Nurofen Forte, 400 mg 12 pcs

The mechanism of action of ibuprofen, a propionic acid derivative of the group of non-steroidal anti-inflammatory drugs (NSAIDs), is due to inhibiting the synthesis of prostaglandins – mediators of pain, inflammation and hyperthermia. Indiscriminately blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), thereby inhibiting the synthesis of prostaglandins. It has a fast directed action against pain (analgesic), antipyretic and anti-inflammatory effect. In addition, ibuprofen reversibly inhibits platelet aggregation. The analgesic effect of the drug lasts up to 8 hours.

Indications

Headache, Osteoarthritis, Pain, Migraine, Pain after injuries and operations, Lumbago, Sciatica, Toothache, Arthritis, Angina, Neck Pain, Back Pain, Joint Pain (arthralgia), Flu, Myalgia (muscle pain), Sore throatNurofen® Forte is used for headache, migraine, toothache, painful menstruation, neuralgia, back pain, muscle pain, rheumatic pain and joint pain; Also for feverishness from the flu and colds.

Active ingredient

Ibuprofen

Composition

One coated tablet contains:

active ingredient:

ibuprofen 400 mg:

excipients:

croscarmellose sodium 60 mg,

sodium lauryl sulfate 1 mg,

Sodium citrate 87 mg,

stearic acid 4 mg,

colloidal silica 2 mg.

composition of the shell: sodium carmellose 1.4 mg, talc 66 mg, acacia gum 1.2 mg, sucrose 232.2 mg, titanium dioxide 2.8 mg, macrogol 6000 0.4 mg, red ink [Opacode S-1-15094] (shellac 41,49 %, iron oxide red dye (E172) 31 %, butanol* 14 %, isopropapol* 7 %, propylene glycol 5,5 %, aqueous ammonia 1 %, simethicone 0,01 %).

*Solvents evaporated after the printing process.

How to take, the dosage

For oral administration. Patients with hypersensitivity of the stomach are recommended to take the drug with food.

Only for short-term use. Read the instructions carefully before taking the preparation.
Adults and children over 12 years of age orally 1 tablet (400 mg) up to 3 times per day.

Tablets should be washed down with water.

The interval between the intake of tablets should be at least 6 hours.

The maximum daily dose is 1200 mg (3 tablets). The maximum daily dose for children from 12 to 18 years of age is 800 mg (2 tablets).

If the symptoms persist or intensify while taking the drug for 2-3 days it is necessary to stop the treatment and consult a physician.

Interaction

Simultaneous use of ibuprofen with the following drugs should be avoided:

– Acetylsalicylic acid: except for low doses of acetylsalicylic acid (not more than 75 mg per day), prescribed by a physician, because the combined use may increase the risk of side effects. Simultaneous use of ibuprofen reduces anti-inflammatory and antiplatelet effects of acetylsalicylic acid (increased incidence of acute coronary failure is possible in patients receiving low doses of acetylsalicylic acid as antiplatelet agents after starting ibuprofen administration).

– Other NSAIDs, particularly selective COX-2 inhibitors: concomitant use of two or more drugs from the group of NSAIDs should be avoided because of possible increased risk of side effects.

With caution, use simultaneously with the following drugs:

– Anticoagulants and thrombolytics: NSAIDs may increase the effect of anticoagulants, in particular warfarin and thrombolytics.

– Antihypertensives (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effectiveness of drugs in these groups. In some patients with impaired renal function (e.g., in patients with dehydration or elderly patients with impaired renal function), the simultaneous administration of ACE inhibitors or angiotensin II antagonists and cyclooxygenase inhibiting agents may cause functions, including development of acute renal failure (usually reversible). These interactions should be considered in patients taking coxibs concomitantly with ACE inhibitors or angiotensin II antagonists. In this regard, the combined use of the above drugs should be administered with caution, especially in the elderly. It is necessary to prevent dehydration in patients and to consider monitoring renal function after initiation of such combined treatment and periodically thereafter. Diuretics and ACE inhibitors may increase nephrotoxicity of NSAIDs.

– Glucocorticosteroids: increased risk of GI ulcers and gastrointestinal bleeding.

– Antiaggregants and selective serotonin reuptake inhibitors: increased risk of GI bleeding.

– Cardiac glycosides: concomitant administration of NSAIDs and cardiac glycosides may worsen heart failure, decrease glomerular filtration rate and increase the concentration of cardiac glycosides in plasma.

