Momentact Analgesico

Ibuprofen.

White or ivory-white granules.
Each pack contains: Ibuprofen (as ibuprofen sodium dihydrate) 400 mg.
Excipients/Inactive Ingredients: Sucrose, potassium hydrocarbonate, orange flavor, potassium acesulfam, aspartame.

Pharmacological group: Other analgesics and antipyretic, anti-inflammatory drugs. ATC Code: M01AE01.
Pharmacology: Pharmacodynamics: Ibuprofen is a non-steroidal anti-inflammatory drug, belonging to the propionic group, derived from aryl carboxylic acid. Ibuprofen has the following properties: Analgesic property, Antipyretic property, Anti-inflammatory property, Property of short-term inhibition of platelet function.
Experimental data suggest that ibuprofen competitively inhibits the effect of low doses of acetylsalicylic acid on platelet aggregation when co-administered. Pharmacodynamic studies show that when single doses of ibuprofen 400 mg were taken within 8 hours before or within 30 minutes after administration of immediate-release acetylsalicylic acid (81 mg), a decrease in the effect acetylsalicylic acid on thromboxane formation or platelet aggregation occurs. Although there are uncertainties regarding the extrapolation of these data to clinical situations, the possibility that regular, long-term ibuprofen use, may reduce the cardioprotective effect of low doses of acetylsalicylic acid cannot be excluded. No clinically relevant effects are considered likely with occasional use of ibuprofen.
Pharmacokinetics: Absorption: Maximum serum concentration is reached approximately 25 minutes after oral administration.
After a single dose, the maximum serum concentrations are proportional to the dose (Cmax between 56.4 = 13.6 ug/ml for the 400 mg dose).
Concomitant food intake does not influence the rate of absorption but delays absorption by about 1 hour, resulting in a lower Cmax (about 50%).
Distribution: The administration of ibuprofen does not give rise to accumulation phenomena. It is 99 percent bound to plasma proteins.
In the synovial fluid, ibuprofen is found with stable concentrations between the second and eighth hour after intake, the synovial Cmax, being approximately equal to one third of the plasma Cmax After taking 400 mg of ibuprofen every 6 hours by breastfeeding women, the amount of ibuprofen found in their milk is less than 1 mg per 24 hours.
Metabolism: Ibuprofen has no enzyme-inducing effect. It is metabolized for 90% in the form of inactive metabolites.
Excretion: The plasma half-life is 1-2 hours. More than 90% of the dose is recovered in the urine in the form of metabolites and conjugates.
Less than 1% is excreted in the urine unchanged.
Special Groups: Elderly: No signs of accumulation or retention in specific compartments were observed in the elderly. A dose modification is therefore not warranted.
Kidney failure: Mild to moderate renal impairment does not appear to prolong plasma elimination half-life. Patients with end stage renal disease should not take ibuprofen as it is likely to increase the risk of systemic accumulation.
Liver failure: There is little evidence of altered plasma pharmacokinetics in mild hepatic impairment. Patients with severe liver disease should not take ibuprofen as it is likely to increase the risk of systemic accumulation.
Children: The pharmacokinetics of ibuprofen in children aged 12 years and over are comparable to those observed in adults.

Symptomatic treatment of painful conditions of mild to moderate intensity and/or febrile states.
Treatment of mild to moderate migraine attack with or without aura.

Method of administration: Oral route.
Pour the contents of the sachet into a glass of water.
Drink immediately after complete dissolution.
Posology: Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Reserved for adults and children over 30 kg (about 11-12 years old).
Pain and/or fever: 1 sachet of ibuprofen 400 mg. If necessary, the dose may be increased but not exceed 1200 mg/day (3 sachets/day).
The interval between 2 doses is 4 hours.
The duration of the drug is no more than 10 days for adults and 3 days for adolescents from 12-18 years old.
Elderly subjects: No dosage adjustment is necessary for elderly patients. However, measures should be taken to limit undesirable effects (see Precautions).
It is best to take the medicine with meals.
The interval between doses is a minimum of 6 hours.
Migraine: 1 sachet of 400 mg as soon as possible from the onset of the migraine attack.
If a patient is not relieved after the first dose, a second dose should not be taken during the same attack. However, the crisis can be treated with another treatment that is not a nonsteroidal anti-inflammatory drug or aspirin.
If a patient has been relieved but the symptoms reappear, a second dose can be taken provided that an interval of at least 8 hours is imperatively observed between two doses.

