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

Nurofen® Forte is used for headaches, migraines, toothaches, painful menstruation, neuralgia, back pain, muscle pain, rheumatic pain and joint pain; as well as in case of fever due to influenza and colds.

Pharmacological effect

The mechanism of action of ibuprofen, a derivative of propionic acid from the group of non-steroidal anti-inflammatory drugs (NSAIDs), is due to inhibition of the synthesis of prostaglandins – mediators of pain, inflammation and hyperthermic reaction. Indiscriminately blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), as a result of which it inhibits the synthesis of prostaglandins. It has a rapid, targeted effect against pain (analgesic), antipyretic and anti-inflammatory effects. In addition, ibuprofen reversibly inhibits platelet aggregation. The analgesic effect of the drug lasts up to 8 hours.

Special instructions

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

For short term use only. Read the instructions carefully before taking the drug.

Adults and children over 12 years of age, take 1 tablet (400 mg) orally up to 3 times a day. The tablets should be taken with water. The interval between taking 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 symptoms persist or worsen after taking the drug for 2-3 days, you should stop treatment and consult a doctor.

Active ingredient

Ibuprofen

Composition

One film-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 silicon dioxide 2 mg.

shell composition: carmellose sodium 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%, red iron oxide dye (E172) 31%, butanol* 14%, isopropapol* 7%, propylene glycol 5.5%, aqueous ammonia 1%, simethicone 0.01%).

*Solvents that have evaporated after the printing process.

Pregnancy

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

Contraindications

• Hypersensitivity to ibuprofen or any of the components included in the drug.
• Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, and intolerance to acetylsalicylic acid or other NSAIDs (including a history).
• Erosive and ulcerative diseases of the gastrointestinal tract (including gastric and duodenal ulcers, Crohn’s disease, ulcerative colitis) or ulcerative bleeding in the active phase or in history (two or more confirmed episodes of peptic ulcer or ulcerative bleeding).
• History of bleeding or perforation of a gastrointestinal ulcer caused by the use of NSAIDs.
• Severe liver failure or active liver disease.
• Severe renal failure (creatinine clearance • Decompensated heart failure; period after coronary artery bypass grafting.
• Cerebrovascular or other bleeding.
• Fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency.
• Hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis.
• pregnancy (III trimester).
• Children under 12 years of age.

With caution:

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

Side Effects

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

Elderly people experience an increased incidence of adverse reactions with NSAID use, especially gastrointestinal bleeding and perforation, in some cases fatal.

Side effects are predominantly dose dependent.

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

The frequency of adverse reactions was assessed based on the following criteria: very common (≥1/10), common (from ≥1/100 to

Blood and lymphatic system disorders

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

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

• Very rare: severe hypersensitivity reactions, including swelling of the face, tongue and larynx, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe anaphylactic shock).

Gastrointestinal disorders

• Uncommon: abdominal pain, nausea, dyspepsia (including heartburn, bloating).

• Rare: diarrhea, flatulence, constipation, vomiting.

• Very rare: peptic ulcer, perforation or gastrointestinal bleeding, melena, hematemesis, 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 dysfunction, increased activity of liver transaminases, hepatitis and jaundice.
Renal and urinary tract disorders

• Very rare: acute renal failure (compensated and decompensated), especially with long-term use, in combination with an increase in the concentration of urea in the blood plasma and the appearance of edema, hematuria and proteinuria, nephritic syndrome, nephrotic syndrome, papillary necrosis, interstitial nephritis, cystitis.

Nervous system disorders

• Uncommon: headache.
• Very rare: aseptic meningitis.

Cardiovascular system disorders

• Frequency unknown: heart failure, peripheral edema, with long-term use increased risk of thrombotic complications (for example, myocardial infarction), increased blood pressure.

Disorders of the respiratory system and mediastinal organs

• Frequency unknown: bronchial asthma, bronchospasm, shortness of breath.

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)
• activity of “liver” transaminases (may increase)
If side effects occur, you should stop taking the drug and consult a doctor.

