Nurofen Express Forte, 400 mg capsules 20 pcs

The mechanism of action of ibuprofen, a propionic acid derivative of the group of non-steroidal anti-inflammatory drugs (NSAIDs), is due to the inhibition of prostaglandin synthesis – mediators of pain, inflammation and hyperthermia. It blocks indiscriminately cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) and inhibits the synthesis of prostaglandins.

It has rapid directed action against pain (analgesic), antipyretic and anti-inflammatory effects. In addition, ibuprofen reversibly inhibits platelet aggregation.

Indications

Pain after injuries and operations, rheumatoid arthritis, fever, pain, toothache, pain in the joints (arthralgia), back pain, headache, sore throatNurofen Express Forte is used for headache, migraine, toothache, painful menstruation, neuralgia, back pain, muscle and rheumatic pain; with fevers for the flu and colds.

Active ingredient

Ibuprofen

Composition

One capsule contains

active ingredient – ibuprofen 400 mg,

excipients: macrogol-600 335.3 mg, potassium hydroxide 44.82 mg, water 29.88 mg;

capsule shell: gelatin 197 mg, sorbitol (partially dehydrated) 95.68 mg, water 25.02 mg, crimson dye [Ponceau 4R] (E124) 0.79 mg, white ink [Opacode WB NS-78-18011] (water 48 %, titanium dioxide (E171) 29 %, propylene glycol 10 %, isopropanol 8 %, Hypromellose ZcP 5 %).

How to take, the dosage

Read the instructions carefully before taking this medicine.

To be taken orally. For short-term use only.

Adults and children over 12 years: Orally take 1 capsule without chewing. The capsule should be taken with water. The interval between each dose should be at least 4 hours. Maximum daily dose is 1200 mg.

The maximum daily dose for children 12-17 years old is 800 mg.

If symptoms persist or worsen when taking the drug for 2-3 days, you should stop treatment and see a doctor.

Interaction

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

– Acetylsalicylic acid: except in low doses of acetylsalicylic acid (no more than 75 mg per day) prescribed by a physician, because co-administration may increase the risk of side effects. When concomitant use, ibuprofen reduces anti-inflammatory and antiplatelet effects of acetylsalicylic acid (the incidence of acute coronary failure may increase in patients receiving low doses of acetylsalicylic acid as antiplatelet agents after starting ibuprofen administration).

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

Cautiously use concomitantly with the following drugs:

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

Hypotensive drugs (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effectiveness of drugs in these groups. Diuretics may increase the nephrotoxicity of NSAIDs.

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

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

– Cardiac glycosides: concomitant use of NSAIDs and cardiac glycosides may worsen heart failure, decrease glomerular filtration rate, and increase plasma concentrations of cardiac glycosides.

Lithium drugs: there is data on the likelihood of increased plasma lithium concentrations with NSAIDs.

– Methotrexate: there is data on the likelihood of increased plasma concentrations of methotrexate with NSAIDs.

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

– Mifepristone: NSAIDs should not be started earlier than 8-12 days after mifepristone is finished, because NSAIDs may decrease the effectiveness of mifepristone.

– Tacrolimus: simultaneous 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 hematomas in HIV-positive patients with hemophilia co-treated with zidovudine and ibuprofen.

– Quinolone antibiotics: patients co-treated with NSAIDs and quinolone antibiotics may have an increased risk of seizures.

Special Instructions

It is recommended that the drug be taken in as short a course as possible and in the minimum effective dose necessary to eliminate symptoms. During long-term treatment it is necessary to monitor the peripheral blood picture and the functional state of the liver and kidneys. If gastropathy symptoms occur, close monitoring is indicated, including esophagogastroduodenoscopy, general blood test (hemoglobin determination), fecal occult blood test. If it is necessary to determine 17-ketosteroids, the drug should be cancelled 48 hours before the study. During the treatment period it is not recommended to take ethanol.

Patients with renal insufficiency should consult a physician before using the drug, since there is a risk of impairment of renal function.

Patients with arterial hypertension, including a history of and/or chronic heart failure, should consult a physician before using the drug, as the drug may cause fluid retention, increased blood pressure, and edema.

Information for women planning pregnancy: The drug suppresses cyclooxygenase and prostaglandin synthesis and may affect ovulation, impairing female fertility (reversible after discontinuation of treatment).

Influence on driving, operating machinery

Patients who experience dizziness, drowsiness, lethargy or visual disturbances while taking ibuprofen should avoid driving or operating machinery.

Contraindications

• Hypersensitivity to ibuprofen or any of the ingredients of the drug.
• Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and sinuses, and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including history).
• Erotic ulcerative diseases of the gastrointestinal tract (including gastric and duodenal ulcer, Crohn’s disease, ulcerative colitis) or ulcer bleeding in the active phase or in the anamnesis (two or more confirmed episodes of peptic ulcer or ulcer bleeding).
• Bleeding or gastrointestinal ulcer perforation in history triggered by use of NSAIDs.
• Severe hepatic impairment or active liver disease.
• Severe renal impairment (creatinine clearance < 30 ml/min), confirmed hyperkalemia.
• Decompensated heart failure; period after coronary artery bypass.
• Cerebrovascular or other bleeding.
• Hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis.
• Fructose intolerance.
• Pregnancy (III trimester).
• Children under 12 years.

Cautions

If you have any of the conditions listed in this section, please consult your doctor before using the drug.

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

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.

Side effects are mainly dose-dependent.

The following adverse reactions have been observed with short-term administration of ibuprofen in doses not exceeding 1200 mg/day (3 capsules). During treatment of chronic conditions and during 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 (≥ 1/100 to < 1/10), infrequent (≥ 1/1000 to < 1/100), rare (≥ 1/10 000 to < 1/1000), very rare (< 1/10 000), frequency unknown (no data on frequency assessment).

Disorders of the blood and lymphatic system

Overdose

In children, overdose symptoms may occur after a dose greater than 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, epigastric pain or, less frequently, diarrhea, tinnitus, headache and gastrointestinal bleeding. In more severe cases, manifestations of the central nervous system are observed: drowsiness, rarely – agitation, convulsions, disorientation, coma. In cases of severe poisoning metabolic acidosis and increased prothrombin time, acute 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.

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

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

Similarities

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