Levifen Oral Susp 150ml 100mg/5ml Orange Flavor Without Zu

Oral suspension based on ibuprofen.

Therapeutic indications

Levifen is used for the symptomatic treatment of fever and mild to moderate pain.

Dosage and Posology

The drug should be taken according to the following doses and methods: 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 needed to control symptoms (see section 4.4). In children between 3 and 6 months of age, limit administration to those weighing more than 5.6 kg. Oral administration to infants and children aged 3 months to 12 years should be done using the measuring syringe provided with the product. The graduated scale on the body of the syringe highlights the notches for the different dosages; in particular, the 2.5 ml mark corresponds to 50 mg of ibuprofen and the 5 ml mark corresponds to 100 mg of ibuprofen. The daily dose of 20-30 mg / kg body weight, divided 3 times a day at intervals of 6-8 hours, can be administered according to the following scheme:

• 5.6 - 7 Kg - 3 - 6 months: 2.5 ml
• 7 - 10 Kg - 6 - 12 months: 2.5 ml
• 10 - 15 Kg - 1 - 3 years: 5 ml
• 15 - 20 Kg - 4 - 6 years: 7.5 ml (5 ml + 2.5 ml)
• 20 - 28 Kg - 7 - 9 years: 10 ml
• 28 - 43 Kg - 10 - 12 years: 15 ml

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 subside. In infants aged 3 to 5 months, a doctor should be consulted if symptoms persist for more than 24 hours or if symptoms worsen. If the use of the medicine is necessary for more than 3 days in infants and children over 6 months of age, or in the case of worsening of symptoms, the doctor should be consulted.

1. Unscrew the cap by pushing it down and turning it to the left.
2. Fully insert the tip of the syringe into the hole in the undercap.
3. Shake well.
4. Turn the bottle upside down, then, holding the syringe firmly, gently pull the plunger downward, allowing the suspension to flow into the syringe to the mark corresponding to the desired dose.
5. Put the bottle back upright and remove the syringe by twisting it gently.
6. Introduce the tip of the syringe into the child's mouth, and exert a slight pressure on the plunger to drain the suspension.
7. After use, screw the cap to close the bottle and wash the syringe with warm water. Let it dry, keeping it out of the reach and sight of children.

Overdose

Signs and symptoms of toxicity were generally not observed at doses below 100 mg / kg in children or adults. However, supportive treatment may be required in some cases. Children have been observed to exhibit signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg / kg or greater.

Most patients who have ingested significant 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. Effects on the central nervous system (CNS) include headache, tinnitus, dizziness, seizures, 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, arousal state, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible.

There is no specific antidote to ibuprofen overdose. In the event of an overdose, symptomatic and supportive treatment is therefore indicated. Particular attention is paid to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic amount. Alternatively, gastric lavage should be considered in adults within one hour of ingesting a potentially life-threatening overdose. Adequate diuresis must be ensured and renal and hepatic functions closely monitored. The patient should remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged seizures should be treated with intravenous diazepam. Depending on the clinical condition of the patient, other supportive measures may be necessary. For more information, contact your local poison control center.

Contraindications

• Hypersensitivity to the active substance 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, non-steroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyposis and asthma
• Active peptic ulcer
• Severe renal or hepatic insufficiency
• Severe heart failure
• 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 specific COX-2 inhibitors
• Pregnancy and breastfeeding

Side effects

The side effects observed with ibuprofen are common to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs. Hypersensitivity reactions Rarely: anaphylactoid reactions (urticaria with or without angioedema), dyspnoea (from laryngeal obstruction or bronchospasm), shock, syndrome characterized by abdominal pain, fever, chills, nausea and vomiting; bronchospasm.

- Gastrointestinal disorders

• The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, particularly in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of Levifen.
• Gastritis was observed less frequently. Epigastric pain, heartburn. Gastric upset can be reduced by taking the drug on a full stomach.
• Rarely: hepatitis, jaundice, abnormal liver function tests, pancreatitis, duodenitis, oesophagitis, hepatorenal syndrome, hepatic necrosis, liver failure.

