ANTINF 20BUST 25MG

FASTUMDOL ANTINFIAMMATORIA 25 MG GRANULATE FOR ORAL DEPARTMENT

active ingredients

Each bag of granulate per oral solution contains 25 mg of dexketoprofene as dexketoprofene tromethylamolo Excipients with known effects: sucrose: 2.418 g For the full list of excipients, see paragraph 6.1.

Excellent

Glycyrrizinate ammonium Neoesperidine-dihydrocalcone Chinoline Yellow (E104) Lemon aroma Saccarosio

Therapeutic indications

Syntomatic treatment of short duration of painful affections of mild to moderate intensity, such as acute musculoskeletal pain, dysmenorrhea and dental pain.

Contraindications

Fastumdol Antinflammatory granulate for oral solution should not be administered in the following cases: - patients with hypersensitivity to the active ingredient, or any other NSAID, or any of the excipients listed in paragraph 6.1; - patients who have developed asthma, bronchospasm, acute rhinitis, hive nasal polyps or angioedema after exposure to substances from the mechanism of similar action (e.g. acetylsalicylic acid, or other NSAIDs) - patients with photoallergic or phototoxic reactions known during treatment with ketoprofen or fibres; - patients with bleeding anamnesis or gastrointestinal perforation related to a previous therapy with NSAIDs; - patients with active peptic ulcer/gastrointestinal bleeding in place or any previous anamnestic bleeding, ulceration or gastrointestinal perforation; - patients with chronic dyspepsia; - patients who have other bleeding in place or clotting disorders; - patients with Crohn disease or ulcerative colitis; - patients with severe heart failure; - patients with moderate to severe renal failure (cantonance of creatinine ≤59 ml/min); - patients with severe liver failure (pointing Child-Pugh 10-15); - patients with hemorrhagic dialysis and other clotting disorders; - patients with severe dehydration (caused by vomiting, diarrhea or insufficient liquid intake); - during the third trimester of pregnancy and nursing (see paragraph 4.6).

Population

Population Adults Depending on the nature and intensity of pain, the recommended dose is 25 mg every 8 hours. The total daily dose should not exceed 75 mg. Undesirable effects can be minimized using the minimum effective dose for the time strictly necessary to eliminate symptoms (see paragraph 4.4). Fastumdol Antinflammatory is indicated only for short-term treatments and administration is limited to only symptomatic period. Seniors In older patients it is recommended to start therapy with the lowest therapeutic dose (50 mg the total daily dose). The dosage can be increased so as to reach the recommended one for the adult only after a good tolerance has been established. Due to the risk profile (see paragraph 4.4), the elderly must be closely monitored. Epathetic insufficiency Patients with mild to moderate liver failure should start therapy at reduced doses (50 mg of total daily dose) under strict medical control. Fastumdol Antinflammatory should not be used in patients with severe liver failure. Insufficiency renal In patients with mild renal insufficiency (cantonance of creatinine 60 - 89 ml/min) the initial dosage must be reduced to 50 mg of total daily dose (see paragraph 4.4). Fastumdol Antinflammatory should not be used in patients with mild to severe renal failure (creatiny ≤59 ml/min) (see paragraph 4.3). Pediatric population Fastumdol Antinflammatory granulate for oral solution was not studied in children and adolescents. Therefore, not being available security and effectiveness data, the product should not be used in children and adolescents. Method of administration Dissolve the entire contents of each bag in a glass of water: mix well to dissolve completely. The solution thus obtained must be ingested immediately after reconstitution. The concomitant administration of food delays the rate of absorption of the drug (see “Property pharmacokinetics”), so, in case of acute pain, it is recommended to administer the drug at least 15 minutes before meals.

Conservation

This medicine does not require special precautions for conservation.

