Nurofen Plus

Active material: Codeine, Ibuprofen
When ATH: N02AA59
CCF: NPVS combined composition
ICD-10 codes (testimony): G43, J06.9, J10, K08.8, M25.5, M79.1, M79.2, N94.4, N94.5, R50, R51, R52.0, R52.2
At KFU: 05.01.01.06
Manufacturer: RECKITT BENCKISER HEALTHCARE INTERNATIONAL Ltd. (Great Britain)

Pharmaceutical form, composition and packaging

Pills, coated white, lenticular, in the form of capsules, with the embossed inscription “N ” on one side.

Excipients: microcrystalline cellulose, sodium starch glycolate, gipromelloza, pre-gelatinized starch, opasprej m-1-7111V, talc.

2 PC. – blisters (1) – packs cardboard.
2 PC. – blisters (2) – packs cardboard.
4 PC. – blisters (1) – packs cardboard.
4 PC. – blisters (2) – packs cardboard.
6 PC. – blisters (1) – packs cardboard.
6 PC. – blisters (2) – packs cardboard.
12 PC. – blisters (1) – packs cardboard.
12 PC. – blisters (2) – packs cardboard.
12 PC. – blisters (4) – packs cardboard.

Pharmacological action

Combined preparation, action is due to the effects of its constituent components. It has analgesic, pyretic, anti-inflammatory and antitussive effect.

Ibuprofen – NSAIDs, phenylpropionic acid derivative. The mechanism of action is due to inhibition of the synthesis of prostaglandins by blocking cyclooxygenase enzyme.

Codeine phosphate – phenanthrene alkaloid of opium series, agonist opioid receptors. Reduces the excitability of the cough center, When coupled with the use of ibuprofen enhances its analgesic action.

Pharmacokinetics

Absorption and distribution

After taking the drug ibuprofen inside almost completely absorbed from the digestive tract. Linking blood plasma proteins- 90%. Slowly into the joint cavity, is delayed in the synovial tissue, creating great concentration, than in plasma.

Metabolism and excretion

After absorption of about 60% pharmacologically inactive R-form slowly converted into the active form of S-. Treated biotransformation. Report the news (unaltered no more 1%) and to a lesser extent – the bile. T_1/2 ibuprofen – 2 no, T_1/2 codeine – 3 no.

Testimony

Mild to moderate pain syndrome severity:

- Headache;

- Migraine;

- toothache;

- Algomenorrhea;

- Neuralgia;

- Myalgia;

-arthralgia;

-rheumatic pain.

Feverish condition with flu and colds.

Dosage regimen

Adults and children over 12 years the drug is prescribed for 1-2 tab. 3-4 times / day. To achieve a rapid therapeutic effect dose can be increased to 2 tab. 3 times / day.

The maximum daily dose – 6 tab. (1.2 g). The tablets should be taken with water.

Patients should be warned, What if when taking medication for 2-3 days symptoms persist, you must stop treatment and seek medical advice.

Side effect

From the digestive system: nausea, vomiting, heartburn, anorexia, epigastric discomfort, diarrhea, flatulence, stomach ache, abnormal liver function, abdominal pain, aggravation of gastric ulcer.

CNS: headache, dizziness, hearing loss, noise in ears, insomnia, excitation, drowsiness, depression.

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

From the urinary system: edematous syndrome, impairment of renal function.

From the hematopoietic system: anemia, thrombocytopenia, agranulocytosis, leukopenia.

Allergic reactions: skin rash, itch, hives, angioedema.

The respiratory system: bronchospasm, respiratory depression, oppression kashlevogo reflex.

Other: increased sweating.

Prolonged use of high doses: ulceration of the gastrointestinal mucosa, bleeding (incl. from the gastrointestinal tract, right, Royal, hemorrhoidal), visual impairment (impaired color vision, amblyopia, scotoma).

When applying Nurofena^® Plus for 2-3 days there are virtually no side effects. Described side effects may occur with long-term use.

Contraindications

- Erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, incl. yazvennыy colitis;

- Heart failure;

- Respiratory failure;

-severe hypertension;

-increased intracranial pressure;

- Traumatic brain injury;

- “Aspirin” bronchial asthma, hives, rhinitis, provoked by taking acetylsalicylic acid (salicylates) or other NSAIDs;

-diseases of the optic nerve, impaired color vision, amblyopia, scotoma;

- Expressed human liver;

- Expressed by the human kidney;

- Hemophilia, state hypocoagulation;

- Leukopenia;

- Hearing loss, pathology of the vestibular apparatus;

- Chronic constipation;

- Pregnancy;

- Children up to age 12 years;

-hypersensitivity to ibuprofenu or to the preparation components.

FROM caution should appoint ulcers stomach and duodenal ulcers in history, gastritis, enteritis, cars, bleeding from the digestive tract disorder, with kidney or liver failure, chronic heart failure, blood diseases of unknown etiology, asthma, krapivnice, rhinitis, Polyps of the nasal mucosa, giperʙiliruʙinemii, gipotireoze, and elderly patients.

Pregnancy and lactation

Contraindicated use Nurofena^® Plus during pregnancy.

If you must use Nurofena^® Plus lactation should decide on the termination of breastfeeding.

Cautions

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

The patient should be informed about, that the appearance of side effects, stop taking the drug and seek medical advice.

Against the background of the use of the drug is not recommended to use of alcohol.

Monitoring of laboratory parameters

During prolonged use of the drug needed to be monitored picture peripheral blood and functional status of the liver and kidney. When symptoms of gastropathy shows careful monitoring, comprising carrying out esophagogastroduodenoscopy, General blood analysis (hemoglobin determination), occult blood feces analysis.

Effects on ability to drive vehicles and management mechanisms

Patients should refrain from all activities, requiring attention, psychomotor speed reactions.

Overdose

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

Treatment: gastric lavage (Only one hour after administration), administration of activated charcoal, alkaline water, diurez; if necessary, symptomatic therapy. When oppression breath using naloxone.

Drug Interactions

Not recommended simultaneous reception of Nurofen^® Plus 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 (alteplase, streptokinase, urokinase) increased risk of bleeding.

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, that leads to increased nephrotoxic effect.

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 (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 raises gipoglikemiceski effect oral protivodiabeticakih funds (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.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

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