Ibuprofen EG Stada: detailed information

Package leaflet: Information for the user

Ibuprofen EG STADA 600 mg Film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Keep this leaflet; you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet:

What Ibuprofen EG STADA is and what it is used for
What you need to know before taking Ibuprofen EG STADA
How to take Ibuprofen EG STADA
Possible side effects
How to store Ibuprofen EG STADA
Contents of the pack and other information

1. What Ibuprofene EG STADA is and what it is used for

Ibuprofene EG STADA contains ibuprofen, an active substance belonging to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). NSAIDs are medicines used to relieve pain and inflammation.
Ibuprofene EG STADA is used to treat pain such as:

injuries (e.g. those caused by sports), toothache (e.g. after tooth extraction or dental and oral surgery), postpartum pain, menstrual pain, eye pain (e.g. following eye surgery), headache, pain after surgical procedures;
rheumatic diseases such as: inflammation of muscles, tendons, nerves and joints (periarthritis, radiculoneuritis, tenosynovitis, myositis, fibrositis), back pain (lumbago), leg pain due to sciatic nerve inflammation (sciatica), degenerative joint diseases (osteoarthritis), such as cervical, dorsal, lumbar osteoarthritis, shoulder, hip or knee osteoarthritis, or generalized osteoarthritis, a chronic progressive autoimmune disease primarily affecting the joints (rheumatoid arthritis), and a rare inflammatory disease called Still's disease.

2. What you should know before taking Ibuprofene EG STADA

Do not take Ibuprofene EG STADA

if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
if you have had allergic reactions after taking aspirin (acetylsalicylic acid), other painkillers, fever-reducing medicines, or other non-steroidal anti-inflammatory drugs (NSAIDs), especially if associated with nasal polyps, facial swelling (angioedema), and/or asthma;
if you have a lesion in the wall of the stomach or intestine (severe or active peptic ulcer);
if you have previously experienced an episode of perforation or bleeding in the stomach or intestine caused by taking medicines;
if you have had two or more separate episodes of bleeding or injury to the stomach or intestinal wall (recurrent peptic ulcer);
if you have severe liver or kidney problems;
if you suffer from severe heart problems (severe heart failure);
if you have any disease that increases the risk of bleeding;
if you are in a state of severe dehydration, for example, if you have had severe episodes of vomiting, diarrhoea, or drink very little;
if you are in the last 3 months of pregnancy.

Do not use Ibuprofene EG STADA in children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ibuprofene EG STADA if

you suffer from systemic lupus erythematosus (SLE) or mixed connective tissue disease, conditions affecting connective tissue causing joint or muscle pain, skin changes, and problems in other organs;
you have had stomach or intestinal problems, such as ulcers, Crohn’s disease, or ulcerative colitis (see the section below “BE CAREFUL” on gastrointestinal risks and “Do not take Ibuprofene EG STADA”);
you have reduced kidney function;
you have liver problems;
you have blood clotting disorders;
you have or have had allergies (e.g. hay fever);
you have nasal inflammation (chronic rhinitis) or nasal polyps;
you suffer from asthma or long-lasting (chronic) respiratory diseases;
you have previously experienced swelling of the face, throat, lips, or other body parts (angioedema);
you are elderly, as you are more likely to develop adverse reactions to this medicine, particularly bleeding and perforations of the stomach and intestine, which may be life-threatening (see the section below “BE CAREFUL” on gastrointestinal risks);
you have chickenpox, as pain and anti-inflammatory medicines (NSAIDs) may worsen the severity of skin lesions caused by it. In such cases, your doctor may advise against using this medicine;
you are a dehydrated adolescent or an elderly person, as you are more likely to have kidney problems.

Take particular care with Ibuprofene EG STADA:
Heart attack and stroke
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking Ibuprofene EG STADA if you:

have heart problems, including heart attack, angina (chest pain), or history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation to legs or feet due to narrowing or blockage of arteries), or any type of stroke (including “mini-stroke” or “TIA”, transient ischemic attack);
have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

