EIREN

PACKAGE LEAFLET: INFORMATION FOR THE USER

EIREN 400 mg film-coated tablets

For adolescents from the age of 12 years and adults
Ibuprofen
Read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not notice improvement or if you notice worsening of symptoms after 3 days in adolescents or after 4 days in adults.

Contents of this leaflet:

1. What EIREN 400 mg is and what it is used for
2. What you need to know before taking EIREN 400 mg
3. How to take EIREN 400 mg
4. Possible side effects
5. How to store EIREN 400 mg
6. Contents of the pack and other information

1. What EIREN 400 mg 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

2. What you should know before taking EIREN 400 mg

Do not take EIREN 400 mg
in the following circumstances:

• if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
• if you previously experienced reactions such as shortness of breath, asthma attacks, nasal mucosal swelling, angioedema, or skin reactions after using acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• unspecified blood cell formation disorders
• if you currently have or have previously had stomach/duodenal ulcers (peptic ulcers) or recurrent gastrointestinal bleeding (at least two confirmed episodes of ulcer or bleeding)
• if you have previously experienced gastrointestinal bleeding or perforation related to previous NSAID therapy
• cerebrovascular haemorrhage 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 have severe heart failure
• if you are severely dehydrated (due to vomiting, diarrhoea, or insufficient fluid intake)
• if you are under 12 years of age, as this dosage is unsuitable due to the high amount of active ingredient

Warnings and precautions
Talk to your doctor or pharmacist before taking EIREN 400 mg.
Pay special attention when using EIREN 400 mg in the following circumstances:

• inherited blood cell formation disorders (e.g. acute intermittent porphyria)
• certain immune system disorders (systemic lupus erythematosus and mixed connective tissue disease, conditions affecting connective tissue leading to joint pain, skin changes, and organ dysfunction), 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 are dehydrated (e.g. due to 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 mucosal swelling, or chronic obstructive airway disease, as you may be at higher 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 at increased risk of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.
Gastrointestinal bleeding, ulceration or perforation
Gastrointestinal bleeding, ulceration, and perforation: During treatment with all NSAIDs, at any time during therapy, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal bleeding, ulceration, or perforation have been reported, which may be fatal.
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. Treatment should be initiated at the lowest available dose. Consult your doctor, as concomitant therapy with protective agents may be considered. This also applies if you are taking low-dose acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal events.
If you have previously experienced gastrointestinal toxicity, especially if you are elderly, inform your doctor of any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially during the initial stages of treatment. Caution is required if you are taking concomitant medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants like warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as acetylsalicylic acid.
If you develop bleeding or ulcers during treatment with this medicine, stop treatment immediately.
Skin reactions
Serious skin reactions have been reported with treatment using EIREN 400 mg. Discontinue use of EIREN 400 mg and consult your doctor immediately if you develop rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a severe skin reaction. See section 4.
Severe skin reactions associated with ibuprofen include exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
Stop using EIREN 400 mg and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.
Infections
EIREN 400 mg may mask symptoms of infections such as fever and pain. Therefore, EIREN 400 mg may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.
It is advisable to avoid using this medicine during chickenpox.
Ibuprofen, the active ingredient in EIREN 400 mg film-coated tablets, may temporarily inhibit platelet function (platelet aggregation). Patients with coagulation disorders should therefore be closely monitored.
If your doctor considers long-term ibuprofen therapy necessary, regular monitoring of liver function, kidney function, and blood cell counts should be performed.
During treatment with this medicine, consult/inform your doctor or dentist before undergoing any surgical procedure.
In very rare cases, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. Treatment must be discontinued at the first signs of a hypersensitivity reaction after taking EIREN 400 mg.
Depending on the symptoms, appropriate medical procedures must be carried out by trained medical personnel.
You should drink sufficient fluids during treatment, especially in case of fever, diarrhoea, or vomiting.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Prolonged use of any painkiller for headache may worsen it. If this occurs or is suspected, medical advice should be sought and treatment discontinued. Medication-overuse headache (MOH) should be suspected in patients with frequent or daily headaches despite (or because of) regular use of headache medications.
In general, habitual use of painkillers, particularly combinations of different analgesic substances, may cause permanent kidney damage with risk of kidney failure (analgesic nephropathy).
Effect on the cardiovascular system
Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, especially 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, discuss treatment with your doctor or pharmacist:

