ALGOFEN 24CPR RIV 200MG

ALGOFEN 200 MG STATEMENTS

active ingredients

A coated tablet contains: Active ingredient: ibuprofen 200 mg. Excipient with known effects: sucrose. For the full list of excipients, see section 6.1.

Excellent

Corn starch, stearic acid, sodium croscarmellosa, anidra colloidal silica, povidone, sodium carmellosa, lacquer rubber, arabic rubber, titanium dioxide, calcium sulphate, sucrose, carnauba wax.

Therapeutic indications

Pain from various origins and nature (headache, toothache, neuralgia, osteoarticocular and muscle pain, menstrual pain).

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1; • Subjects with hypersensitivity to acetylsalicylic acid or other analgesics, antipyretics, non-steroid anti-inflammatory drugs (NSAID), especially when hypersensitivity is associated with nasal and asthma polypoxes, and occurs with bronchospasm, hives or acute rhinitis (see also paragraph 4.4); • Do not administer under 12 years; • Serious or active peptic ulcer (see paragraph 4.4); • History of gastrointestinal hemorrhage or perforation related to previous active treatments or history of hemorrhage/recurring peptic ulcer (two or more separate episodes of proven ulceration or bleeding); • Hemopoietic disorders of unknown origin; • cerebrovascular hemorrhage or other type; • Disorders involving an increase in the tendency to bleeding; • Hepatic or serious kidney failure (see paragraph 4.4); • Severe dehydration (caused by vomiting, diarrhea or insufficient liquid supply); • Third quarter of pregnancy (see paragraph 4.6); • severe heart failure (IV class NYHA).

Population

Population. . Adults and boys over 12 years: 1-2 tablets coated 2-3 times a day. Do not exceed the dose of 6 tablets coated daily. Do not exceed the recommended doses: especially older patients should comply with the above minimum dosages. Undesirable effects can be minimized with the use of the minimum effective dose for the shortest possible treatment duration needed to control symptoms (see paragraph 4.4). Method of administration: It is recommended to take the drug on a full stomach. In case the use of the medicine is necessary for more than 3 days in adolescents, or in case of worsening of the symptomatology the doctor must be consulted.

Conservation

This medicine does not require any special condition of conservation.

