Nurofen Express Forte analgesic capsules, 400mg, 20pcs

Composition

One capsule contains the 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, red dye [Ponceau 4R] (E 124) 0.79 mg, white ink [Opacode WB NS-78-18011] (water 48%, titanium dioxide (E 171) 29%, propylene glycol 10%, isopropanol 8%, hypromellose ZsR 5%).

Pharmacological action

The mechanism of action of ibuprofen, a propionic acid derivative from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), is due to inhibition of prostaglandin synthesis – mediators of pain, inflammation and hyperthermic reaction. It selectively blocks cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), thereby inhibiting prostaglandin synthesis. It has a rapid directed action against pain (analgesic), antipyretic and anti-inflammatory effect. In addition, ibuprofen reversibly inhibits platelet aggregation.

Indications

Nurofen Express Forte is used for headaches, migraines, toothache, painful menstruation, neuralgia, back pain, muscle and rheumatic pains; for feverish conditions with flu and colds.

Contraindications

• Hypersensitivity to ibuprofen or any of the components that make up the drug.
• Complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, and intolerance to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (including in the anamnesis).
• Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum, Crohn’s disease, ulcerative colitis) active or history of ulcerative bleeding (two or more confirmed episodes of peptic ulcer disease or ulcerative bleeding).
• Bleeding or perforation of a history of gastrointestinal ulcers caused by the use of NSAIDs.
• Severe liver failure or active liver disease.
• Severe renal insufficiency (creatinine clearance
• Decompensated heart failure; the period after coronary artery bypass grafting.
• Cerebrovascular or other bleeding.
• Hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis.
• Fructose intolerance.
• Pregnancy (third trimester).
• Children under 12 years of age.

With caution

If you have the conditions described in this section, you should consult a doctor before using the drug.

Concomitant use of other NSAIDs, a history of a single episode of gastric ulcer or ulcerative bleeding of the gastrointestinal tract; gastritis, enteritis, colitis, Helicobacter pylori infection, ulcerative colitis; bronchial asthma or allergic diseases in the acute stage or in the anamnesis – possible development of bronchospasm; systemic lupus erythematosus or mixed connective tissue disease (Sharp’s syndrome) – increased risk of aseptic meningitis; renal failure insufficiency, including dehydration (creatinine clearance 30-60 ml/min), nephrotic syndrome; liver failure, cirrhosis of the liver 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 artery diseases; smoking; frequent alcohol consumption; concomitant use of medications that may increase the risk of ulceration or bleeding, in particular oral glucocorticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline); pregnancy I-II trimester, breast-feeding period, old age.

Side effects

The risk of side effects can be minimized if you take the drug in a short course at the minimum effective dose necessary to eliminate symptoms. Side effects are mostly dose-dependent. The following adverse reactions were observed with short-term use of ibuprofen in doses not exceeding 1200 mg / day (3 capsules). In the treatment of chronic conditions and with prolonged use, other adverse reactions may occur. The frequency of adverse reactions is estimated 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 (Disorders of the blood and lymphatic system· Very rare: hematopoietic disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of such disorders are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe weakness, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology. Immune system disorders· Infrequently: hypersensitivity reactions – non-specific allergic reactions and anaphylactic reactions, respiratory tract reactions (bronchial asthma, including its exacerbation, bronchospasm, shortness of breath), skin reactions (pruritus, urticaria, purpura, Quincke’s edema, exfoliative and bullous dermatoses, including toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, and 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 * Infrequently: abdominal pain, nausea, dyspepsia (including heartburn, bloating). * Rarely: 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. Liver and biliary tract disorders· Very rare: liver function disorders (especially with prolonged use), hepatitis, jaundice. Disorders of the kidneys and urinary system· Very rare: acute renal failure, hematuria and proteinuria, nephritic syndrome, nephrotic syndrome, papillary necrosis, interstitial nephritis, cystitis. Nervous system disorders * Infrequently: headache. * Very rare: aseptic meningitis (isolated cases of aseptic meningitis symptoms such as occipital muscle rigidity, headache, nausea, vomiting, fever, and disorientation have been observed with ibuprofen in patients with autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disease)). Disorders of the cardiovascular system * Frequency unknown: heart failure, peripheral edema, prolonged use increases the risk of thrombotic complications (for example, myocardial infarction or stroke), increased blood pressure. Respiratory, thoracic and mediastinal disorders * Frequency unknown: bronchial asthma, bronchospasm, shortness of breath. Laboratory parameters * 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 “hepatic” transaminases (may increase)If side effects occur, you should stop taking the drug and consult a doctor.

Interaction

Concomitant use of ibuprofen with the following medications 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 co-use may increase the risk of side effects. When used concomitantly, ibuprofen reduces the anti-inflammatory and antiplatelet effects of acetylsalicylic acid (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after starting ibuprofen).

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

Use with caution at the same time as the following medications: :

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

* Antihypertensive agents (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.

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

* Cardiac glycosides: concomitant use of NSAIDs and cardiac glycosides may worsen heart failure, reduce glomerular filtration rate, and increase the concentration of cardiac glycosides in blood plasma.

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

* Methotrexate: There is evidence of increased plasma concentrations of methotrexate associated with NSAID use.

* Cyclosporine: increased risk of nephrotoxicity with concomitant use of NSAIDs and cyclospore

· Mifepristone: NSAIDs should be started no earlier than 8-12 days after the end of mifepristone use, as 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 lead to increased hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia treated with zidovudine and ibuprofen.

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

How to take, course of use and dosage

Please read the instructions carefully before taking the drug.

For oral use. Only for short-term use.

Adults and children over 12 years of age: inside 1 capsule, without chewing. The capsule should be washed down with water. The interval between doses of the drug should be at least 4 hours. The maximum daily dose is 1200 mg.

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

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

Overdose

In children, overdose symptoms may occur after taking a dose exceeding 400 mg / kg of 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, there are manifestations of the central nervous system: 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 can develop. Patients with bronchial asthma may have an exacerbation of this disease.

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

If ibuprofen has already been absorbed, an alkaline drink may be prescribed to remove the acidic ibuprofen derivative by the kidneys, forced diuresis. Frequent or prolonged seizures should be stopped by intravenous use of diazepam or lorazepam. When exacerbating bronchial asthma, the use of bronchodilators is recommended.

Special instructions

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

Patients with renal insufficiency should consult a doctor before using the drug, as there is a risk of deterioration of the functional state of the kidneys.

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

Information for women planning pregnancy: the drug suppresses cyclooxygenase and prostaglandin synthesis and may affect ovulation, disrupting female reproductive function (reversible after discontinuation of treatment).

Influence on the ability to drive vehicles and mechanisms

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

Form of production

Capsules

Storage conditions

Store at a temperature not exceeding 25 °C. Keep the product out of the reach of children.

Shelf

life is 3 years.

Active ingredient

Ibuprofen

Dosage form

Capsules

Purpose

Children over 12 years of age, Pregnant women in the first and second trimester as prescribed by a doctor, Nursing mothers as prescribed by a doctor, For adults

Indications

Arthritis, Rheumatoid Arthritis, Migraine, Periarthritis, Osteoarthritis, Sciatica, Osteoarthritis, Sore Throat, Lumbago, Cold, Flu