Nurofen UltraKap

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)

Pharmaceutical form, composition and packaging

◊ Capsules hard gelatin, Oval, translucent, of red color, with an inscription “NUROFEN” white; contents of capsules – transparent liquid from colorless to slightly pink in color.

Excipients: macrogol 600, Alfa-tokoferola succinate (Vitamin E), povidone K17.

Composition of a gelatin capsule: gelatin, maltitol, liquid, sorbitol 76% (solution), carmine dye (poncho 4R), opakod NS-78-180011 (Titanium dioxide, propylene glycol, gipromelloza, isopropanol, Purified water).

4 PC. – blisters (1) – cardboard boxes.
10 PC. – blisters (1) – cardboard boxes.

Pharmacological action

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.

Pharmacokinetics

Absorption and distribution

Once inside quickly and highly absorbed from the digestive 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.

Testimony

-headache and toothache;

- Migraine;

- Algomenorrhea;

- Neuralgia;

- Back pain;

- Mialgii;

- Rheumatic pain;

- Fever with flu and SARS.

Dosage regimen

Adults and older children 12 years appointed interior 200 mg 3-4 times / day.

To achieve a rapid therapeutic effect dose can be increased to 400 mg (2 caps.) 3 times / day.

Should not take more 6 caps. / 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 capsules 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.

Side effect

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: increased sweating; may decrease blood glucose concentrations.

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

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;

- The period after coronary artery bypass grafting;

- Zhedudochno-intestinal bleeding and intracranial hemorrhage;

- Severe hepatic impairment or active liver disease;

- Severe renal insufficiency, confirmed hyperkalemia;

- Pregnancy;

- Children up to age 12 years;

- Hypersensitivity to the drug;

- Hypersensitivity to aspirin or other NSAIDs 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/Hyperlipidemia, diabetes, peripheral arterial disease, smokers, with frequent use of alcohol, liver cirrhosis with portal hypertension, at CC< 60 ml / min, 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, the presence of infection, caused by Helicobacter pylori, When blood diseases unclear etiology (leukopenia and anemia), lactation, long-term use of NSAIDs, patients with severe somatic diseases, 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).

Pregnancy and lactation

Nurofen^® Ul′traKap is contraindicated for use in the third trimester of pregnancy.

Use of the drug in the first and second trimesters of pregnancy and during lactation is possible only, when the intended benefits to the mother outweighs the potential risk to the fetus or infant.

If necessary, the appointment during lactation should decide the issue of termination of breastfeeding.

Cautions

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.

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.

Drug Interactions

Not recommended simultaneous reception of Nurofen^® Ul′traKap 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.

Preparations, possessing mielotoksičeskim activity reinforce manifestations gematotoksicnosti Nurofena^® Ul′traKap.

Caffeine increases the analgesic effect of ibuprofen.

Conditions of supply of pharmacies

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

Conditions and terms

The drug should be stored in a dry, inaccessible to children at temperature not exceeding 25 ° C. Shelf life - 2 year.