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 taking Ibuprofene EG STADA immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
Skin reactions
Serious skin reactions have been reported during treatment with Ibuprofene EG STADA, 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). Stop using Ibuprofene EG STADA and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4. If you notice any severe symptoms such as rash, mucosal lesions, blisters, or other signs of allergy, stop using Ibuprofene EG STADA, as these may be early signs of a very serious skin reaction.
Ibuprofene EG STADA may temporarily prolong bleeding time.
Talk to your pharmacist or nurse if you have an infection – see the section “Infections” below.
Infections
Ibuprofene EG STADA may mask symptoms of infections such as fever and pain. Therefore, Ibuprofene EG STADA may delay appropriate treatment of the infection, which could increase 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 the symptoms of infection persist or worsen, consult your doctor immediately.
BE CAREFUL, because during treatment with all non-steroidal anti-inflammatory drugs for pain and inflammation (NSAIDs):

at any time, with or without warning symptoms, even in patients without previous serious stomach or intestinal (gastrointestinal) problems, bleeding, ulceration, or perforation of the stomach or intestine have been reported, which can be life-threatening (see section “Do not take Ibuprofene EG STADA”). If you are elderly or have previously had such problems, the risk of experiencing these events increases if you take higher doses of the medicine. In this case, your doctor will advise starting treatment with the lowest available dose and may also prescribe a medicine to protect your stomach (gastroprotective agents such as misoprostol or proton pump inhibitors) to be taken together with Ibuprofene EG STADA;
although very rarely, serious skin reactions, some of which fatal, have been reported, manifesting as redness, blistering, and peeling (e.g. exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis). Your risk of developing these reactions is higher in the early stages of treatment, particularly within the first month;
severe allergic reactions (anaphylactoid reactions, up to anaphylactic shock) may occur;
signs of infection may be masked, which may present, for example, as fever, pain, and swelling;
eye disorders may occur when using Ibuprofene EG STADA. Periodic eye examinations are necessary during treatment, especially for prolonged therapy;
headache may occur, particularly if used for long periods and at high doses; in such cases, do not increase the dose of Ibuprofene EG STADA to relieve the pain.

If you have reduced heart, liver, or kidney function (especially if you suffer from systemic lupus erythematosus), your doctor will prescribe periodic specific tests, particularly for prolonged treatments, and will prescribe the lowest effective dose for the shortest possible duration needed to control symptoms.
The risk of experiencing side effects can be reduced by using the lowest effective dose for the shortest possible duration needed to control symptoms. Do not exceed the dose of Ibuprofene EG STADA or take it for long periods; always follow your doctor’s instructions carefully.
STOP treatment and contact your doctor if:

you notice any stomach or intestinal (gastrointestinal) symptoms, especially bleeding, particularly if this occurs early in treatment, if you are elderly, or if you have previously had gastrointestinal problems;
a skin rash, mucosal lesions, or any other sign of allergic reaction appears (e.g. redness, itching, swelling of the face and throat, sudden drop in blood pressure);
you experience vision problems;
you develop liver problems.

Children
Do not use Ibuprofene EG STADA in children under 12 years of age. If necessary, consult your doctor, as lower dosage forms specific for these patients are available.
Other medicines and Ibuprofene EG STADA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Ibuprofene EG STADA may affect or be affected by other medicines. For example:

other medicines that reduce pain and inflammation (NSAIDs), including those called selective COX-2 inhibitors, as this may increase the risk of ulcers or gastrointestinal bleeding;
cardiac glycosides (e.g. digoxin), medicines used for heart conditions;
sulfonylureas, medicines used for diabetes;
medicines with anticoagulant effect (i.e. substances that thin the blood to prevent clotting, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
cyclosporine and tacrolimus, medicines that suppress the immune system;
medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan, diuretics);
medicines containing cortisone or cortisone-like substances, used to treat inflammation (corticosteroids);
medicines called selective serotonin reuptake inhibitors (SSRIs), used as antidepressants;
aminoglycoside and quinolone antibiotics;
zidovudine and ritonavir, medicines used in HIV infections;
methotrexate, used in cancer treatment and for certain immune system disorders, e.g. rheumatoid arthritis;
cholestyramine, a medicine used to lower blood cholesterol levels;
lithium, used in depression;
medicines that inhibit CYP2C9, such as voriconazole and fluconazole, medicines used for fungal infections;
Ginkgo Biloba, a herbal extract used to improve circulation;
probenecid, a medicine used for gout;
phenytoin, a medicine used for epilepsy;
bisphosphonates, medicines used to treat osteoporosis;
oxpentifylline, a medicine used for blood vessel problems;
baclofen, a medicine used to relax muscles;
mifepristone, a medicine used for medical termination of pregnancy;
moclobemide, a medicine used to treat depression.

