Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe

Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe is an over-the-counter medicine specifically formulated for the symptomatic treatment of fever and mild to moderate pain in children over 3 months of age. The active ingredient is ibuprofen , a nonsteroidal anti-inflammatory drug (NSAID) widely used in pediatrics for its efficacy and safety. Each ml of suspension contains 20 mg of ibuprofen, ensuring precise and personalized dosing based on the weight and age of the child.

The 120 ml pack is equipped with a 5 ml dosing syringe , which allows for simple, accurate and hygienic administration, making it easier for even the youngest children to take it. The oral suspension has a pleasant berry aroma , designed to make it more pleasant for children to take it. The formulation is sugar-free, but contains sweeteners such as sorbitol and maltitol, making it suitable for those who must avoid taking simple sugars.

Algidrin children is indicated for the treatment of fever (for example in case of flu symptoms, respiratory tract infections, exanthematous diseases) and for the control of mild or moderate pain such as headache, toothache, muscle and joint pain typical of pediatric age. Thanks to its rapid action and the possibility of flexible dosing, it represents an effective and safe solution for the well-being of children in case of malaise.

The oral suspension Algidrin 20 mg/ml is particularly appreciated for its ease of use and for the precision in the dosage , essential to guarantee maximum efficacy and safety in the little ones. The product is suitable for pediatric use and can be administered directly or diluted in water, according to the child's preferences. The presence of the graduated dosing syringe allows parents to administer the exact amount of drug, reducing the risk of dosing errors.

Algidrin 20 mg/ml 120 ml oral suspension for children with 5 ml syringe is the ideal choice for those looking for a reliable, practical and well-tolerated antipyretic and analgesic , designed to respond to the needs of fever and pain in children in a safe and controlled way.

ACTIVE INGREDIENTS

Active ingredients contained in Algidrin 20 mg/ml 120 ml oral suspension for children with 5 ml syringe - What is the active ingredient of Algidrin 20 mg/ml 120 ml oral suspension for children with 5 ml syringe?

Each ml of oral suspension contains: 20 mg ibuprofen (provided by 34.17 mg ibuprofen lysine). Excipients with known effect: Sorbitol (E-420) 25 mg, maltitol (E-965) 100 mg, Allura AC red colouring (E-129) 0.0786 mg, methyl parahydroxybenzoate (E-218) 1.45 mg, ethyl parahydroxybenzoate (E-214) 0.32 mg, propyl parahydroxybenzoate (E-216) 0.22 mg. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe - What does Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe contain?

Purified water, Microcrystalline cellulose, Sodium carboxymethylcellulose, Sorbitol (E-420), Maltitol (E-965), Beta-cyclodextrin, Sodium saccharin, Sucralose (E-955), Forest fruit flavour, Allura-AC red colour (E-129), Methyl parahydroxybenzoate (E-218), Ethyl parahydroxybenzoate (E-214), Propyl parahydroxybenzoate (E-216).

DIRECTIONS

Therapeutic indications Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe - Why is Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe used? What is it used for?

ALGIDRIN is indicated for children over 3 months of age and adolescents: • for the symptomatic treatment of fever; • for the symptomatic treatment of mild to moderate pain.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe - When should Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe not be used?

- Hypersensitivity to ibuprofen, to any other NSAID or to any of the excipients listed in section 6.1; - Patients who have developed allergic reactions, asthma attacks, acute rhinitis, urticaria or angioneurotic oedema after taking substances with similar actions (e.g. acetylsalicylic acid or other anti-inflammatory drugs); - A history of gastrointestinal bleeding or perforation related to previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs); - Peptic ulcer, active or recurrent gastrointestinal bleeding (two or more separate episodes of ulceration or haemorrhage); - Patients with diseases that tend to increase bleeding; - Severe heart failure (NYHA: class IV); - Severe renal insufficiency (glomerular filtration rate below 30 ml/min); - Severe hepatic insufficiency; - Patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake); - During the third trimester of pregnancy (see section 4.6).

DOSAGE

Quantity and method of taking Algidrin 20 mg/ml 120 ml oral suspension for children with 5 ml syringe - How do you take Algidrin 20 mg/ml 120 ml oral suspension for children with 5 ml syringe?

