Disprin Extra Strength

  • Name:

    Disprin Extra Strength

  • Company:
    info
  • Active Ingredients:

    Acetylsalicylic Acid

  • Legal Category:

    Supply through general sale

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/07/17

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 26/7/2017
print

Print ViewKeyword Search SmPC

Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Bonjela Oromucosal Gel Active Ingredients Cetalkonium Chloride, Choline Salicylate
Medicine Name Bonjela Teething Gel Oromucosal Gel Active Ingredients Cetalkonium Chloride, Choline Salicylate
Medicine Name Dettol Antiseptic Disinfectant 4.8 % w/v Concentrate for Cutaneous Solution Active Ingredients Chloroxylenol
Medicine Name Disprin Active Ingredients Acetylsalicylic acid (Aspirin)
Medicine Name Disprin Direct 300mg Orodispersible Tablets Active Ingredients Aspirin
Medicine Name Disprin Extra Strength Active Ingredients Acetylsalicylic Acid
Medicine Name E45 Cream Active Ingredients Anhydrous Lanolin, Light Liquid Paraffin, White Soft Paraffin
Medicine Name Fybogel Citrus Active Ingredients Ispaghula Husk
Medicine Name Fybogel Mebeverine Active Ingredients Ispaghula Husk, Mebeverine Hydochloride
Medicine Name Fybogel Orange 3.5g Granules Active Ingredients Ispaghula Husk
Medicine Name Gaviscon Advance Oral Suspension Active Ingredients Potassium hydrogen carbonate, Sodium Alginate
Medicine Name Gaviscon Advance Tablets Active Ingredients Potassium Bicarbonate, Sodium Alginate
Medicine Name Gaviscon Extra Chewable Tablets Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Extra Oral Suspension Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Extra Oral Suspension 300ml Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Infant Active Ingredients Magnesium Alginate, Sodium Alginate
Medicine Name Gaviscon Liquid - Peppermint Flavour Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Liquid Aniseed Flavour Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Oral Suspension Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Peppermint Chewable Tablets Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Hydrogen Carbonate
Medicine Name Gaviscon Suspension Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Hc45 Hydrocortisone Acetate 1% w/w Cream Active Ingredients Hydrocortisone Acetate
Medicine Name Lemsip Chesty Cough 50 mg/5 ml Oral Solution Active Ingredients Guaifenesin
Medicine Name Lemsip Cold & Flu Capsules with Caffeine Active Ingredients Caffeine, Paracetamol
Medicine Name Lemsip Cold & Flu Headcold 500mg Powder for Oral Solution Active Ingredients Paracetamol
1 - 0 of 71 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 26 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 26 July 2017 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 25 July 2017 PIL

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 - use in children and adolescents
  • 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 20 March 2015 PIL

Reasons for updating

  • Change to drug interactions

Updated on 4 February 2015 SmPC

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 4.9 - Overdose
  • 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

In section 4.3 - added contraindication of patients under the age of 16 years owing to an associateion of Reye's Syndrome.

In section 4.5 - Added " Not to be taken with any other aspirin containing medicines

In Section 4.9 - Added treatment and managment of Salicylate poisioning and other overdose precautions

Updated on 10 April 2012 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 29 November 2011 SmPC

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 1 May 2009 PIL

Reasons for updating

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

Updated on 19 January 2009 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 6.1 - List of excipients
  • 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

Changes to all sections requested during license renewal

Updated on 10 May 2007 SmPC

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 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.1 - List of excipients
  • 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 4.5: Interaction with other medicaments and other forms of interaction - The following statements need to be added :
Oral hypoglycaemic agents: Inhibition of metabolism of sulfonyl urea drugs, prolonged half-life and increased risk of hypoglycaemia.
 
Methotrexate: Decreased elimination of methotrexate
 
Probenecid: Reduction in metabolism and elimination of NSAID and metabolites
 
Sodium valproate: Asprin may enhance its effects
 
Section 6.1: List of Excipients - Sodium lauryl sulphate needs to be changed to Sodium lauril sulfate
 
Section 10: Date of Revision of the Text - Should be October 2005 

Updated on 19 May 2005 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through general sale

Updated on 23 September 2004 PIL

Reasons for updating

  • New PIL for new product

Updated on 10 August 2004 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through general sale

Updated on 16 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale