Name
Antalgil pain and fever 400 mg granules for oral solution
ibuprofen


What it is and what it is used for
ANTALGIL DOLORE E FEBRE belongs to a group of analgesic and anti-inflammatory drugs called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These drugs work by changing the way the body responds to pain and inflammation.
ANTALGIL PAIN AND FEVER is used in adults and adolescents weighing 40 kg or more (from 12 years of age):
- for the symptomatic treatment of mild to moderate pain of various origins, such as headache, bone and joint pain (osteoarticular), muscle pain, painful conditions associated with colds and flu, toothache, nerve pain (neuralgia), menstrual pain;
- for the symptomatic treatment of fever.
For osteoarticular pain and neuralgia, the medicine should be used only on the advice of a doctor.

See a doctor if you do not feel better or if you feel worse:
- after 3 days for adolescents
- after 3 days of treatment for fever or after 4 days of treatment for pain in adults


What you need to know before taking the medicine
Do not take ANTALGIL PAIN AND FEVER
• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if you have had allergic reactions such as bronchospasm (tightening of the lung muscles which can cause shortness of breath), asthma, runny nose, itching and inflammation of the nose with sneezing, urticaria (itchy skin rash) or angioedema (swelling under the skin) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (medicines for pain or fever);
• if you are a woman in the last three months of pregnancy (see "Pregnancy, breast-feeding and fertility");
• if you suffer from stomach and intestinal diseases (e.g. active or severe gastroduodenal ulcer or bleeding);
• if you have suffered from perforation or bleeding in the stomach or small intestine in relation to previous use of NSAIDs;
• if you have had two or more episodes of ulcer or bleeding in the stomach or small intestine in the past;
• if you suffer from severe heart failure;
• if you suffer from severe liver or kidney failure;
• if you are significantly dehydrated (caused by vomiting, diarrhoea or insufficient fluid intake);
• if you suffer from phenylketonuria, a rare genetic disorder of the metabolism of the amino acid phenylalanine (see paragraph "ANTALGIL PAIN AND FEVER contains aspartame").


Warnings and precautions
Talk to your doctor or pharmacist before taking ANTALGIL PAIN AND FEVER:
- if you suffer from asthma, a runny nose (chronic rhinitis), the presence of polyps in the nose (nasal polyps), inflammation of the nasal mucosa (sinusitis), or if you suffer/have suffered from an allergy to substances other than NSAIDs, because breathing difficulties (bronchospasm), redness of the skin with itching (urticaria) or swelling of the skin and throat (angioedema) may occur;
- if you are taking other NSAIDs (including COX-2 inhibitors (an enzyme involved in inflammatory processes), as this may increase the risk of ulcers and bleeding (see section "Other medicines and ANTALGIL PAIN AND FEVER");
- if you have kidney, heart or liver problems, or if you are taking diuretics or ACE inhibitors, as you may be more prone to developing kidney problems. In addition, the habitual and concomitant use of several painkillers may further increase this risk;
- if you have mild to moderate liver problems (liver dysfunction) or mild to moderate kidney disease;
- if you are elderly, as you are more likely to develop side effects, especially bleeding and perforation of the digestive tract;
- if you have blood clotting problems or if you take medicines that thin the blood (anticoagulants). See section "Other medicines and ANTALGIL PAIN AND FEVER";
- if you suffer from a disease that can affect various organs and tissues of the body (diffuse or systemic lupus erythematosus) or a connective tissue disease that affects many parts of the body, such as bones and cartilage, as on rare occasions, symptoms of "aseptic meningitis" have been observed in patients treated with Ibuprofen. Although aseptic meningitis is more likely to occur in patients with systemic lupus erythematosus and related connective tissue disorders, it has also been observed in patients without concomitant chronic diseases;
- if you have an infection – see the following section “Infections”;
- if you intend to start a pregnancy (see section "Pregnancy, breast-feeding and fertility");
- if you have problems getting pregnant or are undergoing fertility tests (see section "Pregnancy, breast-feeding and fertility");
- signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck area (angioedema) and chest pain, have been reported with ibuprofen.
Stop ANTALGIL PAIN AND FEVER immediately and contact your doctor or emergency services immediately if you notice any of these signs.