Some other medicines may also affect or be affected by treatment with Ibuprofene EG STADA. Therefore, always consult your doctor or pharmacist before using Ibuprofene EG STADA with other medicines.
Ibuprofene EG STADA with alcohol
Some side effects, such as those affecting the stomach and intestine or the nervous system, may be more likely when consuming alcohol during treatment with Ibuprofene EG STADA.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy

Do not use Ibuprofene EG STADA after the sixth month of pregnancy, as such treatment may cause problems to the heart, lungs, or kidneys of the fetus and complications during childbirth (see section 2 “Do not take Ibuprofene EG STADA”).

Do not take Ibuprofene EG STADA during the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. 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 Ibuprofene EG STADA 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 dose for the shortest possible time should be used. If taken for more than a few days from week 20 of pregnancy onwards, Ibuprofene EG STADA may cause kidney problems in the fetus, which may reduce the levels of amniotic fluid surrounding the baby (oligohydramnios) or 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.
Breastfeeding
Avoid taking Ibuprofene EG STADA if you are breastfeeding, as the medicine may pass into breast milk in small amounts.
Fertility
If you are planning a pregnancy or have fertility problems, consult your doctor, as this medicine may impair fertility. This effect is reversible upon discontinuation of the drug.
Driving and using machines
Ibuprofene EG STADA may cause side effects that may impair your reaction to stimuli, such as headache, drowsiness, dizziness, vertigo, fatigue, and visual disturbances. Make sure you do not experience any of these side effects before driving, operating machinery, or doing anything that requires attention. This is particularly important when consuming alcohol during treatment with Ibuprofene EG STADA.

3. How to take Ibuprofene EG STADA

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults and children over 12 years of age:
The recommended dose is 1–3 tablets per day, according to your doctor's advice. The maximum dose is 3 tablets (1800 mg) per day.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If you have an infection, contact your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Elderly:
If you are elderly, your doctor will determine the most appropriate dose for you, possibly reducing the doses indicated above.

Patients with kidney or liver problems:
If you have kidney or liver problems, your doctor will decide the most appropriate dose for you, possibly reducing the doses indicated above. If you have severe kidney or liver problems, you must not take this medicine (see “Do not take Ibuprofene EG STADA”).

Method of administration
It is recommended to take Ibuprofene EG STADA during meals if you have gastric sensitivity.
Ibuprofene EG STADA is for oral use (taken by mouth) and should be taken with plenty of water. Swallow the tablets whole, without chewing, breaking, crushing, or sucking them.
If you are taking Ibuprofene EG STADA for rheumatic diseases, your doctor will instruct you to take the first dose upon waking and subsequent doses with meals.

If you take more Ibuprofene EG STADA than you should
If you have taken more Ibuprofene EG STADA than recommended, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately for advice on potential risks and necessary actions. Bring the medicine’s packaging and patient information leaflet with you.
Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), blood in the urine, diarrhoea, abdominal or chest pain, gastrointestinal bleeding, heart problems such as low blood pressure or changes in heart rhythm (bradycardia, tachycardia), circulatory problems, liver or kidney problems, headache, ringing in the ears (tinnitus), confusion, involuntary and oscillating eye movements (nystagmus), decreased blood pH (metabolic acidosis), low potassium levels in the blood, weakness and dizziness, fainting, seizures (especially in children), disorientation, restlessness, breathing difficulties (including apnoea), and symptoms of central nervous system depression such as drowsiness, feeling cold (hypothermia), loss of consciousness, deep sleep (lethargy), or coma.

If you forget to take Ibuprofene EG STADA
Do not take a double dose to make up for the 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.
Side effects with medicines such as Ibuprofene EG STADA are more common in elderly people.
Side effects are more likely with higher doses and longer duration of treatment.

