Name
IBUPROFENE ZENTIVA ITALIA 200 mg film-coated tablets
Ibuprofen
Equivalent medicine


What it is and what it is used for
IBUPROFENE ZENTIVA ITALIA 200 mg contains ibuprofen, a medicine that belongs to a class of medicines called NSAIDs (non-steroidal anti-inflammatory drugs) which work by reducing pain, inflammation and fever.

IBUPROFENE ZENTIVA ITALIA 200 mg is used in adults, adolescents and children aged 6 years and over to provide relief in the case of:
- mild to moderate pain (such as headache, including migraine, toothache, and fever).
IBUPROFENE ZENTIVA ITALIA 200 mg is used in adults and adolescents from 12 years of age to provide relief in case of:
- menstrual cramps (primary dysmenorrhea).

Talk to your doctor if you do not feel better or if you feel worse after 3 days (in children and adolescents) or after 7 days (in adults).


What you need to know before taking the medicine
Do not take IBUPROFENE ZENTIVA ITALIA 200 mg
- if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6). If you are allergic to other non-steroidal anti-inflammatory drugs;
- if you have suffered from allergic reactions such as asthma, runny nose (rhinitis), itchy skin rashes (hives) or swelling of the lips, face, tongue or throat (angioedema) after taking medicines containing acetylsalicylic acid or other painkillers or anti-inflammatory medicines (NSAIDs);
- if you have suffered from a lesion (ulcer) or bleeding in the stomach or intestine in relation to previous use of painkillers or anti-inflammatory medicines (NSAIDs);
- if you suffer from a lesion (ulcer) or bleeding in the stomach or intestine or have suffered from two or more episodes of this type in the past;
- if you suffer or have suffered from ulcerative colitis, Crohn's disease, peptic ulcer or recurrent gastrointestinal bleeding (defined as two or more distinct episodes of confirmed ulceration or haemorrhage);
- if you suffer or have suffered from congenital porphyrin metabolite disorder (e.g. acute intermittent porphyria);
- chronic alcoholism (14 to 20 drinks/week or more);
- if you suffer from severe liver problems (liver failure), kidney problems (renal failure) or heart problems (cardiac failure) or an alteration of the coronary arteries, the vessels that carry blood to the heart (coronary heart disease);
- if you are in the last three months of pregnancy or are breast-feeding (see section "Pregnancy, breast-feeding and fertility");
- if you suffer from a large loss of fluid from the body (dehydration) caused by vomiting, diarrhoea or insufficient fluid consumption;
- if you have active bleeding (including in the brain);
- if you suffer from a disease of unknown origin that causes abnormal formation of blood cells (dyshematopoiesis);
- if he is under 6 years old.


Warnings and precautions
Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with treatment with IBUPROFENE ZENTIVA ITALIA. Stop using IBUPROFENE ZENTIVA ITALIA and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

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

Anti-inflammatory/pain-relieving drugs such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose or duration of treatment.
Talk to your doctor or pharmacist before taking IBUPROFENE ZENTIVA ITALIA 200 mg if:
- have heart problems including heart attack, angina (chest pain) or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including 'mini-stroke' or 'TIA', transient ischaemic attack);
- have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker;
- suffers from congestive heart failure;
- have an autoimmune disease called systemic lupus erythematosus (SLE) or other diseases that affect the immune system; - have an inherited disorder of haemoglobin, a substance that carries oxygen in the blood (acute intermittent porphyria);
- is significantly dehydrated (caused by vomiting, diarrhea, or insufficient fluid intake);
- suffer from chronic inflammatory bowel diseases such as inflammation of the intestine with ulcers (ulcerative colitis), inflammation of the digestive tract (Crohn's disease) or other diseases of the stomach and intestines;
- have suffered from an ulcer (ulcer) of the stomach or intestine, especially if it was complicated by perforation or accompanied by bleeding. Report to your doctor immediately any unusual symptoms of the stomach or intestine (especially bleeding or ulceration) especially if these symptoms occur at the beginning of treatment. These symptoms are more likely to occur if you are elderly. See section "Possible side effects";
- suffer from disorders of blood cell formation (haematopoiesis disorder);
- suffers from problems related to the normal blood clotting mechanism;
- suffer from allergies, a disease affecting the mucous membranes of the nose (hay fever), asthma, chronic swelling of the nasal passages (adenoids) or chronic obstructive airway diseases (asthma);
- have liver, kidney, heart problems or high blood pressure (especially if you are elderly);
- recently underwent surgery;
- is in the first six months of pregnancy;
- is breastfeeding;
- have blurred vision or other eye symptoms, skin rash, weight gain or fluid retention (edema);
- have an infection – see section “Infections” below.

Respiratory disorders
Special precautions should be taken in asthmatic patients or those with a previous history of asthma, bronchial disease, chronic rhinitis or respiratory disease, since ibuprofen may trigger bronchospasm, urticaria or angioedema in these patients.

Allergic reactions
Severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed rarely. At the first signs of a hypersensitivity reaction after taking Ibuprofen Zentiva Italia, therapy should be discontinued. Medically necessary measures, depending on the symptoms, should be initiated by specialist personnel. Caution is required in patients who have suffered from allergic reactions or hypersensitivity to other substances, as they may have an increased risk of drug reactions, hypersensitivity to ibuprofen. Caution is required in patients suffering from hay fever, nasal polyps or chronic obstructive respiratory tract infections as the risk of allergic reactions increases. These may occur in asthma attacks (so-called analgesic asthma), Quincke's edema or urticaria.

Heart, kidney or liver problems
Precautions should be taken in patients with renal, hepatic or cardiac insufficiency, as the use of NSAIDs may deteriorate renal function. Habitual concomitant ingestion of several painkillers further increases this risk. In these patients the dose should be as low as possible and for the shortest period of time (see section "Do not take Ibuprofen Zentiva Italia").

Effects on the kidneys
At the beginning of treatment, ibuprofen, like other NSAIDs, should be administered with caution. in patients with significant dehydration (there is a risk of renal failure especially in dehydrated children, adolescents and the elderly). As with other NSAIDs, prolonged administration of ibuprofen has caused renal papillary necrosis and other pathological renal changes. Cases of renal toxicity in patients in whom prostaglandins have a compensatory function maintenance of renal perfusion. In these patients, administration of NSAIDs may cause a dose-dependent decrease in prostaglandin formation and, secondarily, renal blood flow, which may precipitate overt renal decompensation. Most patients at risk for this reaction are those with renal dysfunction, heart failure, liver disease, those taking diuretics and ACE inhibitors and elderly patients.
Discontinuation of NSAID therapy is generally followed by recovery to the pre-treatment state.

Aseptic meningitis
On rare occasions, aseptic meningitis has been observed in patients receiving ibuprofen. Although it is more likely to occur in patients with systemic lupus erythematosus and connective tissue diseases, cases of aseptic meningitis have been reported in patients without underlying chronic conditions.

Hematological effects
Ibuprofen, like other NSAIDs, may inhibit platelet aggregation and prolong bleeding time in normal patients.

Exceptionally, chickenpox can cause serious complications, severe skin or soft tissue infections. To date, a role of NSAIDs in worsening these infections cannot be ruled out. Therefore, it is recommended to avoid the use of Ibuprofen Zentiva Italia in case of chickenpox.

Elderly population
Elderly patients have a higher frequency of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which may be fatal.

