Instructions for Darfen long tablets 200mg/500mg No. 10
Composition
active ingredients: ibuprofen, paracetamol;
1 film-coated tablet contains 200 mg of ibuprofen and 500 mg of paracetamol;
excipients: corn starch, crospovidone (Type A) (E 1202), colloidal anhydrous silica (E 551), povidone K-30 (E 1201), pregelatinized corn starch, talc (E 553b), stearic acid (50); film coating: polyvinyl alcohol (E 1203), talc (E 553b), macrogol 3350 (E 1521), titanium dioxide (E 171).
Dosage form
Film-coated tablets.
Main physicochemical properties: oval-shaped tablets, film-coated, white to off-white in color.
Pharmacotherapeutic group
Preparations for the treatment of the musculoskeletal system. Anti-inflammatory and antirheumatic drugs, non-steroidal drugs. Propionic acid derivatives. Ibuprofen, combinations.
ATX code M01A E51.
Pharmacological properties
Pharmacodynamics
The pharmacological action of ibuprofen and paracetamol differs in site and mode of action, but is synergistic, leading to increased analgesic and antipyretic properties compared to those of each substance used alone.
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID), a propionic acid derivative, which has demonstrated efficacy in inhibiting the synthesis of prostaglandins, mediators of pain and inflammation. Ibuprofen has analgesic, antipyretic and anti-inflammatory effects. In addition, ibuprofen reversibly inhibits platelet aggregation.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when administered concomitantly. Some pharmacodynamic studies have shown that when single doses of ibuprofen 400 mg were administered within 8 hours before or within 30 minutes after immediate-release acetylsalicylic acid (81 mg), a reduction in the effect of acetylsalicylic acid on thromboxane formation or platelet aggregation was observed. Although there are doubts 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.
The mechanism of action of paracetamol is still not fully understood, but there is convincing evidence of an analgesic effect on the central nervous system (CNS). Biochemical studies indicate inhibition of cyclooxygenase-2 (COX-2) activity in the CNS. Paracetamol can also stimulate descending pathways of 5-hydroxytryptamine (serotonin) activation, which inhibits the transmission of pain signals in the spinal cord.
The drug is particularly suitable for the treatment of pain that requires a stronger analgesic effect than ibuprofen 400 mg or paracetamol 1000 mg alone. Studies using this combination in a model of acute pain (postoperative dental pain) and chronic knee pain have shown high efficacy of this combination in reducing the severity of acute pain (93.2%) and long-term treatment of chronic pain (60.2%). This drug has a rapid onset of action with a confirmed significant reduction in pain, which is noted on average after 18.3 minutes. Significant pain relief is noted on average after 44.6 minutes. The analgesic effect of this drug is significantly longer (9.1 hours), compared to paracetamol 500 mg (4 hours).
Pharmacokinetics
Ibuprofen is rapidly absorbed from the gastrointestinal tract and is extensively bound to plasma proteins. Ibuprofen is detected in plasma within 5 minutes, reaching peak concentrations 1-2 hours after administration on an empty stomach. Ibuprofen is metabolized in the liver and excreted by the kidneys. The half-life is approximately 2 hours.
Paracetamol is rapidly absorbed from the gastrointestinal tract. At therapeutic concentrations, the level of binding to plasma proteins is low, although dose-dependent.
Paracetamol in blood plasma is detected after 5 minutes, reaching maximum concentration 0.5−0.67 hours after administration on an empty stomach.
Paracetamol is metabolized in the liver and excreted in the urine mainly as conjugates. Less than 5% of paracetamol is excreted unchanged. The hydroxylated metabolite, which is formed in very small quantities in the liver under the influence of mixed oxidases and is detoxified by binding to hepatic glutathione, can accumulate in paracetamol overdose and cause liver tissue damage. The half-life is approximately 3 hours. No significant difference in the pharmacokinetic profile of paracetamol and ibuprofen in elderly patients has been found. The bioavailability and pharmacokinetic profile of ibuprofen and paracetamol in this medicinal product do not change when using a single or repeated dose of such a combination.
The composition of this medicine is developed using technology that ensures the simultaneous release of ibuprofen and paracetamol in such a way as to potentiate the effects of each of the active ingredients.
Indication
Symptomatic treatment of mild to moderate pain in migraine, headache, back pain, menstrual pain, toothache, rheumatic and muscular pain, pain in mild forms of arthritis, symptoms of cold and flu, sore throat and fever.
This medicine is particularly suitable for the treatment of pain that requires a stronger analgesic effect than that of ibuprofen or paracetamol used alone.
