Disprin Direct 300mg Orodispersible Tablets

Addition of interaction with Metamizole

Addition of interaction with carbonic anhydrase inhibitors

Addition of interaction with carbonic anhydrse inhibitors

Section 2:

Text amended from “Aspirin 300mg tablet” to read “Each tablet contains 300mg of acetylsalicylic acid.  For a full list of excipients see section 6.1”

Section 4.2 Posology and Method of Administration:

Amendment to posology to add “The lowest effective dose should be used for the shortest duration necessary to relieve symptoms”.

Addition of paragraphs relating to Hepatic and Renal Impairment

Elderly addition of “There is no indication that dosage need be modified in the elderly”

Amendment to Method of Administration to “Disperses on the tongue without water”

Section 4.3 Contraindications:

Addition of the following contraindications-

Hypersensitivity to acetylsalicylic acid or to any of the excipients

Hypersensitivity to other NSAIDs

Active or history of recurrent peptic ulcer/haemorrhage

Haemophilia

Severe hepatic impairment

Severe renal impairment

Severe heart failure

Last trimester of pregnancy

Breast-feeding

Section 4.4 Special Warnings and precautions for use:

Addition of the following warnings-

Product should be taken only when necessary.  Prolonged use except medical advice can be harmful.  Doctor should be consulted if there is no improvement in 24 hours.  If patient is on any medication consult the doctor or pharmacist before using.

Amendment of text or addition of information in relation to: Gastrointestinal effects, Cardiovascular and cerebrovascular effects, Respiratory effects, Renal & Hepatic effects, other NSAIDS, Female fertility, Gout and Surgical procedures

Section 4.5 Interaction with other medicines and other forms of interaction:

Amendment of text or addition of information in relation to-

Other NSAIDs or other salicylates, Ibuprofen, Corticosteroids, Anti-platelet agents, SSRIs, Calcium channel blockers, Varicella vaccine, Antihypertensives, Oral hypoglycaemic agents, Anti-coagulants, cyclosporine, Tacrolimus, Zidovudine, Metoclopramine & domperidone, Valproate, Quinolone antibiotics, Uricosurics, Mifepristone, Methotrexate and Lithium.

Section 4.6 Fertility, pregnancy and lactation:

Text amended to read as follows-

Pregnancy - The product is contraindicated in the third trimester of pregnancy (see section 4.3) and should be avoided during the first and second trimesters.  Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, acetylsalicylic acid should not be given unless clearly necessary. If acetylsalicylic acid is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

In the last three months of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

·         cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);

·         renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;  

In the last three months of pregnancy, all prostaglandin synthesis inhibitors may expose the mother and the neonate to:

·         possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses;

·         inhibition of uterine contractions resulting in delayed onset and increased duration of labour.

Consequently, acetylsalicylic acid at doses of 100 mg/day and higher is contraindicated during the third trimester of pregnancy.

Breast-feeding - Use of the product is contraindicated in breast-feeding. Acetylsalicylic acid given in breast-feeding mothers may pose a risk of Reye’s syndrome in nursing infants (see section 4.3).

Fertility - There is some evidence that drugs which inhibit cyclo-oxygenase / prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.

Section 4.7 Effect on ability to drive and use machines

Text amend from “None stated” to “Not known”

Section 4.8 Undesirable effects

Information amended to MedDRA table format

Addition of Adverse Events in relation to Blood and Lymphatic System, Immune System, Metabolism and Nutrition, Nervous System, Cardiac, Vascular, Respiratory, Thoracic and Mediastinal, Gastrointestinal, Hepatobiliary, Skin and subcutaneous Tissue, Renal and Urinary disorders. 

Addition of local information of Reporting of Adverse Reactions

Section 4.9 Overdose

Additional information provided in relation to symptoms and management