Nurofen Plus
Nurofen Plus: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Nurofen Plus
ATX code: M01AE51
Active ingredient: Ibuprofen + Codeine phosphate hemihydrate
Manufacturer: Reckitt Benckiser Healthcare International Ltd. (United Kingdom)
Description and photo update: 2018-22-10
Prices in pharmacies: from 646 rubles.
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Nurofen Plus is a combined non-steroidal anti-inflammatory drug (NSAID).
Release form and composition
Dosage form - film-coated tablets: capsular biconvex shape, white, engraved "N +" on one side (in a blister: 2, 4 or 6 pcs., In a cardboard box 1 or 2 blisters; 12 pcs., In cardboard box 1, 2 or 4 blisters).
Active substances in Nurofen Plus (1 tablet):
- ibuprofen - 200 mg;
- codeine phosphate hemihydrate - 12.8 mg, which is equivalent to the content of 10 mg of codeine.
Additional components in Nurofen Plus:
- excipients: hypromellose, microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl starch;
- shell composition: opaspray M-1-7111B [hypromellose, titanium dioxide, purified water and denatured alcohol (removed during production)], hypromellose, talc.
Pharmacological properties
Pharmacodynamics
Nurofen Plus has antipyretic, analgesic, anti-inflammatory and antitussive effects. The therapeutic effect of the drug is determined by the active substances - ibuprofen and codeine. Their difference in the mechanism and site of action allows, in combination, to achieve a more pronounced decrease in pain sensitivity.
Ibuprofen is a propionic acid derivative from the NSAID group. The mechanism of its action is due to a slowdown in the synthesis of prostaglandins - mediators of pain, hyperthermic reaction and inflammation. Inhibition of prostaglandin synthesis occurs against the background of indiscriminate blocking of COX-1 and COX-2 (cyclooxygenase-1 and cyclooxygenase-2). This causes a rapid targeted analgesic, antipyretic and anti-inflammatory effect, reversibly inhibits platelet aggregation.
Codeine is an analgesic that acts on the opioid receptors of the central nervous system (CNS) and has an antitussive effect.
Pharmacokinetics
The high absorption of ibuprofen allows it to reach its maximum concentration in the blood plasma of an adult patient 0.75 hours after taking it on an empty stomach and after 1-2 hours when taken with food.
Binding to blood plasma proteins is 90%. It penetrates slowly into the joint cavity, remains in the synovial tissue and creates higher concentrations in it than in plasma.
After absorption, there is a slow transformation of approximately 60% of the pharmacologically inactive R-form to the active S-form. Metabolized in the liver.
The half-life (T 1/2) is 2 hours. It is excreted through the kidneys (no more than 1% unchanged) and, to a small extent, with bile.
After oral administration, codeine is rapidly absorbed from the gastrointestinal tract (GIT). The maximum concentration in blood plasma is reached after 1 hour.
The binding of codeine to blood plasma proteins is 30%.
In the liver, it is metabolized to active metabolites.
It is excreted through the kidneys (unchanged - 5-15%, in the form of morphine and its metabolites - 10%), as well as with bile.
T 1/2 codeine - 3-4 hours.
Indications for use
The use of Nurofen Plus is indicated for short-term symptomatic therapy of mild and moderate pain syndrome after ineffective NSAID monotherapy:
- migraine;
- headache;
- toothache;
- rheumatic pain;
- backache;
- neuralgia;
- algodismenorrhea;
- myalgia.
