IBUPROFEN PENSA*12TAB 400MG

IBUPROFENE PENSAVITAL 400 mg film-coated tablets
Ibuprofen

What it is and what it is used for
IBUPROFENE PENSAVITAL belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs) which act by reducing pain, inflammation and fever.

IBUPROFENE PENSAVITAL 400 mg is used for the symptomatic treatment of mild to moderate pain such as headache, dental pain, menstrual pain and fever (less than 3 days).

What you need to know before taking the medicine
Do not take IBUPROFENE PENSAVITAL if:
- you are allergic to ibuprofen or any other ingredient of this medicine (listed in paragraph 6). Symptoms of an allergic reaction may include swelling of the eyelids, lips, tongue or throat
- you have ever had an allergic reaction (such as bronchospasm (stiffening of the lung muscles which can cause asthma and shortness of breath), asthma attacks, runny nose, swelling of the airways, skin reactions or sudden swelling) after taking acetylsalicylic acid or other similar painkillers (NSAIDs) or suffer from blood formation disorders of unknown nature
- you have recurring stomach/duodenal ulcers (peptic ulcers) or bleeding (at least 2 different confirmed episodes of ulcers or bleeding), have a history of gastrointestinal haemorrhage or perforation associated with previous NSAID treatment, or suffer from any active bleeding (including cerebral bleeding)
- you suffer from severe impairment of the liver, kidneys or heart
- you have severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)
- you suffer from chronic alcoholism (14 to 20 drinks/week or more)
- you are a child under 12 years of age or an adolescent weighing less than 40 kg
- you are in the last three months of pregnancy

Warnings and precautions
Talk to your doctor or pharmacist before taking IBUPROFENE PENSAVITAL.

Undesirable effects can be minimised by using the lowest effective dose to control symptoms for the shortest possible treatment period.

You should discuss the treatment with your doctor or pharmacist before taking IBUPROFENE PENSAVITAL if:
- you suffer from systemic lupus erythematosus (SLE, sometimes known as lupus) or connective tissue disease (an autoimmune disease that affects connective tissue), have or have had gastrointestinal diseases (such as ulcerative colitis, Crohn's disease) as your condition may worsen
- you suffer from certain hereditary blood formation diseases (e.g. acute intermittent porphyria)
- you have reduced liver and kidney function
- you have recently undergone major surgery
- you suffer from hay fever, nasal polyps or chronic obstructive respiratory disease, because there is an increased risk of allergic reactions. Allergic reactions can present as asthma attacks (so-called analgesic asthma), Quincke's oedema (rapid swelling) or urticaria
- you are dehydrated
- you have an infection - see the Infections section below.

Effects on the gastrointestinal tract
The combined use of IBUPROFENE PENSAVITAL with another non-steroidal anti-inflammatory drug (NSAID), a so-called COX-2 inhibitor (cyclooxygenase-2 inhibitor), should be avoided.

Gastrointestinal bleeding, ulcers and perforations
Gastrointestinal bleeding, ulcers and perforation, sometimes fatal, have been reported with all NSAIDs. These occurred at any time during therapy, with or without previous warning symptoms or a history of serious gastrointestinal events.

The risk of gastrointestinal haemorrhage, ulcers and perforation is greater with increasing NSAID dose and is greater in patients with a history of ulcers, especially with bleeding or perforation complications (see paragraph 2: Do not take IBUPROFENE PENSAVITAL) and in elderly patients. These patients should start treatment at the lowest available dose.
For these patients, as well as for patients requiring additional treatment with low doses of acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal disorders, combination treatment with protective medicines (e.g. misoprostol or proton pump inhibitors) should be considered.

If you have a history of gastrointestinal side effects, especially if you are elderly, you should contact a doctor in case of unusual abdominal symptoms (especially gastrointestinal bleeding), particularly at the start of therapy.

Caution is advised if you are also taking other medicines that may increase the risk of ulcers or bleeding, e.g. oral corticosteroids, anticoagulants (blood thinners) such as warfarin, selective serotonin reuptake inhibitors (used to treat psychiatric disorders including depression) or platelet aggregation inhibitors such as acetylsalicylic acid (see paragraph 2: Other medicines and IBUPROFENE PENSAVITAL).

Treatment should be discontinued and a doctor should be consulted if you develop gastrointestinal bleeding or ulcers during treatment with IBUPROFENE PENSAVITAL. Effects on the cardiovascular system. Anti-inflammatory/pain relief medicines such as ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, especially if used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss the treatment with your doctor or pharmacist before taking IBUPROFENE PENSAVITAL if:
- you have heart problems including heart failure and angina pectoris (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor blood circulation in the legs or feet due to narrowed or blocked arteries) or any type of stroke (including mini-stroke or transient ischemic attack TIA).
- you have high blood pressure, diabetes or high cholesterol, have a family history of heart disease or stroke or if you are a smoker.

Renal effects
Caution should be exercised when initiating treatment with ibuprofen in patients with significant dehydration. There is a risk of renal impairment especially in dehydrated children, adolescents and the elderly.
As with other NSAIDs, long-term administration of ibuprofen has resulted in renal papillary necrosis and other renal pathological changes. Renal toxicity has also been observed in patients in whom renal prostaglandins have a compensatory role in maintaining renal perfusion. In these patients, NSAID administration may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may lead to renal failure. Patients at greater risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pre-treatment state.

