Bonifen forte pills coated 550mg №20

Therapeutic indications

• diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis (Bechterew's disease); gouty arthritis, rheumatoid lesions of the soft tissues, osteoarthritis of the peripheral joints and the spine, including with radicular syndrome, and idiopathic syndrome;
• pain syndrome of mild or moderate severity: neuralgia, ossalgia, myalgia, lumboischialgia, post-traumatic pain syndrome (sprain and bruises), accompanied by inflammation, postoperative pain (in traumatology, orthopedics, gynecology, maxillofacial surgery), headache, in traumatology, orthopedics, gynecology, maxillofacial pain, headache, in traumatology, orthopedics, gynecology, maxillofacial pain, headache, in traumatology, orthopedics, gynecology, maxillofacial pain, headache, trauma, orthopedic adnexitis, toothache;
• in the complex treatment 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

Inside with plenty of water.You should strictly follow the instructions of the doctor, do not stop treatment and do not change the dosage without prior consultation with the doctor.

Recommended regimen

The usual daily dose used to relieve pain is 1-2 tablets. (550-1100 mg).

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

When using the drug as a febrifuge, the initial dose is 1 pill (550 mg), then ½ pill (275 mg) is taken every 6-8 hours.

To prevent migraine attacks recommended 1 tab. (550 mg) 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 signs of migraine attack should be taken 1½ table. (825 mg), and if necessary - another ½ table. (275-550 mg) after 30 minutes.

To relieve menstrual pain and spasms, pain after the introduction of the IUD (intrauterine devices) and other gynecological pains, it is recommended to prescribe the drug in the initial dose of 1 tab. (550 mg), then by ½ table. (275 mg) every 6-8 hours

With an acute attack of gout, the initial dose is 1½ table. (825 mg), then 1 table. (550 mg) after 8 h, and then ½ table. (275 mg) every 8 hours until the cessation of the attack.

In 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, morning and evening. The initial daily dose, ranging from 1½ (825 mg) -3 table.(1650 mg), it is recommended for patients with severe night pain and / or severe morning stiffness, for patients transferred to sodium Naproxen treatment from high doses of other NSAIDs, and for patients in whom pain is the leading symptom. Usually the daily dose is 1 table. (550 mg) -2 table. (1100 mg), prescribed in two 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.

Contraindications

• hypersensitivity to naproxen or naproxen sodium; with anamnestic data about the attack of bronchial obstruction, rhinitis, urticaria after taking Acetylsalicylic acid or other NSAIDs (complete or incomplete intolerance syndrome of acetylsalicylic acid - rhinosinusitis, urticaria, nasal mucous polyps, bronchial asthma);
• the period after coronary artery bypass surgery;
• erosive and ulcerative changes of the gastric or duodenal mucosa, active Gastrointestinal bleeding;
• inflammatory bowel disease in the acute phase (ulcerative colitis, Crohn's disease);
• cerebrovascular bleeding or other bleeding and impaired hemostasis;
• severe liver failure or active liver disease;
• severe renal insufficiency (Cl creatinine less than 20 ml / min), including confirmed hyperkalemia, progressive kidney disease;
• oppression of bone marrow hematopoiesis;
• pregnancy, breastfeeding period;
• children and adolescents under 15 years of age (the content of naproxen in 1 tab. - 550 mg).

Carefully: IHD, cerebrovascular diseases, congestive heart failure, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral artery disease, smoking, Cl creatinine less than 60 ml / min; history of the development of ulcerative lesions of the gastrointestinal tract, the presence of infection Helicobacter pylori, advanced age, long-term use of NSAIDs, frequent alcohol use, severe somatic diseases, concomitant therapy with the following drugs: anticoagulants (for example warfarin), antiaggregants (for example acetylsalicylic acid, clopidogrel), oral GK (for example, prednisolone), SIOZS (for example citalopram, fluoxethestetseltek) paroxetine, sertraline). To reduce the risk of adverse events from the gastrointestinal tract, use the minimum effective dose of the minimum possible course. Children under 16 years old are prescribed only on the recommendation of a doctor.

Special instructions and precautionary measures

Do not exceed the dose specified in the instructions. To reduce the risk of adverse events from the gastrointestinal tract, use the minimum effective dose of the shortest possible course.

If pain and fever persist or become stronger, consult a doctor.

