FROBEFLU 20CPR EFF 330MG+200MG

FROBEFLU 330 MG + 200 MG COMPRESENT EFFERENCES

active ingredients

Each effervescent tablet contains:

Active ingredients:	acetylsalicylic acid	330 mg
	ascorbic acid	200 mg

Excipient with known effects: sodium bicarbonate, sodium benzoate For the complete list of excipients, see paragraph 6.1.

Excellent

Sodium bicarbonate, citric acid anidro, glycine, benzoate sodium.

Therapeutic indications

FROBEFLU is indicated in adults and adolescents over 16 years of age for headaches and teeth, nerves, menstrual pain, rheumatic and muscle pain. Syntomatic therapy of fever states and flu and cooling syndromes.

Contraindications

• Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. • Hypersensitivity to salicylates or other nonsteroidal anti-inflammatory drugs. • 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). • Gastro-duodenal ulcer in active phase and other gastropathies. • Hemorrhagic diathesis (especially hemophilia, hypoprotrombinemia and vitamin K deficiency). • Severe heart failure. • Hepatic or severe kidney failure. • Patients with bronchial asthma, especially if it is associated with nasal polypoxes and angioedema. • Children and teenagers under the age of 16. • Dosi > 100 mg/die during the third quarter of pregnancy (see paragraph 4.6). • Children and adolescents with symptoms of flu or chickenpox due to the risk of Reye syndrome. • Deficit of glucose-6-phosphate dehydrogenases.

Population

Posology. Adults and teenagers aged 16. The recommended doses are as follows: - as an antipyretic and analgesic for mild or moderate intensity pain: 1 tablet every 4-6 hours, according to need; - rheumatic and muscle pain, neuralgia: 1-2 tablets, two-three times a day. Seniors: Senior patients should stick to the above minimum dosages. Do not exceed the recommended doses without the advice of your doctor. Method of administration: Dissolve the tablets in a glass of water. Take a full stomach.

Conservation

Do not store at temperature above 25°C. Keep the container closed.

Warnings

This medicine should not be used in children and adolescents under the age of 16 (see paragraph 4.3). Drugs containing acetylsalicylic acid are contraindicated in children and adolescents with viral infections, especially affect A, influence B and chickenpox, due to the risk of Reye syndrome, a very rare disease, but dangerous for life, requiring immediate medical intervention (see paragraph 4.3). Reye syndrome is manifested with persistent vomiting and signs of progressive damage of the central nervous system (torpore, until the appearance of generalized and coma seizures), signs of liver injury and hypoglycemia. Subjects over 70 years of age, especially in the presence of concomitant therapies, must use this medicine only after consulting the doctor. After three days of use at the maximum dose or after 5-7 days of use without appreciable results consult your doctor. Any use of high doses and/or for a long time should be carried out only after consulting the doctor and under the direct control of the doctor. Caution is also necessary in the following cases: - Senior subjects with reduced renal function or lowered plasma albumin levels, for the risk of higher toxicity. - Subjects with G-6-PD deficits (Glucose-6-phosphate dehydrogenases), for the possible occurrence of hemolysis, gastric disorders and chronic or recurrent intestinal disorders or impaired kidney function. - Subjects in contemporary treatment with anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-aggregant agents such as aspirin, for increased risk of hemorrhages (see paragraph 4.5). - Subjects in concomitant treatment with corticosteroids, for increased risk of gastrointestinal hemorrhage (see paragraph 4.5). In case of hypoxodium, it should be noted that an effervescent tablet contains 485 mg of sodium (equal to 21 mEq). The use of FROBEFLU should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Undesirable effects can be minimized with the use of the minimum effective dose for the shortest possible duration of treatment needed to control symptoms. 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). 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 FROBEFLU treatment must be suspended. NSAIDs should be given 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). Precaution is needed in patients with a history of hypertension and/or heart failure since, in association with NSAID therapy, water retention and edema have been reported. Severe skin reactions some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and epidermal toxic necrolysis, have been reported very rarely in association with the use of NSAIDs (see paragraph 4.8). In the early stages of therapy patients seem to be at higher risk: the onset of reaction occurs in most cases within the first month of treatment. FROBEFLU must be stopped at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Ascorbic acid (vitamin C) must be used with caution by individuals who suffer, or have suffered in the past, nephrolitiase (renal calculosis) and those suffering from G6PD deficiency (Glucosio-6-phosphate deidrogenase), hemochromatosis, thalassaemia or sideroblastic anemia. The activity of substances such as spironolactone, furosemide and anti-goctase preparations is diminished by acetylsalicylic acid. Therefore, avoid the use of the latter with the above-mentioned drugs, unless otherwise advised by the doctor (see paragraph 4.5). Pre-operative use as it can hinder intra-operative hemostasis. If prolonged vomiting and deep drowsiness occur during treatment, stop administration. This medicine contains 485 mg of sodium per tablet, equivalent to 24% of the maximum daily sodium intake recommended by the WHO. The maximum daily dose of this medicine is 145% of the maximum daily sodium intake recommended by the WHO. FROBEFLU is considered to be high in sodium. This must be carefully evaluated for those who follow an hypoxodic diet.