Posology The lowest effective dose should be taken as quickly as possible to control symptoms (see section 4.4). Paediatric population: The dose of ibuprofen to be administered depends on the age and weight of the child. For children aged 3 months to 12 years, the recommended daily dose of ibuprofen is 20 to 30 mg/kg body weight, divided into three or four individual doses (see table below). The use of this medicinal product is not recommended in children under 3 months of age or weighing less than 5 kg. The interval between doses depends on the course of symptoms, but should never be less than 4 hours. The following dosage schedule is recommended as a guideline. Doses may be repeated every 6 to 8 hours, without exceeding the daily quantities given in the last column:

DOSAGE FOR CHILDREN
Age/Weight	Frequency	Dose	Maximum daily dose
From 3 to 6 months From 5 to 7.6 kg approximately	3 times a day	50 mg (2.5 ml)/dose	150 mg (7.5 ml)
From 6 to 12 months From 7.7 to 9 kg approximately	3 to 4 times a day	50 mg (2.5 ml)/dose	150-200 mg (7.5-10 ml)
From 1 to 3 years From 10 to 15 kg approximately	3 to 4 times a day	100 mg (5 ml)/dose	300-400 mg (15-20 ml)
From 4 to 6 years From 16 to 20 kg approximately	3 to 4 times a day	150 mg (7.5 ml)/dose	450-600 mg (22.5-30 ml)
From 7 to 9 years From 21 to 29 kg approximately	3 to 4 times a day	200 mg (10 ml)/dose	600-800 mg (30-40 ml)
From 10 to 12 years From 30 to 40 kg approximately	3 to 4 times a day	300 mg (15 ml)/dose	900-1200 mg (45-60 ml)

Adolescents (over 12 years of age): The recommended dose is 10-20 ml (equivalent to 200-400 mg ibuprofen) every 4-6 hours, if necessary, without exceeding the daily dose of 1200 mg ibuprofen in 24 hours. Given the quantity of ibuprofen in this medicinal product, the use of other pack sizes with more appropriate doses is recommended for the treatment of adults and adolescents over 12 years of age. Renal impairment: Certain precautions should be taken when using nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with renal impairment, since ibuprofen is usually eliminated by the kidneys. Lower doses are used for patients with mild to moderate renal dysfunction. Ibuprofen should not be used in patients with severe renal impairment (see section 4.3). Hepatic impairment: Although no differences in the pharmacokinetic profile of ibuprofen have been observed in patients with hepatic impairment, caution is advised when using NSAIDs in these patients. Patients with mild to moderate hepatic impairment should start treatment at lower doses and be carefully monitored. Ibuprofen should not be used in patients with severe hepatic impairment (see section 4.3). Method of administration This medicinal product is administered orally. It can be administered directly or diluted with water. Shake the bottle before use. The packs contain a 5 ml graduated oral syringe for accurate dosing. The syringe should be removed from the bottle, dismantled, washed and dried well after each use. Patients with gastric problems should take the medicine during meals.

CONSERVATION

Storage Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe - How is Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe stored?

Do not store above 30°C.

WARNINGS

Warnings Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe - About Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe it is important to know that:

Masking of symptoms of underlying infections: ALGIDRIN may mask the symptoms of infection, which may lead to a delay in starting appropriate treatment and thus worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and in bacterial complications of varicella. When ALGIDRIN is administered to relieve fever or pain related to infection, monitoring for infection is recommended. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen. Adverse reactions caused by the combination of the active substance and concomitant alcohol consumption, in particular reactions related to the gastrointestinal tract or the central nervous system, may be increased by the use of NSAIDs. Gastrointestinal risks: Gastrointestinal bleeding, ulcers and perforations: Reports of gastrointestinal bleeding, ulcers and perforations (which may be fatal) have been received during treatment with NSAIDs, including ibuprofen, at any time, with or without preceding warning symptoms and with or without a previous history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if ulcers are complicated with haemorrhage or perforation (see section 4.3) and in elderly patients. These patients should start treatment on the lowest possible dose and be prescribed concomitant treatment with protective agents (e.g. misoprostol or proton pump inhibitors); combination treatment should also be considered for patients requiring low dose acetylsalicylic acid or other medicinal products likely to increase gastrointestinal risk factors (see section 4.5). Patients with a history of gastrointestinal toxicity, and particularly elderly patients, should be advised to seek immediate medical attention if they experience infrequent abdominal symptoms (especially gastrointestinal bleeding) during treatment and especially in the initial stages. Special caution is advised in patients receiving concomitant medications which may increase the risk of gastrointestinal ulceration or bleeding such as dicoumarin-based oral anticoagulants or antiplatelet agents such as acetylsalicylic acid (see section 4.5). Furthermore, certain precautions should be taken when oral corticosteroids are administered concomitantly with selective serotonin reuptake inhibitor (SSRI) antidepressants. Treatment should be discontinued immediately in the event of gastrointestinal bleeding or ulceration in patients receiving this medicinal product (see section 4.3). NSAIDs should be administered with caution in patients with a history of ulcerative colitis or Crohn's disease, as they may aggravate these conditions (see section 4.8). Cardiovascular and cerebrovascular risks : Particular care should be taken in patients with a history of hypertension and/or heart failure, as fluid retention and oedema have been associated with NSAID treatment. Clinical trials suggest that use of ibuprofen, particularly at high doses (2400 mg daily), 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 dose ibuprofen (e.g. 1200 mg/day) is associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral artery disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided. Careful consideration should also be made before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), especially if they require high doses of ibuprofen (2400 mg/day). Risk of serious skin reactions: Very rare reports of serious skin reactions, some fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been received in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk of these reactions at the beginning of treatment: in the majority of cases these adverse reactions appear during the first month of treatment. Acute generalised exanthematous pustulosis (AGEP) has been reported in connection with products containing ibuprofen. Administration of the medicinal product should be discontinued immediately at the first symptoms of skin erythema, mucosal lesions or other signs of hypersensitivity. In exceptional cases, chickenpox may cause infectious complications of the skin and soft tissue. To date, the role of NSAIDs in exacerbating these infections cannot be ruled out. Therefore, ibuprofen should be avoided in case of chickenpox. Allergic reactions: In very rare cases, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. Treatment should be discontinued when the first signs of a hypersensitivity reaction appear after taking/administering ibuprofen. Depending on the symptoms, the necessary medical measures should be initiated by specialist personnel. Caution is advised in patients who have suffered from hypersensitivity or allergic reactions to other substances, as this may increase the risk of hypersensitivity reactions to ibuprofen. Caution is advised in patients who suffer from seasonal allergies, nasal polyps or chronic obstructive respiratory disorders, as there is a high risk of allergic reactions. These reactions may present as asthma attacks, Quincke's edema or urticaria. Renal and/or hepatic impairment: Ibuprofen should be used with caution in patients with liver or kidney disease, especially during simultaneous treatment with diuretics, since prostaglandin inhibition may produce fluid retention and impair renal function. If administered to these patients, the dose of ibuprofen should be kept as low as possible and renal function should be monitored regularly. There is a risk of renal impairment in children, adolescents and elderly patients who are dehydrated. In case of dehydration, ensure adequate fluid intake. Special precautions should be taken in children with severe dehydration, for example due to diarrhoea, since dehydration may act as a trigger for the development of renal failure. In general, the habitual use of analgesics, especially the combination of several analgesic substances, may cause long-lasting renal damage, with a risk of renal failure (analgesic nephropathy). Like other NSAIDs, long-term treatment with ibuprofen may cause renal papillary necrosis and other renal diseases. Renal toxicity has also been observed in patients whose renal prostaglandins play a compensatory role in renal perfusion. Elderly patients, patients with renal insufficiency, heart failure, hepatic dysfunction and those treated with diuretics or antihypertensives (ACE inhibitors) have a high risk of experiencing this reaction. Discontinuation of NSAID therapy usually restores the pre-treatment state. Like other NSAIDs, ibuprofen may produce slight transient increases in some liver parameters and significant increases in AST and ALT levels. Treatment should be discontinued in the event of a significant increase in these parameters (see sections 4.2 and 4.3). Use in the elderly population: Elderly patients suffer from an increased incidence of adverse reactions to NSAIDs, in particular gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). Others: As with other NSAIDs, anaphylactic/anaphylactoid reactions may occur without prior exposure to the drug. It should also be used with caution in patients with a history of bronchial asthma, chronic rhinitis and allergic diseases, as cases of bronchospasm, urticaria and angioedema have been reported in these types of patients (see section 4.3). On rare occasions, cases of aseptic meningitis have been reported with the use of ibuprofen. In the majority of cases, patients suffered from some form of autoimmune disease (such as systemic lupus erythematosus or other connective tissue diseases), which represented a risk factor, although cases have also been reported in patients without chronic disease (see section 4.8). Observed symptoms of aseptic meningitis were stiff neck, headache, nausea, vomiting, fever and disorientation. Special medical supervision is required when administering to patients immediately after major surgery. Like other NSAIDs, it should only be used after a rigorous risk/benefit assessment in patients with acute intermittent porphyria. Renal and hepatic function, haematological function and red blood cell count should be monitored as a precaution in patients on long-term treatment, since ibuprofen, like other NSAIDs, may inhibit platelet aggregation and prolong bleeding time. Undesirable effects can be minimised by using the lowest effective dose for as short a period as possible. Warnings on excipients: This medicine may cause allergic reactions because it contains Allura AC red colouring (E-129). It may cause asthma, especially in patients allergic to acetylsalicylic acid. This medicine contains maltitol (E-965) and each ml of suspension contains 25 mg sorbitol (E-420). Patients with hereditary fructose intolerance should not take this medicine. This medicinal product contains methyl parahydroxybenzoate (E-218), ethyl parahydroxybenzoate (E-214) and propyl parahydroxybenzoate (E-216) and may cause allergic reactions (possibly delayed). Interference with analytical tests: Bleeding time (may be prolonged for 1 day after stopping treatment). Blood sugar levels (may be reduced). Creatinine clearance (may be reduced). Haematocrit or haemoglobin levels (may be reduced). Blood urea nitrogen concentrations and serum creatinine and potassium concentrations (may be increased). Liver function tests: increased transaminase values.

