Nurofen 12+ pills 200mg, 12pcs

Composition

Active ingredients:

ibuprofen 200 mg in the form of ibuprofen sodium salt.

Excipients: sodium croscarmellose, xylitol (E 967), microcrystalline cellulose, magnesium stearate, colloidal anhydrous silicon dioxide, sodium carmellose, talc, acacia, sucrose, titanium dioxide (E 171), macrogol 6000, printing ink.

Pharmacological action

Pharmacodynamics .

Ibuprofen is an NSAID whose action is associated with slowing the synthesis of prostaglandins. Ibuprofen has analgesic, antipyretic and anti-inflammatory effects. It is clinically proven that in the treatment of pain, ibuprofen tablets in the form of ibuprofen sodium salt begin to act much faster compared to ibuprofen in the form of acid. When using ibuprofen at a dose of 400 mg, pain relief lasts up to 8 hours. During a study on the treatment of toothache, a significant reduction in the severity of pain was felt after 15 minutes after using 2 tablets of Nurofen 12+ compared to placebo. In this study, significantly more patients experienced a significant reduction in the severity of pain after using 2 tablets of Nurofen 12+ compared to using 2 tablets of paracetamol 500 mg. These patients also showed a significant reduction in pain intensity and a significant reduction in pain severity within 6 hours compared to the use of paracetamol.

Experimental evidence suggests that ibuprofen can competitively inhibit the effect of a low dose of acetylsalicylic acid on platelet aggregation when these drugs are co-administered. Some pharmacodynamic studies show that when single doses of ibuprofen 400 mg were administered within 8 hours before or within 30 minutes after the use of immediate-release acetylsalicylic acid (81 mg), a decrease in the effect of acetylsalicylic acid on thromboxane formation or platelet aggregation was observed. Although there is uncertainty about the extrapolation of these data to the clinical situation, the possibility that regular long-term use of ibuprofen may reduce the cardioprotective effect of low doses of acetylsalicylic acid cannot be excluded. When ibuprofen is used unsystematically, such a clinically significant effect is considered unlikely.

Pharmacokinetics. When administered orally, ibuprofen is rapidly absorbed in the digestive tract and reaches Cmax in blood plasma after 45 minutes when used on an empty stomach. After using ibuprofen with a meal, Cmax in blood plasma is determined after 1-2 hours. The half-life of ibuprofen is almost 2 hours.

At the same time, after using Nurofen 12+ tablets, Cmax in blood plasma is reached 35 minutes after using the drug on an empty stomach.

Ibuprofen actively (90%) binds to plasma proteins, slowly penetrates into the synovial cavities, where its concentration may remain high, while the concentration in the blood plasma decreases.

Ibuprofen is metabolized in the liver. Ibuprofen is rapidly and completely eliminated from the body. More than 90% of the dose is excreted by the kidneys in the form of metabolites and their compounds.

It should be borne in mind that the bioavailability of ibuprofen sodium salt is significantly higher and the effect occurs 2 times faster than when using conventional ibuprofen tablets.

There are no differences in pharmacokinetics depending on the patient’s age.

Indications

• Symptomatic treatment of mild to moderate pain, in particular headache, migraine, back pain, neuralgia, muscle pain, rheumatic pain, menstrual pain, toothache.
• symptomatic treatment of cold, flu, and fever symptoms.

Contraindications

Side effects

Ibuprofen-related adverse reactions are classified by organ system and frequency. Frequency is defined as: very common (≥1/10); common (≥1/100 and <1/10); infrequent (≥1/1000 and <1/100); rare (≥1/10,000 and <1/1000); very rare ( In each group, the frequency of adverse reactions is represented by a decrease in severity.

Data from clinical studies suggest that the use of ibuprofen, especially at a high dose (2400 mg / day), may be associated with an increased risk of arterial thrombotic complications (for example, myocardial infarction or stroke).

From the blood and lymphatic system: very rarely-hematopoietic disorder 1.

From the immune system: infrequently-hypersensitivity reactions accompanied by urticaria and pruritus 2; very rarely-severe hypersensitivity reactions, symptoms of which may include swelling of the face, tongue and larynx, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe shock)2.

From the nervous system: infrequently-headache; very rarely-aseptic meningitis 3; frequency unknown-paresthesia, drowsiness.

From the cardiovascular system: frequency unknown-heart failure, edema 4.

From the vascular system: frequency unknown-hypertension 4.

Respiratory and mediastinal disorders: frequency unknown – respiratory reactivity, including asthma, bronchospasm or dyspnea 2.

