Amaryl 3mg Tablets * Pharmacy Only: Prescription
Company:
SANOFIStatus:
No Recent UpdateLegal 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
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
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
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
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
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
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 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
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
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
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)