Contraindication
The drug is contraindicated:
patients with known individual hypersensitivity to ibuprofen, paracetamol or other components of the medicinal product;
patients with a history of hypersensitivity reactions (e.g. bronchospasm, angioedema, bronchial asthma, rhinitis or urticaria) after taking ibuprofen, acetylsalicylic acid or other NSAIDs;
with gastric and duodenal ulcer/bleeding in active form or history of relapses (two or more severe episodes of ulcer or bleeding);
patients with a history of gastrointestinal bleeding or perforation associated with the use of NSAIDs;
patients with blood clotting disorders;
patients with severe hepatic, severe renal or severe heart failure (NYHA class IV);
with simultaneous use of other drugs containing NSAIDs, including cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid in a daily dose of more than 75 mg, due to an increased risk of adverse reactions;
when used simultaneously with other medicines containing paracetamol, due to an increased risk of serious adverse reactions;
during the last trimester of pregnancy.
Interaction with other medicinal products and other types of interactions
This drug (like other paracetamol-containing drugs) is contraindicated when used with other drugs containing paracetamol due to an increased risk of serious adverse reactions.
This drug (like other ibuprofen-containing drugs and NSAIDs) should not be used in combination with:
acetylsalicylic acid, as this may increase the risk of adverse reactions, unless acetylsalicylic acid (dose not exceeding 75 mg per day) has been prescribed by a doctor.
Experimental data suggest that ibuprofen may inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when used concomitantly. However, the extrapolation of these data to the clinical situation is limited, and therefore there is no definitive conclusion as to whether regular long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. Such clinically significant effects are considered unlikely with non-systematic use of ibuprofen.
− other NSAIDs (including selective COX-2 inhibitors), as this may lead to an increased incidence of side effects.
This drug (as well as other paracetamol-containing products) should be used with caution in combination with the following drugs:
− cholestyramine: the rate of absorption of paracetamol is reduced by cholestyramine, therefore paracetamol should be administered 1 hour before cholestyramine if maximum analgesia is required;
− metoclopramide and domperidone: absorption of paracetamol is increased by metoclopramide and domperidone, but simultaneous administration should not be avoided;
− Warfarin: the anticoagulant effect of warfarin and other coumarins may be enhanced by long-term regular use of paracetamol with an increased risk of bleeding; intermittent use has no significant effect.
This drug (as well as other ibuprofen-containing products and NSAIDs) should be used with caution in combination with the following drugs.
Anticoagulants. NSAIDs may enhance the effect of anticoagulants (increased risk of bleeding). The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with an increased risk of bleeding.
Antihypertensives and diuretics. NSAIDs may reduce the therapeutic effect of these drugs and increase the risk of nephrotoxicity. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the concomitant use of an ACE inhibitor or angiotensin II antagonist and drugs that inhibit cyclooxygenase may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, such combinations should be administered with caution, especially in elderly patients. If long-term treatment is necessary, the patient should be adequately hydrated and consideration should be given to monitoring renal function at the beginning of the combination treatment and periodically thereafter. Diuretics may increase the risk of nephrotoxicity of NSAIDs.
Antiplatelet and selective serotonin reuptake inhibitors: The risk of gastrointestinal bleeding may be increased.
Cardiac glycosides. NSAIDs increase the level of glycosides in the blood plasma, can aggravate cardiac dysfunction, and reduce the glomerular filtration function of the kidneys.
Corticosteroids may increase the risk of adverse reactions in the digestive tract (gastrointestinal ulcers or bleeding).
Lithium and methotrexate: There is evidence of a potential increase in plasma levels of lithium and methotrexate.
Mifepristone: NSAIDs should not be used earlier than 8-12 days after mifepristone administration, as they reduce its effectiveness.
Quinolone antibiotics: Animal studies suggest that NSAIDs may increase the risk of seizures associated with the use of quinoline antibiotics. The risk of seizures is increased when NSAIDs and quinolones are used concomitantly.
Flucloxacillin: Caution should be exercised when using paracetamol with flucloxacillin, as concomitant administration has been associated with high anion gap metabolic acidosis, especially in patients with risk factors.
Tacrolimus: There may be an increased risk of nephrotoxicity with concomitant use of NSAIDs and tacrolimus.
Zidovudine: 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 when zidovudine is co-administered with ibuprofen.
Antiemetics: The rate of absorption of paracetamol may be increased by metoclopramide or domperidone.
Application features
Do not exceed recommended doses.
If symptoms progress, you should consult a doctor.