Skin reactions
Severe 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 IBUPROFENE PENSAVITAL and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in paragraph 4.

During chickenpox infection, it is advisable to avoid the use of IBUPROFENE PENSAVITAL.

Infections
IBUPROFENE PENSAVITAL can mask signs of infections such as fever and pain. It is therefore possible that IBUPROFENE PENSAVITAL may delay appropriate treatment of the infection, which may lead to an increased 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 infection symptoms persist or worsen, consult a doctor immediately.

Respiratory disorders and hypersensitivity reactions
Very rarely, severe acute hypersensitivity reactions have been observed (e.g. anaphylactic shock).
At the first signs of a hypersensitivity reaction after taking/administering IBUPROFENE PENSAVITAL, treatment should be discontinued and a doctor should be consulted. The necessary medical measures, in line with the symptoms, should be initiated by healthcare personnel.

Haematological effects
Ibuprofen can temporarily inhibit platelet function (platelet aggregation). Patients with blood clotting disorders should therefore be carefully monitored.

During prolonged use of IBUPROFENE PENSAVITAL, regular monitoring of liver function tests, kidney function and full blood count is necessary.

If IBUPROFENE PENSAVITAL is taken before surgical procedures, the doctor or dentist must be consulted/informed.

SLE and mixed connective tissue disease
In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders, there may be an increased risk of aseptic meningitis (see below and paragraph 4.8).

Aseptic meningitis
Aseptic meningitis has been observed on rare occasions in patients receiving ibuprofen therapy. Although it is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic illness.

Patients who report eye disorders during ibuprofen treatment should discontinue therapy and undergo eye examinations.

When using NSAIDs, adverse reactions, particularly those affecting the gastrointestinal tract or the central nervous system, may be increased by concomitant alcohol consumption.

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 IBUPROFENE PENSAVITAL immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.

Elderly
In elderly patients, side effects occur more frequently after the use of non-steroidal anti-inflammatory drugs, particularly gastrointestinal bleeding and perforation, which in some cases can be life-threatening. For this reason, particularly close medical supervision is necessary in elderly patients.

Children and adolescents
There is a risk of renal impairment in dehydrated adolescents.

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

The pattern of adverse events reported for ibuprofen is similar to that for other NSAIDs.

Gastrointestinal disorders: The most commonly observed side effects affect the digestive tract. Gastric/duodenal ulcers (peptic ulcers), perforation or bleeding, sometimes fatal, may occur, especially in elderly patients (see paragraph 2: Warnings and precautions). Nausea, vomiting, diarrhoea, flatulence, constipation, digestive disorders, abdominal pain, tarry stools, vomiting blood, wounds (ulceration) in the mouth and throat area (ulcerative stomatitis), worsening of colitis and Crohn's disease (see paragraph 2: Warnings and precautions) have been reported after use. Less commonly, inflammation of the stomach lining (gastritis) has been observed. In particular, the risk of developing gastrointestinal bleeding depends on the dose level and duration of treatment.

Immune system disorders: Hypersensitivity reactions have been reported following NSAID treatment. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, very rarely, erythema multiforme, bullous dermatosis (including Stevens-Johnson syndrome and toxic epidermal necrolysis).

Infections and infestations: Rhinitis and aseptic meningitis (especially in patients with existing autoimmune diseases, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation (see paragraph 4.4).
An exacerbation of infection-related inflammations coinciding with NSAID use has been described. If signs of an infection appear or worsen during ibuprofen use, the patient is therefore advised to consult a doctor immediately.

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

Cardiac and vascular disorders: Oedema, hypertension and heart failure have been reported in association with NSAID treatment. Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a modest increased risk of arterial thrombotic events such as myocardial infarction or stroke (see paragraph 4.4).

Stop using ibuprofen and consult your doctor immediately if you notice any of the following symptoms:
• 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].
• 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 beginning of treatment (acute generalised exanthematous pustulosis).

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, stomach and intestinal bleeding, vomiting blood)
- Rash
- Fatigue

Uncommon (may affect up to 1 in 100 people):
- Rhinitis
- Hypersensitivity
- Insomnia, anxiety
- Paraesthesia
- Drowsiness
- Visual disturbances, hearing impairment
- Vertigo
- Tinnitus
- Bronchospasm, asthma
- Dyspnoea
- Mouth ulceration
- Stomach ulcer, intestinal ulcer, ruptured gastric ulcer, inflammation of the stomach lining
- Hepatitis, jaundice, abnormal liver function
- Pruritus, small bruises on the skin and mucous membranes
- Photosensitivity
- Nephrotoxicity in various forms e.g. tubulointerstitial nephritis, nephrotic syndrome and renal failure

Rare (may affect up to 1 in 1000 people):
- Non-bacterial meningitis

- Leucopenia
- Thrombocytopenia
- Aplastic anaemia
- Neutropenia
- Agranulocytosis
- Haemolytic anaemia
- Anaphylactic reaction
- Depression, confusion
- Optic neuritis
- Toxic optic neuropathy
- Oedema

Very rare (may affect up to 1 in 10,000 people):
- Heart failure, myocardial infarction
- Hypertension
- Pancreatitis, liver failure
- Severe forms of skin reactions (e.g. erythema multiforme, bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis)

Not known (frequency cannot be estimated from the available data):
- Worsening of large intestine ulcers (colitis) and Crohn's disease (intestinal disease)
- Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)
- Acute generalised exanthematous pustulosis (AGEP)
- Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome

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.