Bonifen FORTE

Active material: Naproxen
When ATH: M01AE02
CCF: NSAIDs
ICD-10 codes (testimony): G43, K08.8, M05, M07, M08, M10, M15, M25.5, M42, M45, M54.1, M54.3, M54.4, M65, M70, M71, M79, N70, N94.4, N94.5, R07, R50, R51, R52.0, R52.2
When CSF: 05.01.01.06
Manufacturer: KRKA d.d. {Slovenia}

Pharmaceutical form, composition and packaging

Pills, Film-coated blue, Oval, lenticular, with Valium on one side.

Excipients: povidone, microcrystalline cellulose, talc, magnesium stearate, Purified water.

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

10 PC. – blisters (1) – packs cardboard.

Pharmacological action

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

Pills, Film-coated, dissolve well, rapidly absorbed from the gastrointestinal tract and provide a rapid onset of analgesic effect.

Pharmacokinetics

Absorption

Absorption from the gastrointestinal tract is fast and full. Bioavailability – 95%. Eating virtually no effect on the completeness, or at the rate of absorption. T_max– 1-2 no.

Distribution

Plasma protein binding - more 99%. C_ss achieved to receive 4-5 doses (2-3 day).

Metabolism

It is metabolized in the liver to dimetilnaproksena with CYP2C9 isoenzymes.

Deduction

T_1/2 – 12-15 no. Clearance – 0.13 ml / min / kg. Report the news (98%), 10% of which – in unchanged form; the bile output 0.5-2.5% the dose.

Pharmacokinetics in special clinical situations

When kidney failure is possible accumulation of metabolites.

Testimony

- Diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, Ankylosing spondylitis / Bechterew's disease /, podagricheskiy arthritis, rheumatic soft tissue, osteoarthritis of peripheral joints and spine, incl. with radicular syndrome, tendinitis, ʙursit);

- Pain mild or moderate severity: neuralgia, ossalgia, myalgia, ljumʙoişialgija, post-traumatic pain (sprains and bruises), accompanied by inflammation, post-operative pain (in traumatology, Orthopedics, Gynecology, Maxillofacial Surgery), headache, migraine, algomenorrhea, adnexitis, toothache;

- In the complex treatment of infectious and inflammatory diseases of the ear, throat, nose with severe pain (pharyngitis, tonsillitis, otitis);

- A feverish syndrome with colds and infectious diseases. Bonifen forte is used for symptomatic treatment (to reduce pain, inflammation and reducing elevated body temperature) and the progression of the underlying disease will not affect.

Dosage regimen

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

To Pain Relief appointed 1-2 tab. (550-1100 mg).

At very severe pain and lack of a history of gastrointestinal disease the daily dose can be increased to 3 tab. (1650 mg), but not more than 2 of the week.

IN as an antipyretic starting dose is 1 tab. (550 mg), further – by 1/2 tab. (275 mg) every 6-8 no.

To prevention of migraine attacks – 1 tab. (550 mg) 2 times / day. However, treatment should be discontinued, If the frequency, intensity and duration of migraine attacks do not decrease during 4-6 weeks. At the first sign of migraine attack should take 1.5 tab. (825 mg), and optionally – more 1/2-1 tab. (275-550 mg) through 30 m.

To relieve menstrual pain and cramping, pain after IUD insertion (intrauterine devices) and other gynecological pain (adnexitis, delivery / as analgesic and tocolytic agent /) recommended use of the drug in the initial dose 1 tab. (550 mg), further – by 1/2 tab. (275 mg) every 6-8 no.

At Ostrom approaches podagry starting dose is 1.5 tab. (825 mg), further – 1 tab. (550 mg) through 8 no, and then - 1/2 tab. (275 mg) every 8 h until the termination of the attack.

At rheumatic diseases (rheumatoid arthritis, osteoarthritis and spondylitis ankilozirushtiy) starting dose is 1-2 tab. (550-1100 mg) 2 times / day, morning and evening. The initial daily dose, component 1.5-3 tab. (825-1650 mg) It recommended for patients with expressed night pain and / or severe morning stiffness, patients, translatable to the treatment with naproxen sodium high doses of other NSAIDs, and patients, whose pain is the leading symptom. Usually a daily dosage of 1-2 tab. (550-1100 mg), appointed in 2 admission. Morning and evening doses may not be the same. You can change them depending on the prevalence of symptoms, ie. a night of pain and / or morning stiffness.

Side effect

Side effects most frequently observed with high doses Bonifen Fort.

From the digestive system: constipation, abdominal pain, dyspepsia, nausea, diarrhea, ulcerative stomatitis, erosive and ulcerative lesions and bleeding from the gastrointestinal tract, increase in liver enzymes, abnormal liver function, jaundice, hematemesis, ground.

CNS: hearing loss, dizziness, headache, drowsiness, depression, sleep disorders, impaired concentration, insomnia, malaise, slow reaction rate, aseptic meningitis, cognitive dysfunction.

Dermatological reactions: itch, ecchymosis, increased perspiration, purpura, alopecia, photodermatosis.

From the senses: noise in ears, blurred vision, hearing disorder.

