Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Frequencies of undesirable effects are based on the following categories: 
Very common       (≥ 1/10)
Common            (≥ 1/100 - < 1/10)
Uncommon          (≥ 1/1,000 - < 1/100)
Rare              (≥ 1/10,000 - < 1/1,000)
Very rare         (< 1/10,000)
Not known        (frequency cannot be estimated from the available data) 
The following undesirable effects depend mainly on the dose and may vary individually; this has to be taken into account.

The most commonly observed undesirable effects are gastrointestinal in nature. Peptic ulcers, perforation or haemorrhage, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, digestive problems, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4) have been reported following administration.
Less frequently, gastritis has been observed. Especially the risk of gastrointestinal bleeding depends on the dose and the duration of treatment.

Oedema, hypertension and congestive heart failure have been reported in connection with NSAID therapy.

Clinical trials suggest that use of ibuprofen, particularly at high doses (2,400 mg daily) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

Infections and infestations
Very rarely, worsening of infection-related inflammations (e.g. development of necrotizing fasciitis) has been reported simultaneously with systemic use of NSAIDs (including Ibufen 600). This may be connected to the effect mechanism of NSAIDs.

If during the treatment with Ibufen 600 new infection signs occur or worsen, it is recommended that the patient consult a doctor immediately. It has to be verified whether a therapy with anti-infectives/antibiotics is indicated.

Very rarely, symptoms of aseptic meningitis with stiff neck, headache, nausea, vomiting, fever or disorientation have been reported during ibuprofen use. Patients with autoimmune disorders (SLE, mixed connective tissue disease) seem to be at increased risk.

Blood and lymphatic system disorders

Very rare: abnormal blood formation (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis).
Early signs may be: fever, sore throat, superficial lesions in the mouth, flue-like symptoms, strong exhaustion, nosebleed and ecchymosis.

In these cases, the patient should be instructed to immediately withdraw Ibufen 600, to avoid any self-medication using painkillers or fever-reducing medicines and to consult a physician.

In long-term therapy, the blood count should be checked regularly.

Immune system disorders
Uncommon: hypersensitivity reactions with skin rash and itching skin as well as asthma attacks (possibly with drop in blood pressure).

The patient must be instructed to immediately consult a doctor and to stop taking Ibufen 600 in this case.

Very rare: severe general hypersensitivity reactions. They may be expressed as: facial oedema, tongue swelling, internal swelling of the larynx with restriction of the airways, difficulty in breathing, tachycardia, drop in blood pressure and even life-threatening shock.

With any of these signs, which can already appear at first intake of the medication, immediate medical attention is required.

Psychiatric disorders
Very rare: psychotic reactions, depression.

Nervous system disorders
Common: disturbances of the central nervous system such as headache, dizziness, insomnia, excitation, irritability or fatigue.

Eye disorders
Uncommon: visual impairment. In this case, the patient must be instructed to immediately consult a doctor and to stop taking Ibufen 600.

Ear and labyrinth disorders
Rare: tinnitus, hearing loss.

Cardiac disorders
Very rare: palpitations, oedema, cardiac insufficiency, cardiac infarction.
Not known: Kounis syndrome
Vascular disorders
Very rare: arterial hypertension.

Gastrointestinal disorders


Very common: gastrointestinal complaints like heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation and low gastrointestinal blood losses, which may cause anaemia in exceptional cases.
Common: gastrointestinal ulcers, possibly with bleeding and perforation, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4).
Uncommon: gastritis.
Very rare: oesophagitis, pancreatitis.

The patient must be instructed to stop taking the medication and to immediately consult a doctor if strong pain in the upper abdomen occurs or in case of melena or hematemesis.

Very rare: formation of intestinal, diaphragm-like strictures.

Hepatobiliary disorders
Very rare: liver dysfunction, liver damage, especially in long-term therapy, liver failure, acute hepatitis.

In long-term treatment, hepatic parameters should be checked regularly.

Skin and subcutaneous tissue disorders
Very rare: severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens–Johnson syndrome, and toxic epidermal necrolysis, alopecia.
Not known: drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalised exanthematous pustulosis (AGEP), photosensitivity reactions.

There have been exceptional cases of severe skin infections and soft tissue complications during varicella infection (see "Infections and infestations ").

Renal and urinary disorders
Uncommon: formation of oedema, especially in patients with arterial hypertension or renal insufficiency, nephrotic syndrome; interstitial nephritis, which can accompany an acute renal failure.
Very rare: renal tissue lesions (papillary necrosis) and elevated uric acid concentration in the blood.

Renal function should be checked regularly.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il