ITAMIFAST 10CPR RIV 25MG

ITAMIFAST 25 MG COMPRESENT RIVES WITH FILM

active ingredients

Each tablet contains 25 mg of potassium diclofenac. Excipients: 25 mg tablets: Mannitol: 58.8 mg Potassium hydrogen carbonate of 11.0 mg For full list of excipients, see paragraph 6.1.

Excellent

Compressed core: Mannitol, Potassium hydrogen carbonate, Sodium lauril sulphate, Macrogol, Crospovidone, Magnesium stearate. Coating: Ipromellosa, Macrogol.

Therapeutic indications

In adults, acute painful affections, such as headache, toothache, muscle or joint pain, backache and primary dysmenorrhea. In teenagers over 14 years, short-term symptomatic treatment of pain associated with painful inflammations of the ear, nose or throat, e.g. pharyngitis, tonsillite, otititis (see paragraph 4.4). Short-term symptomatic treatment of postoperative pain after minor surgery.

Contraindications

- Hypersensitivity known to the active ingredient or any of the excipients. - Ulcer, bleeding or gastric or active intestinal perforation. - Anamnesis of bleeding or gastrointestinal perforation linked to previous therapy with NSAID. - Anamnesi of recurrent peptic ulcer/hemorrhage or recurrent peptic ulcer/active bleeding (two or more distinct episodes of ulceration or bleeding) - Last trimester of pregnancy (see paragraph 4.6). - Conditions that cause an increase in the tendency to bleeding. - Severe liver failure. - Hepatic porphyry. - Severe kidney failure (glomerular filtration speed > 30 mL/min). - As with other non steroid anti-inflammatory drugs (FANS), diclofenac is also contraindicated in patients where asthma, urticaria or acute rhinitis attacks are exacerbated by acetilsalicylic acid or other NSAIDs. - Conclaimed congestive congestive heart failure (NYHA class II-IV), ischemic cardiopathy, peripheral arteriopathy and/or cerebral vasculopathy. - Do not use below 14 years

Population

Treatment should be reserved for adults and adolescents over 14 years. Treatment should be initiated at the lowest dose considered effective. The dose can then be adjusted according to the therapeutic response and any side effects, for a maximum daily dose of 75 mg and for a duration not exceeding three days of treatment. Undesirable effects can be reduced to a minimum by providing the minimum effective dose for the minimum duration needed to control symptoms (see paragraph 4.4 Special warnings and precautions). Adults and teenagers over 14 years old Other pain: 25 mg every 8 hours. The highest recommended daily dose is 75 mg. The absorption rate of diclofenac is reduced when Itamifast is taken with food. Therefore we do not recommend taking tablets with food or directly after a meal. Proven liver function: Itamifast is contraindicated in patients with severe liver compression. For patients with mild to moderate liver impairment see paragraph 4.4 Special warnings and precautions of use.

Conservation

This medicine does not require special conditions of conservation.