Gastrointestinal bleeding, ulceration and perforation:
Ibuprofen should be administered with caution to patients with a history of peptic ulcer or other gastrointestinal disease as these conditions may be exacerbated. Cases of life-threatening gastrointestinal bleeding, ulceration and perforation have been reported with all NSAIDs at various stages of treatment, with or without warning symptoms or a history of serious gastrointestinal events. The risk of bleeding, ulceration or perforation is greater with higher doses of ibuprofen, in patients with a history of peptic ulcer, particularly if associated with bleeding or perforation, and in the elderly. In these patients, treatment should be initiated at the lowest effective dose. Concomitant administration of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered in these patients, as well as in those who need to take concomitant low-dose aspirin, or other drugs likely to increase gastrointestinal risk. Precaution should be taken in patients who need to take concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (such as warfarin), selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid. If gastrointestinal bleeding or ulceration occurs in patients receiving Ibuprofene Zentiva Italia, the treatment should be withdrawn. Concomitant administration of Ibuprofene Zentiva Italia with other NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the increased risk of ulceration or bleeding. Patients with a history of gastrointestinal disease, particularly the elderly, should report unusual abdominal symptoms (especially gastrointestinal bleeding) in the early stages of treatment.

Infections
Ibuprofene Zentiva Italia may hide the symptoms of infections such as fever and pain. It is therefore possible that Ibuprofene Zentiva Italia may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or get worse, contact your doctor immediately.

Medicines such as IBUPROFENE ZENTIVA ITALIA 200 mg may be associated with a small increased risk of blood clot formation (arteriovenous thrombotic events) such as heart attack ("myocardial infarction") or stroke (loss of blood flow to the brain): this risk is more likely with high doses and prolonged treatment.
Ibuprofen may temporarily increase the tendency to bleed.

Skin reactions
Serious skin reactions have been reported in association with treatment with IBUPROFENE ZENTIVA ITALIA. Stop taking IBUPROFENE ZENTIVA ITALIA and consult your doctor immediately if you experience a skin 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.

Children and Adolescents
In dehydrated children and adolescents there is a risk of impaired renal function.


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

Infections and infestations
Exacerbations of inflammation related to skin infections (e.g. development of necrotizing fasciitis) coinciding with the use of NSAIDs. If signs of infection occur or worsen during the use of ibuprofen, the patient should be advised to consult a doctor immediately.

Skin and subcutaneous tissue disorders
In exceptional cases, serious skin infections and soft tissue complications may occur during chickenpox infection (see also infections and infestations).

Cardiovascular and cerebrovascular effects
Clinical trials suggest that administration of ibuprofen, particularly at high doses (2400 mg daily) and in long-term treatment, may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see "Warnings and precautions").

Gastrointestinal diseases
The most frequently observed adverse reactions are gastrointestinal in nature. Nausea, dyspepsia, vomiting, haematemesis, flatulence, abdominal pain, diarrhoea, constipation, melaena, aphthous stomatitis, gastrointestinal bleeding, exacerbation of colitis and Crohn's disease have been reported following the administration of these medicinal products. Less frequently, cases of gastritis, duodenal and gastric ulcer and gastrointestinal perforation have been observed.

Side effects are more likely to occur with higher doses and longer duration of treatment. Side effects are listed below according to how often they occur.

The following side effects are important and require immediate attention if they occur.
STOP taking IBUPROFENE ZENTIVA ITALIA 200 mg and consult your doctor immediately if you notice any of the following symptoms:

Very common (affects more than 1 in 10 people) : • digestive tract disorders, such as heartburn (pyrosis), difficult digestion (dyspepsia), abdominal pain, nausea, vomiting, excessive production of gas in the stomach (flatulence), diarrhoea, constipation.

Common (affects 1 to 10 people in 100) :
• intestinal inflammation and worsening of inflammation of the colon, part of the intestine (colitis) and digestive tract (Crohn's disease)
• complication of diverticula, small pockets that form in the terminal part of the intestine (perforation or fistula)
• lesions of the stomach and intestines (gastrointestinal ulcers), sometimes with loss of blood, which may cause anaemia (reduction of haemoglobin in the blood, a substance that carries oxygen in the blood), melaena (black stools), haematemesis (presence of blood in the vomit), ulcerative stomatitis (inflammation of the mucosa of the mouth), colitis. Generally these effects increase with increasing the dose of ibuprofen or if you are taking certain other medicines (See section "Other medicines and IBUPROFENE ZENTIVA ITALIA 200 mg"). Elderly people are more prone to bleeding and perforation of the digestive tract. These effects can also be fatal.
• heachache
• drowsiness
• dizziness
• dizziness
• fatigue
• agitation
• insomnia
• irritability.