Warnings

After three days of treatment without appreciable results consult your doctor. In asthmatic patients, the product must be used carefully by consulting the doctor before taking the product. The use of ALGOFEN should be avoided in conjunction with NSAIDs including selective COX-2 inhibitors (see paragraph 4.5). Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see below paragraphs on gastrointestinal and cardiovascular risks). Like other NSAIDs, ibuprofen can mask signs and symptoms of infection due to its pharmacodynamic properties. Seniors: Senior patients have an increase in the frequency of adverse reactions to NSAIDs, especially hemorrhages and gastrointestinal perforations, which can be fatal (see paragraph 4.2). Cardiovascular and cerebrovascular effects: Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/die) may be associated with a modest increase in the 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/die) are associated with increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (II-III class NYHA), proven ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and should avoid high doses (2400 mg/die). Careful consideration should be exercised even before starting long-term treatment patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg/die) are required of ibuprofen. Before starting treatment in patients with positive anamnesiums for hypertension and/or heart failure, caution is required, as retention of fluids, hypertension and edema were found in association with NSAIDs. Gastrointestinal effects: Gastrointestinal hemorrhage, ulceration and drilling: during treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration and perforation, which may be fatal. In the elderly and in patients with history of ulcer, especially if complicated by hemorrhage or perforation (see paragraph 4.3), the risk of gastrointestinal hemorrhage, ulceration or perforation is higher with increased doses of NSAID. These patients must begin treatment with the lowest dose available. Concurrent use of protective agents (misoprostol or protonic pump inhibitors) must be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see below and paragraph 4.5). Patients with history of gastrointestinal toxicity, especially elderly, must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. Caute should be lent to patients taking concomitant drugs that could increase the risk of ulceration or hemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-aggregating agents such as aspirin (see paragraph 4.5). When bleeding or gastrointestinal ulcer occurs in patients taking ALGOFEN treatment must be suspended. NSAIDs should be administered with caution in patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions can be exacerbated (see paragraph 4.8). Hepatitis effects: When ibuprofen is prescribed to patients with altered liver function, strict medical surveillance is required, as their condition may be exacerbated. As with other NSAIDs, including ibuprofen, the values of one or more liver enzymes can increase. In case the ibuprofen is prescribed for a prolonged period of time, regular monitoring of liver function as a precautionary measure is indicated. If you see persistence or worsening of altered liver function values, if signs or symptoms are developed compatible with the development of liver disease or if other manifestations occur (e.g. eosinophilia, rash), treatment with ibuprofen should be suspended. Using ibuprofen can develop hepatitis without prodromic symptoms. Ibuprofen is contraindicated in case of severe liver failure (see paragraph 4.3). When ibuprofen is administered in patients with liver porphyria, attention is required as the drug may trigger an attack. Renal effects: Since fluid retention and edema have been reported in association with NSAID therapy, including ibuprofen, particular caution is required in patients with impaired heart and kidney function, history of hypertension, elderly, patients who receive a concomitant treatment with diuretics or drugs that can significantly impact kidney function, and in those patients with substantial depletion of extracellular volume from any cause, for example before or after surgery. In such cases when ibuprofen is administered, monitoring of kidney function is recommended as a precautionary measure. The termination of treatment is usually followed by a return to the pretreatment state. Ibuprofen is contraindicated in case of severe kidney or heart failure (see paragraph 4.3). Strict skin reactions: Severe skin reactions some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have rarely been reported in association with the use of NSAIDs including ibuprofen (see paragraph 4.8). In the early stages of therapy patients seem to be higher risk: the onset of reaction occurs in most cases within the first month of treatment. Generalized acute urstolosis (PEAG) was reported in relation to medicines containing ibuprofen. ALGOFEN must be stopped at the first appearance of severe skin reactions, such as rash, mucosa lesions or any other sign of hypersensitivity. To the first signs of hypersensitivity reactions after administration of ibuprofen, treatment must be stopped. Medically assisted measures must be initiated by specialized medical personnel, in line with symptomatology.Pre-existing respiratory diseases: In patients with asthma, seasonal allergic rhinitis, nasal mucosa edema (e.g. nasal polyposi), chronic obstructive pulmonary disease or chronic respiratory tract infections (especially if related to symptoms similar to those of allergic rhinitis), reactions to NSAIDs such as as asthma exacerbation, Quincke edema or hives are more frequent than in other patients. Special caution is recommended in these patients (emergency patients). Ibuprofen is contraindicated in subjects with hypersensitivity to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAID), especially when hypersensitivity is associated with nasal and asthma polypoxes (see paragraph 4.3). Lupus Eritematoso Sistemico (LES) and mixed connective tissue disease: In patients with LES and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see below and paragraph 4.8). Synthetic Meningitis: In patients treated with ibuprofen, a septic meningitis was rarely observed. Although it is likely that this occurs more likely in patients suffering from Lupus Eritematoso Sistemico and related diseases of connective tissue, it has also been reported in subjects without a basic chronic disease. The use of ALGOFEN, as with any drug inhibiting the synthesis of prostaglandins and cyclo-oxidases, it is not recommended in women who intend to start a pregnancy. The administration of ALGOFEN should be suspended in women who have fertility problems or who are subject to fertility surveys (see paragraph 4.6). In dehydrated adolescents there is a risk of alteration of kidney function. ALGOFEN contains sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine.