- Pathologies of the nervous system and sense organs

• Vertigo, headache, irritability, tinnitus.
• Rarely: depression, insomnia, difficulty concentrating, emotional lability, somnolence, aseptic meningitis, convulsions, auditory and visual disturbances.

- Respiratory, thoracic and mediastinal disorders

• Rarely: bronchospasm, dyspnea, apnea.

- Skin and subcutaneous tissue disorders

• Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rarely).
• Skin rashes (including maculopapular type), itching.
• Rarely: vesiculo-bullous eruptions, urticaria, erythema multiforme, alopecia, exfoliative dermatitis, photosensitivity dermatitis.

- Disorders of the blood and lymphatic system

• Very rarely: neutropenia, agranulocytosis, aplastic anemia, haemolytic anemia (possible positive Coombs test), thrombocytopenia (with or without purpura), eosinophilia, decreased hemoglobin and hematocrit, pancytopenia.

- Metabolism and nutrition disorders

• Decreased appetite.

- Cardiac and vascular diseases

• Edema, hypertension and heart failure have been reported in association with NSAID treatment. Fluid retention (usually responds promptly to discontinuation of treatment).
• Very rarely: cerebrovascular accidents, hypotension, congestive heart failure in subjects with impaired heart function, palpitations. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg / day) and for long-term treatment, may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke)

- Renal and urinary disorders

• Very rarely: acute renal failure in subjects with pre-existing significant renal impairment, papillary necrosis, tubular necrosis, glomerulonephritis, renal impairment test, polyuria, cystitis, haematuria.

- Immune system disorders Single cases of aseptic meningitis symptoms such as neck tension, headache, nausea, vomiting, fever, disorientation have been reported in patients with pre-existing autoimmune diseases (e.g. systemic lupus erythematosus, connective system diseases)

• Various

- Rarely: dry eyes and mouth, gum ulcers, rhinitis.

Special warnings

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see below on gastrointestinal and cardiovascular risks). The use of Levifen should be avoided concomitantly with NSAIDs, including selective COX-2 inhibitors. Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause hypersensitivity reactions, potentially serious (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 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.

Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. In dehydrated children there is a risk of impaired renal function.

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 ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with the lowest available dose. 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 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 aspirin.

When gastrointestinal bleeding or ulceration occurs in patients taking Levifen, 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 (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. In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Levifen should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Caution is required 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 treatment with NSAIDs. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg / day) and for long-term treatment, may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, 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 ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ibuprofen 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, non-steroidal anti-inflammatory drugs, requires particular caution:

• in case of asthma: possible bronchoconstriction;
• in the presence of coagulation defects: reduction of coagulability;
• in the presence of kidney, heart or hypertension diseases: possible critical reduction in renal function (especially in subjects with impaired renal or hepatic function, heart failure or being treated with diuretics), nephrotoxicity or fluid retention;
• in the presence of liver disease: possible hepatotoxicity;
• rehydrate the subject before the start and during the course of treatment in case of dehydration (for example due to fever, vomiting or diarrhea).

The following precautions are of relevance 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 arise (blurred or reduced vision, scotomas, altered color perception): stop the treatment and consult the ophthalmologist;
• if signs or symptoms of meningitis develop: evaluate the rare possibility that it is due to the use of ibuprofen (aseptic meningitis; more frequent in subjects with systemic lupus erythematosus or other collagenopathies).

As Levifen contains maltitol, patients with rare hereditary problems of fructose intolerance should not take this medicine. Levifen does not contain sugar and is therefore indicated for patients who need to control their sugar and calorie intake. Each 2.5 ml dose of suspension contains 4.51 mg (0.20 mmol) of sodium; this should be taken into account in cases where a low sodium diet is recommended

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. This medicine does not require any special storage conditions.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

Each ml of Levifen oral suspension contains:

Active principle

Ibuprofen 20 mg

Excipients

Citric acid monohydrate, sodium citrate, acesulfame potassium, xanthan gum, sodium benzoate, orange flavor, maltitol syrup, glycerin, purified water