Active ingredients: Ibuprofen
ANTALGIL 200 mg tablets
Why is Antalgil used? What is it for?
Antalgil contains the active ingredient ibuprofen belongs to the category of non-steroidal anti-rheumatic anti-inflammatory drugs.
Antalgil is used for the symptomatic treatment of pain of various origins and nature (headache, toothache, neuralgia, menstrual pain, osteoarticular and muscle pain).
Talk to your doctor if you don't feel better or if you feel worse after 3 days.
Contraindications When Antalgil should not be used
Do not take ANTALGIL
- if you are allergic to ibuprofen, other chemically similar substances (especially acetylsalicylic acid or other antirheumatics), or any of the other ingredients of this medicine (listed in section 6).
- If you have a history of gastrointestinal bleeding or perforation following previous treatment or a history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of ulcer or stomach bleeding).
- If you have an active gastro-duodenal ulcer or other stomach disease.
- If you have 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.
Precautions for use What you need to know before taking Antalgil
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 together with other NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). You can reduce side effects by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section "Other medicines and ANTALGIL"). Do not take several analgesic substances at the same time as they can cause permanent kidney damage and a risk of kidney failure (analgesic nephropathy).
Senior citizens:
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 category of patients and treatment is considered necessary, use the lowest dose for the shorter duration necessary for symptom control If you do not notice any benefit or if you experience any adverse reactions, contact your doctor who will review your treatment at regular intervals and / or stop it.
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.
If you are elderly and have a history of ulcer, particularly if complicated with haemorrhage 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 patient categories, you should start treatment with the lowest available dose. If you belong to these categories of patients or if you take low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see section "Other medicines and ANTALGIL"), take a drug for stomach protection at the same time (gastroprotectors: misoprostol or proton pump inhibitors).
If you have a history of gastrointestinal toxicity, particularly if you are elderly, report any abnormal gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
Caution should be exercised if you are taking concomitant medications that may 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 (see section "Other medicines and ANTALGIL") .
If gastrointestinal bleeding or ulcer 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, caution should be exercised as fluid retention, hypertension and edema have been reported in association with NSAID therapy.
Medicines such as Antalgil may be associated with a small increased risk of heart attack ('myocardial infarction') or stroke which are more likely if you take high doses and for prolonged periods of time. Do not exceed the recommended dose and duration of treatment.
If you have heart problems, have a history of stroke or think you may be at risk for these conditions (for example if you have high blood pressure, diabetes or high cholesterol or smoke) you should discuss your treatment with your doctor or pharmacist.
Use 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 arterial 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, hyperlipidaemia, diabetes mellitus and smoking).
Kidney effects
If you have a mild or moderate decrease 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 water retention in patients who have never suffered from kidney disease due to its effects on renal perfusion. This can cause them to edema or even lead to heart failure or hypertension if predisposed.
Prolonged intake of ibuprofen, as with other NSAIDs, can cause kidney disease with blood in the urine (acute interstitial nephritis with haematuria), the presence of protein in the urine (proteinuria) and nephrotic syndrome. If you have kidney problems, heart failure, liver problems, if you are taking diuretics and ACE inhibitors and if you are elderly you are at increased risk of developing kidney problems, these problems are resolved when treatment is stopped.
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:
You may experience some severe skin reactions with the use of Antalgil, especially in the early stages of therapy (usually within the first month of treatment) (see section "Possible side effects"). Stop the treatment and contact your doctor if you notice them. skin injuries of any kind.
Other precautions:
If you have or have suffered from bronchial asthma, chronic rhinitis, sinusitis, nasal polyps, adenoids or allergic diseases, symptoms such as bronchospasm, hives or angioedema may be aggravated
If you are an asthmatic patient use this drug 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 suffer from diseases related to blood clotting or are being treated with anticoagulant drugs, you must undergo careful medical supervision, as ibuprofen can prolong the bleeding time and slow down clotting.
Report signs or symptoms of gastrointestinal ulcer or bleeding, blurred vision or other eye symptoms, skin rash, weight gain or edema to your doctor.
If you are a high-risk patient, in case of long-term treatment with ibuprofen you will need to have periodic monitoring of liver and kidney function and perform blood tests.
