Flomax 350 mg 20 sachets granules for oral suspension

Flomax 350 mg 20 sachets granules for oral suspension is an anti-inflammatory drug based on morniflumate , specifically formulated to provide rapid relief from pain, inflammation and fever affecting the upper respiratory tract . Indicated for adults and adolescents over 15 years of age , Flomax 350 mg is particularly effective in the treatment of both painful and painless inflammatory conditions , even those accompanied by fever, affecting the ENT system, such as sinusitis, otitis, tonsillitis, pharyngitis and laryngitis .

Each sachet contains 350 mg of morniflumate , an active ingredient belonging to the class of NSAIDs (nonsteroidal anti-inflammatory drugs), known for its ability to rapidly reduce pain and inflammation in conditions of the respiratory tract, tonsils, ear and paranasal sinuses . The formulation in granules for oral suspension makes Flomax practical and easy to take, ideal for those looking for an effective and fast treatment against the symptoms of sore throat, inflammation and fever .

The presence of banana and fruit flavor makes the suspension pleasant to the palate, making it easier to take even in case of discomfort when swallowing. Flomax 350 mg is a reliable solution for those who want to quickly combat painful and inflammatory symptoms of the respiratory tract , ensuring targeted action and a high tolerability profile . Thanks to its effectiveness, it is often chosen as a reference anti-inflammatory for sore throat and ENT inflammation in adults and adolescents.

ACTIVE INGREDIENTS

Active ingredients contained in Flomax 350 mg 20 sachets granules for oral suspension - What is the active ingredient of Flomax 350 mg 20 sachets granules for oral suspension?

FLOMAX 350 mg granules for oral suspension One bipartite sachet contains: Active ingredient: Morniflumate 350 mg. Excipients with known effect: sucrose, sorbitol, aspartame and orange yellow S (E 110). For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Flomax 350 mg 20 sachets granules for oral suspension - What does Flomax 350 mg 20 sachets granules for oral suspension contain?

Granules : Sucrose, Sorbitol, Banana flavour, Maltodextrin, Fruit flavour, Crospovidone, Hypromellose, Aspartame, Ammonium glycyrrhizinate, Xanthan gum, Polysorbate 20, Sodium lauryl sulphate, Orange yellow S (E 110).

DIRECTIONS

Therapeutic indications Flomax 350 mg 20 sachets granules for oral suspension - Why is Flomax 350 mg 20 sachets granules for oral suspension used? What is it used for?

Adults and adolescents over 15 years of age . Painful and non-painful inflammatory conditions, even those accompanied by fever, affecting the ENT system (sinusitis, otitis, tonsillitis, pharyngitis, laryngitis).

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Flomax 350 mg 20 sachets granules for oral suspension - When should Flomax 350 mg 20 sachets granules for oral suspension not be used?

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; Subjects with gastroduodenal ulcer and subjects with hypersensitivity to the active substance or to any of the excipients listed in section 6.1, history of allergy or asthma caused by the administration of niflumic acid/morniflumate or substances with similar or closely related activity from a chemical point of view such as other NSAIDs and aspirin (see section 4.5); History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding); Severe hepatic, renal and cardiac insufficiency; Third trimester of pregnancy (see section 4.6); Children and adolescents under 15 years of age. Adolescents with a history of ulcer, rectal inflammation or rectal bleeding. The granules (sachets) contain aspartame, therefore it is contraindicated in cases of phenylketonuria.

DOSAGE

Quantity and method of taking Flomax 350 mg 20 sachets granules for oral suspension - How to take Flomax 350 mg 20 sachets granules for oral suspension?

Adults and adolescents over 15 years 2 sachets of FLOMAX 350 mg, 2 times a day. Elderly (over 65 years) 1 sachet of FLOMAX 350 mg, 2-3 times a day. In the treatment of elderly patients, the dosage must be carefully established by the doctor who will have to evaluate a possible reduction of the dosages indicated above. The medicine must be used for short-term treatments. The duration of treatment with Flomax must not exceed 5 days. Paediatric population Do not use in children and adolescents under 15 years of age. Method of administration Opening the sachet along the line marked "full dose" gives a dose of 350 mg. FLOMAX must be administered on a full stomach. Undesirable effects can be minimised by using the shortest possible duration of treatment necessary to control symptoms (see section 4.4).

