BONIFEN FORTE PILLS COATED 550MG

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BONIFEN FORTE PILLS COATED 550MG - 10tabs

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Release form, composition and packaging

Tablets, film coated blue, oval, biconvex, with a risk on one side. 1 tab.
naproxen sodium 550 mg

Excipients: povidone, microcrystalline cellulose, talc, Magnesium stearate, purified water.

The composition of the shell: Opadry dye YS-1-4216 (titanium dioxide (E171), macrogol, indigo carmine dye (E132), hypromellose).

10 - blisters (1) - packs cardboard.

Clinico-pharmacological group: NSAIDs

Registration No.:
tablets, film coated, 550 mg: 10 - P No. 014104/01, December 06, 2007
Description of the drug NALGEZIN FORTE is based on the officially approved instructions for use of the drug NALGEZIN FORTE for specialists and approved by the manufacturer for the 2010 edition.
Pharmacological action | Pharmacokinetics | Indications | Dosing regimen | Side Effects | Contraindications | Pregnancy and lactation | Special instructions | Overdose | Drug Interactions | Terms of sale from pharmacies | Storage conditions and shelf life
pharmachologic effect

NSAIDs. It has analgesic, antipyretic and anti-inflammatory effect. The mechanism of action is associated with non-selective inhibition of the activity of COX-1 and COX-2.

Tablets, film-coated, dissolve well, quickly absorbed from the gastrointestinal tract and provide a rapid onset of analgesic effect.

Pharmacokinetics

Suction

Absorption from the gastrointestinal tract is fast and complete. Bioavailability - 95%. Meal practically does not affect either the fullness or the rate of absorption. Tmax - 1-2 hours

Distribution

Plasma protein binding - more than 99%. Css is achieved by taking 4-5 doses of the drug (2-3 days).

Metabolism

Metabolized in the liver to dimethyl Naproxen with the participation of the isoenzyme CYP2C9.

Removal

T1 / 2 - 12-15 h. Clearance - 0.13 ml / min / kg. Excreted by the kidneys (98%), 10% of which are unchanged; 0.5-2.5% of the dose taken is excreted in the bile.

Pharmacokinetics in special clinical situations

In renal insufficiency, accumulation of metabolites is possible.

Indications for use of the drug NALGEZIN FORTE

- diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis / Bechterew's disease), gouty arthritis, rheumatoid lesions of soft tissues, osteoarthrosis of peripheral joints and the spine, including with radicular syndrome, tenovaginous syndrome, synovitis, peripheral arthritis and spine, including with radicular syndrome, tenovaginous osteoarthrosis of the peripheral joints and spine, including those with radicular syndrome, tenovaginous arthritis, peripheral joints and spine.;

- 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, traumatic surgery, orthopedics, gynecology, maxillofacial pain, headache, trauma, orthopedics, gynecology, maxillofacial pain, headache, traumatic surgery, orthopedics, gynecology, maxillofacial pain, headache, traumatic surgery, orthopedics, gynecology, maxillofacial pain, headache, trauma, orthopedics, gynecology, maxillofacial pain, headache, trauma surgery, orthopedics, gynecology, maxillofacial pain, headache, trauma, orthopedics adnexitis, toothache;

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

- febrile syndrome with colds and infectious diseases. Bonifen forte is used for symptomatic therapy (to reduce pain, inflammation and reduce fever) and does not affect the progression of the underlying disease.

Dosage and administration

The drug is prescribed inside. Do not stop treatment or change the dosage without first consulting with your doctor.

To relieve pain prescribed 1-2 pills (550-1100 mg).

With very severe pain and the absence of a history of gastrointestinal diseases, the daily dose can be increased to 3 pills (1,650 mg), but for no more than 2 weeks.

As a febrifuge, the initial dose is 1 pill (550 mg), then 1/2 pill (275 mg) every 6-8 hours.

To prevent migraine attacks - 1 pill (550 mg) 2 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, 1.5 pills (825 mg) should be taken, and if necessary, another 1 / 2-1 pill (275-550 mg) after 30 minutes.

To relieve menstrual pain and cramps, pain after the introduction of the IUD (intrauterine devices) and other gynecological pains (adnexitis, childbirth / as an analgesic and tocolytic agent /), it is recommended to administer the drug in an initial dose of 1 pill (550 mg), then - 1 / 2 pills (275 mg) every 6-8 hours.

With an acute gout attack, the initial dose is 1.5 pills (825 mg), then 1 pill (550 mg) after 8 hours, and then 1/2 pill (275 mg) every 8 hours until the attack stops.

In rheumatoid diseases (rheumatoid arthritis, osteoarthritis and ankylosing spondylitis), the initial dose is 1-2 pills (550-1100 mg) 2 in the morning and evening. An initial daily dose of 1.5–3 pills (825–1650 mg) is recommended for patients with severe night pain and / or severe morning stiffness, for patients being transferred to sodium naproxen treatment from high doses of other NSAIDs, and for patients with pain as the leading symptom. Usually the daily dose is 1-2 pills (550-1100 mg), prescribed in 2 doses. Morning and evening doses may not be the same. You can change them depending on the predominance of symptoms, i.e. night pain and / or morning stiffness.

Adverse effects

Side effects are most often observed when using high doses of Bonifen Forte.

On the part of the digestive system: constipation, abdominal pain, dyspepsia, nausea, diarrhea, ulcerative stomatitis, erosive and ulcerative lesions and bleeding from the gastrointestinal tract, increased liver enzymes, impaired liver function, jaundice, hematemesh, melena.

