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Natrilix SR

  • Name:

    Natrilix SR

  • Company:
    info
  • Active Ingredients:

    Indapamide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/11/20

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Summary of Product Characteristics last updated on medicines.ie: 18/6/2019

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Servier Laboratories Ireland Ltd

Servier Laboratories Ireland Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name ACERYCAL Active Ingredients Amlodipine besilate, Perindopril arginine
Medicine Name Coverdine Active Ingredients Amlodipine, Indapamide, Perindopril
Medicine Name Coversyl Arginine 10mg Active Ingredients Perindopril arginine
Medicine Name Coversyl Arginine 10mg orodispersible tablets Active Ingredients Perindopril arginine
Medicine Name Coversyl Arginine 5mg Active Ingredients Perindopril arginine
Medicine Name Coversyl Arginine 5mg orodispersible tablets Active Ingredients Perindopril arginine
Medicine Name Coversyl Arginine Plus 10mg/2.5mg film-coated tablets Active Ingredients Indapamide, Perindopril arginine
Medicine Name Coversyl Arginine Plus 2.5mg/0.625mg film-coated tablets Active Ingredients Indapamide, Perindopril arginine
Medicine Name Coversyl Arginine Plus 5 mg/1.25 mg film-coated tablets Active Ingredients Indapamide, Perindopril arginine
Medicine Name Diamicron MR 30 mg Active Ingredients Gliclazide
Medicine Name Diamicron MR 60mg Active Ingredients Gliclazide
Medicine Name LIPERCOSYL Active Ingredients Atorvastatin calcium trihydrate, Perindopril arginine
Medicine Name LIPOCOMB Active Ingredients ezetimibe, Rosuvastatin Calcium
Medicine Name LONSURF Active Ingredients Tipiracil hydrochloride, Trifluridine
Medicine Name Natrilix SR Active Ingredients Indapamide
Medicine Name Oncaspar 750 U/ml powder for solution for injection/infusion Active Ingredients pegaspargase
Medicine Name ONIVYDE Active Ingredients Irinotecan hydrochloride trihydrate
Medicine Name Pixuvri 29 mg Active Ingredients Pixantrone dimaleate
Medicine Name Procoralan film-coated tablets Active Ingredients Ivabradine hydrochloride
Medicine Name Valdoxan 25mg Film-coated Tablets Active Ingredients Agomelatine
Medicine Name Vastarel 20mg Active Ingredients Trimetazidine dihydrochloride
1 - 0 of 21 items.Total: Infinity pages

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 30 November 2020 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 18 June 2019 SPC

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 PIL

Reasons for updating

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

Updated on 2 July 2018 SPC

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 2 July 2018 PIL

Reasons for updating

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

Updated on 27 January 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 January 2016 PIL

Reasons for updating

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

Updated on 25 January 2016 SPC

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 SPC

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 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 25 November 2011 SPC

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 PIL

Reasons for updating

  • Change to side-effects

Updated on 2 September 2011 SPC

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 3 September 2009 PIL

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 SPC

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 SPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 4 June 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

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