Instructions Nurofen Forte film-coated tablets 400 mg No. 24
Composition
active ingredient: ibuprofen; 1 film-coated tablet contains ibuprofen 400 mg;
excipients: croscarmellose sodium, sodium lauryl sulfate, sodium citrate, stearic acid, colloidal anhydrous silicon dioxide, carmellose sodium, talc, acacia, sucrose, titanium dioxide (E 171), macrogol 6000;
printing ink on the tablet (ammonium hydroxide, simethicone, propylene glycol, red iron oxide (E 172), shellac).
Dosage form
Film-coated tablets.
Main physicochemical properties: White or almost white biconvex tablets, coated with a sugar shell with an identifying red inscription on one side.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs. Propionic acid derivatives. ATC code M01A E01.
Pharmacological properties
Pharmacodynamics
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID), a propionic acid derivative, which exerts a directed effect against pain, fever and inflammation by inhibiting the synthesis of prostaglandins - mediators of pain and inflammation. In addition, ibuprofen reversibly inhibits platelet aggregation.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when these drugs are used concomitantly. Some pharmacodynamic studies have shown that single doses of ibuprofen 400 mg administered within 8 hours before and within 30 minutes after immediate-release acetylsalicylic acid (81 mg) reduce the effect of aspirin (acetylsalicylic acid) on thromboxane formation or platelet aggregation. Although there is uncertainty about the extrapolation of these data to the clinical situation, it cannot be excluded that regular long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. With non-systematic use of ibuprofen, such a clinically significant effect is considered unlikely.
Pharmacokinetics
Ibuprofen is well absorbed from the gastrointestinal tract and binds to blood plasma proteins.
The maximum concentration in the blood serum is determined 45 minutes after administration (in the case of administration on an empty stomach). In the case of administration of this drug during food intake, peak levels are observed 1-2 hours after administration. Ibuprofen is metabolized in the liver, excreted by the kidneys in unchanged form or in the form of metabolites. The half-life is almost 2 hours. In elderly patients, no significant differences in the pharmacokinetic profile are observed.
Indication
Symptomatic treatment of headaches, including migraines, toothaches, dysmenorrhea, neuralgia, back pain, joints, muscles, as well as symptoms of colds and flu.
Contraindication
• Hypersensitivity to ibuprofen or to any of the components of the drug.
• Hypersensitivity reactions (eg asthma, rhinitis, angioedema or urticaria) previously observed after taking ibuprofen, acetylsalicylic acid (aspirin) or other NSAIDs.
• Gastric ulcer/bleeding in active form or history of recurrence (two or more severe episodes of ulcer or bleeding).
• History of gastrointestinal bleeding or perforation associated with NSAID use.
• Severe hepatic impairment, renal impairment, heart failure (NYHA (New York Heart Association) class IV).
• Last trimester of pregnancy.
• Cerebrovascular or other bleeding.
• Disorders of hematopoiesis or blood clotting.
Interaction with other medicinal products and other types of interactions
Ibuprofen, like other NSAIDs, should not be used in combination with:
- aspirin, as this increases the risk of adverse reactions, except when aspirin (dose not exceeding 75 mg per day) has been prescribed by a doctor.
Experimental data suggest that ibuprofen may inhibit the effect of low-dose acetylsalicylic acid (aspirin) on platelet aggregation when used concomitantly. However, uncertainty about the extrapolation of these data to the clinical situation precludes definitive conclusions that regular long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. Such clinically significant effects are considered unlikely with non-systematic use of ibuprofen;
- other NSAIDs, including selective cyclooxygenase-2 inhibitors.
Ibuprofen should be used with caution in combination with:
Antihypertensive agents (angiotensin-converting enzyme (ACE) inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effect of diuretics and other antihypertensive agents. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the concomitant use of an ACE inhibitor or angiotensin II antagonist and agents that inhibit cyclooxygenase may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, such combinations should be prescribed with caution, especially in elderly patients. If long-term treatment is necessary, the patient should be adequately hydrated and the need for monitoring of renal function should be determined at the beginning of combined treatment and thereafter. Diuretics increase the risk of nephrotoxic effects of NSAIDs;
corticosteroids: increase the risk of ulcers and bleeding in the gastrointestinal tract;
Lithium: There is evidence of a potential increase in plasma lithium levels.
