ALGOFEN * 24CPR RIV 200MG

ALGOFEN * 24CPR RIV 200MG

Therapeutic indications

Pain of various origins and nature (headache, toothache, neuralgia, osteoarticular and muscle pain, menstrual pain).

Dosage and method of use

Dosage.Adults and children over 12 years:1-2 coated tablets 2-3 times a day. Do not exceed the dose of 6 coated tablets per day. Do not exceed the recommended doses: in particular elderly patients should follow the minimum dosages indicated above. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4).Method of administration: It is advisable to take the drug on a full stomach. If the use of the medicine is necessary for more than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; • Subjects with hypersensitivity to acetylsalicylic acid or to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyposis and asthma, and presents with bronchospasm, urticaria or acute rhinitis (see also paragraph 4.4); • Do not administer under the age of 12; • Severe or active peptic ulcer (see section 4.4); • History of gastrointestinal haemorrhage or perforation related to previous active treatments or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding); • Hematopoietic disorders of unknown origin; • Cerebrovascular or other haemorrhage; • Disorders resulting in an increased tendency to bleed; • severe hepatic or renal insufficiency (see section 4.4); • Severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake); • Third trimester of pregnancy (see section 4.6); • Severe heart failure (NYHA class IV).

Side effects

The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4). Side effects are mostly dose-dependent and may vary from patient to patient. In particular, the risk of gastrointestinal bleeding is dose-dependent and duration of treatment. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of ALGOFEN (see section 4.4). Gastritis has been observed less frequently. Edema, hypertension and heart failure have been reported in association with NSAID treatment. Bullous reactions including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (very rarely). Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg / day), may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Some of the undesirable effects listed below are less frequent when the maximum daily dose is 1200 mg compared to high dose therapy in rheumatic patients. Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10); common (≥1 / 100, Infections and infestations. Very rare: Worsening of inflammation associated with infection (eg development of necrotizing fasciitis) described in conjunction with the use of non-steroidal anti-inflammatory drugs¹.Disorders of the blood and lymphatic system. Very rare: thrombocytopenia, anemia, leukopenia, pancytopenia, agranulocytosis².Disorders of the immune system. Uncommon: hypersensitivity reactions, including skin rash, urticaria, pruritus, purpura and asthma attacks (sometimes with hypotension); (see section 4.4). Rare: lupus erythematosus syndrome; Very rare: anaphylactic reaction, angioedema.Psychiatric disorders. Rare: depression, confusion, hallucinations, psychotic reactions.Nervous system disorders. Common: headache (see section 4.4), somnolence, dizziness, fatigue, agitation, dizziness, insomnia, irritability; Uncommon: paraesthesia; Rare: aseptic meningitis³ (see section 4.4), cerebrovascular accident.Eye disorders. Common: visual disturbances⁵; Rare: amblyopia.Ear and labyrinth disorders. Rare: tinnitus, hearing impairment.Respiratory, thoracic and mediastinal disorders. Uncommon: bronchospasm, rhinitis.Cardiac pathologies. Very rare: palpitations, heart failure (see section 4.4), myocardial infarction, acute pulmonary edema, edema (see section 4.4).Vascular pathologies. Very rare:hypertension(see section 4.4).Gastrointestinal disorders. Very common: gastrointestinal disturbances, such as heartburn, dyspepsia, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation; Common: gastrointestinal ulcers, sometimes with bleeding and perforation (see section 4.4), occult blood loss which may lead to anemia, melaena, haematemesis, ulcerative stomatitis, colitis, exacerbation of inflammatory bowel disease, complications of colonic diverticula (perforation, fistula); Uncommon:gastritis; Rare: worsening of colitis and Crohn's disease (see section 4.4); Very rare: esophagitis, pancreatitis, intestinal narrowing.Hepatobiliary disorders. Uncommon:hepatitis, jaundice, impaired liver function; Very rare: abnormal liver function tests, acute hepatitis, liver damage⁴especially in long-term use, liver failure.Skin and subcutaneous tissue disorders. Common:rash; Uncommon: pruritus, purpura, photosensitivity reaction; Very rare: severe forms of skin reactions (erythema multiforme, exfoliative dermatitis, bullous reactions, including Steven-Johnson syndrome and toxic epidermal necrolysis, alopecia, necrotizing fasciitis (see section 4.4). Serious skin infections with soft tissue complications may occur during chickenpox; Not known: drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (PEAG).Musculoskeletal and connective tissue disorders. Not known: musculoskeletal stiffness.Renal and urinary disorders. Uncommon:development of edema, especially in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis which may be associated with renal insufficiency⁶; Rare: renal failure, kidney tissue damage (papillary necrosis⁴), increased serum concentration of uric acid; Very rare: hematuria.Reproductive system and breast disorders. Very rare: menstrual disorders.Diagnostic tests. Rare: increased urea nitrogen, transaminases and alkaline phosphatase, decreased hemoglobin and hematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium, increased uric acid. ¹ This is likely related to the mechanism of action of non-steroidal anti-inflammatory drugs. If signs of an infection appear during treatment with ibuprofen or an infection worsening is noted, the patient is advised to seek medical attention without delay. It should therefore be assessed whether there is a need for anti-infective / antibiotic therapy. ² The first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, unexplained bruising and bleeding. These blood dyscrasias may appear particularly after long-term use of high doses. In long-term therapy, blood tests should be done gradually (see section 4.4). ³ The first symptoms are: neck tension, headache, nausea, vomiting, fever, disorientation or clouding of consciousness. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) appear to be predisposed (see section 4.4).⁴Particularly in long-term therapy. ⁵ Reversible eye disorders, such as toxic amblyopia, blurred vision, and changes in color perception have been observed. In case of such reactions, ibuprofen should be discontinued.⁶Varying degrees of renal impairment may occur, particularly with long-term use of high doses. Sudden worsening of kidney function may also be associated with a generalized hypersensitivity reaction.Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at:https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