Serious side effects
Stop taking Ibuprofene EG STADA and contact your doctor immediately if you experience any of the following:

chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome;
severe stomach problems, burning or abdominal pain due to injury of the stomach or intestine (peptic ulcers), sudden and severe pain in the upper abdomen or stomach area (gastrointestinal perforation). These side effects are uncommon;
vomiting blood (haematemesis) or black stools (melena), bleeding from the stomach or intestine (gastrointestinal haemorrhage). These conditions are common side effects;
allergic reactions, even severe ones, presenting as more or less sudden appearance of skin lesions, such as widespread redness or spots (rash, purpura), hives, itching, swelling of the face, eyes, lips, angioedema of the throat with possible difficulty breathing and swallowing. These conditions occur with uncommon frequency. Rarely, a severe, life-threatening allergic reaction may also occur, characterized by increased heart rate and sudden drop in blood pressure (anaphylactic reaction, anaphylaxis);
flat, red, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis]. These conditions are very rare;
difficulty breathing (asthma, even severe, bronchospasm or dyspnoea). These conditions are uncommon side effects;
systemic lupus erythematosus (SLE), a disease affecting connective tissue causing joint or muscle pain, skin changes and problems in other organs. This condition is rare;
worsening of infections, such as the onset of necrotizing fasciitis, presenting with fever, chills, weakness, sweating, diarrhoea, vomiting, redness, pain, swelling, bruising in an area of the body due to tissue necrosis (death of tissue cells);
inflammation of the meninges (aseptic meningitis) presenting with: high fever, sudden headache, inability to bend the neck, nausea, vomiting, confusion, drowsiness and sensitivity to light. This condition is rare;
widespread rash, high body temperature, swollen lymph nodes and increased eosinophils (a type of white blood cells) (DRESS syndrome);
widespread, red, scaly rash with bumps under the skin and blisters (mainly located in skin folds, trunk and upper limbs), accompanied by fever. Symptoms usually occur at the beginning of treatment (generalized pustular eruption). Stop using Ibuprofene EG STADA if you develop these symptoms and contact your doctor immediately. See also section 2.

Other side effects
Tell your doctor if you notice:
Common side effects (may affect up to 1 in 10 people)

nausea, vomiting, diarrhoea, intestinal gas (flatulence), constipation, indigestion (dyspepsia), abdominal pain;
headache, dizziness;
fatigue.

Uncommon side effects (may affect up to 1 in 100 people)

inflammation of the nose (rhinitis);
stomach inflammation (gastritis), mouth ulcers;
dizziness, drowsiness, difficulty falling asleep (insomnia), anxiety, changes in sensation (paraesthesia);
impaired hearing, ringing in the ears (tinnitus), vision disturbances;
skin reactions following exposure to sunlight (photosensitivity);
changes in liver function, yellowing of the eyes or skin (jaundice), dark urine, pale stools, itching or abdominal pain, inflammation of the liver (hepatitis);
kidney problems such as nephrotic syndrome, inflammation of the kidney (tubulointerstitial nephritis), changes in function (renal failure).

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

decrease in the number of white blood cells (leucopenia) or of certain types of white blood cells (neutropenia, agranulocytosis), decrease in the number of platelets (thrombocytopenia), decrease in red blood cells due to destruction (haemolytic anaemia) or due to bone marrow problems (aplastic anaemia);
depression, confusion;
vision changes, for example due to inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy;
swelling (oedema).

Very rare side effects (may affect up to 1 in 10,000 people)

reduced liver function, inflammation of the pancreas (pancreatitis);
sensation of heart pounding (palpitations), heart attack (myocardial infarction), reduced heart function (heart failure), high blood pressure (hypertension);
breathing problems due to fluid in the lungs (pulmonary oedema).

Other side effects

pain or burning sensation (pyrosis) in the upper stomach, inflammation of the mouth mucosa with ulcers (ulcerative stomatitis);
worsening of colon inflammation (colitis) or Crohn's disease;
worsening of skin infections caused by chickenpox;
stroke;
hallucinations, malaise.

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 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.

5. How to store Ibuprofene EG STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the
last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to discard
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ibuprofene EG STADA contains

The active substance is ibuprofen. Each tablet contains 600 mg of ibuprofen.
The other components are: tablet core: maize starch, pregelatinized starch, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate. Coating: cellulose derivative/polyoxyethylene 40 stearate, hypromellose (E464), titanium dioxide (E171), propylene glycol (E1520), macrogol 8000.