• if you have heart problems including heart failure, angina (chest pain), or have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including “mini-stroke” or “TIA”, transient ischaemic attack).
• if you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

Signs of an allergic reaction to this medicine, including breathing difficulties, 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 services 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.
Other medicines and EIREN 400 mg
Do not use different types of painkillers simultaneously unless directed by a doctor.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those obtained without a prescription.
EIREN 400 mg may affect or be affected by treatment with certain medicines, including those used to treat/prevent:

• tumours and immune system disorders (methotrexate),
• bipolar disorder (lithium),
• irregular heartbeat (digoxin),
• epilepsy or neuropathic pain (phenytoin),
• pain (acetylsalicylic acid),
• thromboembolic disorders (medicines that are antiplatelet or anticoagulant, i.e. that thin the blood to prevent clotting, e.g. aspirin/acetylsalicylic acid, dicoumarol, warfarin, ticlopidine),
• depression (medicines called SSRIs – selective serotonin reuptake inhibitors),
• high blood pressure (medicines that lower high blood pressure, e.g. ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan, diuretics).
• organ transplant rejection (immunosuppressive medicines such as cyclosporine or tacrolimus)
• inflammation (corticosteroids),
• bacterial infections (some antibiotics including aminoglycosides and quinolone antibiotics),
• fungal infections (antifungals, particularly voriconazole or fluconazole),
• type 2 diabetes mellitus (sulfonylureas),
• high cholesterol (cholestyramine),
• human immunodeficiency virus (HIV) infection (zidovudine).
• gout (probenecid and sulfinpyrazone)

Other medicines may also affect or be affected by treatment with EIREN 400 mg. You should therefore always seek advice from your doctor or pharmacist before using EIREN 400 mg with other medicines.
EIREN 400 mg with food, drinks and alcohol
EIREN 400 mg can be taken with food and drinks. EIREN 400 mg may be taken on an empty stomach for faster relief. If EIREN 400 mg is taken with alcohol, side effects may increase.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take EIREN 400 mg during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labour more than expected. You should not take EIREN 400 mg during the first 6 months of pregnancy unless absolutely necessary and under medical advice.
If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From week 20 of pregnancy, EIREN 400 mg may cause kidney problems in the fetus if taken for more than a few days, thereby reducing levels of amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring. If pregnancy occurs during use of EIREN 400 mg, you must inform your doctor.
Breastfeeding
Only small amounts of the active ingredient ibuprofen and its metabolites pass into breast milk. As no adverse effects in the infant are known, breastfeeding generally does not need to be interrupted during short-term use at recommended doses for the treatment of mild to moderate pain. However, if the medicine is prescribed for prolonged treatment or at high doses, early weaning should be considered.
Fertility
This product belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of treatment.
Driving and using machines
Since undesirable effects such as fatigue, dizziness, and visual disturbances may occur during use of EIREN 400 mg, your ability to react and maintain active vigilance while driving or operating machinery may occasionally be impaired. These effects may be enhanced if alcohol is consumed concurrently.
EIREN 400 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take EIREN 400 mg

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The lowest effective dose for the shortest necessary duration should be used to relieve symptoms. If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Recommended dose:
Age Single dose Maximum daily dose
12–15 years ½ tablet 1½ tablets
(equivalent to 200 mg of (equivalent to 600 mg of
ibuprofen) ibuprofen)
Over 15 years ½–1 tablet 3 tablets
(equivalent to 200–400 mg of (equivalent to 1200 mg of
ibuprofen) ibuprofen)
If you have taken the maximum single dose, you must wait at least 6 hours before taking the next dose.
Do not exceed the recommended dose.
If you feel that the effect of EIREN 400 mg is too strong or too weak, talk to your doctor or pharmacist.
The tablet may be divided into equal doses.
If your treatment requires dividing a tablet, this is the best way to do it.
Place the tablet with the score line facing upwards on a hard, flat surface. Then press firmly with your thumb or index finger on the upper notched part.