Interaction

The simultaneous use of ibuprofen with the following drugs should be avoided:

· Acetylsalicylic acid: with the exception of low doses of acetylsalicylic acid (no more than 75 mg per day) prescribed by a doctor, since combined use may increase the risk of side effects. With simultaneous use, ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (an increase in the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent is possible after starting ibuprofen).

· Other NSAIDs, in particular selective COX-2 inhibitors: the simultaneous use of two or more drugs from the NSAID group should be avoided due to a possible increased risk of side effects.

Use with caution simultaneously with the following medications:

· Anticoagulants and thrombolytic drugs: NSAIDs may enhance the effect of anticoagulants, in particular warfarin and thrombolytic drugs.

· Antihypertensive drugs (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 (eg, dehydrated patients or elderly patients with impaired renal function), coadministration of ACE inhibitors or angiotensin II antagonists and cyclooxygenase inhibitors may result in adverse effects, including the 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 prescribed with caution, especially in the elderly. It is necessary to prevent dehydration in patients, and consider monitoring renal function after initiation of this combination treatment and periodically thereafter. Diuretics and ACE inhibitors may increase the nephrotoxicity of NSAIDs.

· Glucocorticosteroids: increased risk of gastrointestinal ulcers and gastrointestinal bleeding.

· Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.

· Cardiac glycosides: simultaneous administration of NSAIDs and cardiac glycosides can lead to worsening heart failure, a decrease in glomerular filtration rate and an increase in the concentration of cardiac glycosides in the blood plasma.

· Lithium preparations: there is evidence of the likelihood of an increase in the concentration of lithium in the blood plasma during the use of NSAIDs.

· Methotrexate: there is evidence of the likelihood of an increase in the concentration of methotrexate in the blood plasma during the use of NSAIDs.

· Cyclosporine: increased risk of nephrotoxicity when NSAIDs and cyclosporine are co-administered.

· Mifepristone: NSAIDs should be started no earlier than 8-12 days after taking mifepristone, as NSAIDs may reduce the effectiveness of mifepristone.

· Tacrolimus: When NSAIDs and tacrolimus are co-administered, there may be an increased risk of nephrotoxicity.

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

· Quinolone antibiotics: Patients receiving concomitant treatment with NSAIDs and quinolone antibiotics may have an increased risk of seizures.

· Myelotoxic drugs: increased hematotoxicity.

· Cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin: increased incidence of hypoprothrombinemia.

· Drugs that block tubular secretion: decreased excretion and increased plasma concentrations of ibuprofen.

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

· Microsomal oxidation inhibitors: reducing the risk of hepatotoxicity.

· Oral hypoglycemic drugs and insulin, sulfonylurea derivatives: increased effect of drugs.

· Antacids and cholestyramine: decreased absorption.

· Uricosuric drugs: decreased effectiveness of drugs.

· Estrogens, ethanol: increased risk of side effects.

· Caffeine: enhanced analgesic effect.

Overdose

In children, overdose symptoms 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 case of overdose is 1.5-3 hours.

Symptoms: nausea, vomiting, epigastric pain or, less commonly, diarrhea, tinnitus, headache and gastrointestinal bleeding. In more severe cases, manifestations from the central nervous system are 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. In patients with bronchial asthma, exacerbation of this disease is possible.

Treatment: symptomatic, with mandatory maintenance of airway patency, monitoring of ECG and vital signs until the patient’s condition is normalized. It is recommended that oral activated charcoal or gastric lavage be given within 1 hour of taking a potentially toxic dose of ibuprofen.

If ibuprofen has already been absorbed, an alkaline drink may be prescribed in order to eliminate the acidic derivative of ibuprofen by the kidneys, forced diuresis. Frequent or prolonged seizures should be treated with intravenous diazepam or lorazepam. If bronchial asthma worsens, the use of bronchodilators is recommended.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life

3 years.

Manufacturer

Reckitt Benckiser Healthcare International Ltd, UK