Reckitt Benckiser Nurofenkid Fever And Pain 100mg Ibuprofen 24 Softgels

NurofenKid Fever and Pain are soft capsules based on Ibuprofen.

Therapeutic indications

NurofenKid Fever and Pain is used in the short-term symptomatic treatment of mild to moderate pain such as toothache, headache, and fever and pain associated with the common cold.

Dosage and Posology

In children, the dose of ibuprofen depends on body weight, usually 5 - 10 mg / kg body weight as a single dose. The maximum daily dosage of Nurofenkid Fever and Pain is 20-30 mg / kg body weight. Administer according to the following doses:

• 20-29 kg (7-9 years): Single dose - 200 mg of ibuprofen (corresponding to 2 capsules) Maximum daily dose - 600 mg of ibuprofen (corresponding to 6 capsules)
• 30-40 kg (10-12 years): Single dose - 300 mg of ibuprofen (corresponding to 3 capsules) Maximum daily dose - 900 mg of ibuprofen (corresponding to 9 capsules)

Doses should be administered approximately every 6 to 8 hours (or with a minimum interval of 6 hours between doses), if required. Do not use the medicine in children under 7 years of age or weighing less than 20 kg. If the medicine is to be given to the child for more than three days or if symptoms worsen, the doctor should be consulted.

How to use

The product must be chewed before swallowing. No water is needed

Overdose

In children, ibuprofen doses above 400 mg / kg can cause symptoms of toxicity, while the risk of toxic effects should not be excluded with a dose higher than 100 mg / kg.

In adults, the dose-response effect is less clear. The half-life in case of overdose is 1.5-3 hours.

Symptoms: Most patients who have ingested clinically significant amounts of NSAIDs will develop nothing more than nausea, vomiting, epigastric pain or, more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more severe cases of intoxication, central nervous system toxicity is observed, manifesting as drowsiness, occasionally excitability and disorientation, or coma. Occasionally, patients develop seizures. In the event of severe intoxication, metabolic acidosis may occur and the prothrombin time / INR may be prolonged, possibly due to interference with the action of circulating coagulation factors. Acute renal failure and liver damage can occur. An exacerbation of asthma is possible in asthmatics.

Treatment: Treatment should be symptomatic and supportive and should include maintaining a patent airway and monitoring cardiac function and vital signs until stabilization. Oral administration of activated charcoal should be considered if the patient presents within one hour of ingesting a potentially toxic amount. Seizures should be treated with intravenous diazepam or lorazepam if they are frequent or prolonged. Administer bronchodilators for asthma.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients.
• Patients who have already shown hypersensitivity reactions (e.g., asthma, rhinitis, angioedema or urticaria) in response to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• In the presence or in the case of a history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
• History of gastrointestinal bleeding or perforation related to previous NSAID therapy.
• Severe heart failure (NYHA class IV), severe renal failure or severe hepatic failure
• Last trimester of pregnancy
• This medicine contains soy lecithin. If you have a peanut or soy allergy, do not use this medicine.
• Cerebrovascular haemorrhage or other active bleeding episodes.
• Unclear disorders of blood formation.
• Severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake).

Side effects

The list of undesirable effects below refers to all undesirable effects that have occurred during treatment with ibuprofen, including those seen during long-term and high-dose treatment in patients with rheumatism. Frequencies reported, which occur with incidence higher than very rare cases, refer to short-term use of daily doses of up to 1200 mg ibuprofen for the oral dosage form and a maximum of 1800 mg for suppositories. . It should be taken into account that the following undesirable effects are predominantly dose-dependent and vary from individual to individual. Adverse reactions associated with the use of ibuprofen are listed below by system organ class and frequency.

Frequencies are defined as follows: Very common (≥ 1/10) Common (≥ 1/100 to <1/10) Uncommon (≥ 1 / 1,000 to <1/100) Rare (≥ 1 / 10,000 a <1 / 1,000) Very rare (<1 / 10,000) Not known (cannot be estimated from the available data) Within each frequency class, adverse events are reported in order of decreasing severity.

