Nurofen forte film-coated tablets of 400 mg, blister of 12 pcs

• active substance: ibuprofen; 1 film-coated tablet contains 400 mg of ibuprofen;
• excipients: sodium croscarmellose, sodium lauryl sulfate, sodium citrate, stearic acid, colloidal anhydrous silicon dioxide, sodium carmellose, talc, acacia, sucrose, titanium dioxide (E 171), macrogol 6000;
• ink for printing on the tablet (ammonium hydroxide, simethicone, propylene glycol, iron oxide red (E 172), shellac).

• Hypersensitivity to ibuprofen or to any of the components of the drug.
• Hypersensitivity reactions (such as asthma, rhinitis, angioedema, or urticaria) that have occurred previously after using ibuprofen, acetylsalicylic acid (aspirin), or other NSAIDs.
• Gastric ulcer disease / bleeding in an active form or recurrences in history (two or more pronounced episodes of ulcer disease or bleeding).
• History of gastrointestinal bleeding or perforation associated with NSAID use.
• Severe hepatic impairment, renal impairment, heart failure (class IV according to the NYHA (New York Heart Association) classification).
• The last trimester of pregnancy.
• Cerebrovascular or other bleeding.
• Disorders of hematopoiesis or blood coagulation.

Data from clinical studies indicate that the use of ibuprofen, especially at a high dose of 2400 mg per day, slightly increases the risk of arterial thrombotic complications (for example, myocardial infarction or stroke).

From the side of the digestive tract. Infrequently – abdominal pain, dyspepsia and nausea; rarely – diarrhea, flatulence, constipation and vomiting; very rarely – ulcer disease, perforations or gastrointestinal bleeding, melena, bloody vomiting, sometimes fatal (especially in elderly patients), ulcerative stomatitis, gastritis, pancreatitis, exacerbation of colitis and Crohn’s disease.

From the side of the nervous system. Infrequently – headache; rarely – vertigo; very rarely – aseptic meningitis (see below), some symptoms of which (rigidity of the occipital muscles, headache, nausea, vomiting, confusion or disorientation) may occur in patients with autoimmune diseases such as systemic lupus erythematosus, mixed connective tissue disease ; unknown – paresthesias, drowsiness.

For oral administration with short-term use.

The lowest effective dose should be used for the shortest time necessary to relieve symptoms.

Adults and children over 12 years old. The drug is used 1 tablet every 4 hours. Tablets should be washed down with water. Do not take more than 3 tablets within 24 hours. The maximum daily dose is 1200 mg.

Use during pregnancy or breastfeeding

During the first and second trimester of pregnancy, ibuprofen should not be prescribed unless necessary. If ibuprofen is used by a woman who is trying to get pregnant, or during the first and second trimesters of pregnancy, the dose should be as low as possible, and the duration of treatment should be as short as possible.

Ibuprofen is contraindicated during the third trimester of pregnancy.

Ibuprofen has been found in breast milk in very low concentrations in some studies, so it is unlikely that it could adversely affect a breastfed infant.

Children

Do not apply to children under 12 years of age.

The ability to influence the speed of reaction when driving vehicles or other mechanisms

If used in accordance with the recommended doses and duration of treatment, the drug does not affect the speed of reaction when driving a vehicle or working with other mechanisms. Patients who experience dizziness, drowsiness, disorientation or visual disturbances while taking NSAIDs should refrain from driving or operating machinery.

The use of the drug in children in a dose of more than 400 mg/kg can cause the appearance of symptoms of intoxication. In adults, the dose effect is less pronounced. The half-life in case of overdose is 1.5 – 3 hours.

Symptoms In most patients who participated in clinical trials, the use of a significant amount of NSAIDs caused only nausea, vomiting, pain in the epigastric region, and very rarely – diarrhea. Tinnitus, headache, dizziness, and gastrointestinal bleeding may also occur. In case of more severe poisoning, toxic damage to the central nervous system can occur, which manifests itself in the form of drowsiness, nystagmus, impaired vision, sometimes – an excited state and disorientation or coma. Sometimes patients have convulsions. In severe poisoning, hyperkalemia and metabolic acidosis, acute renal failure, liver damage, arterial hypotension, respiratory failure, and cyanosis may occur. Patients with bronchial asthma may experience an exacerbation of the course of asthma.

Treatment. Treatment should be symptomatic and supportive, as well as include ensuring the patency of the respiratory tract and monitoring vital signs until the condition normalizes. Oral use of activated charcoal or gastric lavage within 1 hour after administration of a potentially toxic dose of the drug is recommended. If ibuprofen has already been absorbed into the body, alkaline substances can be administered to accelerate the excretion of acidic ibuprofen with urine.

For frequent or prolonged seizures, diazepam or lorazepam should be administered intravenously. Bronchodilators should be used in case of bronchial asthma.

Store in the original packaging at a temperature not higher than 25 °C. Keep out of the reach of children.