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  • Angelini MomentKid Children Suspension Oral 150ml -46%

Angelini MomentKid Children Suspension Oral 150ml

4.89€ 9.10€
  • Brand: ANGELINI SpA
  • Product Code: 038666018
  • EAN:
  • Availability: In Stock
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Angelini

MomentKid Children

Oral suspension

Composition:

Each ml of oral suspension contains 20 mg of ibuprofen. Excipients: sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate. For the full list of excipients see section 6.1.

Excipients

Sucrose, xanthan gum, monopalmitate sucrose, cetyl alcohol, citric acid monohydrate, banana flavor, sodium edetate, methyl parahydroxybenzoate, simethicone emulsion, honey aroma, propyl parahydroxybenzoate, colloidal anhydrous silica, purified water.

Therapeutic indications

Symptomatic treatment of fever and mild or moderate pain.

Contraindications

• Hypersensitivity to the active ingredient or to any of the excipients. • Children under 3 months or weighing less than 5.6 Kg. • Hypersensitivity to acetylsalicylic acid or to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), in particular when hypersensitivity is associated with nasal polyposis and asthma. • Active peptic ulcer. • Severe hepatic or renal insufficiency. • Severe heart failure. • History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic hemorrhage / ulcer (two or more distinct episodes of demonstrated ulceration or bleeding). • Concomitant use of NSAIDs, including COX-2 inhibitors. • Pregnancy and breast-feeding (see section 4.6).

dosage

To improve the palatability of the suspension, a formulation has been developed that can give rise to the presence of a product that has not been dissolved in the upper part of the bottle; however, this presence does not indicate deterioration. It is recommended to shake the bottle before use. The daily dose is structured based on the patient's age and weight. In children aged 3 to 6 months limit the administration to those weighing more than 5.6 kg. For oral administration to infants and children aged 3 months to 12 years use the dosing syringe supplied with the product. The graduated scale on the syringe shows the notches for two different dosages: the 2.5 ml notch corresponding to 50 mg of ibuprofen and the 5 ml notch corresponding to 100 mg of ibuprofen. The daily dose of 20-30 mg / kg of body weight, divided 3 times a day at intervals of 6-8 hours, can be administered based on the following scheme:

Weight Age Single dose in ml maximum number of administrations / day
5.6-7 kg 3-6 months 2.5 ml 3 in the 24 hours
7-10 kg 6-12 months 2.5 ml
10-15 kg 1-3 years 5 ml
15-20 kg 4-6 years 7.5 ml (5 + 2.5 ml)
20-28 kg 7-9 years 10 ml
28-43 kg 10-12 years 15 ml

In the case of post-vaccination fever refer to the dosage indicated above, administering a single dose followed, if necessary, by another dose after 6 hours. Do not give more than two doses in 24 hours. Consult your doctor if the fever does not decrease. The product is intended for short-term treatments. Consult your doctor if symptoms persist for more than three days. In children under the age of six months, consult a doctor if symptoms persist after 24 hours of treatment.