The most commonly observed adverse reactions are gastrointestinal in nature. Adverse reactions depend in most cases on the dose, in particular the risk of onset of gastrointestinal haemorrhage depends on the dosage and duration of treatment. Peptic ulcer, gastrointestinal perforation or haemorrhage, sometimes fatal, may occur, especially in the elderly (see section 4.4). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, worsening of colitis and Crohn's disease have been reported following administration of the medicinal product. Gastritis was observed less frequently. Edema, hypertension and heart failure have been reported in association with NSAID treatment. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg per day), may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Worsening of infection-related inflammation (eg, development of necrotizing fasciitis) has been observed in association with the use of non-steroidal anti-inflammatory drugs. This is likely associated with the mechanism of action of non-steroidal anti-inflammatory drugs. If signs of an infection occur or worsen while using Nurofenkid Fever and Pain, the patient is therefore recommended to seek immediate medical attention, who will consider whether antimicrobial / antibiotic therapy is indicated. CBC should be checked regularly in long-term treatment. The patient should be instructed to notify the physician immediately and to discontinue treatment with Nurofenkid Fever and Pain if any of the symptoms of hypersensitivity reactions occur; this can happen even on first use, in which case you need to seek immediate medical attention. The patient should be instructed to stop taking the medicine and go to the doctor immediately if severe pain in the upper abdomen or in case of melaena or haematemesis occurs.

- Infections and infestations

• Very rare: Worsening of infection-related inflammation (e.g., development of necrotizing fasciitis). In exceptional cases, severe skin infections and soft tissue complications can occur during a chickenpox infection.

- Disorders of the blood and lymphatic system

• Very rare: Haematopoiesis disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs may be: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nosebleeds, skin bleeding and bruising. In such cases, the patient should be advised to stop taking the drug, to avoid self-medication with analgesics or antipyretics and to consult the doctor.

- Immune system disorders - Hypersensitivity reactions characterized by:

• Uncommon: Hives and pruritus
• Very rare: Serious hypersensitivity reactions. Symptoms can be: swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Exacerbation of asthma.
• Not known: Respiratory tract reactivity including asthma, bronchospasm or dyspnoea.

- Psychiatric disorders

• Very rare: Psychotic reactions, depression.

- Nervous system disorders

• Uncommon: Central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or tiredness.
• Very rare Aseptic meningitis

- Eye disorders

• Uncommon: Visual disturbances

- Ear and labyrinth disorders

• Rare: Tinnitus

- Cardiac pathologies

• Very rare: Heart failure, palpitations and edema, myocardial infarction.

- Vascular pathologies

• Very rare: Hypertension, vasculitis.

- Gastrointestinal disorders

• Common: Gastrointestinal disturbances, such as abdominal pain, nausea and dyspepsia. Diarrhea, flatulence, constipation, heartburn, vomiting, slight gastrointestinal blood loss which in exceptional cases can cause anemia.
• Uncommon Gastrointestinal ulcers, gastrointestinal perforation or bleeding, ulcerative stomatitis, worsening of colitis and Crohn's disease, gastritis.
• Very rare: Esophagitis, formation of diaphragm-like intestinal strictures, pancreatitis.

- Hepatobiliary disorders

• Very rare: Hepatic dysfunction, liver damage, especially with prolonged therapy, hepatic failure, acute hepatitis.

- Skin and subcutaneous tissue disorders

• Uncommon Skin rashes of various kinds
• Very rare Severe forms of skin reactions, such as bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis, alopecia.

- Renal and urinary disorders

• Rare: Renal tissue damage (papillary necrosis) and elevated blood urea concentrations may also be observed rarely; high concentrations of uric acid in the blood.
• Very rare Formation of edema, mainly in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute renal insufficiency.

- Diagnostic tests

• Rare: Decrease in hemoglobin levels.

Special warnings

Undesirable effects can be minimized by using the lowest effective dose for the shortest duration of treatment needed to control symptoms (see gastrointestinal and cardiovascular risks below). Elderly subjects have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.

Respiratory system: Bronchospasm may worsen in patients with or with a history of bronchial asthma or allergic disease.

Other NSAIDs: The use of ibuprofen concomitantly with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided (see section 4.5). Systemic Lupus Erythematosus (SLE) and Mixed Connective Tissue Disease: Patients with Systemic Lupus Erythematosus (SLE) and Mixed Connective Tissue Disease may have an increased risk of aseptic meningitis

Porphyrin metabolism: Caution is required in patients with congenital disorders of porphyrin metabolism (eg acute intermittent porphyria).

