Nurofen Express - instructions for use, dose, side effects, contraindications

Composition:One capsule contains active substance - ibuprofen 200 mg, Excipients: macrogol-600 218.33 mg, potassium hydroxide 25.6 mg, water 17.07 mg; shell capsules: gelatin 119.8 mg, sorbitol 76% solution 58.19 mg,(water, 48%, titanium dioxide (E171) 29%, propylene glycol 10%, isopropanol 8%, water, hypromellose 5%).

Description:Soft oval capsules with a red translucent gelatin shell, with an identifying inscription of white NUROFEN, containing a clear liquid from colorless to light pink.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).

ATX: & nbsp

M.01.A.E.01 Ibuprofen

Pharmacodynamics:The mechanism of action of ibuprofen, a derivative of propionic acid from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermia. Non-selectively blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), which inhibits the synthesis of prostaglandins. Has a quick directional action against pain (analgesic), antipyretic and anti-inflammatory action. Besides, ibuprofen reversibly inhibits platelet aggregation.

Pharmacokinetics:

Absorption is high, quickly and almost completely absorbed from the gastrointestinal tract (GIT). After taking 2 capsules of the drug on an empty stomach ibuprofen is detected in blood plasma after 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 an equivalent dose of Nurofen®, in the form of a tablet coated with 200 mg. Taking the drug along with food can increase the time to reach the maximum concentration (TCmax). Communication with plasma proteins is more than 90%, half-life (T1 / 2) - 2 hours. Slowly penetrates into the joint cavity, is retained in the synovial fluid, creating in it greater concentrations than in the blood plasma. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into an active S-form. It is metabolized in the liver. It is excreted by the kidneys (in an unchanged form not more than 1%) and, to a lesser extent, with bile.

In the elderly, there were no significant differences in the pharmacokinetic profile of the drug compared to younger people.

In limited studies ibuprofen was found in breast milk in very low concentrations.

Indications:Nurofen® Express is used for headache, migraine, toothache,painful menstruation, neuralgia, back pain, muscle and rheumatic pain; at feverish conditions at a flu and catarrhal diseases.

Contraindications:

- Hypersensitivity to ibuprofen or any of the components that make up the drug.

- Complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses, and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in the anamnesis).

- Erosive and ulcerative diseases of the gastrointestinal tract (including gastric and duodenal ulcer, Crohn's disease, ulcerative colitis) or ulcerative bleeding in the active phase or in the anamnesis (two or more confirmed episodes of peptic ulcer or ulcer bleeding).

- Bleeding or perforation of the gastrointestinal ulcer in history, triggered by the use of NSAIDs.

- Severe hepatic insufficiency or liver disease in the active phase.

- Renal failure of severe severity (creatinine clearance <30 ml / min), confirmed hyperkalemia.

- Decompensated heart failure; period after aortocoronary bypass surgery.

- Cerebrovascular or other bleeding.

- Hemophilia and other disorders of blood clotting (including hypocoagulation), hemorrhagic diathesis.

- Intolerance to fructose.

- Pregnancy (III trimester).

- Children under 12 years.

Carefully:

In the presence of conditions specified in this section, before using the drug should consult a doctor.

Simultaneous reception of other NSAIDs, a history of a single episode of peptic ulcer or gastric ulcer bleeding; gastritis, enteritis, colitis, the presence of Helicobacter pylori infection, ulcerative colitis; A bronchial asthma or allergic diseases in a stage of an exacerbation or in the anamnesis - development of a bronchospasm is possible; systemic lupus erythematosus or mixed connective tissue disease (Sharpe's syndrome) - increased risk of aseptic meningitis; renal insufficiency, including dehydration (creatinine clearance less than 30-60 ml / min), nephrotic syndrome, hepatic insufficiency, 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 mellitus, peripheral arterial disease, smoking, frequent use of alcohol, simultaneous reception

medicines that may increase the risk of ulcers or bleeding, in particular, oral glucocorticosteroids (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, breast-feeding period, elderly age.