Warnings and precautions - take special care with ANTALGIL DOLORE E FEBBRE
In association with treatment with serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported. Stop using ANTALGIL and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Gastrointestinal precautions
NSAIDs can cause gastrointestinal bleeding, ulceration, or perforation, which may be fatal, with or without warning symptoms or a previous history of serious gastrointestinal events.
The risk is higher if NSAIDs are used at high doses, in case of previous history of ulcer, particularly if complicated by haemorrhage or perforation (see paragraph "Other medicines and ANTALGIL PAIN AND FEVER") and in the elderly.
Discuss your treatment with your doctor or pharmacist before taking ANTALGIL PAIN AND FEVER
- if you are elderly or have suffered from ulcers in the past, especially if complicated by perforation or accompanied by bleeding (see section "Do not take ANTALGIL PAIN AND FEVER"), since the risk of gastrointestinal bleeding, ulceration or perforation is higher with high doses of anti-inflammatory drugs. In these cases, you should start treatment with the lowest available dose and your doctor may prescribe a medicine to protect your stomach (misoprostol or proton pump inhibitors). This possibility should also be taken into account if you take low doses of acetylsalicylic acid or medicines that can increase the risk of stomach and/or intestinal diseases (see section "Other medicines and ANTALGIL PAIN AND FEVER");
- if you suffer or have suffered in the past from chronic inflammatory diseases of the intestine, such as inflammation of the colon with ulcers (ulcerative colitis) or inflammation of the digestive tract (Crohn's disease), as these conditions may worsen (see section 4 "Possible side effects");
- if you have had stomach and intestinal diseases related to the use of drugs, and in particular if you are elderly, you should report to your doctor any unusual intestinal symptoms (especially bleeding), particularly in the initial stages of treatment;
- if you are taking other medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids (such as prednisolone), medicines to thin the blood (such as warfarin), selective serotonin reuptake inhibitors (a medicine for depression) or anti-platelet agents (such as acetylsalicylic acid). See section "Other medicines and ANTALGIL PAIN AND FEVER". If gastrointestinal bleeding or ulceration occurs in patients taking ANTALGIL PAIN AND FEVER, the treatment should be stopped.

Cardiovascular precautions
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking ANTALGIL PAIN AND FEVER if you have:
- heart problems including heart failure, angina (chest pain), or if you have had a heart attack, coronary artery bypass graft surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including 'mini-stroke' or 'TIA', transient ischaemic attack).
- high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or are a smoker.

Skin reactions
Serious skin reactions have been reported in association with treatment with ANTALGIL DOLORE E FEBBRE. Stop taking ANTALGIL DOLORE E FEBBRE and contact a doctor immediately if you experience a skin rash, mucosal lesions, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.

Infections
ANTALGIL DOLORE E FEBBRE may mask the signs of infection such as fever and pain. It is therefore possible that ANTALGIL DOLORE E FEBBRE may delay the appropriate treatment of the infection, resulting in an increased risk of complications. This phenomenon has been observed in bacterial pneumonia and in bacterial skin infections related to chickenpox.
Consult a doctor immediately if you take this medicine during an infection and the symptoms of the infection persist or worsen.

Medicines such as ANTALGIL PAIN AND FEVER can:
- be associated with the onset of serious kidney disease (such as renal papillary necrosis, antalgic nephropathy and renal failure), especially in case of prolonged and/or habitual use; if necessary, your doctor will monitor your kidney function;
- cause eye problems, for which it is recommended, in case of prolonged treatments, to carry out periodic eye checks. If you experience vision problems, stop treatment with ANTALGIL DOLORE E FEBBRE.

Teenagers
If the teenager is dehydrated there is a risk of developing kidney disease.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Undesirable effects may be minimised by taking the lowest dose for the shortest time necessary to relieve symptoms.
In case of ulcer, bleeding in the stomach and/or intestine or lesions of the skin and/or mucous membranes, stop treatment with ANTALGIL DOLORE E FEBBRE and contact your doctor. These side effects are usually more frequent in the elderly.

