VEGEDOL 20CPR RIV 400MG

VEGEDOL 400 MG COMPRESENT RIVES WITH FILM

active ingredients

Each film-coated tablet contains 400 mg of ibuprofen (such as 684 mg of ibuprofene lysine). For the full list of excipients, see paragraph 6.1.

Excellent

Compressed core: Silicized microcrystalline cellulose, Copovidone, sodium starch (type A), magnesium stearate. Coating film: Opadry 200 White 200F280000 (alcohol powder partially hydrolyzed; titanium dioxide [E171]; polyethyleneglycol 4000; talc; methacrylic-ethyl acid copolymer (1:1); hydrogencarbonate sodium.

Therapeutic indications

Short-term symptomatic treatment of mild to moderate pain, such as headache, migraine, toothache, dysmenorrhea, muscle pain, lumbar pain, rheumatic pain, fever and symptoms associated with cold and flu. Vegedol 400 mg tablets coated with film is indicated for use in adults and adolescents over the age of 12 and weighing at least 40 kg.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Patients who have previously manifested hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, angioedema or hives) in response to aspirin (acetylsalicylic acid) or to other non-steroidal anti-inflammatory drugs (NSAID). Active or anamnesian disease of peptic ulcer/recurrent peptic bleeding (two or more distinctly documented episodes of ulceration or bleeding). Anamnesis of bleeding or gastrointestinal perforation, related to previous treatments with NSAIDs. Severe heart failure (IV NYHA class), renal or hepatic (see paragraph 4.4). Last trimester of pregnancy (see paragraph 4.6). Patients with cerebrovascular hemorrhage, or other active bleeding. Patients with unclear disorders in blood formation. Patients with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake). Teenagers with body weight less than 40 kg and children under 12 years of age.

Population

Population The lowest effective dose should be used for the shortest period necessary to relieve symptoms (see paragraph 4.4). Adults and teenagers ≥ 40 kg (12 years of age or older): If in children and adolescents aged 12 to 18 years this medicine is required for more than 3 days, or if symptoms worsen, a doctor must be consulted. In adults, the patient should consult a doctor if symptoms persist or worsen or if the medicine is required for more than 5 days for pain treatment and for more than 3 days for migraine or fever treatment. The recommended dose is 1 tablet, taken with water, up to three times a day if necessary. Let it pass at least 6 hours between doses. Do not take more than 3 tablets (1200 mg of ibuprofen) in a period of 24 hours. Undesirable effects can be minimized with the use of the minimum effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.4). Special groups of patients Pediatric population: Vegedol is contraindicated in adolescents weighing less than 40 kg or in children under 12 years (see paragraph 4.3). Seniors: No particular dose adjustment is required. Given the possible profile of the side effects (see paragraph 4.4), it is recommended to monitor the elderly with particular attention. Renal Comprogation: No dose reduction is required in patients with mild-moderate impairment of kidney function (for patients with severe kidney failure, see paragraph 4.3). Hepatic compromise (see paragraph 5.2): No dose reduction is required in patients with mild-moderate impairment of liver function (for patients with severe liver dysfunction, see paragraph 4.3). Method of administration For oral administration and only for short term use. The film-coated tablet must be taken with water. It is recommended for patients with sensitive stomach to take Vegedol with food.

Conservation

Store at a temperature below 30 °C.