From the digestive tract: often — abdominal pain, nausea, dyspepsia 5; rarely — diarrhea, flatulence, constipation, vomiting; rarely — stomach ulcer and duodenal ulcer, gastrointestinal perforation or gastrointestinal bleeding, melena, hematemesis, sometimes fatal, ulcerative stomatitis, gastritis; the frequency is unknown — the exacerbation of colitis and Crohn’s disease 6.

From the liver: very rarely — impaired liver function; frequency unknown-with prolonged treatment, hepatitis and jaundice may occur.

From the skin and subcutaneous tissue: infrequently-skin rash 2; very rarely-bullous reactions, including Stevens-Johnson syndrome, erythema polymorphic and toxic epidermal necrolysis 2; frequency unknown-photosensitivity.

From the side of the kidneys and urinary system: very rarely-acute renal dysfunction 7; frequency unknown-renal failure, nephrotoxicity, including interstitial nephritis and nephrotic syndrome.

From the side of the psyche: frequency unknown – only with prolonged use: depression, hallucinations, confusion.

From the side of the organ of vision: the frequency is unknown — with long-term treatment, visual disturbances and optic neuritis may occur.

On the part of the organ of hearing: the frequency is unknown — with prolonged treatment, tinnitus and dizziness are possible.

Laboratory tests: very rarely — a decrease in the level of hemoglobin.

Notes.

1 Include anemia, leukopenia, thrombocytopenia, pancytopenia, and agranulocytosis. The first signs of such disorders are fever, sore throat, superficial ulcers in the oral cavity, flu-like symptoms, severe exhaustion, bleeding and hematomas of unknown etiology.

2 To hypersensitivity reactions may concern: non-specific allergic reactions and anaphylaxis; reactivity of the Airways, including ASTHMA, exacerbation of ASTHMA, bronchospasm and shortness of breath, or various forms of skin reactions, including pruritus, urticaria, purpura, angioedema and more rarely exfoliative and bullous dermatosis, including toxic epidermal necrolysis, and Stevens — Johnson syndrome and erythema multiforme.

3 The pathogenic mechanism of drug-induced aseptic meningitis has not been elucidated. Available data on aseptic meningitis associated with NSAID use indicate a hypersensitivity reaction (given the temporary association with taking the drug and the disappearance of symptoms after discontinuation of the drug). Patients with autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disease) have had isolated cases of aseptic meningitis symptoms (occipital muscle rigidity, headache, nausea, vomiting, fever, and loss of consciousness).

4 Clinical studies and epidemiological data suggest that the use of ibuprofen (especially at high doses of 2400 mg / day) and long-term treatment may be associated with a slightly increased risk of arterial thrombotic complications (for example, myocardial infarction or stroke).

5 Gastrointestinal side effects were most common.

6 See SPECIAL INSTRUCTIONS.

7 Especially with prolonged use of NSAIDs in combination with increased urea levels in blood plasma and the appearance of edema. It also includes papillonecrosis.

Interaction

Ibuprofen, like other NSAIDs, should not be used in combination with:

acetylsalicylic acid, as this increases the risk of adverse reactions, except when acetylsalicylic acid (dose not exceeding 75 mg/day) was prescribed by a doctor;

other NSAIDs, including selective COX-2 inhibitors: the simultaneous use of two or more NSAIDs should be avoided, as this increases the risk of adverse reactions.

Experimental evidence suggests that ibuprofen may inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when used concomitantly. However, limitations in extrapolating these data to the clinical situation do not allow us to draw definitive conclusions that regular long-term use of ibuprofen can reduce the cardioprotective effect of low doses of acetylsalicylic acid. When ibuprofen is used unsystematically, such clinically significant effects are considered unlikely.

Ibuprofen should be used with caution in combination with the following medications.

Anticoagulants: NSAIDs may increase the effect of anticoagulants such as warfarin.

Antihypertensive agents (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the severity of the therapeutic effect of these drugs. In some patients with impaired renal function (dehydrated patients or elderly patients with impaired renal function), concomitant use of an ACE inhibitor or angiotensin II antagonist and COX-inhibiting drugs may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered when the patient is co-administered with a selective COX-2 inhibitor and ACE inhibitors or angiotensin II antagonists. Therefore, such combinations should be administered with caution, especially in elderly patients. If long-term treatment is necessary, the patient should be adequately hydrated and renal function monitoring should be considered at the beginning of combined treatment, as well as at certain intervals thereafter. Diuretics may increase the risk of toxic effects of NSAIDs on the kidneys.

