Bonifen - a drug for symptomatic therapy with antipyretic, analgesic and anti-inflammatory effects.
Release form and composition
Bonifen released in the form of tablets, film-coated: blue, oval, biconvex (10 pieces in blisters, 1-2 blisters in a cardboard box).
The composition of 1 tablet includes:
- Active ingredient: naproxen sodium - 275 mg;
- Auxiliary components: microcrystalline cellulose, povidone, talc, magnesium stearate, purified water;
- Shell: Opadry YS-1-4215 (macrogol, titanium dioxide (E171), hypromellose, indigo carmine dye (E132)).
Indications for use
- Pain syndrome moderate or weak expression: neuralgia, myalgia, ossaliya, sciatica, accompanied by inflammation of traumatic pain (bruising and stretch), postoperative pain (in orthopedics, traumatology, maxillofacial surgery, gynecological), adnexitis, headache, tuberculosis, migraine , toothache;
- Disorders of the musculoskeletal system (juvenile chronic, psoriatic and rheumatoid arthritis, spondylitis (ankylosing spondylitis disease); rheumatic soft tissue, gouty arthritis, osteoarthritis of the spine and peripheral joints, including with radicular syndrome, bursitis, tenosynovitis);
- Febrile syndrome in infectious and catarrhal diseases;
- Infectious and inflammatory diseases of the ear, throat, nose, accompanied by severe pain, including tonsillitis, pharyngitis, otitis media (along with other drugs).
Bonifen is prescribed for symptomatic treatment (reducing pain, inflammation and reducing elevated body temperature), the drug has no effect on the progression of the underlying disease.
- Active gastrointestinal bleeding, erosive and ulcerative changes in the gastric mucosa or duodenal ulcer;
- Cerebrovascular bleeding or other bleeding and impaired hemostasis;
- The period after coronary artery bypass surgery;
- Inflammatory bowel disease in the acute phase (Crohn's disease, ulcerative colitis);
- Active liver disease or severe liver failure;
- Oppression of bone marrow hematopoiesis;
- Severe renal failure (with creatinine clearance less than 20 ml per minute), including progressive kidney disease and confirmed hyperkalemia;
- Instructions in the history of the attacks of bronchial obstruction, urticaria, rhinitis after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (complete or partial intolerance syndrome acetylsalicylic acid - rhinosinusitis, nasal mucous polyps, urticaria, bronchial asthma);
- Pregnancy and lactation;
- Hypersensitivity to the components of the drug, as well as to naproxen, acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.
Bonifen is not recommended for children under 9 years old and / or body weight up to 27 kg (1 tablet contains 275 mg of naproxen). Children 9-12 years old, the drug can be taken only after a doctor.
Caution requires the use of Bonifen in the presence of the following diseases / conditions:
- Coronary heart disease;
- Cerebrovascular diseases;
- Congestive heart failure;
- Hyperlipidemia and / or dyslipidemia;
- Peripheral artery diseases;
- Renal failure with creatinine clearance less than 60 ml per minute;
- Anamnestic data on the development of ulcerative lesions of the gastrointestinal tract;
- The presence of Helicobacter pylori infection;
- Severe somatic diseases;
- Long-term use of nonsteroidal anti-inflammatory drugs;
- Frequent drinking, smoking;
- The simultaneous use of oral corticosteroids (e.g. prednisone), anticoagulants (e.g. warfarin), selective serotonin reuptake ingibitoramiy (such as citalopram, fluoxetine, paroxetine, sertraline), antiplatelet agents (e.g. acetylsalicylic acid, clopidogrel);
- Elderly age.
Dosing and Administration
Bonifen taken orally, drinking plenty of water.
As an analgesic drug is usually prescribed 2-4 tablets per day. With pain of high intensity and the absence of gastrointestinal diseases in history, it is possible to increase the daily dose to 6 tablets, but not longer than 14 days.
As a febrifuge, Bonifen is prescribed in an initial single dose of 2 tablets, after which the drug is taken every 6-8 hours, 1 tablet.
The dosage regimen is determined by the indications:
- Migraine attacks (for the purpose of prevention): 2 times a day, 550 mg (2 tablets). If the frequency, duration and intensity of migraine attacks do not decrease within 1-1.5 months, therapy should be interrupted;
- Migraine attack: once 3 tablets (at the first signs), after 30 minutes, if necessary, you can take another 1-2 tablets;
- Menstrual pain and cramps, pain after the introduction of the intrauterine device and other gynecological pain: initial dose - 2 tablets, then every 6-8 hours, 1 tablet;
- Acute gout attacks: initial dose - 3 tablets, then after 8 hours - 2 tablets, after which 1 tablet should be taken with the same interval until the attack stops;
- Rheumatoid diseases (rheumatoid arthritis, ankylosing spondylitis, osteoarthritis): the initial average dose is 2 times a day (in the morning and evening) 2-4 tablets. In the initial daily dose of 3-6 tablets, the drug is prescribed for pronounced night pains and / or pronounced morning stiffness, as well as for patients transferred to Bonifen from taking other nonsteroidal anti-inflammatory drugs in high doses, and for patients in whom pain is the leading symptom.
