RESPRIN

Dosage Over 16 years, adults and the elderly: 3-4 suppositories every 4 hours. Not more than 24 suppositories to be used in any 24 hours. g. for Kawasaki’s Disease).

Children (under 16 years):

Not recommend except under medical supervision for use for example in juvenile rheumatoid arthritis. Method of Administration Remove from plastic mould and insert rectally.

Side effects are grouped on the basis of System Organ Class. Within each system organ class the frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data) Blood and lymphatic system disorders Common: Increased bleeding tendencies.

Rare:

Thrombocytopenia, agranulocytosis, aplastic anaemia.

Not known:

Cases of bleeding with prolonged bleeding time such as epistaxis, gingival bleeding. Symptoms may persist for a period of 4–8 days after acetylsalicylic acid discontinuation. As a result there may be an increased risk of bleeding during surgical procedures.

Existing (haematemesis, melaena) or occult gastrointestinal bleeding, which may lead to iron deficiency anaemia (more common at higher doses). Anaemia, haemolytic anaemia, hypoprothrombinaemia, pancytopenia, occult blood loss, elevated transaminase levels Immune system disorders Rare: Hypersensitivity reactions, angio-oedema, allergic oedema, anaphylactic reactions including shock.

Metabolism and digestive system disorders Not known:

Hyperuricemia.

Nervous system disorders Rare:

Intracranial haemorrhage Not known: Headache, vertigo.

Ear and labyrinth disorders Not known:

Reduced hearing ability; tinnitus.

Vascular disorders Rare:

Haemorrhagic vasculitis.

Respiratory, thoracic and mediastinal disorders Uncommon:

Rhinitis, dyspnoea.

Rare:

Bronchospasm, asthma attacks.

Reproductive system and mammary disorders Rare:

Menorrhagia Gastrointestinal disorders Common: Dyspepsia.

Rare:

Severe gastrointestinal haemorrhage, nausea, vomiting.

Not known:

Gastric or duodenal ulcers and perforation which can occasionally be major (may develop bloody or black tarry stools, severe stomach pain and vomiting blood), gastrointestinal irritation (mild stomach pain), erosions, heartburn, Fatalities have occurred.

Hepatobiliary disorders Not known:

Hepatic insufficiency, hepatitis (particularly in patients with SLE or connective tissue disease) Skin and subcutaneous tissue disorders Uncommon: Urticaria.

Rare:

Steven-Johnsons syndrome, Lyells syndrome, purpura,erythema nodosum, erythema multiforme.

Renal and urinary tract disorders Not known:

Impaired renal function Body as a whole – general disorders Not known: Salicylism – (mild chronic salicylate intoxication may occur after repeated administration of large doses, symptoms include dizziness, tinnitus, deafness, sweating, nausea, vomiting, headache and mental confusion, and may be controlled by reducing the dose) Children Aspirin may be associated with the development of Reye’s Syndrome (encephalopathy and hepatic failure) in children presenting with an acute febrile illness.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

There is a possible association between Aspirin and Reye’s Syndrome when given to children. Reye’s Syndrome is a very rare disease, which affects the brain and liver, and can be fatal. g Kawasaki’s Syndrome Aspirin Suppositories should be used with caution in patients with: • Acetylsalicylic acid may promote bronchospasm and asthma attacks or other hypersensitivity reactions.

Risk factors are existing asthma, hay fever, nasal polyps or chronic respiratory diseases. g. with skin reactions, itching or urticaria). • Anaemia (may be exacerbated by gastrointestinal blood loss) • Cardiac failure (conditions which predispose to fluid retention) • Dehydration • Glucose-6-phosphate dehydrogenase deficiency (aspirin rarely causes haemolytic anaemia) • Gout (serum urate may be increased) • Acetylsalicylic acid should be used with caution in patients with moderately impaired renal or hepatic function (contraindicated if severe), or in patients who are dehydrated since the use of NSAIDs may result in deterioration of renal function.

Liver function tests should be performed regularly in patients presenting slight or moderate hepatic insufficiency. g. tooth extraction). Use with caution before surgery, including tooth extraction. Temporary discontinuation of treatment may be necessary.

2). Where prolonged therapy is required, patients should be reviewed regularly. • Before commencing long-term aspirin therapy for the management of cardiovascular or cerebrovascular disease patients should consult their doctor who can advise on the relative benefits versus the risks for the individual patient.

5). • Acetylsalicylic acid is not recommended during menorrhagia where it may increase menstrual bleeding. • Acetylsalicylic acid is to be used with caution in cases of hypertension and when patients have a past history of gastric or duodenal ulcer or haemorrhagic episodes or are undergoing therapy with anticoagulants.

• Patients should report any unusual bleeding symptoms to their physician. If gastrointestinal bleeding or ulceration occurs the treatment should be withdrawn. 8). Acetylsalicylic acid should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

e. 5). If the combination cannot be avoided, close observation for signs of bleeding is recommended. 5). • Acetylsalicylic acid in low doses reduces uric acid excretion. 5). 5).

• Known hypersensitivity to aspirin, other ingredients in the product, other salicylates or non-steroidal anti-inflammatory drugs (a patient may have developed anaphylaxis, angioedema, asthma, rhinitis or urticaria induced by aspirin or other NSAIDs).

• Nasal polyps associated with asthma (high risk of severe sensitivity reactions). • Active peptic ulceration or a past history of ulceration or dyspepsia. • Haemophilia or other haemorrhagic disorder (including thrombocytopenia) as there is an increased risk of bleeding.

• Concurrent anticoagulant therapy should be avoided. 5). g. Kawasaki's disease).