Doses of 400 mg/kg in children may cause symptoms. In adults, dose-response effects are less pronounced. The half-life of overdose is 1.5-3 hours.
Symptom: The symptoms of overdose usually are: nausea, stomach pain, vomiting (bleeding) and diarrhea (bloody), dizziness, cramps, nystagmus and double vision, headache and tinnitus.
In more severe cases of poisoning, toxicity is seen in the central nervous system, manifested by drowsiness, occasional irritation and disorientation or coma. Sometimes patients have seizures.
In severe cases of poisoning, metabolic acidosis may occur with impaired renal function, hypotension, impaired consciousness, and coma (it is unclear whether impaired renal function is a consequence of intoxication or hypotension). Due to the influence of coagulation factors, prothrombin/INR clotting time may be prolonged. Acute renal failure and liver damage may occur. Paroxysmal asthma attacks can occur in asthmatic patients.
Prolonged use at doses higher than recommended can lead to severe hypokalemia and tubular acidosis. Symptoms may include decreased levels of consciousness and general weakness.
Treatment: Ibuprofen overdose should be treated immediately. There is no specific antidote for ibuprofen. The stomach should be emptied as soon as possible. The patient should be encouraged to vomit if possible. Activated charcoal may be used to reduce the absorption of ibuprofen. Consider charcoal within 1 hour of ingestion of a potentially toxic amount. Gastric lavage and supportive treatment of severe electrolyte disturbances are recommended. If seizures are frequent or prolonged, treatment should include intravenous diazepam or lorazepam. Bronchodilators should be used for asthma.

Ibuprofen is contraindicated in the following cases: Hypersensitivity to ibuprofen or any ingredient of the drug; Women in the last 3 months of pregnancy (see Use in Pregnancy & Lactation); Patients with a history of hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, angioedema, urticaria with other NSAIDs, aspirin); Patients with a history of gastrointestinal bleeding or perforation during previous treatment with NSAIDs; Patients with gastrointestinal haemorrhage, cerebrovascular haemorrhage or other progressive haemorrhage, such as ulcerative colitis; Patients with active peptic ulcer, history of peptic ulcer or recurrent bleeding (2 or more separate bleeding episodes or ulcers); Severe hepatic impairment; Severe kidney failure; Internal hemorrhage; Severe heart failure (NYHA Class IV); Systemic Lupus Erythematosus; Combined with mifamurtide (see Interactions).