Interactions

Anticoagulanti: nSAIDs can increase the effects of anticoagulants, such as warfarin (see paragraph 4.4). Any interactions with cumarinic anticoagulants must be taken into account and therefore patients subjected to treatment with such drugs must consult the doctor before taking the product. Serotonin reuptake selective agents and inhibitors (SSRIs): increased risk of gastrointestinal hemorrhage (see paragraph 4.4). Corticosteroids: increased risk of gastrointestinal ulceration or hemorrhage (see paragraph 4.4). Acetyllic acid: Concurrent administration of ibuprofen and acetylsalicylic acid is not generally recommended due to the potential increase in unwanted effects. Experimental data suggests that ibuprofen can competitively inhibit the effect of acetylsalicylic acid at low doses on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of this data to the clinical situation, the possibility that regular use, long-term of ibuprofen, can reduce the cardioprotective effect of acetylsalicylic acid at low doses. No significant clinical effect is considered likely due to occasional use of ibuprofen (see paragraph 5.1). Other NSAIDs included selective COX-2 inhibitors: avoid the concomitant use of two or more NSAIDs as this entails an increase in the risk of adverse effects (see paragraph 4.4). Litio: hybuprofen can increase plasma concentrations of lithium, for reduced elimination of the latter. It is therefore recommended to monitor the serum levels of lithium. Heart glycosides: ibuprofen, like other NSAIDs, can exacerbate heart failure, reduce glomerular filtration speed (VFG) and increase plasma concentrations of glycosides. It is therefore recommended to monitor the serum levels of glycosides. Diuretics, ACE inhibitors, angiotensin antagonists II and Beta blockers: nSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function) co-administration of an inhibitor ACE or an angiotensin II antagonist and agents inhibiting the cyclo-oxidase system can lead to further deterioration of kidney function, which includes a possible acute kidney failure, generally reversible. These interactions must be considered in patients taking ALGOFEN in conjunction with ACE inhibitors or antagonists of angiotensin II. So the combination should be given with caution, especially in elderly patients. Patients should be properly hydrated and monitoring the kidney function should be taken into consideration after the start of the concomitant therapy. The hypotensive effect of beta-blockers can be reduced. Concurrent use of NSAIDs and beta-blockers can be associated with the risk of acute renal failure.Sulfaniluree: nSAIDs can enhance the effect of sulfaniluree. Rare cases of hypoglycemia were reported in patients treated with sulfaniluree taking ibuprofen. Methodology: nSAIDs can reduce metotrexate clearance through tubular secretion inhibition. The administration of ibuprofen 24 hours before or after the administration of metotrexate may lead to an increase in the concentration of metotrexate and to an increase in its toxic effect. Therefore, the concomitant use of NSAIDs and high doses of metotrexate should be avoided. If concurrent administration is necessary, the patient must be carefully monitored for toxicity, especially myeloppression and gastrointestinal toxicity. In addition, the potential risk of interactions should also be taken into account in low dose treatment of metotrexate (Ciclosporin and tacrolimus: the risk of a nephrotoxic effect due to cyclosporin and tacrolimus, due to the reduction of the synthesis of prostaglandins in the kidney, increased from the concomitant administration of some non-steroidal anti-inflammatory drugs, including ibuprofen. Therefore, ibuprofen should be administered at lower doses than those used in patients who do not take these immunosuppressive agents and kidney function is strictly controlled. Fluoquinox antibacterial: there have been isolated cases of seizures that may have been induced by the concomitant use of fluorochinolone and NSAIDs. Fenitoine: when using phenytoin in conjunction with ibuprofen, blood levels of phenytoin can increase. The monitoring of plasma concentrations of phenytoin is therefore recommended. Colestipolo e colestiramina: when administered at the same time to 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 administration of colestipolo/colestiramine. Powerful inhibitors of CYP2C9: concurrent administration of ibuprofen with inhibitors of CYP2C9 (such as sulfinpirazone, fluconazole and voriconazole) requires caution, because it could lead to a significant increase in peak plasma concentrations and exposure to ibuprofen, due to the inhibition of ibuprofen metabolism. In a study with voriconazole and fluconazole (CYP2C9) inhibitors, an increase in exposure to the S(+)-ibuprofen approximately from 80 to 100% was highlighted. Therefore a reduction in the dose of ibuprofen should be considered when administered in conjunction with powerful CYP2C9 inhibitors, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole. Zidovudina: there is an increased risk of hematological toxicity in case of simultaneous administration with NSAIDs. There are evidence of an increased risk of hematrosis and hematomas in seropositive hemophilic patients for HIV treated simultaneously with zidovudine and ibuprofen. Alcohol, biphosphonate and pentoxyphylline: can enhance gastrointestinal side effects and the risk of bleeding and ulcer. Baclofene: increased toxicity of baclofene. Plant extracts: Ginkgo Biloba can increase the risk of bleeding if taken in association with NSAIDs.

