Nurofen Express Forte analgesic capsules 400mg, 10pcs

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:

197 mg gelatin,

sorbitol (partially dehydrated) to 95,68 mg,

the water of 25.02 mg,

dye crimson [Ponceau 4R] (E124) of 0.79 mg,

white ink [Opacode WB NS-78-18011] (water 48%, titanium dioxide (E171) 29%, propylene glycol 10%, isopropanol 8%, hypromellose 3cP 5%).

Pharmacological action

Capsule c with a liquid Active ingredient in double concentration (400 mg of ibuprofen) * * * acts directly on the source of pain, helping to get rid of it.

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.

Pharmacokinetics

Absorption – high, quickly and almost completely absorbed from the gastrointestinal tract (GIT). After taking the drug on an empty stomach, ibuprofen is detected in blood plasma in 15 minutes, the maximum concentration (Cmax) of ibuprofen in blood plasma is reached in 30-40 minutes, which is twice as fast as after taking the equivalent dose of Nurofen®, in the dosage form of 200 mg coated tablets.

Taking the drug with food may increase the time to reach the maximum concentration (TMAX). The connection with plasma proteins is more than 90%, the half-life (T 1/2) is 2 hours. It slowly penetrates the joint cavity, lingers in the synovial fluid, creating higher concentrations in it than in the blood plasma. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. It is metabolized in the liver. It is excreted by the kidneys (no more than 1% unchanged) and, to a lesser extent, with bile.

There were no significant differences in the pharmacokinetic profile of the drug in older people compared to younger people.

In limited studies, ibuprofen has been detected in breast milk at very low concentrations.

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.

The simultaneous intake of other NSAIDs, a history of a single episode of gastric ulcer or ulcer bleeding in the gastrointestinal tract;

gastritis, enteritis, colitis, the presence of Helicobacter pylori infection, ulcerative colitis;

bronchial asthma or allergic disease in the acute stage or in history – perhaps the development of bronchospasm;

systemic lupus erythematosus or mixed connective tissue disease (sharp’s syndrome) – increased risk of aseptic meningitis;

renal failure including dehydration (creatinine clearance 30-60 ml/min), nephrotic syndrome;

hepatic 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 artery disease;

Smoking;

frequent alcohol consumption;

concomitant use of medicinal products that may increase the risk of ulceration or bleeding, in particular of oral corticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective inhibitors of serotonin reuptake (including citalopram, fluoxetine, paroxetine, and sertraline);

pregnancy I-II trimester, breastfeeding, elderly 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

· Uncommon: hypersensitivity reactions are non – specific allergic reactions and anaphylactic reactions, reactions of the respiratory tract (bronchial asthma, including its exacerbation, bronchospasm, shortness of breath), skin reactions (pruritus, urticaria, purpura, angioedema,

bullous and exfoliative dermatitis including toxic epidermal necrolysis (Lyell’s syndrome), and 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).

Disorders of the gastrointestinal tract

* 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 treatment 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

The use of the drug in children at a dose of 400 mg / kg may lead to symptoms of intoxication. In adults, the dose effect is less pronounced. The half-life of overdose is 1.5-3 hours.

Symptoms.

Most patients who used clinically significant amounts of NSAIDs developed only nausea, vomiting, epigastric pain, or very rarely diarrhea. Tinnitus, headache, and gastrointestinal bleeding may also occur. With more severe poisoning, toxic lesions of the central nervous system are possible, which manifest as vertigo, drowsiness, sometimes agitation and disorientation or coma.

Sometimes patients have seizures. In severe poisoning, hyperkalemia and metabolic acidosis may develop, and there may be an increase in prothrombin time / an increase in the prothrombin index, possibly as a result of exposure to circulating blood clotting factors. Acute renal failure, liver damage, hypotension, respiratory failure, and cyanosis may occur.

Patients with bronchial asthma may have an exacerbation of the course of the disease.

Treatment.

Treatment should be symptomatic and supportive, as well as include ensuring airway patency and monitoring the performance of the heart and vital functions until the condition returns to normal.

Oral use of activated charcoal or gastric lavage is recommended within 1: 00 hours after a potentially toxic dose of the drug is administered. If ibuprofen is already absorbed into the body, alkaline substances can be administered to speed up the excretion of acidic ibuprofen in the urine.

For frequent or prolonged seizures, diazepam or lorazepam should be administered intravenously. For the treatment of exacerbation of bronchial asthma, bronchodilators should be used.

Form of production

Capsules. 10 capsules in a PVC blister/PVDH/Aluminum. 1 blister pack (10 capsules) or 2 blisters (10 capsules each)place in a cardboard box together with the instructions for use.

Storage conditions

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

Shelf

life is 3 years. Do not use after the date indicated on the package.

Active ingredient

Ibuprofen

Dosage form

Capsules

Purpose

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

Indications

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