VEGETALLUMINA FEB 12BS

VEGETALLUMINA DOLOGY AND FEBRUARY 400 MG GRANULATE FOR ORAL FUTURE

active ingredients

A bag contains: active ingredient: ibuprofen sodium salt dihydrate 512 mg (corresponding to 400 mg of ibuprofen). Excipients with known effects: Sucrose 2148 mg; Aspartame 20 mg; Potassium 90 mg; Sodium 46 mg; Sulfites (contained in orange aroma)

Excellent

Saccarosio, potassium bicarbonate, orange aroma, potassium acesulfame, aspartame.

Therapeutic indications

Pain from various origins and nature: headaches, toothache, nerves, osteo-articocular and muscle pain, menstrual pain. Helpful in the symptomatic treatment of feverish and flu states.

Contraindications

• Hypersensitivity to the active ingredient or other substances closely related to a chemical point of view and/or any of the excipients listed in the paragraph 6.1. • History of gastrointestinal hemorrhage or drilling related to previous treatments with non-steroidal anti-inflammatory drugs (NSAID). • History of hemorrhage/recurring peptic ulcer (two or more separate episodes of proven ulceration or bleeding). • Active and recurrent peptic ulcer. • Gastrointestinal bleeding • Other bleeding in place such as cerebrovascular bleeding • ulcerative and Crohn's disease. • Severe liver and/or kidney failure • Hemorrhagic diathesis • Severe heart failure (IV class NYHA). • Due to the possibility of allergic reactions crusaded with acetylsalicylic acid or with other non-steroidal anti-inflammatory drugs, the product is contraindicated in patients in which such drugs induce allergic reactions such as bronchospasm, asthma, hives, rhinitis, nasal polyposi, angioedema. • In case of systemic erythematous lupus and collagen diseases, before use of VEGETALLUMINA DOLORE AND FEBBRE must be consulted by the doctor. • Third quarter of pregnancy (see par. 4.6)