Keep out of reach of children.
Paracetamol.
Paracetamol should be administered with caution to patients with severe renal and hepatic impairment. The risk of paracetamol overdose is higher in patients with non-cirrhotic alcoholic liver disease. In case of overdose, seek medical attention immediately, even if the patient feels well, because of the risk of delayed serious liver damage.
Caution should be exercised when using paracetamol with flucloxacillin due to the increased risk of high anion gap metabolic acidosis, especially in patients with severe renal insufficiency, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those taking maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.
Do not take other medicines containing paracetamol. If this happens, you should immediately consult a doctor, even if the patient feels well, as this may lead to an overdose.
Ibuprofen.
Undesirable effects can be minimized by using the lowest effective dose necessary to relieve symptoms, for the shortest period of time necessary to eliminate symptoms, and with food.
Elderly patients.
Elderly patients are more likely to experience adverse reactions to NSAIDs, especially gastrointestinal bleeding or perforation, which can be fatal. If NSAIDs are necessary, they should be used at the lowest effective dose for the shortest duration possible.
The patient should be regularly monitored for the possibility of gastrointestinal bleeding during NSAID therapy.
Effects on the respiratory system.
In patients who suffer from bronchial asthma or allergic diseases after using NSAIDs or have a history of these diseases, bronchospasm may occur.
Systemic lupus erythematosus and mixed connective tissue disease.
Patients with systemic lupus erythematosus and mixed connective tissue disease may be at increased risk of developing aseptic meningitis.
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 is necessary), since fluid retention, hypertension and edema have been reported with ibuprofen, as with other NSAIDs.
Clinical trial data suggest that ibuprofen use, particularly at high doses (2400 mg/day), may be associated with an increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Overall, epidemiological data do not suggest that low-dose ibuprofen (e.g.
≤ 1200 mg per day) is associated with an increased risk of arterial thrombotic complications.
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 assessment should also be carefully considered before initiating long-term treatment in patients with risk factors for cardiovascular complications (such as hypertension, hyperlipidemia, diabetes mellitus, smoking), especially if high doses of ibuprofen (2400 mg/day) are required.
NSAIDs may cause a dose-dependent decrease in prostaglandin formation and the development of renal failure. Patients with impaired renal function, cardiac dysfunction, hepatic dysfunction, patients taking diuretics and elderly patients are at increased risk. In such patients, renal function should be monitored.
Effect on the gastrointestinal system.
NSAIDs should be prescribed with caution to patients with a history of gastrointestinal disorders (ulcerative colitis and Crohn's disease), as these conditions may be exacerbated.
Cases of gastrointestinal bleeding, perforation, and ulceration, which can be fatal, have been reported at any stage of NSAID treatment, regardless of the presence of alarm symptoms or a history of severe gastrointestinal disorders.
The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing NSAID dose, with a history of ulcer, especially ulcer complicated by bleeding or perforation, and in the elderly. In these patients, treatment should be initiated at the lowest effective dose. In these patients, as well as in patients taking low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal bleeding, combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered.
Patients with a history of gastrointestinal disorders, especially elderly patients, should be informed of any adverse gastrointestinal symptoms (especially bleeding), particularly at the beginning of treatment.
The drug should be prescribed with caution to patients receiving concomitant medications that may 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 the event of gastrointestinal bleeding or ulceration in patients receiving ibuprofen-containing drugs, treatment with this drug should be discontinued immediately.
Severe skin reactions.
Very rarely, severe skin reactions, sometimes fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, may occur with NSAIDs (see section 4.8). The risk of these reactions is highest at the beginning of therapy. In most cases, these reactions began within the first month of treatment. A case of acute generalized exanthematous pustulosis has also been reported after the use of ibuprofen-containing medicines. The drug should be discontinued at the first signs and symptoms of skin lesions, such as skin rashes, mucosal lesions and other manifestations of hypersensitivity.
Masking the symptoms of underlying infections.
Darfen® Long 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. If ibuprofen 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 attention if symptoms persist or worsen.
Impact on fertility in women.
There is limited evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may affect ovulation. This process is reversible after discontinuation of treatment. Women who have problems conceiving or who are being investigated for infertility should refrain from taking the drug.
Use during pregnancy or breastfeeding
Pregnancy
There is no experience with the use of the drug in pregnant women.
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, starting from the 20th week of gestation. Darfen® Long should be discontinued if oligohydramnios or narrowing of the ductus arteriosus is detected.