Special warnings when using the drug: Concomitant use of ibuprofen with other NSAIDs, including selective cyclooxygenase 2 (COX-2) inhibitors, should be avoided because the risk of adverse effects may be increased.
Undesirable effects may be limited by using the lowest effective dose for the shortest duration necessary to ensure symptom control.
Patients with asthma and chronic rhinitis, chronic sinusitis and/or nasal polyps are at increased risk of allergic reactions when taking NSAIDs and/or aspirin.
The drug may cause asthma attacks, especially in some subjects allergic to NSAIDs or aspirin.
Gastrointestinal effects: Gastrointestinal bleeding, ulceration or perforation may occur at any time during NSAID treatment. These adverse events can be fatal and may occur with or without warning symptoms or a history of serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulceration or perforation is higher in elderly patients or with increasing doses or in patients with complications of bleeding or perforation. Initiation of treatment with the lowest possible dose, combined with gastrointestinal protective agents (e.g. misoprostol or proton pump inhibitors) should be considered in these patients and in patients requiring concomitant low-dose aspirin or other drugs likely to increase the risk of gastrointestinal adverse events.
Patients with a history of gastrointestinal disease, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) early in treatment.
Caution should be exercised when ibuprofen is used concomitantly with drugs that may increase the risk of ulceration or bleeding, such as oral corticosteroids, oral anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin.
If symptoms of gastrointestinal bleeding or ulceration occur in a patient taking ibuprofen, treatment should be discontinued immediately.
NSAIDs should be used with caution and with close monitoring in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), due to the risk of aggravation of symptoms.
Cardiovascular and cerebrovascular effects: Risk of cardiovascular thrombosis: Systemic non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur as early as the first few weeks of treatment and may increase with duration of treatment. The risk of cardiovascular thrombosis has been observed mainly at high doses.
Physicians should periodically assess the occurrence of cardiovascular events, even in the absence of previous cardiovascular symptoms. Patients should be warned about the symptoms of serious cardiovascular events and should seek medical attention immediately if these symptoms occur.
To minimize the risk of adverse events, Momentact Analgesico should be used at the lowest effective daily dose for the shortest possible duration.
Patients with a history of hypertension and/or mild to moderate heart failure should be closely monitored, as fluid retention and edema have been reported in association with NSAID therapy.
Clinical studies have shown that the use of ibuprofen, especially at high doses (2400 mg daily), may increase the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low doses of ibuprofen (≤ 1200 mg daily) are associated with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (grade II, III), myocardial ischemia, peripheral arterial disease and/or stroke should only be treated with ibuprofen after careful consideration and high doses (2400 mg daily) should be avoided.
Careful consideration should be given before initiating long-term treatment in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking), especially at high doses of 2400 mg daily.
Conceals the symptoms of the underlying infection: The drug may mask symptoms of infection, delaying adequate treatment and thus worsening the progression of the disease. This has been observed in cases of community-acquired pneumonia and complications of bacterial varicella.
When ibuprofen is used to reduce fever or relieve pain due to infection, the infection should be carefully monitored. If symptoms persist or worsen, a doctor should be consulted.
Skin effects: Serious, potentially fatal skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and Lyell syndrome, have been reported very rarely with NSAID therapy.
The risk of skin reactions is usually early, and may appear early in the course of ibuprofen use, in most cases within the first month of treatment. Cases of acute generalized exanthematous pustulosis (AGEP) have been reported with ibuprofen. Discontinue ibuprofen at the first sign of rash, mucosal lesions or any other sign of skin reactions.
Varicella can be a cause of serious infectious complications of the skin and soft tissues. The effect of NSAIDs in exacerbating these infections cannot be excluded at this time. Therefore, ibuprofen should be avoided in chickenpox.
Functional renal failure: NSAIDs, by inhibiting the vasodilating action of renal prostaglandins, are likely to cause functional renal failure by reducing glomerular filtration. This side effect is dose dependent.
At the start of treatment or after increasing the dose, monitoring of diuresis and renal function is recommended in patients with the following risk factors: elderly subjects; associated medications such as: ACE inhibitors, sartans, diuretics (see Interactions); hypovolaemia whatever the cause; heart failure, chronic renal failure; nephrotic syndrome; lupus nephropathy; decompensated hepatic cirrhosis.
Tubular acidosis and hypokalemia may occur after acute overdose and in patients who take ibuprofen for a long time at high doses (usually more than 4 weeks), including doses in excess of the recommended daily dose.
Water and sodium retention: Water and sodium retention with possibility of edema, hypertension or increase in hypertension, worsening of heart failure. Clinical monitoring is necessary from the start of treatment in the event of hypertension or heart failure. A decrease in the effect of antihypertensives is possible.
Hyperkalaemia: Hyperkalaemia favored by diabetes or concomitant treatment with hyperkalaemic medicinal products.
Regular monitoring of serum potassium should be performed in these circumstances.
Taking this medicine should be avoided in case of treatment with another nonsteroidal anti-inflammatory drug, with an oral anticoagulant, with lithium, with acetylsalicylic acid at analgesic, antipyretic or anti-inflammatory doses, with methotrexate at doses greater than 20 mg per week, with low molecular weight and related heparins and unfractionated heparins (at curative doses and/or in the elderly), with pemetrexed, in patients with weak to moderate renal function.
Precautions for use: Ibuprofen, like any drug that inhibits the synthesis of cyclooxygenases and prostaglandins, can impair fertility via an effect on ovulation. This effect is reversible upon discontinuation of treatment. The use of ibuprofen is not recommended in women who wish to conceive a child.
Caution is advised in patients with coagulation disorders.
Particular care should be taken when initiating treatment with ibuprofen in severely dehydrated patients.
Regular and prolonged use of analgesics carries a risk of headache and analgesic nephropathy.
Bronchospasm can be triggered in patients suffering from or having a history of bronchial asthma or allergic pathology.
Ibuprofen can mask objective and subjective signs of infection. In isolated cases, worsening of infectious inflammation (eg. development of necrotizing fasciitis) has been described temporally related to the use of NSAIDs. Ibuprofen should therefore be used with caution in patients with an infection.
Caution should be exercised in patients with collagen diseases other than systemic lupus erythematosus.
In the event of visual disturbances appearing during treatment, a complete ophthalmological examination should be carried out.
During prolonged treatments, it is recommended to check the blood count, hepatic and renal functions.
Warnings regarding excipients: This medicinal product contains 44.56 mg sodium per sachet, equivalent to 2.23% of the maximum recommended daily intake of sodium for adults of 2 g.
This medicinal product contains 81.9 mg potassium per sachet. This should be taken into account in patients with impaired renal function or in patients on a controlled potassium supplement.
This medicinal product contains 2.148 g sucrose per sachet. If the patient have been diagnosed with intolerance to certain sugars, consult the doctor before taking this medicinal product. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this medicinal product.
This medicinal product contains 20 mg aspartame per sachet. Aspartame is hydrolysed in the gastrointestinal tract when taken orally. One of the main hydrolysis products is phenylalanine. Therefore, it may be dangerous for people with phenylketonuria (PKU).
There is no nonclinical or clinical evidence to evaluate the use of aspartame in children under 12 weeks of age.
Effects on the Ability to Drive and Use Machines: Patients should be warned that adverse effects such as dizziness and visual disturbances may occur after taking NSAIDs. Single or short-term use is unlikely to affect the ability to drive or use machines.
Use in Children: Children (age ≥12 years and <18 years): There is a risk of kidney damage in dehydrated children/adolescents.
Use in the Elderly: Older adults are at increased risk of adverse effects from NSAIDs, especially gastrointestinal bleeding and gastric perforation, which can be fatal.