Warnings

Undesirable effects can be minimized using the minimum effective dose for the shortest period of time needed to control symptoms (see below sections on GI and cardiovascular risks). The elderly have an increased frequency of adverse reactions to the NSAIDs, especially bleeding and gastrointestinal perforation, which can be fatal. Respiratory effects: There may be aggravation of bronchospasm in patients suffering from, or with bronchial asthma anamnesis or allergic disease. Other NSAIDs: The use of ibuprofen in conjunction with NSAIDs, including selective cycloxygenase-2 inhibitors should be avoided (see paragraph 4.5). LES and mixed connective tissue disease: Patients with systemic erythematosum Lupus and mixed connective tissue disease - have an increased risk of aseptic meningitis (see paragraph 4.8). Renal effects: Patients with renal function impairment may develop further worsening of renal function (see paragraphs 4.3 and 4.8). Hepatitis effects: Hepatic dysfunction (see paragraphs 4.3 and 4.8). Cardiovascular and cerebrovascular effects: It requires caution (disputing with the doctor or pharmacist) before starting treatment in patients with anamnesi of hypertension and/or heart failure, since the therapy with NSAID was associated with fluid retention, hypertension and edema. 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 a low dose of ibuprofen (e.g. ≤ 1200 mg/die) is associated with an increase in the 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 of 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. Promoted female fertility: There are some evidence that drugs that inhibit cyclooxygenase/synthesis of prostaglandins can cause a compromise of female fertility due to ovulation. This is reversible after the termination of treatment. Gastrointestinal effects: NSAIDs should be administered with caution in patients with gastrointestinal disease anamnesis ( ulcerative colitis, Crohn's disease) since such conditions may aggravate (see paragraph 4.8). With all NSAIDs, bleeding, ulceration or GI drilling have been reported potentially fatal, at any time during treatment, with or without warning symptoms or with a previous anamnesi of GI events. The risk of bleeding, ulceration or GI drilling is greater with the use of increasing doses of NSAIDs, in patients with ulcer anamnesis, especially if complicated by hemorrhage or perforation (see paragraph 4.3), and in the elderly. These patients must begin treatment with the lowest dose available. Patients with GI toxicity anamnesis, especially the elderly, must report any unusual abdominal symptoms (especially GI bleeding) especially in the early stages of treatment. Precaution in patients treated with concomitant medicines that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or pyastrinic antiaggregant agents such as aspirin (acetylsalicylic acid) (see paragraph 4.5). In case of bleeding or GI ulceration in patients taking ibuprofen, treatment must be stopped. Strict skin reactions: In association with the use of NSAIDs, severe skin reactions were reported very rarely, some of which fatal, including exfoliatory dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (see paragraph 4.8). Patients seem to be at higher risk for these reactions in the early stages of the course of therapy: the beginning of the reaction occurs almost always within the first month of treatment. Generalized acute urstolosis (PEAG) was reported in relation to medicines containing ibuprofen. Ibuprofen should be stopped at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Exceptionally, chickenpox can cause severe infectious complications of skin and soft tissue. To date, the contribution of the NSAs in the worsening of these infections cannot be excluded. Therefore, it is recommended to avoid the use of Vegedol in case of chickenpox. Other notes: Precaution in patients: • With congenital disorder of porphyrin metabolism (e.g., acute intermittent porphyria); • Right after a major surgery; • With dehydration; • That have had hypersensitivity or allergic reactions to other substances, since they can be at greater risk for hypersensitivity reactions with Vegedol; • Who suffers from hay cold, nasal polyps or chronic obstructive respiratory diseases, since they have a higher risk of allergic reactions. These can occur in the form of asthma attacks (the so-called analgesic asthma), Quincke edema or hives. In rare cases severe acute hypersensitivity reactions were observed (e.g. anaphylactic shock). To the first signs of reaction of hypersensitivity after taking Vegedol, therapy must be interrupted. Measures necessary from the medical point of view, appropriate to symptomatology must be initiated by competent staff. Ibuprofen, the active ingredient of Vegedol, can temporarily inhibit the pyastrinic function (aggregation of thrombocytes). Therefore, it is recommended to carefully monitor patients with clotting disorders. Prolonged Vegedol administration requires regular monitoring of liver and kidney function tests as well as blood count. Prolonged use of any kind of painkiller for cephales may aggravate the symptoms. If you look at or suspect this situation, contact a doctor and stop treatment. Diagnosis of cephalea from excessive use of drugs (MOH, Medication Overuse Headache) should be suspected in patients who have frequent or daily headaches despite (or due to) regular use of drugs against cephalea. In general, the usual intake of painkillers, especially a combination of more analgesic substances, can cause permanent kidney damage with risk of kidney failure (nephropathy from analgesics). This risk can be increased during a physical effort associated with loss of salts and dehydration. Concurrent use of NSAIDs and alcohol may increase the appearance of undesirable effects associated with the drug, particularly those affecting the gastrointestinal tract or the central nervous system. NSAIDs can mask symptoms of infection and fever. Masking the symptoms of underlying infections: Vegedol 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 Vegedol is administered for relief from fever or pain 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. Pediatric population In dehydrated adolescents there is a risk of renal impairment. This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is essentially ‘without sodium’.