This is a schematic drawing of a tablet. Therefore, the shape may be slightly different from your tablet.
Method of administration
For oral use.
Film-coated tablets should be swallowed whole with water.
Patients with gastric sensitivity are advised to take EIREN 400 mg during meals.
Duration of treatment
For short-term use only.
If use of the medicine is required for more than 3 days in adolescents, or if symptoms worsen, consult your doctor.
If use of the medicine is required for more than 4 days in adults, or if symptoms worsen, consult your doctor.
If you take more EIREN 400 mg than you should
If you have taken more EIREN 400 mg than you should, or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on the risk and guidance on actions to take.
Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, tinnitus, confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties have been reported.
If you forget to take EIREN 400 mg
Do not take a double dose to make up for a missed dose.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 breathing difficulties
• An infection with symptoms such as fever and severe worsening of your general condition, or fever with signs of local infection such as sore throat/pharynx/mouth or urinary problems. EIREN 400 mg may cause a reduction in the number of white blood cells (agranulocytosis), leading to decreased resistance to infections (an uncommon side effect). It is important to inform your doctor about this medicine.
• Severe skin and mucous membrane reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis and/or erythema multiforme (a very rare side effect). Additionally, a serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell). Stop taking Ibuprofen 400 mg and contact a doctor if you develop a skin rash or mucosal lesions. Severe rashes may include blisters on the skin, especially on the legs, arms, hands, and feet, which may also involve the face and lips. This may worsen further, with blisters becoming larger and spreading, 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-elevated reddish spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, and ulcers of the mouth, throat, nose, genitals, and eyes. These severe skin reactions 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 swollen lymph nodes (DRESS syndrome).
• Generalized widespread rash, red and scaly with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption). Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Other possible side effects:
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
• Bronchospasm, asthma
• Mouth ulcerations
• Stomach ulcer, intestinal ulcer, perforation of stomach ulcer, inflammation of the stomach lining
• Hepatitis, jaundice, abnormal liver function
• Itching, small bruises on the skin and mucous membranes
• Skin becomes light-sensitive
• Impaired kidney function
• Blood count abnormalities
• Anaemia (reduction in red blood cells or haemoglobin, which may cause paleness and lead to weakness)
• Drowsiness
• Tingling sensation
• Hearing loss

Rare (may affect up to 1 in 1,000 people):

• Aseptic meningitis
• Allergic reaction
• Depression, confusion
• Visual disturbances, tinnitus (ringing in the ears), dizziness
• 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 available data):

• Worsening of ulcers in the large intestine (colitis) and Crohn's disease (intestinal disorder)
• Heart failure, heart attack, hypertension
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome
• Drug-induced fixed eruption

Please note that EIREN 400 mg may prolong bleeding time.
Very rarely, severe skin infections may occur in case of chickenpox. When using an NSAID, skin inflammation related to an infection may develop or worsen (e.g. conditions such as necrotizing fasciitis, characterized by severe pain, high fever, swollen and warm skin, blister formation, necrosis). If signs of a skin infection appear or worsen during treatment with ibuprofen, immediate medical advice is recommended.
Medicines such as EIREN 400 mg may cause a slight increase in the risk of heart attack or stroke.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store EIREN 400 mg

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 blister and carton after EXP. The
expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What EIREN 400 mg contains
The active substance is ibuprofen.
Each film-coated tablet contains 400 mg of ibuprofen.
The other components are:
Tablet core
Modified maize starch, croscarmellose sodium, hypromellose, stearic acid, anhydrous colloidal silica.
Coating
Hypromellose, macrogol 8000, titanium dioxide.
Description of the appearance of EIREN 400 mg and package contents
Film-coated tablets, white in colour, round, biconvex, with a break line on one side to divide the tablet.
EIREN 400 mg is available in packages containing 6, 10, 12, 20, 30, 50, 60, 100 and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
AURORA LICENSING srl
Via del Milliario, 32
40133 Bologna, Italy
Manufacturer
Merckle GmbH
Ludwig – Merckle Strasse 3
89143 Blaubeuren - Germany
This medicinal product is authorized in the European Economic Area countries under the following
names:
Denmark Ibuprofen Teva
Germany Ibuprofen – ratio 400 mg Filmtabletten
Italy EIREN