Children and adolescents
The use of Antalgil is not indicated in children under 12 years of age. There is a risk of impaired renal function in dehydrated adolescents.
Interactions Which drugs or foods can change the effect of Antalgil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take ibuprofen together with the following substances:
- Low dose acetylsalicylic acid: Ibuprofen may inhibit the effects of low dose acetylsalicylic acid on blood clotting.
- Other NSAIDs: Concomitant use may increase the risk of gastrointestinal ulcers and bleeding.
- Anticoagulants such as warfarin or heparin: NSAIDs can increase the anticoagulant effects. In case of concomitant treatment, monitoring of the coagulation status is recommended.
- Ticlopidine: NSAIDs increase the risk of an additive effect in the inhibition of platelet function.
- Methotrexate: Ibuprofen if administered within 24 hours before or after administration of methotrexate can lead to elevated concentrations of methotrexate and an increase in its toxic effects. In addition, the potential risk of interactions in low dose treatment with methotrexate should be considered. particularly if you suffer from impaired renal function In combined treatment, renal function should be monitored.
Take ibuprofen (like other NSAIDs) with caution in combination with the following substances:
- Phenytoin, lithium and cardiac glycosides (e.g. digoxin): concomitant administration of ibuprofen may increase the serum levels of these medicinal products. If you take ibuprofen with these substances, your doctor will tell you to monitor your serum levels of lithium, phenytoin and digoxin.
- Diuretics and antihypertensives: Diuretics and ACE inhibitors may increase the toxic effect of NSAIDs. NSAIDs may reduce the effect of diuretics and antihypertensives including ACE inhibitors (eg captopril) and beta blockers. If you have impaired kidney function (eg you are dehydrated or elderly with impaired kidney function), concomitant use of an ACE inhibitor and angiotensin II antagonist with a cyclooxygenase inhibitor drug may lead to further worsening of kidney function, which includes possible acute renal failure, usually reversible. In this case use caution in taking these drugs, especially if you are elderly. Immediately after starting combination therapy with ibuprofen and diuretics / antihypertensives, always drink enough and have your kidney monitored periodically. Concomitant administration of ibuprofen and potassium-sparing diuretics or ACE inhibitors may cause an excessive increase in blood potassium. (hyperkalaemia), it is therefore necessary that you undergo careful monitoring of potassium levels.
- Corticosteroids as they may increase the risk of gastrointestinal ulceration or bleeding (see section "Warnings and precautions").
- Cholestyramine: Concomitant treatment with cholestyramine and ibuprofen may interfere with the absorption of ibuprofen. Take these medicines with at least one "hour interval.
- Zidovudine: There is evidence of an increased risk of haemarthrosis (shedding of blood in a "joint) and hematoma (bruising) in HIV positive haemophilia patients who have received concomitant treatment with zidovudine and ibuprofen. If you take ibuprofen and zidovudine, get tested. haematological 1-2 weeks after starting this treatment.
- Sulfonylureas: NSAIDs may increase the hypoglycaemic effect of sulphonylureas, ie reduce blood sugar levels. If you are taking this type of medication at the same time, monitor your blood glucose levels carefully.
- Drugs that prevent blood clotting (antiplatelet agents such as clopidogrel and ticlopidine) and antidepressants in particular selective serotonin reuptake inhibitors (SSRIs): may increase the risk of gastrointestinal bleeding (see section "Warnings and precautions").
Other possible interactions:
- Ciclosporin Tacrolimus: as there is a risk of kidney damage.
- Probenecid and sulfinpyrazone: as they can cause a delay in the elimination of ibuprofen.
- Quinolone antibiotics: if you take NSAIDs and quinolones you may have an increased risk of developing seizures.
- Other medicines such as mifepristone, moclobemide, ritonavir, aminoglycosides, alcohol, bisphosphonates, oxpentifylline (pentoxyfylline) and baclofen may interact with treatment with ibuprofen.
Consult your doctor before using ibuprofen with other medicines.
ANTALGIL with alcohol
Alcohol consumption should be avoided as it can intensify the side effects of NSAIDs, especially if it affects the gastrointestinal tract or central nervous system.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should not take ANTALGIL during the first and second trimester of pregnancy, unless strictly necessary, as an increased risk of abortion, heart malformation and abdominal wall defects has been observed.