INTERACTIONS

Interactions Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe - Which medicines or foods can modify the effect of Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe?

In general, NSAIDs should be used with caution when used with other drugs that may increase the risk of gastrointestinal ulceration, gastrointestinal bleeding and renal dysfunction. Interactions have been reported with the following medicinal products: - Diuretics : may increase the nephrotoxicity of NSAIDs, as a consequence of the reduction in renal blood flow. As with other NSAIDs, concomitant treatment with potassium-sparing diuretics may be associated with an increase in potassium levels, making it necessary to monitor plasma potassium levels. - Anticoagulants : NSAIDs may increase the effects of dicoumarin anticoagulants such as warfarin (see section 4.4). - Antiplatelet agents : increase the risk of gastrointestinal bleeding (see section 4.4). NSAIDs should not be combined with ticlopidine, due to the risk of an additive effect in inhibiting platelet function. - Corticosteroids : may also increase the risk of gastrointestinal ulceration or bleeding (see section 4.4). - Selective serotonin reuptake inhibitors (SSRIs) : may also increase the risk of gastrointestinal bleeding (see section 4.4). - Antihypertensive agents (including ACE inhibitors, beta-blockers and angiotensin II receptor antagonists) : NSAIDs may reduce the efficacy of antihypertensive agents, including ACE inhibitors or beta-blocking agents and angiotensin II receptor antagonists. Simultaneous treatment with NSAIDs, ACE inhibitors, beta-blockers or angiotensin receptor blockers may be associated with the risk of acute renal disease, including acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be well hydrated and regular monitoring of renal function should be considered after initiation of concomitant treatment. - Acetylsalicylic acid and other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors : Simultaneous use should be avoided, since the administration of multiple NSAIDs may increase the risk of gastrointestinal ulceration and bleeding. - Acetylsalicylic acid : In general, the concomitant administration of ibuprofen and acetylsalicylic acid is not recommended due to the potential for increased adverse effects. Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when administered concomitantly. Although there are uncertainties regarding the extrapolation of these data to clinical situations, the possibility that long-term regular use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. There is likely to be no clinically relevant effect with occasional use of ibuprofen (see section 5.1). - Lithium : NSAIDs may increase lithium plasma levels, probably due to a decrease in its renal clearance. Co-administration should be avoided unless lithium levels are monitored. A reduction in the lithium dose should be considered. - Methotrexate administered at doses of 15 mg/week or more : if NSAIDs and methotrexate are administered within a 24-hour interval, an increase in methotrexate plasma levels may occur (NSAIDs appear to reduce the tubular secretion and renal clearance of methotrexate), with an increased risk of methotrexate toxicity. Therefore, the use of ibuprofen in patients receiving high-dose methotrexate treatment should be avoided. - Methotrexate administered at low doses, below 15 mg/week : ibuprofen increases methotrexate levels. When used in combination with low-dose methotrexate, the patient's blood chemistry should be closely monitored, especially during the first weeks of simultaneous administration. Vigilance should also be increased in cases of even minimally impaired renal function and in elderly patients. Renal function should be monitored to prevent any possible decrease in methotrexate clearance. - Sulfonylureas : NSAIDs may enhance the effect of sulfonylureas. Rare cases of hypoglycaemia have been reported in patients treated with sulfonylureas and ibuprofen. - Mifepristone : theoretically, the efficacy of this drug may be reduced due to the antiprostaglandin properties of NSAIDs. Limited evidence suggests that concomitant administration of an NSAID on the same day as a prostaglandin does not negatively impact the effects of mifepristone or the prostaglandin on cervical ripening or uterine contractility and does not reduce clinical efficacy in inducing abortion. - Cardiac glycosides (digoxin) : NSAIDs may exacerbate cardiac failure, reduce glomerular filtration rate and increase cardiac glycoside levels, thereby increasing the risk of digoxin toxicity. - Pentoxifylline: The risk of haemorrhage may be increased in patients receiving ibuprofen in combination with pentoxifylline. Therefore, monitoring of bleeding time is recommended. - Probenecid and sulfinpyrazones : May cause an increase in plasma concentrations of ibuprofen; This interaction may be due to an inhibitory mechanism at the level of renal tubular secretion and glucuronidation, and the dose of ibuprofen may need to be adjusted. - Quinolone antibiotics : Data from animal studies indicate that NSAIDs may increase the risk of convulsions associated with the use of quinolone antibiotics. Patients who have taken NSAIDs and quinolones may be at increased risk of experiencing convulsions. - Hydantoins (phenytoin) and sulphonamides: The toxic effects of these substances may be increased. During simultaneous treatment with ibuprofen, plasma levels of phenytoin may increase. - Cholestyramine: Concomitant administration of ibuprofen and cholestyramine may reduce the absorption of ibuprofen from the gastrointestinal tract, although the clinical relevance is unknown. - Tacrine: Co-administration of ibuprofen with tacrine increases the toxicity of tacrine, with episodes of delirium, due to possible inhibition of its binding to plasma proteins. - Ciclosporin, tacrolimus : Simultaneous administration of NSAIDs may increase the risk of nephrotoxicity due to a reduction in renal prostaglandin synthesis. If administered concomitantly, renal function should be closely monitored. - Thrombolytics : The risk of haemorrhage may increase. - Zidovudine : The risk of haematological toxicity may increase when NSAIDs are administered with zidovudine. There is an increased risk of joint bleeding and haematomas in HIV (+) patients with haemophilia receiving concomitant treatment with zidovudine and ibuprofen. - Aminoglycosides : NSAIDs may reduce the excretion of aminoglycosides. - Herbal extracts : Ginkgo biloba may increase the risk of haemorrhage with NSAIDs. - Alcohol : Concomitant use of alcohol may increase adverse effects related to the use of NSAIDs, especially those involving the gastrointestinal tract and the central nervous system (see sections 4.4 and 4.8). - Food: Administration of ibuprofen with food reduces the rate of absorption, although this has no effect on the extent of absorption (see section 5.2). - CYP2C9 inhibitors : Administration of ibuprofen with CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). A study with voriconazole and fluconazole (CYP2C9 inhibitors) showed an increase of approximately 80% to 100% in exposure to S(+) ibuprofen. A lower dose of ibuprofen should be considered when co-administered with a potent CYP2C9 inhibitor, especially when ibuprofen is co-administered at high doses with voriconazole or fluconazole.