After three days of treatment without appreciable results, consult your doctor. In asthmatic patients the product should be used with caution consulting your doctor before taking the product. The use of ALGOFEN should be avoided concomitantly with NSAIDs including selective COX-2 inhibitors (see section 4.5). Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see below on gastrointestinal and cardiovascular risks). Like other NSAIDs, ibuprofen can mask the signs and symptoms of infection due to its pharmacodynamic properties.Elderly people:Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2).Cardiovascular and cerebrovascular effects: Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg / day) may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg / day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg / day) should be avoided. ). Careful consideration should also be exercised before initiating long-term treatment patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking), especially if high doses (2400 mg / die) of ibuprofen. Caution is required before starting treatment in patients with a history of hypertension and / or heart failure, as fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs.Gastrointestinal effects: Gastrointestinal haemorrhage, ulceration and perforation: Gastrointestinal haemorrhage, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low dose aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be exercised in patients taking 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 aspirin (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking ALGOFEN the treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).Hepatic effects: When ibuprofen is prescribed to patients with impaired liver function, close medical surveillance is required, as their condition may be exacerbated. As with other NSAIDs, including ibuprofen, the values of one or more liver enzymes may increase. If ibuprofen is prescribed for an extended period of time, regular monitoring of liver function is indicated as a precautionary measure. If persistence or worsening of abnormal liver function values are observed, if signs or symptoms consistent with the development of liver disease develop or if other manifestations (e.g. eosinophilia, rash) occur, treatment with ibuprofen should be discontinued. With the use of ibuprofen, hepatitis can develop without prodromal symptoms. Ibuprofen is contraindicated in severe hepatic insufficiency (see section 4.3). Caution is required when ibuprofen is administered to patients with hepatic porphyria as the drug could trigger an attack.Kidney effects: As fluid retention and edema have been reported in association with NSAID therapy, including ibuprofen, particular caution is required in patients with impaired cardiac and renal function, history of hypertension, elderly, patients receiving concomitant treatment with diuretics or drugs that can significantly impact renal function, and in those patients with substantial extracellular volume depletion from any cause, for example before or after major surgery. In these cases when ibuprofen is administered, monitoring of renal function is recommended as a precautionary measure. Discontinuation of treatment is usually followed by a return to the pretreatment state. Ibuprofen is contraindicated in severe renal or cardiac insufficiency (see section 4.3).Severe skin reactions: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported rarely in association with the use of NSAIDs including ibuprofen (see section 4.8). In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with medicinal products containing ibuprofen. ALGOFEN should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other signs of hypersensitivity. At the first signs of hypersensitivity reactions after administration of ibuprofen the treatment should be discontinued. Medically assisted measures must be initiated by specialized medical personnel, in line with the symptoms.Pre-existing respiratory diseases:In patients with asthma, seasonal allergic rhinitis, edema of the nasal mucosa (e.g. nasal polyposis), chronic obstructive pulmonary disease or chronic respiratory tract infections (especially when linked to symptoms similar to those of allergic rhinitis), reactions to NSAIDs as exacerbation of asthma, Quincke's edema or urticaria are more frequent than in other patients. Particular caution is recommended in these patients (emergency ready). Ibuprofen is contraindicated in subjects with hypersensitivity to acetylsalicylic acid or to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyposis and asthma (see section 4.3).Systemic lupus erythematosus (SLE) and mixed connective tissue disease:There may be an increased risk of aseptic meningitis in patients with SLE and mixed connective tissue disorders (see below and section 4.8).Aseptic meningitis: Aseptic meningitis has been observed very rarely in patients treated with ibuprofen. Although this is likely to occur more likely in patients with systemic lupus erythematosus and related connective tissue diseases, it has also been reported in individuals without an underlying chronic disease. The use of ALGOFEN, as with any prostaglandin synthesis and cyclo-oxygenase inhibitor drug, is not recommended in women who intend to become pregnant. Administration of ALGOFEN should be discontinued in women who have fertility problems or who are undergoing investigation of fertility (see section 4.6). There is a risk of impaired renal function in dehydrated adolescents.ALGOFEN contains sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine.

