MOMENTkid children 100 mg/5 ml ibuprofen oral suspension - 150ml

Symptomatic treatment of fever and mild to moderate pain.

Active Ingredients

Each ml of oral suspension contains: Active ingredient: ibuprofen 20 mg. Excipients with known effect : sucrose, sucrose monopalmitate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium. For a full list of excipients, see section 6.1.

Excipients

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

Dosage

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. Dosage The daily dose is structured according to the weight and age of the patient. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment necessary to control symptoms (see section 4.4). In children aged between 3 and 6 months, limit administration to those weighing more than 5.6 kg. Method of administration For oral administration to infants and children aged between 3 months and 12 years, use the dosing syringe provided with the product. Patients who suffer from stomach problems can take the medicine during meals. 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 according to the following scheme. (Do not exceed the recommended doses) The graduated scale on the body of the syringe clearly shows the notches for the different dosages: in particular the 2.5 ml notch corresponding to 50 mg of ibuprofen and the 5 ml notch corresponding to 100 mg of ibuprofen.

Special populations: in case of post-vaccination fever refer to the dosage indicated above, it is recommended to administer a single dose (2.5 ml) 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 treatments. In infants aged between 3 and 5 months, a doctor should be consulted if the symptoms persist for a period of more than 24 hours or in case of worsening of the symptoms. If the use of the medicine is necessary for more than 3 days in infants and children aged over 6 months and in adolescents, or in case of worsening of the symptoms, a doctor should be consulted. Instructions for using the dosing syringe: Shake the bottle before use and then follow the instructions below. After unscrewing the cap, pushing it downwards and simultaneously turning it to the left, insert the tip of the syringe fully into the hole in the undercap. Turn the bottle upside down. Holding the syringe firmly, gently pull the plunger downwards, filling the syringe up to the mark corresponding to the desired dose. Put the bottle back in an upright position. Remove the syringe by gently turning it. Insert the tip of the syringe into the child's mouth and apply gentle pressure on the plunger to allow the solution to flow out. After use, close the bottle by screwing the cap tightly and wash the syringe with hot water. Leave it to dry, keeping it out of the reach and sight of children.

Warnings

• Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see 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-inflammatory drugs can cause potentially serious hypersensitivity reactions (anaphylactoid reactions), even in subjects not previously exposed to this type of drug. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have shown such reactions after the use of other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), nasal polyposis or previous episodes of angioedema (see paragraphs 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. • There is a risk of impaired renal function in dehydrated children and adolescents (see sections 4.3 and 4.8). 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 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. • Caution should be advised in patients taking concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid (aspirin) (see section 4.5). • When gastrointestinal bleeding or ulceration occurs in patients receiving Momentkid the treatment should be withdrawn. • 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 in the early stages of therapy: the onset of the reaction occurs 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. • Chickenpox may exceptionally be the cause of serious infectious complications of the skin and soft tissues. To date, the contribution of NSAIDs to the worsening of these infections cannot be excluded, therefore it is advisable to avoid the use of Momentkid in case of chickenpox. • Caution is advised (discuss with your doctor or pharmacist) before initiating treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID treatment. • 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 small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤1200 mg/day) are associated with an increased risk of myocardial infarction. • Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration. Similar considerations should be made before starting long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). The use of ibuprofen, acetylsalicylic acid or other analgesics, antipyretics, nonsteroidal anti-inflammatory drugs requires particular caution: • in case of asthma or allergic diseases in progress or in the past: possible deterioration of bronchoconstriction; • in the presence of coagulation defects: reduction of coagulability; • in the presence of renal, cardiac diseases or hypertension: possible critical reduction of renal function (especially in subjects with impaired renal or hepatic function, cardiac failure or in treatment with diuretics), nephrotoxicity or fluid retention; • in the presence of liver diseases: possible hepatotoxicity; • rehydrate the subject before the start and during treatment in case of dehydration (for example due to fever, vomiting or diarrhoea). The following precautions are relevant during prolonged treatments: • monitor for signs or symptoms of gastrointestinal ulceration or bleeding; • monitor for signs or symptoms of hepatotoxicity; • monitor for signs or symptoms of nephrotoxicity; • if visual disturbances occur (blurred or reduced vision, scotomas, alteration of colour perception): stop treatment and consult an ophthalmologist; • if signs or symptoms of meningitis occur: evaluate the rare possibility that it is due to the use of ibuprofen (aseptic meningitis; more frequent in subjects affected by systemic lupus erythematosus and mixed connective tissue disease or other collagen diseases) (see section 4.8). 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. - methyl parahydroxybenzoate and propyl parahydroxybenzoate : may cause allergic reactions (possibly delayed). - sodium : this medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially "sodium-free".

