sanofi-aventis

Update SPC in line with the latest guidance on the Minimum Clinical Particulars for NSAIDs

Section 4.3

Following information added;

• NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.
• Active or history of recurrent peptic ulcer/hemorrage (two or more distinct episodes of proven ulceration or bleeding).
• hepatic failure and renal failure

Section 4.4

Additional information added with regard to caution in elderly patients;

as they have an increased frequency of adverse reactions to NSAIDs

Section 4.5

No information information added - paragraphs given titles concerning the drug classes

Section 4.6

Following information added;

• Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern
• Surgam should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus.
• use in the last trimester of pregnancy is contraindicated.
• The onset of labour may be delayed
  and the duration increased with an increased bleeding tendency in both mother and child (see section 4.3).

Section 4.7

Following information added;
Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.

Section 4.8

Following side effects added;

• melaena
• haematemesis
• Pancreatitis has been reported very rarely.
• Hypersensitivity reactions have been reported following treatment with NSAIDs
• Nervous disorders: reports of aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting,
  fever or disorientation (See section 4.4)

Section 4.9

Following information added;

a) Symptoms
Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage are possible.

b) Therapeutic measure
Patients should be treated symptomatically as required.
Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.
Good urine output should be ensured.
Renal and liver function should be closely monitored.
Patients should be observed for at least four hours after ingestion of potentially toxic amounts.
Frequent or prolonged convulsions should be treated with intravenous diazepam.
Other measures may be indicated by the patient's clinical condition.

'Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.'

Section 4.3 (Contraindications): Severe Heart failure is now contraindicated.

Section 4.4 (Special warnings and precautions for use): The following section added:

             ' Undesirable effects may be minimised by using the lowest effective dose for the shortest duration         
               necessary to control symptoms.

 Cardiovascular and cerebrovascular effects         

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

 Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for tiaprofenic acid.

 Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with tiaprofenic acid after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).'

 Section 4.8 (Undesirable effects): The following information has been added:

                 'Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.

 Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke)'

 Section 7 (Marketing Authorisation Holder): Change in MA Holder's details