Warnings

General notices Undesirable effects can be reduced to a minimum by providing the minimum effective dose for the minimum duration needed to control symptoms (see paragraph 4.2 and gastrointestinal and cardiovascular risks below). Itamifast’s concomitant use with systemic NSAIDs must be avoided, including selective cycloxygenase-2 inhibitors due to the absence of any evidence showing synergistic benefits and the possibility of side effects. For medical reasons, care is recommended in elderly patients. In particular, it is recommended to use the lowest effective dose in fragile elderly patients or those with low body weight. Older patients have a greater risk of adverse reactions to NSAIDs in particular bleeding and gastrointestinal perforation that can be fatal. It is also more likely that elderly patients suffer from kidney, heart or liver impairment. As with other NSAIDs, with diclofenac in rare cases, allergic reactions may arise, including anaphylactic/anaphylactic reactions without recent exposure to the drug. Hypersensitivity reactions can also evolve into Kounis syndrome, a severe allergic reaction that can cause myocardial infarction. The current symptoms of such reactions may include chest pain that occurs in association with an allergic reaction to diclofenac. As with other NSAIDs, due to its pharmacodynamic properties Itamifast can mask the signs and symptoms of infections. Short-term oral diclofenac forms with cephalea indication: Prolonged use of any kind of painkiller for headache can make it worse. If you suspect or develop this situation, you should ask for advice to your doctor and treatment should be stopped. In patients with daily or frequent headaches despite (or due to) regular use of cephalea medications should be hypothesized a diagnosis of drug abuse headaches (MOH). Gastrointestinal effects With all NSAIDs, including diclofenac, bleeding, ulceration or gastrointestinal perforation have been reported, which can be fatal and can occur at any time during treatment, with or without alarm symptoms or a previous anamnesi of severe gastrointestinal events. They generally have more serious consequences in the elderly. If bleeding or gastrointestinal ulceration occurs in patients treated with Itamifast, the medicine must be suspended. As with all NSAIDs, including diclofenac, medical surveillance is essential and special caution should be exercised when it prescribes Itamifast in patients with indicative symptoms of gastrointestinal disorders or anamnesis that suggests ulceration, bleeding or gastric or intestinal perforation (see paragraph 4.8). The risk of gastrointestinal bleeding is greater with the increase in the dose of the NSAID or in patients with ulcer anamnesis, especially if complicated by hemorrhage or perforation. In older patients the frequency of adverse reactions to NSAIDs has increased, in particular bleeding and gastrointestinal perforation, which can be fatal. To reduce the risk of gastrointestinal toxicity in patients with ulcer anamnesis, especially if complicated by hemorrhage or perforation, and in the elderly, treatment must be started and maintained at the lowest effective dose. For these patients, and also for patients requiring the concomitant use of medicines containing low doses of acetylsalicylic acid (ASA)/aspirin or other medicines that may increase the gastrointestinal risk should be taken into account the therapy of association with protective agents (e.g. protonic or misoprostol pump inhibitors). Patients with gastro-intestinal toxicity anamnesis, especially elderly patients, must report any unusual abdominal symptoms (especially gastro-intestinal bleeding). Caution is recommended in patients treated with concomitant drugs could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, pyastrinic antiaggregants or selective serotonin reuptake inhibitors (see paragraph 4.5). In patients with ulcerative colitis or Crohn's disease, strict medical and caution must be exercised, because these conditions can be exacerbated (see paragraph 4.8). NSAIDs, including diclofenac, may be associated with an increase in the risk of gastrointestinal anastomosis. It is recommended to have close medical and caution when using diclofenac as a result of gastrointestinal surgery. Hepatitis effects When you prescribe Itamifast to patients with compromised liver function it is necessary to close medical surveillance, because this condition can be exacerbated. As with other NSAIDs, severe liver damage was reported during treatment with diclofenac (see paragraph 4.8) As with other NSAIDs, including diclofenac, can increase the values of one or more liver enzymes. During prolonged treatment with Itamifast, regular monitoring of liver function as a precautionary measure is indicated. If liver function tests continue to be abnormal or worsen, if signs and clinical symptoms are consistent with the development of a liver disease, or if other manifestations occur (e.g. esosinophilia, eruption), Itamifast must be stopped. With the use of diclofenac can occur hepatitis without prodromic symptoms. It