Corticosteroids: increased risk of ulcers and bleeding in the gastrointestinal tract.

Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.

Cardiac glycosides: NSAIDs may increase cardiac dysfunction, decrease glomerular filtration function of the kidneys, and increase plasma glycosides.

Lithium: There is evidence of a potential increase in plasma lithium levels.

Methotrexate: There is a potential for increased levels of methotrexate in the blood plasma.

Cyclosporine: increased risk of nephrotoxicity.

Mifepristone: NSAIDs should not be used earlier than 8-12 days after mifepristone use, as they may reduce its effectiveness.

Tacrolimus: the risk of nephrotoxicity may increase with concomitant use of NSAIDs and tacrolimus.

Zidovudine: There is a known increased risk of hematological toxicity with concomitant use of zidovudine and NSAIDs. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-infected patients with hemophilia receiving concomitant treatment with zidovudine and ibuprofen.

Quinolone antibiotics: Concomitant use with NSAIDs may increase the risk of seizures.

Preparations of sulfonylureas and phenytoin: it is possible to increase the effect of drugs.

How to take, course of use and dosage

Use orally in adults and children over the age of 12 years. Only for short-term use.

Undesirable effects can be minimized by applying the minimum effective dose for the shortest period necessary to control symptoms.

The minimum effective dose needed to treat symptoms should be used for a short period of time. A single dose for children aged 12 years and adults is 1-2 tablets (200-400 mg of ibuprofen) up to 3 times a day, every 4-6 hours if necessary. The maximum daily dose is 1200 mg (6 tablets per day).

The elderly do not require special dose adjustment, except in cases of severe renal or hepatic insufficiency.

The drug is taken during or after a meal, without chewing, with water if necessary.

If the symptoms of the disease persist for more than 3 days or the drug must be used for more than 10 days, you should consult a doctor to clarify the diagnosis and correct the treatment regimen. The duration of treatment is determined by the doctor individually, depending on the course of the disease and the patient’s condition.

Children: the drug is used in children over the age of 12 years.

Overdose

The use of the drug in children at a dose higher than 400 mg / kg of body weight may lead to symptoms of intoxication. In adults, the dose effect is less pronounced. The half-life of an overdose is 1.5–3 hours.

Symptoms of intoxication. Nausea, vomiting, epigastric pain, very rarely diarrhea. Tinnitus, headache, and gastrointestinal bleeding may occur. With more severe poisoning, toxic lesions of the central nervous system may occur, manifested in the form of vertigo, drowsiness, sometimes-an excited state, disorientation or coma. Convulsions were sometimes reported in patients. In severe poisoning, hyperkalemia and metabolic acidosis may occur, as well as an increase in prothrombin time/international normalized ratio (probably due to interaction with blood clotting factors circulating in the bloodstream). Acute renal failure, liver damage, hypotension, respiratory depression, and cyanosis may occur. Patients with BA may have an exacerbation of BA.

Treatment. Treatment should be symptomatic and supportive, as well as include ensuring airway patency and monitoring of cardiac function and basic vital signs until the patient’s condition returns to normal. Oral use of activated carbon is recommended within 1 hour after a potentially toxic dose of the drug is administered. In case of frequent or prolonged muscle spasms, treatment should be carried out by use of diazepam or lorazepam. In the case of asthma, bronchodilators should be used.

Special instructions

Side effects that occur after the use of ibuprofen and the entire group of NSAIDs in general can be reduced by applying the minimum effective dose necessary to treat symptoms for a short period of time.

Effects on the respiratory system. Bronchospasm may occur in patients with asthma or a history of allergic diseases.

Other NSAIDs. Concomitant use of ibuprofen with other NSAIDs, including selective COX-2 inhibitors, increases the risk of adverse reactions and should therefore 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 the increased risk of aseptic meningitis.

Effect on the kidneys. Long-term use of NSAIDs can lead to a dose-dependent decrease in prostaglandin synthesis and provoke the development of renal failure. A high risk of this reaction is noted in patients with impaired renal function, cardiac disorders, impaired liver function, patients who take diuretics, and elderly patients. Renal function should be monitored in these patients.

Effect on the liver. Impaired liver function.

Effects on the cardiovascular and cerebrovascular systems. Patients with hypertension and/or a history of moderate to moderate congestive heart failure should start treatment with caution (consult a doctor), as cases of fluid retention, hypertension, and edema have been reported during ibuprofen therapy, as with other NSAIDs.

