Amaryl 3mg Tablets *
Pharmacy Only: Prescription

  • Company:

    SANOFI
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

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

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 16 September 2021

File name

PIL Amaryl 1mg 3mg IE947 (1)_1631781490.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 04 June 2019

File name

PIL Amaryl 1mg 3mg IE947 _1559643326.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 08 March 2019

File name

PIL Amaryl 1mg 3mg _1552044373.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 08 March 2019

File name

SPC Amaryl 3mg tablets _1552044631.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Amaryl contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp total lactase deficiency or glucose‑galactose malabsorption should not take this medicine.

Updated on 22 November 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 22 November 2017

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.3 added :-

Diabetes mellitus type 1

4.3 removed :-

insulin dependent diabetes

4.6 added :-

Fertility,

Fertility
No data on fertility is available.

4.7 added :-
Rare: dysgeusia.
Rare: alopecia.
Rare: weight gain.

Updated on 21 November 2017

File name

PIL_14671_243.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 November 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 04 August 2015

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 5.1: updated to change the denomination of A10BB group from Sulfonamides and urea deriviatives to Sulfonylureas.

Updated on 31 July 2015

Reasons for updating

  • Change to name of manufacturer

Updated on 29 October 2013

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Type II variation n° C.I.4 to update of Summary of Product Characteristics section 4.5 to include information on a drug interaction between glimepiride and colesevelam.

Updated on 23 October 2013

Reasons for updating

  • Change to side-effects

Updated on 24 July 2013

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Type IB variation n° B.II.a.1b to include changes in scoring/break lines intended to divide into equal doses with consequential changes to the SmPC and Patient leaflet

Updated on 16 May 2013

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Type II Procedure variation n° C.I.4 Update of Summary of Product Characteristics to include the adverse reaction: ‘Severe thrombocytopenia with platelet count less than 10,000/µl and thrombocytopenic purpura’. Minor editorial updates to the SPC are also included.

Updated on 10 May 2013

Reasons for updating

  • Change to side-effects

Updated on 17 September 2012

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.5 updated to include pack size of 300 tablets

Updated on 13 September 2012

Reasons for updating

  • Introduction of new pack/pack size

Updated on 20 January 2011

Reasons for updating

  • Change of manufacturer

Updated on 22 November 2010

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 10 : Date of revision of the text

Updated on 10 November 2010

Reasons for updating

  • 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 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.5: Addition of a drug interaction with disopyramide

Section 4.4, 4.5 & 5.1: Typographical errors amended

Updated on 08 November 2010

Reasons for updating

  • Change to drug interactions

Updated on 05 May 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2 - Addition of excipient information.
Section 4.8 - Information on frequency

Updated on 28 April 2010

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 August 2008

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

update sections 4.2, 5.1 & 5.2

Updated on 19 August 2008

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update Section 10 Date of Revision

Updated on 01 July 2008

Reasons for updating

  • 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:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update Sections: 4.5 - Interactions, 10 Date of revision.

Updated on 26 March 2008

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)