CONSERVATION

Storage Flomax 350 mg 20 sachets granules for oral suspension - How should Flomax 350 mg 20 sachets granules for oral suspension be stored?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Flomax 350 mg 20 sachets granules for oral suspension - About Flomax 350 mg 20 sachets granules for oral suspension it is important to know that:

Like other NSAIDs, morniflumate may contribute to the initiation of an asthma attack in patients with asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis. Administration of morniflumate may provoke an asthma attack, particularly in certain subjects allergic to acetylsalicylic acid or an NSAID. Morniflumate may mask the usual signs and symptoms of an infection, therefore it should be used with caution in patients with active infections or in those at risk of infection, even if well controlled. Exceptionally, chickenpox may cause serious infectious complications of the skin and soft tissues. At present, it cannot be excluded that NSAIDs may promote the worsening of these infections. Consequently, it is advisable to avoid the use of morniflumate in case of chickenpox (see section 4.8). During prolonged treatment, periodic blood counts and liver and kidney function tests are advisable. Precautions for use Urine volume and renal function should be closely monitored at the start of treatment with morniflumate in patients with chronic heart failure, renal or hepatic insufficiency, who are taking diuretics, who have undergone major surgery resulting in hypovolaemia, and particularly in the elderly. The use of FLOMAX should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and gastrointestinal and cardiovascular risks below). Cardiovascular and cerebrovascular effects Appropriate monitoring and advice are necessary in patients with a history of hypertension and/or mild to moderate congestive heart failure since fluid retention and oedema have been reported in association with NSAID therapy. Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for morniflumate. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with morniflumate after careful consideration. Similar consideration should be made before initiating long term treatment in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events. The relative risk is increased in the elderly, in debilitated subjects, in people with low body weight and in patients receiving anticoagulants or antiplatelet therapy. When gastrointestinal bleeding or ulceration occurs in patients receiving FLOMAX, the treatment should be withdrawn. NSAIDs should be administered with caution and under close medical supervision in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease, hiatus hernia) as these conditions may be exacerbated (see section 4.8 Undesirable effects). Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5). Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2). The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3). These patients should start treatment on the lowest dose available. Concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients taking low dose aspirin or other drugs likely to increase gastrointestinal risk (see section 4.5). Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Skin effects Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. FLOMAX should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Interference with laboratory tests False-positive results in the urine immunoassay for cannabinoids have been reported in subjects treated with niflumic acid or morniflumate (see section 4.8). Further testing is required to confirm a positive result. Paediatric population As with other NSAIDs, the use of morniflumate in paediatrics should be undertaken after careful risk-benefit assessment for each individual patient. In the treatment of paediatric patients, it is advisable to strictly adhere to the recommended dosage (see section 4.2), avoiding therapeutic combinations that may increase the risk of any adverse reactions. Literature data suggest that the use of niflumic acid in the paediatric population could be associated with an increased risk of serious mucocutaneous reactions. The granules (sachets) contain sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine; take this into account when administering to diabetic patients and those on low-calorie diets. The granules also contain sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine; it may cause gastric problems and diarrhoea. The use of FLOMAX, as with any drug inhibiting the synthesis of prostaglandins and cyclooxygenase, is not recommended in women intending to become pregnant.

INTERACTIONS

Interactions Flomax 350 mg 20 sachets granules for oral suspension - Which medicines or foods can modify the effect of Flomax 350 mg 20 sachets granules for oral suspension?

