LEVIFEN "CHILDREN 100 MG/5 ML ORAL SUSPENSION STRAWBERRY FLAVOUR WITHOUT SUGAR" 1 BOTTLE OF 150 ML WITH DOSING SYRINGE"

Name
LEVIFEN Children 100mg/5ml oral suspension strawberry flavour sugar free
LEVIFEN Children 100mg/5ml oral suspension orange flavour sugar free
Ibuprofen


What it is and what it is used for
LEVIFEN Children contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic (pain-relieving), antipyretic (fever-reducing) and anti-inflammatory activity.
LEVIFEN Children is indicated for the symptomatic treatment of fever and mild to moderate pain.


What you need to know before taking the medicine
Do not take LEVIFEN Children
- If you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
- If you are allergic to acetylsalicylic acid and other painkillers (analgesics), fever reducers (antipyretics), non-steroidal anti-inflammatory drugs (NSAIDs), in particular when the allergy is associated with nasal congestion due to secretion of the mucous membrane inside the nose (nasal polyposis) and asthma;
- If you suffer from active peptic ulcer (ulcer of the stomach and upper intestine);
- In case of children under 3 months of age or weighing less than 5.6 kg;
- If you suffer from severe kidney or liver problems (severe renal or hepatic insufficiency);
- If you suffer from severe heart problems (severe heart failure);
- If you are pregnant or breastfeeding;
- If you have suffered in the past from stomach or intestinal disorders associated with bleeding or lesions (gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic bleeding/ulcer);
- If you are taking other anti-inflammatory medicines (NSAIDs, including selective COX-2 inhibitors) at the same time.


Warnings and precautions
Talk to your doctor or pharmacist before using LEVIFEN

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause allergic reactions (hypersensitivity), even in subjects who have not previously taken this type of drug. The risk of allergic reactions after taking ibuprofen is higher in subjects who have presented such reactions after the use of other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and in subjects with asthma, nasal disorders (polyposis) or who have had allergic-type reactions in the past that manifested themselves with swelling of the face (angioedema) (see paragraphs “LEVIFEN Children” and “Possible side effects”).

Allergic-type reactions occur especially in the initial phases of treatment (first month). Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely with the use of anti-inflammatory drugs (see section “Possible side effects”).

Stop treatment with LEVIFEN Paediatrics at the first appearance of skin rash (eruption), mucosal lesions or any other sign of allergic reaction.

Stomach and/or intestinal problems
During treatment with anti-inflammatory drugs (NSAIDs), stomach bleeding (gastrointestinal bleeding, ulceration and perforation) may occur, which can be fatal. These events can happen at any time, with or without warning symptoms or a previous history of serious gastrointestinal events.

Elderly patients have an increased frequency of adverse effects to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration or perforation is higher when using high doses of NSAIDs. If you belong to this category of patients, you should start treatment with the lowest available dose .
In these cases, contact your doctor, who may advise you to combine LEVIFEN with medicines that protect the stomach, especially if you take other medicines (for example aspirin or other medicines that increase the risk of gastrointestinal problems).
During treatment with this medicine, particularly if you are elderly or have a history of stomach or intestinal problems, you should report to your doctor any unusual symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.

If bleeding or ulcers in the stomach and/or intestines occur, stop taking LEVIFEN Paediatrics.

Use this medicine with caution and talk to your doctor to discuss treatment with Levifen if:
• are taking medicines which may increase the risk of ulceration or bleeding, such as oral corticosteroids (cortisone and similar), anticoagulants such as warfarin (used to thin the blood), selective serotonin reuptake inhibitors (used as antidepressants) or antiplatelet agents such as aspirin (which block platelets, the cells responsible for clotting);
• have suffered from intestinal disorders in the past (ulcerative colitis, Crohn's disease, inflammatory bowel disease);
• have suffered or suffer from high blood pressure (hypertension);
• suffer from heart problems (heart failure, congestive heart failure, ischemic heart disease);
• have or have had peripheral arterial disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or have had any type of stroke (including 'mini-stroke' or 'TIA', transient ischaemic attack);
• suffers from breathing problems (asthma);
• suffer from blood clotting disorders;
• suffer from kidney, heart or liver disease;
• have risk factors for cardiovascular events such as high blood pressure, increased fat in the blood (hyperlipidemia), diabetes mellitus and smoking.

Use of ibuprofen, especially at high doses and for long-term treatment, may be associated with a small increased risk of heart attack or stroke (arterial thrombotic events). Do not exceed the recommended dose or duration of treatment.

Avoid using Levifen if you are taking other similar medicines (nonsteroidal anti-inflammatory drugs, NSAIDs including selective COX-2 inhibitors), because the risk of side effects may increase.

