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A.Menarini Pharmaceuticals Ltd
2nd Floor, Castlecourt, Monkstown, Monkstown, Co. Dublin, Ireland
Telephone: +353 1 284 6744
Fax: +353 1 284 6769
E-mail: ireland@menarini.ie
Medical Information Direct Line: 1800 283 045
Summary of Product Characteristics last updated on medicines.ie: 17/11/2009
SPC Omesar 10mg, 20mg and 40mg Film-Coated Tablets

When a pharmaceutical company changes an SPC or PIL, 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 17/11/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   29-Oct-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


4.3 Contraindications
Lactation (see section 4.6) – removed

4.6 Pregnancy and lactation
The first sentence is put into a box:
The use of angiotensin II antagonists is not recommended during the first trimester of pregnancy (see section 4.4). The use of angiotensin II antagonists is contra-indicated during the 2nd and 3rd trimester of pregnancy (see sections 4.3 and 4.4).

Information on lactation expanded. The use of Omesar is not recommended during breast-feeding.

Updated on 07/08/2008 and displayed until 17/11/2009
Reasons for adding or 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 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Changes to the SmPC following renewal of the Marketing Authorisation
Updated on 18/09/2007 and displayed until 07/08/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.2 Update to information on hepatic impairment
Section 4.4 Update to information on hepatic impairment
Section 5.2 Update to information on hepatic impairment
 
Updated on 23/11/2006 and displayed until 18/09/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.2 Elderly posology updated
Section 4.4 Lactose warning added
Section 4.8 Additional information on special populations
Section 5.2 Pharmacokinetics in special populations - elderly
 
Updated on 04/05/2006 and displayed until 23/11/2006
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Updated on 17/11/2005 and displayed until 04/05/2006
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Updated on 09/11/2004 and displayed until 17/11/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Updated on 04/08/2004 and displayed until 09/11/2004
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
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