Effects

The most commonly observed adverse events are gastrointestinal. Peptic ulcers, perforation or gastrointestinal hemorrhage may occur, sometimes fatal, especially in the elderly (see paragraph 4.4). Undesirable effects are mostly dose-dependent and may vary from patient to patient. In particular, the risk of gastrointestinal hemorrhage is dependent on dose and duration of treatment. After administration ALGOFEN were reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see paragraph 4.4). Less frequently gastritis were observed. In association with the treatment with the NSAIDs were reported edema, hypertension and heart failure. Bollose reactions including Stevens-Johnson Syndrome and Epidermal Toxic Necrolysis (very rarely). Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/die), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see paragraph 4.4). Some of the side effects are less frequent when the maximum daily dose is 1200 mg compared to high dose therapy in rheumatic patients. Adverse reactions are listed below, according to the classification for systems and organs and frequency. The frequencies are defined as: very common (≥ 1/10); common (≥1/100, Infections and infestations. Very rare: worsening of inflammations associated with infection (e.g. development of necrotizing fascites) described in coincidence with the use of non-steroidal anti-inflammatory drugs1. Emolinfopoietic system pathologies. Very rare: thrombocytopenia, anemia, leucopenia, pancitopenia, agranulocytosis2. Immune system disorders. Not common: hypersensitivity reactions, including skin antema, hives, itching, purple and asthmatic attacks (sometimes with hypotension); (see paragraph 4.4). Rare: lupus erythematose syndrome; Very rare: anaphylactic reaction, angioedema. Psychiatric disorders. Rare: depression, confusion, hallucinations, psychotic reactions. Diseases of the nervous system. Common: headache (see paragraph 4.4), drowsiness, dizziness, fatigue, agitation, dizziness, insomnia, irritability; Not common: parestesia; Rare: aseptic meningitis3 (see paragraph 4.4), cerebrovascular accidents. Pathologies of the eye. Common: visual disorders ⁵; Rare: ambliopia. Ear and labyrinth pathologies. Rare: tinnitus, compromise of hearing. Respiratory, chest and mediastinic pathologies. Not common: bronchospasm, rhinitis. Heart disease. Very rare: palpitations, heart failure (see paragraph 4.4), myocardial infarction, acute pulmonary edema, edema (see paragraph 4.4). Vascular diseases. Very rare: arterial hypertension (see paragraph 4.4). Gastrointestinal diseases. Very common: gastrointestinal disorders, such as pyrosis, dyspepsia, abdominal pain, nausea, vomiting, flatulence, diarrhea, stipsi; Common: gastrointestinal ulcers, sometimes with bleeding and perforation (see paragraph 4.4), loss of occult blood that can lead to anemia, melena, ematemesis, ulcerative stomatitis, colitis, exacerbation of intestinal inflammatory diseases, complications of colon diverticula (perforation, fistola); Not common: gastritis; Rare: worsening of colitis and Crohn's disease (see paragraph 4.4); Very rare: esophagitis, pancreatis, intestinal shrinkage. Hepatobiliary diseases. Not common: hepatitis, jaundice, alteration of liver function; Very rare: alteration of liver function tests, acute hepatitis, liver damage⁴ especially in long-term use, liver failure. Pathologies of skin and subcutaneous tissue. Town: rash; Not common: itching, purple, photosensitivity reaction; Very rare: severe forms of skin reactions (mulform erythema, exfoliative dermatitis, bollose reactions, including Steven-Johnson syndrome and toxic epidermal necrolysis, alopecia, necrotizing fascites (see paragraph 4.4). Severe skin infections with complications of soft tissues may occur during chickenpox; Notable: reaction from drug with heosinophilia and systemic symptoms ( DRESS syndrome), generalized acute hexantholysis (PEAG). Diseases of musculoskeletal system and connective tissue. Note: Skeletal muscle stiffness. Kidney and urinary pathologies. Not common: edema development, especially in patients with arterial hypertension or kidney failure, nephrotic syndrome, interstitial nephritis that can be associated with kidney failure ⁶; Rare: kidney failure, renal tissue damage (paint necrosis⁴), increased serum concentration of uric acid; Very rare: hematuria. Pathologies of the reproductive apparatus and of the breast. Very rare: menstrual disorders. Diagnostic examinations. Rare: increase in urethic nitrogen, transaminase and alkaline phosphatease, decrease in hemoglobin and heatocrite values, inhibition of piastrinic aggregation, prolongation of bleeding time, decrease in serum calcium, increase in uric acid. 1 This is probably related to the mechanism of action of non-steroidal anti-inflammatory drugs. If signs of an infection appear during treatment with ibuprofen or worsening of an infection, it is recommended for the patient to address without delay to a doctor. It should therefore be evaluated if there is the need for anti-infective/antibiotic therapy. 2 The first signs are: fever, throat, superficial ulcers of the mouth, flu-like symptoms, severe fatigue, bruises and inexplicable bleeding. These ethical disorders may appear particularly after long-term use of high doses. In long-term therapy, blood tests should be carried out gradually (see paragraph 4.4). 3 The first symptoms are: nucal tension, headache, nausea, vomiting, fever, disorientation or clouding of consciousness. Patients with autoimmune disorders (Lupus Eritematoso Sistemico, mixed connective tissue disease) seem to be predisposed (see paragraph 4.4). ⁴ In particular in long-term therapy. ⁵ Reversible ailments of the eye have been observed, such as toxic ambliopia, clouded vision and alterations of color perception. In case of such reactions, ibuprofen should be suspended. ⁶Various degrees of impairment of kidney function may occur, especially with long-term use of high doses. A sudden worsening of kidney function can also be associated with a general reaction from hypersensitivity. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . .

Overdosing

Toxicity Signs and symptoms of toxicity were generally not observed at doses less than 100 mg/kg in children or adults. However, in some cases you may need a support treatment. It has been observed that children manifest signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or greater. Synonyms In cases of severe poisoning, it is possible that metabolic acidosis occurs. Most patients who have ingested significant quantities of ibuprofen will manifest symptoms within 4-6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy and drowsiness. The effects on the central nervous system (SNC) include headaches, tinnitus, dizziness, convulsions (even myoclonic seizures in children), dizziness and loss of consciousness. In severe poisoning may prolong protrobinin/ INR probably because of interference with the actions of the circulating factors of the clotting. Rarely, nistagm, metabolic acidosis, hypothermia, kidney effects, gastrointestinal bleeding, coma, apnea, cyanosis, diarrhea and depression of SNC and respiratory system have also been reported. Disorientation, state of excitement, fainting and cardiovascular toxicity including hypotension, bradycardia, tachycardia. Asthmatic patients can exacerbate the condition. In cases of significant overdose are possible kidney failure and liver damage. Treatment There is no specific antidote for overdosing ibuprofen. In case of overdose, a symptomatic and support treatment is therefore indicated. Particular attention is given to the control of blood pressure, acid-base balance and gastrointestinal bleeding. Within an hour of the ingestion of a potentially toxic quantity must be considered the administration of activated carbon. Alternatively, in the adult, within an hour of the ingestion of a potentially dangerous overdose for life, the gastric lavender must be taken into account. An adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours after ingestion of a potentially toxic drug. Any occurrence of frequent or prolonged seizures must be treated with intravenous diazepam. Other support measures may be required in relation to the patient's clinical conditions. For more information, contact the local anti-veleni center.

Pregnancy

: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, ALGOFEN it must not be administered unless clearly necessary. If ALGOFEN is used by a woman waiting for conception, or during the first and second trimester of pregnancy, the dose and duration of treatment must 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 arterial duct and pulmonary hypertension); • kidney dysfunction, which can progress in kidney failure with oligoidramnios. The mother and the newborn, at the end of pregnancy, to: • Possible prolongation of bleeding time, and anti-aggregating effect that may also be necessary at very low doses; • Inhibition of uterine contractions resulting in delay or extension of labor. Consequently, ALGOFEN is contraindicated during the third trimester of pregnancy.

Food

: Hybuprofen passes into breast milk in small quantities. Although no undesirable effects in the infant are known today, caution should be given when ibuprofen is given to a nursing woman.

Fertility

: There are evidence that drugs that inhibit cycloxygenase/prostaglandin synthesis can cause a reduction in female fertility due to ovulation. This event is however reversible with the suspension of treatment.

Source: Farmadati