ANTALGIL*10TAB 200MG

ANTALGIL 200 mg tablets
Ibuprofen

What it is and what it is used for
Antalgil contains the active ingredient ibuprofen, which belongs to the category of non-steroidal anti-inflammatory anti-rheumatic drugs.

Antalgil is used for the symptomatic treatment of pain of various origins and natures (headaches, toothaches, neuralgia, menstrual pain, osteoarticular and muscular pain).

Consult your doctor if you do not feel better or if you feel worse after 3 days.

What you need to know before taking the medicine
Do not take ANTALGIL
- if you are allergic to ibuprofen, to other chemically similar substances (in particular to acetylsalicylic acid or other anti-rheumatic drugs), or to any of the other ingredients of this medicine (listed in section 6);
- if you have a history of gastrointestinal bleeding or perforation following previous treatments or a history of recurrent peptic bleeding/ulcer (two or more distinct episodes of ulcer or bleeding in the stomach);
- if you suffer from active gastroduodenal ulcer or other stomach conditions;
- if you suffer from severe heart failure;
- if you are in the last trimester of pregnancy or are breastfeeding;
- if you suffer from severe kidney or liver failure.

Antalgil is contraindicated in children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking ANTALGIL.

The use of ANTALGIL is contraindicated during pregnancy and breastfeeding or if you are planning a pregnancy. Discontinue Antalgil if you have fertility problems or if you are undergoing fertility investigations (see section Pregnancy, breastfeeding and fertility).

Do not take Antalgil together with other NSAIDs (Non-Steroidal Anti-inflammatory Drugs). You can reduce side effects by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section Other medicines and ANTALGIL). Do not take several analgesic substances simultaneously as they can cause permanent kidney damage and the risk of kidney failure (analgesic nephropathy).

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck region (angioedema) and chest pain, have been reported with ibuprofen. Stop ANTALGIL immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.

Elderly:
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially stomach and intestinal bleeding and perforation, which can be fatal. If you belong to this category of patients and treatment is considered necessary, use the lowest dose for the shortest duration necessary to control symptoms. If you do not notice any benefit or if you experience adverse reactions, contact your doctor who will regularly review the treatment and/or discontinue it.

Gastrointestinal bleeding, ulceration and perforation:
Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported at any time during treatment with all NSAIDs, with or without warning symptoms or a prior history of serious gastrointestinal events.
If you are elderly and have a history of ulcer, especially if complicated by bleeding or perforation (see section Do not take Antalgil), the risk of gastrointestinal bleeding, ulceration or perforation is higher with higher doses of NSAIDs. If you belong to these categories of patients or if you are taking low doses of aspirin or other medicines that may increase the risk of gastrointestinal events (see section Other medicines and ANTALGIL), you should simultaneously take a stomach protection medicine (gastroprotectants: misoprostol or proton pump inhibitors).
If you have a history of gastrointestinal toxicity, especially if you are elderly, report any abnormal gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
You should exercise caution if you are simultaneously taking medicines that could increase the risk of ulcer or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as aspirin (see section Other medicines and ANTALGIL).
If gastrointestinal bleeding or ulcer occurs while taking Antalgil, you should discontinue treatment.

If you have a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), you should take NSAIDs with caution as these conditions may be exacerbated (see section Possible side effects).

Cardiovascular and cerebrovascular effects
If you have a history of hypertension and/or heart failure, you should exercise caution as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a modest increase in the risk of heart attack or stroke, especially if administered in high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss therapy with your doctor or pharmacist before taking ANTALGIL if you have:
- heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowing or obstruction of the arteries) or any type of stroke (including mini-stroke or TIA, transient ischemic attack);
- high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

Exercise caution if you are being treated with diuretics, ACE inhibitors and angiotensin II antagonists (see section Other medicines and ANTALGIL).
If you experience uncontrolled high blood pressure (hypertension), congestive heart failure, ischemic heart disease, peripheral artery disease and/or cerebrovascular disease, you can only take ibuprofen after careful consideration by your doctor. The same doctor will make similar considerations before starting longer-term treatment if you have risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus and smoking).

Kidney effects
If you suffer from mild or moderate kidney function reduction, your doctor will tell you to take the lowest possible dosage for the shortest duration necessary to control symptoms, and kidney function must be monitored.
Ibuprofen can cause sodium retention, potassium retention and fluid retention in patients who have never suffered from kidney disorders due to its effects on renal perfusion. This can cause oedema or even lead to heart failure or hypertension if predisposed.
Prolonged use of ibuprofen, as with other NSAIDs, can cause kidney disease with blood in the urine (acute interstitial nephritis with haematuria), presence of protein in the urine (proteinuria) and nephrotic syndrome. If you suffer from kidney problems, heart failure, liver problems, if you are taking diuretics and ACE inhibitors, and if you are elderly, you are at greater risk of developing kidney problems. Such problems resolve with the discontinuation of treatment.