Renal impairment: Renal failure in terms of renal function may be further aggravated. There is a risk of renal failure in dehydrated children. In general terms, the habitual intake of analgesics, in particular in combination with several active substances with a pain-relieving effect, can lead to permanent renal damage with the risk of renal failure (analgesic nephropathy).

Hepatic impairment: Hepatic dysfunction.

Surgical interventions: Caution is required immediately following major surgeries.

Allergies: Caution is required in patients with allergic reactions to other substances, as there is an increased risk of hypersensitivity reactions occurring even with the use of Nurofenkid Fever and Pain. There is an increased risk of allergic reactions in patients suffering from hay fever, nasal polyps or chronic obstructive breathing disorders. These can present in the form of asthma attacks (so-called analgesic asthma), Quincke's edema or urticaria. Severe acute hypersensitivity reactions (eg anaphylactic shock) are observed very rarely. At the first signs of hypersensitivity reactions after using Nurofenkid Fever and Pain, the treatment should be stopped. Medically necessary measures, in line with symptoms, should be undertaken by trained personnel.

Cardiovascular and cerebrovascular effects: Caution is required (in consultation with your doctor or pharmacist) before starting 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 studies suggest that the use of ibuprofen, especially in high doses (2400 mg per day) may be associated with a modest increased risk of arterial thrombotic events (eg, myocardial infarction or stroke).

Overall, epidemiological studies do not indicate that low doses of ibuprofen (e.g., ≤ 1200 mg per day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), overt ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg per day) should be avoided. . Particular care should also be taken before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g., hypertension, hyperlipidaemia, diabetes mellitus, smoking), especially if high doses of ibuprofen (2400 mg per day) are required. .

Impaired Female Fertility: There is limited evidence that drugs that inhibit cyclooxygenase / prostaglandin synthesis may cause impaired female fertility by exerting an effect on ovulation. This is reversible upon discontinuation of treatment.

Gastrointestinal system: NSAIDs should be administered with caution to patients with a history of gastrointestinal disorders (ulcerative colitis, Crohn's disease), as these conditions can be exacerbated. Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or 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, especially if complicated with haemorrhage or perforation, and in the elderly. Such patients should start treatment with the lowest available dose. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and, in addition, for patients taking concomitantly low dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events. Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly in the early stages of treatment. Caution should be advised in patients concomitantly taking medicinal products that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid. When gastrointestinal bleeding or ulceration occurs in patients taking ibuprofen, treatment should be stopped.

Dermatological 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. Patients appear to be at increased risk of these reactions in the early stages of therapy: in the majority of cases, the onset of the reaction occurred within the first month of treatment. Ibuprofen should be discontinued at the first appearance of rash, mucosal lesions or any other signs of hypersensitivity. Exceptionally, chickenpox can cause severe infectious skin and soft tissue complications. To date, the contribution of NSAIDs in the worsening of these infections cannot be ruled out. Therefore, it is recommended to avoid the use of Nurofenkid Fever and Pain in case of chickenpox.

Platelet function: Because they can interfere with platelet function, NSAIDs should be used with caution in patients with idiopathic thrombocytopenic purpura (ITP) and bleeding diathesis. In case of prolonged administration of Nurofenkid Fever and Pain, a periodic check of liver values, renal function, as well as blood count is necessary. Prolonged use of any type of pain reliever for headaches can worsen the symptoms. If this situation occurs or is suspected, the doctor should be consulted and the treatment stopped. The diagnosis of drug overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of headache medications. Undesirable effects related to the active substance, especially those affecting the gastrointestinal tract or the central nervous system, may increase in case of concomitant alcohol intake while using NSAIDs. NSAIDs can mask the symptoms of infection and fever. This product contains glucose. Patients with rare hereditary problems of glucose-galactose malabsorption should not take this medicine. This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Expiry and Retention

Do not store at temperatures above 25 ° C.

Warning: do not use Nurofen Kid after the expiry date stated on the package

Composition

Each capsule of Nurofen Kid contains:

Active principle

100 mg of ibuprofen

Excipients

Gelatin Purified water Glucose, liquid Sucrose Fumaric acid (E297) Sucralose Citric acid (E330) Acesulfame K (E950) Sodium edetate Glycerin Orange flavor Red iron oxide (E172) Yellow iron oxide (E172) Capsule ink Titanium dioxide (E171) Propylene glycol HPMC 2910 / Hypromellose 3cP (E464) Processing aids Medium-chain triglycerides Lecithin (derived from soy) Stearic acid