Nurofen Forte: instructions for using the medicine, structure, Contraindications

Active material: Ibuprofen
When ATH: M01AE01
CCF: NSAIDs
ICD-10 codes (testimony): G43, J06.9, J10, K08.8, M25.5, M54, M79.1, M79.2, N94.4, N94.5, R50, R51, R52.0, R52.2
When CSF: 05.01.01.06
Manufacturer: RECKITT BENCKISER HEALTHCARE INTERNATIONAL Ltd. (Great Britain)

Nurofen Forte: dosage form, composition and packaging

◊ Pills, coated white, sugar; round, lenticular, with an inscription “Nurofen 400” of red color.

Excipients: sodium croscarmellose, sodium lauryl, sodium citrate, stearic acid, colloidal silicon dioxide, carmellose sodium, talc, acacia, sucrose, Titanium dioxide, macrogol 6000, Purified water, ink (opakod S-1-9460 HV Brown, industrial methylated spirit).

6 PC. – blisters (1) – packs cardboard.
6 PC. – blisters (2) – packs cardboard.
12 PC. – blisters (1) – packs cardboard.
12 PC. – blisters (2) – packs cardboard.

Nurofen Forte: pharmachologic effect

NPVC. It has analgesic, antipyretic and anti-inflammatory action. Indiscriminately blocking COX-1 and COX-2. The mechanism of action of ibuprofen due to inhibition of prostaglandin synthesis – mediators of pain, inflammation and hyperthermic response.

Nurofen Forte: pharmacokinetics

Absorption and distribution

After ingestion highly absorbed from the gastrointestinal tract. C_max ibuprofen plasma levels achieved after 1-2 no.

Plasma protein binding is 90%. Slowly into the joint cavity, is delayed in the synovial tissue, creating in it a higher concentration, than in plasma. After absorption of about 60% pharmacologically inactive R-form slowly converted into the active form of S-.

Metabolism and excretion

Biotransformiroetsa body. Excreted by the kidneys as metabolites (unchanged not more 1%) and, less, the bile. T_1/2 – 2no.

Nurofen Forte: testimony

• headache;
• toothache;
• migraine;
• algomenorrhea;
• neuralgia;
• backache;
• mialgii;
• rheumatic pain;
• fever with flu and colds.

Nurofen Forte: dosing regimen

Adults and children over 12 years inwards 400 mg (1 tab.). If necessary, every 4 h take 1 tab. (but you can not take more 3 tab. / day). The maximum daily dose Adult is 1.2 g. The maximum daily dose children and adolescents between the ages of 12 to 17 years is 1 g.

The tablets should be taken with water.

Patients should be warned, what, if while taking the drug for 2-3 days symptoms persist, you must stop treatment and seek medical advice.

Nurofen Forte: side effects

From the digestive system: NSAID-gastropathy (stomach ache, nausea, vomiting, heartburn, decreased appetite, diarrhea, flatulence, constipation; perhaps – increase in liver transaminases; rarely – erosive and ulcerative lesions of the gastrointestinal mucosa, which in some cases are complicated by perforation and bleeding); irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the mucous membrane of the gums, thrush, pancreatitis, hepatitis.

CNS: headache, dizziness, insomnia, anxiety, nervousness, irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations; rarely – aseptic meningitis (more frequently in patients with autoimmune diseases).

Cardio-vascular system: heart failure, tachycardia, increased blood pressure.

From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (swelling), polyuria, cystitis; perhaps – decrease in QC, increase in serum creatinine concentration.

From the senses: hearing loss, ringing or noise in the ears, toxic damage of the optic nerve, blurred vision or diplopia, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic genesis), scotoma.

The respiratory system: breathlessness, bronchospasm.

From the hematopoietic system: anemia (incl. hemolytic and aplastic), thrombocytopenia, trombotsitopenicheskaya purpura, agranulocytosis, leukopenia; perhaps – increase in bleeding time, decrease in hematocrit or hemoglobin.

Allergic reactions: skin rash (usually erythematous or hives), itching, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnoea, fever, erythema multiforme exudative (v.t.ch. Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eozinofilija, nasal allergy.

Other: may decrease blood glucose concentrations.

When applying the preparation for 2-3 day side effects are very rare.

Nurofen Forte: Contraindications

• erosive and ulcerative lesions of the gastrointestinal tract in the acute phase (incl. gastric ulcer and duodenal ulcer, Crohn's disease, NYAK);
• hemophilia, state hypocoagulation, hemorrhagic diathesis;
• period after coronary artery bypass grafting;
• gastrointestinal bleeding and intracranial hemorrhage;
• severe liver failure or active liver disease;
• severe renal failure, confirmed hyperkalemia;
• pregnancy;
• lactation;
• Children up to age 12 years;
• hypersensitivity to the drug;
• hypersensitivity to acetylsalicylic acid or other NSAIDs in history: incl. indications of attacks of bronchial obstruction, coryza, urticaria after ingestion of aspirin or other NSAIDs; complete or partial syndrome of intolerance to acetylsalicylic acid (rinosinusit, hives, polyps of the nasal mucosa, bronchial asthma).

