Instructions Nurofen film-coated tablets 200 mg blister No. 24
Composition
active ingredient: ibuprofen;
1 film-coated tablet contains 200 mg of ibuprofen;
excipients: croscarmellose sodium, sodium lauryl sulfate, sodium citrate, stearic acid, colloidal anhydrous silicon dioxide, sodium carmellose, talc, acacia, sucrose, titanium dioxide (E 171), macrogol 6000, printing ink (shellac, black iron oxide (E 172), propylene glycol (E 1520).
Dosage form
Film-coated tablets.
Main physicochemical properties: white or almost white biconvex tablets in a sugar shell with an identifying black 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, that has demonstrated efficacy by inhibiting prostaglandin synthesis. In humans, ibuprofen reduces inflammatory pain, swelling, and fever. In addition, ibuprofen reversibly inhibits platelet aggregation.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose aspirin (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 or within 30 minutes after immediate-release aspirin (81 mg) have been shown to 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. Such a clinically significant effect is considered unlikely with non-systematic use of ibuprofen.
Nurofen® relieves pain, reduces inflammation and lowers fever.
Pharmacokinetics
Ibuprofen is rapidly absorbed after administration and is rapidly distributed throughout the body. Excretion is rapid and complete and occurs via the kidneys.
Maximum plasma concentrations are reached 45 minutes after oral administration in the fasted state. When administered with food, peak levels are observed after 1-2 hours. This time may vary for different dosage forms.
The half-life is approximately 2 hours.
In limited studies, ibuprofen has been found in breast milk at very low concentrations.
Indication
Symptomatic treatment of headache and toothache, menstrual pain, neuralgia, back pain, joint pain, muscle pain, rheumatic pain, as well as cold and flu symptoms.
Contraindication
Hypersensitivity to ibuprofen or to any of the excipients of the drug.
History of hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) following the use of aspirin or other NSAIDs.
History of active or recurrent gastric or duodenal ulcer/bleeding (two or more severe episodes of confirmed ulceration or bleeding).
History of gastrointestinal bleeding or perforation associated with the use of NSAIDs.
Severe heart failure (NYHA class IV), severe renal failure or severe hepatic failure.
The last trimester of pregnancy.
Active inflammatory bowel disease.
Hemorrhagic diathesis or other blood clotting disorders.
Interaction with other medicinal products and other types of interactions
In general, caution should be exercised when using NSAIDs in combination with other drugs that may increase the risk of gastrointestinal ulcers, gastrointestinal bleeding, or deterioration of renal function.
Ibuprofen, like other NSAIDs, should not be used in combination with:
- aspirin (acetylsalicylic acid): It is generally not recommended to use ibuprofen simultaneously with acetylsalicylic acid due to the potential for increased adverse reactions, except when aspirin is used in low doses (not higher than
75 mg per day) was prescribed by a doctor.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose aspirin (acetylsalicylic acid) on platelet aggregation when used concomitantly. 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.
- other NSAIDs, including selective cyclooxygenase-2 inhibitors: the simultaneous use of two or more NSAIDs should be avoided as this may increase the risk of adverse reactions.
- corticosteroids: increased risk of ulcers or bleeding in the gastrointestinal tract;
- Antihypertensives and diuretics: NSAIDs may reduce the effect of these drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with compromised renal function), concomitant use of an ACE inhibitor or angiotensin II antagonist and drugs that inhibit cyclooxygenase may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients receiving coxibs concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, such combinations should be used with caution, especially in the elderly. If treatment is necessary, ensure that the patient is adequately hydrated and consider the need to monitor renal function at the beginning of combination therapy and periodically thereafter. Diuretics may increase the risk of nephrotoxicity of NSAIDs;
- anticoagulants: NSAIDs may enhance the effect of anticoagulants such as warfarin;
- antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding;
- cardiac glycosides: NSAIDs can exacerbate cardiac dysfunction, reduce glomerular filtration function of the kidneys and increase the level of glycosides in the blood plasma;
- 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;
- cyclosporine: increased risk of nephrotoxicity;
- mifepristone: NSAIDs should not be used earlier than 8-12 days after mifepristone administration, as NSAIDs may reduce the effectiveness of mifepristone;
- tacrolimus: possible increased risk of nephrotoxicity with simultaneous use of NSAIDs and tacrolimus;
- zidovudine: 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;
- Quinolone antibiotics: Animal data suggest that NSAIDs may increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolone antibiotics concomitantly may be at increased risk of convulsions.