The use of LEVIFEN Children, acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs requires particular caution:
• in case of previous gastrointestinal ulcerations, perforations or bleeding;
• in case of asthma;
• in the presence of coagulation defects (reduction in the blood's ability to clot);
• if you have kidney or heart disease or high blood pressure, especially if you are an elderly patient or if you have impaired kidney or liver function, have heart failure or are being treated with diuretics, drugs used in the treatment of high blood pressure and heart failure);
• in the presence of liver disease;
• if you are dehydrated (for example due to fever, vomiting or diarrhoea). You will need to be rehydrated before starting and during treatment.

During treatment, especially if prolonged:

• watch out for signs or symptoms of ulceration or bleeding in your stomach or intestines and report them to your doctor immediately;
• watch for signs or symptoms of liver or kidney toxicity, and report them to your doctor immediately;
• if visual disturbances occur (blurred or reduced vision, scotomas, i.e. loss of vision in some parts of the visual field, alterations in colour perception) stop treatment and consult your doctor;
• if signs or symptoms of meningitis (inflammation of the membranes covering the brain) occur: contact your doctor who will have to evaluate the rare possibility that it is due to the use of this medicine (more frequent in subjects affected by systemic lupus erythematosus or other collagen diseases).

Children In dehydrated children there is a risk of impaired renal function.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following serious side effects may occur with the use of LEVIFEN Children:
- Gastrointestinal effects, such as: peptic ulcers (of the stomach and upper intestine), perforations or gastrointestinal bleeding, sometimes fatal, particularly in the elderly (see section “Warnings and precautions”).
- Allergic reactions, hives with or without facial swelling (angioedema), shock, syndrome characterized by abdominal pain, fever, chills, nausea and vomiting, difficulty breathing, bronchospasm (closure of the bronchi).
- Hepatitis (inflammation of the liver), jaundice (yellowing of the skin), abnormal liver function tests, pancreatitis (inflammation of the pancreas), duodenitis (inflammation of part of the intestine), esophagitis (inflammation of the esophagus, the tube that connects the mouth with the stomach), hepatorenal syndrome (a complication of liver disease, involving the kidney), liver necrosis (death of liver cells), liver failure.
- Nausea, vomiting, diarrhoea, flatulence (passing of gas from the intestine), constipation, dyspepsia (indigestion), abdominal pain, melaena (presence of digested blood in the stool), haematemesis (passing of blood with vomiting), ulcerative stomatitis (mouth ulcers), worsening of colitis and Crohn's disease (inflammatory bowel disease) (see section “Warnings and precautions”).
- Stomach pain, gastritis, heartburn (heartburn). Stomach discomfort may be reduced by taking the medicine on a full stomach.
- Dizziness, headache, irritability, tinnitus (perception of a ringing in the ear).
- Skin rashes (including maculopapular type) itching.
- Reduction of appetite.
- Swelling due to fluid accumulation in a part of the body (edema).
- High blood pressure and heart failure.
- Fluid retention (usually responds promptly to discontinuation of treatment).
- In patients with pre-existing autoimmune diseases (e.g. systemic lupus erythematosus, connective tissue diseases), single cases of aseptic meningitis symptoms such as neck tension, headache, nausea, vomiting, fever, disorientation have been reported.
- Depression, insomnia, difficulty concentrating, emotional instability, drowsiness, aseptic meningitis, convulsions, hearing and vision disturbances.
- Bronchospasm (closure of the bronchi), dyspnea (difficulty breathing), apnea (stopping of breathing).
- Skin disorders with formation of blisters and bubbles (vesiculobullous eruptions), urticaria, skin irritation (erythema multiforme, exfoliative dermatitis, photosensitivity dermatitis).
- Severe skin disorders (bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis).
- Alopecia (hair loss).
- Dry eyes and mouth, gum ulcers, rhinitis (inflammation of the nasal mucosa).
- Gastritis.
- Various Blood problems: neutropenia (decrease in neutrophils, a type of white blood cell), agranulocytosis (severe reduction in white blood cells), aplastic anaemia (anaemia caused by poor bone marrow function), haemolytic anaemia (anaemia caused by the breakdown of white blood cells) (possible positive Coombs test, a test that checks the compatibility of blood), thrombocytopenia (decrease in the number of platelets, the cells responsible for clotting) (with or without purpura, small bleeding in the skin), eosinophilia (increase in the number of eosinophils, a type of white blood cell), reduction in haemoglobin and haematocrit (degree of concentration of blood), pancytopenia (decrease in all types of blood cells).
- Cerebrovascular accidents (such as stroke), low blood pressure, heart problems (congestive heart failure in people with impaired heart function).
- Palpitations.
- Kidney problems (acute renal failure in subjects with existing renal impairment, papillary necrosis, tubular necrosis, glomerular nephritis, alteration of renal function tests).
- Polyuria (passing of copious urine), cystitis (inflammation of the bladder), hematuria (blood in the urine).

The use of Ibuprofen, particularly 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).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.