methotrexate: there is evidence of a potential increase in plasma levels of methotrexate;
Zidovudine: There is an increased risk of hematological toxicity when zidovudine is used concomitantly with NSAIDs. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-infected patients with hemophilia when zidovudine is used concomitantly with ibuprofen.
cardiac glycosides: NSAIDs can exacerbate cardiac dysfunction, reduce glomerular filtration function of the kidneys, and increase the level of glycosides in the blood plasma;
antiplatelet agents and selective serotonin inhibitors: the risk of gastrointestinal bleeding increases;
cyclosporine, tacrolimus: increased risk of nephrotoxicity;
Mifepristone: NSAIDs should not be used earlier than 8 to 12 days after mifepristone administration, as they reduce its effectiveness;
quinolone antibiotics: simultaneous administration with ibuprofen increases the risk of seizures;
with sulfonylurea drugs and phenytoin: possible enhancement of the effect.
Application features
The side effects of ibuprofen can generally be reduced by using the lowest effective dose needed to treat symptoms for the shortest period of time.
Caution should be exercised when treating patients with:
• systemic lupus erythematosus and mixed connective tissue disease;
• diseases of the gastrointestinal tract and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• arterial hypertension and/or heart failure;
• impaired kidney function;
• liver dysfunction;
• blood clotting disorders (ibuprofen may prolong bleeding time).
Cardiovascular and cerebrovascular effects: Patients with hypertension and/or a history of mild to moderate congestive heart failure should be cautious when initiating long-term treatment (consultation with a doctor is necessary), as fluid retention, hypertension and oedema have been reported with ibuprofen, as with other NSAIDs.
Clinical trial data suggest that ibuprofen use, particularly at high doses (2400 mg/day), may be associated with an increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Overall, epidemiological data do not suggest that low-dose ibuprofen use (e.g. ≤ 1200 mg/day) is associated with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful clinical assessment. High doses (2400 mg/day) should be avoided. The clinical assessment should also be carefully considered before initiating long-term treatment in patients with risk factors for cardiovascular complications (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking), especially if high doses of ibuprofen (2400 mg/day) are required.
Respiratory effects: Bronchospasm may occur in patients with or with a history of bronchial asthma or allergic diseases.
Other NSAIDs: Concomitant use of ibuprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors, increases the risk of adverse reactions and should be avoided.
Systemic lupus erythematosus and mixed connective tissue diseases.
Ibuprofen should be used with caution in cases of systemic lupus erythematosus and mixed connective tissue diseases due to the increased risk of aseptic meningitis.
Children and adolescents with dehydration are at risk of developing kidney failure.
Hepatic Effects: Caution should be exercised when treating patients with impaired liver function.
Effects on female fertility. There is some evidence that medicinal products that inhibit cyclooxygenase/prostaglandin synthesis may affect ovulation. This effect is reversible after discontinuation of treatment. Long-term use (at doses of 2400 mg/day and for treatment durations exceeding 10 days) of ibuprofen may impair female fertility and is not recommended in women attempting to conceive. This medicinal product should not be used in women who have difficulty conceiving or who are undergoing investigation for infertility.
Gastrointestinal effects: NSAIDs should be used with caution in patients with chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated. Gastrointestinal bleeding, perforation, and ulceration, some fatal, have been reported during treatment with NSAIDs, regardless of the presence of warning symptoms or a history of severe gastrointestinal events.
The risk of gastrointestinal bleeding, perforation, ulceration increases with increasing doses of NSAIDs in patients with a history of ulcer, especially if complicated by bleeding or perforation, and in elderly patients. These patients should start treatment with minimal doses. Caution should be exercised when treating patients receiving concomitant medications that increase the risk of gastrotoxicity or bleeding, such as oral corticosteroids, anticoagulants (e.g. warfarin) or antiplatelet agents (e.g. aspirin). With prolonged treatment in these patients, as well as in patients who require concomitant use of low doses of acetylsalicylic acid (aspirin) or other drugs that increase the risk for the gastrointestinal tract, the doctor may need to prescribe combination therapy with misoprostol or proton pump inhibitors.
Patients with a history of gastrointestinal disorders, especially elderly patients, should report any unusual gastrointestinal symptoms (predominantly bleeding), especially gastrointestinal bleeding at the beginning of treatment. In the event of gastrointestinal bleeding or ulceration in patients receiving ibuprofen, treatment should be discontinued immediately.
Severe skin reactions.
Rare serious skin reactions, which can be fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with the use of non-steroidal anti-inflammatory drugs (NSAIDs) (see section 4.8).
