Nurofen 12+, 200 mg 12 pcs

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Indications

Active ingredient

Composition

Active substances:

ibuprofen 200 mg in the form of ibuprofen sodium salt.

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

How to take, the dosage

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

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

Persons of advanced age do not require special dosage adjustment except in cases of severe renal or hepatic impairment.

The drug is taken with or after meals, without chewing, with water if necessary.

If the symptoms of the disease persist for more than 3 days or if the drug needs to be used for more than 10 days, it is necessary to see a physician to clarify the diagnosis and to adjust the course of treatment. The duration of treatment is determined by the doctor individually, depending on the course of the disease and the condition of the patient.

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

Interaction

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

Acetylsalicylic acid, as this increases the risk of adverse reactions, unless acetylsalicylic acid (dose no higher than 75 mg/day) has been prescribed by a physician;

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

Experimental evidence suggests that when used concomitantly, ibuprofen may inhibit the effect of low doses of acetylsalicylic acid on platelet aggregation. However, the limited extrapolation of these data to the clinical situation does not allow definitive conclusions that regular long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. With non-systemic use of ibuprofen, such clinically significant effects are considered unlikely.

With caution, ibuprofen should be used in combination with the following drugs.

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

Antihypertensives (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may decrease the therapeutic effect of these drugs.

In some patients with impaired renal function (patients with dehydration or elderly persons with impaired renal function) the simultaneous use of ACE inhibitor or angiotensin II antagonist and COX-inhibiting drugs may lead to further impairment of renal function, including possible ARF, which is usually reversible. These interactions should be considered when a patient simultaneously uses a selective COX-2 inhibitor and ACE inhibitors or angiotensin II antagonists.

Therefore, such combinations should be prescribed with caution, especially in elderly patients. If long-term treatment is necessary, adequate hydration of the patient should be performed and renal function monitoring should be considered at the beginning of the combination treatment and at certain intervals thereafter. Diuretics may increase the risk of renal toxic effects of NSAIDs.

Corticosteroids: increased risk of gastrointestinal ulcers and bleeding.

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

Heart glycosides: NSAIDs may increase cardiac dysfunction, decrease renal glomerular filtration function, and increase plasma levels of glycosides.

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

Methotrexate: There is potential to increase plasma levels of methotrexate.

Cyclosporine: increased risk of nephrotoxicity.

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

Tacrolimus: There may be an increased risk of nephrotoxicity with concomitant use of NSAIDs and tacrolimus.

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

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

Sulfonylurea drugs and phenytoin: may increase the effect of the drugs.

Special Instructions

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

The effects on the respiratory organs. Bronchospasm may occur in patients with a history of AD or allergic diseases.

Other NSAIDs. Concomitant use of ibuprofen with other NSAIDs, including COX-2 selective inhibitors, increases the risk of adverse reactions, so it should be avoided.

Systemic lupus erythematosus and mixed connective tissue disease. Caution should be used with ibuprofen in manifestations of systemic lupus erythematosus and mixed connective tissue disease because of the increased risk of aseptic meningitis.

The effect on the kidneys. Prolonged use of NSAIDs may lead to a dose-dependent decrease in prostaglandin synthesis and provoke the development of renal failure. High risk of this reaction is noted in patients with renal dysfunction, cardiac disorders, liver dysfunction, patients who take diuretics, and elderly patients. Renal function should be monitored in these patients.

The effect on the liver. Impaired liver function.

The effect on the cardiovascular and cerebrovascular system. In patients with AH and/or moderate to moderate congestive heart failure history, treatment should be initiated with caution (medical consultation necessary), because cases of fluid retention, AH and edema have been reported during therapy with ibuprofen, as with other NSAIDs.

The clinical trial and epidemiologic data suggest that 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 (e.g., myocardial infarction or stroke). In general, data from epidemiological studies do not suggest that low-dose ibuprofen (e.g., ≤1200 mg/day) is associated with an increased risk of arterial thrombotic complications.

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

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

The effects on the gastrointestinal tract. NSAIDs should be used with caution in patients with chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) because these conditions may worsen. Cases of gastrointestinal bleeding, ulcer perforation, sometimes fatal, have been reported at any stage of NSAID treatment, regardless of the presence of warning symptoms or a history of severe GI disorders.

The risk of gastrointestinal bleeding, ulcer perforation increases with increasing doses of NSAIDs, in patients with a history of ulcers, 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 drugs that increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors or antiplatelet agents (e.g., acetylsalicylic acid). In long-term treatment for these patients, and for patients who require concomitant use of low-dose acetylsalicylic acid or other drugs that increase gastrointestinal risk, the physician 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 GI symptoms (predominantly bleeding), especially gastrointestinal bleeding at the start of treatment. In the case of gastrointestinal bleeding or ulceration in patients receiving ibuprofen, treatment should be stopped immediately.

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

The effect on fertility in women. There is limited evidence that drugs that inhibit COX/prostaglandin synthesis can cause impaired fertility in women by affecting ovulation. This effect is reversible when therapy is withdrawn.

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

The use during pregnancy and lactation. Suppression of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Evidence from epidemiological studies indicates an increased risk of miscarriage, congenital heart defects and gastroschisis following the use of prostaglandin synthesis inhibitors early in pregnancy.

The risk is thought to increase with increasing dose and duration of therapy. The use of ibuprofen during the first and second trimesters of pregnancy should be avoided unless the potential benefit to the patient exceeds 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.

In the third trimester of pregnancy, fetal effects such as cardiopulmonary toxicity (premature closure of the fetal arterial duct with pulmonary hypertension) and impaired renal function, which may progress to renal failure with manifestation of oligohydramnios, are possible when any prostaglandin synthesis inhibitors are used.