Fertility: If ibuprofen is administered to a woman wishing to become pregnant, the dose should be as low as possible and the duration of treatment as short as possible.
Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonal/foetal development. Data from epidemiological studies indicate an increased risk of miscarriage, fetal cardiac malformations and gastroschisis following use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk for cardiovascular malformations increased from less than 1% to approximately 1.5%. The risks increased with increasing dose and duration of treatment. In animals, use of prostaglandin synthesis inhibitors has been shown to increase pre- and post-implantation loss and embryonic mortality. In addition, increased incidences of other malformations, including cardiovascular, have been reported in animals treated with prostaglandin synthesis inhibitors during organogenesis. During the first and third trimesters of pregnancy, ibuprofen should not be used unless clearly necessary. If ibuprofen is used in a woman trying to conceive or in the first and second trimesters of pregnancy, the dose should be kept as low and the duration of treatment as short as possible.
From the 20th week of pregnancy onwards, the use of ibuprofen may cause oligohydramnios due to fetal renal dysfunction. This may occur soon after starting treatment and is usually reversible on discontinuation of treatment. In addition, there have been reports of ductus arteriosus constriction following treatment in the second trimester, but most resolved after discontinuation of treatment. Therefore, ibuprofen should not be used during the first and second trimesters unless clearly necessary. If ibuprofen is used in a woman trying to conceive or in the first and second trimesters of pregnancy, the lowest effective dose should be used for as short a period as possible. Consider antenatal monitoring for oligohydramnios and ductus arteriosus after ibuprofen use for several days from the 20th week of pregnancy onwards. Ibuprofen should be discontinued if oligohydramnios or ductus arteriosus is detected.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may cause the following adverse effects in the fetus: Cardiopulmonary toxicity (constriction/premature closure of the ductus arteriosus and pulmonary hypertension); Renal dysfunction.
In the mother and newborn, during late pregnancy: May prolong bleeding time, antiplatelet effects may occur even at very low doses.
Inhibition of uterine contractions leading to delay or prolongation of labor.
Ibuprofen is therefore contraindicated during the third trimester of pregnancy.
Lactation: Ibuprofen and its breakdown products/metabolites pass into breast milk. However, no effect on newborns/breastfed infants is expected when ibuprofen, granules for oral solution in sachet-dose is administered at therapeutic doses. As the harmful effects on the infant are still unknown, it is generally not necessary to interrupt breast-feeding in the event of short-term treatment at the recommended dose in the event of pain and mild to moderate fevers.