If you are planning to become pregnant or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors, such as ANTALGIL, can exhibit:
- your baby a
- cardiopulmonary toxicity with premature closure of the artery that carries blood to the lung and increase in blood pressure in the lungs (pulmonary hypertension);
- renal dysfunction, which can degenerate into renal failure with reduced production of amniotic fluid;
- you and your child to:
- possible prolongation of bleeding time, which can occur even at very low doses;
- inhibition of uterine contractions with consequent delay or prolongation of labor ANTALGIL is contraindicated during the third trimester of pregnancy.
Feeding time
The use of ANTALGIL is contraindicated during lactation.
Ibuprofen is excreted in breast milk, but at therapeutic doses and during short-term treatment, the risk of influenza on the newborn seems unlikely. If, on the other hand, treatment is long-term, you should consider stopping breastfeeding. breast.
Fertility
Medicines such as ANTALGIL can impair female fertility by affecting ovulation. However, this condition is reversible upon discontinuation of treatment.
Driving and using machines
Due to the possible onset of dizziness, headache or insomnia, ANTALGIL may impair the ability to drive and use machines.
Dosage and method of use How to use Antalgil: Dosage
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults and adolescents over 12 years:
The recommended dose is 1-2 tablets 2-3 times a day.
Do not exceed the dose of 6 tablets per day
Do not exceed the recommended doses; in particular if you are an elderly patient, you should contact your doctor and follow the minimum dosages indicated above. Take this medicine on a full stomach.
This medicine is for short term use only and should not exceed 3 days of treatment. If symptoms persist or worsen you should consult a doctor.
If the use of the medicine is necessary for more than 3 days in adolescents, or if the symptoms worsen, you should consult your doctor.
How to use
Swallow the tablets with a glass of water during or after a meal.
Swallow with copious amounts of fluids.
Overdose What to do if you have taken too much Antalgil
In case of accidental ingestion / intake of an overdose of Antalgil notify your doctor immediately or go to the nearest hospital.
The possible symptoms of an overdose of the drug are the following: nausea, vomiting stomach pain, or more rarely, diarrhea, perception of noises in the ear (such as whistling or buzzing), headache, dizziness, vertigo and gastrointestinal bleeding may also occur. . In more severe cases of intoxication, the toxicity is central nervous system, manifesting as drowsiness, occasionally excitement, disorientation or coma. Occasionally, seizures may develop. Children may also develop cramps caused by a major and involuntary muscle contraction. Acute renal failure, liver damage, low blood pressure (hypotension), respiratory depression and cyanosis may also occur. If you are an asthmatic patient, your asthma may become worse.
Treatment
Tell your doctor immediately if you suspect overdose. The doctor will decide what measures to take depending on the severity of the poisoning.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Antalgil
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects are mostly dependent on the dose you have taken. In particular, the risk of the onset of gastrointestinal bleeding depends on the dosage and duration of treatment. Ibuprofen, particularly in high doses (2400 mg per day) and in long-term treatment, may be associated with a modest increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Edema (fluid accumulation in the tissues resulting in swelling), hypertension (increased blood pressure) and heart failure have been reported in association with NSAID treatment.
The undesirable effects are listed below in order of how often they appear:
Very common (may affect more than 1 in 10 people):
- gastrointestinal disturbances, such as heartburn, dyspepsia (difficulty in digestion), abdominal pain, nausea, vomiting, diarrhea, 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 can lead to anemia, melaena, haematemesis (loss of blood from the stomach, esophagus and "intestine), ulcerative stomatitis, colitis, aggravation 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 insufficiency, nephrotic syndrome, interstitial nephritis which may be associated with renal insufficiency.
- Photosensitivity
- Hypersensitivity reactions such as hives, itching, purpura and rash as well as asthma attacks (sometimes with hypotension)
Rare (may affect up to 1 in 1,000 people):
- Increase in azotemia, serum transaminases and alkaline phosphatase, decrease in hemoglobin and hematocrit 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 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 edema, edema.
- haematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Early symptoms or signs may include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nasal and skin bleeding.
- Aseptic (non-infectious) meningitis
- Tinnitus
- Esophagitis, pancreatitis, intestinal strictures
- Renal papillary necrosis in long-term use (see section "Warnings and precautions").