Contraindications
- incomplete or complete combination of intolerance to acetylsalicylic acid or other NSAIDs, bronchial asthma, recurrent polyposis of the nose and paranasal sinuses (including history);
- the period of exacerbation of erosive and ulcerative pathologies of the gastrointestinal tract, including ulcerative colitis, gastric ulcer and duodenal ulcer, Crohn's disease, peptic ulcer (including if indicated in history);
- acute period of ulcer bleeding in patients with two or more confirmed episodes of peptic ulcer disease or ulcer bleeding (including history);
- an indication in the history of bleeding or perforation of the gastrointestinal ulcer caused by previous use of NSAIDs;
- paralytic intestinal obstruction;
- respiratory failure;
- decompensated heart failure;
- severe course of arterial hypertension;
- period after coronary artery bypass grafting;
- increased intracranial pressure;
- traumatic brain injury (including history);
- intracranial hemorrhage;
- deficiency of glucose-6-phosphate dehydrogenase;
- hemophilia and other blood clotting disorders;
- hemorrhagic diathesis;
- state of hypocoagulation;
- severe hepatic failure and the active phase of other liver dysfunction;
- renal failure of severe severity [creatinine clearance (CC) less than 30 ml / min];
- confirmed hyperkalemia;
- chronic constipation;
- high level of metabolism of codeine isoenzyme CYP2D6;
- the period of simultaneous administration of monoamine oxidase inhibitors (MAO) and within 14 days after their cancellation;
- period of pregnancy;
- breast-feeding;
- age up to 12 years;
- the period after adenoidectomy and tonsillectomy in children;
- hypersensitivity to the components of the drug.
Care should be taken when prescribing Nurofen Plus in combination with other NSAIDs, drugs that can increase the risk of ulcers or bleeding (including oral glucocorticosteroids, anticoagulants, selective serotonin reuptake inhibitors, antiplatelet agents), with a history of one episode of peptic ulcer disease stomach or gastrointestinal ulcer bleeding, patients with gastritis, ulcerative colitis, enteritis, Helicobacter pylori infection, colitis, bronchial asthma or allergic diseases in history or in an exacerbation stage, systemic lupus erythematosus or mixed connective tissue disease (Sharp's syndrome), ischemic heart disease, heart failure and / or arterial hypertension, cerebrovascular pathologies, peripheral arterial disease,hyperlipidemia, liver failure, liver cirrhosis with portal hypertension, renal failure with CC 30-60 ml / min (including conditions with dehydration), nephrotic syndrome, blood diseases of unknown etiology (anemia, leukopenia), hyperbilirubinemia, severe somatic diseases, when indicated in a history of drug dependence to codeine, exhaustion, smoking, frequent alcohol consumption, in elderly patients, before immediate surgery and within the first 24 hours after it, if a history of hypothyroidism, arterial hypotension, cholelithiasis, adrenocortical insufficiency, myasthenia gravis is indicated gravel or cramps.renal failure with a CC 30-60 ml / min (including dehydration), nephrotic syndrome, blood diseases of unknown etiology (anemia, leukopenia), hyperbilirubinemia, severe somatic diseases, with a history of drug dependence to codeine, exhaustion, smoking, frequent alcohol consumption, in elderly patients, before immediate surgery and within the first 24 hours after it, with a history of hypothyroidism, arterial hypotension, cholelithiasis, adrenocortical insufficiency, myasthenia gravis or convulsions.renal failure with a CC 30-60 ml / min (including dehydration), nephrotic syndrome, blood diseases of unknown etiology (anemia, leukopenia), hyperbilirubinemia, severe somatic diseases, with a history of drug dependence to codeine, exhaustion, smoking, frequent alcohol consumption, in elderly patients, before immediate surgery and during the first 24 hours after it, with a history of hypothyroidism, arterial hypotension, cholelithiasis, adrenocortical insufficiency, myasthenia gravis or convulsions.smoking, frequent alcohol consumption, in elderly patients, before immediate surgery and within the first 24 hours after it, with a history of hypothyroidism, arterial hypotension, cholelithiasis, adrenocortical insufficiency, myasthenia gravis or convulsions.smoking, frequent alcohol consumption, in elderly patients, before immediate surgery and within the first 24 hours after it, with a history of hypothyroidism, arterial hypotension, cholelithiasis, adrenocortical insufficiency, myasthenia gravis or convulsions.
Instructions for use of Nurofen Plus: method and dosage
The tablets are taken orally with plenty of water.
Since Nurofen Plus is intended only for symptomatic short-term therapy, the course of its use should be as short as possible using the minimum effective dose.
