Nurofen fever & pain 200mg/5ml orange 100 ml

Product Description

Nurofen Fever and Pain 200 mg/5ml is a medicine for the symptomatic treatment of fever and mild to moderate pain.

Composition

Each ml of oral suspension contains;

• Active ingredient: ibuprofen 40 mg. Excipients with known effects: maltitol syrup 445 mg.
• Excipients:Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, orange flavoring, domiphene bromide, purified water.

Directions for use and Dosage

• Method of administration: Oral administration to infants and children aged between 3 months and 12 years should be done using the measuring syringe or measuring spoon provided with the product. Patients who suffer from stomach problems can take the medicine during meals.
• Dosage: The daily dose is structured according to the weight and age of the patient. In children aged between 3 and 6 months, limit administration to those weighing more than 5.6 kg.

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 (the graduated scale on the body of the syringe clearly shows the notches for the different dosages; the measuring spoon has two concave blades at the ends for the different dosages: the 2.5 ml mark corresponding to 100 mg of ibuprofen and the 5 ml mark corresponding to 200 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 treatment. 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 24 hours, consult your doctor. 3 days in infants and children over 6 months of age and in adolescents, or in case of worsening of symptoms, a doctor should be consulted.

Instructions for using the dosing syringe

1. Unscrew the cap by pushing it downwards and turning it to the left.
2. Insert the tip of the syringe fully into the hole in the undercap. 
3. Shake well.
4. Invert the bottle, then, holding the syringe firmly, gently pull the plunger downwards, allowing the suspension to flow into the syringe up to the mark corresponding to the desired dose.
5. Return the bottle to an upright position and remove the syringe by gently twisting it.
6. Insert the tip of the syringe into the child's mouth and apply gentle pressure on the plunger to allow the suspension to flow out. 
7. After use, screw the cap to close the bottle and wash the syringe with hot water. Let it dry, keeping it out of the reach and sight of children.

Contraindications

Hypersensitivity to ibuprofen or to any of the excipients listed. 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 polyps and asthma. Active peptic ulcer. Severe renal or hepatic insufficiency. Severe cardiac insufficiency. 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.

Warnings

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. The use of the drug 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 this type of drug. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have experienced such reactions after using other analgesics, antipyretics, nonsteroidal anti-inflammatory drugs, and in subjects with bronchial hyperreactivity (asthma), nasal polyps, or previous episodes of angioedema. Gastrointestinal bleeding, ulceration, and perforation: Gastrointestinal bleeding, ulceration, and perforation, which can be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. There is a risk of impaired renal function in dehydrated children and adolescents. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. In the elderly and in patients with a history of ulcers, particularly if complicated with haemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration, or perforation is higher with increasing doses of NSAIDs. These patients should start treatment on the lowest available dose. Concomitant use of protective agents (e.g., 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. Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that could 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 (aspirin). If gastrointestinal bleeding or ulceration occurs in patients taking Nurofen Fever and Pain, the 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. 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 highest risk early in the course of therapy: the onset of the reaction occurs in the majority of cases within the first month of treatment. Nurofen Fever and Pain should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. 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 edema have been reported in association with NSAID treatment. Clinical studies 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-dose ibuprofen (e.g., <= 1200 mg/day) is 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 should be made before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g., hypertension, hyperlipidemia, diabetes mellitus, smoking). The use of ibuprofen, acetylsalicylic acid, or other analgesics, antipyretics, or nonsteroidal anti-inflammatory drugs requires particular caution: in case of asthma or current or previous allergic diseases: possible deterioration of bronchoconstriction; in the presence of coagulation defects: reduced coagulability; in the presence of renal, cardiac, or hypertension diseases: possible critical reduction in renal function (especially in subjects with impaired renal or hepatic function, heart failure, or on diuretic therapy), nephrotoxicity, or fluid retention; in the presence of liver disease: possible hepatotoxicity. Rehydrate the patient before the start and during treatment in case of dehydration (e.g., due to fever, vomiting, or diarrhea); The following precautions are important during prolonged treatment: 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, altered color perception): discontinue treatment and consult an ophthalmologist; if signs or symptoms of meningitis occur: consider the rare possibility that it is due to the use of ibuprofen (aseptic meningitis; more common in patients with systemic lupus erythematosus and mixed connective tissue disease or other collagen diseases). Since the drug contains maltitol, patients with rare hereditary problems of fructose intolerance should not take this medicine. The medicine does not contain sugar and is therefore suitable for those patients who must monitor their sugar and calorie intake. Each 2.5 ml dose of suspension contains 4.63 mg (0.20 mmol) sodium; this should be taken into consideration if a controlled sodium diet is recommended.

Format

200 mg/5 ml vial, orange flavour.