Pregnancy and lactation:Contraindicated use of the drug in the III trimester of pregnancy. You should avoid the use of the drug in the I-II trimesters of pregnancy, if necessary, you should consult a doctor. There is evidence that ibuprofen in small quantities can penetrate into breast milk without any negative consequences for the health of the infant,therefore usually at short-term admission of necessity in the termination of thoracal feeding does not arise. If it is necessary to take the drug for a long time, you should consult a doctor to resolve the issue of stopping breastfeeding for the period of drug use.

Dosing and Administration:

Read the instructions carefully before taking the drug.

For oral administration. Only for short-term use.

Adults and children over 12 years: inside by 1 capsule (200 mg), not liquid, until

3-4 times a day. Capsule should be washed down with water. Interval between doses

preparation should be 6-8 hours.

To achieve a more rapid therapeutic effect in adults, a single dose can be increased to 2 capsules (400 mg) up to 3 times a day.

The maximum daily dose is 1200 mg.

The maximum daily dose for children 12-17 years is 1000 mg.

If you take the drug for 2-3 days, the symptoms persist or

intensify, it is necessary to stop treatment and consult a doctor.

Side effects:

The risk of side effects can be minimized if you take the drug with a short course, at the lowest effective dose needed to eliminate the symptoms.

Side effects are predominantly dose-dependent.The following adverse reactions were noted with a short-term intake of ibuprofen in doses not exceeding 1200 mg / day (6 capsules). In the treatment of chronic conditions and with prolonged use, other side reactions may occur.

The incidence of adverse reactions was assessed on the basis of the following criteria: very frequent (> 1/10), frequent (> 1/100 to <1/10), infrequent (> 1/1000 to <1/100), rare from> 1/10 000 to <1/1000), very rare (<1/10 000), the frequency is unknown (there is no data on frequency estimation).

Violations of the blood and lymphatic system

- Very rare: hematopoiesis 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 bruising, bleeding, and bruising of unknown etiology.

Immune system disorders

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

- Very rare: severe hypersensitivity reactions, including swelling of the face, tongue and larynx, dyspnea, tachycardia, arterial hypotension (anaphylaxis, Quincke's edema or severe anaphylactic shock).

Disorders from the gastrointestinal tract

- 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.

- The frequency is unknown: exacerbation of colitis and Crohn's disease.

Disturbances from the liver and bile ducts

- Very rare: violations of the liver (especially with prolonged use), hepatitis and jaundice.

Disorders from the kidneys and urinary tract

- Very rare: acute renal failure (compensated and decompensated), especially with prolonged 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.

Disturbances from the nervous system

- Infrequent: headache.

- Very rare: aseptic meningitis.

Disorders from the cardiovascular system

- The frequency is unknown: heart failure, peripheral edema, with prolonged use increased risk of thrombotic complications (eg, myocardial infarction), increased blood pressure.

Disturbances from the respiratory system and mediastinal organs

- The frequency is unknown: bronchial asthma, bronchospasm, dyspnea.

Other

- Very rare: edema, including peripheral.

Laboratory indicators

- hematocrit or hemoglobin (may decrease)

- bleeding time (may increase)

- the concentration of glucose in the blood plasma (may decrease)

- clearance of creatinine (may decrease)

- plasma creatinine concentration (may increase)

- activity of "liver" transaminases (may increase)

If side effects occur, stop taking the medication and consult a doctor.

Overdose:

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

Symptoms: nausea, vomiting, pain in the epigastric region or, more rarely, diarrhea, tinnitus, headache and gastrointestinal bleeding. In more severe cases, there are manifestations of the central nervous system: drowsiness, rarely - excitation, convulsions, disorientation, coma. In cases of severe poisoning, metabolic acidosis and an increase in prothrombin time, renal failure, damage to liver tissue, lowering blood pressure, respiratory depression and cyanosis may develop. Patients with bronchial asthma may exacerbate this disease.

Treatment: symptomatic, with mandatory provision of airway patency, monitoring of ECG and basic indicators of vital activity, up to the normalization of the patient's condition.Recommended oral administration of activated carbon or gastric lavage within 1 hour after taking a potentially toxic dose of ibuprofen. If ibuprofen already absorbed, alkaline drink may be prescribed to excrete the acid derivative of ibuprofen by the kidneys, forced diuresis. Frequent or prolonged seizures should be stopped with intravenous diazepam or lorazepam. When bronchial asthma worsens, the use of bronchodilators is recommended.