Uncommon (affects 1 to 10 people in 1000) :
• inflammation of the stomach (gastritis)
• kidney problems (nephrotic syndrome), development of edema (swelling due to fluid accumulation), swelling of the legs, inflammation of the kidneys (interstitial nephritis), reduction in kidney function (renal failure)
• increased sensitivity of the skin to the sun (photosensitivity)
• vision disorders
• insomnia
• anxiety
• paresthesia
• hearing impairment
• profuse secretion from the nasal passages (rhinitis)
• difficulty breathing (bronchospasm)
• allergic reactions, such as skin rashes (exanthema and urticaria), itching, redness of the skin due to broken capillaries (purpura), asthma attacks sometimes accompanied by low blood pressure (hypotension)

Rare (affects 1 to 10 people in 10,000) : • depression
• state of confusion
• hallucinations (perception of things that do not exist in reality)
• optic neuritis
• toxic optic neuropathy
• SLE, systemic lupus erythematosus (disease affecting the immune system)
• lazy eye (toxic amblyopia) increased blood urea nitrogen (a substance present in the blood, the increase of which may indicate a kidney or liver disorder)
• increased levels of liver enzymes (substances present in the blood, the increase of which may indicate a liver disorder)
• decrease in hemoglobin (a substance that carries oxygen in the blood)
• decreased hematocrit (volume of blood occupied by red blood cells, a type of blood cell)
• reduction of the aggregation activity of platelets (cells present in the blood, involved in the coagulation process) and prolongation of bleeding time
• decrease in calcium in the blood

Very rare (affects less than 1 in 10,000 people) :
• perception of heartbeat (palpitations)
• reduced ability of the heart to pump blood around the body (heart failure)
• heart attack (myocardial infarction)
• fluid build-up in the lungs (acute pulmonary edema)
• swelling due to fluid accumulation (edema)
• kidney disease (papillary necrosis)
• high blood pressure (hypertension)
• disorders of red blood cell formation (with symptoms such as: fever, sore throat, lesions on the surface of the mouth, flu-like symptoms, severe tiredness, nose and skin bleeding)
• noises in the ear (tinnitus)
• esophagitis (inflammation of the esophagus, the tube that carries food to the stomach), pancreatitis (inflammation of the pancreas (gland that has the function of digesting certain substances and regulating blood sugar levels))
• narrowing of the intestine (intestinal stenosis)
• acute inflammation of the liver (acute hepatitis)
• yellowing of the skin or whites of the eyes (jaundice)
• liver dysfunction or failure (reduced liver function)
• liver damage
• pancreatitis
• aseptic meningitis (inflammation without infection of the meninges which are membranes that cover the brain)
• Non-raised, target-shaped or circular reddish patches on the trunk, often with central blisters, skin peeling, 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)
• severe hypersensitivity reactions with swelling of the face, tongue, throat, narrowing of the airways, difficulty breathing (dyspnoea), increased heart rate (tachycardia), reduction in blood pressure up to life-threatening shock
• kidney damage. This effect occurs in particular if you/the child have previously suffered from kidney, heart or liver problems, if you are taking diuretic medicines or ACE inhibitors (See section "Other medicines and IBUPROFENE ZENTIVA ITALIA 200 mg") or if you are elderly. This effect usually disappears when the therapy is stopped.
• hair loss (alopecia)
• reduction in the number of: red blood cells (anaemia), white blood cells (leukopenia), platelets (thrombocytopenia), all blood cells (pancytopenia). These conditions may cause fever, sore throat, ulcers on the surface of the mouth, flu-like symptoms, severe tiredness, nosebleeds and skin bleeding

Not known (frequency cannot be estimated from the available data):
• A widespread, red, scaly rash with pustules under the skin and blisters mainly located in the skin folds, trunk and upper limbs accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using IBUPROFENE ZENTIVA ITALIA if you develop these symptoms and contact your doctor immediately. See also section 2.
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome. A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.