– Lithium preparations: there is data about possibility of increasing of lithium concentration in plasma against the background of NSAID use.

– Methotrexate: there are data on the possibility of increased concentration of methotrexate in blood plasma against the background of NSAID use.

– Cyclosporine: increased risk of nephrotoxicity with concomitant administration of NSAIDs and cyclosporine.

– Mifepristone: NSAIDs should not be started earlier than 8-12 days after mifepristone administration because NSAIDs may reduce the effectiveness of mifepristone.

– Tacrolimus: concomitant use of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.

– Zidovudine: concomitant use of NSAIDs and zidovudine may increase hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-positive patients with hemophilia who received concomitant treatment with zidovudine and ibuprofen.

– Quinolone antibiotics: in patients receiving concomitant treatment with NSAIDs and quinolone antibiotics, an increased risk of seizures is possible.

– Myelotoxic drugs: increase of hematotoxicity.

– Cefamandole, cefoperazone, cefotetan, valproic acid, plikamycin: increased rate of hypoprothrombinemia.

– Drugs that block tubule secretion: decrease in excretion and increase in plasma concentration of ibuprofen.

– Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants): increased production of hydroxylated active metabolites, increased risk of severe intoxication.

– Inhibitors of microsomal oxidation: reduced risk of hepatotoxic effect.

– Oral hypoglycemic drugs and insulin, sulfonylurea derivatives: increase in the effect of drugs.

– Antacids and colestyramine: decrease in absorption.

– Uricosuric drugs: reduction of drug effectiveness.

– Estrogens, ethanol: increased risk of side effects.

– Caffeine: increased analgesic effect.

Special Instructions

For oral administration. Patients with hypersensitivity of the stomach are recommended to take the drug with food.

Only for short-term use. Read the instructions before taking the drug.

Adults and children over 12 years of age orally 1 tablet (400 mg) up to 3 times per day. The interval between the intake of tablets should be at least six hours.

Maximal daily dose is 1200 mg (3 tablets). The maximum daily dose for children from 12 to 18 years of age is 800 mg (2 tablets).

If the symptoms remain or intensify during 2-3 days after taking the preparation it is necessary to stop the treatment and consult a physician.

Contraindications

– Hypersensitivity to ibuprofen or any of the components of the drug.
– Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and sinuses, and intolerance to acetylsalicylic acid or other NSAIDs (including history).
– Gastrointestinal erosive and ulcerative diseases (including gastric and duodenal ulcers, Crohn’s disease, ulcerative colitis) or ulcer bleeding in the active phase or in the anamnesis (two or more confirmed episodes of ulcer disease or ulcer bleeding).
– Bleeding or gastrointestinal ulcer perforation in the history, provoked by the use of NSAIDs.
– Severe hepatic insufficiency or liver disease in the active phase.
– Severe renal insufficiency (creatinine clearance – Decompensated heart failure; period after aortocoronary bypass.
– Cerebrovascular or other bleeding.
– Fructose intolerance, glucose-galactose malabsorption, sucrose-isomaltase deficiency.
– Hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis.
– Pregnancy (III trimester).
– Children under 12 years.

With caution:

Concurrent use of other NSAIDs, history of a single episode of gastric and duodenal ulcer or GI ulcer bleeding; gastritis, enteritis, colitis, presence of Helicobacter pylori infection, ulcerative colitis; bronchial asthma or allergic diseases in the acute stage or in the history – possible development of bronchospasm; systemic lupus erythematosus or mixed connective tissue disease (Sharp syndrome) – increased risk of aseptic meningitis; renal failure, including dehydration (creatinine clearance less than 30-60 ml/min), nephrotic syndrome, liver failure, cirrhosis with portal hypertension, hyperbilirubinemia, arterial hypertension and/or heart failure, cerebrovascular diseases, blood diseases of unclear etiology (leukopenia and anemia), severe somatic diseases, dyslipidemia/hyperlipidemia, diabetes, peripheral arterial disease, smoking, frequent alcohol consumption, concomitant use of medications that may increase the risk of ulceration or bleeding, particularly oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) or antiaggregants (including acetylsalicylic acid, clopidogrel), I-II trimester pregnancy, breastfeeding, advanced age.

Side effects

The risk of side effects can be minimized if the drug is taken in a short course, in the minimum effective dose required to eliminate symptoms.