- Severe forms of skin reactions (erythema multiforme, exfoliative dermatitis, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, alopecia, necrotizing fasciitis, i.e. a major and severe skin infection with tissue destruction).
- Hypertension
- Severe hypersensitivity reactions.Symptoms may include: facial edema, swelling of the tongue, internal larynx, swelling with constricted airways, dyspnoea, tachycardia, drop in blood pressure to the point of life-threatening shock.
- Hepatic dysfunction, liver damage, especially in long-term use, liver failure, acute hepatitis, jaundice.
Additional side effects in children and adolescents
There is a risk of impaired renal function in dehydrated adolescents
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package.
No special storage precautions.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What ANTALGIL contains
- The active ingredient is ibuprofen. Each 200 mg tablet contains 200 mg of ibuprofen.
- The other ingredients are: corn starch, pregelatinised starch, hypromellose, microcrystalline cellulose, sodium starch glycolate, precipitated silica, sodium lauryl sulfate, E 104 aluminum lake, E 110 aluminum lake, titanium dioxide, propylene glycol, carnauba wax.
What ANTALGIL looks like and contents of the pack
Antalgil comes in tablet form for oral use
The contents of the package are 10 tablets for oral use of 200 mg
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ANTALGIL 200 MG TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active ingredient: Ibuprofen 200 mg
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Tablets
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptomatic treatment of pain of various origins and nature (headache, toothache, neuralgia, menstrual pain, osteoarticular and muscle pain).
04.2 Posology and method of administration
Adults and children over 12 years: 1-2 tablets 2-3 times a day.
Do not exceed the dose of 6 tablets per day.
Do not exceed the recommended dose.
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration it takes to control symptoms
This medicine is for short-term use only and 3 days of treatment should not be exceeded. If symptoms persist or worsen, a doctor should be consulted.
If Antalgil is needed for more than 3 days or if symptoms worsen, or persist, you should see your doctor.
Elderly: NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events and are at increased risk of life-threatening gastrointestinal bleeding, ulceration or perforation (see section 4.4). If treatment is considered necessary, the lowest dose for the shortest duration necessary for symptom control should be used (see section 4.4). Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or if intolerances occur.
Children: ANTALGIL is contraindicated in children below 12 years of age (see section 4.3).
Renal insufficiency: In patients with mild or moderate impairment of renal function, the dosage should be kept as low as possible for the shortest duration necessary to control symptoms and renal function should be monitored. ANTALGIL is contraindicated in patients with severe renal insufficiency (see section 4.3).
Hepatic impairment: In patients with mild or moderate liver function impairment, the dosage should be kept as low as possible for the shortest duration necessary to control symptoms and liver function should be monitored. ANTALGIL is contraindicated in patients with severe hepatic impairment (see section 4.3).
Method of administration:
The tablet should be swallowed with a glass of water during or after a meal.
04.3 Contraindications
Children under 12 years (see section 4.2)
Hypersensitivity to the active substance or to other closely related substances from a chemical point of view and / or to any of the excipients.
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).
Active gastro-duodenal ulcer or other gastropathies
Severe heart failure
Last trimester of pregnancy and lactation (see section 4.6)
Severe renal or hepatic insufficiency (see section 4.2).
04.4 Special warnings and appropriate precautions for use
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration needed to control symptoms (see section 4.2 and Gastrointestinal and cardiovascular risks below)
It is advisable to take the drug on a full stomach.
In asthmatic patients the product should be used with caution, consulting your doctor before taking the product.
The use of Antalgil should be avoided in conjunction with NSAIDs including selective COX-2 inhibitors.
Senior citizens : Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. (see section 4.2).
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 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 (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 (see below and section 4.5).
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 may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-aging agents such as aspirin (see section 4.5).
When gastrointestinal bleeding or ulceration occurs in patients taking Antalgil 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).
Cardiovascular and cerebrovascular effects
Caution should be exercised in patients with a history of hypertension and / or heart failure as fluid retention, hypertension and edema have been reported in association with NSAID therapy. NSAIDs may reduce the effect of diuretics, and other antihypertensive drugs (see section 4.5).
Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2,400 mg / day) and for long-term treatments, may be associated with a modest increased risk of arterial thrombotic events (eg. myocardium or stroke) In general, epidemiological studies suggest only low doses of ibuprofen (e.g. myocardial infarction.
Patients with uncontrolled hypertension, congestive heart failure, 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 longer term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus and smoking).
Skin
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 (see section 4.8). In the early stages of therapy patients appear to be higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Antalgil should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.
Kidney effects
Ibuprofen can cause sodium, potassium and water retention in patients who have never suffered from kidney disease due to its effects on kidney perfusion. This can cause edema or even lead to heart failure or hypertension in predisposed patients.
As with other NSAIDs, prolonged administration of ibuprofen in animals has led to renal papillary necrosis and other renal pathological changes. In humans, there have been reports of acute interstitial nephritis with hematuria, proteinuria, and nephrotic syndrome from time to time. Cases of renal toxicity have also been observed in patients in whom prostaglandins play a compensatory role in maintaining renal perfusion. In these patients, NSAID administration may cause a dose-dependent reduction in prostaglandin production and, secondarily, in renal blood flow, which can precipitate overt renal failure. Patients at greatest risk of suffering from this reaction are those with renal dysfunction, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID treatment is usually followed by recovery of the pre-treatment status.
Other precautions
Bronchospasm, urticaria or angioedema can precipitate in patients with or with a previous history of bronchial asthma, chronic rhinitis, sinusitis, nasal polyps, adenoids or allergic diseases.
Ibuprofen may mask the signs or symptoms of infection (fever, pain and swelling). Over the long term, use of high doses of pain relievers for headaches not treated with high doses of the medicine may occur. In general, the habitual intake of analgesics, in particular the use in combination of different analgesic substances, can cause permanent kidney damage and the risk of renal failure (analgesic nephropathy). 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) .
Ibuprofen can temporarily inhibit platelet aggregation and prolong bleeding time. Therefore, patients with coagulation defects or on anticoagulation therapy should be carefully observed.
In case of long-term treatment with ibuprofen, periodic monitoring of liver and kidney function as well as blood counts is necessary, especially in high-risk patients.
Alcohol consumption should be avoided as it can intensify the side effects of NSAIDs, especially if it affects the gastrointestinal tract or central nervous system.
Patients treated with Antalgil should report signs or symptoms of gastrointestinal ulcer or bleeding, blurred vision or other eye symptoms, skin rash, weight gain or edema to their doctor.
The use of Antalgil, like any drug that inhibits prostaglandin synthesis and cyclooxygenase, is not recommended in women who intend to become pregnant.
Antalgil should be discontinued in women who have fertility problems or who are undergoing fertility investigations.
There is a risk of impaired renal function in dehydrated adolescents.
04.5 Interactions with other medicinal products and other forms of interaction
The concomitant use of ibuprofen and the following substances should be avoided :
Low-dose acetylsalicylic acid: Experimental data indicate that ibuprofen may inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when drugs are administered concomitantly. However, the limited data and the uncertainties relating to their application to the clinical situation do not allow definitive conclusions to be drawn for the continued use of ibuprofen; there appears to be no clinically relevant effect from the occasional use of ibuprofen (see section 5.1).
Other NSAIDs: As a result of synergistic effects, concomitant use of several NSAIDs may increase the risk of gastrointestinal ulcers and bleeding. Concomitant administration of ibuprofen with other NSAIDs should therefore be avoided (see section 4.4).
Anti-coagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin or heparin (see section 4.4). In case of concomitant treatment, monitoring of the coagulation status is recommended.
Ticlopidine: NSAIDs should not be combined with ticlopidine due to a risk of an additive effect in inhibiting platelet function.
Methotrexate: NSAIDs inhibit tubular secretion of methotrexate and some metabolic interactions may occur resulting in reduced clearance of methotrexate. Administration of Ibuprofen within 24 hours before or after administration of methotrexate can lead to a high concentration of methotrexate and an increase in its toxic effects. Therefore, the concomitant use of NSAIDs and high doses of methotrexate should be avoided. In addition, the potential risk of interactions in low dose methotrexate treatment should be considered, particularly in patients with impaired renal function. In combined treatment, function. renal disease should be monitored.
Ibuprofen (like other NSAIDs) should be taken with caution in combination with the following substances:
Moclobemide: increases the effect of ibuprofen.