Pregnancy and breastfeeding

Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, ALGOFEN should not be administered except in strictly necessary cases. If ALGOFEN is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: • Cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); • Renal dysfunction, which can progress to renal failure with oligohydramnios. The mother and the newborn, at the end of pregnancy, to: • Possible prolongation of the bleeding time, and antiplatelet effect which can occur even at very low doses; • Inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, ALGOFEN is contraindicated during the third trimester of pregnancy.Feeding time: Ibuprofen passes into breast milk in small amounts. Although no undesirable effects in the infant are known to date, caution should be exercised when ibuprofen is administered to a nursing woman.FertilityThere is evidence showing that drugs that inhibit cyclooxygenase / prostaglandin synthesis can cause decreased female fertility by effect on ovulation. However, this event is reversible upon discontinuation of treatment.

Expiry and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

Anticoagulants:NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4). Any interactions with coumarin-type anticoagulants should be kept in mind and therefore patients undergoing treatment with such drugs should consult their doctor before taking the product.Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs):increased risk of gastrointestinal bleeding (see section 4.4).Corticosteroids:increased risk of gastrointestinal ulceration or bleeding (see section 4.4).Acetylsalicylic acid:Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects. Experimental data suggest that ibuprofen can competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility cannot be excluded that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. No relevant clinical effects are considered likely following occasional use of ibuprofen (see section 5.1).Other NSAIDs including selective COX-2 inhibitors: Avoid concomitant use of two or more NSAIDs as this leads to an increased risk of adverse effects (see section 4.4).Lithium: ibuprofen can increase plasma concentrations of lithium, due to reduced elimination of the latter. Therefore, monitoring of serum lithium levels is recommended.Cardiac glycosides: Ibuprofen, like other NSAIDs, can exacerbate heart failure, reduce glomerular filtration rate (GFR) and increase plasma concentrations of glycosides. Therefore, monitoring of serum glycoside levels is recommended.Diuretics, ACE inhibitors, angiotensin II antagonists and Beta blockers:NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, usually reversible. These interactions should be considered in patients taking ALGOFEN concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy. The hypotensive effect of beta-blockers can be reduced. Concomitant use of NSAIDs and beta-blockers may be associated with the risk of acute renal failure.Sulfonylureas:NSAIDs can potentiate the effect of sulfonylureas. Rare cases of hypoglycaemia have been reported in patients treated with sulfonylureas taking ibuprofen.Methotrexate:NSAIDs can reduce the clearance of methotrexate through inhibition of tubular secretion. Administration of ibuprofen 24 hours before or after administration of methotrexate can lead to an increase in the concentration of methotrexate and an increase in its toxic effect. Therefore, concomitant use of NSAIDs and high doses of methotrexate should be avoided. If concomitant administration is necessary, the patient should be carefully monitored for toxicity, especially myelosuppression and gastrointestinal toxicity. In addition, the potential risk of interactions should also be considered in low dose methotrexate treatment (Ciclosporin and tacrolimus: the risk of a nephrotoxic effect due to cyclosporine and tacrolimus due to reduced synthesis of prostaglandins in the kidney is increased by concomitant administration of some non-steroidal anti-inflammatory drugs, including ibuprofen Therefore, ibuprofen should be administered at lower doses than those used in patients not taking these immunosuppressive agents and renal function should be closely