During the third trimester, all prostaglandin synthesis inhibitors pose risks to the fetus.
cardiopulmonary toxicity (premature narrowing/closure of the ductus arteriosus and pulmonary hypertension);
§ – renal dysfunction (see above);
Risks for the woman at the end of pregnancy and for the newborn:
Delayed labor or prolonged labor may occur, with increased bleeding tendencies in both mother and baby.
The drug should be avoided during the first and second trimesters of pregnancy, as well as during childbirth; the drug is contraindicated in the third trimester of pregnancy.
Breastfeeding period
Ibuprofen and its metabolites may pass into breast milk in very low concentrations (0.0008% of the maternal dose). Harmful effects on infants are unknown.
Paracetamol passes into breast milk, but in clinically insignificant quantities. Available published data do not rule out the possibility of taking the drug during breastfeeding.
Therefore, there is no need to discontinue breastfeeding during short-term therapy with this drug at recommended doses.
Ability to influence reaction speed when driving vehicles or other mechanisms
Side effects such as dizziness, drowsiness, fatigue, and visual disturbances are possible after taking NSAIDs. Patients who experience these side effects should not drive or operate machinery.
Method of administration and doses
For oral short-term use only.
The lowest effective dose should be used for the shortest duration necessary to control symptoms (see section "Special warnings and precautions for use").
If the symptoms of the disease persist for more than 3 days, it is necessary to consult a doctor to clarify the diagnosis and adjust 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.
Adults should take 1 tablet up to 3 times a day with an interval of at least 6 hours between doses. Swallow the tablets with water.
If 1 tablet does not relieve the symptoms of the disease, 2 tablets should be taken at a time, but not more than 3 times a day. The interval between doses should be at least 6 hours. Do not take more than 6 tablets (3000 mg of paracetamol, 1200 mg of ibuprofen) within 24 hours.
To minimize the likelihood of side effects, take the medicine with meals.
Elderly patients.
Do not require dose adjustment.
Because of the potential for adverse effects, elderly patients should be monitored particularly closely. If NSAIDs are necessary, the lowest effective dose should be used for the shortest possible time. The patient should be monitored regularly for gastrointestinal bleeding during NSAID therapy.
Children
Do not use in children under 18 years of age.
Overdose
Paracetamol: Liver damage is possible in adults who have taken 10 g (equivalent to 20 tablets) or more of paracetamol. Taking 5 g (equivalent to 10 tablets) or more of paracetamol may cause liver damage if:
the patient is receiving long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort, or drugs that induce liver enzymes;
the patient regularly consumes alcohol;
the patient is likely to be glutathione deficient (e.g., has fibrocystic degeneration, HIV infection, cachexia, or is starving).
Treatment. Paracetamol overdose requires immediate medical attention. The patient should be taken to hospital for medical examination immediately, even if there are no early symptoms of overdose. Symptoms may be limited to nausea and vomiting and may not reflect the severity of the overdose or the risk of organ damage. Treatment should be carried out in accordance with established treatment guidelines.
Treatment with activated charcoal should be considered within 1 hour of ingestion of an overdose of paracetamol. Plasma paracetamol concentrations should be measured 4 hours or later after ingestion (earlier concentrations are unreliable).
N-acetylcysteine treatment can be given up to 24 hours after paracetamol ingestion, but maximum protection is obtained when administered within 8 hours of the overdose. The efficacy of the antidote decreases sharply after this time. If necessary, the patient should be given N-acetylcysteine intravenously according to the established dose schedule. In the absence of vomiting, oral methionine may be used as a suitable alternative in remote areas outside the hospital.
Patients who develop severe liver dysfunction within 24 hours of taking paracetamol should be treated according to established guidelines.
Ibuprofen. The use of ibuprofen in doses greater than 400 mg/kg in children may cause symptoms of overdose. In adults, the dose-dependent effect is less pronounced. The half-life in overdose is 1.5-3 hours.
Symptoms. Most patients who have taken clinically significant amounts of NSAIDs may experience only nausea, vomiting, epigastric pain or, very rarely, diarrhoea. Tinnitus, headache and gastrointestinal bleeding may also occur. In more severe poisoning, CNS toxicity may occur, manifested by drowsiness, sometimes by nervous excitement and disorientation or coma. Sometimes patients experience convulsions. In severe poisoning, metabolic acidosis may occur; the prothrombin index/international normalized ratio (INR) may be elevated, probably due to effects on blood clotting factors. Acute renal failure and liver damage may occur with dehydration. Patients with bronchial asthma may experience exacerbation of the disease.