Phenytoin, lithium: Concomitant administration of ibuprofen and phenytoin or lithium preparations may increase the serum levels of these medicinal products. Monitoring of the serum lithium level is necessary and it is recommended that the serum phenytoin levels be monitored.
Cardiac glycosides (eg digoxin): NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase plasma levels of cardiac glycosides. Monitoring of serum digoxin is recommended.
Diuretics and antihypertensives: diuretics and ACE inhibitors may increase the nephrotoxicity of NSAIDs. NSAIDs may reduce the effect of diuretics and antihypertensives including ACE inhibitors and beta-blockers. In patients with impaired renal function (eg dehydrated patients or elderly patients with impaired renal function), concomitant use of an ACE inhibitor and angiotensin II antagonist with a cyclooxygenase inhibitor drug may lead to further deterioration of renal function including possible acute renal failure, usually reversible. This combination should therefore be used with caution, especially in elderly patients.Patients should be instructed to drink sufficient fluid and periodic monitoring of renal values should be considered for the time immediately following the initiation of combination therapy.
Concomitant administration of ibuprofen and potassium-sparing diuretics or ACE inhibitors may cause hyperkalaemia. Careful monitoring of potassium levels is necessary.
Captopril: Experimental studies indicate that ibuprofen counteracts the effect of captopril of increased sodium excretion.
Aminoglycosides: NSAIDs can slow down the elimination of aminoglycosides and increase their toxicity.
Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4) Ciclosporin: the risk of cyclosporine-induced renal damage is increased by concomitant administration of some NSAIDs. This effect cannot be excluded for the combination of cyclosporine and ibuprofen.
Cholestyramine: Concomitant treatment with cholestyramine and ibuprofen results in prolonged and reduced (25%) absorption of ibuprofen. Medicines should be administered with at least one hour interval.
Tacrolimus: high risk of nephrotoxicity.
Zidovudine: There is evidence of an increased risk of haemarthrosis and hematoma in HIV positive haemophilia patients who received concomitant treatment of zidovudine and ibuprofen. There may be an increased risk of haematotoxicity with concomitant use of zidovudine and NSAIDs. A blood test 1-2 weeks after starting use together is recommended.
Ritonavir: May increase plasma concentrations of NSAIDs.
Mifepristone: If NSAIDs are used within 8-12 days after administration of mifepristone they can reduce the effect of mifepristone.
Probenecid or sulfinpyrazone: May cause a delay in the elimination of ibuprofen. The uricosuric action of these substances is diminished.
Quinolone antibiotics: Patients taking NSAIDs and quinolones may have an increased risk of developing seizures.
Sulfonylureas: NSAIDs may increase the hypoglycaemic effect of sulfonylureas. In the case of simultaneous treatment, monitoring of blood glucose levels is recommended.
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Anti-platelet aggregation agents (e.g. clopidogrel and ticlopidine): increase the risk of gastrointestinal bleeding (see section 4.4).
Alcohol, bisphosphonates and oxpentifylline (pentoxyflline): can potentiate gastrointestinal side effects and the risk of bleeding and ulcer.
Baclofen: High toxicity baclofen.
04.6 Pregnancy and lactation
Pregnancy
Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development.
Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk has been believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality.
In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.
During the first and second trimester of pregnancy, ANTALGIL should not be administered except in strictly necessary cases.
If ANTALGIL is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose
the fetus to:
- cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
- renal dysfunction, which can progress to renal failure with oligo-hydroamnios;
the mother and the newborn, at the end of pregnancy, to:
- possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses;
- inhibition of uterine contractions resulting in delayed or prolonged labor
- Consequently ANTALGIL is contraindicated during the third trimester of pregnancy.
It is also advisable not to use the product during breastfeeding.
Feeding time
Ibuprofen is excreted in breast milk, but at therapeutic doses during short-term treatment, the risk of influenza on the newborn seems unlikely. If, on the other hand, the treatment is longer term, early weaning should be considered.
Fertility There is some evidence that medicinal products that inhibit cyclo-oxygenase / prostaglandin synthesis may cause impairment of female fertility by effect on ovulation. This is reversible upon discontinuation of treatment.