Conservation

This medicinal product does not require any special storage conditions.

Contraindications

• Hypersensitivity to ibuprofen or to any of the excipients listed in section 6.1. • Children under 3 months of age or weighing less than 5.6 kg. • The medicinal product is contraindicated in patients who show or have previously shown hypersensitivity (e.g. asthma, rhinitis, angioedema, or urticaria) to acetylsalicylic acid or other analgesics, antipyretics, nonsteroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyposis and asthma. • Active peptic ulcer. • Severe renal or hepatic insufficiency (see section 4.4). Severe cardiac insufficiency (see section 4.4). • History of gastrointestinal bleeding or perforation related to previous NSAID therapy, history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • Concomitant use of NSAIDs, including specific COX-2 inhibitors. • During the last trimester of pregnancy (see section 4.6).

Overdose

Toxicity Signs and symptoms of toxicity have not generally been observed at doses below 100 mg/kg in children or adults. However, in some cases supportive treatment may be necessary. Children have been observed to show signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or greater. The half-life of the drug following overdose is 1.5-3 hours. Symptoms Most patients who accidentally ingest clinically relevant amounts of ibuprofen will experience symptoms within 4-6 hours. The most commonly reported symptoms of overdose include nausea, vomiting, abdominal pain, lethargy and somnolence. Central nervous system (CNS) effects include headache, tinnitus, dizziness, convulsions and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea, and CNS and respiratory depression have also been reported rarely. Disorientation, excitement, fainting, and cardiovascular toxicity including hypotension, bradycardia, and tachycardia have been reported. Renal failure and liver damage are possible in cases of significant overdose. In more serious cases, prolongation of prothrombin time (INR) may occur, probably due to interference with the action of circulating clotting factors. In asthmatic subjects, exacerbation of the symptoms of the disease may occur. In cases of severe poisoning, metabolic acidosis may occur. Treatment There is no specific antidote for ibuprofen overdose. In the event of overdose, symptomatic and supportive treatment is indicated and should include maintaining a clear airway and monitoring cardiac function and vital signs until the patient is stabilized. Particular attention should be paid to monitoring blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingestion of a potentially toxic amount. Alternatively, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose in adults. Adequate diuresis should be ensured and renal and hepatic function should be closely monitored. The patient should remain under observation for at least four hours following ingestion of a potentially toxic amount. Frequent or prolonged convulsions should be treated with intravenous diazepam or lorazepam. If ibuprofen has already been absorbed, alkaline agents should be administered to promote excretion of acidic ibuprofen in the urine. Bronchodilators should be administered in cases of asthma. Other supportive measures may be necessary depending on the clinical condition of the patient. For more information, contact your local poison control center.

Pregnancy

It is unlikely that subjects under the age of 12 years will become pregnant or breast-feed. However, in such circumstances the following considerations should be taken into account. Pregnancy During the first and second trimester of pregnancy, administration of ibuprofen should be avoided. Ibuprofen is contraindicated during the third trimester of pregnancy. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the 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. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: • cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); • renal dysfunction which may progress to renal failure with oligo-hydroamniosis; the mother and neonate, at the end of pregnancy, to: • possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; • inhibition of uterine contractions resulting in delayed or prolonged labor. Breast-feeding There are limited data demonstrating that ibuprofen may pass into breast milk in low concentrations and is unlikely to have any adverse effects on the neonate. Fertility Not applicable.