Nurofen Plus, film-coated tablets, 12 pcs.

Nurofen® Plus

When using Nurofen® Plus for 2-3 days, practically no side effects are observed. In case of long-term use, the following side effects may occur:

From the gastrointestinal tract:

Nausea, vomiting, heartburn, anorexia, pain and discomfort in the epigastrium, diarrhea, flatulence, possible erosive and ulcerative lesions of the gastrointestinal tract (in some cases complicated by perforation and bleeding), abdominal pain, irritation, dryness of the oral mucosa or pain in the mouth, ulceration of the gum mucosa, aphthous stomatitis, pancreatitis, constipation, hepatitis.

From the nervous system:

Headache, dizziness, insomnia, agitation, drowsiness, depression, confusion, hallucinations, aseptic meningitis (more often in patients with autoimmune diseases).

From the cardiovascular system:

Heart failure, increased blood pressure (BP), tachycardia.

From the urinary system:

Nephrotic syndrome (edema), acute renal failure, allergic nephritis, polyuria, cystitis.

From the hematopoietic organs:

Anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.

From the senses:

Hearing loss, ringing or tinnitus, reversible toxic optic neuritis, blurred vision or diplopia, dry and irritated eyes, swelling of the conjunctiva and eyelids (allergic origin), scotoma.

Allergic reactions:

Skin rash, itching, urticaria, Quincke's edema, anaphylactoid reactions, anaphylactic shock, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.

From the respiratory system:

Bronchospasm, shortness of breath, respiratory failure, suppression of the cough center.

Other: increased sweating.

With long-term use in large doses - ulceration of the mucous membrane of the gastrointestinal tract, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (impaired color vision, scotoma, amblyopia).

Regular use of codeine leads to the development of dependence, as well as agitation and irritability when the drug is discontinued.

If side effects occur, you should stop taking the drug and consult a doctor.

Nurofen Plus, film-coated tablets, 12 pcs.

Avoid simultaneous use of the drug with the following drugs:

Acetylsalicylic acid: with the exception of low doses of acetylsalicylic acid (no more than 75 mg/day) prescribed by a doctor, since combined use may increase the risk of side effects. When administered simultaneously, 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.

Prescribe with caution simultaneously with the following drugs

Anticoagulants: NSAIDs may enhance the effect of anticoagulants, in particular warfarin.

Antihypertensives (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 (for example, dehydrated patients or elderly patients with impaired renal function), co-administration of ACE inhibitors or angiotensin II antagonists and COX-inhibiting agents may lead to deterioration of renal function, 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 elderly people.

Patients should be prevented from dehydration and consideration should be given to monitoring renal function upon initiation of this combination treatment and periodically thereafter. Diuretics and ACE inhibitors may increase the nephrotoxicity of NSAIDs.

GCS: increased risk of gastrointestinal ulcers and gastrointestinal bleeding.

Antiplatelet agents and SSRIs: increased risk of gastrointestinal bleeding.

Cardiac glycosides: simultaneous administration of NSAIDs and cardiac glycosides can lead to worsening heart failure, a decrease in GFR 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 are administered concomitantly with cyclosporine.

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

Tacrolimus: When NSAIDs and tacrolimus are coadministered, the risk of nephrotoxicity may increase.

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: In patients receiving concomitant treatment with NSAIDs and quinolone antibiotics, the risk of seizures may be increased.

Myelotoxic drugs: enhance the manifestations of hematotoxicity of the drug.

Caffeine enhances the analgesic effect.

MAO inhibitors: When using codeine in patients receiving therapy with MAO inhibitors or who have received it within the previous two weeks, CNS depression or worsening of the clinical picture may occur.

Moclobemide: risk of developing hypertensive crisis.

Hydroxyzine: Concomitant use of hydroxyzine (anxiolytic) and codeine can lead to increased analgesic effects, as well as greater CNS depression, increased sedative and antihypertensive effects.

CNS depressants (sedatives): The sedative effect of codeine is enhanced by substances that depress the central nervous system, such as alcohol, anesthetics, hypnotics, sedatives, tricyclic antidepressants and antipsychotic drugs and phenothiazines.