Warnings

Use with precaution in patients with anamnesi of allergic conditions. It must be avoided the concomitant use of Fastumdol Antinflammatory with other NSAIDs, including selective cyclooxygenase-2 inhibitors. Undesirable effects can be minimized using the lowest effective dose for the time strictly necessary to eliminate symptoms (see paragraph 4.2 and gastrointestinal and cardiovascular risks below). Gastrointestinal safety Blood, ulceration or potentially fatal gastrointestinal perforation have been reported with all NSAIDs at any time during treatment, with or without premonitory symptoms or previous anamnesi of serious gastrointestinal events. When a gastrointestinal bleeding or ulceration occurs in patients who are administered Fastumdol Antinflammatory, the therapy must be immediately interrupted. The risk of bleeding, ulceration or gastrointestinal perforation increases with the increase of the dosage of NSAIDs in patients with pregress ulcer, especially if complicated by hemorrhage or perforation (see paragraph 4.3) and in the elderly. Elders: older people have a greater frequency of adverse reactions to NSAIDs, especially bleeding and gastrointestinal perforation that can be fatal (see paragraph 4.2). These patients must begin treatment with the minimum dose available. As with all NSAIDs, before starting treatment with dexketoprofene tromethylamolo, it is necessary to investigate exophagiated, gastriti and/or peptic ulcers and ensure their total healing. Patients with gastrointestinal or anamnesi symptoms of gastrointestinal disease must be carefully monitored for the appearance of digestive disorders, especially gastrointestinal bleeding. NSAIDs should be given with caution to patients with anamnes of gastrointestinal pathologies ( ulcerative colitis, Crohn's disease), since such conditions may be exacerbated (see paragraph 4.8). Concurrent use of protective agents (e.g. misoprostol or protonic pump inhibitors) must be considered for these patients and for patients who receive a low concomitant dose of acetylsalicylic acid or other drugs that may increase gastrointestinal risk (see below and paragraph 4.5). Patients with an anamnesi of gastrointestinal toxicity, especially if elderly, must report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially in the early stages of treatment. Precaution is recommended in patients who are administered at the same time medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors and -anti-aggregant agents such as acetyl acid (see paragraph 4.5). Renal safety Use carefully in patients with compromised kidney function. In these patients the use of NSAIDs can cause deterioration of kidney function, fluid retention and edema. Caution is needed for increased risk of nephrotoxicity, even in patients in diuretic therapy or who risk developing hypovolemia. During treatment it is necessary to ensure adequate intake of liquids to prevent dehydration and the risk of kidney toxicity. Like all NSAIDs, the product can cause an increase in azotemia and creatininemia. As with other prostaglandin synthesis inhibitors, undesirable effects can occur on the kidney that can lead to glomerular nephritis, interstitial nephritis, kidney papillar necrosis, nephrosic syndrome and acute kidney failure. Senior patients are the most exposed to the risk of kidney failure (see paragraph 4.2). Epathetic safety Caution is needed in patients with impairment of liver function. Like other NSAIDs, it can cause small transient increments of some hepatic function parameters, and also significant increases of GOT and GPT. In the event of a significant increase in these parameters, therapy must be interrupted. Senior patients are the most exposed at risk of liver failure (see paragraph 4.2). Cardiovascular and cerebrovascular safety For patients with an anamnesi of hypertension and/or mild to moderate heart failure, appropriate monitoring is required. Particular caution should be given in cardiopathic patients, especially if with heart failure anamnesis since there is increased risk of heart failure, since fluid and edema were reported in conjunction with the use of NSAIDs. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially high dosages and protracted therapies) may be associated with a slight increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). There is no sufficient data to exclude such risk for dexketoprofene. Therefore patients with uncontrolled hypertension, congestive heart failure, established ischemic cardiopathy, peripheral arteriopathy and/or cerebrovascular pathologies should be treated with dexketoprofen only after careful evaluation. Analogue attention should be paid before starting long-term treatment in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). All non-selective NSAIDs are able to inhibit piastrinic aggregation and prolong bleeding time by inhibiting prostaglandin synthesis. The use of dexketoprofen is therefore not recommended in patients receiving another therapy that interferes with hemostasis, such as warfarin or other cumarinics or eparine (see paragraph 4.5). Older patients are more likely to have alterations in the cardiovascular function (see paragraph 4.2). Skin reactions Severe skin reactions (some of which fatal), including exfoliative dermatitis, Stevens-Johnson's syndrome and epidermal toxic necrolysis were reported very rarely in association with the use of NSAIDs. In the early stages of therapy patients seem at higher risk: the onset of reactions occurs, in most cases, within the first month of treatment. At the first appearance of skin rash, mucosa lesions or any other symptom of hypersensitivity, therapy with Fastumdol Antinflammatory must be interrupted. Masking the symptoms of underlying infections Dexketoprofen can mask the symptoms of infection, which may delay the start of proper treatment and thus worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When this medicine is administered for pain relief related to infection, it is recommended to monitor the infection. In non-hospital contexts, the patient should contact the doctor if symptoms persist or worsen. In exceptional cases chickenpox can be associated with severe infectious complications of the skin and soft tissues. To date, a role of NSAIDs cannot be excluded in the aggravation of such infections, so it is advisable to avoid the use of inflammatory Fastumdol in patients with chickenpox. Other information Particular caution is required in patients with: - congenital abnormalities of porphyrin metabolism (e.g. acute intermittent porphyria) - dehydration - immediately after major surgery If the doctor considers a long-term therapy with dexketoprofen it is necessary to regularly monitor liver, kidney and hemochrome function. Strict reactions from acute hypersensitivity (e.g. anaphylactic shock) have been observed in rare cases. At the first manifestation of severe reactions of hypersensitivity after taking Fastumdol Antinflammatory stop treatment immediately. Depending on the symptoms, immediately start the necessary medical procedures, with qualified medical personnel. Patients with asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polypoxes have a higher risk of allergy to acetylicylic acid and/or NSAIDs than the rest of the population, The administration of this medicine may cause asthma or bronchospasm attacks especially in allergic to acetylsalicylic acid or NSAIDs (see paragraph 4.3). Fastumdol Antinflammatory must be administered with caution to patients suffering from hematopoietic disorders, systemic lupus erythematous or mixed connective tissue disease. This medicine contains sucrose. Patients with fructose intolerance, glucose-galactosis mal absorption or isomaltase sucrasis failure should not take this medicine. To consider in people with diabetes mellitus. Pediatric population Safety of use in children and adolescents has not been established.