The daily dose on average is 2-4 tablets with a frequency of 2 times a day. Morning and evening doses may not be the same. Depending on the predominance of symptoms (morning stiffness and / or night pain), after a medical consultation, it is possible to change the dosage regimen.
For children from 9 years old and / or with a body weight of more than 27 kg, Bonifen is prescribed in 2 doses in a daily dose of 10 mg / kg.
Most often side effects develop with the use of Bonifen in high doses. The following disorders may occur during therapy:
- The digestive system: constipation, diarrhea, abdominal pain, nausea, dyspepsia, ulcerative stomatitis, bleeding and erosive-ulcerative lesions of the gastrointestinal tract, increased activity of liver enzymes, bloody vomiting, functional disorders of the liver, jaundice, melena;
- Cardiovascular system: congestive heart failure, edema, palpitations, shortness of breath, vasculitis;
- Central nervous system: cognitive dysfunction, headache, hearing loss, insomnia, dizziness, drowsiness, depression, sleep disorders, aseptic meningitis, slower reaction rate, inability to concentrate, muscle weakness and myalgia, malaise;
- Urinary system: menstrual disorders, hematuria, glomerulonephritis, renal failure, interstitial nephritis, nephrotic syndrome, renal papillary necrosis;
- Skin: photodermatosis, pruritus, excessive sweating, ecchymosis, alopecia, purpura;
- Respiratory system: eosinophilic pneumonitis;
- Organs of blood formation: thrombocytopenia, granulocytopenia, eosinophilia, leukopenia, aplastic anemia;
- Sense organs: hearing and sight impairment, tinnitus;
- Allergic reactions: Stevens-Johnson syndrome, urticaria, skin rash, erythema multiforme, angioedema, epidermal necrosis;
- Other: hemolytic anemia, thirst, hyperthermia, hypoglycemia, hyperglycemia.
To reduce the risk of adverse events from the gastrointestinal tract, you need to take the lowest effective dose of Bonifen as the least possible course.
In the event that a fever or pain persists or intensifies, it is necessary to consult a doctor.
In diseases of the liver and renal failure, Bonifen is prescribed with caution. When creatinine clearance below 20 ml per minute is not recommended to take the drug. In other cases, in renal failure, creatinine clearance should be monitored. In patients with chronic alcoholic and other forms of cirrhosis, the concentration of unbound naproxen increases, so the drug should be taken in lower doses. Elderly patients are also advised to reduce the daily dose of Bonifen.
Only after medical consultation and with caution it is necessary to take the drug to patients with bleeding disorders, bronchial asthma, as well as patients with hypersensitivity to other analgesics.
If there are no doctor's prescriptions, Bonifen should not be taken simultaneously with other anti-inflammatory drugs and analgesics.
Patients who follow a diet with a restriction of salt intake should take into account that one tablet contains approximately 25 mg of sodium.
It is necessary to avoid taking the drug for 48 hours after surgery.
If it is necessary to determine 17-corticosteroids, Bonifen should be canceled 48 hours prior to the study. Also, the drug can affect the determination of 5-hydroxyindole acetic acid in the urine.
Bonifen may slow down the reaction rate, which must be taken into account when driving and performing work that requires increased attention.
With simultaneous use of Bonifen with some drugs, the following effects may occur:
- Other nonsteroidal anti-inflammatory drugs: an increased risk of side effects (the combination is not recommended);
- Anticoagulants: increased bleeding time;
- Propranolol and other beta-blockers: a decrease in the antihypertensive effect;
- Anticoagulants, hydantoins, or other drugs that bind largely with plasma proteins: potentiation of the action or the occurrence of an overdose of drugs;
- Furosemide: reduced natriuretic effect;
- Angiotensin-converting enzyme inhibitors: an increased risk of developing renal failure;
- Probenecid: an increase in the level of naproxen in plasma;
- Methotrexate, phenytoin, sulfonamides: an increase in the risk of their toxic action, slowing their excretion;
- Cyclosporine: an increased risk of developing renal failure;
- Antacid preparations containing magnesium and aluminum: a decrease in the absorption of naproxen.
Terms and conditions of storage
Keep out of reach of children at temperature up to 25 ° C.
Shelf life - 5 years.