Diuretics and antihypertensive agents: The antihypertensive effects of diuretics and antihypertensive agents may be enhanced when used concomitantly with opioid pain relievers.

Antidiarrheals and motility suppressants: Concomitant use of codeine and antidiarrheals and motility suppressants, such as loperamide and kaolin, may increase the risk of severe constipation.

Antimuscarinics: Concomitant use of antimuscarinics or drugs with muscarinic effects, such as atropine and some antidepressants, may increase the risk of severe constipation, which in turn may lead to severe paralytic ileus and/or urinary retention.

Muscle relaxants: The respiratory depression effects caused by muscle relaxants may be additive to the major respiratory depression effects associated with opioid analgesics.

Quinidine: May inhibit the analgesic effect of codeine.

Mexiletine: Codeine may delay the absorption of mexiletine, and thereby reduce the antiarrhythmic effect of the latter.

Metoclopramide, cisapride and domperidone: Codeine may suppress the gastrointestinal effects of metoclopramide, cisapride and domperidone.

Cimetidine: Cimetidine inhibits the metabolism of opioid painkillers, resulting in increased plasma concentrations.

Naloxone: Naloxone inhibits the analgesic, CNS, and respiratory depressant effects of opioid pain medications.

Naltrexone also blocks the therapeutic effects of opioids.

Impact on laboratory test results: Opioid painkillers affect the results of a number of laboratory tests, including determination of plasma concentrations of amylase, lipase, bilirubin, alkaline phosphatase, LDH, ALT and AST.

Opioids may also interfere with examinations because they slow gastric emptying, and hepatobiliary imaging using disophenine, a technetium Tc 99m opioid, may cause contraction of the sphincter of Oddi and increased bile duct pressure.

Nurofen® plus (Nurofen plus)

Concomitant use of Nurofen Plus with acetylsalicylic acid and other NSAIDs is not recommended.

When administered simultaneously, ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (an increase in the incidence of acute coronary insufficiency may occur after starting ibuprofen in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent).

When used simultaneously with anticoagulants and thrombolytic drugs (alteplase, streptokinase, urokinase), the risk of bleeding increases.

When used together with ibuprofen, cefamandole, cefoperazone, cefotetan, valproic acid, and plicamycin increase the incidence of hypoprothrombinemia.

When used together, cyclosporine and gold preparations enhance the effect of ibuprofen on prostaglandin synthesis in the kidneys, which leads to an increased nephrotoxic effect.

Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of developing its hepatotoxic effects.

Drugs that block tubular secretion, when used simultaneously, reduce the excretion and increase the plasma concentration of ibuprofen.

When used together, inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of developing severe intoxications.

Inhibitors of microsomal oxidation reduce the risk of developing hepatotoxic effects of ibuprofen.

When used together, ibuprofen reduces the hypotensive activity of vasodilators, the natriuretic effect of furosemide and hydrochlorothiazide.

Ibuprofen reduces the effectiveness of uricosuric drugs and enhances the effect of indirect anticoagulants, antiplatelet agents, and fibrinolytics.

Increases the side effects of mineralocorticoids, corticosteroids, estrogens, ethanol.

When used together, it increases the hypoglycemic effect of oral antidiabetic agents (sulfonylurea derivatives) and insulin.

When taken simultaneously, antacids and cholestyramine reduce the absorption of ibuprofen.

When used together, ibuprofen increases the blood concentration of digoxin, lithium, and methotrexate.

Caffeine enhances the analgesic effect of ibuprofen.

Nurofen plus tab.pp.p.o.200mg No. 12

Indications

Symptomatic treatment as an anti-inflammatory and antipyretic agent: inflammatory and degenerative diseases of the joints and spine (including rheumatic and rheumatoid arthritis, ankylosing spondylitis, osteoarthritis), articular syndrome with exacerbation of gout, psoriatic arthritis, ankylosing spondylitis, tendinitis, bursitis, radiculitis , traumatic inflammation of soft tissues and the musculoskeletal system. Neuralgia, myalgia, pain syndrome due to infectious and inflammatory diseases of the ENT organs, adnexitis, algodismenorrhea, headache and toothache. Fever in infectious and inflammatory diseases, childhood infections, post-vaccination reactions in children (in appropriate dosage forms).

pharmachologic effect

NSAIDs, a derivative of phenylpropionic acid. It has anti-inflammatory, analgesic and antipyretic effects.