Diuretics, ACE inhibitors and angiotensin II antagonists NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking morniflumate concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy. Risk associated with hyperkalaemia Some medicinal products or therapeutic classes may promote the onset of hyperkalaemia: potassium salts, diuretics, ACE (angiotensin converting enzyme) inhibitors, angiotensin II inhibitors, NSAIDs, heparins (both low molecular weight and unfractionated), ciclosporin, tacrolimus and trimethoprim. The onset of hyperkalaemia may depend on the existence of associated factors. This risk increases when there is a combination with the medicinal products mentioned above. Risk associated with the antiplatelet effect Many substances are involved in interactions due to their antiplatelet properties: aspirin and NSAIDs, ticlopidine and clopidogrel, tirofiban, eptifibatide and abciximab, iloprost. The use of many antiplatelet agents increases the risk of haemorrhage as does their combination with heparins, oral anticoagulants and thrombolytics. Such use should be subject to regular clinical and biological monitoring. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4). Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4). Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4). The concomitant administration of morniflumate with the following products requires close clinical and biological monitoring of the patient. Combinations not recommended With other NSAIDs (including acetylsalicylic acid and other salicylates) An increased risk of gastrointestinal ulcers and haemorrhages has been observed (additive synergy). With other anticoagulants An increased risk of bleeding has been observed (inhibition of platelet function and damage to the gastroduodenal mucosa caused by NSAIDs). If this combination cannot be avoided, close clinical and laboratory monitoring of the patient is required. With heparin at curative doses or in elderly patients An increased risk of haemorrhage has been observed (inhibition of platelet function and irritation of the gastroduodenal mucosa caused by NSAIDs). If this combination cannot be avoided, close clinical and laboratory monitoring of the patient is required. NSAIDs should be administered for a few days. With lithium Lithium levels in the blood are increased and toxic concentrations may be reached (reduced renal excretion of lithium). If necessary, lithium levels in the blood should be closely monitored and the lithium dosage should be adjusted during the combination treatment and after treatment with NSAIDs has been stopped. With methotrexate, used at doses greater than 15 mg per week An increased risk of haematological toxicity caused by methotrexate has been observed (anti-inflammatory drugs reduce the renal clearance of methotrexate). Combinations requiring precautions for use With diuretics, ACE inhibitors, and angiotensin II inhibitors Acute renal failure has been observed in patients at risk (elderly and/or dehydrated subjects) due to a decrease in glomerular filtration (NSAIDs inhibit vasodilatory prostaglandins). Rehydrate the patient. Renal function should be monitored at the beginning of treatment. With methotrexate used at doses lower than 15 mg per week An increased risk of haematological toxicity caused by methotrexate has been observed (anti-inflammatories reduce the renal clearance of methotrexate). Haematological counts should be monitored weekly during the first weeks of combination treatment. In case of renal failure (even if mild), and in elderly patients, close monitoring is required. Combinations to be taken into account With other antiplatelet agents (ticlopidine, clopidogrel, tirofiban, eptifibatide and abciximab, iloprost) and with heparins at prophylactic doses an increased risk of haemorrhage has been observed. With other agents causing hyperkalaemia (potassium salts, potassium-sparing diuretics, ACE (angiotensin converting enzyme) inhibitors, angiotensin II inhibitors, other NSAIDs, heparins (both low molecular weight and unfractionated), ciclosporin, tacrolimus and trimethoprim) an increased risk of hyperkalaemia has been observed. With beta-blockers (by extrapolation of indomethacin data) a reduction of the antihypertensive effect has been observed (NSAIDs inhibit vasodilatory prostaglandins). With ciclosporin Risk of potentiation of nephrotoxic effects, particularly in elderly patients.

SIDE EFFECTS

Like all medicines, Flomax 350 mg 20 sachets granules for oral suspension can cause side effects - What are the side effects of Flomax 350 mg 20 sachets granules for oral suspension?

The most commonly observed adverse events with NSAIDs are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Oedema, hypertension and cardiac failure have been reported in association with NSAID therapy. The frequency of the adverse events listed in the table below cannot be estimated from the available data as they have been reported in the post-marketing experience.