Description of the appearance of Ibuprofene EG STADA and package contents
Ibuprofene EG STADA is presented as film-coated tablets. Each pack contains 30 tablets.
Marketing Authorization Holder
EG S.p.A., Via Pavia 6 – 20136 Milan, Italy
Manufacturer
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo 1, 03012 Anagni (FR), Italy

Package leaflet: Information for the user

Ibuprofene EG STADA 600 mg Effervescent Granules

Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Keep this leaflet; you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

What Ibuprofene EG STADA is and what it is used for
What you need to know before taking Ibuprofene EG STADA
How to take Ibuprofene EG STADA
Possible side effects
How to store Ibuprofene EG STADA
Contents of the pack and other information

1. What is Ibuprofene EG STADA and what is it used for?

Ibuprofene EG STADA contains ibuprofen, which belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). NSAIDs are medicines used to relieve pain and inflammation.
Ibuprofene EG STADA is used to treat pain such as:

injuries (e.g. those caused by sports), toothache (e.g. after tooth extraction or dental and oral surgery), postpartum pain, menstrual pain, eye pain (e.g. following eye surgery), headache, pain after surgical procedures;
rheumatic diseases such as: inflammation of muscles, tendons, nerves and joints (periarthritis, radiculoneuritis, tenosynovitis, myositis, fibrositis), back pain (lumbago), leg pain due to sciatic nerve inflammation (sciatica), degenerative joint diseases (osteoarthritis), such as cervical, dorsal, lumbar osteoarthritis, shoulder, hip or knee osteoarthritis, or generalized osteoarthritis, a chronic progressive autoimmune disease primarily affecting the joints (rheumatoid arthritis), and a rare inflammatory disease called Still's disease.

2. What you should know before taking Ibuprofene EG STADA

Do not take Ibuprofene EG STADA

if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
if you have had allergic reactions after taking aspirin (acetylsalicylic acid) or other painkillers, fever-reducing medicines, or other non-steroidal anti-inflammatory drugs (NSAIDs), especially if associated with nasal polyps, facial swelling (angioedema), and/or asthma;
if you have a lesion in the wall of the stomach or intestine (severe or active peptic ulcer);
if you have previously experienced an episode of perforation or bleeding in the stomach or intestine caused by taking medications;
if you have had two or more separate episodes of bleeding or injury to the stomach or intestinal wall (recurrent peptic ulcer);
if you have severe liver or kidney problems;
if you suffer from severe heart problems (severe heart failure);
if you have any disease that increases the risk of bleeding;
if you are in a severe state of dehydration, for example, if you have had severe episodes of vomiting, diarrhoea, or drink very little;
if you are in the last 3 months of pregnancy.

Do not use Ibuprofene EG STADA in children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ibuprofene EG STADA if

you suffer from systemic lupus erythematosus (SLE) or mixed connective tissue disease, conditions affecting connective tissue causing joint or muscle pain, skin changes, and problems in other organs;
you have had stomach or intestinal problems, such as ulcers, Crohn’s disease, or ulcerative colitis (see the section below “PAY ATTENTION” on gastrointestinal risks and “Do not take Ibuprofene EG STADA”);
you have reduced kidney function;
you have liver problems;
you have blood clotting disorders;
you have or have had allergies (e.g. hay fever);
you have nasal inflammation (chronic rhinitis) or nasal polyps;
you suffer from asthma or long-standing (chronic) respiratory diseases;
you have previously experienced swelling of the face, throat, lips, or other body parts (angioedema);
you are elderly, as you are more likely to develop adverse events with this medicine, particularly bleeding and perforations of the stomach and intestine, which can be life-threatening (see the section below “PAY ATTENTION” on gastrointestinal risks);
you have chickenpox, as pain and anti-inflammatory medicines (NSAIDs) may worsen the severity of skin lesions caused by it. In such cases, your doctor may advise against using this medicine;
you are a dehydrated adolescent or an elderly person, as you are more likely to experience kidney problems.

Exercise particular caution with Ibuprofene EG STADA:
Heart attack and stroke
Anti-inflammatory/painkillers such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking Ibuprofene EG STADA if you have:

heart problems, including heart attack, angina (chest pain), or a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowing or blockage of arteries), or any type of stroke (including “mini-stroke” or “TIA”, transient ischemic attack);
high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