FROM caution prescribers elderly patients, Patients with heart failure, hypertension, CHD, cerebrovascular diseases, dyslipidemia, diabetes, peripheral arterial disease, smokers, with frequent use of alcohol, liver cirrhosis with portal hypertension, hepatic and / or renal failure, patients with nephrotic syndrome, hyperbilirubinemia, When specifying a history of gastric ulcer and duodenal ulcer, patients with gastritis, enteritis, KOLITA, blood diseases of unknown etiology (leukopenia and anemia), lactation, long-term use of NSAIDs, with severe medical conditions, simultaneously with oral corticosteroids (v.t.ch with prednisolone), with anticoagulants (incl. warfarin), with antiplatelet (incl. acetylsalicylic acid, with clopidogrel), selective serotonin reuptake inhibitors (incl. with citalopram, fluoxetine, paroxetine, sertraline).

Nurofen Forte: Pregnancy and lactation

Nurofen^® Forte is contraindicated during pregnancy and lactation.

Nurofen Forte: Special instructions

Drug treatment should be conducted in the minimum effective dose, the lowest possible short-course.

The patient should be informed about, that the appearance of side effects, stop taking the drug and seek medical advice. During the period of treatment is not recommended to use ethanol.

Monitoring of laboratory parameters

During long-term treatment is necessary to monitor patterns of peripheral blood and functional state of the liver and kidneys. When symptoms of gastropathy shows careful monitoring, comprising carrying out esophagogastroduodenoscopy, general blood analysis (hemoglobin determination), fecal occult blood test.

If you want to determine the 17-ketosteroids drug should be discontinued for 48 h before the test.

Effects on ability to drive vehicles and management mechanisms

Patients should refrain from all activities, require attention and speed of psychomotor reactions.

Nurofen Forte: overdose

Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, noise in ears, metabolic acidosis, coma, acute renal failure, decrease in blood pressure, bradycardia, tachycardia, Atrial fibrillation, respiratory arrest.

Treatment: gastric lavage (Only one hour after administration), Activated carbon, alkaline water, diurez; if necessary, symptomatic therapy.

Nurofen Forte: drug interaction

Not recommended simultaneous reception of Nurofen^® Forte with acetylsalicylic acid and other NSAIDs.

When concomitant administration of ibuprofen reduces inflammatory and antiplatelet effect of aspirin (may increase the incidence of acute coronary insufficiency after you start taking ibuprofen in patients, receiving antiplatelet agents as low-dose acetylsalicylic acid).

While the use of anticoagulants and thrombolytic drugs (incl. alteplase, streptokinase, urokinase) increased risk of bleeding.

Simultaneous treatment with serotonin reuptake inhibitors (incl. citalopram, fluoxetine, paroxetine, sertraline) increases the risk of serious bleeding from the gastrointestinal tract.

When combined with ibuprofen tsefamandol, cefoperazone, cefotetan, valproic acid, plicamycin increase the frequency of gipoprotrombinemii.

When combined drugs cyclosporine and gold intensify the effect of ibuprofen on prostaglandin synthesis in the kidneys, which leads to increased nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporin and the probability of its hepatotoxic effects.

Drugs, block tubular secretion, while the application of reduced excretion and increase plasma concentrations of ibuprofen.

In a joint application inducers of microsomal oxidation (incl. phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe intoxication.

Inhibitors of microsomal oxidation reduce the risk of hepatotoxic action of ibuprofen.

In a joint application ibuprofen reduces the hypotensive activity of vasodilators, natriuretic effect of furosemide and hydrochlorothiazide.

Ibuprofen reduces the effectiveness of drugs urikozuricheskih, It increases the effect of indirect anticoagulants, antiagregantov, fibrinolitikov.

Strengthens side effects of mineralocorticoid, GCS, estrogen, ethanol.

In a joint application enhances the effect of oral hypoglycemic agents (sulfonylureas) and insulin.

At the same time taking antacids and cholestyramine reduce the absorption of ibuprofen.

In a joint application ibuprofen increases blood concentration of digoxin, lithium preparations, methotrexate.

Caffeine increases the analgesic effect of ibuprofen.

Nurofen Forte: terms of dispensing from pharmacies

The drug is resolved to application as an agent Valium holidays.

Nurofen Forte: terms and conditions of storage

The drug should be stored in a dry place inaccessible to children at temperature not exceeding 25 ° C. Shelf life – 3 year.