Treatment. Treatment should be symptomatic and supportive, and include maintaining a patent airway and monitoring cardiac symptoms and vital signs until the condition returns to normal. Oral administration of activated charcoal is recommended within 1 hour of ingestion of a potentially toxic amount of the drug. Intravenous diazepam or lorazepam should be used for frequent or prolonged seizures. Bronchodilators should be used for the treatment of bronchial asthma.
Side effects
The results of clinical studies conducted with this medicinal product do not indicate the presence of any other adverse reactions than those observed with the use of ibuprofen or paracetamol separately.
The following are adverse reactions observed in patients taking ibuprofen or paracetamol alone during short-term and long-term use.
The frequency 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), frequency unknown (cannot be estimated from the available data).
On the part of the organs of vision: very rarely - visual impairment.
From the side of the organs of hearing and vestibular apparatus: very rarely - tinnitus and vertigo.
Respiratory system: very rare - respiratory sensitivity, including asthma, asthma exacerbation, bronchospasm and dyspnoea.2
Gastrointestinal: common: abdominal pain, vomiting, diarrhea, nausea, dyspepsia, and gastrointestinal discomfort5; uncommon: peptic ulcer, gastrointestinal perforation, gastrointestinal bleeding, melena, hematemesis6, oral ulcers, exacerbation of colitis and Crohn's disease7, gastritis, pancreatitis, flatulence, and constipation.
Hepatobiliary disorders: very rarely - liver dysfunction, hepatitis and jaundice.8
Renal and urinary disorders: very rarely - nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome; acute and chronic renal failure.9
Nervous system disorders: uncommon – headache and dizziness; very rare – aseptic meningitis3, paresthesia, optic neuritis and drowsiness.
On the part of the psyche: very rarely - confusion, depression and hallucinations.
Cardiovascular system: very rarely - heart failure, edema, arterial hypertension.4
Blood and lymphatic system disorders: very rare – disorders of the hematopoietic system.1
Skin and subcutaneous tissue disorders: common: hyperhidrosis; uncommon: skin rash2; very rare: bullous reactions, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis2, exfoliative dermatosis, purpura, photosensitivity; frequency unknown: acute generalized exanthematous pustulosis, rash with eosinophilia and systemic symptoms (DRESS syndrome).
General disorders: very rarely - fatigue and discomfort.
Laboratory parameters: often - increased alanine aminotransferase (ALT), increased gamma-glutamyltransferase and worsening of liver function tests caused by paracetamol, increased blood creatinine, increased blood urea; infrequently - increased aspartate aminotransferase (AST), increased blood alkaline phosphatase, increased blood creatine kinase, decreased hemoglobin and increased platelets.
Description of selected adverse reactions
1Examples include agranulocytosis, anemia, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, and thrombocytopenia. Initial signs include fever, sore throat, mouth ulcers, flu-like symptoms, severe fatigue, unexplained bleeding, bruising, and nosebleeds.
2Hypersensitivity reactions have been reported. These reactions include:
nonspecific allergic reactions and anaphylaxis;
respiratory tract reactions, including bronchial asthma, asthma exacerbation, bronchospasm or shortness of breath;
various skin reactions, including rashes of various types, itching, urticaria, purpura, angioedema and, less commonly, exfoliative and bullous dermatoses (including epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme).
3The 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 (with symptoms occurring during drug administration and resolving after drug withdrawal). In particular, isolated cases of symptoms of aseptic meningitis such as nuchal rigidity, 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) (see section 4.4).
4Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/day), may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4).
5The most common adverse events are gastrointestinal.
6Sometimes fatal, especially in the elderly.
7See section "Application features".
8In overdose, paracetamol may cause acute hepatic failure, hepatic insufficiency, hepatic necrosis and liver damage (see section “Overdose”).
9Especially with long-term use, associated with increased serum urea and edema. Also includes papillary necrosis.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after the marketing authorisation of a medicinal product is an important procedure. It allows for continued monitoring of the benefit-risk balance of the medicinal product in question. Healthcare professionals should report any suspected adverse reactions via the national reporting system.
Expiration date
4 years.
Storage conditions
Store in the original packaging to protect from light at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
10 tablets in a blister; 1 blister in a pack.
Vacation category
Without a prescription.
Producer
Rontis Hellas Medical and Pharmaceutical Products S.A.
Location of the manufacturer and address of its place of business
P.O. Box 3012 Larisa Industrial Area, Larisa, 41004, Greece.
Applicant
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the applicant and address of its place of business
Ukraine, 02093, Kyiv, Boryspilska St., 13.