is necessary caution when using Itamifast in patients with liver porphyria, because it can trigger an attack. Treatment with NSAIDs in patients with chronic liver disease should be avoided when possible due to increased risk of gastrointestinal bleeding. Renal effects Since, associated with NSAID therapy, including diclofenac, cases of fluid retention and edema have been reported, special caution is required in patients with impaired heart or kidney function, anamnesi of hypertension, in elderly patients, in patients treated in conjunction with diuretics or medicines that may have a significant impact on renal function, e.g. cyclosporin, and in these patients with depletion any extracellular volume, and major surgery. It is recommended to monitor the kidney function as a precautionary measure when using Itamifast in these cases. The interruption of therapy is usually followed by a return to the state before treatment. Skin effects In association with the use of NSAIDs, rash reactions were rarely reported, some of which fatal, including exfoliating dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (see paragraph 4.8). Patients seem to be at greater risk of developing these reactions at the beginning of the therapy cycle: the onset of the reaction occurs in most cases within the first month of treatment. The therapy with Itamifast must be interrupted to the first appearance of rash, lesions to mucosa or other signs of hypersensitivity. Exceptionally, the chickenpox can be the origin of serious infectious complications of skin and soft tissues. So far the role of NSAIDs in the worsening of these infections cannot be excluded. Therefore it is recommended to avoid the use of Itamifast in cases of chickenpox. Cardiovascular and cerebrovascular effects Caution is necessary (discussion with the doctor or pharmacist) before starting treatment in patients with an anamnesi of hypertension and/or heart failure because in association with NSAID therapy cases of fluid retention, hypertension and edema were reported. Clinical studies and epidemiological data suggest that inappropriate use of diclofenac, especially at high doses (150 mg per day) and in long term treatment may be associated with a small increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). The available data does not suggest an increase in risk with the use of low doses of diclofenac). Patients who present significant risk factors of cardiovascular events (e.g., hypertension, hyperlipidemia, diabetes mellitus, smoking) should be treated with diclofenac only after careful consideration. Since cardiovascular risks of diclofenac can increase with dose and duration of exposure, the minimum possible duration and the minimum effective daily dose must be used. The response to therapy and the need for improved symptoms must be reassessed periodically. Ematologic effects During prolonged treatment with diclofenac, as well as with other NSAIDs, blood count monitoring is recommended. Like other NSAIDs, diclofenac can temporarily inhibit platelet aggregation. Patients with hemostasis defects must be carefully monitored Pre-existing asthma In patients suffering from asthma, seasonal allergic rhinitis, swelling of nasal mucosa (e.g. polyps), chronic obstructive bronchopathy or chronic respiratory infections (especially if related to allergic symptoms similar to rhinitis), reactions due to NSAIDs as an asthma (the so-called analgesic intolerances/asthma by analgesics). This also applies to patients allergic to other active ingredients, e.g., with skin, itching or hives. Other As with other NSAIDs, Itamifast may, in rare cases, cause allergic reactions including anaphylactic/anaphylactic reactions (see paragraph 4.8). As with other NSAIDs, pharmacodynamic properties of diclofenac lead him to mask signs or symptoms of infection. Patients with systemic erythematose lupus must be carefully monitored during treatment with diclofenac. Patients treated with oral or antidiabetic anticoagulants should be monitored during treatment with diclofenac. Laboratory tests must be carried out to ensure that the desired effect of anticoagulants is maintained. Isolated cases of hypoglycemia and hyperglycemic effects have been reported which require a dose adjustment of antidiabetic agents. NSAIDs can inhibit the diuretic effect and increase the effects of potassium saving of diuretics, which makes it necessary to monitor sieric potassium levels. The use of diclofenac can reduce fertility and therefore is not recommended in women who are trying to conceive. This is true for all medicines that inhibit the synthesis of cyclooxygenase and prostaglandine. The effect is reversible and ends when the use of these types of medicines is interrupted. Teenagers over 14 years In teenagers over 14 years of age with pain related to infections with the inflammatory component of the ear, nose and throat regions, the basic pathology must be treated with a basic anti-infective therapy, as appropriate from the therapeutic point of view. The fever alone without an inflammatory component is not an indication.

