Momentkid children - analgesic anti-inflammatory oral suspension 150 ml

Product Description

Oral Suspension

Composition:

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

Excipients

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

Therapeutic indications

Symptomatic treatment of fever and mild to moderate pain.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients. • Children under 3 months of age or weighing less than 5.6 kg. • Hypersensitivity to acetylsalicylic acid or other analgesics, antipyretics, nonsteroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyps and asthma. • Active peptic ulcer. • Severe hepatic or renal insufficiency. • Severe cardiac insufficiency. • 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). • Concomitant use of NSAIDs, including COX-2 inhibitors. • Pregnancy and breastfeeding (see section 4.6).

Posology

To improve the palatability of the suspension, a formulation has been developed that may give rise to the presence of non-solubilized product in the upper part of the bottle; however, this presence is not an indication of deterioration. It is recommended to shake the bottle before use. The daily dose is structured according to the patient's age and weight. In children aged between 3 and 6 months, limit administration to those weighing more than 5.6 kg. For oral administration to infants and children aged between 3 months and 12 years, use the dosing syringe provided with the product. The graduated scale on the syringe clearly shows the markings for two different dosages: the 2.5 ml mark corresponding to 50 mg of ibuprofen and the 5 ml mark 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 used to treat a wide range of conditions. be administered according to the following schedule:

In 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 administer more than two doses in 24 hours. Consult your doctor if the fever does not decrease. The product is intended for short-term treatment. Consult your doctor if symptoms persist for more than three days. In children under six months of age, consult your 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 may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see sections below on gastrointestinal and cardiovascular risks). The use of Momentkid should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Analgesics, antipyretics, and nonsteroidal anti-inflammatory drugs can cause potentially serious hypersensitivity reactions (anaphylactoid reactions), even in subjects not previously exposed to these types of drugs. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have experienced such reactions after using other analgesics, antipyretics, and nonsteroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), nasal polyps, or previous episodes of angioedema (see sections 4.3 and 4.8). 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. 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 if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses. These patients should start treatment on the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients, as well as for patients taking low-dose 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 when elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment. Patients receiving concomitant medications that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs), or antiplatelet agents such as aspirin, should be carefully monitored (see section 4.5). If gastrointestinal bleeding or ulceration occurs in patients taking Momentkid, treatment should be discontinued. NSAIDs should be administered with caution to 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 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, with the onset of the reaction occurring in the majority of cases within the first month of treatment. Momentkid should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Caution is required before initiating treatment in patients with a history of hypertension and/or heart failure, as fluid retention, hypertension, and edema have been reported in association with NSAID therapy. Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg/day) and in long-term treatment, may be associated with a modest increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low doses of ibuprofen (e.g.,