On the part of the central nervous system: hearing loss, dizziness, headache, drowsiness, depression, sleep disturbances, impaired concentration, insomnia, malaise, slow reaction, aseptic meningitis, cognitive dysfunction.

Dermatological reactions: itching, ecchymosis, increased sweating, purpura, alopecia, photodermatosis.

On the part of the senses: tinnitus, impaired vision, impaired hearing.

Cardiovascular: swelling, shortness of breath, palpitations, congestive heart failure, vasculitis.

On the part of the urogenital system: glomerulonephritis, hematuria, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis, menstrual disorders.

From the hematopoietic system: eosinophilia, granulocytopenia, leukopenia, thrombocytopenia, aplastic anemia, hemolytic anemia

On the part of the respiratory system: eosinophilic pneumonitis.

Allergic reactions: skin rash, urticaria, angioedema, epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.

Other: thirst, hyperthermia, hyperglycemia, hypoglycemia, lengthening bleeding time, myalgia, muscle weakness.

Contraindications to the use of the drug NALGEZIN FORTE

- the period after coronary artery bypass surgery;

- erosive and ulcerative lesions of the stomach or duodenum, active Gastrointestinal bleeding;

- inflammatory bowel disease, in the acute phase (UC, Crohn's disease);

- cerebrovascular bleeding or other bleeding and impaired hemostasis;

- severe liver failure or active liver disease;

- severe renal failure (CC less than 20 ml / min), incl. confirmed hyperkalemia, progressive kidney disease;

- inhibition of bone marrow hematopoiesis;

- pregnancy;

- breastfeeding period;

- Anamnestic data on the attack of bronchospasm, rhinitis, urticaria after taking Acetylsalicylic acid or another NSAID (complete or incomplete intolerance syndrome of acetylsalicylic acid - rhinosinusitis, urticaria, nasal mucosa polyps, asthma);

- hypersensitivity to naproxen or naproxen sodium.

The drug is not recommended for children and adolescents under 15 years of age.

Precautions should be prescribed the drug for ischemic heart disease, cerebrovascular diseases, congestive heart failure, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral artery disease, smoking, QC less than 60 ml / min, anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, the presence of Helicobacter pylori infection, prolonged use NSAIDs, frequent use of alcohol, severe somatic diseases, elderly patients, concomitant therapy with the following drugs: anticoagulants (for example, warfarin), ant iagreganty (for example, acetylsalicylic acid, clopidogrel), oral GCS (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, Fluoxetine, paroxetine, sertraline).

The use of the drug NALHEZIN FORTE during pregnancy and breastfeeding

Bonifen forte is not recommended for use during pregnancy and during breastfeeding.

The use of naproxen, as well as other drugs that block the synthesis of prostaglandins, may affect fertility, therefore it is not recommended for women who want to become pregnant.

special instructions

Do not exceed recommended doses.

To reduce the risk of adverse events from the gastrointestinal tract, a minimum effective dose should be prescribed in a short course.

If pain and fever persist or get worse, consult a doctor. Patients with bronchial asthma, bleeding disorders, as well as patients with hypersensitivity to other analgesics should receive advice from a doctor before taking Bonifen forte.

Precautions should be prescribed to patients with liver disease and renal failure. In patients with renal insufficiency, CC should be monitored. When QA is less than 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 these patients.

Bonifen forte should not be taken with other anti-inflammatory and analgesic drugs, with the exception of doctor's prescriptions.

Older patients are also recommended lower doses.

Naproxen should be avoided within 48 hours prior to surgery.

If necessary, determine the 17-corticosteroids drug should be canceled 48 hours before the study. Similarly, naproxen can influence the determination of 5-hydroxyindolecetic acid in the urine.

1 pill Bonifen forte 550 mg contains approximately 50 mg of sodium, which should be considered when limiting salt intake.

Use in pediatrics

Children under 16 years old are prescribed only on the recommendation of a doctor.

Influence on ability to drive motor transport and control mechanisms

Naproxen slows down the response rate in patients. This should be considered when driving a car and performing tasks that require increased attention.

Overdose

Symptoms: A significant overdose can be characterized by drowsiness, dyspeptic disorders (heartburn, nausea and vomiting, pain in the abdomen), weakness, tinnitus, irritability, and in severe cases hemorrhaging, melena, impaired consciousness, convulsions, and renal failure develops.

Treatment: a patient who has taken a randomly or deliberately large amount of Bonifen forte requires flushing the stomach and symptomatic therapy: activated charcoal, antacids, histamine H2-receptor blockers, proton pump inhibitors. Hemodialysis is ineffective.

Drug interaction

When treating with anticoagulants, it should be borne in mind that naproxen may increase bleeding time.

Do not use the drug at the same time as other NSAIDs (increased risk of side effects).

Patients who simultaneously receive hydantoins, anticoagulants, or other drugs that bind to a large extent with plasma proteins should monitor signs of potentiation of the action or overdose of these drugs.

The drug Bonifen forte may reduce the antihypertensive effect of propranolol and other beta-blockers, and may also increase the risk of developing 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 its concentration in the blood plasma.

Taking probenecid increases the level of naproxen in the blood plasma.

Cyclosporine increases the risk of developing renal failure.

Naproxen slows down the elimination of Methotrexate, phenytoin, sulfonamides, increasing the risk of their toxic action.

Antacid preparations containing magnesium and aluminum reduce naproxen absorption.

Pharmacy sales terms

The drug is available on prescription.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not higher than 25 ° C. Expiration date - 5 years

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