ANADIN ORIGINAL

Adults, the elderly and young persons aged 16 and over:

One to two film-coated tablets (325 mg to 650 mg acetylsalicylic acid + 15 mg to 30 mg caffeine) every four to six hours as required. Do not exceed 12 tablets in 24 hours. g. Kawasaki’s disease). The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment.

For migraine indication: use of this medicine is not recommended for children and adolescents under 18 years of age.

MedDRA SOC Adverse Reaction Frequency Adverse events are more likely to occur with increasing dose and duration of use. The following convention has been utilised for the classification of the frequency of adverse reactions: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Adverse reactions from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labeled dose and considered attributable are tabulated below by MedDRA System Organ Class.

As these reactions are reported voluntarily from a population of uncertain size, the frequency of these reactions is not known but likely to be rare or very rare (<1/1000). Acetylsalicylic acid Caffeine MedDRA SOC Adverse Reaction Frequency Central Nervous System Nervousness Not known Dizziness Not known Cardiac disorders Palpitation Not known Gastrointestinal disorders Nausea, vomiting, dyspepsia.

Gastrointestinal ulceration, gastrointestinal haemorrhage and gastritis. Not known Renal and urinary disorders Renal dysfunction, increased blood uric acid levels. Not known Hepatobiliary disorders Reye’s syndrome. (see Warnings and Precautions) Elevation in aminotransferase levels.

Not known Blood and lymphatic system disorders Prolonged bleeding time. Thrombocytopenia. Ecchymosis Not known Metabolism and Nutrition disorders Sodium and fluid retention. g. rhinitis, angioedema, urticaria, bronchospasm, skin reactions and anaphylaxis.

Not known Ear and labyrinth disorders Tinnitus, temporary hearing loss. Not known Psychiatric disorders Insomnia, restlessness, anxiety and irritability, nervousness Not known Gastrointestinal disorders Gastrointestinal disturbances Not known When the recommended acetylsalicylic acid-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects.

Serious hypersensitivity reactions or anaphylaxis can occur, bronchospasm may be precipitated in patients suffering from or with a previous history of asthma, allergic disease or nasal polyps. Acetylsalicylic acid is known to cause sodium and water retention which may exacerbate hypertension, congestive heart failure and renal impairment.

Caution should be exercised in patients with uncontrolled hypertension (in whom target blood pressure has not been achieved), impairment of hepatic or renal function (avoid if severe), dehydration or diabetes mellitus. Haematological and haemorrhagic effects can occur and may be severe.

Patients should report any unusual bleeding symptoms to their physician. Doses more than 1 g acetylsalicylic acid daily may precipitate acute haemolytic anaemia in patients with G6PDH deficiency. Gastrointestinal (GI) bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs and may occur at any time during treatment, with or without warning symptoms or a previous history of serious GI events.

These effects generally have more serious consequences in the elderly (see Interactions). Do not exceed the stated dose. If symptoms persist for more than 3 days consult your doctor. There is a possible association between aspirin and Reye’s syndrome when given to children, especially during or immediately after a viral illness.

Reye’s syndrome is a very rare disease, which affects the brain and liver and can be fatal. g. Kawasaki’s disease). Should be used with particular caution in elderly patients who are more prone to adverse events. The concomitant use of acetylsalicylic acid with other systemic NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the potential for additive undesirable effects (see Interactions).

g. coffee, tea and some canned drinks) should be avoided while taking this product.

Hypersensitivity to the active ingredients or any of the other constituents. - Patients in whom asthma, bronchospasm, angioedema, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or non-steroidal anti- inflammatory drugs (NSAIDs).

- History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy. - Peptic ulceration and those with a history of peptic ulceration; - A history of haemophilia, concurrent anti-coagulant therapy, hypothrombinaemia or other clotting disorders.

73m2) - Hepatic failure - A history of gout - Children under 16 years and - When breast feeding because of possible risk of Reyes Syndrome.