Disprin Direct 300mg Orodispersible Tablets

*
General Sale: Non-prescription
  • Company:

    Reckitt Benckiser Ireland Limited
  • Status:

    No Recent Update
  • Legal Category:

    Supply through general sale
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 02 October 2020

File name

Disprin Direct PIL.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Free text change information supplied by the pharmaceutical company

Addition of interaction with Metamizole

Updated on 04 August 2020

File name

Disprin Direct SmPC.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Supply through general sale

Updated on 05 December 2019

File name

Disprin Direct 300mg Orodispersible Tablets SmPC.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Addition of interaction with carbonic anhydrase inhibitors

Updated on 05 December 2019

File name

Disprin Direct 300mg Orodispersible Tablet PIL.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Free text change information supplied by the pharmaceutical company

Addition of interaction with carbonic anhydrse inhibitors

Updated on 19 February 2019

File name

Disprin Direct Orodisperisble Tablet SmPC (Feb19).pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category:Supply through general sale

Updated on 26 July 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 26 July 2017

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

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

Updated on 25 July 2017

File name

PIL_9014_948.pdf

Reasons for updating

  • New PIL for new product

Updated on 25 July 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose

Updated on 19 March 2015

Reasons for updating

  • Change to drug interactions

Updated on 30 January 2015

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.3 - Addition of contraindication of patients under 16 with Reye's Syndrome
Section 4.5 - Addition of statment advising not to take Disprin Direct with othter Aspirin containing products

Section 10 - update to date revision of the text

Updated on 19 April 2012

Reasons for updating

  • Change to improve clarity and readability

Updated on 29 November 2011

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company



Section 10 - change in the revision date

Updated on 17 June 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • PIL re-instated

Updated on 04 December 2008

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

All sections updated due to license renewal

Updated on 10 May 2007

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 7.  Change of address of Marketing Authorisation Holder to: 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.

Updated on 29 August 2006

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 3: Pharmaceutical Form - Discription to be changed to 'A white circular tablet with odour and taste of Lemon.  On one surface indented with 'sword motif', the other plain'
 
Section 9: Date of First Authorisation / Renewal of Authorisation - should be 26th July, 1983 / 26th July, 2003
 
Section 10: Date of (partial) Revision of the Text - should be March 2006

Updated on 19 May 2005

Reasons for updating

  • Improved electronic presentation

Legal category:Supply through general sale

Updated on 23 September 2004

Reasons for updating

  • New PIL for new product

Updated on 10 August 2004

Reasons for updating

  • Improved electronic presentation

Legal category:Supply through general sale

Updated on 16 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through general sale