LODINE SR

4) Adults: One tablet daily. If a lower dose is sufficient, conventional Lodine capsules or tablets may be used. The safety of doses in excess of 600mg per day has not been established. No occurrence of tolerance or tachyphylaxis has been reported.

Elderly:

No change in initial dosage is generally required in the elderly (see precautions). The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration.

The patient should be monitored regularly for GI bleeding during NSAID therapy.

Paediatric population:

Not recommended. Method of administration For oral administration. To be taken preferably with or after food. Swallow the tablet whole with a tumblerful of water.

Oedema, hypertension and cardiac failure, have been reported in association with NSAID treatment. 4). 4) have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.

Hypersensitivity:

Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consists of (a) non-specific allergic reactions 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 more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

4).

Renal:

Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure. 4), depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.

Haematological:

Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.

Dermatological:

Bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (very rare). Photosensitivity.

Skin and subcutaneous tissue disorders:

Acute generalised exanthematous pustulosis (AGEP) (frequency not known). Fixed drug eruption (FDE) (frequency not known).

Immune system disorder:

Anaphylactic reaction (frequency not known). 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.

2, and GI and cardiovascular risks below). 2) 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 Lodine. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with Lodine after careful consideration.

g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

Respiratory disorders:

Caution is required if Lodine is administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients. 3). Caution is required since the use of NSAIDs may result in a dose dependent reduction in prostaglandin formation and precipitate renal failure.

The dose should be kept as low as possible. However, impairment of renal or hepatic functions due to other causes may alter drug metabolism; patients receiving concomitant long term therapy, especially the elderly, should be observed for potential side effects and their drug doses adjusted as needed, or the drug discontinued.

Gastrointestinal bleeding, ulceration and perforation:

Serious gastrointestinal adverse effects such as bleeding, ulceration and perforation, which can be fatal, has been reported and can occur at any time with or without warning symptoms in patients treated with NSAIDs or a previous history of serious GI events.

1. Lodine should not be used in patients with severe heart failure. Lodine should not be used in patients with active or history of recurrent peptic ulceration or a history of peptic ulcer disease (with two or more distinct episodes of proven ulceration or bleeding).

g. asthma, rhinitis angioedema or urticaria) during therapy with ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs. 6) History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.