Description
film release form
film-coated tablets
packaging 10 pcs
Pharmacological action
Pharmacotherapeutic group – non-steroidal anti-inflammatory drug.
ATX code: M01AE02
Pharmacological properties.
Nalgesin forte, is a naproxen preparation, has analgesic, antipyretic and anti-inflammatory effects. The mechanism of action is associated with non-selective inhibition of the activity of cyclooxygenase 1 and 2 (COX-1, COX-2). Film-coated tablets, Nalgezin forte dissolve well, are rapidly absorbed from the gastrointestinal tract and provide a quick onset of analgesic effect.
Pharmacokinetics
Absorption from the gastrointestinal tract – fast and complete, bioavailability – 95% (food intake practically does not affect either completeness or absorption rate). The time to reach 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. Ground 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, cumulation of metabolites is possible.
Indications
Diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis (ankylosing spondylitis) gouty arthritis, rheumatism of soft tissues, osteoarthritis of the peripheral joints and spine, including with radicular syndrome, tendovaginitis, bursitis),
Pain syndrome of mild or moderate severity, neuralgia, neuralgia lumbar ischialgia, post-traumatic pain syndrome (sprains and bruises), accompanied by inflammation, postoperative pain (in traumatology, orthopedics, gynecology, maxillofacial surgery), naya pain, migraine, tuberculosis, adnexitis, toothache.
As part of the complex treatment of infectious and inflammatory diseases of the ear, throat, nose with severe pain (pharyngitis, tonsillitis, otitis media).
Feverish syndrome with colds and infectious diseases. Nalgesin forte is used for symptomatic therapy (to reduce pain, inflammation and lower fever) and does not affect the progression of the underlying disease.
Contraindications
Hypersensitivity to naproxen or naproxen sodium with anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs (complete or incomplete intolerance syndrome of acetylsalicylic acid, – urticaria, polyps of the nasal mucosa, asthma)
Period after coronary artery bypass grafting
Erosive-ulcerative changes in the gastric or duodenal mucosa, active gastrointestinal bleeding
Inflammatory bowel disease, in the acute phase (Nonspecific Ulcer, Ulcerative (ulcerative) )
Cerebrovascular bleeding or other bleeding and hemostatic disorders
Severe liver failure or active liver disease
Severe renal failure (clearance creatine Nina less than 20 ml / min), including hyperkalemia confirmed, progressive renal disease
Inhibition of bone marrow hematopoiesis
pregnancy, breast-feeding period
Bonifen forte one tablet contains 550 mg of naproxen therefore, the drug is not recommended for children and adolescents under 15 years of age.
Precautions: coronary heart disease, cerebrovascular disease, congestive heart failure, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral artery disease, smoking, creatinine clearance less than 60 ml / min history of gastrointestinal ulcer, presence of Helicobacter pylori infection, , prolonged use of NSAIDs, frequent alcohol consumption, severe somatic diseases, concomitant therapy with the following drugs: anticoagulants (e.g. warfarin), antiplatelet Ty (e.g., acetylsalicylic acid, clopidogrel), oral glgokokortikoidy (e.g., prednisone), selective serotonin reuptake inhibitor (such as 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 lowest possible rate. For children under 16 years of age, the drug is prescribed only on the recommendation of a doctor.
Use during pregnancy and lactation
Nalgesin forte is not recommended for use during pregnancy and lactation.
Composition
1 film-coated tablet contains:
Kernel:
Active ingredient: naproxen sodium 550 mg.
Excipients: it looks like microcrystalline cellulose, talc, magnesium stearate, purified water.
Shell: Opadry dye YS-I-4216 (this ready-to-use mixture of titanium dioxide (171), macrogol, indigo carmine dye (E 132) and hypromellose.
Dosage and Administration
Inside. Strictly follow the doctor s instructions. You should not stop treatment or change the dosage without first consulting your doctor. Check with your doctor for the duration of the drug.
Recommended treatment regimen:
The usual daily dose used to relieve pain is 1 2 tablets (550 1100 mg).
With very severe pain and no history of gastrointestinal diseases, the doctor may increase the daily dose to 3 tablets (1650 mg), but not more than 2 weeks. When using the drug as an antipyretic, the initial dose is 1 tablet (550 mg), then 1A tablet (275 mg) is taken every 6-8 hours. To prevent migraine attacks, 1 tablet (550 mg) twice a day is 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 Ug tablets (825 mg), and if necessary still 1/2 – 1 tablet (275 – 550 mg) after 30 minutes.
To relieve menstrual cramps and cramps, pain after the introduction of IUDs (intrauterine devices) and other gynecological pains (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 1/2 tablet (275 mg) every 6 -8 ocloc’k.
In an acute attack of gout, the initial dose is 11/2 tablets (825 mg), then 1 tablet (550 mg) after 8 hours, and then 1/2 tablet (275 mg) every 8 hours until the attack stops.
For rheumatoid diseases (rheumatoid arthritis, osteoarthritis and ankylosing spondylitis), the usual initial dose of the drug is 1-2 tablets (550-1100 mg), twice a day in the morning and evening. An initial daily dose of 1/2 (825 mg) – 3 tablets (1650 mg) is recommended for patients with severe night pain and / or severe morning stiffness, to patients being transferred to treatment with sodium naproxen from high doses of other non-steroidal anti-inflammatory drugs, and to patients in whom pain is a leading symptom. Typically, the daily dose is 1 tablet (550 mg) – 2 tablets (1100 mg), administered 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. If you have the impression that the effect of the drug is very strong or weak, inform your doctor or pharmacist.
Side effects of
Side effects are most common when using high doses of nalgesin forte:
– from the digestive system: constipation, abdominal pain, dyspepsia, nausea, diarrhea, ulcerative stomatitis, erosive and ulcerative lesions and bleeding of the gastrointestinal tract, activity of liver enzymes, impaired liver function, 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 the sensory organs tinnitus, visual impairment, hearing impairment
– on the part us cardiovascular system: edema, dyspnea, palpitations, congestive heart failure, vasculitis
– genitourinary: glomerulonephritis, hematuria, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis,
menstrual irregularities – from the hematopoietic organs: eosinophilia, granulocytopenia, leukopenia, thrombocytopenia, aplastic anemia
– from the respiratory system: eosinophilic pneumonitis
– allergic reactions, skin rashes, urticaria, angioedema, angiorrhythmoma from otorrhea, necrosis syndrome Johnson
– others: thirst, hyperthermia, hyperglycemia, hypoglycemia, increases bleeding time, hemolytic anemia.
If you notice such phenomena, stop taking the drug and, if possible, consult a doctor.
Overdose
Significant overdose with the drug can be characterized by drowsiness, dyspeptic disorders (heartburn, nausea and vomiting, abdominal pain), weakness, tinnitus, irritability, severe rash, .
A patient who has accidentally or intentionally taken a large amount of the drug Nalgesin Forte, it is necessary to wash the stomach and carry out symptomatic therapy: activated charcoal, antacids, h2receptor blockers, proton pump inhibitors. Hemodialysis is ineffective.
Storage conditions
In the dark place at a temperature of no higher than 25 ° C.
Expiration
5 years.
Deystvuyuschee substances
Naproxen
Terms of delivery from pharmacies
Prescription
Dosage form
dosage form
tablets
KRKA d.d. Novo mesto AO, Slovenia
