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Servier Laboratories Ireland Ltd
Block 2, West Pier Business Campus, Old Dunleary Road, Dun Laoghaire, Co. Dublin,
Telephone: +353 1 663 8110
Fax: +353 1 663 8120
Summary of Product Characteristics last updated on medicines.ie: 25/11/2011
SPC Natrilix SR

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 25/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   24-Nov-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 7 (marketing authorization holder) change from:

Les Laboratoires Servier

22, rue Garnier

92200 Neuilly-sur-Seine

France

to

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex-France
Updated on 02/09/2011 and displayed until 25/11/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   29-Aug-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
In section 4.8 (undesirable effects) the following has been added:$0$0 Not known: $0$0$0Syncope$0$0Torsade de pointes (potentially fatal) (see sections 4.4 and 4.5)$0$0Possibility of onset of hepatic encephalopathy in case of hepatic insufficiency (see sections 4.3 and 4.4)$0$0$0Hepatitis$0$0$0$0$0$0Investigations$0$0Not known: $0$0- Electrocardiogram QT prolonged (see sections 4.4 and 4.5)$0$0- Blood glucose increased and blood uric acid increased during treatment: appropriateness of these diuretics must be very carefully weighed in patients with gout or diabetes$0$0- Elevated liver enzyme levels.$0$0 $0$0Metabolism and nutrition disorder$0$0During clinical trials, hypokalaemia (plasma potassium <3.4 mmol/l) was seen in 10 % of patients and < 3.2 mmol/l in 4 % of patients after 4 to 6 weeks treatment. After 12 weeks treatment, the mean fall in plasma potassium was 0.23 mmol/l.$0$0Very rare : Hypercalcaemia$0$0Not known: $0$0-   Potassium depletion with hypokalaemia, particularly serious in certain high risk populations (see section 4.4).$0$0-   Hyponatraemia with hypovolaemia responsible for dehydration and orthostatic hypotension. Concomitant loss of chloride ions may lead to secondary compensatory metabolic alkalosis: the incidence and degree of this effect are slight.$0$0 $0$0Deleted:$0$0·         Elevated liver enzyme levels$0$0·         Laboratory parameters :$0$0During clinical trials, hypokalaemia (plasma potassium <3.4 mmol/l) was seen in 10 % of patients and < 3.2 mmol/l in 4 % of patients after 4 to 6 weeks treatment. After 12 weeks treatment, the mean fall in plasma potassium was 0.23 mmol/l.$0$0·         Not known: Hyponatraemia with hypovolaemia responsible for dehydration and orthostatic hypotension. Concomitant loss of chloride ions may lead to secondary compensatory metabolic alkalosis: the incidence and degree of this effect are slight.$0$0·         Increase in plasma uric acid and blood glucose during treatment: appropriateness of these diuretics must be very carefully weighed in patients with gout or diabetes.$0
Updated on 13/08/2009 and displayed until 02/09/2011
Reasons for adding or updating:
  • Change to section 6.4 - Special precautions for storage
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Jun-2008
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 4.2: Information on administration to patients with renal failure, hepatic impairment, elderly patients, children and adolescents has been added.

Section 4.3: "Hypersensitivity to sulfonamides" is replaced by "Hypersensitivity to indapamide, to other sulfonamides or to any of the excipients"

Section 4.4: Information on photosensitivity reactions and excipients has been added.

Section 4.8: The frequency of undesirable effects is now explained.Some undesirable effects have been added.

Section 5.1: The pharmacotherapeutic group has been changed to: "Sulfonamides, plain"

Section 6.4: Store below 30º C has been added.


  
Updated on 16/04/2007 and displayed until 13/08/2009
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   03/2003
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Addition of 60 pack size.
Updated on 04/06/2003 and displayed until 16/04/2007
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Indapamide