Recommended dosage: 1 pc. 3-4 times a day with an interval between doses of at least 4 hours. For adult patients, in order to accelerate the achievement of a therapeutic effect, you can take 2 pcs. 3 times a day. The daily dose of the drug for adults should not exceed 6 pcs., For children and adolescents aged 12-18 years - 5 pcs.
The duration of the course of treatment is no more than 3 days.
In the absence of a clinical effect (persistence of symptoms of the disease or their intensification) after 2-3 days of therapy, it is necessary to stop taking the tablets and consult a doctor.
Side effects
- from the immune system: infrequently - hypersensitivity reactions (nonspecific reactions of an allergic and anaphylactic nature), allergic rhinitis, eosinophilia, bronchial asthma (including its exacerbation), shortness of breath, bronchospasm, dyspnoea, pruritus, urticaria, Quincke's edema, purpura or exfoliative dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrolysis, or Lyell's syndrome, erythema multiforme); very rarely - a severe form of hypersensitivity reaction, including shortness of breath, edema of the face, tongue and larynx, arterial hypotension (angioedema, anaphylaxis, severe anaphylactic shock), tachycardia;
- from the hematopoietic system: very rarely - anemia, hemolytic anemia, aplastic anemia, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia;
- from the nervous system: infrequently - headache; very rarely - aseptic meningitis; frequency unknown - weakness, convulsions, dizziness, dyskinesia, increased intracranial pressure;
- on the part of the psyche: the frequency is unknown - depressed mood, depression of the central nervous system, confusion, hallucinations, drug dependence, nightmares, agitated state;
- on the part of the cardiovascular system: the frequency is unknown - peripheral edema, heart failure, against the background of long-term therapy - an increased risk of thrombotic complications (including myocardial infarction and stroke), arterial hypertension, bradycardia;
- from the gastrointestinal tract: infrequently - dyspepsia, abdominal pain, nausea; rarely - vomiting, diarrhea or constipation, flatulence; very rarely - melena, perforation or gastrointestinal bleeding, peptic ulcer, bloody vomiting (including fatal, more often in elderly patients), gastritis, ulcerative stomatitis; frequency unknown - dry mouth, exacerbation of colitis, exacerbation of Crohn's disease;
- on the part of the hepatobiliary system: very rarely - liver dysfunctions (often with prolonged use), increased activity of hepatic transaminases, hepatitis, jaundice; frequency unknown - biliary colic;
- on the part of the organ of hearing and balance: the frequency is unknown - vestibular dizziness;
- on the part of the organ of vision: the frequency is unknown - diplopia, blurred vision;
- from the urinary system: very rarely - hematuria, proteinuria, cystitis, acute renal failure, interstitial nephritis, nephrotic syndrome, nephritic syndrome, papillary necrosis; frequency unknown - dysuria, renal colic;
- from the respiratory system: the frequency is unknown - respiratory depression, shortness of breath, bronchospasm, bronchial asthma, cough suppression;
- dermatological reactions: infrequently - skin rash; very rarely - severe forms of skin reactions; frequency unknown - hot flashes;
- from the side of metabolism and nutrition: the frequency is unknown - decreased appetite;
- from the musculoskeletal system: frequency unknown - muscle stiffness;
- general disorders: very rarely - fatigue, excessive sweating, edema (including peripheral), irritability, anxiety, hypothermia;
- laboratory parameters: a decrease in the level of hematocrit or hemoglobin in the blood, an increase in the bleeding period, a decrease in the concentration of glucose in the blood plasma, a decrease in creatinine clearance, an increase in the plasma concentration of creatinine, an increase in the activity of hepatic transaminases.
These side reactions can occur with short-term use of ibuprofen (in a dose of up to 1200 mg, or 6 tablets per day). In the treatment of chronic diseases and long-term use of the drug, other adverse reactions may develop.
If symptoms of side effects appear, immediate discontinuation of the drug and a visit to a doctor are required.
Overdose
Since Nurofen Plus has a combined composition, the concentration and toxicity threshold of each active ingredient are different, therefore it is believed that in case of an overdose, the toxic effect of codeine will manifest itself earlier than ibuprofen. In case of an overdose, the half-life of ibuprofen is 1.5–3 hours.