Adverse effects are mainly related to the pharmacological effects of ibuprofen on prostaglandin synthesis.
Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg daily) is likely to be associated with a slightly increased risk of arterial thrombotic events (myocardial infarction or stroke, for example) (see Precautions).
The most frequently observed side effects are of a gastrointestinal nature. Peptic ulcers, perforations or gastrointestinal bleeding, sometimes fatal, may occur, particularly in the elderly (see Precautions).
Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, ulcerative stomatitis, abdominal pain, melaena, haematemesis, exacerbation of rectocolitis or Crohn's disease (see Precautions) have been reported following administration of NSAIDs. Less frequently, gastritis has been observed.
Edema, hypertension and heart failure have been reported in association with NSAID therapy.
The table as follows lists adverse reactions by system organ class and frequency (very common ≥1/10, common [≥1/100, <1/10], uncommon [≥1/1,000, <1/100], rare [≥1/10,000, <1/1,000], very rare [<1/10,000] and not known [cannot be estimated from the available data]). (See table.)


Click on icon to see table/diagram/image


Pediatric population: Based on accumulated clinical experience, no clinically meaningful differences in the safety profile have been observed between adults and the approved pediatric population E 12 years of age) in terms of the nature, frequency, severity and reversibility of effects unwanted.
"Immediately notify the doctor or pharmacist for any undesirable effects encountered when using the drug".