Interactions

Aspirin (acetylsalicylic acid) Concurrent administration of ibuprofen and aspirin (acetylsalicylic acid) is not generally recommended due to the potential increase in unwanted effects unless a doctor recommended aspirin (acetylsalicylic acid) at low dosage (not more than 75 mg per day) (see paragraph 4.4). Experimental data suggests that ibuprofen can competitively inhibit the effect of aspirin (acetylsalicylic acid) at low doses on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data from the clinical situation, it cannot be excluded the possibility that regular, long-term use 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, including selective cycloxygenase-2 inhibitors: avoid the concomitant use of two or more NSAIDs, since it could increase the risk of adverse reactions (see paragraph 4.4) Courtesy: since these may increase the risk of gastrointestinal ulceration or bleeding (see section 4.4) Antihypertensives (ACE inhibitors, beta-blockers and angiotensin II antagonists) and diuretics: nSAIDs can reduce the effect of diuretics and other antihypertensive medicines. In some patients with impaired kidney function (e.g. dehydrated or elderly patients with impaired kidney function), co-administration of an ACE inhibitor, beta-blocker or angiotensin antagonist- II and agents inhibiting cycloxygenase can determine the further deterioration of kidney function, including a possible acute kidney failure, which is usually reversible. Therefore, the combination should be given with caution, especially in the elderly. Patients should be properly hydrated and should be taken into account the monitoring of renal function after the start of concomitant therapy and subsequently with regular cadence. The contemporary administration of Vegedol, and potassium-saving diuretics can lead to hyperpotassium. Anticoagulanti: nSAIDs can increase the effects of anticoagulants, such as warfarin (see paragraph 4.4). Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see paragraph 4.4). Digoxin, phenytoin, lithium: concomitant use of Vegedol with digoxin, phenytoin or lithium-based preparations can increase the serum levels of these drugs. Control of serum levels of lithium, digoxin and phenytoin is not required as a rule if the product is used correctly (maximum within 3 days). Metotressed: the administration of Vegedol within 24 hours prior to or following the administration of metotressate may lead to high concentrations of metotressate and an increase in the toxic effect of the latter. Probenecid and sulfinpyrazone: medicines containing probenecid or sulfinpyrazone may delay the excretion of ibuprofen. Sulfoniluree: clinical investigations have demonstrated interactions between NSAIDs and antidiabetics (sulfonylureas).Rare cases of hypoglycaemia have been reported in patients with concomitant use of sulfonylurea and ibuprofen.It is recommended to monitor blood glucose values as a precaution in concomitant use. Ciclosporin: increased risk of nephrotoxicity.Mifepristone: nSAIDs should not be used for 8-12 days after mifepristone administration, as they may reduce the effect of mifepristone. Tacrolimus: increased risk of nephrotoxicity when NSAIDs are administered along with tacrolimus. Zidovudine: increased risk of hematological toxicity when NSAIDs are administered along with zidovudine. There is evidence of greater risk of hematomas and hematomas in HIV hemophiliacs (+) that receive concomitant treatment with zidovudine and ibuprofen. Quinolone antibiotics: animal data indicate that NSAIDs can increase the risk of seizures associated with chinolonic antibiotics. Patients taking NSAIDs and kinolones may have a greater risk of developing seizures. Herbal Extracts: Ginkgo biloba may increase the risk of bleeding with NSAIDs. CYP2C9 inhibitors: concurrent administration of ibuprofen and inhibitors of CYP2C9 may increase exposure to ibuprofen (substrate of CYP2C9). In a study with voriconazole and fluconazole (CYP2C9) inhibitors, an increased exposure to S(+)-ibuprofen from approximately 80% to 100% was observed. Consider reducing the dose of ibuprofen when administering at the same time powerful CYP2C9 inhibitors, especially when high-dose ibuprofen is administered along with voriconazole or fluconazole.

Effects

The list of the following side effects includes all those that have been documented during treatment with ibuprofen, including side effects caused by long-term and high-dose therapy in patients with rheumatism. The indicated frequencies, which have been reported at a higher frequency than “very rare”, refer to the short-term use of daily doses up to a maximum of 1200 mg of ibuprofen for oral dosage forms, and a maximum of 1800 mg for the supposed. It should be taken into account that the following side effects are predominantly dose-dependent and vary inter-individually. The most commonly observed side effects are gastrointestinal. Peptic ulcers, puncture or GI bleeding may occur, sometimes fatal, especially in the elderly (see paragraph 4.4). After administration, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, ematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see paragraph 4.4). Less often, gastritis was observed. In particular, the risk of gastrointestinal bleeding depends on the dosage interval and duration of treatment. In association with the treatment with the NSAIDs were reported edema, hypertension and heart failure. 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). Note that within each frequency class, unwanted effects are presented in decreasing order of gravity. Very common (≥1/10); Common (≥1/100,