Death in adults can occur when taking codeine at a dose of more than 500 mg.
In children, overdose symptoms are dose-dependent and may occur after taking the drug at a dose higher than 400 mg per 1 kg of body weight.
Symptoms: usually - epigastric pain, nausea, vomiting; less often - diarrhea, headache, tinnitus, gastrointestinal bleeding. Possible changes in blood pressure, the development of tachycardia, metabolic acidosis, renal failure, an increase in prothrombin time, with bronchial asthma - an exacerbation of the disease. From the side of the central nervous system (in more severe cases) - drowsiness, seizures, agitation, disorientation and coma may appear. An increase in the manifestation of effects from the central nervous system can cause the simultaneous use of alcohol or other sedatives. Treatment: symptomatic therapy, ensuring airway patency, simultaneous monitoring of electrocardiography and vital signs (until the patient is fully restored to the normal state). Gastric lavage or ingestion of activated charcoal is recommended within the first hour after the ingestion of a potentially toxic dose of codeine: in adults - more than 350 mg per 1 kg of body weight, in children - more than 5 mg per 1 kg. If absorption of ibuprofen has already occurred, the patient should be prescribed an alkaline drink, forced diuresis. For the relief of frequent or prolonged seizures, diazepam or lorazepam should be administered intravenously, bronchial asthma - bronchodilators should be prescribed. To restore pulmonary ventilation, the use of naloxone, a specific opioid antagonist, is indicated.forced diuresis. To relieve frequent or prolonged seizures, diazepam or lorazepam should be administered intravenously, bronchial asthma - bronchodilators should be prescribed. To restore pulmonary ventilation, the use of naloxone, a specific opioid antagonist, is indicated.forced diuresis. For the relief of frequent or prolonged seizures, diazepam or lorazepam should be administered intravenously, bronchial asthma - bronchodilators should be prescribed. To restore pulmonary ventilation, the use of naloxone, a specific opioid antagonist, is indicated.
After an overdose, medical supervision of the patient is required for 4 hours or more.
special instructions
To minimize the likelihood of side effects, Nurofen Plus should be taken only in the minimum effective dose in a short course.
Elderly patients are prone to an increased frequency of adverse reactions associated with the use of NSAIDs, especially to gastrointestinal bleeding and perforation, in some cases up to death.
Side effects are dose-dependent.
The risk of aseptic meningitis increases with the use of Nurofen Plus in patients with Sharp's syndrome and systemic lupus erythematosus.
The first symptoms of hematopoietic disorders are: sore throat, fever, mouth mucosa, severe weakness, flu-like symptoms, bruising and bleeding of unknown etiology, nosebleeds, subcutaneous hemorrhages.
With an exacerbation of bronchial asthma and allergic diseases, or there is a history of indications of them, taking the drug can contribute to the occurrence of bronchospasm.
Long-term therapy should be accompanied by careful monitoring of the peripheral blood picture, the functional state of the kidneys and liver.
In the event of symptoms of gastropathy, the patient is shown an esophagogastroduodenoscopy, a general blood test to determine the level of hemoglobin and an analysis of feces for occult blood.
If it is necessary to study urine for the determination of 17-ketosteroids, Nurofen Plus should be canceled 48 hours before the analysis.
During the period of treatment, you should not use alcoholic beverages and ethanol-containing products.
With renal failure, arterial hypertension, chronic heart failure, taking pills is allowed only as directed by a doctor.
When planning conception, women should take into account that taking Nurofen Plus inhibits the activity of cyclooxygenase, the synthesis of prostaglandins, and negatively affects ovulation. Female reproductive function is restored after discontinuation of treatment.
Influence on the ability to drive vehicles and complex mechanisms
Since taking opioid pain relievers may affect the patient's mental function, care must be taken during the treatment with Nurofen Plus when managing complex mechanisms and performing other potentially dangerous activities.
Application during pregnancy and lactation
The use of Nurofen Plus is contraindicated during gestation and breastfeeding.
Pediatric use
Do not take pills to children under 12 years of age.
