Natrilix SR *
Pharmacy Only: Prescription

  • Company:

    Servier Laboratories Ireland Ltd
  • 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

Updated on 02 December 2021

File name

SmPC Natrilix SR 1.5mg_1638445466.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 02 December 2021

File name

Natrilix SR 1.5 PIL_1638445426.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 29 September 2021

File name

Natrilix PIL_1632923693.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 26 July 2021

File name

Natrilix 1.5 mg PIL_1627310980.pdf

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 - interactions with other medicines, food or drink
  • 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 26 July 2021

File name

Natrilix SmPC 072021_1627310894.pdf

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 30 November 2020

File name

Natrilix SR 1.5 mg PIL_1606735608.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 18 June 2019

File name

Natrilix SR_1560868659.pdf

Reasons for updating

  • File format updated to PDF

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

Updated on 20 November 2018

File name

Natrilix SR 1.5mg PIL_1542724528.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 02 July 2018

File name

Natrilix SR.docx

Reasons for updating

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

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

Updated on 02 July 2018

File name

Natrilix SR PIL.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 27 January 2016

File name

PIL_8834_300.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 January 2016

Reasons for updating

  • Change to drug interactions
  • Change to information about pregnancy or lactation

Updated on 25 January 2016

Reasons for updating

  • New SPC for new product

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

Updated on 25 January 2016

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation

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

Free text change information supplied by the pharmaceutical company

$0Section 4.5 “Interaction with other medicinal products and other forms of interaction”: addition of interaction with allopurinol (combination requiring precaution for use).$0$0Section 4.6 “Fertility, Pregnancy and Lactation”: compliance with the latest version of the CMDh QRD template (revised April 2013).$0$0 $0

Updated on 15 February 2012

Reasons for updating

  • Change to MA holder contact details

Updated on 25 November 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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 15 September 2011

Reasons for updating

  • Change to side-effects

Updated on 02 September 2011

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

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 03 September 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Change of special precautions for disposal

Updated on 13 August 2009

Reasons for 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

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 April 2007

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

Addition of 60 pack size.

Updated on 20 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 04 June 2003

Reasons for updating

  • New SPC for medicines.ie

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