Interactions

The following interactions include those observed with diclofenac gastro-resistant tablets and/or other pharmaceutical forms of diclofenac. Drug interactions Antiagulants and anti-platelet compounds: caution is recommended since concurrent administration could increase the risk of bleeding. Although clinical studies do not seem to indicate that diclofenac affects the action of anticoagulants, there were cases of an increase in the risk of hemorrhages in patients treated with diclofenac and anticoagulants in concomitance. The close monitoring of these patients is therefore recommended. Diuretics and antihypertensives: like other NSAIDs, the concomitant use of diclofenac with diuretics or antihypertensives (e.g. beta-blockers, angiotensin antagonists II and angiotensin conversion enzyme inhibitors (ACE)) can cause a reduction of its antihypertensive effect. Therefore the association must be administered with caution and blood pressure must be monitored periodically, especially in elderly patients. Patients should be properly hydrated and attention should be paid to the monitoring of kidney function after the start of concomitant therapy and periodically in the following period, especially for diuretics and ACE inhibitors due to increased risk of nephrotoxicity. Concurrent treatment with potassium-saving drugs may be associated with an increase in potassium levels, which must therefore be frequently monitored (see paragraph 4.4). Other NSAIDs: concurrent administration of diclofenac and other systemic or corticosteroid NSAIDs can increase the frequency of unwanted gastrointestinal effects (see paragraph 4.4). Selective serotonin reuptake inhibitors (SSRI): concurrent administration of systemic NSAIDs, including diclofenac, and SSRI may increase the risk of gastrointestinal bleeding (see paragraph 4.4). Antibacterial kinolonic: isolated cases of seizures have been reported that may have been due to concomitant use of kinolonics and NSAIDs. They can occur in patients with or without anamnesi pregress of epilepsy or seizures. For this reason, caution is needed when taking kinolonics into patients who already take NSAIDs. Oral antidiabetics: clinical studies have shown that diclofenac can be administered along with oral antidiabetics without affecting the clinical effect. However, isolated cases of hypo- and hyperglycemic effects were reported which required changes in the doses of antidiabetics during treatment with diclofenac. For this reason, it is recommended to monitor the blood glucose level as a precautionary measure during concurrent therapy. Corticosteroids: concurrent treatment with diclofenac and corticosteroids can increase the risk of gastrointestinal bleeding. Drug interactions Effects of diclofenac on pharmacokinetics of other medicines: Methodology: diclofenac can inhibit renal tubular clearance of metotrexate thus increasing metotrexate levels. Concurrent treatment with diclofenac and high doses of metotrexate should be avoided. Caution should be observed during the concomitant use of a treatment with low doses of metotrexate and patients must be monitored for possible toxicity related to metotrexate. It is recommended caution when NSAIDs, including diclofenac, are administered less than 24 hours before or after treatment with metotrexate, because plasma metotrexate concentrations can increase and the toxicity of this substance can increase. Litio: diclofenac reduces renal clearance of 20% lithium, thus increasing the serum levels of lithium. Lithium concentration monitoring is recommended. Ciclosporine and tacrolimus: diclofenac, like other NSAIDs, can increase the nephrotoxicity of cyclosporin due to the effect on kidney prostaglandins. The risk is likely to be present during treatment with tacrolimus. Therefore it should be administered at lower doses than those would be used in patients not treated with cyclosporin. Digoxin: the introduction of diclofenac in people treated with digoxin can cause increased plasma levels of digoxin. It is recommended to monitor the serum level of digoxin. Fenitoine: when using phenytoin in conjunction with diclofenac, it is recommended to monitor plasma concentrations of phenytoin due to the expected increase in exposure to phenytoin. Effects of other medicines on pharmacokinetics of diclofenac: Drugs that inhibit or induce CYP2C9 enzyme: diclofenac metabolism is catalysed by the CYP2C9 enzyme. Concurrent treatment with drugs that inhibit this enzyme (such as fluconazole, finpirazone and voriconazole) probably leads to high plasma concentrations of diclofenac. Drugs that induce the activity of CYP2C9 such as rifampin, carbamazepine and barbituric, can reduce plasma concentrations of diclofenac at therapeutic sub-levels. The diazepam, which is metabolized through the CYP2C19, increases the plasma concentration of diclofenac by 50-100%. The voriconazole, which is metabolized through the CYP2C19, increased the C_max and the AUC of the diclofenac (single dose of 50 mg) of 114% and 78% respectively. A dose adjustment of the NSAID may be required. Colestipolo e colestiramina: concurrent administration of diclofenac with choleestipol or choleesthramine reduces the absorption of diclofenac by about 30% (colestipol) and 60% (chlystyramine). Therefore it is recommended to administer diclofenac at least one hour before or 4-6 hours after the administration of choleestipolo/colestiramina.