Interactions

The administration of acetylsalicylic acid, especially in the case of protracted therapy, can enhance the unwanted effects of metotrexate-, the effects and secondary manifestations of all NSAIDs, the effect of oral hypoglycemizers (sulfaniluree). NSAIDs can increase the activity of anticoagulant drugs (e.g. cumarinic derivatives -warfarin- and heparine) (see paragraph 4.4). This medicine may increase the risk of gastro-intestinal hemorrhage in case of contemporary treatment with corticosteroids, anti-aggregating agents and selective serotonin reuptake inhibitors (SSRIs) (see paragraph 4.4). Acetylsalicylic acid, on the contrary, reduces the activity of substances such as spironolactone, furosemide and anti-goctosis preparations. Metamizole can reduce the effect of acetylsalicylic acid on piastrinic aggregation if taken simultaneously. Therefore, this combination should be used with caution in patients taking aspirin at low doses for cardioprotection. Ascorbic acid can interfere, at high doses, on the results of some diagnostic tests, in particular the search for glucose in the urine with non-specific means. It is therefore advisable to suspend taking vitamin C a few days before proceeding this examination.

Effects

The most commonly observed adverse events are gastrointestinal. Emolinfopoietic system pathologies: - hemorrhagic syndromes (epistassi, gum hemorrhages, thrombocytopenia, purple) with increased bleeding time. This effect persists for 4-8 days after the interruption of the administration of acetylsalicylic acid. It is the cause of hemorrhagic risk in patients suffering from surgery; - high doses of vitamin C (> 1 g) can increase hemolysis in patients with deficiency of G6PD-Dedrogenase in the form of chronic hemolysis Immune system disorders: - allergic reactions: angioedema, rashes (orticaria, erythema), larynx edema, bronchospasm, Quincke edema, anaphylactic reactions, asthma, nasal polyps, rhyrrhea; - acute asthma attack in sensitive patients Diseases of the nervous system: - tinnitus; - decrease in hearing; - headache. Heart disease: - edema, hypertension and heart failure were reported in treatment with NSAIDs. Gastrointestinal diseases: - gastric disturbances (pyrosis, epigastralgia), constipation, nausea, vomiting, diarrhea, flatulence, dispepsia, abdominal pain, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see paragraph 4.4); - peptic ulcer, even perforated; - gastrointestinal hemorrhage, which can be manifested (ematemesis, melena) and sometimes fatal, or occult, and cause sideropenic anemia. These bleedings are more frequent with increased dose, especially in older patients (see paragraph 4.4); - gastritis (note less frequently). Pathologies of skin and subcutaneous tissue: - Bollose reactions including Stevens-Johnson syndrome and epidermal toxic necrolysis. Kidney and urinary pathologies: - decrease in kidney blood flow and acute renal breakdown in patients with reduced kidney function; - formation of oxalate and uric acid calculations with high doses of vitamin C (> 1 g); - Reye's syndrome. Pregnancy, Puerperio and Perinatali: - childbirth delay. If headaches and gastrointestinal disorders occur, consisting mainly of laxative type phenomena, it is appropriate to stop treatment. 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 the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

In case of suspect overdose, keep the patient under observation for 24 hours, as high blood symptoms and levels of salicylates may appear after several hours. In case of acute overdose, drain the stomach through hemetics or suction and gastric lavender. For lighter intoxication make drinking abundant amounts of liquids. In case of severe intoxication (plasmic concentrations of salicylates greater than 500 mg/ml in the adult and 300 mg/ml in the child) practice forced and continued alkaline diuresis until reaching a plasma concentration of salicylates less than 350 mg/ml in the adult. At this point intravenous administration can be suspended and the patient invited to take oral fluids. Plasma electrolytes, especially potassium and acid/base balance must be regularly controlled. Acidemia must be corrected by infusion of bicarbonate sodium before starting forced diuresis. In the presence of heart or kidney failure or very severe intoxication, hemodialysis or endoperitoneal dialysis may be necessary. Acute allergic reactions resulting from acetylsalicylic acid intakes can be treated, if necessary, with adrenaline, corticosteroids and an antihistamine.

Since acetylsalicylic acid can cause hemorrhagic phenomena in the fetus and in the mother, childbirth delays and, in the birth, early closure of Botallo's duct, its use is contraindicated in the third trimester of pregnancy (see paragraph 4.3).

Pregnancy.

Low doses (up to 100 mg/day acetylsalicylic acid): Clinical studies indicate that doses of up to 100 mg/die can be considered safe only for obstetric use, requiring specialist monitoring. Doses of 100-500 mg/day acetylsalicylic acid: There are insufficient clinical data related to the use of doses greater than 100 mg/die up to 500 mg/die. Therefore, the recommendations below for 500 mg/die doses also apply to this dosage range. Doses of 500 mg/day acetylsalicylic acid and beyond: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and heart disease and gastroschisis 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 has been estimated 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-system and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disease, was reported in animals to which prostaglandin synthesis inhibitors were administered during the organogenetic period. During the first and second trimester of pregnancy acetylsalicylic acid should not be administered if not in strictly necessary cases. If acetylsalicylic acid 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 oligo-hydroamniosis. The mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and anti-aggregating effect that can also be necessary at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Consequently, acetylsalicylic acid at doses > 100 mg/die is contraindicated during the third trimester of pregnancy.

Nursing:

During breastfeeding, after a single dose, the amount of milking is negligible, while high doses by the mother must be avoided.

Source: Farmadati