ANTALGIL 200 MG TABLETS 10 TABLETS

Name
ANTALGIL 200 mg tablets
Ibuprofen


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

Antalgil is used for the symptomatic treatment of pain of various origins and nature (headache, toothache, neuralgia, menstrual pain, osteoarticular and muscular pain).

Contact 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 antirheumatics), 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 ulcer/haemorrhage (two or more distinct episodes of stomach ulcer or bleeding);
- if you suffer from active gastroduodenal ulcer or other stomach diseases;
- if you suffer from severe heart failure;
- if you are in the last trimester of pregnancy or if you are breastfeeding;
- if you suffer from severe kidney or liver failure;

Antalgil is contraindicated in children under 12 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before taking ANTALGIL.

The use of ANTALGIL is contraindicated during pregnancy and breastfeeding, or if you are planning to become pregnant. Stop taking Antalgil if you have fertility problems or are undergoing fertility tests (see section "Pregnancy, breastfeeding, and fertility").

Do not take Antalgil with other NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). You can reduce side effects by using the lowest effective dose for the shortest duration necessary to control symptoms (see section "Other medicines and Antalgil"). Do not take multiple painkillers at the same time, as this may cause permanent kidney damage and the risk of kidney failure (analgesic nephropathy).

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

Elderly people :
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially bleeding and perforation of the stomach and intestines, which can be fatal. If you belong to this group of patients and treatment is considered necessary, use the lowest dose for the shortest duration necessary to control symptoms. If you experience no benefit or if you experience adverse reactions, contact your doctor, who will regularly review your 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 previous history of serious gastrointestinal events. If you are elderly or have a history of ulcers, particularly if complicated by haemorrhage or perforation (see the 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 patient groups, you should start treatment with the lowest available dose. If you belong to these patient groups or if you take low-dose aspirin or other drugs that may increase the risk of gastrointestinal events (see the section "Other medicines and Antalgil"), take a stomach-protective medication at the same time (gastroprotectives: misoprostol or proton pump inhibitors). If you have a history of gastrointestinal toxicity, particularly if you are elderly, report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
Caution should be exercised if you are taking concomitant medications that could increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (see section "Other medicines and ANTALGIL").
If gastrointestinal bleeding or ulceration occurs while taking Antalgil, treatment should be discontinued.
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 edema have been reported in association with NSAID therapy.
Anti-inflammatory/painkiller medications 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 if you have:
- heart problems including heart attack, angina (chest pain) or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "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 have uncontrolled high blood pressure (hypertension), congestive heart failure, ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease, you should take ibuprofen only after careful consideration by your doctor. Your doctor will also consider similar measures before initiating longer-term treatment if you have risk factors for cardiovascular events (e.g., hypertension, hyperlipidemia, diabetes mellitus, and smoking).

Renal effects :
If you have mild or moderate reduction in kidney function, your doctor will tell you to take the lowest possible dose for the shortest duration necessary to control your symptoms, and your kidney function should be monitored.
Ibuprofen can cause sodium, potassium, and fluid retention in patients with no history of kidney disease due to its effects on renal perfusion. This can cause edema 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 hematuria), protein in the urine (proteinuria), and nephrotic syndrome. People with kidney problems, heart failure, liver problems, diuretics, and ACE inhibitors, as well as elderly patients, are at increased risk of developing kidney problems. These problems resolve with discontinuation of treatment.

Liver failure :
If you have mild or moderate reduction in liver function, your doctor will tell you to take the lowest possible dose for the shortest duration necessary to control your 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), and acute generalized 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 may mask the symptoms of infections, such as fever and pain. Therefore, Antalgil may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms 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 have asthma, use this medication with caution and only after consulting your doctor.

Ibuprofen may 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 have a blood clotting disorder or are taking anticoagulant drugs, you should be monitored closely by your doctor, as ibuprofen can prolong bleeding time and slow clotting.

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

If you are a high-risk patient, you will need to have your liver and kidney function monitored periodically and have blood tests performed if you are on long-term treatment with ibuprofen.

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 altered renal function.


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

Stop using Ibuprofen and see your doctor immediately if you notice any of these symptoms:
- Flat, target-shaped or circular reddish spots on the trunk, often with central blisters, peeling skin, and 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 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 daily) and in long-term treatment, may be associated with a modest increased risk of arterial thrombotic events (for example, myocardial infarction or stroke).

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

The following side effects are listed in order of frequency of occurrence:

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

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

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

Rare (may affect up to 1 in 1,000 people):
- Increased azotemia, serum transaminases and alkaline phosphatase, decreased hemoglobin and hematocrit values, inhibition of platelet aggregation, prolongation of bleeding time, decreased serum calcium, increased 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 which however regresses when the drug is stopped).
- Depression, confusion, hallucinations.

Very rare (may affect up to 1 in 10,000 people):
- Palpitations, heart failure, myocardial infarction, acute pulmonary edema, edema.
- Hematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Early symptoms or signs may include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding.
- Aseptic (non-infectious) meningitis
- Tinnitus
- Esophagitis, pancreatitis, intestinal stenosis
- 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, necrotizing fasciitis, i.e. a significant and serious skin infection with tissue destruction.
- Hypertension
- Severe hypersensitivity reactions. Symptoms may include facial swelling, swelling of the tongue and internal larynx, swelling with airway constriction, dyspnea, tachycardia, and a drop in blood pressure to the point of shock and potentially life-threatening.
- Liver dysfunction, liver damage, especially with long-term use, liver failure, acute hepatitis, jaundice.

Not known (frequency cannot be estimated from the available data):
- A serious 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, scaly rash with pustules under the skin and blisters, mainly located in the skin folds, trunk, and upper limbs, accompanied by fever at the start 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 renal function.

Reporting of side effects
If you experience 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.