FLOMAX OS GRAT 20BUST 350MG

FLOMAX 350 MG FREE FOR ORAL SUSPENTION

active ingredients

FLOMAX 350 mg granulated oral suspension A bipartite bag contains: Active ingredient: Morniflumato 350 mg Eccipienti with known effect: sucrose, sorbitol, aspartame and orange yellow S (E 110) For the complete list of excipients, see paragraph 6.1.

Excellent

Granulated: Saccarosio, Sorbitol, Banana Aroma, Maltodextrin, Fruit Aroma, Crospovidone, Ipromellosa, Aspartame, Glicirrizinato d'ammonio, Gomma xantana, Polisorbato 20, Sodium laurilsolfato, Yellow Orange S (E 110).

Therapeutic indications

A dulti and teenagers over 15 years. Dolorous and non-dolorous phlogistic states, also accompanied by fever, dependent on the apparatus O.R.L. (sinusitis, otititis, tonsillitis, pharyngitis, laryngitis).

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Subjects with gastroduodenal ulcer and subjects with hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1, precedents of allergy or asthma caused by the administration of niflumic/morniflumate acid or substances with similar or strictly related activities from the chemical point of view like other NSAIDs and aspirin (see paragraph 4.5). 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). Severe liver, kidney and heart failure. Third quarter of pregnancy (see paragraph 4.6). Children and adolescents under 15 years of age. Teenagers with ulcerative anamnesis, rectitititis or rectorragies. The granulate (bustine) contains aspartame, therefore it is contraindicated in the cases of phenylketonuria.

Population

Population Adults and teenagers over 15 years 2 bags of FLOMAX 350 mg, 2 times a day. Seniors (over 65 years) 1 bag of FLOMAX 350 mg, 2-3 times a day 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. The medicinal product must be used for short-term treatment. The duration of treatment with Flomax should not exceed 5 days. Pediatric population Do not use in children and adolescents under the age of 15. Method of administration By opening the sachet along the indicated line "full dose" you get a dose of 350 mg. FLOMAX must be given full stomach. Undesirable effects can be minimized by the use of the shortest possible duration of treatment needed to control symptoms (see paragraph 4.4).

Conservation

This medicine does not require any special condition of conservation.

Warnings

Like other NSAIDs, morniflumato can help trigger an asthmatic crisis in patients with asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyposi. The administration of morniflumato may result in an asthma attack, particularly in certain allergic individuals to acetylsalicylic acid or an NSAID. morniflumato may mask the usual signs and symptoms of an infection, therefore it must be used with caution in patients with infections in place or in those at risk of infection, even if well controlled. Exceptionally, chickenpox can cause severe infectious complications of skin and soft tissue. At the moment it cannot be excluded that the NSAIDs can promote the aggravation of these infections. Therefore it is advisable to avoid the use of morniflumato in case of chickenpox (see paragraph 4.8). Periodic emochromocytometric examinations and liver and kidney function indices are recommended during prolonged treatment. Precautions for use The urinary volume and kidney function must be strictly controlled at the beginning of the treatment with morniflumato in patients with chronic heart failure, kidney or liver failure, taking diuretics, which have been subjected to increased surgical interventions resulting in hypovolemia, and especially in older subjects. The use of FLOMAX must be avoided in conjunction with FANS, including selective COX-2 inhibitors. Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.2 and the paragraphs below on gastrointestinal and cardiovascular risks). Cardiovascular and cerebrovascular effects 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 and epidemiological data suggest that the use of some NSAIDs (especially high doses and long-term treatments) may be associated with a modest increase in the risk of arterial thrombotic events (p.es. infarction of myocardial or stroke). There is no sufficient data to exclude a similar risk for oxide. Patients with uncontrolled hypertension, congestive heart failure, established ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with morphous only after careful evaluation. Analogue considerations must be made before starting a long-term treatment in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). Gastrointestinal bleeding, 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. The relative risk increases in the elderly, in debilitated individuals, in people with low body weight and in patients who are subjected to therapy with anticoagulants or pyastrinic anti-aggregants. When bleeding or gastrointestinal ulceration occurs in patients taking FLOMAX the treatment must be suspended. I NSAIDs should be administered with caution and under strict medical control in patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease, iatal hernia) since such conditions can be exacerbated (see paragraph 4.8 Undesirable Effects). 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). 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). 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 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. Skin effects 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 section 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. FLOMAX must be interrupted by the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Interference with laboratory analysis In subjects treated with niflumic acid or morniflumato, false-positive results were reported in the immunological dosing test to detect the presence of cannabinoids in the urine (see paragraph 4.8). Further analysis is required to confirm the positive result. Pediatric population As with other NSAIDs, the use of morphology in pediatrics will be carried out after careful assessment of the risk-benefit ratio for each individual patient. In the treatment of pediatric patients it is appropriate to adhere strictly to the recommended dosage (see paragraph 4.2), avoiding therapeutic associations that can enhance the risk of any adverse reactions. Literature data suggest that the use of niflumic acid in the pediatric population may be associated with an increased risk of severe muco-cutaneous reactions. The granulate contains sucrose: patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose mal absorption, or sucrasis-isomaltase deficiency, should not take this medicine; take into account this for administration to diabetic patients and those subjected to hypocaloric dietary regimes. The granulate also contains sorbitol: patients suffering from rare hereditary problems of fructose intolerance, should not take this medicine; can cause gastric problems and diarrhea. The use of FLOMAX, as of any drug inhibitor of the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to start a pregnancy.