Effects

Gastrointestinal disorders are the most commonly reported side effects. About 10% of patients experience these effects at the beginning of treatment. These side effects normally disappear after a few days, although the treatment is continued. Peptic ulcers, perforation or gastrointestinal bleeding may occur, particularly in older patients (see paragraph 4.4). These problems can occur at any time during treatment, with or without alarm symptoms and with or without an amnesian disease. Diclofenac causes temporary inhibition of platelet aggregation that can lead to increased risks in patients with various bleeding conditions. Exceptionally, cases of severe infectious skin complications and soft tissues occur during the chickenpox. The adverse reactions shown in the table are classified in frequency order from the most frequent using the following convention: Very common (> 1/10); Common (≥ 1/100, Diseases of the emolinfopoeitic system Very rare Trombocytopenia, leucopenia, anemia (including hemolytic and aplastic anemia), agranulocytosis. Immune system disorders Rare Hypersensitivity, anaphylactic and anaphylactic reactions (including hypotension and shock). Very rare Anjourotic edema (including facial edema). Psychiatric disorders Very rare Disorientation, depression, insomnia, nightmares, irritability, psychotic disorders. Diseases of the nervous system Town Cephalea, chief. Rare Sleep. Very rare Parestesia, impairment of memory, convulsions, anxiety, tremors, aseptic meningitis, alteration of taste, cerebrovascular accidents. Pathologies of the eye Very rare Visual disturbances, blurred vision, diplopia. Ear and labyrinth pathologies Town Vertigo. Very rare Tinnitus, compromise of hearing. Heart disease Very rare Palpitations, chest pain, heart failure, myocardial infarction. Notable Kounis Syndrome Vascular diseases Very rare Hypertension, vasculitis. Respiratory, chest and mediastinic pathologies Not common Broncospasmo Rare Asthma (including dispnea). Very rare Polmonitis. Gastrointestinal diseases Town Epigastric pain, nausea, vomiting, diarrhea, abdominal pain, dyspepsia, flatulence, anorexia. Rare Gastritis, gastrointestinal hemorrhage, hematemesis, hemorrhagic diarrhea, melena, gastrointestinal ulcer (with or without bleeding or perforation). Very rare Diaphragm type intestinal shrinkage. Colite (including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), stips, stomatitis (including ulcerative stomatitis), glossitis, esophageal disorder. Pancreatis. Notable Ischetical Colite Hepatobiliary diseases Town Increase in transaminers (AST, ALT). Rare Hepatitis, jaundice, liver disorders. Very rare Lightning hepatitis, liver necrosis, liver failure. Pathologies of skin and subcutaneous tissue Town Skin rash. Rare Orticaria. Very rare Bollous eruption, eczema, erythema, multiform erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), exfoliative dermatitis, hair loss, photosensitivity reaction, purple, allergic purple, itching. Kidney and urinary pathologies Very rare Acute renal insufficiency, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, kidney papillar necrosis. Pathologies of the reproductive apparatus and of the breast Rare Impotence (doubt causal relationship) Systemic pathologies and conditions for administration Rare Edema Clinical experiments and epidemiological data consistently indicate an increase in the risk of arterial thrombotic events (for example, myocardial infarction or stroke) associated with the use of diclofenac, especially at high doses (150 mg/die) and long-term treatment (for special contraindications and warnings and precautions of use see paragraphs 4.3 and 4.4). Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring 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 the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Toxicity The administration of 300 mg - 3 g in adults usually only causes slight intoxication. 2.8 g administered over a week caused intestinal perforation in an adult patient; 2 g in an adult patient have caused kidney effects. It has been reported necrosis of the reversible bone marrow due to overdose of diclofenac administered intramuscularly for a kidney colic in a dose of 75 mg repeated at intervals of 30 minutes for 12 doses for a total dose of 900 mg. Synonyms There is no typical clinical picture caused by overdose with diclofenac. Overdose can cause symptoms such as nausea, vomiting, gastrointestinal hemorrhage, diarrhea, abdominal pain, dizziness, drowsiness, headache, tinnitus, anxiety, hallucinations, kidney effects, in rare liver effects, a tendency to edema, possible metabolic acidosis or seizures. In case of significant poisoning, acute kidney failure and liver damage are possible. Therapeutic measures The management of acute poisoning with NSAIDs, including diclofenac, consists mainly of support measures and symptomatic treatment. Support measures and symptomatic treatment should be administered for complications such as hypotension, kidney failure, seizures, gastrointestinal disorders and respiratory depression. Special measures such as forced diuresis, dialysis or hemoperfusion are probably no help in eliminating NSAIDs, including diclofenac, due to its high link to proteins and extended metabolism. After the ingestion of a potentially toxic overdose, activated charcoal can be considered, while after the ingestion of a potentially dangerous overdose for life, gastric decontamination can be considered (e.g. vomiting, gastric lavender). Acids, supplemented if necessary with sucralfate. Ensure the efficiency of diuresis. Syntomatic treatment.