04.7 Effects on ability to drive and use machines
Due to the possible onset of dizziness, headache or insomnia, ANTALGIL may impair the ability to drive and use machines.
04.8 Undesirable effects
The following spontaneous adverse events have been reported with the use of ibuprofen tablets, and within each organ or system class, are collected by frequency, using the following convention:
Very common (> 1/10) Common (> 1/100, 1 / 1,000, 1 / 10,000,
The side effects are mostly dose-dependent. Especially the risk for the onset of gastrointestinal bleeding depends on the dose range and duration of treatment. Other known risk factors, see section 4.4.
Clinical studies and epidemiological data suggest that the use of 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 (eg myocardial infarction or stroke). (see section 4.4).
Edema, hypertension and heart failure have been reported in association with NSAID treatment.
Laboratory tests
Rare: increased azotemia, serum transaminases and alkaline phosphatase, decreased hemoglobin and hematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium, increased serum uric acid.
Cardiac pathologies
Very rare: palpitations, heart failure, myocardial infarction, acute pulmonary edema, edema
Disorders of the blood and lymphatic system
Very rare: haematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Early symptoms or signs may include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nasal and skin bleeding Nervous system disorders
common: headache, drowsiness, dizziness, fatigue, agitation, insomnia, irritability
Very rare: aseptic meningitis
Eye disorders
Uncommon: Visual disturbances
Rare: toxic amblyopia
Ear and labyrinth disorders
Very rare: tinnitus
Respiratory, thoracic and mediastinal disorders
Uncommon: rhinitis, bronchospasm
Gastrointestinal disorders
Very common: gastrointestinal complaints, such as heartburn, dyspepsia, abdominal pain and nausea, vomiting, flatulence, diarrhea, constipation
Common: gastrointestinal ulcers, sometimes with haemorrhage and perforation (see section 4.4), occult blood loss, which may lead to anemia, melaena, haematemesis, ulcerative stomatitis, colitis, exacerbation of inflammatory bowel disease, complications of colonic diverticula (perforation, fistula)
Uncommon: gastritis
Very rare: esophagitis, pancreatitis, intestinal strictures.
Renal and urinary disorders
Uncommon: development of edema especially in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis which may be associated with renal insufficiency Very rare: renal papillary necrosis in long-term use (see section 4.4)
Skin and subcutaneous tissue disorders
Uncommon: photosensitivity
Very rare: severe forms of skin reactions (erythema multiforme, exfoliative dermatitis, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, alopecia, necrotizing fasciitis
Vascular disorders
Very rare: hypertension
Disorders of the immune system
Uncommon: hypersensitivity reactions such as hives, itching, purpura and rash as well as asthma attacks (sometimes with hypotension)
Rare: Lupus Erythematosus Syndrome
Very rare: severe hypersensitivity reactions. Symptoms may include: facial edema, swelling of the tongue, internal larynx, swelling with constricted airways, dyspnoea, tachycardia, drop in blood pressure to the point of life-threatening shock.
Alterations of the hepatobiliary system
Very rare: liver dysfunction, liver damage, especially in long-term use, liver failure, acute hepatitis, jaundice.
Psychiatric disorders
Rare: depression, confusion, hallucinations
Reporting of suspected adverse reactions
The reporting of suspected adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Italian Medicines Agency. , Website: http://www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Symptoms
Most patients who have clinically ingested large amounts of NSAIDs develop nausea, vomiting, epigastric pain, or more rarely, diarrhea, tinnitus, headache, dizziness, vertigo and gastrointestinal bleeding may also occur. In more severe intoxications, toxicity is at the level of the central nervous system, which manifests itself as drowsiness, occasionally excitement and disorientation or coma. Occasionally patients develop seizures. Children can also develop myoclonic cramps. In severe metabolic intoxication acidosis may occur and the prothrombin time / INR may be prolonged, possibly due to the circulating actions of coagulation factors. Acute kidney failure, liver damage, hypotension, respiratory depression, and cyanosis can occur. Exacerbation of asthma is possible in asthma.