Application features
Undesirable effects can be minimized by using the lowest effective dose necessary to relieve symptoms for the shortest period of time.
Elderly people have an increased incidence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.
Effects on the respiratory system.
Bronchospasm may occur in patients who suffer from bronchial asthma or allergic diseases, or have a history of these diseases.
Other NSAIDs.
The concomitant use of ibuprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
Systemic lupus erythematosus and mixed connective tissue disease.
Ibuprofen should be used with caution in patients with systemic lupus erythematosus and mixed connective tissue disease due to an increased risk of aseptic meningitis.
Cases of aseptic meningitis have been reported with ibuprofen. Although this effect is more likely in patients with systemic lupus erythematosus and other connective tissue diseases, such cases have also been reported in some patients without chronic diseases, so this should be taken into account when using this drug.
Effects on the cardiovascular and cerebrovascular systems.
Patients with a history of hypertension and/or heart failure should be treated with caution (consultation with a doctor or pharmacist is necessary), as cases of fluid retention, hypertension and edema have been reported in association with NSAID therapy.
Clinical trial data suggest that the use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Overall, epidemiological data do not suggest that low-dose ibuprofen (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), established 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 picture should also be carefully assessed before starting 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 per day) are required.
Caution should be exercised in patients with renal insufficiency due to the possibility of worsening of renal function. Ibuprofen should be used with caution in patients with renal or hepatic disease, and especially during concomitant therapy with diuretics, since prostaglandin inhibition may lead to fluid retention and further deterioration of renal function. In such patients, the lowest possible dose of ibuprofen should be used and renal function should be monitored regularly. In case of dehydration, adequate fluid intake should be ensured. There is a risk of renal insufficiency in children (from 6 years of age) and adolescents with dehydration.
In general, the systematic use of analgesics, especially combinations of different analgesics, can lead to long-term kidney damage with the risk of renal failure (analgesic nephropathy). The highest risk of this reaction exists in elderly patients, patients with renal failure, heart failure and liver failure, as well as in those receiving diuretics or ACE inhibitors. After discontinuation of NSAID therapy, a return to the state observed before treatment is usually achieved.
As with other NSAIDs, ibuprofen may cause a small, transient increase in certain liver function tests, as well as a significant increase in AST and ALT levels. In the event of a significant increase in these values, treatment should be discontinued.
With prolonged use of ibuprofen, liver function tests, kidney function, and hematological function/blood count should be checked regularly.
Impact on fertility in women.
There is limited evidence that medicinal products that inhibit cyclooxygenase/prostaglandin synthesis may impair female fertility by affecting ovulation. This process is reversible upon discontinuation of treatment.
Effect on the gastrointestinal tract.
NSAIDs should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), as these conditions may be exacerbated.
Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported at any time during treatment with all NSAIDs, regardless of the presence of warning symptoms or a previous history of gastrointestinal disorders.
The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing doses of NSAIDs, in patients with a history of ulcer, especially complicated by bleeding or perforation, and in the elderly. Such patients should start treatment with the lowest available dose. In these patients, as well as in patients who require concomitant use of low doses of acetylsalicylic acid or other drugs that may increase the risk from the gastrointestinal tract, combination therapy with protective drugs (e.g. misoprostol or proton pump inhibitors) is recommended.
Patients with a history of gastrointestinal toxicity, especially elderly patients, should be reported for any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly at the beginning of treatment.
Prolonged use of any painkiller for headache may worsen this condition. In such cases, a doctor should be consulted and treatment should be discontinued. The possibility of medication overuse headache should be considered in patients who suffer from frequent or daily headaches despite (or because of) regular use of headache medications.
Caution should be exercised when treating patients receiving concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors or antiplatelet agents (e.g. aspirin).
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, it cannot be excluded that NSAIDs may worsen these infections, so it is recommended to avoid the use of Nurofen® in case of chickenpox.
Nurofen® 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® is used for fever or to relieve pain in an infection, monitoring for the infectious disease is recommended. In outpatient settings, the patient should seek medical advice if symptoms persist or worsen.