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 taking Ibuprofene EG STADA immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
Skin reactions
Serious skin reactions have been reported in association with treatment with Ibuprofene EG STADA, 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). Stop using Ibuprofene EG STADA and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
If you notice any serious symptoms such as rash, mucosal lesions, blisters, or other signs of allergy, stop using Ibuprofene EG STADA, as these may be early signs of a very serious skin reaction.
Ibuprofene EG STADA may temporarily prolong bleeding time.
Talk to your pharmacist or nurse if you have an infection – see the section «Infections» below.
Infections
Ibuprofene EG STADA may mask symptoms of infections such as fever and pain. Therefore, Ibuprofene EG STADA may delay appropriate treatment of the infection, which could increase 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.
PAY ATTENTION, because during treatment with all non-steroidal anti-inflammatory drugs for pain and inflammation (NSAIDs):

at any time, with or without warning symptoms, even in patients without previous serious stomach or intestinal (gastrointestinal) problems, bleeding, injury (ulceration), or perforation of the stomach or intestine have been reported, which can be life-threatening (see section “Do not take Ibuprofene EG STADA”). If you are elderly or have previously had such problems, the risk of these events occurring will be higher if you take higher doses of the medicine. In this case, your doctor will advise you to start treatment with the lowest available dose, and may also prescribe a medicine to protect your stomach (gastroprotective agents such as misoprostol or proton pump inhibitors) to be taken together with Ibuprofene EG STADA;
although very rarely, serious skin reactions, some of which have been fatal, have been reported, manifesting as redness, blistering, and peeling (e.g. exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis). Your risk of developing these reactions is higher in the early stages of treatment, particularly within the first month;
serious allergic reactions (anaphylactoid reactions, up to anaphylactic shock) may occur;
signs of infection may be masked, which may present, for example, as fever, pain, and swelling;
eye problems may occur if Ibuprofene EG STADA is used for prolonged treatments. Periodic eye examinations are necessary during therapy;
especially if used for prolonged periods and at high doses, headache may occur; in such cases, do not increase the dose of Ibuprofene EG STADA to relieve pain.

If you have reduced heart, liver, or kidney function (especially if you suffer from systemic lupus erythematosus), your doctor will prescribe periodic specific tests, particularly in case of prolonged treatment, and will prescribe the lowest effective dose for the shortest possible duration needed to control symptoms.
The risk of experiencing side effects can be reduced by using the lowest effective dose for the shortest duration necessary to control symptoms. Do not exceed the dose of Ibuprofene EG STADA or take it for long periods; always follow your doctor’s instructions carefully.
STOP treatment and contact your doctor if:

you notice any stomach or intestinal (gastrointestinal) symptoms, especially if they involve bleeding, particularly if this occurs early in treatment, if you are elderly, or if you have previously had gastrointestinal problems;
a skin rash, mucosal lesions, or any other sign of allergic reaction appear (e.g. redness, itching, facial or throat swelling, sudden drop in blood pressure);
you develop vision problems;
you experience liver problems.

Children and adolescents
Do not use Ibuprofene EG STADA in children under 12 years of age. If necessary, consult your doctor, as lower specific dosages are available for such patients.
Other medicines and Ibuprofene EG STADA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Ibuprofene EG STADA may affect or be affected by other medicines. For example:

other medicines that reduce pain and inflammation (NSAIDs), including those called selective COX-2 inhibitors, as this may increase the risk of ulcers or gastrointestinal bleeding;
cardiac glycosides (e.g. digoxin), medicines used for heart conditions;
sulfonylureas, medicines used for diabetes;
medicines with anticoagulant effects (i.e. substances that thin the blood, preventing clot formation, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
cyclosporine and tacrolimus, medicines that suppress the immune system;
medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan, diuretics);
medicines containing cortisone or cortisone-like substances, used to treat inflammation (corticosteroids);
medicines called selective serotonin reuptake inhibitors (SSRIs), used as antidepressants;
aminoglycoside and quinolone antibiotics;
zidovudine and ritonavir, medicines used in HIV infections;
methotrexate, used in cancer treatment and for certain immune system disorders, e.g. rheumatoid arthritis;
cholestyramine, a medicine used to lower cholesterol levels in the blood;
lithium, used in depression;
medicines that inhibit CYP2C9, such as voriconazole and fluconazole, used in fungal infections;
Ginkgo Biloba, a herbal extract used to improve circulation;
probenecid, a medicine used for gout;
phenytoin, a medicine used for epilepsy;
bisphosphonates, medicines used to treat osteoporosis;
oxpentifylline, a medicine used for blood vessel problems;
baclofen, a medicine used to relax muscles;
mifepristone, a medicine used for medical termination of pregnancy;
moclobemide, a medicine used to treat depression.