Pregnancy Inhibition of prostaglandin synthesis may have adverse effects on pregnancy and/or embryo-fetal development. Data from epidemiological studies suggest an increase in the risk of abortion, heart disease and gastroschisis after the use of an inhibitor of prostaglandin synthesis at the beginning of pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1% to about 1.5%. It is believed that the risk increases with dose and duration of therapy. In animals, it has been shown that the administration of a prostaglandin synthesis inhibitor causes an increase in pre- and post-implant losses and embryo-fetal mortality. Moreover, in animals treated with an inhibitor of prostaglandinic synthesis during the genetic organ period, the increase in the incidences of various malformations, including cardiovascular malformations was reported. From 20^a week of pregnancy onwards, the use of Itamifast could cause oligoidramnios resulting from fetal kidney dysfunction. This condition may be found shortly after the start of treatment and is usually reversible with the termination of treatment. Moreover, cases of constriction of arterial duct were reported following treatment in the second quarter, most of which were resolved after the suspension of treatment. Therefore, during the first and second trimester of pregnancy Itamifast should not be administered if not strictly necessary. If Itamifast is used by a woman who is planning a pregnancy, or during the first and second trimester of pregnancy, the lowest possible dose should be used for the shortest time possible. Following the exhibition at Itamifast for several days from 20^a week of gestation onwards, it should be considered an antenatal monitoring of oligoidramnios and the constriction of arterial duct. In case of oligoidramnios or of compulsion of arterial duct, treatment with Itamifast must be stopped. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (premature constriction/closing of arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligoidramnios (see above); the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, and anti-aggregating effect that can also occur at very low doses; - inhibition of uterine contractions that involve delay or extension of labor. As a result, Itamifast is contraindicated during the third trimester of pregnancy (see paragraphs 4.3 and 5.3). Food: Like other NSAIDs, diclofenac passes into breast milk in small quantities. Therefore, Itamifast should not be administered during breastfeeding to avoid unwanted effects in the child. Fertility As with other NSAIDs, the use of diclofenac can compromise female fertility and is not recommended in women who are trying to conceive. In women who have difficulty in conceiving or who are subject to sterility controls, the suspension of diclofenac must be considered.

Source: Farmadati