Interactions

The following interactions are characteristics of non-steroidal anti-inflammatory drugs (NSAID) in general: Unrecommended associations - Other NSAIDs (including selective oxygenase-2 inhibitors) and high doses of salicylates (≥3 g/die): simultaneous administration of multiple NSAIDs can increase the risk of gastrointestinal ulceration and bleeding due to a synergistic effect; - Antiagulants: NSAIDs can enhance the effects of anticoagulants, such as warfarin (see paragraph 4.4), due to the high plasma protein bond of dexketoprofene, inhibition of pyasternic function and damage to gastro-duodenal mucosa. If it is not possible to avoid the association, rigorous clinical observation and monitoring of laboratory parameters are necessary. - Eparine: increased risk of hemorrhage (due to the inhibition of the pyastrinic function and the damage to gastrointestinal mucosa). If it is not possible to avoid the association, rigorous clinical observation and monitoring of laboratory parameters are necessary. - Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see paragraph 4.4). - Lithium (described with many NSAIDs): NSAIDs increase blood levels of lithium with the risk of reaching toxic values (renal excretion of decreased lithium); therefore, this parameter requires careful monitoring at the beginning, during adjustment and at the end of treatment with dexketoprofene. - Metotrexate when used at high doses (≥ 15 mg/week): increased hematological toxicity of metotrexate due to a decrease in its kidney clearance, in general with the NSAIDs. - Idantoins and sulfonamides: the toxic effects of these substances can be enhanced. Associations requiring caution - Diuretics, ACE inhibitors, aminoglycosidic antibiotics and antagonists of angiotensin receptor II: dexketoprofen can reduce the effect of diuretics and antihypertensive drugs. In some patients with compromised kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function), the concomitant administration of agents that inhibit cyclooxygenase and ACE inhibitors, antagonists of angiotensin II receptor or aminoglycosidic antibiotics may cause further deterioration of kidney function, usually reversible. In case of concomitant prescription of dexketoprofene and diuretic, it is essential to ensure proper hydration of the patient and to control the kidney function both at the beginning of the treatment and periodically afterwards. Concurrent administration of Fastumdol Antinflammatory and potassium-saving diuretics can cause hypercaliemia. It is necessary to monitor blood potassium concentrations (see paragraph 4.4). - Metotrexate if used at low doses (Associations to be carefully evaluated - Beta-blockers: treatment with NSAIDs can decrease their antihypertensive effect due to the inhibition of prostaglandin synthesis. - Ciclosporin and tacrolimus: NSAIDs can enhance nephrotoxicity due to the mediated effects of kidney prostaglandins. During therapy, check kidney function. - Trombolitics: increased risk of hemorrhage. - Anti-platelet agents and SSRIs (selective serotonin reuptake inhibitors): increased risk of gastrointestinal bleeding (see paragraph 4.4). - Probenecid: it can increase the plasma concentrations of dexketoprofen; this interaction can be due to an inhibitory mechanism at the level of the secretion of the renal tubule and glucuronoconjugation and requires a adjustment of the dose of dexketoprofen. - Cardioactive glycosides: NSAIDs can increase plasma concentrations of cardioactive glycosides. - Mifepristone: there is the theoretical risk that prostaglandin-synthesis inhibitors may alter the effectiveness of mifepristone. Limited evidence suggests that the concomitant administration of NSAIDs on the same day of prostaglandine administration does not adversely affect the effects of mifepristone or prostaglandins on cervical maturation or uterine contractility and does not reduce the clinical effectiveness of the medical interruption of pregnancy. - Chinolonics: animal studies indicate that high doses of chinolonic antibiotics in combination with NSAIDs can increase the risk of seizures. - Tenofovir: Concurrent use with NSAIDs can increase atathemia and creatinine, so the kidney function must be monitored to control a possible synergistic influence on the kidney function. - Deferasirox: Concurrent use with NSAIDs can increase the risk of gastrointestinal toxicity. When administering deferasirox with these substances it is necessary to carry out rigorous clinical monitoring. - Pemetrexed: Concurrent use with NSAIDs can reduce the elimination of pemetrexed, therefore it is necessary to exercise caution in administering higher doses of NSAIDs. In patients with mild to moderate kidney failure (cancerance of creatinine between 45 and 79 ml/min), the concomitant administration of pemetrexed with FANS must be avoided for 2 days before and 2 days after the administration of pemetrexed.

Effects

In the table below, grouped by apparatus and listed in frequency order, adverse events are reported, probably related to dexketoprofen, verified during clinical studies and after the marketing of Fastumdol Antinflammatory granules. Plasma levels C_max dexketoprofen in the formulation in granules are higher than those reported for formulation in tablets, therefore it is not possible to exclude a potential increase in the risk of adverse events (gastrointestinal).