Recommendations for patients with sugar malabsorption
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Recommendations for patients on a controlled sodium diet
This medicinal product contains 1.1 mmol (or 25.3 mg) sodium per 2 doses (2 tablets). This should be taken into consideration by patients on a controlled sodium diet.
Use during pregnancy or breastfeeding
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonal/fetal development. Epidemiological data suggest an increased risk of miscarriage, congenital heart defects and gastroschisis following the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to approximately 1.5%. The risk is believed to increase with increasing dose and duration of therapy.
In animals, the use of prostaglandin synthesis inhibitors has resulted in an increase in the incidence of pre- and post-implantation loss and embryo/fetal lethality. In addition, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals treated with prostaglandin synthesis inhibitors during the period of organogenesis.
From the 20th week of pregnancy, ibuprofen may cause oligohydramnios due to fetal renal dysfunction. This may occur shortly after initiation of treatment and is usually reversible after discontinuation of treatment. In addition, there have been reports of narrowing of the ductus arteriosus following treatment in the second trimester of pregnancy, most of which resolved after discontinuation of treatment. Therefore, ibuprofen should not be given during the first and second trimesters of pregnancy unless clearly necessary. If ibuprofen is used by a woman attempting to conceive or during the first and second trimesters of pregnancy, the dose should be kept as low and the duration of treatment as short as possible. Antenatal monitoring for oligohydramnios and narrowing of the ductus arteriosus should be considered after exposure to ibuprofen for several days from the 20th week of gestation. Nurofen® should be discontinued if oligohydramnios or narrowing of the ductus arteriosus is detected.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may pose risks:
Risks to the fetus:
– cardiopulmonary toxicity (premature narrowing/closure of the ductus arteriosus and pulmonary hypertension);
– renal dysfunction (see above);
Risks for the mother at the end of pregnancy and for the newborn:
– possible prolongation of bleeding time, anti-aggregation effect, which can occur 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 (see Contraindications section).
In limited studies, ibuprofen has been found in breast milk at very low concentrations, so it is unlikely that it would have any adverse effects on 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 is not expected to affect the reaction speed when driving vehicles or other mechanisms.
Method of administration and doses
For internal use. For short-term use only.
The tablets should be swallowed with water, not chewed. During short-term use, if symptoms persist or worsen, the patient should consult a doctor.
Undesirable effects can be minimized by using the lowest effective dose for the shortest period of time necessary to control symptoms.
The lowest effective dose should be used for the shortest time necessary to relieve symptoms (see section "Special instructions for use"). If symptoms persist for more than 5 days after starting treatment or worsen, you should consult a doctor.
The drug is prescribed to adults and children weighing more than 20 kg (age - approximately 6 years). The recommended daily dose of the drug is 20-30 mg/kg body weight. Do not exceed the dose of 30 mg/kg body weight per day.
Adults and children weighing more than 30 kg: 200-400 mg (1-2 tablets) per dose. Repeat dose if necessary after 4-6 hours. Do not exceed 1200 mg (6 tablets) per day.
Elderly people do not require special dosage.
Children
Do not use in children weighing less than 20 kg and under 6 years of age.
Overdose
Most cases of overdose reported were asymptomatic. The risk of symptoms occurs at doses of ibuprofen above 80-100 mg/kg. The use of the drug in children at a dose of more than 400 mg/kg may cause symptoms of intoxication. In adults, the dose effect is less pronounced. The half-life in overdose is 1.5-3 hours.
Symptoms. Symptoms of overdose occur within 4 hours of administration. In most patients, the use of clinically significant amounts of NSAIDs has caused symptoms of mild overdose, including nausea, vomiting, epigastric pain or, less commonly, diarrhea. Tinnitus, headache and gastrointestinal bleeding may also occur. In more severe poisoning, toxic lesions of the central nervous system are possible, in the form of vertigo, dizziness, lethargy, drowsiness, sometimes - an excited state, ataxia, disorientation or coma. Sometimes patients develop convulsions. In severe poisoning, hyperkalemia, metabolic acidosis and an increase in prothrombin time/INR (probably due to interaction with blood clotting factors circulating in the bloodstream) may occur. In rare cases, moderate to severe symptoms such as acute renal failure, liver damage, hypotension, hypothermia, cyanosis, dyspnea/acute respiratory distress syndrome and short-term episodes of apnea (in children after administration of large amounts of the drug) have been observed. In patients with bronchial asthma, exacerbation of asthma is possible. Nystagmus, visual impairment and loss of consciousness are possible.