The risk of these reactions is high at the beginning of therapy. The onset of the reaction occurs in most cases within the first month of treatment. A case of acute generalized exanthematous pustulosis has also been reported after the use of ibuprofen-containing medicines.
Ibuprofen should be discontinued at the first signs and symptoms of skin lesions, such as skin rashes, mucosal lesions, or any other signs of hypersensitivity.
In exceptional cases, chickenpox can cause severe skin and soft tissue infections. At this time, the effect of NSAIDs on the worsening of these infections cannot be excluded, therefore it is recommended to avoid the use of ibuprofen in case of chickenpox.
Masking the symptoms of underlying infections.
Nurofen® Forte may mask the symptoms of an infectious disease, which may delay the initiation of appropriate treatment and thereby complicate the course of the disease. This has been observed in bacterial community-acquired pneumonia and bacterial complications of chickenpox. When Nurofen® Forte is used for fever or to relieve pain in an infection, monitoring for the infectious disease is recommended. In outpatient settings, the patient should consult a doctor if symptoms persist or worsen.
1 tablet contains 232.2 mg (0.68 mmol) of sucrose. The drug should be used with caution in patients with diabetes.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase or isomaltase insufficiency should not take this medicine.
Each tablet contains approximately 25.1 mg (1.09 mmol) of sodium, which should be taken into account when prescribing the drug to patients on a low-sodium diet.
Use during pregnancy or breastfeeding
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/foetal development. Epidemiological data indicate an increased risk of miscarriage, congenital heart defects and gastroschisis following exposure to prostaglandin synthesis inhibitors during early pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to approximately 1.5%. The risk is thought to increase with dose and duration of treatment. In animals, the use of prostaglandin synthesis inhibitors has been associated with an increased incidence of pre- and post-implantation loss and embryo/foetal lethality. In addition, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals treated with prostaglandin synthesis inhibitors during organogenesis.
Ibuprofen should not be taken during the first two trimesters of pregnancy unless clearly necessary. Women trying to conceive and during the first and second trimesters of pregnancy should use the lowest possible dose for the shortest possible period of time.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors pose the following risks:
for the fetus: cardiopulmonary toxicity (characterized by premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure, accompanied by oligohydramnios;
for the mother at the end of pregnancy and the newborn: increased bleeding time, antiplatelet effect, which may develop even at very low doses; suppression of uterine contractions, leading to delayed or prolonged labor.
Therefore, ibuprofen is contraindicated during the third trimester of pregnancy.
In some studies, ibuprofen has been found in breast milk at very low concentrations, so it is unlikely that it would negatively affect a breastfed infant.
Ability to influence reaction speed when driving vehicles or other mechanisms
When used in accordance with the recommended doses and duration of treatment, the drug does not affect the reaction rate when driving or operating other mechanisms. Patients who experience dizziness, drowsiness, disorientation or visual disturbances while taking NSAIDs should refrain from driving or operating mechanisms.
Method of administration and doses
For oral administration for short-term use.
The lowest effective dose should be used for the shortest time necessary to relieve symptoms (see section "Special instructions").
Adults and children over 12 years of age. The drug is used 1 tablet every 4 hours. The tablets should be washed down with water. Do not take more than 3 tablets within 24 hours. The maximum daily dose is 1200 mg.
Undesirable effects can be minimized by using the lowest effective dose for the shortest period of time necessary to control symptoms. If symptoms persist for more than 3 days after starting treatment or worsen, you should consult a doctor.
Elderly patients do not require special dosage.
Patients with mild or moderate renal and hepatic impairment do not require dose adjustment.
Children: Do not use in children under 12 years of age.
Overdose
The use of the drug in children in doses exceeding 400 mg/kg may cause 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 studies, the use of a significant amount of NSAIDs caused only nausea, vomiting, epigastric pain, very rarely diarrhea. Tinnitus, headache, dizziness and gastrointestinal bleeding may also occur. In more severe poisoning, toxic lesions of the central nervous system may occur, which manifest themselves in the form of drowsiness, nystagmus, visual impairment, sometimes - an excited state and disorientation or coma. Sometimes patients experience convulsions. In severe poisoning, hyperkalemia and metabolic acidosis, acute renal failure, liver damage, arterial hypotension, respiratory failure and cyanosis may occur. In patients with bronchial asthma, exacerbation of the course of asthma may occur.
