EIREN*12COATED TABS 400MG

EIREN 400 mg film-coated tablets
Ibuprofen

What it is and what it is used for
EIREN 400 mg is a medicine that reduces pain (non-steroidal anti-inflammatory drug [NSAID]).

EIREN 400 mg is used for the short-term symptomatic treatment of:
- mild to moderate pain.

What you need to know before taking the medicine
Do not take EIREN 400 mg in the following circumstances:
- if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
- if, after previous use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, you have experienced reactions such as shortness of breath, asthma attacks, swelling of the nasal lining, angioedema or skin reactions;
- unspecified blood formation disorders;
- if you have active or a history of stomach/duodenal ulcers (peptic ulcers) or recurrent bleeding (at least two different confirmed episodes of ulcer or bleeding);
- if you have previously suffered from gastrointestinal bleeding or perforation related to previous NSAID therapy;
- cerebrovascular bleeding or other types of active bleeding;
- if you suffer from severe impairment of liver or kidney function;
- during the last 3 months of pregnancy;
- if you suffer from severe heart failure;
- if you suffer from severe dehydration (due to vomiting, diarrhoea or insufficient fluid intake);
- if you are under 12 years of age, because this dosage is not suitable due to the high amount of active ingredient.

Warnings and precautions
Talk to your doctor or pharmacist before taking EIREN 400 mg.
Be particularly careful with EIREN 400 mg in the following circumstances:
- hereditary blood formation disorders (e.g. acute intermittent porphyria);
- certain immune system disorders (systemic lupus erythematosus and mixed connective tissue disease, immune system conditions that affect connective tissue resulting in joint pain, skin changes and other organ disorders) as there may be an increased risk of aseptic meningitis;
- gastrointestinal disorders or chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
- impaired kidney or liver function;
- if you suffer from dehydration (e.g. in case of vomiting or diarrhoea);
- high blood pressure or heart failure;
- if you suffer from allergies (e.g. skin reactions to other medicines, asthma, hay fever), chronic swelling of the mucous membranes or chronic constrictive airway disease, as you are more exposed to the risk of hypersensitivity reactions;
- immediately after major surgery;
- if you have an infection - see the infections section below.

Concomitant use of EIREN 400 mg and other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.

Elderly: Elderly patients are subject to an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.

Gastrointestinal bleeding, ulceration or perforation
Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time during therapy, with or without warning symptoms or a previous history of serious gastrointestinal events.

The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs, if you have previously suffered from ulcers, especially if complicated by bleeding or perforation, and in elderly patients. You should start treatment at the lowest available dose. Consult your doctor, as co-therapy with protective agents may be considered. This also applies if you are simultaneously taking low doses of acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal events.

If you have previously suffered from gastrointestinal toxicity, especially if you are elderly, you should report any unusual abdominal symptoms (especially gastrointestinal bleeding) to your doctor, particularly in the initial stages of treatment. Caution is required if you are simultaneously taking medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants like warfarin, selective serotonin reuptake inhibitors or antiplatelet agents like acetylsalicylic acid.

If you experience bleeding or ulcers during treatment with this medicine, stop treatment immediately.

Skin reactions
Serious skin reactions have been reported in association with EIREN 400 mg treatment. Stop taking EIREN 400 mg and consult your doctor immediately if you develop a 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.

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 EIREN 400 mg and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Infections
EIREN 400 mg can mask symptoms of infection such as fever and pain. Therefore, it is possible that EIREN 400 mg 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, consult your doctor immediately.

It is recommended to avoid using this medicine during chickenpox.

Ibuprofen, the active ingredient in EIREN 400 mg film-coated tablets, can temporarily inhibit platelet function (platelet aggregation). Patients with blood clotting disorders should therefore be carefully monitored.

If your doctor deems prolonged ibuprofen therapy necessary, regular checks of liver values, kidney function and blood cell count should be performed.

While taking this medicine, consult/inform your doctor or dentist before undergoing surgery.

In very rare cases, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. Therapy should be discontinued at the first signs of a hypersensitivity reaction after taking EIREN 400 mg. Depending on the symptoms present, the necessary medical procedures should be performed by specialised personnel.

You should drink enough fluids during treatment, especially in case of fever, diarrhoea or vomiting.

Undesirable effects can be reduced if the lowest effective dose is used for the shortest period of time necessary to control symptoms.