Population

Population Adults and boys over 12 years: 1 bag 2-3 times a day. The maximum daily dose should not exceed 1200 mg per day. The lowest effective dose should be used for the shortest period necessary to relieve symptoms (see paragraph 4.4). Seniors: elderly patients should stick to the above minimum dosages. In the treatment of elderly patients, posology must be carefully established by the doctor who will have to assess a possible reduction of the dosages indicated above. - In patients with altered kidney, liver or heart function, dosages should be reduced. - Hepatic insufficiency: caution should be taken in the treatment of patients with reduced liver function. In such patients, periodic monitoring of clinical and laboratory parameters should be used, especially in case of prolonged treatment (see par. 4.4). The use of VEGETALLUMINA DOLORE AND FEBRUARY is contraindicated in patients with severe liver failure (see par. 4.3). - Renal insufficiency: caution should be taken in the treatment of patients with reduced kidney function. In such patients, periodic monitoring of clinical and laboratory parameters should be used, especially in case of prolonged treatment (see par. 4.4). The use of VEGETALLUMINA DOLORE AND FEBBRE is contraindicated in patients with severe kidney failure (see par. 4.3). In adolescents (aged ≥ 12 years at the Way of Administration: The granulate is dissolved in a glass of water (50-100 ml) and taken immediately after the preparation of the solution. The granulate for oral solution should be taken with food.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment that is necessary to control symptoms (see par. 4.2 and the underlying paragraph “Gastrointestinal and cardiovascular risks”). Adequate monitoring and appropriate instructions are necessary in patients with positive anamnesiums for hypertension and/or mild to moderate congestive heart failure, as fluid and edema retention was found in association with NSAIDs. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/die), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. severe skin reactions: Serious skin reactions have been reported, some of which are fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis in association with the use of NSAIDs (see paragraph 4.8). Patients seem to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Generalized acute urstolosis (PEAG) was reported in relation to medicines containing ibuprofen. Ibuprofen should be suspended at the first appearance of severe skin signs and symptoms such as rash, mucosa lesions or any other sign of hypersensitivity. Hepatotoxic reactions may occur in the context of generalized hypersensitivity reactions. Caute should be adopted in the treatment of patients with bronchospasm precedents, especially if following the use of other drugs, and in those with clotting disorders and kidney and/or liver or reduced heart function. In such patients, periodic monitoring of clinical and laboratory parameters should be used, especially in case of prolonged treatment (see par. 4.2). In patients with bronchial asthma or allergic disease, bronchospasm may aggravate. Systemic lupus erythematose or other collagen affections constitute risk factors for serious manifestations of generalized hypersensitivity, therefore caution is required in patients with these pathologies. Having been detected, although very rarely, eye alterations in the course of treatment with ibuprofen, it is recommended in the event of a disturbance of the sight to interrupt the treatment and to carry out an ophthalmological examination. The use of VEGETALLUMINA DOLORE AND FEBRUARY, as with any drug inhibitor of the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to start a pregnancy, as it can cause impairment of female fertility through an effect on ovulation. The administration of VEGETALLUMINA DOLORE AND FEBRUARY must be suspended in women who have fertility problems or who are subject to fertility surveys (see par. 4.6). It is necessary to use caution when you start treatment with ibuprofen in patients with severe dehydration. Masking the symptoms of underlying infections: VEGETALLUMINA DOLORE AND FEBRUARY can mask the symptoms of infection, which may delay the start of an adequate treatment and therefore worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When VEGETALLUMINA DOLORE AND FEBBRE 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. Ibuprofen can mask the objective and subjective signs of an infection. In isolated cases an exacerbation of infectious inflammations (e.g. development of necrotizing fascites) was described in temporal correlation with the NSAIDs. Therefore, in patients affected by infection ibuprofen therapy should be used with caution. FANS can cause an increase in the results of liver function tests Important information about some excipients. . VEGETALLUMINA ONLY AND FEBRUARY contains: • sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. A bag contains 2.148 g sucrose (sugar). To consider in people with diabetes mellitus. • 46 mg (1.94 mmol) of sodium (main component of the kitchen hall) for sachet, equivalent to 2.3% of the maximum daily intake recommended by the WHO that corresponds to 2 g sodium for an adult. • 90 mg of potassium (2,3 mm) for sachet. To be considered in patients with reduced kidney function or in patients who follow a low potassium diet. • Aspartame: this medicine contains 20 mg of aspartame per sachet, equivalent to 20 mg/3000 mg (bag weight). Aspartame is a source of phenylalanine. It can be harmful if it is suffering from phenylchetonuria, a rare genetic disease that causes the accumulation of phenylalanin because the body fails to dispose of it properly. • sulphites (contained in orange aroma): this medicine can rarely cause serious reactions of hypersensitivity and bronchospasm.