Treatment: Treatment should be symptomatic and supportive, and include maintaining a patent airway and monitoring vital signs until the condition returns to normal. Oral administration of activated charcoal or gastric lavage is recommended within 1 hour of a potentially toxic dose. If ibuprofen has already been absorbed, alkaline agents may be administered to accelerate the excretion of acidic ibuprofen in the urine.
In case of frequent or prolonged seizures, intravenous diazepam or lorazepam should be administered. In case of bronchial asthma, bronchodilators should be used.
Adverse reactions
Clinical trial data suggest that the use of ibuprofen, especially at a high dose of 2400 mg per day, slightly increases the risk of arterial thrombotic complications (e.g. myocardial infarction or stroke).
Adverse reactions to ibuprofen are classified by system organ class and frequency of occurrence: very common: ≥ 1/10; common: ≥ 1/100 -
From the side of the cardiac system.
Not known – heart failure, edema.
From the digestive tract.
Uncommon: abdominal pain, dyspepsia and nausea; rare: diarrhoea, flatulence, constipation and vomiting; very rare: peptic ulcer, perforation or gastrointestinal bleeding, melena, haematemesis, sometimes fatal (especially in elderly patients), ulcerative stomatitis, gastritis, pancreatitis, exacerbation of colitis and Crohn's disease.
From the nervous system.
Uncommon: headache; rare: vertigo; very rare: aseptic meningitis (see below), some symptoms of which (rigidity of the occipital muscles, headache, nausea, vomiting, fever or disorientation) may occur in patients with autoimmune diseases such as systemic lupus erythematosus, mixed connective tissue disease; not known: paraesthesia, drowsiness.
On the part of the kidneys and urinary system.
Very rare: acute renal failure, papillary necrosis, especially in
with prolonged use, associated with increased blood urea levels, and edema, hypernatremia (sodium retention), scanty urination; unknown - renal failure, nephrotoxicity, including interstitial nephritis and nephrotic syndrome.
From the liver.
Very rare - liver dysfunction; unknown - hepatitis and jaundice may occur with prolonged treatment.
From the vascular system.
Very rare: arterial hypertension; unknown: arterial thrombosis (myocardial infarction or stroke).
On the skin and subcutaneous tissue.
Rarely - various skin rashes; very rarely - severe forms of skin reactions, such as Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis; unknown - photosensitivity.
Not known: drug reaction with eosinophilia and systemic symptoms (DRESS syndrome); acute generalized exanthematous pustulosis; photosensitivity reactions.
From the blood and lymphatic system.
Very rare - anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis, which may occur with prolonged treatment, the first signs of which are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe exhaustion, bleeding of unknown origin and bruising.
From the psychological side.
Rarely – mental disorders, depression, insomnia, agitation, hallucinations, confusion.
From the organs of vision.
Unknown - with prolonged treatment, visual impairment and optic neuritis may occur.
From the hearing organs.
Rarely, with prolonged treatment, ringing in the ears and dizziness are possible.
From the immune system.
Rarely - hypersensitivity reactions (see below), including urticaria and pruritus; very rarely - severe hypersensitivity reactions, symptoms of which may include swelling of the face, tongue and larynx, shortness of breath, tachycardia, hypotension, anaphylactic reactions, angioedema, or severe shock; not known - airway reactivity, including bronchial asthma, exacerbation of asthma, bronchospasm.
General violations.
Malaise and fatigue, irritability.
Laboratory studies.
Very rare: decreased hemoglobin level.
Description of selected adverse reactions
Hypersensitivity reactions have been reported following treatment with ibuprofen. These include non-specific allergic reactions and anaphylaxis, respiratory tract reactions including bronchial asthma, exacerbation of asthma, bronchospasm or dyspnoea, various skin disorders including rashes of various types, pruritus, urticaria, purpura, angioedema and, less commonly, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
The mechanism of pathogenesis of drug-induced aseptic meningitis is not fully understood. However, available data on aseptic meningitis associated with NSAIDs suggest a hypersensitivity reaction (due to temporal association with drug intake and resolution of symptoms after drug withdrawal). In particular, isolated cases of symptoms of aseptic meningitis (such as neck stiffness, headache, nausea, vomiting, fever or disorientation) have been reported during treatment with ibuprofen in patients with autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease).
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
12 tablets in a blister, 1 or 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Reckitt Benckiser Healthcare International Limited.
Location of the manufacturer and its business address
Nottingham site, Thane Road, Nottingham, NG90 2DB, United Kingdom.