Ibuprofen is contraindicated in the third trimester of pregnancy because of the possibility of inhibition of uterine contractile function, which may lead to increased duration of labor with possible increased bleeding time for mother and child, even when very low doses are used.

In limited studies, ibuprofen was detected in breast milk at very low concentrations. It is unlikely to have an adverse effect on a breastfed infant. NSAIDs are not recommended for use while breastfeeding.

Children. The drug is used in children aged 12 years and older.

The ability to affect reaction time when driving vehicles and other mechanisms. No effect of the drug on the ability to drive or operate vehicles or other machinery is expected if the recommendations regarding the dosage and duration of treatment are followed.

But patients who experience dizziness, drowsiness, disorientation or visual disturbances while taking NSAIDs should avoid driving or operating machinery.

Contraindications

Side effects

Adverse reactions associated with the use of ibuprofen are classified by organ system and frequency. Frequency is defined as follows: 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 (< 1/10 000), frequency unknown (cannot estimate frequency from available data). In each frequency group, adverse reactions are presented by decreasing severity.

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

With the blood and lymphatic system: very rare – disorders of hematopoiesis1.

Intrinsic system disorders: infrequent hypersensitivity reactions accompanied by urticaria and pruritus2; very rare – severe hypersensitivity reactions, symptoms of which may include swelling of the face, tongue and throat, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe shock)2.

Nervous system disorders: infrequent – headache; very rare – aseptic meningitis3; frequency unknown – paresthesias, somnolence.

Cardiovascular system: frequency unknown – heart failure, edema4.

Vascular system: incidence unknown – AH4.

Respiratory and mediastinal disorders: incidence unknown – airway reactivity, including AD, bronchospasm or dyspnea2.

Gastrointestinal tract disorders: Infrequent – abdominal pain, nausea, dyspepsia5; rare – diarrhea, flatulence, constipation, vomiting; very rare – gastric and duodenal ulcer, gastrointestinal perforation or gastrointestinal bleeding, melena, bloody vomiting, sometimes fatal, ulcerative stomatitis, gastritis; frequency unknown – worsening colitis and Crohn’s disease6.

Hepatic disorders: very rare – impaired liver function; frequency unknown – hepatitis and jaundice may occur with prolonged treatment.

Skin and subcutaneous tissue disorders: infrequent – skin rash2; very rare – bullous reactions including Stevens-Johnson syndrome, polymorphic erythema and toxic epidermal necrolysis2; frequency unknown – photosensitivity.

Renal and urinary system disorders: very rare – acute renal dysfunction7; frequency unknown – renal failure, nephrotoxicity, including interstitial nephritis and nephrotic syndrome.

Psychiatric disorders: frequency unknown – only with long-term use: depression, hallucinations, confusion.

Visual organs: frequency is unknown – with prolonged treatment may cause visual impairment, optic neuritis.

Hearing organ: frequency is unknown – tinnitus and dizziness may occur with long-term treatment.

Laboratory tests: very rare – decrease in hemoglobin levels.

Notes.

1 Include anemia, leukopenia, thrombocytopenia, pancytopenia, and agranulocytosis. The first signs of these disorders are fever, sore throat, superficial mouth sores, flu-like symptoms, severe exhaustion, bleeding, and hematomas of unknown etiology.

2 Hypersensitivity reactions may include: nonspecific allergic reactions and anaphylaxis; respiratory reactivity, including AD, exacerbation of AD, bronchospasm and shortness of breath; or various forms of skin reactions, including itching, urticaria, purpura, angioneurotic edema and, less frequently, exfoliative and bullous dermatosis, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme.

3 The pathogenic mechanism of drug-induced aseptic meningitis is unclear. The available data on aseptic meningitis associated with NSAID ingestion suggest a hypersensitivity reaction (given the temporary association with drug ingestion and disappearance of symptoms after drug withdrawal).

In patients with autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disease) there have been isolated cases of symptoms of aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever and loss of consciousness).

4 Clinical trial data and epidemiologic data suggest that ibuprofen use (especially in high doses of 2400 mg/day) and with long-term treatment may be associated with a slightly increased risk of arterial thrombotic complications (e.g., myocardial infarction or stroke).

5 Gastrointestinal adverse reactions developed most frequently.

6 See SPECIAL NOTES.

7 Especially when prolonged use of NSAIDs is combined with increased plasma urea levels and the appearance of edema. Also includes papillonecrosis.

Overdose

The use of the drug in children in a dose above 400 mg/kg body weight may lead to symptoms of intoxication. The dose effect is less pronounced in adults. T½ in overdose is 1.5-3 hours.

The symptoms of intoxication. Nausea, vomiting, pain in epigastric region, very rarely – diarrhea. Tinnitus, headache and gastrointestinal bleeding may occur. At more severe poisoning toxic CNS lesions may occur, manifesting as vertigo, somnolence, and sometimes – agitation, disorientation or coma.

Sometimes seizures were noted in patients. In severe poisoning, hyperkalemia and metabolic acidosis, increased prothrombin time/international normalized ratio may occur (probably due to interaction with clotting factors circulating in the bloodstream). OPN, liver damage, arterial hypotension, respiratory depression and cyanosis may occur. In patients with AD, exacerbation of AD is possible.

Treatment. Treatment should be symptomatic and supportive, and should include ensuring airway patency and monitoring cardiac function and basic vital signs until the patient’s condition normalizes.

The oral administration of activated charcoal within 1 h of a potentially toxic dose of the drug is recommended. In frequent or prolonged muscle spasms, treatment should be by administration of diazepam or lorazepam. In case of AD, bronchodilators should be used.

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