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

composition shell: carmellose sodium 1.4 mg.talcum 66 mg, acacia gum 1.2 mg, sucrose 232.2 mg, titanium dioxide 2.8 mg, macrogol 6000 0.4 mg, red ink [Opacode S-1-15094] (shellac 41.49%, iron dye oxide red (E172) 31%, buganol * 14%, isopropanol * 7%, propylene glycol 5.5%, ammonia water 1%, simethicone 0.01%).

Solvents evaporated after the printing process.

Description:Round biconvex tablets covered with a white coating with a white coating with a red Nurofen 400 overprint on one side of the tablet.

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. The analgesic effect of the drug lasts up to 8 hours.

Pharmacokinetics:

Absorption is high, quickly and almost completely absorbed from the gastrointestinal tract (GIT). After taking the drug on an empty stomach, the maximum concentration (Cmax) of ibuprofen in the blood plasma is reached after 45 minutes. Taking the drug along with food can increase the time to reach the maximum concentration (TCmax) up to 1-2 hours. Connection with blood plasma proteins - 90%. Slowly penetrates into the joint cavity, is retained in the synovial fluid, creating in it greater concentrations than in the blood plasma. In the cerebrospinal fluid, lower concentrations

ibuprofen compared with 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. The half-life (T1 / 2) is 2 hours. It is excreted by the kidneys (in an unchanged form not more than 1%) and, to a lesser extent, with bile.

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

Indications:Nurofen Forte is used for headache, migraine, toothache, painful menstruation, neuralgia, back pain, muscle pain, rheumatic pain and joint pain: as well as febrile 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 polyposis and paranasal sinuses, and intolerance to acetylsalicylic acid or other NSAIDs (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.

- Intolerance to fructose, glucose-gepaktosnaya malabsorption, insufficiency of sucrose-isomaltase.

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

- Pregnancy (III trimester).

- Children under 12 years.

Carefully:

Simultaneous reception of other NSAIDs, a history of a single episode of peptic ulcer of stomach and duodenal 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 physical illnesses, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral artery disease, smoking,frequent use of alcohol, simultaneous use of drugs 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, the period of breastfeeding, and advanced 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, so usually with a short-term admission of the need to stop breastfeeding does not occur. If prolonged use of the drug is necessary, you should consult your doctor to resolve thetermination of breastfeeding for the period of drug use.

Dosing and Administration:

For oral administration. Patients with increased sensitivity of the stomach are advised to take the drug while eating.

Only for short-term use. Read the instructions carefully before taking the drug.

Adults and children over 12 years old inside 1 tablet (400 mg) up to 3 times a day. Tablets should be washed down with water.

The interval between taking the tablets should be at least 6 hours. The maximum daily dose is 1200 mg (3 tablets). The maximum daily dose for children from 12 to 18 years is 800 mg (2 tablets). If the symptoms persist or worsen during 2-3 days, 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.

In elderly people, there is an increased incidence of adverse reactions when NSAIDs are used, especially gastrointestinal bleeding and perforations, in some cases fatal. 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 (3 tablets). 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 ulcers in the mouth, flu-like symptoms, severe weakness, nosebleeds and

subcutaneous hemorrhage, 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, increased activity of "liver" transaminases, 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.

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, in particular selective inhibitors of COX-2: should avoid the simultaneous use of two or more drugs from the group of NSAIDs because of the possible increase in the risk of side effects.

Use with caution at the same time as the following

means:

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

- Antihypertensives (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may decrease the effectiveness of these drugs. In some patients with impaired renal function (eg, in patients with dehydration or in elderly patients with impaired renal function) simultaneous administration of ACE inhibitors or angiotensin II antagonists and agents inhibiting cyclooxygenase can lead to impaired 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 joint use of the above-mentioned drugs should be administered with caution, especially in the elderly. It is necessary to prevent dehydration in patients, and also to consider the possibility of monitoring renal function after the beginning of such combined treatment and periodically - in the future. 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: increased risk of gastrointestinal bleeding.

Cardiac glycosides: simultaneous appointment of NSAIDs and cardiac glycosides may lead to worsening of heart failure, a decrease in the 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 an increase in the concentration of methotrexate in the blood plasma against the background of NSAIDs. Cyclosporine: increased risk of nephrotoxicity with the 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 the simultaneous appointment of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.

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.

- Myelotoxic drugs: increased hematotoxicity.

- Cefamandol, cefoperazone, cefotetai, valproic acid, plikamycin: increased frequency of hypoprothrombinemia.

- Drugs that block tubular secretion: decreased elimination and increased plasma concentrations of ibuprofen.

- Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants): an increase in the production of hydroxylated active metabolites, an increased risk of severe intoxication.

- Inhibitors of microsomal oxidation: reducing the risk of hepatotoxic action.

- Oral hypoglycemic drugs and insulin, sulfonylureas: strengthening the effect of drugs.

- Antacids and colestramine: reduction of absorption.

- Urikozuric preparations: a decrease in the effectiveness of drugs.

- Estrogens, ethanol: increased risk of side effects.

- 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. If you need to take the drug for more than 10 days, you need to see a doctor.

In patients with bronchial asthma or allergic disease in the acute stage, as well as in patients with an anamnesis of bronchial asthma / allergic disease, the drug can provoke bronchospasm.The use of the drug in patients with systemic lupus erythematosus or a mixed disease of connective tissue is associated with an increased risk of developing aseptic meningitis.

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 pregnancy: the drug suppresses cyclooxygenase and the synthesis of prostaglandins, affects 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:

The tablets covered with a cover of 400 mg.

Packaging:

For 6 or 12 tablets per blister (PVC / PVDC / aluminum).

For 1 or 2 blisters (6 or 12 tablets) are placed in a cardboard box along with instructions for use.

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

Shelf life:

3 years.

Do not use the drug with expired shelf life.

Terms of leave from pharmacies:Without recipe

Registration number:P N 016033/01

Date of registration:02.04.2008

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: & nbsp13.03.2013

Illustrated instructions

Instructions

Nurofen® forte (Nurofen® forte)