Warnings and precautions

After three days of treatment without appreciable results, consult your doctor. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see the paragraphs below on gastrointestinal and cardiovascular risks). The use of Momentkid should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Analgesics, antipyretics, non-steroidal anti-inflammatories can cause potentially serious hypersensitivity reactions (anaphylactoid reactions), even in subjects not previously exposed to this type of drugs. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have presented such reactions after the use of other analgesics, antipyretics, non-steroidal anti-inflammatories and in subjects with bronchial hyperreactivity (asthma), nasal polyposis or previous episodes of angioedema (see sections 4.3 and 4.8). Gastrointestinal haemorrhage, ulceration and perforation: gastrointestinal haemorrhage, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs at any time, with or without warning symptoms or history of severe gastrointestinal events. Elderly: elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2). In patients with a history of ulcer, particularly the elderly, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should 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 section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, must report any unusual gastrointestinal symptoms (especially gastrointestinal haemorrhage), particularly in the early stages of treatment. Carefully monitor patients taking concomitant medications that may increase the risk of ulceration or hemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs) or anti-aggregating agents such as aspirin (see section 4.5). When bleeding or gastrointestinal ulceration occurs in patients taking Momentkid treatment should be discontinued. NSAIDs should be administered with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). Serious skin reactions, some of which are 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). In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Momentkid should be stopped at the first appearance of a skin rash, mucosal lesions or any other sign of hypersensitivity. Caution is required before starting treatment in patients with a history of hypertension and / or heart failure since fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg / day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (eg myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of Ibuprofen (eg ≤1200 mg / day) are associated with an increased risk of myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should be treated with ibuprofen only after careful consideration. Similar considerations must be made before starting a long-term treatment in patients with risk factors for cardiovascular events (eg hypertension, hyperlipidemia, diabetes mellitus, smoking). The use of ibuprofen, acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatories, requires particular caution: • in case of asthma: possible bronchoconstriction; • in the presence of coagulation defects: reduction of coagulability; • in the presence of kidney disease, heart disease or hypertension: possible critical reduction of renal function (especially in the elderly or in subjects with impaired renal or hepatic function, heart failure or in treatment with diuretics), nephrotoxicity or fluid retention; • in the presence of liver disease: possible hepatotoxicity. • rehydrate the subject before starting and during treatment in the event of dehydration (for example, fever, vomiting or diarrhea); The following precautions are important during prolonged treatments: • monitor the signs or symptoms of ulceration or gastrointestinal bleeding; • monitor the signs or symptoms of hepatotoxicity; • monitor the signs or symptoms of nephrotoxicity; • if visual disturbances arise (blurred or reduced vision, scotomas, alteration of color perception): stop treatment and consult an ophthalmologist; • if signs or symptoms of meningitis arise: assess the rare possibility that it is due to the use of ibuprofen (aseptic meningitis; more frequent in patients with systemic lupus erythematosus or other collagen diseases). Momentkid children contains: • sucrose (0.6 g / ml): patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. • parahydroxybenzoates that can cause allergic reactions (even delayed).

Interactions

The following interactions are common to ibuprofen, acetylsalicylic acid and other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs): • avoid the simultaneous use of two or more analgesics, antipyretics, non-steroidal anti-inflammatories: increased risk of side effects; • corticosteroids: increased risk of ulceration or gastrointestinal bleeding (see section 4.4); • antibacterials: possible increase in the risk of quinolone-induced convulsions; • anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4); • anti-aggregating agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4); • antidiabetics: possible increase in the effect of sulfonylureas; • antivirals: ritonavir, possible increase in the concentration of NSAIDs; • cyclosporine: increased risk of nephrotoxicity; • cytotoxic: methotrexate, reduction of excretion (increased risk of toxicity); • lithium: reduction of excretion (increased risk of toxicity); • tacrolimus: increased risk of nephrotoxicity; • uricosurics: probenecid, slowing NSAID excretion (increased plasma concentrations). • methotrexate: potential increase in methotrexate plasma concentration. • zidovudine: increased risk of hemarthrosis and hematoma in HIV (+) hemophiliacs if treated concomitantly with zidovudine and ibuprofen. Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (eg dehydrated patients or elderly patients with impaired renal function) co-administration of an ACE inhibitor or angiotensin II antagonist and cyclo-oxygenase inhibiting system agents may lead to a further deterioration of renal function, which includes a possible acute renal failure, generally reversible. These interactions should be considered in patients taking Momentkid concomitantly with ACE inhibitors or angiotensin II antagonists. Thus, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and renal function monitoring should be considered after initiation of concomitant therapy. Experimental data indicate that ibuprofen can inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when drugs are concomitantly administered. However, the limited data and uncertainties relating to their application to the clinical situation do not allow definitive conclusions to be drawn for the continuous use of ibuprofen; there appears to be no clinically relevant effects from the occasional use of ibuprofen (see section 5.1).