Clinical trial data and epidemiological data suggest that the use of ibuprofen, especially in high doses (2400 mg / day), as well as long-term treatment may be associated with an increased risk of arterial thrombotic complications (for example, myocardial infarction or stroke). In general, epidemiological data do not suggest that a low dose of ibuprofen (e. g. < 1200 mg/day) is associated with an increased risk of arterial thrombotic complications.

Patients with uncontrolled hypertension, congestive heart failure (NYHA class II–III), CHD, peripheral artery disease, and/or cerebrovascular disease should be treated with ibuprofen only after careful assessment of the clinical picture. High doses (2400 mg/day) should be avoided.

Patients with risk factors for cardiovascular events (such as hypertension, hyperlipidemia, diabetes mellitus, smoking) should be prescribed long-term NSAID treatment, especially if high doses of ibuprofen (2400 mg / day) are required, only after careful analysis.

Effect on the gastrointestinal tract. NSAIDs should be used with caution in patients with chronic inflammatory bowel diseases (ulcerative colitis, Crohn’s disease), as these conditions may worsen. Gastrointestinal bleeding and ulceration, sometimes fatal, have been reported at any stage of NSAID treatment, regardless of the presence of warning symptoms or a history of severe gastrointestinal disorders.

The risk of gastrointestinal bleeding, ulceration increases with increasing doses of NSAIDs, in patients with a history of ulceration, especially if it is 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 ulceration or bleeding, such as oral corticosteroids, anticoagulants (such as warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents (such as acetylsalicylic acid). In long-term treatment for these patients, as well as for patients who require concomitant use of low doses of acetylsalicylic acid or other medications that increase the risk for the gastrointestinal tract, the doctor should consider the feasibility of combined therapy with misoprostol or proton pump inhibitors.

Patients with a history of gastrointestinal disorders, especially the elderly, should report any unusual gastrointestinal symptoms (mainly bleeding), especially gastrointestinal bleeding at the beginning of treatment. If gastrointestinal bleeding or ulceration occurs in patients receiving ibuprofen, treatment should be discontinued immediately.

Effects on the skin and subcutaneous tissue. Very rarely, severe skin reactions may occur with NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. The highest risk of such reactions is observed in the early stages of therapy, in most cases the onset of such reactions occurs during the first month of treatment. Ibuprofen should be discontinued at the first sign of skin rash, abnormal changes in the mucous membranes, or any other signs of hypersensitivity.

Effects on female fertility. There is limited evidence that drugs that inhibit COX/prostaglandin synthesis can cause poor fertility in women by affecting ovulation. This effect is reversible upon discontinuation of therapy.

Each tablet contains about 24.3 mg (1.06 mmol) of sodium, which should be considered when prescribing the drug to patients who are indicated for a low-sodium diet.

Use during pregnancy and lactation. Inhibition of prostaglandin synthesis can negatively affect pregnancy and/or embryo / fetal development. Epidemiological data indicate an increased risk of miscarriage, congenital heart defects, and gastroschisis after the use of prostaglandin synthesis inhibitors in early pregnancy. It is believed that the risk increases with increasing dose and duration of therapy. Ibuprofen should be avoided during the first and second trimesters of pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. If ibuprofen is used by a woman who is trying to become pregnant, or during the first or second trimester of pregnancy, the minimum effective dose should be used for as short a period of time as possible.

During the third trimester of pregnancy, when using any prostaglandin synthesis inhibitors, such effects on the fetus as cardiopulmonary toxicity (premature closure of the arterial duct of the fetus with pulmonary hypertension) and impaired renal function, which can progress to renal failure with the manifestation of oligohydramnion, are possible. Ibuprofen is contraindicated in the third trimester of pregnancy due to the possibility of inhibition of contractile function of the uterus, which can lead to an increase in the duration of labor with a possible increase in bleeding time in the mother and child, even with very low doses.

During limited studies, ibuprofen was detected in breast milk in very low concentrations. It is unlikely that this will negatively affect the breastfed infant. NSAIDs are not recommended for use during breast-feeding.

Children. The drug is used in children aged from 12 years.

Ability to influence the reaction rate when driving vehicles and other mechanisms. If the recommendations regarding dosage and duration of treatment are followed, the effect of the drug on the ability to drive vehicles or other mechanisms is not expected. However, patients who experience dizziness, drowsiness, disorientation, or visual disturbances while taking NSAIDs should refrain from driving vehicles or working with mechanisms.

Active ingredient

Ibuprofen

Dosage form

Tablets