SIDE EFFECTS

Like all medicines, Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe can cause side effects - What are the side effects of Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe?

The most frequently observed adverse reactions are gastrointestinal in nature. Peptide ulcers, perforation or gastrointestinal haemorrhage, in some cases fatal, may occur, especially in the elderly (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis and exacerbation of colitis and Crohn's disease have also been reported (see section 4.4). The occurrence of gastritis has been observed less frequently. The adverse reactions are reported by organ system and by frequency according to the following classification: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1 / 10,000, < 1/1,000); very rare (< 1/10,000); frequency not known (cannot be estimated from the available data). The frequencies given below refer to short-term use at maximum daily doses of 1200 mg oral ibuprofen. Gastrointestinal disorders Common: dyspepsia, diarrhoea, nausea, vomiting, abdominal pain, flatulence, constipation, melaena, haematemesis, gastrointestinal haemorrhage; Uncommon: gastritis, duodenal ulcer, gastric ulcer, mouth ulcer, gastrointestinal perforation; Very rare: pancreatitis; Frequency not known: exacerbation of colitis, Crohn's disease. Skin disorders and hypersensitivity reactions Uncommon: rash, urticaria, pruritus, purpura (including allergic purpura), photosensitivity reaction; Very rare: bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, erythema multiforme. Serious skin infections and soft tissue complications may exceptionally occur during chickenpox (see also “Infections and infestations” and section 4.4). Frequency not known: drug reaction with eosinophilic and systemic symptoms (Dress syndrome). Acute generalised exanthematous pustulosis (AGEP). Infections and infestations¹ Uncommon: rhinitis; Rare: aseptic meningitis (see section 4.4). Immune system disorders Uncommon: hypersensitivity²; Rare: anaphylactic reaction: symptoms may include swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Central nervous system disorders Common: headache, dizziness; Uncommon: paraesthesia, somnolence; Rare: optic neuritis. Psychiatric disorders Uncommon: insomnia, anxiety; Rare: depression, confusion, disorientation. Ear and labyrinth disorders Uncommon: hearing impairment; Rare: vertigo, tinnitus. Eye disorders Uncommon: visual disturbances; Rare: reversible toxic amblyopia. Respiratory, thoracic and mediastinal disorders Uncommon: asthma, bronchospasm, dyspnoea. Blood and lymphatic system disorders Rare: thrombocytopenia, leucopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia. Initial symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, excessive tiredness and nose and skin bleeding of unknown cause. Cardiac disorders Very rare: cardiac failure, myocardial infarction (see section 4.4). Vascular disorders ⁴ Very rare: hypertension. Hepatobiliary disorders Uncommon: hepatitis, jaundice, liver dysfunction; Rare: liver failure; Very rare: liver failure. Renal and urinary disorders Uncommon: interstitial nephritis, nephrotic syndrome, renal failure, acute renal failure, papillary necrosis (especially after prolonged use), associated with increased urea. Systemic disorders Common: fatigue; Rare: oedema. ¹ Infections and infestations: exacerbation of infection-related inflammation (e.g. necrotising fasciitis) has been reported in association with the use of NSAIDs. A doctor should be consulted as soon as possible if there are signs or worsening of infection during use of ibuprofen. ² Hypersensitivity : hypersensitivity reactions have been observed after treatment with NSAIDs. These may consist of: (a) non-specific respiratory tract allergy and anaphylaxis; (b) respiratory tract reactivity such as asthma, aggravated asthma, bronchospasm or dyspnoea; or (c) various skin changes, including rashes of various types, pruritus, purpura, angioedema and, in very rare cases, erythema multiforme and dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrosis). ^3,4 Cardiac and vascular disorders : Clinical trials suggest that use of ibuprofen, particularly at high doses (2,400 mg daily) may be associated with a small increased risk of arterial thrombotic events (such as myocardial infarction or stroke, see section 4.4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. 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 Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe - What are the risks of Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe in case of overdose?