With impaired renal function
The use of Nurofen Plus is contraindicated in patients with severe renal failure (CC less than 30 ml / min).
The drug should be taken with caution in renal failure, including dehydration, nephrotic syndrome.
For violations of liver function
The use of Nurofen Plus is contraindicated in severe liver failure or active phase of liver disease.
Patients with cirrhosis of the liver with portal hypertension, hepatic insufficiency should be prescribed the drug with caution.
Use in the elderly
Patients in the elderly should be prescribed Nurofen Plus treatment with caution.
Drug interactions
With the simultaneous use of Nurofen Plus:
- acetylsalicylic acid (except for taking in a daily dose of up to 75 mg) increases the risk of side effects (in patients taking acetylsalicylic acid in small doses as an antiplatelet agent, an increase in the development of acute coronary insufficiency is possible);
- other NSAIDs, including COX-2 inhibitors, may increase the risk of side effects, so two or more drugs from the NSAID group should not be used;
- anticoagulants, including warfarin, can enhance their effect;
- ACE inhibitors (angiotensin-converting enzyme) and angiotensin II receptor antagonists (antihypertensive drugs), diuretics reduce their therapeutic effect, may increase the nephrotoxicity of the drug;
- cyclosporine, tacrolimus increase the risk of nephrotoxicity;
- antiplatelet agents, selective serotonin reuptake inhibitors increase the likelihood of gastrointestinal bleeding;
- glucocorticosteroids increase the risk of gastrointestinal ulcers and gastrointestinal bleeding;
- cardiac glycosides can increase their concentration in blood plasma, cause an aggravation of heart failure, a decrease in the glomerular filtration rate;
- lithium preparations, methotrexate increase the risk of an increase in their concentration in blood plasma;
- mifepristone can reduce its effectiveness, so the drug can be taken only 8-12 days after taking mifepristone;
- zidovudine can cause an increase in hematotoxicity, with hemophilia in patients with HIV-positive status, the risk of hemarthrosis and hematomas increases;
- quinolone antibiotics may increase the risk of seizures;
- MAO inhibitors (including when taken within the previous two weeks) cause depression of the central nervous system, may worsen the clinical picture;
- myelotoxic drugs increase the manifestation of the drug's hematotoxicity;
- caffeine increases the analgesic effect;
- moclobemide raises the risk of a hypertensive crisis;
- hydroxyzine (anxiolytic) can cause an increase in the analgesic effect, depression of the central nervous system, sedative and antihypertensive action;
- anesthetics, hypnotics, tricyclic antidepressants, antipsychotics, phenothiazines and ethanol enhance the sedative effect of codeine;
- diuretics, antihypertensive drugs enhance their hypotensive effect;
- depressing motility and antidiarrheal drugs can increase the risk of developing severe constipation;
- Antimuscarinic drugs (atropine and some antidepressants) increase the risk of severe constipation, which can cause urinary retention and / or severe paralytic ileus.
- muscle relaxants enhance the effect of respiratory depression;
- quinidine can suppress the analgesic effect of codeine;
- mexiletine reduces its antiarrhythmic effect;
- metoclopramide, domperidone and cisapride reduce their therapeutic effect;
- cimetidine causes an increase in plasma concentrations of opioid pain relievers;
- naloxone suppresses the effects of opioid pain relievers;
- naltrexone blocks the therapeutic effect of opioids.
According to the instructions, Nurofen Plus influences the results of laboratory tests to determine the level of concentration of amylase, lipase, bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase in blood plasma. The drug can distort the results of examinations when imaging the hepatobiliary system using dysophenin.
Analogs
Nurofen Plus analogs are Nurofen Plus N, Ibuprofen, Ibufen.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C, protected from moisture.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Nurofen Plus
The few reviews about Nurofen Plus indicate the effectiveness of the drug not only when used to relieve severe pain, but also to reduce body temperature.
Price for Nurofen Plus in pharmacies
The price of Nurofen Plus for 12 tablets per pack is about 400 rubles.
Nurofen Plus: prices in online pharmacies
Drug name Price Pharmacy |
Nurofen Plus coated tablets 12 pcs. 646 r Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!