Other medicines may also affect or be affected by treatment with Ibuprofene EG STADA. Therefore, always consult your doctor or pharmacist before using Ibuprofene EG STADA with other medicines.
Ibuprofene EG STADA with alcohol
Some side effects, such as those affecting the stomach and intestine or the nervous system, may be more likely when consuming alcohol during treatment with Ibuprofene EG STADA.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy

Do not use Ibuprofene EG STADA after the sixth month of pregnancy, as such treatment may cause problems to the fetus’s heart, lungs, or kidneys and complications during childbirth (see section 2 “Do not take Ibuprofene EG STADA”).

Do not take Ibuprofene EG STADA during the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. It may cause kidney and heart problems in the fetus. It could affect your and your baby’s tendency to bleed and delay or prolong labour more than expected.
You should not take Ibuprofene EG STADA 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. If taken for more than a few days from the 20th week of pregnancy onwards, Ibuprofene EG STADA may cause kidney problems in the fetus, which may reduce the levels of amniotic fluid surrounding the baby (oligohydramnios) or cause 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.
Breastfeeding
Avoid taking Ibuprofene EG STADA if you are breastfeeding, as the medicine may pass into breast milk in small amounts.
Fertility
If you are planning a pregnancy or have fertility problems, consult your doctor, as this medicine may impair fertility. This effect is reversible upon discontinuation of the drug.
Driving and using machines
Ibuprofene EG STADA may cause side effects that may impair your responsiveness to stimuli, such as headache, drowsiness, dizziness, vertigo, fatigue, and visual disturbances. Make sure you do not experience any of these side effects before driving, operating machinery, or doing anything requiring attention. This is particularly important when consuming alcohol during treatment with Ibuprofene EG STADA.
Ibuprofene EG STADA contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Talk to your doctor or pharmacist if you need 3 or more sachets per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.

3. How to take Ibuprofene EG STADA

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults and children over 12 years of age (weight > 40 kg):
The recommended dose is 1–3 sachets per day, according to your doctor’s advice. The maximum dose is 3
sachets (1800 mg) per day.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have
an infection, contact your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
Elderly:
If you are elderly, your doctor will decide the most appropriate dose for you, possibly reducing the doses indicated above.
Patients with kidney or liver problems:
If you have kidney or liver problems, your doctor will determine the most appropriate dose for you, possibly reducing the
doses indicated above. If you have severe kidney or liver problems, you must not take this medicine
(see “Do not take Ibuprofene EG STADA”).
Method of administration
Ibuprofene EG STADA is for oral use (taken by mouth). Dissolve the contents of the sachet in
a large glass of water. You may experience some burning sensation in the mouth or throat after taking it.
It is recommended to take Ibuprofene EG STADA with food in patients with gastric sensitivity.
If you are using Ibuprofene EG STADA for rheumatic diseases, take the first dose in the morning upon waking and subsequent doses with meals.
If you take more Ibuprofene EG STADA than you should
If you have taken more Ibuprofene EG STADA than recommended, or if your child has accidentally taken this medicine,
contact a doctor or the nearest hospital immediately for advice on the risk and necessary actions.
Bring the medicine pack and the package leaflet with you.
Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with blood traces), blood in the urine,
diarrhoea, abdominal or chest pain, bleeding in the stomach or intestines, heart problems such as low blood pressure or
changes in heart rate (bradycardia, tachycardia) and circulatory problems, liver or kidney problems, headache, ringing in the ears (tinnitus), confusion and involuntary oscillating eye movements (nystagmus), decreased blood pH (metabolic acidosis), low potassium levels in the blood, weakness and dizziness, fainting, seizures (especially in children), disorientation, excitement, breathing difficulties (including apnea), depression and reduced activity of the central nervous system such as drowsiness, feeling cold (hypothermia), loss of consciousness, deep sleep (lethargy), coma.
If you forget to take Ibuprofene EG STADA
Do not take a double dose to make up for the missed dose.
If you have any doubts 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.
Side effects of medicines such as Ibuprofene EG STADA are more common in elderly people.
Side effects are more likely with higher doses and longer duration of treatment.