The elderly have an increased incidence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforations, in some cases with a fatal outcome.

Side effects are mainly dose-dependent.

The following adverse reactions were observed during short-term administration of ibuprofen in doses not exceeding 1200 mg/day (3 tablets). During treatment of chronic conditions and during long-term use other adverse reactions may occur.

Evaluation of the frequency of adverse reactions is based on the following criteria: very frequent (≥1/10), frequent (from ≥1/100 to

Violations of the blood and lymphatic system

– Very rare: Blood disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of such disorders are fever, sore throat, superficial mouth ulcers, flu-like symptoms, marked weakness, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology. Immune system disorders

– Infrequent: hypersensitivity reactions – non-specific allergic reactions and anaphylactic reactions, reactions from the respiratory tract (bronchial asthma, including its exacerbation, bronchospasm, dyspnea), skin reactions (itching, urticaria, purpura, Quincke’s edema, exfoliative and bullous dermatoses, including toxic epidermal necrolysis (Lyell syndrome), Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia.

– Very rare: severe hypersensitivity reactions, including edema of the face, tongue and throat, dyspnea, tachycardia, arterial hypotension (anaphylaxis, Quincke’s edema or severe anaphylactic shock).

Gastrointestinal disorders

– Infrequent: abdominal pain, nausea, dyspepsia (including heartburn, bloating).

– Rare: diarrhea, flatulence, constipation, vomiting.

– Very rare: peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, in some cases fatal, especially in elderly patients, ulcerative stomatitis, gastritis.

– Frequency unknown: exacerbation of colitis and Crohn’s disease.

Disorders of the liver and biliary tract

– Very rare: liver function disorders, increased activity of “liver” transaminases, hepatitis and jaundice.

Kidney and urinary tract disorders

– Very rare: Acute renal failure (compensated and decompensated) especially with prolonged use, combined with an increase in plasma urea concentration and the appearance of edema, hematuria and proteinuria, nephritic syndrome, nephrotic syndrome, papillary necrosis, interstitial nephritis, cystitis.

Nervous system disorders

– Infrequent: headache.

– Very rare: aseptic meningitis.

Cardiovascular system disorders

– Frequency unknown: heart failure, peripheral edema, with prolonged use, increased risk of thrombotic complications (such as myocardial infarction), increased blood pressure.

Respiratory and mediastinal disorders

– Frequency is unknown: bronchial asthma, bronchospasm, dyspnea.

Laboratory indicators

– hematocrit or hemoglobin (may decrease)
– bleeding time (may increase)
– plasma glucose concentration (may decrease)
– creatinine clearance (may decrease) – plasma creatinine concentration (may increase)
– hepatic transaminase activity (may increase)

If side effects occur, discontinue the drug and consult a physician.

Overdose

In children, symptoms of overdose may occur after taking a dose exceeding 400 mg/kg body weight. In adults the dose-dependent effect of overdose is less pronounced. The half-life of the drug in overdose is 1.5-3 hours.

Symptoms: nausea, vomiting, pain in the epigastric region or, less frequently, diarrhea, tinnitus, headache and gastrointestinal bleeding. In more severe cases the following symptoms of the central nervous system may be observed: drowsiness, rarely – agitation, convulsions, disorientation, coma.

In cases of severe poisoning metabolic acidosis and increased prothrombin time, renal failure, liver tissue damage, decreased blood pressure, respiratory depression and cyanosis may develop. Patients with bronchial asthma may have exacerbation of this disease.

Treatment: symptomatic, with mandatory provision of airway patency, ECG monitoring and basic vital signs until the patient’s condition normalizes. It is recommended to use activated charcoal or gastric lavage within 1 hour after taking a potentially toxic dose of ibuprofen.

If ibuprofen is already absorbed, alkaline drinking may be prescribed in order to eliminate acidic derivative of ibuprofen by kidneys, forced diuresis. Frequent or prolonged seizures should be controlled with intravenous diazepam or lorazepam. In worsening bronchial asthma the use of bronchodilators is recommended.

Pregnancy use

Nurofen forte is not prescribed during pregnancy, lactation and children under 6 years of age.

Similarities

Nurofen, Nurofen Express, Brufen, Ibuprofen, Dolgit, Ibuprofen-Chemopharm, MIG 400, Faspik, Nurofen Express Lady, Nurofen Express Forte, Nurofen Children, Next Uno Express, Nurofast