Risk of hyperkalaemia: Risk related to hyperkalaemia.
Certain drugs or therapeutic classes are likely to promote the onset of hyperkalaemia: potassium salts, hyperkalaemic diuretics, angiotensin-converting enzyme inhibitors, angiotensin II inhibitors, non-steroidal anti-inflammatory drugs, heparins (low molecular weight or unfractionated), immunosuppressants such as ciclosporin or tacrolimus, trimethoprim.
The combination of these drugs increases the risk of hyperkalaemia. This risk is particularly high with potassium-sparing diuretics, especially when they are combined with each other or with potassium salts, while the combination of an ACE inhibitor and an NSAID, for example, is at a lower risk as soon as as long as the recommended precautions are implemented.
To know the risks and levels of constraints specific to hyperkalaemic drugs, it is advisable to refer to the interactions specific to each substance.
However, certain substances, such as trimethoprim, are not the subject of specific interactions with regard to this risk. Nevertheless, they can act as contributing factors when combined with other drugs such as those mentioned previously.
Simultaneous administration of ibuprofen with the following products requires rigorous monitoring of the patient's clinical and biological status: Combination contraindications: Mifamurtide: At high doses of NSAIDs, risk of reduce efficacy of mifamurtide.
Combination not recommended: Other NSAIDs: Increased risk of ulcerogenic and digestive bleeding.
Aspirin at anti-inflammatory doses (≥1g per dose and/or ≥3g per day) or at analgesic/antipyretic doses (≥500 mg per dose and/or <3 g per day): Increased risk of ulcerogenic and digestive bleeding.
Oral anticoagulants: Increased risk of bleeding from oral anticoagulant (aggression of the gastroduodenal mucosa by NSAIDs). NSAIDs may potentiate the effects of anticoagulants, such as warfarin.
If the association cannot be avoided, close clinical and biological monitoring.
Heparins (in curative doses and/or in the elderly): Increased risk of bleeding (aggression of the gastroduodenal mucosa by NSAIDs).
If the association cannot be avoided, close clinical monitoring.
Lithium: Increase in lithium in plasma which can reach toxic values (decreased renal excretion of lithium). If the combination cannot be avoided, closely monitor the lithium and adapt the lithium dosage during the combination and after stopping the NSAID.
Methotrexate used at doses greater than 20 mg/week: Increased toxicity, in particular haematological, of methotrexate (decreased renal clearance of methotrexate by anti-inflammatories).
Nicorandil: Increased risk of ulcerogenic and digestive bleeding.
Pemetrexed (in case of weak to moderate kidney function): Risk of increased toxicity of pemetrexed (decreased renal clearance by NSAIDs).
Combinations subject to precautions for use: Aminosides: NSAIDs may reduce the excretion of aminoglycosides.
Antibiotics from the quinolone group: The combination with non-steroidal anti-inflammatory drugs (NSAIDs) is likely to increase the risk of seizures.
Ciclosporin, tacrolimus: Risk of addition of nephrotoxic effects, especially in the elderly. Monitor renal function at the start of treatment with NSAIDs.
Cobimetinib: Increased risk of bleeding.
Clinical monitoring.
Diuretics, ACE inhibitors, Angiotensin II receptor antagonists: Causes acute renal failure in patients with risk factors (elderly patients, dehydrated, taking diuretics, impaired renal function) due to reduced glomerular filtration levels (NSAIDs inhibit the vasodilator effect of prostaglandins). This impact is usually reversible. Moreover, the combination of NSAIDs with diuretics, ACE-converting enzyme inhibitors, and angiotensin II receptor inhibitors also reduces the antihypertensive effect.
Patients should be adequately hydrated and should be monitored for kidney function after initiation of concurrent treatment and periodic follow-up thereafter.
Hypoglycemia: Ibuprofen potentiates the hypoglycemic effect of oral hypoglycemic agents and insulin. Dosage adjustment may be necessary.
Mifepristone: Combination with non-steroidal anti-inflammatory drugs (NSAIDs) is likely to increase exposure to NSAIDs. A reduction in the efficacy of mifepristone is theoretically possible due to the anti-prostaglandin properties of NSAIDs. Studies carried out on the effects of ibuprofen in single administration or in repeated administrations starting on the day of administration of the prostaglandins (or in case of necessity) have shown no deleterious effect on the action of mifepristone nor on the general clinical effectiveness of the pregnancy termination protocol.
Methotrexate used at doses less than or equal to 20 mg/week: Increased toxicity, in particular haematological, of methotrexate (decreased renal clearance of methotrexate by anti-inflammatories).
Weekly control of the blood count during the first weeks of the association.
Increased monitoring in the event of impairment (even slight) of renal function, as well as in the elderly.
Pemetrexed (patients with normal kidney function): Risk of increased toxicity of pemetrexed (decreased renal clearance by NSAIDs).
Biological monitoring of the renal function.
Phytotherapy products: The combination of ginkgo biloba and NSAIDs can increase the risk of bleeding.
Tenofovir disoproxil+Pemetrexed (patients with normal kidney function): Risk of increased toxicity of pemetrexed (decreased renal clearance by NSAIDs).
Biological monitoring of the renal function.
Voriconazole or fluconazole: Concomitant use of ibuprofen may increase ibuprofen exposure and plasma concentrations.
Zidovudine: Concomitant administration of zidovudine and ibuprofen may increase the risk of haemarthroses and hematomas in HIV-infected haemophilia patients.
Associations to consider: Acetylsalicylic acid at anti-aggregation doses (from 50 mg to 375 mg per day in 1 or more doses): Increased risk of ulcerogenic and digestive bleeding.
Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the increased potential for adverse effects.
Experimental data suggest that ibuprofen competitively inhibits the effect of low doses of acetylsalicylic acid on platelet aggregation when co-administered. Although there are uncertainties regarding the extrapolation of these data to clinical situations, the possibility that regular, long-term ibuprofen use may reduce the cardioprotective effect of low doses of acid acetylsalicylic acid cannot be excluded. No clinically relevant effects are considered likely for occasional use of ibuprofen.
Antiplatelet agents: Increased risk of gastrointestinal bleeding (see Precautions).
Beta-blockers (except esmolol) (including eye drops): Reduction of the antihypertensive effect (inhibition of vasodilator prostaglandins by nonsteroidal anti-inflammatory drugs).
Deferasirox: Increased risk of ulcerogenic and digestive bleeding.
Glucocorticoids (except hydrocortisone): Increased risk of gastrointestinal ulceration and bleeding (see Precautions).
Heparins (preventive doses): Increased risk of bleeding.
Selective serotonin reuptake inhibitors: Increased risk of bleeding.
Mixed adrenergic-serotonergic drugs: Increased risk of bleeding.
Pentoxifylline: Increased risk of bleeding.
Impact on diagnostic test results: Bleeding time (possible prolongation of bleeding time up to 1 day after stopping treatment); Blood sugar (possible reduction); Creatinine clearance (possible reduction); Hematocrit or hemoglobin (possible reduction); Concentrations of blood urea nitrogen, serum creatinine, potassium (possible elevation); Liver function test (possible elevation of transaminases).
Drug incompatibility: Because there is no research on drug incompatibility, do not mix this drug with other drugs.

Store at temperatures below 30°C.
Shelf Life: 36 months from the date of manufacture.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.