Stop taking the medicine and see a doctor immediately if you experience any of the following conditions:
• skin rashes or lesions, dry skin, severe skin reactions such as rashes that may affect the whole body, peeling, blistering or flaking (e.g. Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis/Lyell's syndrome)
• mucosal lesions
• signs of allergic reaction, even severe (erythema, itching, urticaria, asthma, swelling of the skin and mucous membranes, anaphylactic shock)
• vision problems
• liver disease (liver dysfunction)
• severe pain in the upper abdomen, vomiting blood, stools containing blood and/or black stools (these may be signs of bleeding, ulceration and perforation of the stomach and intestines, which can be fatal, especially in the elderly)
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome
• reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, peeling skin, ulcers of the mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis]
• widespread skin rash, high body temperature and swollen lymph nodes (DRESS syndrome)
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

If you experience any of the above allergic reactions, go to hospital, as appropriate equipment, medicines and personnel for emergency treatment must be available immediately, as in rare cases serious side effects, sometimes with fatal outcome, have been reported following the use of ibuprofen, even in the absence of a known allergy.
The risk of manifesting these symptoms is higher in the early stages of therapy: in most cases the reaction occurs within the first month of treatment.

In addition, further side effects may occur which have also been reported with other medicines similar to ANTALGIL DOLORE E FEBBRE and which are listed below according to frequency:

common (may affect up to 1 in 10 people):
• malaise
• dizziness
• fatigue
• heartburn (pyrosis), abdominal pain, nausea, vomiting, heaviness in the stomach, indigestion, excessive intestinal gas (flatulence), diarrhea, constipation and slight gastrointestinal blood loss

uncommon (may affect up to 1 in 100 people):
• inflammation of the stomach (gastritis)
• gastrointestinal ulcers, sometimes with bleeding and perforation
• blood in the stool (melena), vomiting blood (haematemesis), sores inside the mouth (ulcerative stomatitis) and inflammation of the intestine and worsening of inflammation of the colon (colitis) and digestive tract (Crohn's disease) (see section "Warnings and precautions")
• anxiety, insomnia
• numbness of the limbs or other parts of the body, drowsiness
• nasal congestion (rhinitis)
• difficulty breathing (bronchospasm, dyspnea)
• temporary interruption of breathing (apnea)
• vision disorders
• hearing disorders
• tinnitus (ringing in the ears)
• dizziness (vertigo)
• liver disorders (altered liver function)
• inflammation of the liver (hepatitis)
• yellowish coloration of the skin and eyes (jaundice)
• kidney disease (damage to kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure)
• allergic reactions such as rash, hives, itching, red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), asthma, difficulty breathing (bronchospasm or wheezing), asthma attacks with drop in blood pressure
• skin reactions to light (photosensitivity)

rare (may affect up to 1 in 1,000 people):
• reduction in the number of blood cells: reduction in white blood cells (leukopenia, neutropenia, agranulocytosis), reduction in red blood cells (aplastic anemia, haemolytic anemia), reduction in the concentration of platelets in the blood (thrombocytopenia)
• reduction in clotting ability
• depression, confusion, hallucinations
• inflammation of the optic nerve (optic neuritis)
• inflammation of the meninges, the membranes covering the brain (aseptic meningitis), especially in patients with pre-existing autoimmune disorders (see section "Warnings and precautions") with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation
• eye disorders with visual disturbances and optic nerve disease (toxic optic neuropathy)
• swelling due to fluid accumulation in the tissues
• lupus erythematosus syndrome
• high levels of nitrogen in the blood
• changes in liver function tests (increased transaminases, increased alkaline phosphatase)
• abnormal blood tests (decreased hemoglobin, decreased hematocrit, prolonged bleeding time, decreased calcium in the blood, increased uric acid in the blood)

very rare (may affect up to 1 in 10,000 people):
• inflammation of the pancreas
• accentuated perception of the heartbeat (palpitation)
• heart disease (heart failure)
• heart attack (myocardial infarction)
• increased fluid in the lungs (acute pulmonary edema)
• liver disease (liver failure)
• high blood pressure (hypertension)
• serious allergic reactions, which may include symptoms such as swelling of the face, tongue and throat that makes breathing difficult, rapid heartbeat, severe allergic reaction that happens rapidly and can cause death (anaphylaxis)
• severe skin reactions, such as rashes or peeling of the skin (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme). In exceptional cases, severe skin infections and soft tissue complications may occur during chickenpox infection
• worsening of inflammation caused by an existing infection (for example, development of necrotizing fasciitis)

not known (frequency cannot be established from the available data):
• serious skin reaction known as DRESS syndrome. Symptoms of DRESS syndrome include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell)
• a widespread, red, scaly rash, with pustules forming under the skin and blisters, mainly in the skin folds, on the trunk and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking ANTALGIL DOLORE E FEBBRE if you develop these symptoms and contact a doctor immediately. See also section 2.

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.