Most cases of overdose are asymptomatic. Generally, no signs of toxicity have been observed at doses below 100 mg/kg in children and adults. However, in some cases additional care may be required. Children have been observed to show signs and symptoms of toxicity after ingesting amounts of 400 mg/kg or more. Symptoms Most patients who have taken significant amounts of ibuprofen have shown symptoms within the next 4 to 6 hours. The most frequently reported symptoms of overdose include abdominal pain, nausea, vomiting, lethargy, and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, convulsions, loss of consciousness, and ataxia. Rare cases of nystagmus, metabolic acidosis, hypothermia, impaired renal function, gastrointestinal bleeding, coma, apnoea, and central nervous system and respiratory depression have also been reported. Cardiovascular disease, including hypotension, bradycardia and tachycardia, has been reported. In severe poisoning, metabolic acidosis may occur. In severe overdose, kidney and liver damage may occur. Therapeutic measures for overdose: Treatment is symptomatic and there is no specific antidote. For amounts where symptoms are unlikely to occur (less than 50 mg/kg ibuprofen), water may be given to minimize gastrointestinal discomfort. If large amounts have been ingested, activated charcoal should be given. Emptying the stomach by vomiting should only be considered within 60 minutes of ingestion. Therefore, gastric lavage should not be considered unless the patient has ingested a life-threatening amount of the drug and less than 60 minutes have elapsed since ingestion. The benefit of measures such as forced diuresis, hemodialysis, or hemoperfusion is questionable, since ibuprofen is highly bound to plasma proteins.

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 Algidrin 20 mg/ml 120 ml oral suspension for children with 5 ml syringe.

Pregnancy 1) First and second trimester of pregnancy Inhibition of prostaglandin synthesis adversely affects the pregnancy and/or the development of the embryo/fetus. Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformations and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk appears to increase with dose and duration of treatment. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo/fetal mortality. There have also been reports of increased incidences of various malformations, including cardiovascular malformations, in animals given a prostaglandin synthesis inhibitor during the organogenic period. From the 20th ^week of pregnancy onwards, the use of ibuprofen may cause oligohydramnios resulting from fetal renal dysfunction. This may occur shortly after initiation of treatment and is usually reversible upon discontinuation of treatment. In addition, there have been reports of constriction of the ductus arteriosus following treatment in the second trimester, most of which resolved after discontinuation of treatment. Therefore, ibuprofen should not be administered during the first and second trimesters of pregnancy unless considered strictly necessary. If ibuprofen must be used in a woman attempting to become pregnant, or during the first and second trimesters of pregnancy, the dose and duration of treatment should be reduced as much as possible. Following exposure to ibuprofen for several days from the 20th gestational ^week onwards, prenatal monitoring for oligohydramnios and constriction of the ductus arteriosus should be considered. Treatment with ibuprofen should be discontinued if oligohydramnios or constriction of the ductus arteriosus is observed. 2) Third trimester of pregnancy 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, at the end of pregnancy, to: - possible prolongation of bleeding time and of the antiplatelet effect, which may occur even at very low doses, - inhibition of uterine contractions resulting in delayed or prolonged delivery (with a tendency towards increased bleeding in the mother and child). Therefore, this medicinal product is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3). Breastfeeding Ibuprofen and its metabolites enter breast milk at low concentrations. To date, no harmful effects on newborns have been found, so in general breastfeeding should not be stopped during short-term treatment at the recommended dose for pain and fever. Fertility The use of ibuprofen may impair female fertility and is not recommended in women attempting to become pregnant. Women with difficulties conceiving or who are undergoing fertility tests should consider stopping this medicine.

DRIVING AND USE OF MACHINERY

Taking Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe before driving or using machines - Does Algidrin 20 mg/ml 120 ml oral suspension children with 5 ml syringe affect driving or using machines?

Patients who experience dizziness, vertigo, visual disturbances or other central nervous system disturbances while taking ibuprofen should avoid driving or operating machinery. Patients taking ibuprofen may find that their reaction times are affected; this should be borne in mind when performing tasks requiring increased alertness, such as driving or operating machinery. This effect is accentuated by simultaneous consumption of alcohol.