Serious side effects
Stop taking Ibuprofene EG STADA and contact your doctor immediately if you experience any of the following:

chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome;
severe stomach problems, burning or abdominal pain due to injury of the stomach or intestinal wall (peptic ulcer), sudden and severe pain in the upper abdomen or stomach area (gastrointestinal perforation). These side effects are uncommon;
vomiting blood (haematemesis) or black stools (melena), bleeding from the stomach or intestines (gastrointestinal haemorrhage). These conditions are common side effects;
allergic reactions, even severe ones, manifesting as more or less sudden appearance of skin lesions, such as widespread or spotted redness (rash, purpura), urticaria, itching, swelling of the face, eyes, lips, angioedema of the throat with possible difficulty in breathing and swallowing. These conditions occur with uncommon frequency. Rarely, a severe, potentially life-threatening allergic reaction may also occur, characterized by increased heart rate and a sudden drop in blood pressure (anaphylactic reaction, anaphylaxis);
flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis]. These conditions occur very rarely;
difficulty breathing (asthma, even severe, bronchospasm or dyspnoea). These conditions are uncommon side effects;
systemic lupus erythematosus (SLE), a disease affecting connective tissue causing joint or muscle pain, skin changes and problems in other organs. This condition occurs rarely;
worsening of infections, such as the onset of necrotizing fasciitis, presenting with fever, chills, weakness, sweating, diarrhoea, vomiting, redness, pain, swelling, bruising in an area of the body due to tissue necrosis (death of tissue cells);
inflammation of the meninges (aseptic meningitis), presenting with: very high fever, sudden headache, inability to flex the neck, nausea, vomiting, confusion, drowsiness, and light sensitivity. This condition occurs rarely;
widespread rash, high body temperature, swollen lymph nodes and increased eosinophils (a type of white blood cells) (DRESS syndrome);
widespread, red, scaly rash with bumps under the skin and blisters (mainly located in skin folds, trunk and upper limbs), accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption). Stop using Ibuprofene EG STADA if you develop these symptoms and contact your doctor immediately. See also section 2.

Other side effects
Tell your doctor if you notice:
Common side effects (may affect up to 1 in 10 people)

nausea, vomiting, diarrhoea, intestinal gas (flatulence), difficulty passing stools (constipation), indigestion (dyspepsia), abdominal pain;
headache, dizziness;
fatigue.

Uncommon side effects (may affect up to 1 in 100 people)

inflammation of the nose (rhinitis);
inflammation of the stomach (gastritis), mouth ulcers;
dizziness, drowsiness, difficulty falling asleep (insomnia), anxiety, changes in sensation (paraesthesia);
impaired hearing, ringing in the ears (tinnitus), vision disturbances;
skin reaction following exposure to sunlight (photosensitivity);
changes in liver function, yellowing of the eyes or skin (jaundice), dark urine, pale stools, itching or abdominal pain, inflammation of the liver (hepatitis);
kidney problems such as nephrotic syndrome, inflammation of the kidney (tubulointerstitial nephritis), changes in function (renal failure).

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

decrease in the number of white blood cells (leucopenia) or certain types of white blood cells (neutropenia, agranulocytosis), decrease in the number of platelets (thrombocytopenia), decrease in red blood cells due to destruction (haemolytic anaemia) or bone marrow problems (aplastic anaemia);
depression, confusion;
vision disturbances, for example due to inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy;
swelling (oedema).

Very rare side effects (may affect up to 1 in 10,000 people)

reduced liver function, inflammation of the pancreas (pancreatitis);
sensation of heart pounding (palpitations), heart attack (myocardial infarction), reduced heart function (heart failure), high blood pressure (hypertension);
breathing problems due to fluid accumulation in the lungs (pulmonary oedema).

Other side effects

pain or burning sensation (pyrosis) in the upper stomach, inflammation of the mouth mucosa with ulcers (ulcerative stomatitis);
worsening of colon inflammation (colitis) or Crohn's disease (frequency not known: frequency cannot be estimated from available data);
worsening of skin infections caused by chickenpox;
stroke;
hallucinations, malaise.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may 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.

5. How to store Ibuprofene EG STADA

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ibuprofene EG STADA contains

The active substance is ibuprofen. Each sachet contains 600 mg of ibuprofen.
The other components are: anhydrous citric acid, sodium lauryl sulfate, povidone, sodium saccharin, anhydrous sodium carbonate, sodium bicarbonate, anhydrous colloidal silica, anhydrous lactose, orange flavour.

Description of the appearance of Ibuprofene EG STADA and contents of the pack
Ibuprofene EG STADA is an effervescent granulate. Each pack contains 30 sachets.
Marketing Authorization Holder
EG S.p.A., Via Pavia 6 – 20136 Milan
Manufacturer
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo 1, 03012 Anagni (FR), Italy