Interactions

Diuretics, ACE inhibitors and antagonists of angiotensin II: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function) co-administration of an inhibitor ACE or an angiotensin II antagonist and agents inhibiting the cyclo-oxidase system may lead to further deterioration of kidney function, which includes a possible acute kidney failure, generally reversible. These interactions must be considered in patients taking VEGETALLUMINA DOLORE AND FEBBRE in conjunction with ACE inhibitors or antagonists of angiotensin II. Therefore, the combination should be given with caution, especially in elderly patients. Patients should be properly hydrated and monitoring the kidney function should be taken into consideration after the start of the concomitant therapy. Courtesy: increased risk of gastrointestinal ulceration or hemorrhage (see par. 4.4). Antiagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin (see par. 4.4). Protrombine time should be kept carefully under control during the first weeks of combined treatment and the dosage of anticoagulants may require adjustment. Serotonin re-uptake selective anti-aggregating agents and inhibitors (SSRIs): increased risk of gastrointestinal hemorrhage (see par. 4.4). Furosemide and thiazide diuretics: a reduction in the effectiveness of thiazide furosemide and diuretics, probably due to sodium retention associated with the inhibition of synthetic prostaglandin at renal level.Beta-blockers: the hypotensive effect of beta-blockers can be reduced. Concurrent use of NSAIDs and beta-blockers can be associated with the risk of acute renal failure. Other non-steroidal anti-inflammatory drugs (FANS) including selective COX-2 inhibitors: ibuprofen should be used with caution in association with other NSAIDs because it can increase the risk of adverse reactions in the gastrointestinal tract. Acetylsalicylic acid: the concomitant administration of ibuprofen and acetylylylethyl acid is not generally recommended due to the potential increase in unwanted effects. Experimental data suggests that ibuprofen can competitively inhibit the effect of acetylsalicylic acid at low doses on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, it cannot be ruled out 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 par. 5.1). Digoxin, phenytoin and lithium: isolated cases of high plasma levels of digoxin, phenytoin and lithium are reported in literature as a result of the therapy combined with ibuprofen. Methodology: ibuprofen can cause an increase in plasma levels of metotrexate. Zidovudina: concomitant therapy with Zidovudine and ibuprofen can increase the risk of hematoma and hematoma in HIV(+). Tacrolimus: the concomitant use of ibuprofene and tacrolimus can increase the risk of nephrotoxicity due to the reduction in the renal synthesis of prostaglandine. Hypoglycemic drugs: ibuprofen increases the hypoglycemic effect of oral hypoglycemic drugs and insulin. You may need to adjust the dosage.Ciclosporin: Concurrent use of non-steroidal anti-inflammatory drugs (FANS) can lead to an increase in the risk of nephrotoxicity of cyclosporin. Voriconazole or fluconazole: concurrent use of ibuprofen can lead to increased exposure to ibuprofen and plasma concentration. Mifepristone: Concurrent use of non-steroidal anti-inflammatory drugs (NSAID) can lead to an increase in exposure to NSAIDs. A decrease in the effectiveness of mifepristone can theoretically occur due to the antiprostaglandinic properties of NSAIDs. Some studies on the effect of the single or repeated administration of ibuprofen from the day of administration of prostaglandin (or when necessary) have not found evidence of a negative influence on the action of mifepristone, and the overall clinical effectiveness of the protocol of termination of pregnancy. Chinolonic Antibiotics: Concurrent use of non-steroidal anti-inflammatory drugs (NSAID) can lead to an increase in the risk of seizures. Herbal Extracts: Biloba ginkgo can enhance the risk of bleeding with NSAID drugs. Aminoglycosides: NSAIDs can decrease aminoglycoside excretion. Interactions with diagnostic examination results: • Hemorrhage time (can extend hemorrhage time up to 1 day after the suspension of therapy); • Syeric concentrations of glucose (can decrease); • Creatine clearance (can decrease); • Ematocrite or hemoglobin (can decrease); • Azotemia, concentrations of creatinine sierica and potassium (can increase); • Examination of liver function (an increase in transaminers may occur).

Effects

The side effects are mainly related to the pharmacological effect of ibuprofen on the synthesis of prostaglandins. Gastrointestinal diseases: the most commonly observed adverse events are gastrointestinal. Peptic ulcers, perforation or gastrointestinal hemorrhage may occur, sometimes fatal, especially in the elderly (see par. 4.4). After administration VEGETALLUMINA DOLORE AND FEBRUARY have been reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, gastric pyrosis, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see par. 4.4). Less frequently gastritis were observed. Pathologies of skin and subcutaneous tissue: Bollose reactions including Stevens-Johnson Syndrome and Epidermal Toxic Necrolysis (very rarely) and drug reactions with heosinophilia and systemic symptoms (DrESS syndrome). Heart and vascular disease: edema, hypertension and heart failure were reported in conjunction with NSAID treatment. 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 par. 4.4). Below is a table for the frequency of adverse events: Frequency: very common (≥1/10); common (≥1/100,

