EASOFEN MAX STRENGTH

The list of the following adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

Gastrointestinal Disorders	Uncommon:	Abdominal pain, dyspepsia and nausea.
	Rare:	Diarrhoea, flatulence, constipation and vomiting.
	Very rare:	Peptic ulcer, perforation or gastrointestinal haemorrhage, sometimes fatal, particularly in the elderly (see section 4.4). Melaena, haematemesis, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease (see section 4.4). Less frequently, gastritis has been observed.
Nervous System	Uncommon:	Headache, dizziness, hearing disturbance.
Renal	Very rare:	Decrease of urea excretion and oedema can occur. Also, acute renal failure. Papillary necrosis, especially in long-term use, and increased serum urea concentrations have been reported.
Hepatobiliary Disorders	Very rare:	Liver disorders, especially in long-term treatment.
Blood and Lymphatic system Disorders	Very rare:	Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding.
Skin and Subcutaneous Disorders	Very rare:	Severe forms of skin reactions such as erythema, erythema multiforme, epidermal necrolysis, bullous reactions, Stevens-Johnson Syndrome, maculopapular rash and exfoliative dermatitis can occur.
Immune System	Very rare:	In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed (see section 4.4).
Hypersensitivity Reactions	Uncommon:	Hypersensitivity reactions with urticaria and pruritus.
	Very rare:	Severe hypersensitivity reactions. Symptoms could be: facial, tongue and larynx swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock). Exacerbation of asthma and bronchospasm.
Cardiac Disorders	Very rare:	Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment at high doses.

Post-marketing surveillance

Clinical studies suggest that the use of ibuprofen (particularly at high doses 2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie;e-mail: medsafety@hpra.ie.

The list of the following adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

Gastrointestinal Disorders	Uncommon:	Abdominal pain, dyspepsia and nausea.
	Rare:	Diarrhoea, flatulence, constipation and vomiting.
	Very rare:	Peptic ulcer, perforation or gastrointestinal haemorrhage, sometimes fatal, particularly in the elderly (see section 4.4). Melaena, haematemesis, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease (see section 4.4). Less frequently, gastritis has been observed.
Nervous System	Uncommon:	Headache, dizziness, hearing disturbance.
Renal	Very rare:	Decrease of urea excretion and oedema can occur. Also, acute renal failure. Papillary necrosis, especially in long-term use, and increased serum urea concentrations have been reported.
Hepatobiliary Disorders	Very rare:	Liver disorders, especially in long-term treatment.
Blood and Lymphatic system Disorders	Very rare:	Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding.
Skin and Subcutaneous Disorders	Very rare:	Severe forms of skin reactions such as erythema, erythema multiforme, toxic epidermal necrolysis, bullous reactions, Stevens-Johnson Syndrome, maculopapular rash and exfoliative dermatitis can occur.
Immune System	Very rare:	In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed (see section 4.4).
Hypersensitivity Reactions	Uncommon:	Hypersensitivity reactions with urticaria and pruritus.
	Very rare:	Severe hypersensitivity reactions. Symptoms could be: facial, tongue and larynx swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock). Exacerbation of asthma and bronchospasm.
Cardiac Disorders	Very rare:	Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment at high doses.
Infections and infestations	Very rare:	Exacerbation of infection related inflammation (e.g. development of necrotizing fasciitis), in exceptional cases, severe skin infections and soft-tissue complications may occur during a varicella infection.

Post-marketing surveillance

Clinical studies suggest that the use of ibuprofen (particularly at high doses 2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.