Index of drugs

Treatment of mild to moderate pain, such as headache, migraine, back pain, dysmenorrhea, toothache, rheumatic and muscular pain, and fever and sore throat in the course of colds and flu.

1 sachet contains 400 mg of Ibuprofen in the form of ibuprofen with lysine (and 1.26 g of sucrose and 0.0067 mg of tartrazine - E102).

A non-steroidal anti-inflammatory drug. It reduces pain caused by inflammation, swelling and fever by inhibiting prostaglandin synthesis. In addition, it inhibits platelet aggregation in a reversible manner. After oral administration, ibuprofen lysine disintegrates to acid and lysine. Lysine has no pharmacokinetic activity. Ibuprofen is well absorbed from the gastrointestinal tract and largely binds to plasma proteins. It penetrates into the synovial fluid. C_max is obtained within 25 minutes of administering Nurofen Express Forte soluble (400 mg ibuprofen lysine salt), compared to 90 min after tablet administration. Nurofen 200 mg x 2 (ibuprofen as acid) and 30 min after tablet administration. Nurofen 200 mg x 2 (ibuprofen in the form of lysine salt). Ibuprofen is metabolized in the liver to form two major metabolites, which are excreted by the kidneys in conjugated or unchanged form, together with small amounts of unchanged ibuprofen. Renal excretion is fast and complete. T_0,5 in the phase of elimination is about 2 h. There were no significant differences regarding the pharmacokinetic profile in the elderly.

Hypersensitivity to Ibuprofen, other NSAIDs, tartrazine (E102) or to any of the other excipients. Past hypersensitivity reactions such as bronchial asthma, rhinitis, angioneurotic edema or urticaria caused by the administration of salicylates (including acetylsalicylic acid) or other NSAIDs. Bleeding or perforation of the gastrointestinal tract associated with previous NSAID treatment. Active or recurrent peptic ulcer of the stomach and / or duodenum (two or more distinct episodes of confirmed ulceration or bleeding). Bleeding from cerebral vessels or other active bleeding. Hemorrhagic diathesis or clotting disorders. Hepatic heart failure. Severe hepatic failure. Severe renal failure. Severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake). Third trimester of pregnancy.

Caution should be exercised in elderly patients (increased risk of side effects, in particular bleeding and perforation of the gastrointestinal tract); with asthma or a history of allergic disease (risk of bronchial spasm); with systemic lupus erythematosus and mixed connective tissue disease (increased risk of aseptic meningitis, history of hypertension and / or heart failure (fluid retention, hypertension and edema have been reported), history of gastrointestinal disease - ulcerative The risk of bleeding, ulceration or perforation of the gastrointestinal tract increases with higher doses of NSAIDs, in patients with a history of ulceration, especially if complicated by haemorrhage or perforation, and in the elderly. These treatments should be started with the lowest available dose, and in these patients, as well as patients requiring concomitant treatment with low-dose Acetylsalicylic acid or other active substances that may increase the risk of gastrointestinal Combined with protective drugs (eg misoprostol or proton pump inhibitors). It is recommended to discontinue treatment if ibuprofen patients experience bleeding or ulceration of the gastrointestinal tract and at the onset of the first symptoms of skin rash, changes in mucous membranes or other signs of hypersensitivity. It is recommended to avoid using the drug in case of chickenpox. Do not use this medicine in patients under 12 years of age.The drug contains sucrose - should not be used in patients with rare hereditary fructose intolerance, malabsorption of glucose-galactose and sucrase-isomaltase deficiency.

Ibuprofen should not be used in the first and second trimester of pregnancy, unless it is clearly necessary (risk of miscarriage and the occurrence of congenital heart defects and gastrosharing due to the use of prostaglandin synthesis inhibitor in early pregnancy, the total risk of cardiovascular malformations increases from less than 1% up to about 1.5%, the risk increases with the dose and duration of treatment). If ibuprofen is to be used in women planning pregnancy or in the first or second trimester of pregnancy, the lowest possible dose should be used for the shortest possible time. In the third trimester, the use of ibuprofen is contraindicated. Ibuprofen used in the third trimester of pregnancy may cause pulmonary hypertension, premature closure of the ductus arteriosus and renal dysfunction, which may be converted into renal failure with oligohydramnios; in the mother - suppress the uterine contractile function; in the mother and in the fetus an anti-aggregation effect may be manifested by the prolongation of coagulation time. Ibuprofen and its metabolites can penetrate into breast milk in very small amounts. Interruption of feeding is not necessary with short-term use of ibuprofen in doses used to treat pain and fever. Ibuprofen may affect fertility in women by affecting ovulation; this effect is transient and disappears after completion of therapy.

Common: abdominal pain, nausea, indigestion, heartburn. Uncommon: skin rash, hypersensitivity reactions with rash and itchy skin and asthma attacks (with possible reduction of blood pressure), headache, dizziness, insomnia, tinnitus, agitation, irritability, fatigue, blurred vision, diarrhea, bloating, constipation, vomiting. Rare: tinnitus, damage to kidney tissue (wart necrosis), increase in uric acid in the blood. Very rare: exacerbation of inflammatory conditions associated with infections (eg necrotizing fasciitis), aseptic meningitis (especially in patients with systemic lupus erythematosus or mixed connective tissue disease), haematological abnormalities - anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis (the first symptoms may include fever, sore throat, superficial wounds in the mouth, flu-like symptoms, fatigue, bleeding, among others, from the nose); severe general hypersensitivity reactions (eg swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension, life-threatening shock), psychotic reactions, depression, hypertension, oesophagitis, pancreatitis, formation of membranes of the intestine, peptic ulcers, perforation or bleeding (sometimes fatal, especially in the elderly), tarry stools, bloody vomiting, ulcerative oral mucositis, gastritis, exacerbation of colitis and Crohn's disease, formation of edema (especially in patients with hypertension or renal failure), nephrotic syndrome, interstitial nephritis (which may be accompanied by acute renal failure), liver dysfunction, Stevens-Johnson syndrome and toxic epidermal necrolysis. In exceptional cases, severe infections of the skin and complications of soft tissues may occur during infection with chickenpox. Nolvulas, hypertension and heart failure have been reported with NSAIDs. Clinical studies and epidemiological data suggest that intake of ibuprofen, especially at high doses (2,400 mg / day) over a long period may be associated with a small increase in the risk of arterial blockages (eg myocardial infarction or stroke).

Orally. Adults and children> 12 years: 1 sachet up to 3 times a day. There should be at least a 6-hour break between doses. The maximum daily dose is 1200 mg ibuprofen. If there is a need to take the drug for more than 3 days in the case of fever or for more than 5 days in the treatment of pain or if the symptoms get worse, please consult your doctor.Special groups of patients. No dose adjustment is required in the elderly or in patients with mild to moderate renal or hepatic impairment, but caution should be exercised. Do not use in children <12 years.Application method. Dissolve the contents of the sachet in a glass of water, mix and drink immediately.