Side effects

Undesirable effects seen with ibuprofen are generally common to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs. Edema, hypertension and heart failure have been reported in association with NSAID treatment. Gastric disorders can be reduced by taking the drug on a full stomach. In patients with pre-existing autoimmune diseases (eg systemic lupus erythematosus, connective system diseases) individual cases of symptoms of aseptic meningitis such as nuchal tension, headache, nausea, vomiting, fever, disorientation have been reported (see section 4.4). Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg / day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (eg myocardial infarction or stroke) (see section 4.4). The following scales of values were used: - very common (≥ 1/10); - common (≥ 1/100, <1/10); - uncommon (≥ 1/1000, <1/100); - rare (≥ 1/10000, <1/1000); - very rare (<1/10000); - not known (frequency cannot be defined based on available data). Infections and infestations Rare: aseptic meningitis, rhinitis. Very rare: cystitis. Blood and lymphatic system disorders Very rare: neutropenia, agranulocytosis, aplastic anemia, haemolytic anemia (possible positive Coombs test), thrombocytopenia (with or without purpura), eosinophilia, reduced hemoglobin and reduced hematocrit value, pancytopenia. Immune system disorders Rare: anaphalactic-anaphylactoid reactions (serious reactions that may include: hives with or without angioedema, dyspnoea - due to laryngeal obstruction or bronchospasm - shock); syndrome characterized by abdominal pain, fever, chills, nausea and vomiting; bronchospasm (see sections 4.3 and 4.4). Metabolism and nutrition disorders Reduced appetite, water retention. Psychiatric disorders Irritability. Rare: depression, emotional lability. Nervous system disorders Headache, vertigo. Rare: insomnia, difficulty in mental concentration, drowsiness, convulsions. Very rare: cerebrovascular accident. Rare eye disorders: visual disturbances, dry eyes . Ear and labyrinth disorders Tinnitus. Rare: hearing disorder. Cardiac disorders Very rare: aggravated heart failure (in subjects with impaired cardiac function), palpitations. Vascular disorders Very rare: hypotension. Respiratory, thoracic and mediastinal disorders Rare: Bronchospasm, dyspnea, apnea. Gastrointestinal disorders Common: peptic ulcers, gastrointestinal perforation or (sometimes fatal) bleeding, particularly in the elderly (see section 4.4), nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, aggravated colitis , aggravated Crohn's disease. Rare: gastritis, epigastric pain, gastric pyrosis, pancreatitis, duodenitis, esophagitis, dry mouth, gingival ulcers. Hepatobiliary disorders Rare: hepatitis, jaundice, hepatorenal syndrome, hepatic necrosis, liver failure. Skin and subcutaneous tissue disorders Rare: vesico-bullous eruption, urticaria, erythema multiforme, alopecia, exfoliative dermatitis, photosensitivity dermatitis. Very rare: bullous eruption (including Stevens-Johnson syndrome and Epidermal Toxic Necrolysis), rashes and exanthems (including maculopapular exanthema), itching. Renal and urinary disorders Very rare: aggravated acute renal failure (in subjects with pre-existing significant impairment of renal function (see section 4.4), renal papillary necrosis, tubular necrosis, glomerulonephritis, polyuria, hematuria Diagnostic tests Rare: alteration of liver function tests Very rare: abnormal kidney function test.

Pregnancy and breastfeeding

People under the age of 12 are unlikely to get pregnant, or breast-feed. Moreover, in these circumstances the following considerations must be kept in mind. Inhibition of prostaglandin synthesis may negatively 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 cardiac malformations increased from less than 1% to around 1.5%. The risk was considered to increase with the dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre and post-implant loss and embryo-fetal mortality. Furthermore, an increase in the incidence of various malformations, including the cardiovascular one, was reported in animals to which prostaglandin synthesis inhibitors had been administered during the organogenetic period. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may exhibit: the fetus to: • cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); • renal dysfunction that can progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: • possible prolongation of the bleeding time, an anti-aggregating effect that can occur even at very low doses; • inhibition of uterine contractions resulting in delay or prolongation of labor.

Format: 150ml bottle

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