The mechanism of action is associated with inhibition of the activity of COX, the main enzyme in the metabolism of arachidonic acid, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever. The analgesic effect is due to both peripheral (indirectly, through suppression of prostaglandin synthesis) and central mechanisms (inhibition of prostaglandin synthesis in the central and peripheral nervous system). Suppresses platelet aggregation.

Drug interactions

With simultaneous use, ibuprofen reduces the effect of antihypertensive drugs (ACE inhibitors, beta-blockers), diuretics (furosemide, hydrochlorothiazide).

When used simultaneously with anticoagulants, their effect may be enhanced.

When used simultaneously with GCS, the risk of side effects from the gastrointestinal tract increases.

When used simultaneously, ibuprofen can displace indirect anticoagulants (acenocoumarol), hydantoin derivatives (phenytoin), and oral hypoglycemic drugs, sulfonylurea derivatives, from compounds with blood plasma proteins.

When used simultaneously with amlodipine, a slight decrease in the antihypertensive effect of amlodipine is possible; with acetylsalicylic acid - the concentration of ibuprofen in the blood plasma decreases; with baclofen - a case of increased toxic effects of baclofen has been described.

When used simultaneously with warfarin, an increase in bleeding time is possible; microhematuria and hematomas were also observed; with captopril - the antihypertensive effect of captopril may be reduced; with cholestyramine - a moderate decrease in the absorption of ibuprofen.

When used simultaneously with lithium carbonate, the concentration of lithium in the blood plasma increases.

When used simultaneously with magnesium hydroxide, the initial absorption of ibuprofen increases; with methotrexate - the toxicity of methotrexate increases.

The simultaneous use 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.

There is evidence of the likelihood of an increase in the concentration of methotrexate in the blood plasma during the use of NSAIDs.

With simultaneous use of NSAIDs and cyclosporine, the risk of nephrotoxicity increases.

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

Concomitant use of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.

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 who received concomitant treatment with zidovudine and ibuprofen.

In patients receiving concomitant treatment with NSAIDs and quinolone antibiotics, the risk of seizures may increase.

In patients receiving concomitant NSAIDs and myelotoxic drugs, hematotoxicity increases.

With the simultaneous use of ibuprofen and cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin, the incidence of hypoprothrombinemia increases.

With the simultaneous use of ibuprofen and drugs that block tubular secretion, there is a decrease in excretion and an increase in plasma concentration of ibuprofen.

With the simultaneous use of ibuprofen and inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), there is an increase in the production of hydroxylated active metabolites and an increased risk of developing severe intoxications.

Dosage regimen

Taken orally. The individual dosage regimen depends on the indications, the severity of clinical manifestations, and the patient’s age.

A single dose for adults and children over 6 years of age is 200-400 mg. Can be taken 3-4 times a day.

The maximum daily dose for adults is 1200 mg; for children aged 12-17 years - 1000 mg; for children aged 6 to 12 years - 800 mg.

For children under 6 years of age, the dose depends on the age and body weight of the child. The maximum daily dose should not exceed 30 mg/kg body weight with intervals between doses of the drug of 6-8 hours.

Contraindications for use

Hypersensitivity to ibuprofen; erosive and ulcerative lesions of the gastrointestinal tract in the acute phase or ulcerative bleeding in the active phase or in history (2 or more confirmed episodes of peptic ulcer disease or ulcerative bleeding); a history of bleeding or perforation of a gastrointestinal ulcer caused by the use of NSAIDs; severe heart failure (functional class IV according to the NYHA classification); severe renal and/or liver dysfunction; diseases of the optic nerve, “aspirin triad”, hematopoietic disorders; period after coronary artery bypass surgery; intracranial or other bleeding; hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis; III trimester of pregnancy.