Classification by systems and organs	Adverse reaction
Infections and infestations(*)	Worsening of skin infections (in the presence of chickenpox, see section 4.4)
Pathologies of the haemolymphopoietic system	Thrombocytopenia, leukopenia
Immune system disorders	Anaphylactic shock
Nervous system disorders	Headache, dizziness
Cardiovascular diseases	Myocardial infarction or cerebrovascular accident (see section 4.4)**, oedema, hypertension and cardiac failure, hypotension, vasculitis,
Respiratory, thoracic and mediastinal pathologies	Asthma crisis (especially in patients allergic to acetylsalicylic acid or other NSAIDs)
Gastrointestinal disorders(*)	Peptic ulcer, gastrointestinal perforation, gastrointestinal haemorrhage (sometimes fatal, particularly in the elderly, see section 4.4), nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, epigastralgia, melaena, haematemesis, ulcerative stomatitis, gastrointestinal ulcers (with or without haemorrhage), haemorrhagic colitis, exacerbation of colitis and Crohn's disease, gastritis.
Skin and subcutaneous tissue disorders	Rash, urticaria, purpura, pruritus, erythema multiforme, erythema multiforme and dermatitis, bullous eruptions including Stevens-Johnson syndrome and toxic epidermal necrolysis, photosensitivity dermatitis, angioedema of the face, tongue, eyelids, lips, larynx, pharynx
Kidney and urinary disorders	Acute renal failure, tubulointerstitial nephritis, nephrotic syndrome, hematuria
Injury, poisoning and procedural complications	Fluorosis (high doses for several years)
Diagnostic tests	Abnormal liver function tests, false positive urine test for cannabinoids (see section 4.4)

(*) Increases in dosage and duration of treatment influence the increase in the frequency of gastrointestinal adverse reactions (see section 4.4). In case of chickenpox, serious skin infectious complications may occur (see section 4.4). (**) Clinical trials and epidemiological data suggest that the use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a modest increased risk of arterial thrombotic events (i.e. myocardial infarction or cerebrovascular accident; see section 4.4). Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Flomax 350 mg 20 sachets granules for oral suspension - What are the risks of Flomax 350 mg 20 sachets granules for oral suspension in case of overdose?

In case of overdose with niflumic acid/morniflumate the predictable symptoms are: gastrointestinal irritation, drowsiness (5%) and headache. A subject who ingested 7.5 g of niflumic acid showed glomerulonephritis, which resolved without sequelae. In case of overdose, symptomatic treatment is indicated, in addition to gastric lavage and the administration of activated charcoal (oral forms only).

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Flomax 350 mg 20 sachets granules for oral suspension.

Fertility . Cases of secondary non-ovulatory infertility caused by failure of the Graafian follicle to rupture have been reported in female patients of childbearing age receiving long-term treatment with prostaglandin synthesis inhibitors. This infertility is reversible upon discontinuation of treatment. Pregnancy. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1%, up to approximately 1.5%. The risk was believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-foetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. From the 20th week of pregnancy onwards, the use of FLOMAX may cause oligohydramnios resulting from fetal renal dysfunction. This condition may be encountered soon after initiation of treatment and is usually reversible upon discontinuation of treatment. In addition, cases of constriction of the ductus arteriosus have been reported following treatment in the second trimester, most of which resolved after discontinuation of treatment. Therefore, during the first and second trimesters of pregnancy, FLOMAX should not be administered unless clearly necessary. If FLOMAX is used by a woman planning to become pregnant, or during the first and second trimester of pregnancy, the lowest possible dose should be used for the shortest possible duration. Following exposure to FLOMAX for several days from the 20th week of gestation onwards, antenatal monitoring for oligohydramnios and constriction of the ductus arteriosus should be considered. In case of oligohydramnios or constriction of the ductus arteriosus, treatment with FLOMAX should be discontinued. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: - cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension), - renal dysfunction (see above); the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, and anti-aggregating effect which may occur even at very low doses, - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, FLOMAX is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3). Breast-feeding. The concentration of niflumic acid/morniflumate in milk is low. However, as a precaution, breastfeeding should be discontinued.

DRIVING AND USE OF MACHINERY

Taking Flomax 350 mg 20 sachets granules for oral suspension before driving or using machines - Does Flomax 350 mg 20 sachets granules for oral suspension affect driving or using machines?

Similar to other nonsteroidal anti-inflammatory drugs, the drug may induce drowsiness or sensory dullness with impairment of activities requiring alertness (driving a motor vehicle, using machinery, etc.). The patient must be warned of the possibility of manifestations such as dizziness or drowsiness.