Treatment
Treatment should be symptomatic and supportive and include maintaining a patent airway and monitoring cardiac and vital signs until they become stable. Gastric emptying or oral administration of activated charcoal is indicated if the patient presents symptoms within one hour of ingestion of more than 400 mg per kg body weight. If Antalgil has already been absorbed, alkaline substances should be administered to promote the excretion of acid ibuprofen in the urine. If prolonged or frequent, seizures should be treated with intravenous diazepam or lorazepam. Bronchodilators should be given for asthma. No specific antidote is available.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
ATC code: M01AE01
Pharmacotherapeutic group: non-steroidal anti-inflammatory / antirheumatic drugs.
Ibuprofen is a synthetic analgesic-anti-inflammatory, also endowed with strong antipyretic activity. Chemically it is the progenitor of phenylpropionic derivatives with anti-inflammatory activity.
The analgesic activity is non-narcotic.
As with other non-steroidal anti-inflammatory drugs, the mechanism of action of ibuprofen is linked to the reversible inhibition of the enzyme cyclo-oxygenase (COX), responsible for the conversion of arachidonic acid into cyclic endoperoxides, such as to reduce the synthesis of thromboxanes ( TXA2), prostacyclin (PGI2) and prostaglandins (PG).
Experimental data indicate that ibuprofen may inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. In one study, following administration of a single 400 mg dose of ibuprofen, taken within 8 hours before or 30 minutes after the administration of acetylsalicylic acid (81 mg), there was a decrease in the effect of acetylsalicylic acid on thromboxane formation and platelet aggregation. However, the limited data and the uncertainties relating to their application to the clinical situation do not allow definitive conclusions to be drawn for the continued use of ibuprofen; there appears to be no clinically relevant effect from the occasional use of ibuprofen.
05.2 "Pharmacokinetic properties
Absorption. Ibuprofen (phenylpropionic acid derivative) is a racemic compound in which the S (+) enantiomer has almost all the pharmacological activity. Ibuprofen is well absorbed following oral administration and rapidly reaches optimal blood levels.
Distribution: the volume of distribution is 0.8-0.11 l / kg. Ibuprofen diffuses slowly into the synovial fluid, reaching significantly lower concentrations than plasma concentrations measured over the same period. Plasma protein binding, mainly with albumin, is 99%.
Metabolism: the main site of metabolism is the liver, where ibuprofen is converted into hydroxylated derivatives [(+) - 2- (p- (hydroxy-methyl-propyl) phenyl) propionic acid], carboxylated (-) - 2- (p- 2carboxy-propyl) phenyl) propionic acid] and related beta-1-O-glucuronic conjugates, all inactive.
Excretion: Ibuprofen is excreted rapidly and completely in the urine, in fact more than 90% of the administered dose is eliminated in 24 hours in the form of metabolites or other conjugated compounds. The half-life of ibuprofen is approximately 1.8-2 hours.
05.3 Preclinical safety data
Chronic toxicity
The subchronic and chronic toxicity of ibuprofen evaluated in animal studies manifests itself in the form of lesions and ulcers of the gastrointestinal tract.
Mutagenic and carcinogenic potential
In-vitro and in-vivo mutagenicity studies did not provide any clinically relevant indication of a mutagenic effect of ibuprofen.
Studies conducted in rats and mice on the carcinogenic potential of this substance did not report any indications of carcinogenic effects.
Reproductive toxicity
Experimental studies in two animal species have shown that ibuprofen crosses the placenta. Two studies in rats demonstrated a high incidence of midline and ventricular septal defects in the fetus at higher doses.
There is no further information on preclinical data other than that already reported elsewhere in this Summary of Product Characteristics (see section 4.6).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Maize starch, pregelatinised starch, hypromellose, microcrystalline cellulose, sodium starch glycolate, precipitated silica, sodium lauryl sulfate, E 104 aluminum lake, E 110 aluminum lake, titanium dioxide, propylene glycol, carnauba wax.
06.2 Incompatibility
Not known.
06.3 Period of validity
5 years
06.4 Special precautions for storage
No special storage precautions.
06.5 Nature of the immediate packaging and contents of the package
Blister of 10 tablets in opaque PVC / Aluminum.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Welcome Pharma S.p.A., Via Campobello, 1 - 00071 Pomezia (Rome)
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 027432020
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 21/9/89
Date of most recent renewal: 1/6/2010
10.0 DATE OF REVISION OF THE TEXT
AIFA determination of 28/07/2015