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Lercaril 10 mg/10 mg Film-coated Tablets

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Pharmacy Only: Prescription

Updated on 24 April 2024

File name

IE_Lercaril 10-10_PIL_April2021.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Upload of PIL

Updated on 19 April 2024

File name

IE_Lercaril 10-10_SmPC_July2021.pdf

Reasons for updating

  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.

Updated on 22 December 2019

File name

lercaril-10mg-10mg-spc-July 2019.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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose

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

Updated on 04 March 2015

File name

PIL_13971_44.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 March 2015

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 02 March 2015

Reasons for updating

  • New SPC for new product

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

Updated on 02 March 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Multiple changes made to the SPC as a result of the licence renewal and the RAS-EMEA-H-A-31-1370-PRAC recommendations:
In Section 2.2
Excipients "with known effects" was added
In Section 3
"Circular" replaces "round" and size (8.5mm) added
In Section 4.2

Paediatric population:

Deleted statement about clinical experience and added "There is no relevant use of Lercaril in the paediatric population in the indication of hypertension."
In Section 4.3
Added:

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

   ·         History of angioedema associated with ACE-inhibitor therapy

·         Hereditary or idiopathic angioedema

·         Association with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1)

Deleted:

            A history of angioedema caused by previous therapy with an ACE-inhibitor

            Hereditary or idiopathic angioedema
In Section 4.4
Added multiple new warnings and data to most sections
In Section 4.6
For enalapril
Added "Maternal oligohydramnios, presumably representing decreased fetal renal function, has occurred and may result in limb contractures, craniofacial deformations and hypoplastic lung development. "
For enalapril and lercanidipine in association

Added "There are no or limited amount of data from the use of enalapril maleate/lercanidipine HCl in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3)."

Added "Lercaril should not be used in the second and third trimester of pregnancy. It is not recommended in the first trimester of pregnancy and in women of childbearing potential not using contraception."

In Section 4.7
 Added "Lercaril has minor influence on the ability to drive and use machines"
In Section 4.8
Added

Summary of the safety profile

Deleted current ADR table and added new table
In Section 4.9
Added post marketing experience
In Section 5.1
Added results from ONTARGET and VA NEPHRON-D clinical trials

Also various typos and grammar corrected throughout SPC

Deleted:

Deleted:

Updated on 21 October 2014

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Revision date corrected to be in line with current approved (HPRA) SPC
Spelling errors corrected

Updated on 27 June 2012

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic 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

In Section 4.6. Added a detailed paragraph on the pharmacokinetics of enalapril in breast milk
In Section 4.8  The table of undesirable effects has been amended to reflect the effects reported in controlled clinical trials in the (higher)Lercaril 20mg / 10mg dose. This has resulted in the following changes to the table: Headache frequency has moved from "uncommon" to "common", tachycardia has been removed, circulatory collapse has been removed, throat has been deleted and "pharyngeal pain" added, hypersensitivity has been removed and angioedema added, "(including dizziness postural)" has been added to dizziness.
In Section 5.2 A Lactation paragraph explaining the plasma levels in milk of enalapril and enalaprilat has been added
In Section 10 Date of Revision of text has been amended

Updated on 26 June 2012

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 22 June 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation

Updated on 08 January 2009

Reasons for updating

  • New SPC for new product

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

Updated on 08 January 2009

Reasons for updating

  • New PIL for new product