Liver failure:
If you have a mild or moderate reduction in liver function, your doctor will tell you to take the lowest possible dosage for the shortest duration necessary to control symptoms and will monitor your liver function.

Skin reactions:
Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. 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.

Infections:
Antalgil can mask the symptoms of infections such as fever and pain. Therefore, Antalgil may delay appropriate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, contact your doctor immediately.

Other precautions:
If you suffer or have suffered from bronchial asthma, chronic rhinitis, sinusitis, nasal polyps, adenoids or allergic diseases, symptoms such as bronchospasm, urticaria or angioedema may worsen.
If you are an asthmatic patient, use this medicine with caution, and only after consulting your doctor.

Ibuprofen can mask the signs or symptoms of infection (fever, pain and swelling).
During treatment with ibuprofen, some cases with symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation, have been observed in patients with existing autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease).

If you suffer from blood clotting disorders or are on anticoagulant therapy, you must undergo careful medical monitoring, as ibuprofen can prolong bleeding time and slow clotting.

Report to your doctor signs or symptoms of gastrointestinal ulcer or bleeding, blurred vision or other eye symptoms, skin rash, weight gain or oedema.

If you are a high-risk patient, in case of long-term treatment with ibuprofen, you will need to undergo periodic monitoring of liver and kidney function and blood tests.

Children and adolescents
The use of Antalgil is not indicated in children under 12 years of age.
In dehydrated adolescents, there is a risk of impaired kidney function.

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

Stop using Ibuprofen and consult your doctor immediately if you notice any of these symptoms:
• Reddish, non-raised, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
• Widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Side effects are mostly dose-dependent. In particular, the risk of gastrointestinal bleeding depends on the dosage and duration of treatment.
Ibuprofen, particularly at high doses (2400 mg per day) and in long-term treatment, may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).

Oedema (fluid accumulation in the tissues with consequent swelling), hypertension (increased blood pressure), heart failure and chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome, have been reported in association with NSAID treatment.

The side effects are listed below in order of frequency of appearance:

Very common (may affect more than 1 in 10 people):
- Gastrointestinal disorders, such as heartburn, dyspepsia (indigestion), abdominal pain, nausea, vomiting, diarrhoea, flatulence (bloating), constipation.

Common (may affect up to 1 in 10 people):
- Headache, drowsiness, dizziness, fatigue, insomnia, irritability.
- Gastrointestinal ulcers sometimes with bleeding and perforation (see section Warnings and precautions), occult blood loss (not visible to the naked eye), which can lead to anaemia, melaena, haematemesis (blood loss from the stomach, oesophagus and intestine), ulcerative stomatitis, colitis, worsening of inflammatory bowel disease, complications of colon diverticula (perforation, fistula).

Uncommon (may affect up to 1 in 100 people):
- Visual disturbances
- Rhinitis, bronchospasm
- Gastritis
- Development of oedema, especially in patients with arterial hypertension or kidney failure, nephrotic syndrome, interstitial nephritis which may be associated with kidney failure
- Photosensitivity
- Hypersensitivity reactions such as urticaria, itching, purpura and exanthema as well as asthma attacks (sometimes with hypotension)

Rare (may affect up to 1 in 1,000 people):
- Increase in azotaemia, serum transaminases and alkaline phosphatase, decrease in haemoglobin and haematocrit values, inhibition of platelet aggregation, prolongation of bleeding time, decrease in serum calcium, increase in serum uric acid.
- Weakening of vision in one eye, also known as lazy eye (Toxic amblyopia)
- Lupus erythematosus syndrome (i.e. a syndrome similar to systemic lupus erythematosus but which regresses on discontinuation of the drug).
- Depression, confusion, hallucinations

Very rare (may affect up to 1 in 10,000 people):
- palpitations, heart failure, myocardial infarction, acute pulmonary oedema, oedema.
- haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms or signs may include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin.
- Aseptic meningitis (non-infectious)
- Tinnitus
- Oesophagitis, pancreatitis, intestinal strictures
- Renal papillary necrosis in long-term use (see section Warnings and precautions).
- Bullous reactions, severe forms of skin reactions (erythema multiforme, exfoliative dermatitis, Stevens-Johnson Syndrome and toxic epidermal necrolysis), alopecia, necrotising fasciitis, i.e. a significant and severe skin infection with tissue destruction.
- Hypertension
- Severe hypersensitivity reactions. Symptoms may include: facial oedema, swelling of the tongue, internal larynx, swelling with constriction of the airways, dyspnoea, tachycardia, drop in blood pressure to the point of life-threatening shock.
- Liver dysfunction, liver damage, especially in long-term use, liver failure, acute hepatitis, jaundice.

Not known (frequency cannot be estimated from the available data):
- A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell).
- A widespread, red and scaly rash, with pustules forming under the skin and blisters located mainly on the skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Antalgil if you develop these symptoms and contact your doctor immediately. See also section 2.

Additional side effects in children and adolescents
In dehydrated adolescents, there is a risk of impaired kidney function.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. 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.