Classification for organs and systems	Frequency
Gastrointestinal diseases
Dispepsia, diarrhea	Very common
Abdominal pain, gastric pyrosis, nausea, flatulence, abdominal discomfort	Town
Peptic ulcer, gastrointestinal hemorrhage, vomiting, melena, gastritis, stomatitis	Not common
Gastrointestinal perforation, constipation, hematemesis, ulcerative stomatitis, colitis exacerbation and Crohn's disease	Rare
Anorexia	Notable
Systemic pathologies and conditions for administration
Edema, fever	Notable
Heart disease
Heart failure	Notable
Vascular diseases
Hypertension, arterial thrombosis, hypotension	Notable
Diseases of the nervous system
Kefalea, dizziness	Town
Confusion, sleepiness	Not common
Depression, psychotic reaction, aseptic meningitis	Notable
Sensor Obnubilation	Very rare
Ear and labyrinth pathologies
Tinnitus, hearing disorders	Rare
Pathologies of the eye
Confused vision, ambliopia	Rare
Papilloedema	Notable
Pathologies of skin and subcutaneous tissue
Skin Rash, Skin Disease	Town
Prurito, urticaria, porpora, angioedema, exantema	Not common
Bollose dermatosis (mulform erythema, exfoliative dermatitis, Stevens-Johnson syndrome and Toxic Necrolysis Epidermal), allergic vasculitis	Very rare
Photosensitivity reactions, aggravation of skin reactions	Notable
Drug reaction with heosinophilia and systemic symptoms (DrESS syndrome)	Notable
Generalized acute exantelosis (PEAG)	Notable
Emolinfopoietic system pathologies
Trombocytopenia, agranulocytosis, aplastic anemia, granulocytopenia, hemolytic anemia	Rare
Anemia	Notable
Kidney and urinary pathologies
Ematuria, disuria	Rare
Interstitial nephritis, papillar necrosis, kidney failure, acute kidney failure	Very rare
Hepatobiliary diseases
Hepatitis disorders	Rare
Hepatic damage, hepatitis, ittero	Notable
Diagnostic examinations
Alteration test liver function (transamine increased), color vision disorder	Rare
Alteration test renal function	Notable
Immune system disorders
Allergic reactions	Not common
Anafilas	Rare
Anaphylactic Shock	Notable
Respiratory, chest and mediastinic pathologies
Asthma, aggravation of asthma, bronchospasm, dispnea	Not common
Irritation of the throat	Notable
Diseases of musculoskeletal system and connective tissue
Musculoskeletal rigidity	Notable
Metabolism and nutrition disorders
Increased urchemia, sodium and liquid retention or edema	Notable
Pathologies of the reproductive apparatus and of the breast
Menstrual disorder	Notable

The appearance of side effects during treatment requires immediate suspension of therapy and consultation of the attending physician. Paediatric population: From the cumulative clinical experience, there is no clinically relevant difference by nature, frequency, severity and reversibility of adverse reactions between the safety profile in adults and the approved pediatric population (≥12 years). 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 professionals are required to report any suspected adverse reaction through the national reporting system to the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Toxicity Signs and symptoms of toxicity were generally not observed at doses less than 100 mg/kg in children or adults. However, in some cases you may need a support treatment. It has been observed that children manifest signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or greater. Synonyms Most patients who have ingested significant quantities of ibuprofen will manifest symptoms within 4-6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, gastralgia, abdominal pain, lethargy and drowsiness. The effects on the central nervous system (SNC) include headaches, tinnitus, dizziness, diplopia, spasms, ataxia, rabdomiolisis, seizures, seizures and loss of consciousness. Rarely, nistagm, metabolic acidosis, hypothermia, kidney effects, gastrointestinal bleeding, coma, apnea, diarrhea and depression of the SNC and respiratory system were also reported. Disorientation, state of excitement, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose are possible kidney failure and liver damage. In case of severe poisoning, it is possible that metabolic acidosis occurs. Treatment There is no specific antidote for overdosing ibuprofen. In case of overdose, a symptomatic and support treatment is therefore indicated. Particular attention is given to the control of blood pressure, acid-base balance and gastrointestinal bleeding. Within an hour of the ingestion of a potentially toxic quantity must be considered the administration of activated carbon. Alternatively, in the adult, within an hour of the ingestion of a potentially dangerous overdose for life must be taken into account the gastric lavender and the correction of serious electrolytic abnormalities. Given the high degree of ibuprofen link to plasma proteins (up to 99%), dialysis is unlikely to be useful in case of overdose. An adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours after ingestion of a potentially toxic drug. Any occurrence of frequent or prolonged seizures must be treated with intravenous diazepam. Other support measures may be required in relation to the patient's clinical conditions. For more information, contact the local anti-veleni center.

Pregnancy:

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in pre- and post-system loss and mortality embrione-fetale.Inoltre, an increase in incidence of various malformations, including cardiovascular disease, was reported in animals to which prostaglandin synthesis inhibitors were administered during the organogenic period. During the first and second trimester of pregnancy, VEGETALLUMINA PAIN AND FEVER should not be used unless clearly necessary. If VEGETALLUMINA DOLORE AND FEBRUARY 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-idroamnios; 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 VEGETALLUMINA DOLORE AND FEBRUARY is contraindicated during the third trimester of pregnancy.

Nursing:

It is also not recommended to use the product during breastfeeding and childhood.

Source: Farmadati