Patients with bronchial asthma, with bleeding disorders, as well as patients with hypersensitivity to other analgesics should be consulted with a doctor before taking Bonifen.

Caution should be given to patients with liver disease and renal failure.In patients with renal insufficiency, it is necessary to control the level of creatinine clearance. At the level of Сl creatinine 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 these patients.

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

Elderly patients are also recommended lower doses.

Naproxen should be avoided within 48 hours prior to surgery. If it is necessary to determine 17-corticosteroids, the drug should be discontinued 48 hours before the study. Similarly, naproxen can influence the determination of 5-hydroxyindolecetic acid in urine.

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

Each pill of Bonifen forte contains approximately 50 mg of sodium. When limiting salt intake, this must be taken into account.

Interaction with other drugs

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 simultaneously receiving hydantoins, anticoagulants, or other drugsBinding to a large extent with plasma proteins, should monitor signs of potentiation of 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 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 the level of naproxen in the plasma.

Cyclosporine increases the risk of developing renal failure.

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

Antacid preparations containing Magnesium and aluminum reduce naproxen absorption.

It is necessary to inform your attending physician if you suffer from other diseases or allergies, or are taking any other medicines (including those sold without a doctor's prescription).

Pregnancy and breastfeeding

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

Influence on ability to drive a car and other mechanisms

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

Side effects

Side effects are most frequent when using high doses of Bonifen forte:

From the digestive system: constipation, abdominal pain, dyspepsia, nausea, diarrhea, ulcerative stomatitis, erosive-ulcerative lesions and gastrointestinal bleeding, increased activity of liver enzymes, impaired liver function, jaundice, hematemesis, melena.

From the side of the central nervous system: hearing loss, dizziness, headache, drowsiness, depression, sleep disturbances, inability to concentrate, insomnia, malaise, myalgia and muscle weakness, slow reaction, aseptic meningitis, cognitive dysfunction.

From the skin: itching, ecchymosis, excessive sweating, purpura, alopecia, photodermatosis.

From the senses: tinnitus, blurred vision, hearing loss.

Since the cardiovascular system: puffiness, shortness of breath, palpitations, congestive heart failure, vasculitis.

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

From the blood-forming organs: eosinophilia, granulocytopenia, leukopenia, thrombocytopenia, aplastic anemia.

On the part of the respiratory system: eosinophilic pneumonitis.

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

Others: thirst, hyperthermia, hyperglycemia, hypoglycemia, hemolytic anemia.

In case of occurrence of such phenomena, you should stop taking the drug and, if possible, consult a doctor.

Overdose

A significant overdose of the drug may be characterized by the following symptoms: 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 taken a randomly or deliberately large amount of the drug Bonifen Forte is necessary gastric lavage and symptomatic therapy - Activated carbon, antacids, H2-receptor blockers, proton pump inhibitors. Hemodialysis is ineffective.

Pharmacodynamics

Pharmacotherapeutic group: nonsteroidal anti-inflammatory drug (NSAIDs).

Pharmacological properties.

Bonifen forte is a drug of naproxen, has analgesic, antipyretic and anti-inflammatory effects. The mechanism of action is associated with non-selective inhibition of the activity of COX-1 and COX-2. Tablets, film-coated, Bonifen dissolve well, quickly absorbed from the gastrointestinal tract and provide a quick onset of anesthetic effect.

Pharmacokinetics

Absorption from the gastrointestinal tract - fast and complete, bioavailability - 95% (food intake does not affect either the fullness or the rate of absorption). Tmax - 1-2 hours, communication with plasma proteins> 99%, T1 / 2 - 12-15 hours.Metabolism - in the liver to dimethyl naproxen with the participation of the CYP2C9 enzyme system. Clearance - 0.13 ml / min / kg. Excreted in 98% of the kidneys (of which 10% - unchanged), with bile - 0.5-2.5%. Css is determined to receive 4-5 doses of the drug (2-3 days). In renal insufficiency, accumulation of metabolites is possible.

List of excipients

Excipients: 550 mg tablets

Povidone; MCC; talc; magnesium stearate; purified water

shell: Opadry YS-1-4216 dye (ready-mixed mixture of titanium dioxide (E171), macrogol, indigo carmine dye (E132) and hypromellose)

Special storage conditions

Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.