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 who take morphology 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. Risk connected to hyperpotassium Some medicinal products or therapeutic classes may favour the occurrence of hyperpotassiemia: potassium salts, diuretics, ACE inhibitors (angiotensin conversion enzyme), angiotensin inhibitors II, NSAIDs, eparine (both low molecular weight and not fractionated), cyclosporin, tacrolimus and trimetoprim. The occurrence of hyperpotassiemia may depend on the existence of associated factors. This risk increases when there is a combination with the medicinal products mentioned above. Risk connected to the anti-aggregating effect Many substances are involved in interactions due to their anti-aggregating properties: aspirin and NSAIDs, ticlopidine and clopidogrel, thyrofiban, eptifibatide and abciximab, iloprost. The use of many anti-platelet agents increases the risk of hemorrhage as well as their combination with eparine, oral and trombolitic anticoagulants. This use must be subject to regular clinical and biological control. Serotonin reuptake selective agents and inhibitors (SSRIs): increased risk of gastrointestinal hemorrhage (see paragraph 4.4). Antiagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin (see paragraph 4.4). Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see paragraph 4.4). The contemporary administration of morniflumato with the following products requires close clinical and biological control of the patient. Not recommended combinations With other NSAIDs (including acetylicylic acid and other salicylates) There has been an increased risk of gastrointestinal ulcers and hemorrhages (additive inertia). With other anticoagulants An increased risk of bleeding has been found (inhibition of the pyasternic function and damage to gastroduodenal mucosa caused by NSAIDs). If this combination cannot be avoided, close clinical and laboratory control of the patient is required. With heparine at healing doses or in elderly patients There is an increased risk of hemorrhage (inhibition of the pyasternic function and irritation of the gastroduodenal mucosa caused by FANS). If this combination cannot be avoided, close clinical and laboratory control of the patient is required. NSAIDs must be administered for a few days. With lithium Lithium levels in the blood are increased and toxic concentrations can be achieved (reduced lithium renal excretion). Where necessary, lithium levels in the blood must be strictly controlled and lithium posology must be adjusted during treatment in combination and after treatment with NSAID has been discontinued. With metotressate, used at higher doses of 15 mg per week There has been an increased risk of hematological toxicity caused by metotressate (anti-inflammatory drugs reduce renal clearance of metotressate). Combinations requiring precautions of use With diuretics, ACE inhibitors, and angiotensin inhibitors II Acute kidney failure has been found in risky patients (elders and/or dehydrated subjects) due to a decrease in glomerular filtration (NSID inhibit vasodilating prostaglandins). Rehydrate the patient. The kidney function must be checked at the beginning of the treatment. With metotressate used at doses less than 15 mg per week There has been an increased risk of hematological toxicity caused by metotressate (anti-inflammatory drugs reduce renal clearance of metotressate). The hematological count must be checked weekly during the first weeks of combination treatment. In case of kidney failure (although mild), and in elderly patients, strict control is required. Combinations that must be taken into account With other pyastrinic antiaggregants (ticlopidine, clopidogrel, thyrofiban, eptifibatide and abciximab, iloprost) and with eparine at prophylactic doses an increased risk of hemorrhage was found. With other agents that cause hyperpotassiemia (potassium salts, potassium-saving diuretics, ACE inhibitors (angiotensin conversion enzyme), angiotensin II inhibitors, other NSAIDs, eparine (both low molecular weight and un fractional), cyclosporin, tacrolimus and trimetoprim) an increased risk of hyperpotassium has been found. With beta blockers (for extrapolation of intrametacin data) A reduction in the antihypertensive effect was found (the NSAIDs inhibit vasodilating prostaglandins). With cyclosporin Risk of strengthening neurotoxic effects, especially in the elderly patient.