Treatment. There is no specific antidote. Treatment should be symptomatic and supportive, and include maintaining a patent airway and monitoring cardiac and vital signs until the condition returns to normal. When small amounts of the drug are used (less than 50 mg/kg ibuprofen), water is recommended to minimize gastrointestinal disturbances. When larger amounts are used, oral administration of activated charcoal or gastric lavage is recommended if no more than 1 hour has passed since the patient took a potentially toxic dose of the drug and the patient has not taken a life-threatening amount of the drug. If ibuprofen has already been absorbed, alkaline agents can be used to promote the excretion of acidic ibuprofen in the urine. The benefit of measures such as forced diuresis, hemodialysis and hemoperfusion has not been proven, since ibuprofen is highly bound to plasma proteins. In case of frequent or prolonged seizures, treatment should be carried out with intravenous diazepam or lorazepam. In case of bronchial asthma, bronchodilators should be used. You should consult a doctor for medical advice.
Adverse reactions
Adverse reactions that have occurred with ibuprofen are listed below by system organ class and frequency. The frequency of adverse reactions is defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
The following list of adverse reactions refers to those observed with ibuprofen in non-prescription doses during short-term use. When treating chronic conditions, additional side effects may occur with long-term treatment.
The most frequently observed adverse reactions were gastrointestinal. Most adverse reactions are dose-dependent, in particular the risk of gastrointestinal bleeding depends on the dose and duration of treatment.
From the blood and lymphatic system:
very rare: blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe exhaustion, unexplained bleeding and hematomas of unknown etiology.
On the part of the immune system:
Hypersensitivity reactions1; uncommon: urticaria and pruritus; very rare: severe hypersensitivity reactions, symptoms of which may include swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylactic reaction, angioedema or severe shock); frequency unknown: airway reactivity including bronchial asthma, exacerbation of asthma, bronchospasm or dyspnoea.
From the nervous system:
uncommon: headache; very rare: aseptic meningitis2
From the side of the cardiovascular system:
Clinical trial data and epidemiological data suggest that the use of ibuprofen, especially at high doses of 2400 mg per day and with long-term treatment, may be associated with a slightly increased risk of arterial thrombotic complications (e.g. myocardial infarction or stroke).
From the vascular system:
frequency unknown: arterial hypertension.
From the digestive system:
Infrequent: abdominal pain, nausea, dyspepsia; Rare: diarrhea, flatulence, constipation and vomiting; Very rare: gastric and duodenal ulcers, perforations or gastrointestinal bleeding, melena, haematemesis, sometimes fatal (especially in elderly patients), ulcerative stomatitis, gastritis;
frequency unknown: exacerbation of colitis and Crohn's disease.
On the part of the liver:
very rare: liver dysfunction.
Skin and subcutaneous tissue disorders:
uncommon: various skin rashes; very rare: severe forms of skin reactions such as bullous reactions, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis, may occur.
Not known: drug reaction with eosinophilia and systemic symptoms (DRESS syndrome); acute generalized exanthematous pustulosis; photosensitivity reactions.
From the respiratory tract and mediastinal organs:
frequency unknown: airway reactivity, including asthma, bronchospasm, or dyspnea.
From the kidneys and urinary system:
very rare: acute renal failure, papillonecrosis, especially with prolonged use, associated with increased serum urea levels, and edema; frequency unknown: renal failure.
Laboratory studies:
very rare: decreased hemoglobin level.
Description of selected adverse reactions
1 Hypersensitivity reactions have been reported following treatment with ibuprofen. These reactions include (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactions including bronchial asthma, exacerbation of asthma, bronchospasm or dyspnoea, or (c) 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).
2 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 relationship to 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 observed during treatment with ibuprofen in patients with pre-existing autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease).
Expiration date
3 years.
Storage conditions
Store out of the reach of children at a temperature not exceeding 25 °C.
Packaging
6, 8 or 12 tablets in a blister; 1 blister of 6 tablets, 1 blister of 8 tablets, 1 or 2 blisters of 12 tablets in a cardboard box.
Vacation category
Without a prescription.
Producer
Reckitt Benckiser Healthcare International Limited.
Location of the manufacturer and its business address
Tain Road, Nottingham, Nottinghamshire, NG90 2DB, United Kingdom.