Classification Systemic Organ	Common (from ≥1/100 to	Not common (from ≥1/1.000 to	Raro (from ≥1/10.000 to	Very rare (
Emolinfopoietic system pathologies				Neutropenia, thrombocytopenia
Immune system disorders			Larynx edema	Anaphylactic reactions, including anaphylactic shock
Disorders of metabolism and nutrition			Anorexia
Psychiatric disorders		Insomnia; anxiety
Diseases of the nervous system		Cephalea, dizziness, drowsiness	Parestesia, syncope
Pathologies of the eye				View blur
Ear and labyrinth pathologies		Vertigo		Tinnitus
Heart disease		Palpitations		Tachycardia
Vascular diseases		Heat flashes	Hypertension	Hypotension
Respiratory, chest and mediastinic pathologies			Bradipnea	Broncospasmo, dispnea
Gastrointestinal diseases	Nausea and/or vomiting, abdominal pain, diarrhea, dyspepsia	Gastrite, stipsi, dry mouth, flatulence	Peptic ulcer, hemorrhage or perforation from peptic ulcer (see paragraph 4.4)	Pancreatis
Hepatobiliary diseases			Hepatocellular year
Pathologies of skin and subcutaneous tissue		Rash	Orticaria, acne, increased sweating	Steven Johnson Syndrome, toxic epidermal necrolysis ( Lyell syndrome), angioedema, facial edema, photosensitivity reaction, itching
Skeletal muscle and connective tissue system pathologies			Backache
Kidney and urinary pathologies			Polyuria, acute kidney failure	Nephritis or nephrosic syndrome
Pathologies of the reproductive apparatus and of the breast			Menstrual disorders. Prostatic disorders
Systems and disorders in the administration		Affection, pain, asthenia, shivers, sense of malaise	Peripheral edema
Diagnostic examinations			Anomaly in liver function tests

The most commonly observed side effects are gastrointestinal. Peptic ulcers, perforation or gastrointestinal bleeding may occur, sometimes fatal especially in the elderly (see paragraph 4.4). As a result of the administration, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, ematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see paragraph 4.4) were reported. Gastritis was detected with less frequency. In association with NSAID therapy, edema, hypertension and heart failure were reported. The results of clinical trials and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long periods) may be associated with a slight increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see paragraph 4.4). As with other NSAIDs, the following side effects may appear: aseptic meningitis, which can occur predominantly in patients with systemic erythematous lupus or mixed connectivity; hematological reactions (porpora, aplastic anemia and hemolytics, and rarely agranulocytosis and midollar hypoplasia). 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: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

Syntomatology derived from overdose is not known. Similar medicinal products have caused gastrointestinal disorders (vomite, anorexia, abdominal pain) and neurological disorders (sonnolence, dizziness, disorientation, headache). In case of accidental or excessive intake, immediately take appropriate symptomatic therapy according to the patient’s clinical conditions. Within an hour it is necessary to administer activated charcoal if more than 5 mg/kg were ingested by an adult or child. Dexketoprofene tromethylamolo can be eliminated by dialysis.

Fastumdol Antinflammatory is contraindicated in the third trimester of pregnancy and during lactation (see paragraph 4.3). Pregnancy The inhibition of prostaglandin synthesis can have negative effects on pregnancy and/or on the development of embryo or fetus. Results of epidemiological studies suggest an increased risk of spontaneous abortion and heart and gastroschisis malformation after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure had increased from less than 1% to about 1.5%. It is believed that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in pre- and post-system loss 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 inhibitors of prostaglandin synthesis during the organogenetic period. However, studies with dexketoprofen on animals did not show reproductive toxicity (see paragraph 5.3). During the first and second trimester of pregnancy dexketoprofen should only be administered in strictly necessary cases. If dexketoprofene 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 maintained 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 failure, which can progress in kidney failure with oligoidramnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect that can also occur at very low dosages; - inhibition of uterine contractions, resulting in delay or extension of labor. Food It is not known whether dexketoprofene is excreted in breast milk. Fastumdol Antinflammatory is contraindicated during breastfeeding (see paragraph 4.3). Fertility The use of Fastumdol Antinflammatory can damage female fertility and it is not recommended to administer it to women who wish to have a pregnancy. In the case of women with difficulties of conception or who are carrying out infertility examinations, assess the interruption of the administration of dexketoprofen.

Source: Farmadati