Effects

The most commonly observed adverse events with NSAIDs are gastrointestinal. Peptic ulcers, perforation or gastrointestinal hemorrhage may occur, sometimes fatal, especially in the elderly (see paragraph 4.4). Edema, hypertension and heart failure were reported in association with the treatment with NSAIDs. The frequency of adverse events, shown below in the table, cannot be defined on the basis of the available data, as they were reported during the post-marketing experience.

Classification for systems and organs	Action against
Infections and infestations*	Worse skin infections (in the presence of chickenpox, see paragraph 4.4)
Emolinfopoietic system pathologies	Trombocytopenia, leucopenia
Immune system disorders	Anaphylactic Shock
Diseases of the nervous system	Cephalea, dizziness
Cardiovascular disease	Myocardial infarction or cerebrovascular accidents see paragraph 4.4)*, edema, hypertension and heart failure, hypotension, vasculitis,
Respiratory, chest and mediastinic pathologies	Asthmatic Crisis (especially in allergic patients with acetylsalicylic acid or other NSAIDs)
Gastrointestinal disease(*)	Peptic ulcer, gastrointestinal perforation, gastrointestinal hemorrhage (sometimes fatal, especially in the elderly, see section 4.4), nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, epigastralgia, melena, ematemesis, ulcerative stomatitis, ulceration of the gastrointemornal apparatus (with or.
Pathologies of skin and subcutaneous tissue	Skin rash, hives, purple, itching, multiform erythema, multiform erythema and dermatitis, bollose eruptions including Stevens-Johnson syndrome and toxic epidermal necrolysis, photosensitization dermatitis, angioedema of the face, tongue, eyelids, lips, larynx, pharynx
Kidney and urinary pathologies	Acute renal insufficiency, piping nephritis, nephrotic syndrome, hematuria
Traumatism, poisoning and procedure complications	Fluorosis (high doses for several years)
Diagnostic examinations	Alteration of liver function tests, result false positive to urine test for cannabinoids (see paragraph 4.4)

(*) Increases in posology and duration of treatment affect the increase in frequency of unwanted gastrointestinal effects (see paragraph 4.4). In case of chickenpox, severe infectious skin complications may occur (see paragraph 4.4). (**) Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially high doses and long-term treatments) may be associated with a modest increase in the risk of arterial thrombotic events (i.e. infarction of myocardial or cerebrovascular accidents; see paragraph 4.4). 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 the case of overdose with niflumic acid/morniflumato the predictable symptoms are: gastrointestinal irritation, drowsiness (5%) and headache. A subject that ingested 7.5 g of niflumic acid showed glomerulonephritis, solved without sequel. In case of overdose, a symptomatic treatment is indicated, in addition to gastric lavender and the administration of activated carbon (only oral forms).

Fertility. They were reported in patients, in fertile age, who assumed as long-term treatment inhibitors of prostaglandin synthesis, cases of non-ovulatorial secondary infertility caused by the non-rupture of Graafian follicle. This infertility is reversible with the interruption of treatment. 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 the loss of pre- and post-plant 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 prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, FLOMAX should not be administered if not in strictly necessary cases. If FLOMAX 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 prolongation of labor Consequently, FLOMAX is contraindicated during the third trimester of pregnancy. Nursing. The concentration of niflumic/morniflumate acid in milk is poor. However, for precautionary purposes, breastfeeding must be suspended.

Source: Farmadati