Angettes 75

1. Name Of The Medicinal Product

Angettes 75

2. Qualitative And Quantitative Composition

Each tablet contains: Aspirin BP 75 mg

3. Pharmaceutical Form

Tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

For the secondary prevention of thrombotic cerebrovascular or cardiovascular disease and following by-pass surgery. The advice of a doctor should be sought before commencing therapy for the first time.

4.2 Posology And Method Of Administration

Adults

The usual dosage, for long-term use, is 75mg - 150mg once daily. In some circumstances a higher dose may be appropriate, especially in short-term, and up to 300mg a day may be used on the advice of a doctor.

Elderly

The risk/benefit ratios in the elderly have not been fully established.

Children

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

4.3 Contraindications

Active or history of peptic ulceration, haemophilia and other bleeding disorders, hypersensitivity to aspirin.

4.4 Special Warnings And Precautions For Use

Aspirin may induce gastro-intestinal haemorrhage, occasionally major. Patients with hypertension should be carefully monitored.

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).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Aspirin may enhance the effects of anticoagulants and may inhibit the action of uricosurics.

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 safety in human pregnancy. Aspirin may prolong labour and contribute to maternal and neonatal bleeding, and should be avoided at term.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Aspirin may enhance the effects of anticoagulants and may inhibit the action of uricosurics. Aspirin may precipitate bronchospasm and may induce attacks of asthma in susceptible subjects. Hypersensitivity reactions have been reported in susceptible individuals.

4.9 Overdose

Overdosage is unlikely due to the low level of aspirin in Angettes. If necessary gastric lavage, forced alkaline diuresis and supportive therapy may be employed. Restoration of acid/base balance may be required.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Aspirin has antiplatelet, analgesic, antipyretic and anti-inflammatory properties.

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 hours before or within 30 minutes after immediate release aspirin (81mg), a decreased effect of aspirin 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

After a single oral dose of a salicylate, the plasma concentration becomes appreciable within 30 minutes, reaches a peak in about 2 hours and then slowly declines.

The highest concentrations occur in plasma, kidney, liver, heart and lung.

From 50-80% of salicylic acid in plasma is bound to plasma proteins, mainly albumin.

Salicylate is metabolised chiefly in the smooth endoplasmic reticulum of liver cells.

5.3 Preclinical Safety Data

There are no preclinical safety data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose, maize starch, sodium saccharin.

6.2 Incompatibilities

None.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 30°C.

6.5 Nature And Contents Of Container

28 tablets as 2 blister strips of PVC/PVDC with 20 micron lacquered aluminium/PVC film (20micron/15micron), each containing 2 x 7 tablets.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Bristol-Myers Squibb Holdings Ltd

Uxbridge Business Park

Sanderson Road

Uxbridge, Middlesex UB8 1DH

8. Marketing Authorisation Number(S)

0125/5020R

9. Date Of First Authorisation/Renewal Of The Authorisation

6 June 1990

10. Date Of Revision Of The Text

19 December 2008