Cardio-vascular system: puffiness, breathlessness, heartbeat, congestive heart failure, vasculitis.

With the genitourinary system: glomerulonephritis, hematuria, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis, menstrual irregularities.

From the hematopoietic system: eozinofilija, granulocytopenia, leukopenia, thrombocytopenia, aplasticheskaya anemia, gemoliticheskaya anemia

The respiratory system: eosinophilic pneumonitis.

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

Other: thirst, hyperthermia, giperglikemiâ, gipoglikemiâ, lengthening of bleeding time, myalgia, muscular weakness.

Contraindications

- The period after coronary artery bypass grafting;

- Erosive and ulcerative lesions of the stomach or duodenum, active gastrointestinal bleeding;

- Inflammatory bowel disease, exacerbation (NYAK, Crohn's disease);

- Cerebrovascular bleeding or other bleeding disorders and hemostasis;

- Severe hepatic impairment or active liver disease;

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

- Inhibition of bone marrow hematopoiesis;

- Pregnancy;

- Breastfeeding;

- Anamnestičeskie data on access bronchospasm, coryza, hives after taking aspirin or other NSAIDs (complete or partial syndrome of intolerance to acetylsalicylic acid – rinosinusit, hives, nasal polyps, asthma);

- Hypersensitivity to naproxen or naproxen sodium.

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

FROM caution should be prescribed the drug for IBS, cerebrovascular diseases, Congestive heart failure, dyslipidemia / hyperlipidemia, diabetes, Peripheral arterial disease, smoking, CC less than 60 ml / min, anamnestic data on the development of ulcerative lesions GIT, presence of Helicobacter pylori infection, prolonged use NPVC, Often Drinking, severe somatic diseases, elderly patients, concomitant therapy following medications: antykoahulyantы (eg, warfarin), antiagregantы (eg, acetylsalicylic acid, Clopidogrel), oral corticosteroids (eg, prednisolone), selective serotonin reuptake inhibitor (eg, citalopram, fluoxetine, paroxetine, sertraline).

Pregnancy and lactation

Bonifen forte is not recommended during pregnancy and lactation.

The use of naproxen, as well as other drugs, blocking the synthesis of prostaglandins could affect fertility, therefore not recommended for women, wishing to get pregnant.

Cautions

Do not exceed the recommended dose.

To reduce the risk of adverse effects on the gastrointestinal tract should be given the minimum effective dose, short-course.

If pain and fever persist or become stronger, necessary to consult a doctor. Patients with asthma, bleeding disorders, as well as in patients with hypersensitivity to other analgesics before taking Bonifen forte should consult a doctor.

Precautions should be prescribed to patients with liver disease and kidney failure. In patients with renal failure need to control QC. At least QC 20 ml / min is not recommended to prescribe naproxen.

In chronic alcoholic cirrhosis and other forms of concentration of unbound naproxen is increased, therefore such patients lower doses are recommended.

Bonifen Forte should not be taken with other anti-inflammatory and analgesic drugs, except for doctor's appointments.

Elderly patients also recommended a lower dose.

Avoid receiving naproxen for 48 hours prior to surgery.

If you want to determine the 17-corticosteroid preparation should be canceled for 48 h before the test. Similarly,, naproxen may affect the determination of 5-HIAA in the urine.

1 Fort tablet Bonifen 550 mg contains approximately 50 mg of sodium, that should be taken into account by limiting salt intake.

Use in Pediatrics

Children under 16 years drug is given only on doctor's advice.

Effects on ability to drive vehicles and management mechanisms

Naproxen slows reactions in patients. This should be taken into account when driving or performing tasks, requiring attention.

Overdose

Symptoms: substantial overdose may be characterized by drowsiness, dyspeptic disorders (heartburn, nausea and vomiting, abdominal pain), weakness, tinnitus, irritability, in severe cases, develops hematemesis, ground, disturbance of consciousness, convulsions and renal failure.

Treatment: patient, accidentally or intentionally has accepted a large number of drug Bonifen Fort, you need to wash the stomach and symptomatic therapy: Activated carbon, antacids, histamine H₂-receptors, proton pump inhibitors. Hemodialysis nyeeffyektivyen.

Drug Interactions

In the treatment with anticoagulants should be borne in mind, that naproxen may increase bleeding time.

Do not use the drug concurrently with other NSAIDs (increased risk of adverse effects).

Patients, simultaneously receiving hydantoins, anticoagulants or other drugs, binding largely plasma proteins, You should watch for signs of potentiation of these drugs or overdose.

The drug can reduce Bonifen Fort antihypertensive effect of propranolol and other beta-blockers, and can also increase the risk of developing renal failure, associated with the use of ACE inhibitors.

Under the effect of naproxen inhibited natriuretic effect of furosemide.

Inhibition of renal clearance of lithium increases its concentration in blood plasma.

Receiving probenecid increases the plasma levels of naproxen.

Cyclosporin increases the risk of renal failure.

Naproxen methotrexate slows down, phenytoin, sulfonamides, increasing the risk of their toxic effect.

Antacids, containing magnesium and aluminum, reduce the absorption of naproxen.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C. Shelf life- 5 years.