Bonifen - instructions for use, dose, side effects, contraindications

Ibuprofen is a non-steroidal anti-inflammatory drug that has analgesic, antipyretic and anti-inflammatory effect. The mechanism of action of the drug is associated with oppression of prostaglandin biosynthesis and selective blockade of cyclooxygenase (COX₁ and COX₂). Analgesic effect is most pronounced for inflammatory pains.

Pharmacokinetics:

Ibuprofen is well absorbed from the gastrointestinal tract. Absorption slightly decreases when taking the drug after a meal. Communication with plasma proteins by 90%. Exposed to the systemic and post-systemic metabolism in the liver. The enzyme system CYP2C9 takes part in the metabolism of the drug. The half-life is 2-2.5 hours.It is excreted by the kidneys (in an unchanged form not more than 1%) and to a lesser extent - by bile.

Indications:

- Pain of various origins (headache, neuralgia, joint pain, muscle pain, toothache, pain during menstruation);

- Feverish syndrome with "colds" and other infectious and inflammatory diseases;

- Post-traumatic and postoperative pain syndrome, accompanied by inflammation;

- Algodismenorea, inflammation in the small pelvis, including adnexitis. Ibuprofen It is used for symptomatic therapy and does not affect the progression of the underlying disease.

Contraindications:

- hypersensitivity to ibuprofen or ancillary components;

- period after aortocoronary shunting;

- anamnestic data on the attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, polyps of the nasal mucosa, asthma);

- severe hepatic impairment or active liver disease;

- marked renal failure (creatinine clearance less than 30 ml / min),progressive kidney disease, incl. confirmed hyperkalemia;

Decompensated heart failure;

- erosive and ulcerative changes in the gastric mucosa or duodenum, active gastrointestinal bleeding;

- inflammatory bowel disease, in the phase of exacerbation (Nonspecific ulcerative colitis (NJC), Crohn's disease);

- children's age till 12 years;

- Pregnancy and the period of breastfeeding.

Carefully:

Ischemic heart disease, cerebrovascular disease, congestive heart failure, dyslipidemia / hyperlipidemia, diabetes mellitus, periph- eral arterial disease, smoking, creatinine clearance less than 60 ml / min; anamnestic data on the development of gastrointestinal ulcer, the presence of Helicobacter pylori infection, hyperbilirubinemia, enteritis, colitis, hypertension, blood diseases of unclear etiology (leukopenia, anemia), advanced age, long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) frequent alcohol use, severe physical illness, concomitant therapy with the following drugs: anticoagulants (for example, warfarin), antiplatelet agents (e.g., acetylsalicylic acid, clopidogrel), oral glucocorticoids (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline).

Pregnancy and lactation:Ibuprofen not recommended for use during pregnancy and lactation.

Dosing and Administration:

Inside, after eating. Adults and children over 12 years: 1-2 tablets 2-3 times a day, with plenty of liquid. If necessary, you can take 1 -2 tablets every 4-6 hours, but not more than 6 tablets per day.

When taking the drug for 2-3 days pain or fever stored, as well as other symptoms occurs, discontinue treatment and seek medical advice.

Side effects:From the digestive system: nausea, vomiting, abdominal pain, heartburn, loss of appetite, diarrhea, bloating, pain and discomfort in the epigastrium, irritation, dryness of the oral mucosa, aphthous stomatitis, pancreatitis, constipation, hepatitis.
From the respiratory system: shortness of breath, bronchospasm.
From the sense organs: hearing loss, ringing or noise in the ears, reversible toxic optic neuritis, blurred vision, diplopia, dry conjunctiva and eyelids.
From the nervous system: dizziness, insomnia, anxiety, nervousness and irritability, agitation, drowsiness, depression, confusion, hallucinations.
From the cardiovascular system: development or aggravation of heart failure, tachycardia, increased blood pressure (BP).
From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis. Allergic reactions: skin rash (typically erythematous, urticaria), pruritus, angioedema, anaphylactoid reactions, anaphylactic shock, erythema multiforme (including Steven Johnson), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.
From the hematopoiesis: anemia (including haemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia. Other: increased sweating.
The risk of developing severe adverse reactions increases with prolonged use of the drug in high doses.

Overdose:Symptoms: abdominal pain, nausea, vomiting, retardation, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, lowering blood pressure (BP), bradycardia, tachycardia, atrial fibrillation, respiratory arrest.
Treatment: gastric lavage (only within an hour after administration), Activated carbon, alkaline drink, forced diuresis, symptomatic therapy (correction of acid-base balance, blood pressure (BP)).

Interaction:

The drug should be taken with caution when taking the following medicines at the same time:

- Urikozuric means (reduces their effectiveness);

- indirect anticoagulants, antiaggregants, fibrinolytics (ibuprofen strengthens their effect, increases the risk of hemorrhagic complications);

- corticosteroids and other non-steroidal anti-inflammatory drugs, colchicine, estrogen, ethanol (ibuprofen increases the risk of violations from the gastrointestinal tract);

- cardiac glycosides, lithium, methotrexate (ibuprofen can enhance the toxic effects of these drugs);

- acetylsalicylic acid (ibuprofen reduces the anti-inflammatory and antiaggregant effect of this drug - it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as antiplatelet agents after the onset of ibuprofen administration.

- inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) (production of hydroxylated active metabolites increases, increasing the risk of severe hepatotoxic reactions);

- inhibitors of microsomal oxidation (the risk of hepatotoxic effect is reduced);

- diuretics (furosemide and hydrochlorothiazide) and vasodilators (including slow calcium channel blockers and angiotensin-converting enzyme inhibitors): simultaneous administration can reduce the antihypertensive activity of drugs;

- caffeine (enhances analgesic effect);

- anticoagulant and thrombolytic agents (alteplase, streptokinase, urokinase) (increased risk of bleeding);

- cefamandol, cefaperazone, cefotetan, valproic acid, plikamycin (the frequency of development of hypothrombinemia increases);

- cyclosporine (nephro- and hepatotoxic effects increase) and with gold preparations (nephrotoxic effect increases);

- Myelotoxic drugs (the hematotoxic effect is enhanced);

- probenecid and sulfinpyrazone (ibuprofen, like other NSAIDs, can reduce the effect of these drugs);

- quinolone antibacterial drugs in high doses (can cause convulsions);

- drugs that block tubular secretion (reduced excretion and increased plasma concentration of ibuprofen);

- antacids and colestyramine (reduces absorption of ibuprofen);

- oral hypoglycemic drugs (ibuprofen can potentiate the hypoglycemic effect of these drugs).

Special instructions:

During treatment with the drug it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys.

When the symptoms of gastropathy are shown, careful monitoring, including the conduct of esophagogastroduodenoscopy,a blood test with determination of hemoglobin, hematocrit, analysis of feces for latent blood. To prevent the development of NSAIDs, gastropathy is recommended to be combined with PgE (misoprostol).

During the treatment with ibuprofen, ethanol is not recommended.

Effect on the ability to drive transp. cf. and fur:

During the treatment with the drug it is recommended to refrain from all activities requiring increased attention, rapidity of psychophysical reactions.

Form release / dosage:

Tablets, film-coated, 200 mg.

Packaging:

For 6 tablets in a blister pack. Two blisters together with instructions for use are placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N13690 / 01

Date of registration:13.02.2008

Expiration Date:Unlimited

Date of cancellation:2017-04-28

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

KRKA, d.d. Slovenia

Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Information update date: & nbsp28.04.2017

Illustrated instructions

Instructions

Bonifen (Bonifen)