Infections and infestations Very rare Exacerbation of inflammation of infectious origin (e.g. development of necrotizing fasciitis) has been described in conjunction with the use of nonsteroidal anti-inflammatory drugs.This is probably due to the mechanism of action of nonsteroidal anti-inflammatory drugs.If signs of infection appear or if they worsen during the use of Vegedol, the patient should consult a doctor immediately.It should be investigated whether there is an indication for anti-infective/antibiotic therapy Pathologies of the haemolymphopoietic system Very rare Hemopoietic disorders (anemia, leucopenia, thrombocytopenia, pancitopenia, agranulocytosis). The first signs can be fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, nasal bleeding and skin. In such cases, the patient must stop the medicine, avoid any self-medication with analgesics or antipyretics, and consult a doctor. During long-term therapy, the blood count must be regularly checked. Immune system disorders Uncommon Reactions of hypersensitivity with rashes and itching, as well as attacks of asthma (possibly with decrease of blood pressure), aggravation of asthma, bronchospasm, and dispnea. In this case, the patient must immediately inform the doctor and stop taking Vegedol. Very rare Severe general hypersensitivity reactions.They may present as facial edema, swelling of the tongue, swelling of the inner surface of the larynx with airway stenosis, difficulty breathing, tachycardia, drop in blood pressure, up to life-threatening shock.If any of these symptoms occur, which may also occur on first use, consult a doctor immediately.Symptoms of aseptic meningitis with stiff neck, headache, nausea, vomiting, fever or blurred consciousness have been observed during the use of ibuprofen.Patients with autoimmune diseases (SLE, mixed connective tissue disease) seem to be predisposed. Psychiatric disorders Very rare Psychic reactions, depression Nervous system disorders Uncommon Central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or tiredness. Pathologies of the eye Uncommon Disorders of vision. Ear and labyrinth pathologies Rare Tinnitus. Heart disease Very rare Palpitations, heart failure, myocardial infarction. Vascular diseases Very rare Arterial hypertension, vasculitis. Gastrointestinal diseases Town Gastrointestinal disorders such as pyrosis, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation and slight gastrointestinal blood losses that can cause anemia in exceptional cases. Uncommon Gastrointestinal ulcer, potentially bleeding and drilling. Ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see paragraph 4.4), gastritis. Very rare Esophagitis, pancreatis, formation of symil- diaphragm intestinal stenosis. In the presence of severe pain at the upper part of the abdomen, melena or ematemesis, the patient must suspend the medicine and immediately consult a doctor. Hepatobiliary diseases Very rare Hepatic dysfunction, liver damage, especially in long-term therapy, liver failure, acute hepatitis. Pathologies of skin and subcutaneous tissue Uncommon Various types of rashes. Very rare Bollose reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis/ Lyell syndrome, alopecia. In exceptional cases, severe skin infections and soft tissue complications can occur during a chickenpox infection (see also "Infections and infestations"). Notable Reaction from drug with heosinophilia and systemic symptoms ( DRESS syndrome) Generalized acute acute acute (PEAG) photosensitivity reactions Kidney and urinary pathologies Rare Rarely, renal tissue damage (paint necrosis) and high concentrations of uric acid in the blood can occur. Very rare Formation of edema, especially in patients with arterial hypertension or kidney failure, nephrosic syndrome, and interstitial nephritis, possible that can be accompanied by acute kidney failure. The renal function must therefore be regularly checked. Reporting of suspicious adverse reactions The indication of suspicious adverse reactions that occur after the authorization of the medicinal product is important. 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.agenziafarmaco.gov.it/content/come-segnalare-una-sosp ect-reaction-adversa.

Overdosing

Symptoms are unlikely at doses below 100 mg/kg. Synonyms Most patients who have ingested clinically important amounts of NSAIDs develop only nausea, vomiting, epigastric pain, or more rarely diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible. In the most serious forms of intoxication, toxicity is observed in the central nervous system, which is manifested in the form of drowsiness, and sometimes excitation, disorientation or coma. Occasionally, patients develop seizures. Children can also develop myoclonic cramps. In severe intoxication, metabolic acidosis, protrombine time extension or INR value increase, possibly due to interference with the action of circulating clotting factors. Acute kidney failure, liver damage, fainting, hypotension, nistagm, hypothermia, respiratory depression and cyanosis can occur. Asthma exacerbation is possible in asthmatics. Treatment There is no specific antidote. The treatment must be symptomatic and supportive and include the maintenance of airways for routes and the monitoring of heart and vital signs until stabilization. Consider oral administration of activated charcoal if the patient occurs within 1 hour from ingestion of a potentially toxic amount. If frequent or prolonged, convulsions must be treated with diazepam or lorazepam intravenously. Administer bronchodilators for asthma.

Pregnancy

The inhibition of prostaglandin synthesis can adversely affect pregnancy and/or embryo/fetal development. Data from epidemiological studies suggest an increased risk of miscarriage, heart malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of cardiovascular malformation had increased from less than 1%, up to about 1.5%. It is believed that the risk increases with dose and duration of therapy. In animals, the administration of an inhibitor of prostaglandin synthesis has shown to cause increases in previous losses and following the plant, as well as in embryo-fetal lethal. In addition, there was an increase in the incidence of various malformations, including cardiovascular disease, in animals that had received an inhibitor of the synthesis of prostaglandins during the organogenetic period. During the first and second quarter of pregnancy, Vegedol should not be administered unless strictly necessary. If Vegedol 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 maintained and the treatment should be shortened as much 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 towards 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 doses; - Inhibition of uterine contractions, resulting in delay or extension of labor. Vegedol is therefore contraindicated during the third trimester of pregnancy.

Food

In limited studies, ibuprofen is present in breast milk in very low concentrations and is unlikely to have adverse effects on the newborn who is breastfeeding.

Fertility

See paragraph 4.4 on female fertility.

Source: Farmadati