Prolonged use of any headache painkiller can make it worse. If this situation occurs or is suspected, medical advice should be sought and treatment should be stopped. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) regular use of headache medicines.
In general, habitual intake of painkillers, particularly a combination of different pain-relieving substances, can lead to permanent kidney damage with a risk of kidney failure (analgesic nephropathy).

Effect on the cardiovascular system
Anti-inflammatory/painkilling medicines such as ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment (3 days in adolescents and 4 days in adults).

Before taking EIREN 400 mg you should discuss the treatment with your doctor or pharmacist:
- if you have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, surgical bypass, peripheral artery 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);
- if you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema) and chest pain, have been reported with ibuprofen. Stop EIREN 400 mg immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.

Children and adolescents
In dehydrated adolescents, there is a risk of kidney impairment.
Do not administer this medicine to children and adolescents under 12 years of age.

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

Stop taking EIREN 400 mg and contact a doctor immediately if you experience any of the following symptoms: - angioedema (an uncommon side effect) with symptoms such as: • swelling of the face, tongue or throat;
• difficulty swallowing;
• hives and difficulty breathing;
- an infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as sore throat/pharynx/mouth or urinary problems.
EIREN 400 mg can cause a reduction in the number of white blood cells (agranulocytosis) with reduced resistance to infections (an uncommon side effect). It is important to inform your doctor about the medicine;
- severe changes in the skin and mucous membranes such as toxic epidermal necrolysis and/or erythema multiforme (a very rare side effect). In addition, a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swelling of the lymph nodes and an increase in eosinophils (a type of white blood cell). Stop taking Ibuprofen 400 mg and contact a doctor if you develop a rash or mucous membrane lesions. Severe rashes can include blisters on the skin, especially on the legs, arms, hands and feet which may also involve the face and lips. This can become even more severe, where the blisters become larger and spread and parts of the skin may peel off (toxic epidermal necrolysis). There may also be a severe infection with destruction (necrosis) of the skin, subcutaneous tissue and muscles;
- non-raised reddish, target-shaped or circular patches on the trunk, often with central blisters, peeling of the 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 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 start of treatment (acute generalised exanthematous pustulosis);
- chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Other side effects that may occur:

Common (may affect up to 1 in 10 people):
- headache, dizziness;
- gastrointestinal side effects (indigestion, diarrhoea, nausea, vomiting, abdominal pain, flatulence, constipation, black stools, bleeding in the stomach and intestines, blood in vomit);
- rash - fatigue.

Uncommon (may affect up to 1 in 100 people):
- rhinitis;
- hypersensitivity;
- insomnia, anxiety;
- visual disturbances, hearing damage;
- bronchial spasm, asthma;
- mouth ulcers;
- stomach ulcer, intestinal ulcer, rupture of stomach ulcer, inflammation of the stomach lining;
- hepatitis, jaundice, abnormal liver function;
- itching, small bruises on the skin and mucous membranes;
- the skin becomes sensitive to light;
- impaired kidney function;
- changes in blood count;
- anaemia (reduction in red blood cells or haemoglobin, which can make the skin pale and may lead to weakness);
- drowsiness;
- tingling sensation;
- hearing loss.

Rare (may affect up to 1 in 1,000 people):
- non-bacterial meningitis;
- allergic reaction;
- depression, confusion;
- altered vision, tinnitus (ringing in the ears), vertigo;
- liver damage and fluid retention in the body.

Very rare (may affect up to 1 in 10,000 people):
- Pancreatitis, liver failure.

Not known (frequency cannot be estimated from the available data):
- worsening of ulcers in the large intestine (colitis) and Crohn's disease (inflammatory bowel disease);
- heart failure, heart attack, hypertension;
- chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis Syndrome;
- fixed eruption.

Note that EIREN 400 mg can prolong bleeding time.

Exceptionally, severe skin infections in cases of chickenpox. When an NSAID is used, an infection-related skin inflammation could develop or become more severe (e.g. a condition such as necrotising fasciitis characterised by intense pain, high fever, swollen and hot skin, blistering, necrosis may develop). If signs of a skin infection occur or worsen during the use of ibuprofen, it is recommended to consult your doctor immediately.

Medicines such as EIREN 400 mg may be associated with a slight increase in the risk of heart attack or stroke.

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.