SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Resprin Suppositories 150mg (Aspirin Suppositories 150mg)

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each suppository contains Acetylsalicylic acid (Aspirin) Ph.Eur. 150mg in combination with Hard Fat Ph.Eur. (suppository base).

3    PHARMACEUTICAL FORM

Uniform white suppositories

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Mild to moderate pain including headache, neuralgia and sore throat; pyrexia as in colds and influenza; pain and inflammation in rheumatic disease, arthritis, sciatica.

4.2 Posology and method of administration

Remove from plastic mould and insert rectally.

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.

Do not give to children aged under 16 years, unless specifically indicated (e.g. for Kawasaki’s Disease).

Children (under 16 years):

Not recommend except under medical supervision for use for example in juvenile rheumatoid arthritis.

4.3    Contra-indications

A history of, or active peptic ulceration Haemophilia or other clotting disorders Gout

Patients who have shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non steroidal antiinflammatory drugs.

4.4    Special warnings and precautions for use

If symptoms persist consult your doctor. Prolonged use without medical supervision could be harmful.

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. For this reason, Aspirin should not be given to children aged under 16 years unless specifically indicated (e.g. for Kawasaki’s Disease).

Aspirin Suppositories should be used with caution in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency and a history of gastrointestinal bleeding.

4.5    Interactions with other medicaments and other forms of interaction

Aspirin may enhance the activity of anticoagulants (e.g. warfarin).

High doses of Aspirin diminish the uricosuric action of probenecid.

Aspirin may increase the effect of oral antidiabetic drugs and in large doses may decrease insulin requirements.

Aspirin like the NSAIDS may have additive nephrotoxic effects with tacrolimus and ciclosporin.

Aspirin may diminish the antihypertensive effect of ACE inhibitors and the effect of diuretics.

Plasma salicylate concentrations may be reduced by concurrent use of corticosteroids, and salicylate toxicity may occur following withdrawal of the corticosteroids. The risk of gastrointestinal ulceration and bleeding may be increased when aspirin and corticosteroids are co-administered.

Delayed excretion and increased toxicity of methotrexate may be enhanced by concomitant use of aspirin.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex

vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

4.6 Pregnancy and lactation

There is clinical and epidemiological evidence of the safety of aspirin in pregnancy but it is best avoided at term as it may prolong labour and contribute to maternal and neonatal bleeding. Breast feeding is contraindicated at high doses of aspirin because of the theoretical risk of affecting clotting mechanisms.

4.7 Effects on ability to drive and use machines

None known

4.8 Undesirable effects

Aspirin may precipitate bronchospasm and it can induce attacks of asthma in susceptible individuals. Other hypersensitivity reactions in susceptible individuals may include rashes or other skin reactions, runny nose and swollen face or lips.

4.9 Overdose

Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.

Symptoms:

Common features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases.

A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of four years. In children aged four years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier.

Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopaenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema.

Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.

Management:

Give activated charcoal if an adult presents within one hour of ingestion of more than 250 mg/kg. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.

Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700 mg/L (5.1 mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under ten years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Aspirin has analgesic and anti-pyretic properties similar to those of Paracetamol. It also has anti-inflammatory properties. Aspirin’s mode of action is inhibition of cyclo-oxygenase.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 h before or within 30 min after immediate release aspirin dosing (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.

5.2 Pharmacokinetic properties

Aspirin has anti-pyretic, analgesic and anti-inflammatory properties. After absorption, aspirin is rapidly converted to salicylate. Both aspirin and salicylate have pharmacological activity; only aspirin has an anti-platelet effect. Aspirin and salicylate are extensively bound to plasma proteins and are rapidly distributed to all body parts. Salicylate is mainly eliminated by hepatic metabolism. Salicylate is also excreted unchanged in the urine.

5.3    Preclinical safety data

Aspirin is a well established drug substance whose preclinical profile has been investigated thoroughly and is established.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Hard Fat Ph.Eur. suppository base.

6.2    Incompatibilities

Not applicable.

6.3 Shelf life

Three years from date of manufacture.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Suppositories are presented in strips of five peel-apart, plastilaminate moulds. The plastilaminate consists of a contact layer of polyethylene, an outer layer of polyvinylchloride and polyurethane adhesive layer.

6.6 Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Ricesteele Manufacturing Ltd.,

Cookstown Industrial Estate Tallaght,

Dublin 24 Ireland

8    MARKETING AUTHORISATION NUMBER(S)

PL 01648/0005

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

21/09/1989 / 12/08/2004

10 DATE OF REVISION OF THE TEXT

01/11/2011