With caution: simultaneous use of other NSAIDs; a history of a single episode of gastric and duodenal ulcers or ulcerative bleeding of the gastrointestinal tract; gastritis, enteritis, colitis, the presence of Helicobacter pylori infection, ulcerative colitis; bronchial asthma or allergic diseases in the acute stage or in history; systemic lupus erythematosus or mixed connective tissue disease (Sharpe's syndrome) - increased risk of aseptic meningitis; chicken pox; renal failure, incl. with 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; peripheral arterial disease; smoking; frequent drinking of alcohol; simultaneous use of drugs 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, sertratine) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); I-II trimester of pregnancy; breastfeeding period; elderly age.

Use in children

Can be used according to indications in recommended doses.

Restrictions for children

Possible use

Use in elderly patients

Caution should be used in elderly patients to avoid worsening the course of concomitant diseases.

In elderly patients, there is an increased incidence of adverse reactions due to the use of NSAIDs, especially gastrointestinal bleeding and perforation, in some cases with a fatal outcome.

Restrictions for elderly patients

Use with caution

Use for liver dysfunction

Contraindicated in cases of severe liver dysfunction. Use with caution in case of concomitant liver diseases.

Restrictions for liver dysfunction

Use with caution

Use during pregnancy and breastfeeding

Use during pregnancy and breastfeeding is contraindicated.

Restrictions when breastfeeding

Contraindicated

Restrictions during pregnancy

Contraindicated

Use for renal impairment

Contraindicated in cases of severe renal impairment. Use with caution in case of concomitant kidney diseases.

Restrictions for impaired renal function

Use with caution

special instructions

It is recommended to prescribe ibuprofen for the shortest possible course and at the minimum effective dose necessary to eliminate symptoms. If systemic use is necessary for more than 10 days, you should consult your doctor.

During long-term treatment, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a complete blood count (hemoglobin determination), and a stool test for occult blood.

The use of NSAIDs in patients with chickenpox may be associated with an increased risk of developing severe purulent complications of infectious and inflammatory diseases of the skin and subcutaneous fat (for example, necrotizing fasciitis). Therefore, it is recommended to avoid the use of ibuprofen for chickenpox.

Ibuprofen suppresses COX and prostaglandin synthesis, affects ovulation, disrupting female reproductive function (reversible after discontinuation of treatment).

Impact on the ability to drive vehicles and machinery

Patients who experience dizziness, drowsiness, lethargy, or blurred vision while taking ibuprofen should avoid driving and other activities that require high concentration and speed of psychomotor reactions.

Side effect

From the hematopoietic system: very rarely - hematopoietic disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis).

From the immune system: infrequently - 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 (Lyell's syndrome), Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia; very rarely - severe hypersensitivity reactions, incl. swelling of the face, tongue and larynx, shortness of breath, tachycardia, arterial hypotension (anaphylaxis, Quincke's edema or severe anaphylactic shock).

From the digestive system: infrequently - abdominal pain, nausea, dyspepsia (including heartburn, bloating); rarely - diarrhea, flatulence, constipation, vomiting; very rarely - 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.

From the liver and biliary tract: very rarely - liver dysfunction, increased activity of liver transaminases, hepatitis and jaundice.

From the urinary system: very rarely - 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.

From the nervous system: infrequently - headache; very rarely - aseptic meningitis.

From the cardiovascular system: frequency unknown - heart failure, peripheral edema; with long-term use, the risk of thrombotic complications (for example, myocardial infarction, stroke) and increased blood pressure are increased.

From the respiratory system: frequency unknown - bronchial asthma; bronchospasm; dyspnea.

From the laboratory parameters: possible - decrease in hematocrit or hemoglobin, increase in bleeding time, decrease in the concentration of glucose in the blood plasma, decrease in creatinine clearance, increase in the concentration of creatinine in the blood plasma, increase in the activity of liver transaminases.

Possible product names

• Nurofen plus TB p/o 200 mg N12
• NUROFEN PLUS 200 MG TAB. No. 12
• NUROFEN PLUS 0.2 N12 TABLE
• NUROFEN PLUS TABLE. P/O PLEN X12
• NUROFEN PLUS TAB. P/O PLEEN. No. 12
• NUROFEN PLUS (PKU) 200MG TAB. P/PL/OB. X12
• (Nurofen plus) Nurofen plus TB p/o 200 mg N12