PRODUCT SUMMARY

1. NAME OF THE MEDICINAL PRODUCT

Dispersible Aspirin Tablets BP 300mg Mandaprin Dispersible Aspirin 300mg Tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 300mg Aspirin

3. PHARMACEUTICAL FORM

Compressed tablet.

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

Pharmacy Only packs: as an analgesic, anti-pyretic and anti-inflammatory including use for rheumatoid arthritis, osteoarthritis and acute and chronic relief of influenza and feverish colds. For mild to moderate pain including headache. toothache and dysmenorrhoea.

GSL packs: symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness.

For mild to moderate pain including headache, migraine, neuralgia. toothache, symptomatic relief of influenza,, feverishness and feverish colds.

4.2 Posology and method of administration

This preparation is intended for oral administration.

Adults and children over 16 years of age: 1 to 3 tablets with or after food every four hours up to a maximum of 12 tablets a day.

Children: Do not give to children aged under 16 years, unless specifically indicated (eg for Kawasaki’s disease).

Contra-indications

Aspirin is contraindicated in patients with active peptic ulceration or a history of peptic ulceration.

Aspirin is contraindicated in gout, breast feeding, haemophilia, and concurrent anticoagulant therapy.

4.4 Special warnings and special precautions for use

Administer with caution in the presence of allergic disease, renal or hepatic impairment, dehydration.

There is a possible association between aspirin and Reye’s syndrome when given to children with a fever. 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 (eg for Kawasaki’s disease).

4.5. Interaction with other medicinal products and other forms of interaction

Aspirin antagonises the diuretic effect of spironolactone, potentiates the effect of heparin, increases the risk of bleeding with warfarin and acenocoumarol, increases the toxicity of methotrexate by delaying excretion, inhibits the effect of probenecid and sulfinpyrazone and increases the risk of toxicity of acetazolomide by reducing excretion. Antacids and corticosteroids reduce the effect of aspirin. Metoclopramide potentiates the effect of aspirin.

Concurrent administration of aspirin with other drugs that are known to increase bleeding time, for example anticoagulants and antiplatelet drugs such as clopidrogel and ticlopidine, or that are known to cause gastrointestinal irritation, for example NSAIDs, may increase the risk of haemorrhage and other gastrointestinal side effects.

4.6 Pregnancy and lactation

Do not administer at term or during lactation.

4.7 Effects on ability to drive and use machines

None known.

Undesirable effects

High incidence of gastro-intestinal irritation with slight asymptomatic blood loss, increased bleeding time, bronchospasm and skin reaction in hypersensitive patients. Association with Reye's Syndrome in children. Can lead to hearing disturbances (such as tinnitus), vertigo or mental confusion. Aspirin may precipitate bronchospasm and induce asthma attacks or other hypersensitivity reactions in susceptible individuals.

Other undesirable effects include:

Gastrointestinal ulceration, haematemesis, melaena, iron-deficiency anaemia, gastrointestinal bleeding

4.9 Overdose

Employ gastric lavage, forced alkaline diuresis and supportive therapy. Restoration of acid-base balance may be necessary.

5 PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Absorption of non-ionised aspirin occurs in the stomach. Acetylsalicylates and salicylates are also readily absorbed from the intestine. Hydrolysis to salicylic acid occurs rapidly in the intestine and in the circulation. Salicylates are extensively bound to plasma proteins; aspirin to a lesser degree. Aspirin is an inhibitor of the enzyme cyclo-oxygenase which results in the inhibition of the biosynthesis of prostaglandins.

5.2    Pharmacokinetic properties

Aspirin and salicylates are rapidly distributed to all body tissues; they appear in milk and cross the placenta. The rate of excretion of the aspirin varies with the pH of the urine, increasing as the pH rises and being greatest at pH 7.5 and above. Aspirin is also excreted as salicylic acid and as the glucuronide conjugate and as salicyluric and gentisic acids.

5.3 Preclinical safety data

Preclinical information has not been included because the safety profile of Aspirin has been established after many years of clinical use. Please refer to section 4.

6.1 List of excipients

Each tablet contains Calcium carbonate, maize starch, lactose, citric acid anhydrous, talc, sodium saccharin and sodium lauryl sulphate.

6.2 Incompatibilities

None known.

6.3 Shelf life

The shelf life of the product is 36 months when stored in plastic containers or in paper / aluminium /PVC blister packs.

6.4 Special precautions for storage

For plastic bottles: store in original container, keep container tightly closed. For blister packaging: store in original package inside outer carton.

Store in a dry place at a temperature not exceeding 25°C.

6.5 Nature and contents of container

Polypropylene vial with a polythene wadless lid:

25, 50, 100, 250, 500 and 1000 tablets.

HDPE tub, lined with a plastic bag, with a plastic lid:

1000 tablets.

Child Resistant Blister strips of 0.25mm PVC/35 gsm Glassine (Pergamin) paper/ 0.009mm aluminium enclosed in a cardboard carton:

16, 24, 32, 48 and 96 tablets.

HDPE bucket, lined with a plastic bag, a sachet of silica gel, and a plastic lid: 10000, 15000, 20000, 25000, 30000, and 35000 tablets.

Instructions for use/handling

Not applicable.

7. MARKETING AUTHORISATION HOLDER

M & A Pharmachem Limited

Allenby Laboratories

Wigan Road

Westhoughton

Bolton

BL5 2AL

8. MARKETING AUTHORISATION NUMBER

PL 04077/0175

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Granted 27 August 1992.

Renewed 20 April1999

10 DATE OF REVISION OF THE TEXT

21/10/2011