monitored.Fluoroquinolone antibacterials:there have been isolated cases of seizures which may have been induced by the concomitant use of fluoroquinolone and NSAIDs.Phenytoin:when phenytoin is used concomitantly with ibuprofen, blood levels of phenytoin may increase. Therefore, monitoring of phenytoin plasma concentrations is recommended.Colestipol and cholestyramine:when administered concomitantly with ibuprofen, they can induce a delay or decrease the absorption of the latter. Therefore, it is recommended to administer ibuprofen at least 1 hour before or 4-6 hours after colestipol / cholestyramine administration.Potent CYP2C9 inhibitors:co-administration of ibuprofen with CYP2C9 inhibitory agents (such as sulfinpyrazone, fluconazole and voriconazole) requires caution as it may lead to a significant increase in peak plasma concentrations and exposure to ibuprofen due to inhibition of the metabolism of ibuprofen . In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increase in exposure to S (+) - ibuprofen from approximately 80 to 100% was shown. Therefore, a dose reduction of ibuprofen should be considered when administered concomitantly with potent CYP2C9 inhibitors, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole.Zidovudine:there is an increased risk of haematological toxicity when administered concomitantly with NSAIDs. There is evidence of an increased risk of haemarthroses and hematomas in HIV-positive haemophilia patients treated concomitantly with zidovudine and ibuprofen.Alcohol, bisphosphonates and pentoxifylline: can potentiate gastrointestinal side effects and the risk of bleeding and ulcer.Baclofen: increased baclofen toxicity.Plant extracts: Ginkgo Biloba may increase the risk of bleeding when taken in combination with NSAIDs.

Overdose

ToxicitySigns and symptoms of toxicity were generally not observed at doses below 100 mg / kg in children or adults. However, supportive treatment may be required in some cases. Children have been observed to exhibit signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg / kg or greater.SymptomsIn cases of severe poisoning, metabolic acidosis may occur. Most patients who have ingested significant amounts of ibuprofen will experience symptoms within 4-6 hours. The most commonly reported symptoms of overdose include: nausea, vomiting, abdominal pain, lethargy and somnolence. Effects on the central nervous system (CNS) include headache, tinnitus, dizziness, seizures (including myoclonic seizures in children), lightheadedness, and loss of consciousness. Prolongation of prothrombin time / INR may occur in severe poisoning probably due to interference with the actions of circulating coagulation factors. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, cyanosis, diarrhea, and CNS and respiratory depression have also been reported rarely. Disorientation, arousal state, fainting and cardiovascular toxicity including hypotension, bradycardia, tachycardia have been reported. In asthmatic patients, exacerbation of the condition is possible. In cases of significant overdose, renal failure and liver damage are possible.TreatmentThere is no specific antidote to ibuprofen overdose. In the event of an overdose, therefore, symptomatic and supportive treatment is indicated. Particular attention is paid to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic amount. Alternatively, gastric lavage should be considered in adults within one hour of ingesting a potentially life-threatening overdose. Adequate diuresis must be ensured and renal and hepatic functions closely monitored. The patient should remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged seizures should be treated with intravenous diazepam. Depending on the patient's clinical condition, other supportive measures may be necessary. For more information, contact your local poison control center.

Active principles

One coated tablet contains:Active principle:ibuprofen 200 mg. Excipient with known effect: sucrose. For the full list of excipients, see section 6.1.

Excipients

Corn starch, stearic acid, croscarmellose sodium, colloidal anhydrous silica, povidone, carmellose sodium, shellac, gum arabic, titanium dioxide, calcium sulphate, sucrose, carnauba wax.