with liver disease and renal insufficiency. In patients with renal insufficiency, creatinine clearance should be monitored. When creatinine clearance is below 30 ml/min, naproxen is not recommended. In chronic alcoholic and other forms of liver cirrhosis, the concentration of unbound naproxen increases, so lower doses are recommended for such patients. After two weeks of using the drug, monitoring of liver function indicators is necessary.

Nalgesin forte should not be taken together with other anti-inflammatory and analgesic medications, except as 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 affect the determination of 5-hydroxyindoleacetic acid in the urine.

The use of naproxen, as well as other drugs that block prostaglandin synthesis, can affect fertility, so it is not recommended for women planning pregnancy.

Each tablet of Nalgesin Forte contains approximately 50 mg of sodium. When limiting salt intake, this should be taken into account.

Influence on the ability to drive vehicles and mechanisms

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

Form of production

Film-coated tablets,550 mg.

10 tablets in a blister of PVC/aluminum foil.

1,2 or 6 blisters in a cardboard pack together with the instructions for use.

Storage conditions

At a temperature not exceeding 25 °C, in the original packaging.

Keep out of reach of children.

Shelf

life is 5 years.

Do not use the drug after the expiration date.

Active ingredient

Naproxen

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as prescribed by a doctor, Children over 15 years of age

Indications

Osteoarthritis, Myositis, Neuritis, Bursitis, Sciatica, Tendon Inflammation, Lumbago, Rheumatoid Arthritis, Adnexitis, Osteoarthritis, Otitis Media, Sprains and Sprains, Migraines, Arthritis, Bruises