Interaction:

It should be avoided simultaneous use of ibuprofen with the following medicines:

- Acetylsalicylic acid: with the exception of low doses of acetylsalicylic acid (not more than 75 mg per day) prescribed by the doctor, since joint application may increase the risk of side effects. With simultaneous application ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as antiplatelet agent after the onset of ibuprofen administration).

- Other NSAIDs, including selective COX-2 inhibitors: simultaneous use of two or more drugs from the NSAID group should be avoided because of the possible increase in the risk of side effects.

Use with caution simultaneously with the following medicines:

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

- Antihypertensives (ACE inhibitors and angiotensin I antagonists) and diuretics: NSAIDs may decrease the effectiveness of the drugs of these groups. Diuretics and ACE inhibitors can increase the nephrotoxicity of NSAIDs.

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

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

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

Lithium preparations: there are data on the probability of an increase in the concentration of lithium in blood plasma against the background of NSAIDs. Methotrexate: There are data on the probability of increasing the concentration of methotrexate in the blood plasma when NSAIDs are applied. Cyclosporine: increased risk of nephrotoxicity with simultaneous administration of NSAIDs and cyclosporine.

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

Tacrolimus: with simultaneous administration of NSAIDs and tacrolimus, an increased risk of nephrotoxicity may occur.

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

Antibiotics of the quinolone series: in patients receiving co-treatment with NSAIDs and quinolone antibiotics, an increased risk of seizures is possible.

Cefamandol, cefoperazone, cefotetan, valproic acid, plikamycin: an increase in the frequency of hypoprothrombinemia.

Drugs that block tubular secretion: reduced elimination and increased plasma concentrations of ibuprofen. Inductors 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: a reduction in the risk of hepatotoxic action.

- Oral hypoglycemic drugs and insulin, sulfonylurea derivatives: enhancement of the effect.

- Antacids and colestyramine: reduced absorption.

- Caffeine: increased analgesic effect.

Special instructions:

It is recommended to take the drug as short a course as possible and at the minimum effective dose necessary to eliminate symptoms. During long-term treatment, control of the peripheral blood picture and the functional state of the liver and kidneys is necessary. When symptoms of gastropathy appear, careful monitoring including esophagogastroduodenoscopy, a general blood test (determination of hemoglobin), and analysis of feces for latent blood are shown.If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test. During the period of treatment, ethanol is not recommended.

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

Patients with hypertension, including anamnesis and / or chronic heart failure, should consult with a doctor before using the drug, because the drug can cause fluid retention, increased blood pressure and swelling.

Information for women planning a pregnancy: these drugs suppress cyclooxygenase and synthesis of prostaglandins, affect ovulation, disrupting female reproductive function (reversible after withdrawal of treatment).

Effect on the ability to drive transp. cf. and fur:Patients who report dizziness, drowsiness, blockage, or visual impairment when taking ibuprofen should avoid driving motor vehicles or controlling mechanisms.

Form release / dosage:

Capsules 200 mg.

Packaging:

For 4, 6, 8, 10 or 12 capsules in the blister PVC / PVDC / aluminum. For 1, 2 or 3 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:In a dry place at a temperature of no higher than 25 ° C. Keep the drug out of the reach of children.

Shelf life:

2 years.

Do not use the drug with expired shelf life.

Terms of leave from pharmacies:Without recipe

Registration number:П N014560 / 01

Date of registration:17.10.2008

The owner of the registration certificate:Rekitt Benckiser Helsar International Ltd.Rekitt Benckiser Helsar International Ltd. United Kingdom

Manufacturer: & nbsp

RECKITT BENCKISER HEALTHCARE INTERNATIONAL, Ltd. United Kingdom

Representation: & nbspREKITT BENKIZER HELSKER LTD. REKITT BENKIZER HELSKER LTD. United Kingdom

Information update date: & nbsp27.11.2014

Illustrated instructions

Instructions

Nurofen® Express (Nurofen® Express)